XR-Series Automated Hematology Analyzer

XR-1000/XR-2000
Instructions for Use

KOBE, JAPAN

Code No. BQ658842 en-eu

PRINTED IN JAPAN
Date of issue or revision: 10/2022
Document Version: 5.0
Software Version: 2 onwards

© SYSMEX CORPORATION
Revision history

Revision history

12/2021
Initial issue
Document Version: 1.0
Software Version: 2

02/2022
Document Version: 2.0
Software Version: 2

08/2022
Document Version: 3.0
Software Version: 2

09/2022
Document Version: 4.0
Software Version: 2

10/2022
Document Version: 5.0
Software Version: 2
Changes are listed below:

Revised section Page

4.3 Options 61

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4/604
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Table of contents

Table of contents

Revision history 3

Chapter 1 Introduction 9
1.1 Intended purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.2 Overview of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.3 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.4 About the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.5 Symbols used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.6 Symbols related to the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
1.7 Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.8 Prohibited acts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.9 User permissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Chapter 2 Safety Information 23

2.1 Specified conditions of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.4 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.5 Avoiding infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.6 Handling of reagents, quality control materials, and calibrators . . . . . . . . . . . . 26
2.7 Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.8 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.9 Disposal of materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.10 Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2.11 Computer viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2.12 Use of other software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.13 Notice to the user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.14 Markings on the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Chapter 3 Part Names and Functions 37

3.1 Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3.2 Pneumatic unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
3.3 Sampler section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.4 External indicator light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.5 IPU (Information processing unit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.6 PC for backup (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.7 Operation of the IPU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Chapter 4 Consumables/Accessories/Options 53
4.1 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.3 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Chapter 5 Reagents 63
5.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
5.2 Reagent list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

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Chapter 6 Installation 65
6.1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
6.2 Basic settings of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.3 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Chapter 7 Instrument Specifications 69

7.1 Product specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
7.2 Performance characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
7.3 System limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
7.4 ID Barcode specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
7.5 Functional descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Chapter 8 Basic Operation 113

8.1 Overall flow of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
8.2 Start up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
8.3 Log off from the IPU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
8.4 Operation lock function (Screen Lock) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
8.5 Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
8.6 Restart the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
8.7 On-line manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Chapter 9 Preparing for Analysis

(Registering Information) 135
9.1 Work List functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
9.2 Patient List functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Chapter 10 Performing Quality Control 165

10.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
10.2 Configure quality control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
10.3 Registering and modifying a QC file (lot information input) . . . . . . . . . . . . . . . 168
10.4 Perform QC analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
10.5 Check quality control results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
10.6 Troubleshoot quality control errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
10.7 Manage QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Chapter 11 Analyzing Samples 193

11.1 Types of analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
11.2 Prepare the sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
11.3 Terms used in analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
11.4 Supported sample tubes and racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
11.5 Sample tube and rack barcode labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
11.6 Manual analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
11.7 Body fluid analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
11.8 HPC analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
11.9 Sampler analysis (XR-1000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
11.10 Sampler analysis (XR-2000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

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Chapter 12 Checking Analysis Data

(Sample Explorer) 229
12.1 Sample Explorer functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
12.2 Validate analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
12.3 Sort analysis data list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
12.4 Specify data display conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
12.5 Search for a sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
12.6 Modify sample information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
12.7 Print analysis data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
12.8 Save analysis data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
12.9 Restore saved analysis data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
12.10 Delete analysis data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
12.11 Change layout of analysis data list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259

Chapter 13 Checking Detailed Analysis Information

(Data Browser) 263
13.1 Data Browser screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
13.2 Check all information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
13.3 Check data by time ([Whole Blood] / [Low WBC] / [Pre-Dilution] mode) . . . . 274
13.4 Check data by time ([HPC] mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
13.5 Check data by Q-Flag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
13.6 IP Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
13.7 Change layout of screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299

Chapter 14 Performing Calibration 301

14.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
14.2 About Calibrator Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
14.3 Manage Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
14.4 Perform a precision check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
14.5 Manage the Precision Check History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326

Chapter 15 Instrument Setup 331

15.1 Open the settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
15.2 Analyzer settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
15.3 IPU settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353
15.4 Graphic printer print settings (GP customize). . . . . . . . . . . . . . . . . . . . . . . . . 385
15.5 RU-20 Reagent Unit Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394
15.6 Schedule settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404

Chapter 16 Rules Setup 413

16.1 Types of rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 413
16.2 Rule screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 417
16.3 Enable/Disable rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423
16.4 Sort rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 424
16.5 Print rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425
16.6 Save rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 426
16.7 Restore saved rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 427
16.8 Initialize rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 428

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Chapter 17 Checking the History 429

17.1 About the history screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429
17.2 About the RU history screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437

Chapter 18 Performing Maintenance of Instrument

and Replacing Supply Parts 443
18.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 443
18.2 Daily maintenance tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 447
18.3 Maintenance tasks performed as needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . 447
18.4 Replace reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475
18.5 Replace the fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 490
18.6 Maintenance inspection checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 497
18.7 Test proper operation of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 498
18.8 Check the status of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 505

Chapter 19 Troubleshooting 511

19.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511
19.2 Check the error log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 514
19.3 Error message list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515
19.4 Causes of errors and remedial actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
19.5 Switching the PC in case of IPU failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 559

Appendix 563
Check service data (service) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 563
Check items for research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576
hsA analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 580
Program version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583
Interface Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583
Default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 584

Index 599

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Chapter 1 Introduction

Chapter 1 Introduction

Thank you for purchasing the XR-Series Automated Hematology Analyzer.

Please read this manual carefully before operating this product.
Keep this manual in a safe place for future reference.

Note:
• Data generated by the XR-Series is not intended to replace professional judgment in the
determination of a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there
are any deviations from the instructions in this manual. If the instrument fails to function
properly as a result of either the user's operation not specified in the manual or the user's
utilization of a program not specified by Sysmex, the product warranty would not apply.

Contact Addresses

1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan

Authorized Representative/Importer to EU
Europe, Middle East and Africa

Bornbarch 1, 22848 Norderstedt, Germany

Phone: +49 40 5 27 26-0 / Fax: +49 40 5 27 26-100

Authorized Representatives
Americas

577 Aptakisic Road, Lincolnshire, IL 60069, U.S.A.

Phone: +1-224-543-9500 / Fax: +1-224-543-9505
Asia-Pacific

9 Tampines Grande #06-18 Singapore 528735

Phone: +65-6221-3629 / Fax: +65-6221-3687

Ordering of Supplies and Replacement Parts

If you need to order supplies or replacement parts, please contact your
authorized local Sysmex representative.

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Service and Maintenance

Please contact your authorized local Sysmex representative.

The system described in this manual is marked with the CE mark, which confirms
compliance with the applicable requirements of:
• Directive 98/79/EC on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/EU
• 2014/53/EU relating to the making available on the market of radio equipment

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Chapter 1 Introduction

1.1 Intended purpose

XR-Series Automated Hematology Analyzer is a multi-parameter automated hematology analyzer for classification
and quantification of following parameters in whole blood and body fluid as an aid to diagnosis of patient populations
found in clinical laboratories.
• Whole blood:
WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MicroR, MacroR, PDW, MPV, P-LCR, PCT,
NRBC%, NRBC#, NEUT%, NEUT#, LYMPH%, LYMPH#, MONO%, MONO#, EO%, EO#, BASO%, BASO#, IG%,
IG#, AS-LYMP%, AS-LYMP#, RE-LYMP%, RE-LYMP#, NEUT-RI, NEUT-GI, RET%, RET#, IRF, LFR, MFR, HFR,
RET-He, RBC-He, Delta-He, HYPO-He, HYPER-He, IPF, IPF#, HPC%, HPC#
• Body fluid (Cerebrospinal fluid, serous fluids (peritoneal, pleural), synovial fluids and CAPD (Continuous
ambulatory peritoneal dialysis) fluid):
WBC-BF, RBC-BF, TC-BF#, MN%, MN#, PMN%, PMN#
XR-Series Automated Hematology Analyzer is used by healthcare professionals and properly trained personnel.

1.2 Overview of the system

This instrument is a blood count analyzer for in vitro diagnostic use as an aid to diagnosis of patient populations
found in clinical laboratories. Hereinafter, in this manual, XR-1000/XR-2000 will be specified as "this instrument".
The analysis data appears on the screen of the IPU (Information Processing Unit)*.
* This manual refers to the Information Processing Unit as IPU.

Caution!
Results should always be evaluated in conjunction with clinical or other laboratory findings.

The XR-Series consists of the components and options below, which are used in a suitable combination. The
components and options may be sold as individual units.

Instrument:
• Analyzer (XR-10/XR-20)

Accessories (IVD):
• SA-10/SA-01/SA-20
• PU-17
• RU-20

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Analyzers are classified into 6 types depending on differences in the included channels.
• XR-10: XR-10[B1], XR-10[B2], XR-10[B3], XR-10[B4]
• XR-20: XR-20[A1], XR-20[A2]

Analyzer Type
Channels XR-20 XR-10
[A1] [A2] [B1] [B2] [B3] [B4]
WNR ✓
RBC / PLT ✓
HGB ✓
WDF ✓
WPC ✓ ✓ — — — —
RET ✓ ✓ ✓ — ✓ —
PLT-F ✓ — ✓ ✓ — —

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1.2.1 Configuration description

System expansion is possible by combining components and options.
The system name varies depending on the combination. This manual explains the system configuration below
(XR-1000/XR-2000).

XR-1000
System including 1 analyzer (XR-10/XR-20) and a sampler (SA-10/SA-01).
This will be one of the configurations below, depending on your sampler type.

Analyzer (XR-10/XR-20)

Sampler section (SA-10) Sampler section (SA-01)

* IPU and pneumatic unit are omitted in

External view of XR-1000 this figure.

XR-2000
System including 2 analyzers (XR-10/XR-20) and a sampler (SA-20).

Analyzer (XR-10/XR-20)

Sampler section (SA-20)

* IPU and pneumatic unit are omitted in

this figure.
External view of XR-2000

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1.3 Parameters
This instrument analyzes the following parameters.

[Whole Blood]/[Low WBC]/[Pre-Dilution] mode

XR-20 XR-10
Parameters
[A1] [A2] [B1] [B2] [B3] [B4]
WBC White blood cell (leukocyte) count —
WBC-N WBC counted in the WNR channel ✓
WBC-D WBC counted in the WDF channel ✓
RBC Red blood cell (erythrocyte) count ✓
HGB Hemoglobin concentration ✓
HCT Hematocrit ✓
MCV Mean corpuscular volume ✓
MCH Mean corpuscular hemoglobin ✓
MCHC Mean corpuscular hemoglobin
✓
concentration
PLT Platelet count —
PLT-I PLT counted in the RBC/PLT channel ✓ ✓ ✓ ✓ ✓ ✓
PLT-O PLT counted in the RET channel ✓ ✓ ✓ — ✓ —
PLT-F PLT counted in the PLT-F channel ✓ — ✓ ✓ — —
RDW-SD Red cell distribution width (standard
✓
deviation)
RDW-CV Red cell distribution width (coefficient of
✓
variation)
MicroR Micro RBC ratio ✓
MacroR Macro RBC ratio ✓
PDW Platelet distribution width ✓
MPV Mean platelet volume ✓
P-LCR Platelet-large cell ratio ✓
PCT Plateletcrit ✓
NRBC# Nucleated red blood cell count ✓
NRBC% Nucleated red blood cell percent ✓
NEUT# Neutrophil count ✓
LYMPH# Lymphocyte count ✓
MONO# Monocyte count ✓
EO# Eosinophil count ✓
BASO# Basophil count ✓
NEUT% Neutrophil percent ✓
LYMPH% Lymphocyte percent ✓
MONO% Monocyte percent ✓

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XR-20 XR-10
Parameters
[A1] [A2] [B1] [B2] [B3] [B4]
EO% Eosinophil percent ✓
BASO% Basophil percent ✓
IG# Immature granulocyte count ✓
IG% Immature granulocyte percent ✓
AS-LYMP#* Count of lymphocytes mainly synthesizing
✓
antibodies with high fluorescence intensity
AS-LYMP%* Percentage of lymphocytes mainly
synthesizing antibodies with high ✓
fluorescence intensity
RE-LYMP#* Count of lymphocytes reacting to infection
✓
with high fluorescence intensity
RE-LYMP%* Percentage of lymphocytes reacting to
✓
infection with high fluorescence intensity
NEUT-RI* Neutrophil reactivity intensity ✓
NEUT-GI* Neutrophil granularity intensity ✓
RET% Reticulocyte percent ✓ ✓ ✓ — ✓ —
RET# Reticulocyte count ✓ ✓ ✓ — ✓ —
IRF Immature reticulocyte fraction ✓ ✓ ✓ — ✓ —
LFR Low fluorescence ratio ✓ ✓ ✓ — ✓ —
MFR Medium fluorescence ratio ✓ ✓ ✓ — ✓ —
HFR High fluorescence ratio ✓ ✓ ✓ — ✓ —
RET-He Reticulocyte hemoglobin equivalent ✓ ✓ ✓ — ✓ —
RBC-He Mature RBC hemoglobin equivalent ✓ ✓ ✓ — ✓ —
Delta-He Parameter calculated by an equation of
✓ ✓ ✓ — ✓ —
RET-He - RBC-He
HYPO-He The ratio of the count in the low level area of
the forward scattered light signal in the RBC
✓ ✓ ✓ — ✓ —
(mature red blood cell) area of the RET
scattergram, to mature red blood cells
HYPER-He The ratio of the count in the high level area
of the forward scattered light signal in the
✓ ✓ ✓ — ✓ —
RBC (mature red blood cell) area of the
RET scattergram, to mature red blood cells
IPF Immature platelet fraction ✓ — ✓ ✓ — —
IPF# Immature platelet fraction count ✓ — ✓ ✓ — —
* The availability of these functions depends on your system configuration.

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Sysmex instruments offer different principles and technologies for the measurement to aid laboratories achieve
higher efficiency and reduced turnaround times.

WBC (WBC-N, WBC-D)

WBC-N reflects the count of white blood cells in the WNR channel. WBC-D reflects the count of white blood
cells in the WDF channel. In Low-WBC mode, WBC-D is the default parameter for WBC. In WB mode,
WBC-N is the default parameter for WBC, but under certain conditions a switch to WBC-D can be initiated by
internal algorithm criteria. Both parameters, WBC-N and WBC-D, are fully validated, diagnostic parameters.

BASO (BA-N, BA-D)

BA-N reflects the count of basophils in WNR channel. BA-D reflects the count of basophils in WDF channel.
BA-N is the default parameter for BASO and it is fully validated. BA-D is for research purpose only.

PLT (PLT-I, PLT-F, PLT-O)

PLT-I reflects the count of platelets by impedance method in RBC/PLT channel, PLT-O reflects the count of
platelets by optical method in RET channel and PLT-F reflects the count of platelets by fluorescence method
in PLT-F channel. PLT-I is the default parameter for PLT, but under certain conditions a switch to either PLT-O
or PLT-F can be initiated by internal algorithm criteria and depending on the analyzer configuration and
setting. All parameters, PLT-I, PLT-O and PLT-F are fully validated, diagnostic parameters.

The impedance, optical and fluorescent measurement technologies are included within the QC program of the
IPU when using the Sysmex control product XN CHECK. The QC program separately identifies these as
PLT-I, PLT-O and PLT-F respectively in all forms of QC reporting, including host communication. Please refer
to the Host Communication Protocol document to ensure that the LIS will be able to accept all QC parameters.

Information
WBC-N/WBC-D and PLT-I/PLT-O/PLT-F are research items in IPU, but they have been
appropriately designed, developed and validated in accordance with WBC and PLT.

[Body Fluid] mode

XR-20 XR-10
Parameters
[A1] [A2] [B1] [B2] [B3] [B4]
WBC-BF White blood cell (leukocyte) count ✓
RBC-BF Red blood cell (erythrocyte) count ✓
MN# Mononuclear count ✓
PMN# Polymorphonuclear count ✓
MN% Mononuclear percent ✓
PMN% Polymorphonuclear percent ✓
TC-BF# Total nucleated cell count ✓

* The body fluid analysis can only be performed if the license is activated.

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[HPC] mode

XR-20 XR-10
Parameters
[A1] [A2] [B1] [B2] [B3] [B4]

HPC# Hematopoietic progenitor cell

✓ ✓ — — — —
count

HPC% Hematopoietic progenitor cell

✓ ✓ — — — —
percent

Other parameters are the same as in [Whole Blood] mode.

* HPC analysis can only be performed if the license is activated.

1.4 About the manual

1.4.1 List of manual

The following manual is provided with the instrument:
• Instructions for Use (this manual)
This manual explains how to operate the instrument, focusing primarily on routine work. Each manual is
bound and included in the product; however, a manual with the same content is also built into the IPU.
For procedures on viewing the manual, see Chapter 8.
(➤P.129 "8.7 On-line manuals")

Information
The English manual is provided with the instrument. For the most current version, please
contact your authorized local Sysmex representative.

1.4.2 Structure of this manual

This manual consists of the following chapters.

Chapter Description

Chapter 1: Introduction Explains an overview of this manual and of the instrument.

Chapter 2: Safety Information Explains precautions to be observed for safe use of the
instrument, and also explains the meaning of the safety
symbols that appear on the instrument.

Chapter 3: Part Names and Functions Explains external views, names and functions of each of the
devices connected to the instrument.

Chapter 4: Consumables/ Explains the consumables/accessories/options to be used in

Accessories/Options the instrument.

Chapter 5: Reagents Explains the reagents to be used in the instrument.

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Chapter Description

Chapter 6: Installation Explains preparations and precautions concerning installation

of the instrument.

Chapter 7: Instrument Specifications Explains technical information such as specifications and

principles.

Chapter 8: Basic Operation Explains how to perform basic operations, such as start-up,
shut-down of the system.

Chapter 9: Preparing for Analysis Explains how to register and manage analysis orders, patient
(Registering Information) information, doctor information, and ward information.

Chapter 10: Performing Quality Control Explains how to perform regular administrative tasks to ensure
reliable analysis results.

Chapter 11: Analyzing Samples Explains how to analyze samples.

Chapter 12: Checking Analysis Data Explains the Sample Explorer function used to check and
(Sample Explorer) manage the analysis data in list format.

Chapter 13: Checking Detailed Explains the Data Browser function used to check and manage
Analysis Information (Data the detailed information of the analysis data, and the IP
Browser) message.

Chapter 14: Performing Calibration Explains the calibration function used to ensure the accuracy
of the instrument.

Chapter 15: Instrument Setup Explains various function settings of the analyzer and the IPU.

Chapter 16: Rules Setup Explains an overview of rule and setting rules.

Chapter 17: Checking the History Explains the log registered in the instrument.

Chapter 18: Performing Maintenance of Explains an overview of the maintenance tasks for the
Instrument and Replacing instrument and explains how to perform those tasks, including
Supply Parts the replacement of reagents and supply parts.

Chapter 19: Troubleshooting Explains the errors that may occur in the system and how to
troubleshoot them.

Appendix Explains service and research data, and default setting values.

1.4.3 Points to note about this manual

• You may not reprint the contents of this manual in whole or in part without permission.
• The patient names, doctor names, and others mentioned in this manual do not represent actual people in any
way.
• Images in this manual related to the product are for illustration purposes only and may not exactly match with
what is found on the product itself.
• While we have taken all possible precautions to ensure quality in the content of this manual, please contact
your authorized local Sysmex representative if you find any errors or omissions.

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1.5 Symbols used in this manual

Risk of infection
Indicates a risk of pathogen infection that may ultimately lead to death if the user fails to observe
the indicated instructions.

Warning!
Indicates a risk of death, serious injury, or serious property damage if the user fails to observe
the indicated instructions.

Caution!
Indicates a risk of injury, incorrect output results, or property damage if the user fails to observe
the indicated instructions.

Information
Indicates information for the purpose of maintaining instrument performance and preventing
damage.

Note:
Indicates useful information when using the instrument.

Indicates that the operation supports the touchscreen.

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1.6 Symbols related to the products

In vitro diagnostic medical device Concentrated reagent

Manufacturer Keep away from sunlight

Authorised Representative in the

Use no hooks
European Community

Consult instructions for use This way up

Temperature limitation Keep dry

Biological risks Stacking limit by number

Use by Total stacking limit by number

Batch code Fragile, handle with care

Catalogue number Corrugated recycles

Corrugated recycles*
Serial number * Based on SJ/T 11364 national
standard of China.

Environmental protection use

Date of manufacture
period

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1.7 Trademarks
• Sysmex is a trademark of SYSMEX CORPORATION, Japan.
• CELLPACK, CELLCLEAN, Fluorocell, SULFOLYSER, and Lysercell are trademarks of SYSMEX CORPORATION.
• ISBT128 is a copyrighted system by and is used under a license agreement with the International Council for
Commonality in Blood Bank Automation (ICCBBA).
• Windows is a trademark or registered trademark of Microsoft Corporation in the United States and other countries.

Other company names and product names in this manual are the trademarks or registered trademarks of their
respective owners. The fact that a trademark is not explicitly indicated in this manual does not authorize its use.
TM and  are not explicitly indicated in this manual.

1.8 Prohibited acts

• Modification, translation, reverse engineering, decompiling, and disassembly of this manual and the software is
prohibited. The creation of derivative works based on this manual or the software is prohibited.
• Copying this manual or the software for purposes other than backup based on the license agreement is prohibited.

1.9 User permissions

The permissions of the logged on user may not allow that user to change settings.
Only the user permitted [All Administrators] or [Modify Settings] can change the setting of the various functions.
For the details on user permissions, see Chapter 15.
(➤P.361 "Chapter 15: Change settings and add users")

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Chapter 2 Safety Information

This chapter explains precautions for safe use of this instrument.

2.1 Specified conditions of use

The XR-Series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. Only human
blood, human body fluids or quality control materials should be run. Any other use is regarded as non-specified.
Use only the reagents and cleaning fluids mentioned in this manual.
If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the
user's utilization of a program not specified by Sysmex, the product warranty would not apply.

2.2 General information

Warning!
• Keep your hair, fingers and pieces of your clothing away from the instrument while it is running.
You may get injured by getting them caught in the instrument.
• Do not spill blood samples or reagents into the instrument, or get any metals, such as staples
and clips, inside the instrument.
Doing so could cause a short-circuit.
• The operator should not touch any electrical circuitry inside the cover.
In particular, the risk of electrical shock is especially high when one's hands are wet.
• Avoid damage to the power cable: do not place any heavy object on the power cable or pull on it.
Doing so may cause a fire or shock due to an electrical short or a break in the wiring.
• In the unlikely event that the instrument emits an unusual odor or smoke, immediately turn OFF the main
switch and unplug the power cable. Then contact your authorized local Sysmex representative.
Continued use of the instrument in such conditions could result in fire, electrical shock or personal injury.

Caution!
• Never touch the sample rack while the instrument is working.
Touching a rack or a sample tube especially when the rack is moving could cause sample spillage.
• Do not lean against the instrument.
The resulting impact could damage the instrument or cause it to tip over.
• Do not place any foreign objects on top of the sampler.
Doing so could prevent the rack from being transported, which may lead to incorrect analysis.
• Do not look directly into the light source of the handheld barcode reader.
Doing so may damage your eyes.

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cTÜVus mark indicates that the equipment is tested and certified to comply with the
electrical and fire safety regulations controlled by the US and Canadian
governments.
Those tests were conducted thoroughly by TÜV Rheinland that is accredited as a
Nationally Recognized Testing Laboratory (NRTL) by OSHA (The Occupational
Safety and Health Administration) in the United States, and by SCC (Standards
Council of Canada) in Canada.

2.3 Installation

Warning!
• The unpacking, setup and confirmation of correct initial operation is performed by your
authorized local Sysmex representative.
• This instrument must not be connected to a power outlet rated at anything other than specified
in the rating plate.
Please note that the instrument must be grounded.
Failure to do so may cause a fire or electrical shock.
• Switch OFF the power supply before connecting any peripheral devices (host computer,
printer, etc.).
This is to prevent electrical shock hazard. If a peripheral device is connected after the
instrument is started up, the instrument may stop abnormally.
• When using the external indicator light (SI-14) avoid direct top light emission to your eyes.
There is a risk to damage your eyes.

Caution!
• Install the instrument in a place protected from water splashes.
• Install in a place where the instrument will be protected from high temperature, humidity, dust
and direct sunlight.
• Install the instrument in a stable location where it will not be subject to vibration.
• Make sure the instrument is not exposed to strong vibrations or impacts.
• Install the instrument in a well ventilated place.
• Avoid installation of the instrument near devices that emit electrical interference, such as
radio, centrifuge, etc.
• Do not install the instrument near an area where chemicals are stored or gases are emitted.
• Do not use this instrument in any operating environment which has electroconductive or
flammable gases, including oxygen, hydrogen, and anesthesia.
• Do not place any object on top of the instrument.

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2.4 Electromagnetic compatibility (EMC)

This instrument complies with the following IEC (EN) standards:
• IEC61326-2-6:2005, IEC61326-2-6:2012
Equipment for analysis/control/laboratory use - EMC Requirements
• Electromagnetic Interference (EMI)
For this standard the requirements of class A are fulfilled.
• Electromagnetic Susceptibility (EMS)
For this standard the minimum requirements with regards to susceptibility are fulfilled.
• This instrument has been designed and tested to CISPR11 Class A/Group 1. This means that this product is not
intended to generate and/or use radio-frequency energy in the form of electromagnetic radiation, inductive, and/or
capacitive coupling during operation. This also means that the product is suitable for use in all facilities except for
the following:
- Domestic facilities
- Facilities directly connected to a low voltage power supply network which supplies to buildings used for
domestic purposes
Use in a domestic environment may cause radio interference, which may require you to take measures to mitigate
the interference. The electromagnetic environment should be evaluated prior to operation of the instrument. Do not
use this instrument in close proximity to sources of strong electromagnetic radiation (such as unshielded intentional
radio sources), as these may interfere with the proper operation.

This instrument includes an RFID (Radio-Frequency Identification Device) module.

• RFID device: TR3-C202-A0-8
• Intended use: This RFID module is an electromagnetic induction type non-contact IC that can
read and write RFID tag data.
• Frequency band: 13.56 MHz
• Maximum radio-frequency power: 74.8 dBuV/m at 10 m(QP)
• This instrument complies with IDA Standards.

Caution!
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely
to cause harmful interference in which case the user will be required to correct the interference
at his own expense.

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2.5 Avoiding infections

Risk of infection
• When performing any task on the instrument, such as testing, maintenance, preparation, or
post processing, be sure to wear adequate personal protective equipment, such as protective
gloves, a protective mask, protective eyewear, and a lab coat. Also, wash your hands after
completing the process.
There is a risk of infection.
• Be sure to connect the instrument’s drain tubing to a waste fluid tank at the facility or other
dedicated waste tank.
• If connecting the tubing to a waste fluid tank at the facility, use a tank with a nipple to which the
drain tubing can be attached or a tank with other means of securing the tubing in place so as
to avoid the risk of waste fluid spillage. In addition, exercise care so as to avoid such spillage,
for example by regularly verifying that the tube remains properly secured in place.
• Never touch waste, or parts that have come in contact with waste, with your bare hands.
If you inadvertently come in contact with potentially infectious materials or surfaces,
immediately rinse the skin with large amounts of water, then follow your laboratory's
prescribed cleaning and decontamination procedures.
• Use appropriate care when handling samples and quality control materials. In the unlikely
event that some infectious material gets in the eyes or an open wound, rinse with large
amounts of water and seek immediate medical attention.

2.6 Handling of reagents, quality control materials, and

calibrators

Warning!
• Do not directly touch the reagents.
Reagents may cause irritation to the eyes, skin, and mucous membranes.
If you come into contact with a reagent, immediately rinse your skin thoroughly with large
amounts of water.
If a reagent gets into your eyes, immediately rinse your eyes thoroughly with large amounts of
water and then seek medical attention.
If a reagent is accidentally swallowed, immediately seek medical attention.
• The diluent used with this instrument is a good electrical conductor. If diluent is spilled
inadvertently near electrical cables or appliances, there is a risk of electrical shock. Switch the
instrument off, unplug it and wipe-up the liquid.
• CELLCLEAN AUTO contains sodium hypochlorite.
If CELLCLEAN AUTO comes in contact with the instrument's surface, it may corrode its finish.
Immediately wipe off CELLCLEAN AUTO with a damp cloth.

Caution!
• Follow directions on QC material labeling.
• Do not use products after their use-by date and shelf life after first opening.
• Follow the storage and handling instructions as described in package inserts of reagents/
quality control materials, labels on containers or outer box, and the safety datasheet.

For other cautionary points, see Chapter 5. (➤P.63 "Chapter 5: Reagents")

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2.7 Laser

Warning!
The analyzers have a semiconductor laser unit that is located inside the instrument. To avoid
physical risk of injury from the laser, access is limited to your authorized local Sysmex
representative.

2.8 Maintenance

Information
When performing maintenance, use only the tools specially authorized by Sysmex.

2.9 Disposal of materials

2.9.1 Waste Disposal

Risk of infection
After becoming waste at the end-of-life, this instrument and its accessories are regarded as
infectious. They are therefore exempted from Directive 2012/19/EU on Waste Electrical and
Electronic Equipment and may not be collected by public recycling authorities, to prevent
possible risk of infection of personnel working at those facilities.

Warning!
• Do not dispose of the instrument, accessories, and consumables via public recycling.
• Incineration of contaminated parts is recommended.
• Please contact your authorized local Sysmex representative to receive further instructions for
disposal.
Follow local legal requirements at all times.

Caution!
Waste effluents from the instrument may contain hazardous substances, and any decisions
regarding disposal shall be made only after consultation with local water authorities.

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Waste end-of-life equipment should not be disposed of as unsorted municipal waste. It should be
collected separately.

2.9.2 Decontamination

Warning!
Before decontaminating the instrument, be sure to turn OFF the power supply and unplug the
power cord. This is necessary to avoid the risk of electric shock. When cleaning the instrument,
always wear adequate personal protective equipment. After decontamination, wash hands
carefully with antiseptic solution first and with soap afterwards. Do not decontaminate the
instrument's internal components. Internal decontamination should only be executed by your
authorized local Sysmex representative.

Information
• Decontamination of the instrument's outer surfaces should be performed in the following
situations:
- Immediately after contamination with potentially infectious material
- In advance of repair or maintenance by your authorized local Sysmex representative
• Wear adequate personal protective equipment, such as protective gloves, a protective mask,
protective eyewear, and a lab coat.
• Wipe and clean contaminated surfaces with a common pH-neutral detergent solution until all
visible traces of contaminants, such as dried blood or urine, are removed.
• Wipe the contaminated surfaces by using one of the following disinfectants* and allow
adequate contact time:
- Sodium hypochlorite (between 0.05 % and 0.5 %)
- 70 % ethanol or 70 % isopropyl alcohol
• Wipe the surfaces with a wet cloth dampened with distilled water to remove any remaining
disinfectant on the surfaces.
• Take care to prevent moisture from reaching the inside of the instrument.
• Take care to avoid applying any liquid close to or on the instrument's touchscreen.
• As a final step, wipe the instrument with a dry disposable cloth.
* Make sure that you wet a cloth with the disinfectant before use. Do not apply the solutions
directly to the instrument surfaces. Doing so may cause damage to the surfaces or failure of
the instrument. Although the use of these solutions may cause some discoloration of the
instrument coating, this does not affect the use, safety, or performance of the instrument itself.

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2.10 Operators

Caution!
• Only properly trained personnel should use this instrument.
• In the event that a malfunction of the instrument occurs, take the measures indicated in the
Instructions for Use manual. Further resolution should be referred to your authorized local
Sysmex representative.

2.11 Computer viruses

Warning!
Although our software has already been checked for computer viruses, the configuration of a
specific user environment may make it prone to computer virus infections via the Internet or a
network.
We recommend that our customers consider computer virus countermeasures that suit their
computer operating environment. Customers that use antivirus software in their operating
environment should take the following precautions.
1. Use the antivirus software to periodically check for viruses.
(1) Use antivirus software designed for your operating system.
(2) Disable the antivirus software during instrument software operation as it may adversely
affect instrument operation.
(3) Disable functions that check file access.
(4) Disable firewalls and any other functions that protect or control data transfers.
2. Do not install any software other than the antivirus software.
3. USB memory sticks, CD-Rs and other external memory devices should be checked for
viruses before use.
4. Do not open files attached to email or files of unknown origin without first performing a virus
check.
5. Do not download files from the Internet or other sources that are not required for instrument
operation. However, the virus definition files used by the antivirus software are not subject to
this restriction.
6. Always check for viruses before accessing files in a folder shared with other computers.
7. Check effectiveness of computer virus countermeasures used on other computer systems in
your laboratory, and select the most effective for use on this instrument.
8. The customer must take sole responsibility when connecting to an external network (for
example, the Internet).

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2.12 Use of other software

Warning!
• Do not install any software other than that preinstalled on the instrument. And do not run any
other software on the instrument. However, this restriction does not include the installation of
antivirus software.
• Note that we will accept no liability whatsoever for any malfunctions arising from use of other
software.

2.13 Notice to the user

For a patient or user or third party in the European Union and in countries with identical regulatory regime (Directive
98/79/EC on In vitro Diagnostic Medical Devices); if, during the use of this device or as a result of its use, a serious
incident has occurred, please report it to the manufacturer and/or its authorized representative in the European Union
and to your national competent authority.
Reports to the authorized representative in the European Union, Sysmex Europe SE, must be sent by email to:
[email protected], or by post to Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt, Germany.

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2.14 Markings on the system

Interior of the Analyzer

(1)
(3)

(2)

Front view Left view

(1)

Caution!
Do not perform analysis while cover is open as outside noise will affect the data.

(2)

Risk of infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(3)

Warning!
To avoid electrical shock, unplug the cord before servicing.

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Rear of the Analyzer

(1)
(2)

(1)

Risk of infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(2)

Warning!
• To avoid electrical shock, unplug the cord before servicing.
• Replace only with fuses of the specified type and current rating.

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Sampler section (XR-1000)

SA-10 SA-01
(1)

Top view (2) Top view

(3)

Front interior

(1)

Warning!
• To avoid electrical shock, unplug the cord before servicing.
• Replace only with fuses of the specified type and current rating.

(2)

Risk of infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(3)

Warning!
To avoid electrical shock, unplug the cord before servicing.

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Sampler section (XR-2000)

(1)

(2)

Top view

(3)
Front interior

(1)

Warning!
• To avoid electrical shock, unplug the cord before servicing.
• Replace only with fuses of the specified type and current rating.

(2)

Risk of infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(3)

Warning!
To avoid electrical shock, unplug the cord before servicing.

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Pneumatic unit

(2)

(3)

(1)

Front view Rear view

(1)

Risk of infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(2)

Caution!
Do not block the exhaust opening.

(3)

Warning!
• To avoid electrical shock, unplug the cord before servicing.
• Replace only with fuses of the specified type and current rating.

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External indicator light (SI-14)

(1)

(1) The light emitted from the top of this unit is classified into risk group 2 of the
standard for photobiological safety of lamps and lamp systems IEC62471.

Risk Group 2

Caution!
Possibly hazardous optical radiation emitted from this product. Do not look straight into the light
source during operation. May be harmful to the eyes.

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Chapter 3 Part Names and Functions

This chapter provides an external view and a summary of each device that makes up this instrument.

3.1 Analyzer
Analyzes patient and control samples.

Front view

1 Front top cover

Opens upward. Open this cover to inspect the
interior of the analyzer, or to perform cleaning or
maintenance tasks.
2 Front bottom cover
1 This is a protective cover. Open this cover to
inspect the interior of the analyzer, or to perform
cleaning or maintenance tasks.
3 Tube holder
Used to load the sample tubes for manual
6 analysis.
2 4 Start switch
4 Press to start manual analysis.
5
5 Mode switch
3 Press to switch between manual analysis and
sampler analysis. Pressing it opens and closes the
tube holder.
When the tube holder is open: Manual analysis
When the tube holder is closed: Sampler analysis

6 Status indicator LED

Indicates the status of the device by LED.

Green/orange* Ready (Analysis possible)

Flashing green/ Starting up / Analysis in progress / Mode switching in progress / Shutting down
orange*
Green Waiting to execute maintenance
Flashing green Maintenance in progress
Red Error (without alarm) / Initializing system / Error stop / Stopped
Flashing red Error (with alarm)
Not lit Powered OFF

* Green during normal operation, orange when an error has occurred that allows operation to continue.
The external indicator light is linked to and indicates the status indicated on the instrument status LED. For
details, see the following:
(➤P.44 "3.4 External indicator light")

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Rear view

1 Various tubes/cables
Hydraulic tubes and electrical cables to be
connected to the different devices.
The tubes and cables will be connected your
authorized local Sysmex representative.
2 Waste Fluid Outlet Nipple
Waste fluid is discharged via this nipple. Connect
this to the drain or the waste container.
3 Fuse holder
1 Use a 250 V 10 A (Time Lag low breaking
3 capacity) fuse.
2
4 4 AC power inlet
Supplies power using the provided power cable.

Information
When connecting the waste fluid outlet nipple to the waste container, use the waste tank full
sensor.
Otherwise, waste fluid may overflow.

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Front interior

1
2
3
4 8

1 Pneumatic trap chamber

Prevents the reagent from flowing back into the pneumatic unit, when the instrument malfunctions.
2 0.16 MPa regulator
Regulates the pressure at 0.16 MPa.
3 Main power switch
Turns the main power of the device ON/OFF.

Caution!
Do not turn this switch ON/OFF repeatedly within a short time.
This will overload the fuse and may cause it to blow.

4 0.07 MPa regulator

Regulates the pressure at 0.07 MPa.
5 RBC/PLT detector section
Equipped with a RBC/PLT detector.
6 Tube grabber
Removes the sample tube from the rack and mixes it. Then after the analysis is complete, places the
sample tube back in the rack.
7 Tube rotation mechanism
Rotates the sample tube to read its barcode label.
8 Dye cartridge holder
Holds the dye reagent.

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3.2 Pneumatic unit

PU-17 is an in-vitro diagnostic accessory to supply vacuum and pressure for Sysmex devices. It is used by
healthcare professionals and properly trained personnel. For appropriate use of the product, refer to the
corresponding instructions for use of applicable Sysmex devices.

Front view Rear view

1 3 4

5
6

1 0.25 MPa regulator

Regulates the pressure supplied to the analyzer at 0.25 MPa.
2 Pilot lamp
Lights up when the pneumatic unit's power is ON.
3 Pressure outlet nipple
Pressure is supplied to the analyzer from this nipple. Connect this nipple with the pressure supply nipple on
the analyzer.
4 Vacuum outlet nipple
Vacuum is supplied to the analyzer from this nipple. Connect this nipple with the vacuum supply nipple on
the analyzer.
5 Fuse
Use only with fuses of the specified type and current rating.
100 - 117 VAC: Fuse 250 V 4 A (Time Lag)
220 - 240 VAC: Fuse 250 V 3.15 A (Time Lag)
6 Power connector
Supplies power using the provided power cable.
7 Pneumatic control input connector
An input connector for turning the pneumatic unit ON/OFF. Connect this to the pneumatic control output
connector on the analyzer.

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3.3 Sampler section

Sampler unit is a sampler for Sysmex automated hematology analyzer, and is used by healthcare professionals and
properly trained personnel.

SA-10: Top view (XR-1000)

7
8

5
2

3
6

1 Analysis line
A maximum of two racks are automatically transported laterally. In this line, the sample number barcode
labels are read, and the samples are mixed and aspirated.
2 Right sampler pool
Place the racks in this pool. A maximum of 5 racks can be placed at a time.
Once the sampler analysis starts, the racks are automatically fed to the analysis line.
3 Status indicator LED
Indicates the status of the device by LED.

Green Ready (Analysis possible) / Sampler analysis screen is open / Waiting to execute
maintenance
Flashing green Starting up / Sampler analysis in progress / Maintenance in progress
Orange Sampler analysis is stopped / Sampler analysis is not possible
Red Error (without alarm) / Initializing system
Flashing red Error (with alarm)
Not lit Powered OFF

The external indicator light is linked to and indicates the status indicated on the sampler status LED. For
details, see the following:
(➤P.44 "3.4 External indicator light")

4 Rack feed-out lever

Feeds the finished racks from the analysis line to the left sampler pool.

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5 Left sampler pool

The racks are fed from the analysis line to this pool. Up to 5 analyzed racks can be pooled.
6 Protective cover
7 Main power switch
Turns the main power of the device ON/OFF.
8 Fuse holder
Use a 250 V 3.15 A (Time Lag low breaking capacity) fuse.
9 AC power inlet
Supplies power using the provided power cable.

SA-01: Top view (XR-1000)

4 2

1 Analysis line
Racks are automatically transported. In this line, the samples are mixed and aspirated.
2 Right sampler pool
Place the racks in this pool. A maximum of 5 racks can be placed at a time.
3 Rack feed-out lever
Feeds the finished racks from the analysis line to the left sampler pool.
4 Left sampler pool
The racks are fed from the analysis line to this pool. Up to 5 analyzed racks can be pooled.
5 Protective cover

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SA-20: Top view (XR-2000)

5 2

6 3

1 Analysis line
A maximum of two racks are automatically transported laterally. In this line, the sample number barcode
labels are read, and the samples are mixed and aspirated.
2 Right sampler pool
Place the racks in this pool. A maximum of 10 racks can be placed at a time.
Once the sampler analysis starts, the racks are automatically fed to the analysis line.
3 Status indicator LED
Indicates the status of the device by LED.

Green Ready (Analysis possible) / Sampler analysis screen is open / Waiting to execute
maintenance
Flashing green Starting up / Sampler analysis in progress / Maintenance in progress
Orange Sampler analysis is stopped / Sampler analysis is not possible
Red Error (without alarm) / Initializing system
Flashing red Error (with alarm)
Not lit Powered OFF

The external indicator light is linked to and indicates the status indicated on the sampler status LED. For
details, see the following:
(➤P.44 "3.4 External indicator light")

4 Rack feed-out lever

Feeds the finished racks from the analysis line to the left sampler pool.
5 Left sampler pool
The racks are fed from the analysis line to this pool. Up to 10 analyzed racks can be pooled.
6 Protective cover

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7 Main power switch

Turns the main power of the device ON/OFF.
8 Fuse holder
Use a 250 V 3.15 A (Time Lag low breaking capacity) fuse.
9 AC power inlet
Supplies power using the provided power cable.

3.4 External indicator light

You can confirm the instrument status even from a distance by means of the status of the external indicator light. The
external indicator light indicates the status that has the higher priority of the analyzer, sampler, and IPU statuses.
When using the sampler (SA-01), the sampler status LED is not indicated.

e.g. External indicator light (SI-14)

The external indicator light is linked to the instrument status, and indicates the status as follows. Display
patterns are different between the SI-14 and the SI-10 (optional).

Priority External indicator light

Status indicator LED
levels SI-14*1 SI-10 (optional)*2
Analyzer Ready / Analysis in progress / Side: Linked to the Green
Starting up / Shutting down instrument
Sampler Ready / Analysis in progress / status LED
Low
Starting up Top: Blink

Analyzer Error / Initializing system / Red (Flashes in red if

Stopped an alarm is sounding)
Sampler Analysis not possible
IPU Host computer Side: Red
communication error Top: Blink
Analyzer Power off/Error stop Side: Linked to the Not lit
High
instrument
status LED
Top: Blink

*1 May vary depending on the setting of the instrument.

*2 The external indicator light lights green regardless of the above priority levels during switching of the analysis
mode and while running maintenance.

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3.5 IPU (Information processing unit)

The IPU consists of the PC main unit, display unit, keyboard, and mouse. You can also use a touchscreen display
(optional).
Processes and displays data generated by the analyzer. This is also where you operate the analyzer and specify
various settings.

Information
Refer to the manual included with the computer for information on current operation, the layout
of connection ports and other details.
For more information, please contact your authorized local Sysmex representative.

3.6 PC for backup (optional)

You can back up the data saved in the IPU (such as the setting values, rules, quality control results, analysis results,
patient information, history, reagent information, and layouts). By taking a backup regularly, your data can be restored
in case of IPU failure.
• Automatic backup
You can take a backup of the IPU automatically by setting a schedule. (➤P.406 "Chapter 15: 15.6.1 Set the
schedule", P.127 "Chapter 8: 8.5.4 Perform automatic backup")
• Manual backup
You can take a backup of the IPU at any optional timing. (➤P.410 "Chapter 15: 15.6.3 Take manual backup")
• Instrument automatic startup
When using a PC for backup, you can start the instrument automatically at the specified date and time. (➤P.406
"Chapter 15: 15.6.1 Set the schedule")

Information
Your authorized local Sysmex representative will install and make the initial configuration for the
PC for backup.
For details, please contact your authorized local Sysmex representative.

Note:
If you change the IPU version, the version of the PC for backup will also change during backup.

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3.7 Operation of the IPU

The IPU uses a Windows operating system. For basic information on how to operate the system, refer to the system's
user guide that comes with the OS.
The commonly used functions of the IPU are accessible via the touchscreen. If you are using a touchscreen display
(optional), you can operate the IPU by directly touching the display.

Caution!
The IPU is a dedicated PC for the instrument, and cannot be used as a generic PC.

3.7.1 Main screen layout

The basic screen layout of the IPU is as follows:

Toolbar (fixed) Toolbar (changeable)

Window
(view)

Control menu

Toolbar (fixed) The following frequently-used function buttons are displayed:

[Menu] Click to return from each function screen to the Menu screen.
[QC File] Click to display the QC File screen.
[Work List] Click to display the Work List screen.
[Rule] Click to display the Rule screen.
[Explorer] Click to display the Sample Explorer.
[Browser] Click to display the Data Browser.
Toolbar (changeable) Buttons are displayed according to the displayed function of the window.
While performing each function, clicking the [Close] button displayed on the
right edge closes each function screen displayed on the window.

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Window (view) Area for performing various types of processes and operations.
By default, the Menu screen is displayed. Click the desired icon to execute
its function. (➤P.52 "3.7.3 List of menu items")
You can change the icons to be displayed in the Menu screen. Click the
[Setting] button on the toolbar to select the icons to be displayed.
Icons that are hidden in the menu screen are also hidden on the toolbar.
Control menu Displays the status of each device connected to the IPU.
In addition, you can perform operations on each device, such as analysis
and maintenance.

3.7.2 Control menu

The layout of the Control menu is as follows:
Analyzer area RU area

Sampler area Printer area Host computer area

Analyzer area Displays information about the analyzers. If you use the XR-2000,
information of 2 analyzers can be displayed.
Sampler area Displays information about the sampler.
RU area Displayed when the RU-20 is connected.
Printer area Displays information about the printer.
Host computer area Displays information about the host computer.

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● Analyzer area
The following items are displayed in the analyzer area:
Change Analysis Mode button

Manual Analysis button

Analyzer information Help button

Sampler Analysis button

Analyzer menu button

Reagent remaining volume indicator

Error message

Device status Sample information

Analyzer information Displays the name of the analyzer and its settings.
The meaning of each icon is as follows:
: This is displayed when the X-barM function is ON.
: This is displayed when the blood aspiration sensor is ON.
: This is displayed when [Cap Open] is ON.

Help button This is displayed when there is an error.

Click to display the Help dialog box.
Change Analysis Mode button This is displayed when performing manual analysis.
Click to select an analysis mode.
Manual Analysis button This is displayed when performing manual analysis.
Click to define the settings for the sample.
The displayed icon depends on the [Cap Open] setting.
: This is displayed when [Cap Open] is OFF.
: Blinks when [Cap Open] is ON.

Sampler Analysis button This is displayed when performing sampler analysis.

Click to define the settings for the sample.
In addition, if you click during sample analysis, a dialog box for aborting the
sample analysis is displayed (SA-10/SA-20 only).
Analyzer menu button Click to run various types of maintenance functions.
Clicking this button opens and closes the Analyzer menu. (➤P.52
"3.7.3 List of menu items")
Reagent remaining volume Displays visually how much reagent is remaining. The colors indicate the
indicator color of each reagent's package. The reagents are, from left to right in the
figure below: CELLPACK DCL, SULFOLYSER, Lysercell WNR, Fluorocell
WNR, Lysercell WDF II, Fluorocell WDF, CELLPACK DFL, Fluorocell RET,
Fluorocell PLT, Lysercell WPC, Fluorocell WPC.

Amount remaining

Click the reagent level display to open the reagent replacement dialog.

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Error message Displays the highest priority error among all current errors. The displayed
error is categorized as one of the following error types:
Orange background / black text: Caution
Red background / white text: Warning
Non-urgent information such as notices appear in normal background /
white text.
Device status Indicates the status of the analyzer. The meaning of each displayed color is
the same as the Status indicator LED on the device. (➤P.37
"3.1 Analyzer")
Sample information Displays the information about the sample to be analyzed.
Sample number: Displays the sample number. If [>] appears at the
beginning of the sample number, this indicates that the
next sample can be aspirated. If the sample number is
not read, or if it has not been entered manually, a
message is displayed to prompt the input of the number.
Analysis mode: The selected analysis mode is displayed from the
following:
WB: Whole blood, LW: Low WBC, PD: Pre-Dilution,
BF: Body Fluid, HPC: HPC, hsA: hsA
Discrete: Displays the selected discrete test. This is not displayed
when the analysis mode is BF/HPC.

Sample number

Discrete

Analysis mode

Note:
Clicking other places in the screen while the dialog Minimized dialog
box is displayed will minimize the dialog box, as
shown below. Because the dialog box is still
internally open in this state, you may not be able to
perform other operations.

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● Sampler area
The following items are displayed in the sampler area:

Device status Error message

Device status Indicates the status of the sampler. The meaning of each displayed color is
the same as the Status indicator LED on the device. (➤P.41 "3.3 Sampler
section")
Error message* Displays the highest priority error among all current errors. The displayed
error is categorized as one of the following error types:
Orange background / black text: Caution
Red background / white text: Warning

* When using the sampler (SA-01) in the XR-1000, the error message does not appear.

● RU area
The following items are displayed in the RU area:

RU menu button

Reagent remaining volume indicator

RU status

RU menu button Opens and closes the RU help dialog.

When an error occurs on the RU-20, a help icon appears in the button part.
For details on the RU help dialog, see Chapter 19.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")
Reagent remaining volume Displays visually how much reagent is remaining in the RU-20.
indicator
RU status Indicates the status of the RU-20. The meaning of each displayed color is
as follows:
Green: Ready
Flashing green: Starting up/Maintenance in progress / Reagent
preparation in progress / Automatic operation
(draining / RO water refilling)/Shutting down
Orange: Warning
Red: Error

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● Printer area
The following items are displayed in the printer area:

Printer menu button

Number of print jobs

Printer status

Printer menu button Opens and closes the printer's menu.

Printing can be stopped from the printer menu.
Number of print jobs Shows the number of jobs spooled to the printer.
Printer status Displays the status of connection with the printer. The meaning of each
displayed color is as follows:
Not lit: No connection setting
Green: Connected*
Red: Error in progress

* Displays the printer connection status in the IPU settings. Lights green when the printer power is OFF, and
also when the printer driver is not installed.

● Host computer area

The following items are displayed in the host computer area:

Host menu button

Host setting
Host status

Host menu button Opens and closes the host computer's menu.
The items displayed in this menu are synchronized with the setting in [Host
Computer]. For details, see the following:
(➤P.368 "Chapter 15: 15.3.4 Connection settings")
Host setting Displays the name of the connected host computer.
Host status Displays the status of connection with the host computer.
The meaning of each displayed color is as follows:
Not lit: No connection setting
Green: Connected
Flashing green: Communicating
Red: Cannot connect

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3.7.3 List of menu items

The layout of the items displayed in the basic screen of the IPU are as follows:

Menu QC File Patient Information

Work List Ward Name
Patient List Doctor Name
Rule
Sample Explorer Repeat Rule
Data Browser Rerun/Reflex/Comment Rule
Instructions for Use Validation Rule

LOGOFF Output Rule

Exit IPU
History Audit Log
Precision Check Error Log
Calibration Reagent Replacement Log
Analyzer Setting Maintenance Log
IPU Setting
Version Information
RU Log
GP Customize
Schedule settings

QC Analysis Precision Check

X-barM Setting Calibrator Calibration
Analyzer menu Calibration Calibrator Calibration(PLT-F)
Maintenance
Auto Rinse Cleaning
Shutdown Drain Waste Fluid Chamber
Reagent Replacement Rinse Waste Fluid Chamber
Remove Flowcell Air Bubbles
Rinse Flowcell
Drain Reaction Chamber
Drain RBC Isolation Chamber
Remove RBC Detector Clog
Counter
Pressure Adjustment
Whole Blood Aspiration Motor Test
Sheath Motor Test
Aspiration Unit Motor Test
Tube Holder Motor Test
Hand Test
Reagent Replenishment
Analyzer BR Test
Analyzer Sensor Display
Sampler Operation Test
Sampler BR Test
Sampler Sensor Display

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Chapter 4 Consumables/Accessories/Options

Caution!
Make sure to use only the specified consumables, accessories, and options.
There is a risk of malfunctioning or failure of instrument if non-specified items are used.

4.1 Consumables
The following table describes the consumables that can be additionally purchased:

Part Number Description

266-7768-1 Fuse 50T100H (for the sampler, 250 V 10 A, Time Lag, Low breaking capacity)

266-5011-3 Fuse ST4-4A-N1 (for the pneumatic unit, 250 V 4 A, Time Lag)

AY579418 Fuse 02183.15MXP (for the pneumatic unit, 250 V 3.15 A)

AX880901 Fuse 50T032H (for the sampler, 250 V 3.15 A, Time Lag, low breaking capacity)

4.2 Accessories
XR-1000 accessories
Part Number Names Quantity

AK966611 Intake Tube_Assy No. 12

BM141028 Intake Tube_Assy No. 126

424-3332-1 Sample Rack No. 5-1

— XR-Series software (1XR1X)

* Make sure that the label "1XR1X" is affixed
to the disk. 1

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Part Number Names Quantity

BC324723 Cover No. 2032

1*1

BK729343 Cover_Assy No. 195

1*1

266-7768-1 Fuse 50T100H

(250 V 10 A, Time Lag, Low breaking
capacity) 2

AX880901 Fuse 50T032H

(250 V 3.15 A, Time Lag, Low breaking
capacity) 2*1

462-3520-5 Brush (with cap)

442-4876-2 Tube Joint PD-ML 5-4042-31

CY716130 Tube 14 mm × 10 mm, 8 m

442-5340-5 Tube 9 mm × 6 mm, 1 m

1

442-5338-7 Tube 6 mm × 4 mm, 5 m

442-5055-4 Tube 3.4 mm × 1.8 mm, 2 m

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Part Number Names Quantity

266-4461-8 Convex CV-100 tie wrap

10

266-4462-1 CV-250 tie wrap

5

BQ658842 XR-1000/XR-2000 Instructions for Use

BR650149 Adapter No. 208

60

BK393670 Cover No. 2858

1*2

CC769227 Cover No. 2857

1*2

348-4101-5 Washer built-in screw (sheet t0.5) M3 x 8

4*2

266-7108-4 Spiral tube SS-4 300 mm

1*2

BT850247 Cap No. 559

442-1657-0 Pipe No. 27

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Part Number Names Quantity

BG807462 Plug No. 110

10

CV022305 Spacer No. 813

BK659140 Label No. 1689

462-3122-1 Opener No. 2

BH256480 External indicator light (SI-14)

1

*1 When using the sampler (SA-10)

*2 When using the sampler (SA-01)

XR-2000 accessories
Part Number Names Quantity

AN422528 Intake Tube_Assy No. 10

CW606213 Intake Tube_Assy No. 125

AQ818765 Connecting Tube_Assy No. 18

CQ891968 Wiring Cord No. 6939

1

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Part Number Names Quantity

424-3332-1 Sample Rack No. 5-1

12

— XR-Series software (1XR1X)

* Make sure that the label "1XR1X" is affixed
to the disk. 1

BC324723 Cover No. 2032

BX031359 Cover No. 2036

BJ348973 Cover No. 2038

266-7768-1 Fuse 50T100H

(250 V 10 A, Time Lag, Low breaking
capacity) 4

AX880901 Fuse 50T032H

(250 V 3.15 A, Time Lag, Low breaking
capacity) 2

462-3520-5 Brush (with cap)

442-4876-2 Tube Joint PD-ML 5-4042-31

CY716130 Tube 14 mm × 10 mm, 8 m

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Part Number Names Quantity

442-5340-5 Tube 9 mm × 6 mm, 2 m

1

442-5338-7 Tube 6 mm × 4 mm, 5 m

442-5055-4 Tube 3.4 mm × 1.8 mm, 5 m

266-4461-8 Convex CV-100 tie wrap

20

266-4462-1 CV-250 tie wrap

10

BA798506 Kit No. 167

BQ658842 XR-1000/XR-2000 Instructions for Use

BR650149 Adapter No. 208

120

BT850247 Cap No. 559

442-1657-0 Pipe No. 27

BG807462 Plug No. 110

10

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Part Number Names Quantity

CV022305 Spacer No. 813

BK659140 Label No. 1689

2

462-3122-1 Opener No. 2

BH256480 External indicator light (SI-14)

2

Analyzer (XR-20)
Part Number Names Quantity

BQ559485 XR-20 Main Complete 1

Analyzer (XR-10)
Part Number Names Quantity

CF730361 XR-10 Main Complete 1

Pneumatic Unit (PU-17)

Quantity
Part Number Names
100 - 117 V 220 - 240 V

013-3015-4 PU-17 Main Complete (100 - 117 V) (White) 1 -

013-3016-8 PU-17 Main Complete (220 - 240 V) (White) - 1

923-8092-8 Power Cord No. 15 1 -

265-7153-5 Power Cord TA-6P(A)+TA-5(A) H05VV-F - 1

266-5011-3 Fuse ST4-4A-N1 (250 V 4 A, Time Lag) 2 -

AY579418 Fuse 02183.15MXP (250 V 3.15 A) - 2

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Chapter 4 Consumables/Accessories/Options

Sampler (SA-10)
Part Number Names Quantity

BK186773 SA-10 Main Complete 1

BS483827 Table_Assy No. 23 1

Sampler (SA-20)
Part Number Names Quantity

BY100939 SA-20 Main Complete 1

AR152825 Table_Assy No. 8 1

Sampler (SA-01)
Part Number Names Quantity

BY618122 SA-01 Main Complete 1

BJ595320 Table_Assy No. 64 1

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4.3 Options
Options available for this instrument are as follows. For details, please contact your authorized local Sysmex
representative.

Product Code Item Name Description

1
AJ597361 Dedicated wagon (WG-10)* A wagon for installing the analyzer.
BD655831 Dedicated wagon (WG-15)* 1 You can house reagents, the pneumatic unit (PU-17),
and the IPU.
BP050847 Dedicated wagon (WG-20)*2
BC479026 Reservoir Tank RR-10 A tank to store hemolytic agents and diluents, and
AP594052 Reservoir Tank RR-10 supply them to the analyzer. You can use by installing
(W/O DCL) in dedicated wagons.
Use RR-10 COMPLETE (W/O DCL) when using the
RU-20.

Reservoir Tank RR-10 is an IVD accessory intended to

serve as temporary reservoir of reagent solution for
Sysmex automated hematology analyzers and is used
by healthcare professionals and properly trained
personnel. For appropriate use of the product, refer to
instructions for use of applicable Sysmex automated
hematology analyzers.
CY662767 RU-20 A reagent unit prepares (dilutes) concentrated reagent
using RO water and feeds it to connected analyzers.
- Touchscreen A display unit for the IPU. You can use the
touchscreen to perform some of the operations.
- Data printer Prints analysis data in the ticket format.
- Graphic printer Prints lists of analysis information and results.
Prints hardcopies of analysis results and screenshots
- List printer of histograms, scattergrams, etc.

023-1533-7 Waste tank full sensor Detects when the waste tank is full.
BE296356 External indicator light (SI-10) Enables you to see the current instrument status, even
CE314807 External indicator light from a distance.
(Lamp_Assy No. 7)
- IC card reader Reads an IC card.

*1 This can be used only when using the XR-1000.

*2 This can be used only when using the XR-2000.

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Chapter 5 Reagents

Chapter 5 Reagents

This chapter explains the reagents that are used with the instrument.

5.1 General information

All reagents used with this instrument are exclusively to be used with Sysmex instruments. Do not use them for any
other purpose. Make sure to use the specified reagents with the instrument.

5.2 Reagent list

The reagents, cleaning agents, quality control materials, and calibrators used with this instrument are as follows.
Follow the instructions for use and safety measures provided for each reagent to ensure correct and proper use.
• CELLPACK DCL
• CELLPACK DST
• CELLPACK DFL
• SULFOLYSER
• Lysercell WNR
• Lysercell WDF II
• Lysercell WPC
• Fluorocell WNR
• Fluorocell WDF
• Fluorocell RET
• Fluorocell PLT
• Fluorocell WPC
• CELLCLEAN AUTO
• XN CHECK
• XN CHECK BF
• XN CAL
• XN CAL PF

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Chapter 6 Installation

Chapter 6 Installation

6.1 Installation

6.1.1 Cautions regarding installation

The instrument and associated equipment is installed by your authorized local Sysmex representative. In case
relocation becomes necessary after installation, contact your authorized local Sysmex representative.
Problems resulting from moving of the equipment by anyone other than a Sysmex technical representative are
not covered by the warranty even within the warranty period.

6.1.2 Preparing for installation

This instrument is installed/moved by your authorized local Sysmex representative. The following is a list of
things to do beforehand to prepare for the installation/move.

• Secure ample space for installation, with safety considerations. For details, see the following:
(➤P.66 "6.1.5 Installation space")
• Note the weight of this instrument. Make sure that the floor and/or the equipment on which the instrument is to
be installed can withstand the weight.
• The power cable for this instrument is 2.0 m long. Use a nearby outlet that is designed for it.
• Once this instrument is delivered, check the condition of its packaging as soon as possible.

Information
If the packaging has been damaged in any way, please contact your authorized local Sysmex
representative as soon as possible.

• Until the installation is ready, store this instrument as packaged in a dry place. Store upright.

6.1.3 Grounding
The instrument power cable must be connected to a properly grounded power outlet. An appropriate adaptor
plug and power cable should be used according to your region. For details, please contact your authorized local
Sysmex representative.

Warning!
• Be sure to ground this instrument.
Improper grounding may cause electrical shock.
• Be sure not to exceed socket capacity.
Failure to do so may cause a fire.

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Caution!
Use the power cord that comes with the instrument. Also, do not use it with any other
instrument.

6.1.4 Installation environment

• Use the instrument in an ambient temperature within the range of 15 to 30 °C.
• Relative humidity should be within the range of 20 to 85 %.
• If ambient temperature and relative humidity are not within the suggested range, air-condition the
environment.
• Avoid places of extremely high or low temperatures.
• Avoid a place that is exposed to direct sunlight.
• Choose a well ventilated place.
• Avoid places with wireless communication devices or other equipment that can generate high frequency
waves, as radio interferences can occur.

6.1.5 Installation space

To secure the space required for maintenance, install the IPU on the right side of the analyzer.
Secure a distance of at least 30 cm behind the device.

● When using the XR-1000

The dimensions (width, depth, height) and weight have an acceptable range of ±5 % respectively.

Component Width (mm) Depth (mm) Height (mm) Weight (kg)

Analyzer (including
645 755 855 78
the sampler (SA-10))

Analyzer (including
520 680 840 70
the sampler (SA-01))

Pneumatic Unit 280 355 400 17

855 840

680
645 755 520

When using the sampler (SA-10) When using the sampler (SA-01)

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● When using the XR-2000

The dimensions (width, depth, height) and weight have an acceptable range of ±5 % respectively.

Component Width (mm) Depth (mm) Height (mm) Weight (kg)

Analyzer
(including the 960 880 855 143
sampler)

Pneumatic Unit 280 355 400 17

855

960 880

6.2 Basic settings of the system

After the instrument has been installed, the administrator must check the basic settings.
For the details on the instrument's settings, see the following.
(➤P.331 "Chapter 15: Instrument Setup")

● Check the time.

Make sure that the time displayed on the IPU matches the current time.

● Check the Auto Output settings.

If Auto Output is necessary, check that the instrument is set for automatic output/printing before starting
analysis.

● Set the alarm sound.

When an error occurs in the instrument, the IPU notifies you with an alarm.
There are three types of alarm sounds as indicated below.
• Alarm sound triggered when a warning error occurs
• Alarm sound for any error that stops the sampler analysis
• Alarm sound for emergency stop errors such as an instrument failure (the setting cannot be changed)

The alarm sounds below will come from the analyzer. These alarm sounds cannot be changed in the
configuration.

Short beep When loading the dye cassette or when the next samples can be analyzed
Long beep When an error is in progress
Long beep (continuous) When the dye cartridge is installed incorrectly

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6.3 Warranty
All Sysmex instruments are warranted against defective material or workmanship for a period of one year,
commencing on the date of installation at the customer's premises. This warranty does not however cover any defect,
malfunction or damage due to:
• Accident, neglect or willful mistreatment of the product.
• Failure to use, operate, service or maintain the product in accordance with the applicable Sysmex Instruction for
Use.
• Failure to use the appropriate reagents and supply parts specified for the product.

Information
If the customer moves the instrument or operates it at a different location, the warranty expires.
Please contact your authorized local Sysmex representative before moving.

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Chapter 7 Instrument Specifications

Chapter 7 Instrument Specifications

This chapter explains technical information such as specifications and principles.

7.1 Product specifications

Operating Ambient temperature: 15 to 30 °C (same with the temperature of the supplied

Environment reagent)
Relative humidity: 20 to 85 %
Pollution degree: 2

Storage Conditions Ambient temperature: -10 to 60 °C

Relative humidity: 20 to 95 % (no condensation)
Atmospheric pressure: 70 to 106 kPa

Dimensions • XR-1000
(including the Width: 645 mm (SA-10), 520 mm (SA-01)
sampler) Height: 855 mm (SA-10), 840 mm (SA-01)
Depth: 755 mm (SA-10), 680 mm (SA-01)
• XR-2000
Width: 960 mm
Height: 855 mm
Depth: 880 mm
The dimensions (width, depth, height) have an acceptable range of ±5 % respectively.

Total weight • XR-1000

(including the 78 kg (SA-10), 70 kg (SA-01)
sampler) • XR-2000
143 kg
Weights have an acceptable range of ±5 % respectively.
Pneumatic unit Width: 280 mm
dimensions Height: 400 mm
Depth: 355 mm
The dimensions (width, depth, height) have an acceptable range of ±5 % respectively.

Pneumatic unit 17 kg
weight Weight has an acceptable range of ±5 % respectively.

Power supply Analyzer (XR-10, XR-20) AC100 to 240 V (50 / 60 Hz)

Sampler (SA-10, SA-20) AC100 to 240 V (50 / 60 Hz)
Pneumatic unit AC100 to 117 V (50 / 60 Hz)
AC220 to 240 V (50 / 60 Hz)
Power consumption Analyzer (XR-10, XR-20) 270 VA or less
Sampler (SA-10, SA-20) 110 VA or less
Pneumatic unit 50 Hz: 230 VA or less (100 - 117 V),
220 VA or less (220 - 240 V)
60 Hz: 280 VA or less (100 - 117 V),
250 VA or less (220 - 240 V)
Noise level 60 dB or less
Excludes sounds during rinse cup discharge, shifting/discharge of sample racks,
clamping/release of sample tubes, and alarm sounds.

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Laser class Class I (IEC 60825-1:2007, IEC 60825-1:2014)

Protection type Class I

Safety standard IEC 61010-1:2001, IEC 61010-2-081:2001+A1, IEC 61010-2-101:2002

Throughput Values of the analyzer as a standalone unit are indicated below. The throughput of
[Whole Blood]/ the XR-2000 is equal to that of two analyzers.
[Low WBC] mode*1 CBC 110 samples/hour
CBC+DIFF 110 samples/hour (96 samples/hour*1)
CBC+DIFF+WPC*2 88 samples/hour (68 samples/hour*1)
2
CBC+DIFF+RET* 83 samples/hour (65 samples/hour*1)
CBC+RET* 2
83 samples/hour
CBC+DIFF+WPC+RET*2 71 samples/hour (57 samples/hour*1)
CBC+PLT-F* 2
68 samples/hour
CBC+DIFF+PLT-F*2 68 samples/hour (55 samples/hour*1)
2
CBC+DIFF+WPC+PLT-F* 53 samples/hour (45 samples/hour*1)
2
CBC+DIFF+RET+PLT-F* 47 samples/hour (41 samples/hour*1)
CBC+RET+PLT-F* 2
47 samples/hour
CBC+DIFF+WPC+RET+PLT-F*2 47 samples/hour (41 samples/hour*1)
*1 [Low WBC] mode.
*2 These items do not appear with all analyzer types.

Throughput Values of the analyzer as a standalone unit are indicated below. The throughput of
[Pre-Dilution] mode the XR-2000 is equal to that of two analyzers.
CBC 90 samples/hour
CBC+DIFF 90 samples/hour
CBC+DIFF+RET* 53 samples/hour
CBC+DIFF+PLT-F* 52 samples/hour
CBC+DIFF+RET+PLT-F* 39 samples/hour
* These items do not appear with all analyzer types.

Throughput Values of the analyzer as a standalone unit are indicated below. The throughput of
[Body Fluid] mode*2 the XR-2000 is equal to that of two analyzers.
40 samples/hour

Throughput Values of the analyzer as a standalone unit are indicated below. The throughput of
[HPC] mode*3 the XR-2000 is equal to that of two analyzers.
CBC+DIFF+RET+PLT-F+WPC* 16 samples/hour
CBC+DIFF+RET+WPC* 18 samples/hour
* These items do not appear with all analyzer types.
Sample Volume Sampler analysis: 88 µL
Aspirated Manual analysis: 88 µL
[Whole Blood] mode Micro analysis: 88 µL
[Low WBC] mode Micro analysis*: 88 µL
RBT analysis: 88 µL
* Analysis using a micro collection sample tube.

Sample Volume Micro analysis: 70 µL (The blood volume required for dilution is 20 µL.)
Aspirated Micro analysis*: 70 µL (The blood volume required for dilution is 20 µL.)
[Pre-Dilution] mode * Analysis using a micro collection sample tube.
Sample Volume Manual analysis: 88 µL
Aspirated Micro analysis: 88 µL
[Body Fluid] mode*2 Micro analysis*: 88 µL
* Analysis using a micro collection sample tube.

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Sample Volume Manual analysis: 190 µL

Aspirated Micro analysis: 190 µL
[HPC] mode*3 Micro analysis*: 190 µL
* Analysis using a micro collection sample tube.
Data Storage Samples stored: 100,000 samples
Capacity Patient information: 10,000 records
Wards registered: 200 wards
Doctor names registered: 200 names
Analysis registration function: 2,000 records
QC files: 99 files per analyzer (300 plots per file)
Reagent replacement history: 5,000 records
Maintenance history: 5,000 records
User accounts: 100 records
Quality Control X-bar control (L-J control): 300 plots x 94 files
X-barM control: 300 plots x 5 files

*1 When a Raised Bottom Tube is used, processing throughput decreases.

*2 The body fluid analysis can only be performed if the license is activated.
*3 HPC analysis can only be performed if the license is activated.

Parameters For details on diagnostics parameters, see Chapter 1.

(➤P.14 "Chapter 1: 1.3 Parameters")

Background limits WBC 0.10 x 103/µL or less

RBC 0.02 x 106/µL or less
HGB 0.1 g/dL or less
PLT-I 10 x 103/µL or less
PLT-O* 10 x 103/µL or less
PLT-F* 3 x 103/µL or less
WBC-BF* 0.001 x 103/µL or less
RBC-BF* 0.003 x 106/µL or less
* The availability of these functions depends on your system configuration.

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7.2 Performance characteristics

Note:
Channels and diagnostics parameters are specified depending on the connected analyzer.
For details, see Chapter 1. (➤P.14 "Chapter 1: 1.3 Parameters")

Measuring Interval (Reportable range)

The Measuring Interval comprises the range of measured quantities in which the measurement can be
performed with specified precision. It is set from the Limit of Quantitation (LoQ) as the Lower Limit of the
Measuring Interval to the upper limit of Linearity as the Upper Limit of the Measuring Interval.

Parameter Units Measuring Interval Display Range

WBC x 103/µL 0.03 to 440.00 0.00 to 999.99
RBC x 106/µL 0.01 to 8.60 0.00 to 99.99
HGB g/dL 0.1 to 26.0 0.0 to 30.0
HCT % 0.1 to 75.0 0.0 to 100.0
MCV fL N/A*2 0.0 to 999.9
MCH pg N/A*2 0.0 to 999.9
MCHC g/dL N/A*2 0.0 to 999.9
PLT*1 x 103/µL 2 to 5,000 0 to 9,999
RDW-SD fL N/A*3 0.0 to 999.9
RDW-CV % N/A*3 0.0 to 999.9
MicroR % N/A*4 0.0 to 999.9
MacroR % N/A*4 0.0 to 999.9
PDW fL N/A*3 0.0 to 999.9
MPV fL N/A*2 0.0 to 999.9
4
P-LCR % N/A* 0.0 to 999.9
PCT % 0.01 to 3.00 0.00 to 99.99
NRBC% /100WBC N/A*4 0.0 to 9,999.9
3/µL
NRBC# x 10 0.03 to 20.00 0.00 to 999.99
NEUT% % N/A*4 0.0 to 100.0
NEUT# x 103/µL 0.03 to 440.00 0.00 to 999.99
LYMPH% % N/A*4 0.0 to 100.0
LYMPH# x 103/µL 0.03 to 440.00 0.00 to 999.99
MONO% % N/A*4 0.0 to 100.0
MONO# x 103/µL 0.03 to 440.00 0.00 to 999.99
EO% % N/A*4 0.0 to 100.0
EO# x 103/µL 0.03 to 440.00 0.00 to 999.99
BASO% % N/A*4 0.0 to 100.0
BASO# x 103/µL 0.03 to 440.00 0.00 to 999.99
IG% % N/A*4 0.0 to 100.0
IG# x 103/µL 0.03 to 440.00 0.00 to 999.99

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Parameter Units Measuring Interval Display Range

5 4
AS-LYMP%* % N/A* 0.0 to 100.0
5 3
AS-LYMP#* x 10 /µL 0.03 to 440.00 0.00 to 999.99
RE-LYMP%*5 % N/A* 4
0.0 to 100.0
RE-LYMP#*5 3
x 10 /µL 0.03 to 440.00 0.00 to 999.99
5 2
NEUT-RI* FI N/A* 0.0 to 999.9
5 2
NEUT-GI* SI N/A* 0.0 to 999.9
5
RET%* % N/A 0.00 to 99.99
5 6
RET#* x 10 /µL 0.0100 to 0.7200 0.0000 to 0.9999
IRF*5 % N/A* 4
0.0 to 100.0
LFR*5 % N/A*4 0.0 to 100.0
MFR*5 % N/A*4 0.0 to 100.0
HFR*5 % N/A*4 0.0 to 100.0
RET-He*5 pg N/A*2 0.0 to 999.9
RBC-He*5 pg N/A* 2
0.0 to 999.9
Delta-He*5 pg N/A*6 -999.9 to 999.9
HYPO-He*5 % N/A*4 0.0 to 100.0
HYPER-He*5 % N/A*4 0.0 to 100.0
IPF*5 % N/A*4 0.0 to 100.0
IPF#*5 x 103/µL 1 to 5000 0.0 to 999.9
WBC-BF*5 x 103/µL 0.003 to 10.000 0.000 to 999.999
RBC-BF*5 x 106/µL 0.002 to 5.000 0.000 to 99.999
TC-BF#*5 x 103/µL 0.003 to 10.000 0.000 to 999.999
MN%*5 % N/A*4 0.0 to 100.0
MN#*5 x 103/µL 0.003 to 10.000 0.000 to 999.999
PMN%*5 % N/A*4 0.0 to 100.0
5 103/µL
PMN#* x 0.003 to 10.000 0.000 to 999.999
HPC%*5 % N/A*4 0.00 to 99.99
HPC#*5 x 103/µL 0.008 to 7.000 0.000 to 99.999

*1 The value when PLT-I or PLT-O is selected is described. This may vary depending on your system
configuration.
*2 This parameter does not represent a count but a mean of multiple events.
*3 This parameter does not represent a count.
*4 This parameter does not represent a count but a ratio.
*5 The availability of these functions depends on your system configuration.
*6 This parameter does not represent a count but a sum.

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Repeatability Indicated as coefficients of variation when analysis of peripheral blood (samples

[Whole Blood] mode with nucleated RBC for NRBC, samples with immature granulocyte for IG
[HPC] mode*1 (same-day blood), diluted peripheral blood for PLT-F and samples with at least
RET# 0.020 × 106/µL for RET-He (same-day blood)) or quality control material is
repeated at least 10 times.
(For NRBC and IG, abnormal samples of peripheral blood (samples with nucleated
RBC for NRBC, samples with immature granulocyte for IG (same-day blood))
repeatedly analyzed at least 5 times.)
WBC-N 3.0 % or less (4.00 x 103/µL or more)
WBC-D 3.0 % or less (4.00 x 103/µL or more)
RBC 1.5 % or less (4.00 x 106/µL or more)
HGB 1.0 % or less
HCT 1.5 % or less
MCV 1.0 % or less
MCH 2.0 % or less
MCHC 2.0 % or less
PLT-I 4.0 % or less (100 x 103/µL or more)
PLT-O* 6.0 % or less (100 x 103/µL or more)
PLT-F* 2.5 % or less (PLT 100 x 103/µL or more)
5.0 % or less (PLT 20 x 103/µL or more)
RDW-SD 2.0 % or less
RDW-CV 2.0 % or less
MicroR 15.0 % or less, or within ±1.0 MicroR
MacroR 15.0 % or less, or within ±1.0 MacroR
PDW 10.0 % or less
MPV 4.0 % or less
P-LCR 15.0 % or less
PCT 6.0 % or less
NRBC% 25.0 % or less, or within ±1.5 NRBC% (WBC 4.00 x 103/µL or more)
NRBC# 25.0 % or less, or within ±0.12 x 103/µL
NEUT% 8.0 % or less (NEUT% 30.0 or more, WBC 4.00 x 103/µL or more)
NEUT# 8.0 % or less (1.20 x 103/µL or more)
LYMPH% 8.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
LYMPH# 8.0 % or less (0.60 x 103/µL or more)
MONO% 20.0 % or less (MONO% 5.0 or more, WBC 4.00 x 103/µL or more)
MONO# 20.0 % or less (0.20 x 103/µL or more)
EO% 25.0 % or less, or within ±1.5 EO% (WBC 4.00 x 103/µL or more)
EO# 25.0 % or less, or within ±0.12 x 103/µL
BASO% 40.0 % or less, or within ±1.0 BASO% (WBC 4.00 x 103/µL or more)
BASO# 40.0 % or less, or within ±0.06 x 103/µL
IG% 25.0 % or less or within ±1.5 IG%
(IG% 2.0 % or more, WBC 4.00 x 103/µL or more)
IG# 25.0 % or less or within ±0.12 x 103/µL (IG# 0.10 x 103/µL or more)
AS-LYMP%* 20.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
AS-LYMP#* 20.0 % or less (0.60 x 103/µL or more)
RE-LYMP%* 20.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
RE-LYMP#* 20.0 % or less (0.60 x 103/µL or more)
NEUT-RI* 3.0 % or less (NEUT# 1.20 x 103/µL or more)
NEUT-GI* 3.0 % or less (NEUT# 1.20 x 103/µL or more)

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Repeatability RET%* 15.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
[Whole Blood] mode RET#* 15.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
[HPC] mode*1 IRF* 30.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %,
IRF 20.0 % or more)
LFR* 30.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %,
LFR 20.0 % or more)
MFR* 50.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %,
LFR 20.0 % or more)
HFR* 100.0 % or less or within ±2.0 HFR
(RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
RET-He* 5.0 % or less (RET# 0.0200 x 106/µL or more)
RBC-He* 5.0 % or less
Delta-He* RET-He 5.0 % or less, RBC-He 5.0 % or less
(RET# 0.0200 x 106/µL or more)
HYPO-He* 25.0 % or less, or within ±1.0 HYPO-He
HYPER-He* 25.0 % or less, or within ±1.0 HYPER-He
IPF* 25.0 % or less (PLT 50 x 103/µL or more, IPF 3.0 % or more)
20.0 % or less (PLT 10 to 50 x 103/µL, IPF 10.0 % or more)
IPF#* 25.0 % or less (PLT 50 x 103/µL or more, IPF 3.0 % or more)
20.0 % or less (PLT 10 to 50 x 103/µL, IPF 10.0 % or more)
Indicates the coefficient of variation when peripheral blood (sample with HPC) is
analyzed at least 5 times in succession.
HPC%* 30.0 % or less or within ±1.50 HPC%
HPC#* 30.0 % or less or within ±15/µL
* The availability of these functions depends on your system configuration.

Repeatability Indicated as coefficients of variation when analysis of diluted peripheral blood

[Pre-Dilution] mode (samples with nucleated RBC for NRBC, samples with immature granulocyte for IG
(same-day blood), and samples with at least RET# 0.020 × 106/µL for RET-He
(same-day blood)) or quality control material is repeated at least 10 times.
(For NRBC and IG, abnormal samples of peripheral blood (samples with nucleated
RBC for NRBC, samples with immature granulocyte for IG (same-day blood))
repeatedly analyzed at least 5 times.)
WBC-N 5.0 % or less (4.00 x 103/µL or more)
WBC-D 5.0 % or less (4.00 x 103/µL or more)
RBC 4.5 % or less (4.00 x 106/µL or more)
HGB 3.0 % or less
HCT 4.5 % or less
MCV 4.5 % or less
MCH 4.5 % or less
MCHC 6.0 % or less

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Repeatability PLT-I 12.0 % or less (100 x 103/µL or more)

[Pre-Dilution] mode PLT-O* 13.0 % or less (100 x 103/µL or more)
PLT-F* 5.0 % or less (PLT 100 x 103/µL or more)
10.0 % or less (PLT 20 x 103/µL or more)
RDW-SD 6.0 % or less
RDW-CV 6.0 % or less
MicroR 36.0 % or less, or within ±2.0 MicroR
MacroR 36.0 % or less, or within ±2.0 MacroR
PDW 20.0 % or less
MPV 8.0 % or less
P-LCR 36.0 % or less
PCT 12.0 % or less
NRBC% 50.0 % or less, or within ±3.0 NRBC% (WBC 4.00 x 103/µL or more)
NRBC# 50.0 % or less, or within ±0.25 x 103/µL
NEUT% 16.0 % or less (NEUT% 30.0 or more, WBC 4.00 x 103/µL or more)
NEUT# 16.0 % or less (1.20 x 103/µL or more)
LYMPH% 16.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
LYMPH# 16.0 % or less (0.60 x 103/µL or more)
MONO% 40.0 % or less (MONO% 5.0 or more, WBC 4.00 x 103/µL or more)
MONO# 40.0 % or less (0.20 x 103/µL or more)
EO% 40.0 % or less (WBC 4.00 x 103/µL or more)
EO# 40.0 % or less
BASO% 50.0 % or less, or within ±1.5 BASO% (WBC 4.00 x 103/µL or more)
BASO# 50.0 % or less, or within ±0.06 x 103/µL
IG% 75.0 % or less, or within ±4.5 IG%
(IG% 2.0 % or more, WBC 4.00 x 103/µL or more)
IG# 75.0 % or less, or within ±0.36 x 103/µL (IG# 0.10 x 103/µL or more)
AS-LYMP%* 40.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
AS-LYMP#* 40.0 % or less (0.60 x 103/µL or more)
RE-LYMP%* 40.0 % or less (LYMPH% 15.0 or more, WBC 4.00 x 103/µL or more)
RE-LYMP#* 40.0 % or less (0.60 x 103/µL or more)
NEUT-RI* 6.0 % or less (NEUT# 1.20 x 103/µL or more)
NEUT-GI* 6.0 % or less (NEUT# 1.20 x 103/µL or more)
RET%* 35.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
RET#* 35.0 % or less (RBC 3.00 x 106/µL or more, RET% 1.00 to 4.00 %)
IPF* 40.0 % or less (PLT 50 x 103/µL or more, IPF 3.0 % or more)
IPF#* 40.0 % or less (PLT 50 x 103/µL or more, IPF 3.0 % or more)
* The availability of these functions depends on your system configuration.

Repeatability Indicated as coefficients of variation when analysis of diluted samples of peripheral

[Body Fluid] mode*2 blood or quality control material is repeated at least 10 times.
WBC-BF 30.0 % or less (0.005 to 0.015 x 103/µL)
15.0 % or less (0.016 to 0.030 x 103/µL)
10.0 % or less (0.031 to 0.050 x 103/µL)
RBC-BF 40.0 % or less, or Max - Min ≤ 0.007 x 106/µL
(0.003 to 0.050 x 106/µL)
TC-BF# 30.0 % or less (0.005 to 0.015 x 103/µL)
15.0 % or less (0.016 to 0.030 x 103/µL)
10.0 % or less (0.031 to 0.050 x 103/µL)
*1 The availability of the HPC analysis function depends on your system configuration.
*2 The body fluid analysis can only be performed if the license is activated.

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Precision
The Precision (within-run precision (repeatability), reproducibility, and intermediate precision) is indicated in the
following table as coefficients of variation, when control materials are measured according to CLSI EP05-A3.

Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3

WBC-N 10 % or less 6 % or less 6 % or less
WBC-D 10 % or less 6 % or less 6 % or less
RBC 5 % or less 5 % or less 5 % or less
HGB 4 % or less 3 % or less 3 % or less
HCT 10 % or less 10 % or less 10 % or less
MCV 5 % or less 5 % or less 5 % or less
MCH 9 % or less 8 % or less 8 % or less
MCHC 15 % or less 14 % or less 14 % or less
PLT-I 80 % or less 15 % or less 9 % or less
PLT-O*1 70 % or less 30 % or less 15 % or less
PLT-F*1 45 % or less 30 % or less 15 % or less
RDW-SD 10 % or less 10 % or less 10 % or less
RDW-CV 10 % or less 10 % or less 10 % or less
MicroR 60 % or less 70 % or less 80 % or less
MacroR 50 % or less 40 % or less 40 % or less
PDW 80 % or less 16 % or less 12 % or less
MPV within mean ±9.0 fL 9 % or less 7 % or less
P-LCR within mean ±30.0 P-LCR% 50 % or less 50 % or less
PCT 116 % or less 30 % or less 25 % or less
NRBC% 50 % or less 50 % or less 50 % or less
NRBC# 50 % or less 50 % or less 50 % or less
NEUT% 20 % or less 15 % or less 15 % or less
NEUT# 20 % or less 15 % or less 15 % or less
LYMPH% 40 % or less 20 % or less 20 % or less
LYMPH# 40 % or less 20 % or less 20 % or less
MONO% 80 % or less 60 % or less 50 % or less
MONO# 80 % or less 60 % or less 50 % or less
EO% 50 % or less 50 % or less 50 % or less
EO# 50 % or less 50 % or less 50 % or less
BASO% 78 % or less 78 % or less 78 % or less
BASO# 78 % or less 78 % or less 78 % or less
IG% 30 % or less 30 % or less 25 % or less
IG# 30 % or less 30 % or less 25 % or less
AS-LYMP%*1 60 % or less 50 % or less 50 % or less
AS-LYMP#*1 60 % or less 50 % or less 50 % or less
1
RE-LYMP%* 60 % or less 50 % or less 50 % or less
RE-LYMP#*1 60 % or less 50 % or less 50 % or less

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Parameter XN CHECK Level 1 XN CHECK Level 2 XN CHECK Level 3

1
NEUT-RI* 40 % or less 40 % or less 40 % or less
1
NEUT-GI* 10 % or less 10 % or less 10 % or less
RET%*1 20 % or less 20 % or less 35 % or less
1
RET#* 30 % or less 30 % or less 30 % or less
1
IRF* within mean ±36 IRF% within mean ±36 IRF% within mean ±36 IRF%
LFR*1 within mean ±33 LFR% within mean ±33 LFR% within mean ±33 LFR%
MFR*1 within mean ±28 MFR% within mean ±28 MFR% within mean ±28 MFR%
1
HFR* within mean ±11 HFR% within mean ±11 HFR% within mean ±11 HFR%
RET-He*1 10 % or less 10 % or less 10 % or less
RBC-He*1 20 % or less 20 % or less 20 % or less
Delta-He*1 N/A*2 N/A*2 N/A*2
HYPO-He*1 within mean within mean within mean
±2.0 HYPO-He% ±1.0 HYPO-He% ±0.5 HYPO-He%
HYPER-He*1 within mean within mean within mean
±0.3 HYPER-He% ±0.7 HYPER-He% ±1.0 HYPER-He%
IPF%*1 within mean ±5.0 IPF% within mean ±5.0 IPF% within mean ±5.0 IPF%
IPF#*1 95 % or less 75 % or less 70 % or less

*1 The availability of these functions depends on your system configuration.

*2 Since Delta-He is calculated as the difference of RET-He to RBC-He, the specification is not applicable.

Parameter XN CHECK BF Level 1 XN CHECK BF Level 2

WBC-BF 35 % or less 25 % or less
RBC-BF 35 % or less 25 % or less
TC-BF# 35 % or less 25 % or less
PMN% 100 % or less 100 % or less
PMN# 100 % or less 100 % or less
MN% 100 % or less 100 % or less
MN# 100 % or less 100 % or less

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Limit of Blank, Limit of Detection, Limit of Quantitation

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) for the parameters counted directly
meet the criteria in the following table, when evaluated according to CLSI EP17-A2.

[Whole Blood] mode, [HPC] mode

Parameter Units LoB LoD LoQ
3
WBC-N x 10 /µL 0.00 0.02 0.03
WBC-D x 103 /µL 0.00 0.03 0.03
RBC x 106 /µL 0.00 0.01 0.01
HGB g/dL 0.0 0.1 0.1
HCT % 0.0 0.1 0.1
PLT-I x 103/µL 0 1 2
PLT-O* x 103/µL 0 2 2
PLT-F* x 103/µL 0 1 1
PCT % 0.00 0.01 0.01
NEUT# x 103/µL 0.00 0.03 0.03
LYMPH# x 103/µL 0.00 0.03 0.03
MONO# x 103/µL 0.00 0.03 0.03
EO# x 103/µL 0.00 0.03 0.03
BASO# x 103/µL 0.00 0.03 0.03
IG# x 103/µL 0.00 0.03 0.03
AS-LYMP#* x 103/µL 0.00 0.03 0.03
RE-LYMP#* x 103/µL 0.00 0.03 0.03
NRBC# x 103/µL 0.00 0.02 0.03
RET#* x 106/µL 0.00 0.01 0.01
IPF#* x 103/µL 0.0 1.0 1.0
HPC#* x 103/µL 0.000 0.004 0.007

* The availability of these functions depends on your system configuration.

[Low WBC] mode

Parameter Units LoB LoD LoQ
3
WBC-D x 10 /µL 0.00 0.02 0.03
NEUT# x 103/µL 0.00 0.02 0.03
LYMPH# x 103/µL 0.00 0.02 0.03
MONO# x 103/µL 0.00 0.02 0.03
EO# x 103/µL 0.00 0.02 0.03
BASO# x 103/µL 0.00 0.02 0.03
3
IG# x 10 /µL 0.00 0.02 0.03
AS-LYMP#* x 103/µL 0.00 0.02 0.03
RE-LYMP#* x 103/µL 0.00 0.02 0.03

* The availability of these functions depends on your system configuration.

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[Pre-Dilution] mode
Parameter Units LoB LoD LoQ
WBC-N x 103/µL 0.02 0.04 0.04
WBC-D x 103/µL 0.02 0.05 0.05
6
RBC x 10 /µL 0.00 0.01 0.01
HGB g/dL 0.0 0.1 0.2
HCT % 0.0 0.1 0.1
PLT-I x 103/µL 0 4 4
PLT-O* x 103/µL 0 4 4
PLT-F* x 103/µL 0 3 3
PCT % 0.00 0.01 0.01
NEUT# x 103/µL 0.02 0.05 0.05
LYMPH# x 103/µL 0.02 0.05 0.05
MONO# x 103/µL 0.02 0.05 0.05
EO# x 103/µL 0.02 0.05 0.05
BASO# x 103/µL 0.02 0.05 0.05
IG# x 103/µL 0.02 0.05 0.05
AS-LYMP#* x 103/µL 0.02 0.05 0.05
RE-LYMP#* x 103/µL 0.02 0.05 0.05
NRBC# x 103/µL 0.02 0.04 0.04
RET#* x 106/µL 0.00 0.01 0.01
IPF#* x 103/µL 0 3 3

* The availability of these functions depends on your system configuration.

[Body Fluid] mode*

Parameter Units LoB LoD LoQ
WBC-BF x 103/µL 0.000 0.002 0.003
6/µL
RBC-BF x 10 0.000 0.002 0.002
TC-BF# x 103/µL 0.001 0.002 0.003
MN# x 103/µL 0.000 0.002 0.003
PMN# x 103/µL 0.000 0.002 0.003

* The availability of these functions depends on your system configuration.

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Accuracy Indicated as the average value of the difference between the measured values of
(blood cell count) at least 100 samples of peripheral blood and values measured on a reference
[Whole Blood] mode instrument or standard methods*1.
[HPC] mode*1 WBC-N within ±3 % or ±0.20 x 103/µL
WBC-D within ±3 % or ±0.20 x 103/µL
RBC within ±2 % or ±0.03 x 106/µL
HGB within ±2 % or ±0.2 g/dL
HCT within ±3 % or ±1.0 HCT
MCV within ±3 % or ±2.0 fL
PLT-I within ±5 % or ±10 x 103/µL
2
PLT-O* within ±7 % or ±10 x 103/µL
PLT-F*2 within ±5 % or ±10 x 103/µL
MPV within ±5 % or ±1.0 fL (PLT 100 x 103/µL or more)
PCT within ±5 % or ±0.03 PCT (PLT 100 x 103/µL or more)
Indicated as a correlation factor (r) with the reference data when at least
100 samples of peripheral blood are analyzed. The reference data is obtained from
the reference instrument.
IPF*2 r ≥ 0.8
IPF#*2 r ≥ 0.8
Indicated as a tolerance with respect to the average value reference data when at
least 20 samples of peripheral blood are analyzed.
The reference data are obtained by the standard analysis method using the flow
cytometry method based on the CD34 positive cell analysis method.
HPC#*2 within ±30.0 % or ±10/µL
HPC%*2 within ±30.0 % or ±0.50 HPC%
*1 In the case of HGB, the hemoglobin analysis method using the
cyanmethemoglobin (HiCN) method in accordance with the recommendations
of the ICSH (International Council for Standardization in Haematology).
In the case of HCT, the standard analysis method in accordance with the
recommendations of the ICSH (International Council for Standardization in
Haematology).
In the case of PLT, the reference data is obtained by the standard analysis
method or on the reference instrument by the flow cytometry method based on
standard methods.
*2 The availability of these functions depends on your system configuration.

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Accuracy Indicated as the average value of the difference between the measured values of
(blood cell count) at least 100 samples of diluted peripheral blood and values measured on a
[Pre-Dilution] mode reference instrument or standard methods*1.
WBC-N within ±10 %
WBC-D within ±10 %
RBC within ±8 %
HGB within ±5 %
HCT within ±4 % or ±2.0 HCT
MCV within ±4 % or ±3.0 fL
PLT-I within ±10 %
PLT-O*2 within ±15 %
2
PLT-F* within ±10 %
MPV within ±7 % or ±1.5 fL (PLT 100 x 103/µL or more)
PCT within ±7 % or ±0.04 PCT (PLT 100 x 103/µL or more)
Indicated as a correlation factor (r) with the reference data when at least
100 samples of diluted peripheral blood are analyzed. The reference data is
obtained from the reference instrument.
IPF*2 r is 0.5 or greater
IPF#*2 r is 0.5 or greater
*1 In the case of HGB, the hemoglobin analysis method using the
cyanmethemoglobin (HiCN) method in accordance with the recommendations
of the ICSH (International Council for Standardization in Haematology).
In the case of HCT, the standard analysis method in accordance with the
recommendations of the ICSH (International Council for Standardization in
Haematology).
In the case of PLT, the reference data is obtained by the standard analysis
method or on the reference instrument by the flow cytometry method based on
standard methods.
*2 The availability of these functions depends on your system configuration.

Accuracy Indicates the correlation factor (r) with the reference method and the slope of the
(blood cell count) regression line when 50 or more body fluid samples are analyzed. The reference
[Body Fluid] mode*2 data are obtained from the reference instrument.
WBC-BF r is 0.9 or greater and the slope of the regression line is within 1 ±0.3
RBC-BF r is 0.8 or greater and the slope of the regression line is within 1 ±0.3
TC-BF# r is 0.9 or greater and the slope of the regression line is within 1 ±0.3

*1 The availability of the HPC analysis function depends on your system configuration.
*2 The body fluid analysis can only be performed if the license is activated.

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Accuracy Indicated as a correlation factor (r) with the reference data when at least
(differential blood 100 samples (at least 20 samples for NRBC and IG) of peripheral blood (samples
count) with nucleated RBC for NRBC, samples with immature granulocyte for IG) are
[Whole Blood] mode analyzed.
[HPC] mode*1 The reference data is obtained by a standard analysis method that uses the flow
cytometry method, based on the reference instrument, standard 5-category white
blood cell analysis method, standard NRBC analysis method, or standard
immature granulocyte analysis method.
NRBC% r is 0.80 or greater
NEUT% r is 0.90 or greater
LYMPH% r is 0.90 or greater
MONO% r is 0.75 or greater
EO% r is 0.80 or greater
BASO% r is 0.50 or greater
IG% r is 0.80 or greater
Indicated as the average value of the difference between the measured values of
at least 100 samples (at least 20 samples for NRBC and IG) of peripheral blood
(samples with nucleated RBC for NRBC, samples with immature granulocyte for
IG) and values measured on a reference instrument.
NEUT% within ±3.0 NEUT%
LYMPH% within ±3.0 LYMPH%
MONO% within ±2.0 MONO%
EO% within ±1.0 EO%
BASO% within ±1.0 BASO%
IG% within ±1.5 IG%

Accuracy Indicated as a correlation factor (r) with the reference data when at least
(differential blood 100 samples (at least 20 samples for NRBC) of diluted peripheral blood (samples
count) with nucleated RBC for NRBC) are analyzed.
[Pre-Dilution] mode The reference data is obtained by a standard analysis method that uses the flow
cytometry method, based on the reference instrument, standard 5-category white
blood cell analysis method, standard NRBC analysis method, or standard
immature granulocyte analysis method.
NRBC% r is 0.70 or greater
NEUT% r is 0.70 or greater
LYMPH% r is 0.70 or greater
MONO% r is 0.60 or greater
EO% r is 0.60 or greater
BASO% r is 0.50 or greater
Indicated as the average value of the difference between the measured values of
at least 100 samples (at least 20 samples for NRBC) of peripheral blood (samples
with nucleated RBC for NRBC) and values measured on a reference instrument.
NEUT% within ±3.0 NEUT%
LYMPH% within ±3.0 LYMPH%
MONO% within ±2.0 MONO%
EO% within ±1.0 EO%
BASO% within ±1.0 BASO%

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Accuracy Indicates the correlation factor (r) with the reference method and the slope of the
(differential blood regression line when 50 or more body fluid samples are analyzed. The reference
count) data are obtained from the reference instrument.
[Body Fluid] mode*2 MN# r is 0.9 or greater and the slope of the regression line is within 1 ±0.5
PMN# r is 0.9 or greater and the slope of the regression line is within 1 ±0.5
MN% r is 0.7 or greater and the slope of the regression line is within 1 ±0.5
PMN% r is 0.7 or greater and the slope of the regression line is within 1 ±0.5
*1 The availability of the HPC analysis function depends on your system configuration.
*2 The body fluid analysis can only be performed if the license is activated.

Accuracy Indicated as a correlation factor (r) with the reference data when at least
(reticulocyte 100 samples of peripheral blood are analyzed.
parameters*1) The reference data are obtained from the reference instrument or the visual
[Whole Blood] mode observation method.
[HPC] mode*2 RET% r is 0.90 or greater
RET# r is 0.90 or greater
RET-He r is 0.9 or greater
(More than half of the samples are RET# 0.020 x 106/µL or more)
RBC-He r is 0.9 or greater
Delta-He RET-He r is 0.9 or greater and RBC-He r is 0.9 or greater
Indicated as the average value of the difference between the measured values of
at least 100 samples of peripheral blood and values measured on a reference
instrument.
RET% within ±20 % or ±0.30 RET%
RET# within ±20 % or ±0.0150 x 106/µL
IRF within ±30 % or ±10.0 IRF (within 40.0 IRF*)
LFR within ±30 % or ±10.0 LFR (within 35.0 LFR*)
MFR within ±30 % or ±10.0 MFR (within 30.0 MFR*)
HFR within ±30 % or ±5.0 HFR (within 15.0 HFR*)
* Quality control material or calibrator

Accuracy Indicated as a correlation factor (r) with the reference data when at least
(reticulocyte 100 samples of diluted peripheral blood are analyzed.
parameters*1) The reference data are obtained from the reference instrument or the visual
[Pre-Dilution] mode observation method.
RET% r is 0.80 or greater
RET# r is 0.80 or greater
RET-He r is 0.7 or greater
RBC-He r is 0.7 or greater
Delta-He RET-He r is 0.7 or greater and RBC-He r is 0.7 or greater
Indicated as the average value of the difference between the measured values of
at least 100 samples of diluted peripheral blood and values measured on a
reference instrument.
RET% within ±30 % or ±0.50 RET%
RET# within ±30 % or ±0.020 x 106/µL
IRF within ±50 % or ±10.0 IRF
LFR within ±50 % or ±10.0 LFR
MFR within ±50 % or ±10.0 MFR
HFR within ±50 % or ±5.0 HFR

*1 These messages do not appear with all analyzer types.

*2 The availability of the HPC analysis function depends on your system configuration.

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Linearity Linearity can be assessed by testing levels of a parameter with known

[Whole Blood] mode concentration using peripheral blood or by using commercially available materials
[HPC] mode* qualified for use on the XR. The specification is indicated as "regression
coefficient" and "percentage variation".
WBC-N R2 = 0.95 or greater (0.00 to 440.00 x 103/µL)
within ±3 % or ±0.20 x 103/µL (0.00 to 100.00 x 103/µL)
within ±6 % (100.01 to 310.00 x 103/µL)
within ±11 % (310.01 to 440.00 x 103/µL)
WBC-D R2 = 0.95 or greater (0.00 to 440.00 x 103/µL)
within ±3 % or ±0.20 x 103/µL (0.00 to 100.00 x 103/µL)
within ±6 % (100.01 to 310.00 x 103/µL)
within ±11 % (310.01 to 440.00 x 103/µL)
RBC R2 = 0.95 or greater (0.00 to 8.60 x 106/µL)
within ±2 % or ±0.03 x 106/µL (0.00 to 8.00 x 106/µL)
within ±4 % or ±0.06 x 106/µL (8.01 to 8.60 x 106/µL)
HGB R2 = 0.95 or greater (0.00 to 26.0 g/dL)
within ±2 % or ±0.2 g/dL (0.0 to 25.0 g/dL, 0.00 to 15.52 mmol/L)
within ±5 % or ±0.5 g/dL (25.1 to 26.0 g/dL, 15.53 to 16.14 mmol/L)
HCT R2 = 0.95 or greater (0.0 to 75.0 %)
within ±3 % or ±1.0 HCT (0.0 to 75.0 %)
PLT-I R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±5 % or ±10 x 103/µL (0 to 1,000 x 103/µL)
within ±6 % (1,001 to 5,000 x 103/µL)
PLT-O* R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±7 % or ±10 x 103/µL (0 to 5,000 x 103/µL)
PLT-F* R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±5 % or ±10 x 103/µL (0 to 1,000 x 103/µL)
within ±6 % (1,001 to 5,000 x 103/µL)
PCT R2 = 0.95 or greater (0.0 to 3.0 %)
NRBC% within ±20 % or ±2.0 NRBC% (0.0 to 600.0/100WBC)
NRBC# R2 = 0.95 or greater (0.00 to 20.00 x 103/µL)
within ±10 % or ±0.20 x 103/µL (0.00 to 20.00 x 103/µL)
RET%* within ±20 % or ±0.30 RET% (0.00 to 30.00 %)
RET#* R2 = 0.95 or greater (0.0000 to 0.7200 x 106/µL)
within ±20 % or ±0.0150 x 106/µL (0.0000 to 0.7200 x 106/µL)
HPC# R2 = 0.95 or greater (0.00 to 7.000 x 103/µL)

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Linearity Linearity can be assessed by testing levels of a parameter with known

[Pre-Dilution] mode concentration using peripheral blood or by using commercially available materials
qualified for use on the XR. The specification is indicated as "regression
coefficient" and "percentage variation".
WBC-N R2 = 0.95 or greater (0.00 to 440.00 x 103/µL)
within ±10 % or ±0.40 x 103/µL (0.00 to 440.00 x 103/µL)
WBC-D R2 = 0.95 or greater (0.00 to 440.00 x 103/µL)
within ±10 % or ±0.40 x 103/µL (0.00 to 440.00 x 103/µL)
RBC R2 = 0.95 or greater (0.00 to 8.60 x 106/µL)
within ±8 % or ±0.06 x 106/µL (0.00 to 8.60 x 106/µL)
HGB R2 = 0.95 or greater (0.00 to 26.0 g/dL)
within ±5 % or ±0.5 g/dL (0.0 to 26.0 g/dL, 0.00 to 16.14 mmol/L)
HCT R2 = 0.95 or greater (0.0 to 75.0 %)
within ±4 % or ±2.0 HCT (0.0 to 75.0 %)
PLT-I R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±10 % or ±20 x 103/µL (0 to 5,000 x 103/µL)
PLT-O* R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±15 % or ±20 x 103/µL (0 to 5,000 x 103/µL)
PLT-F* R2 = 0.95 or greater (0 to 5,000 x 103/µL)
within ±10 % or ±20 x 103/µL (0 to 5,000 x 103/µL)
NRBC% within ±20 % or ±2.0 NRBC% (0.0 to 600.0/100WBC)
NRBC# R2 = 0.95 or greater (0.00 to 20.00 x 103/µL)
within ±10 % or ±0.20 x 103/µL (0.00 to 20.00 x 103/µL)
RET%* within ±20 % or ±0.30 RET% (0.00 to 30.00 %)
RET#* R2 = 0.95 or greater (0.0000 to 0.7200 x 106/µL)
within ±20 % or ±0.0150 x 106/µL (0.0000 to 0.7200 x 106/µL)

Linearity Linearity can be assessed by testing levels of a parameter with known

[Body Fluid] mode* concentration using peripheral blood or by using commercially available materials
qualified for use on the XR. The specification is indicated as "regression coefficient"
and "percentage variation".
WBC-BF R2 = 0.95 or greater (0.000 to 10.000 x 103/µL)
within ±0.010 x 103/µL (0.000 to 0.050 x 103/µL, RBC < 1.000 x 106/µL)
within ±20 % (0.051 to 10.000 x 103/µL, RBC < 1.000 x 106/µL)
RBC-BF R2 = 0.95 or greater (0.000 to 5.000 x 106/µL)
within ±2 % or ±0.010 x 106/µL (0.000 to 5.000 x 106/µL)
TC-BF# R2 = 0.95 or greater
(0.000 to 10.000 x 103/µL, RBC < 1.000 x 106/µL)
within ±0.010 x 103/µL (0.000 to 0.050 x 103/µL, RBC < 1.000 x 106/µL)
within ±20 % (0.051 to 10.000 x 103/µL, RBC < 1.000 x 106/µL)

* The availability of these functions depends on your system configuration.

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Carryover Carryover is assessed by testing high levels of a parameter from peripheral blood
[Whole Blood] mode or quality control material three times followed by a diluent with low levels of a
[Pre-Dilution] mode parameter. High to Low Carryover is calculated as follows:
[HPC] mode*1 (1st Low - 3rd Low)
Carryover = [ ] x 100
(3rd High - 3rd Low)

WBC-N 1.0 % or less

WBC-D 1.0 % or less
RBC 1.0 % or less
HGB 1.0 % or less
HCT 1.0 % or less
PLT-I 1.0 % or less
PLT-O 1.0 % or less
PLT-F 1.0 % or less
NEUT# 1.0 % or less
LYMPH# 1.0 % or less
MONO# 1.0 % or less
EO# 1.0 % or less
BASO# 1.0 % or less

Carryover Carryover is assessed by testing high levels of a parameter from body fluids or
[Body Fluid] mode*2 stabilized material such as quality control material three times followed by a diluent
with low levels of a parameter. High to Low Carryover is calculated as follows:
(1st Low - 3rd Low)
Carryover = [ ] x 100
(3rd High - 3rd Low)

WBC-BF 0.3 % or 0.001 x 103/µL or less

RBC-BF 0.3 % or 0.003 x 106/µL or less
TC-BF# 0.3 % or 0.001 x 103/µL or less

*1 The availability of the HPC analysis function depends on your system configuration.
*2 The body fluid analysis can only be performed if the license is activated.

Note:
If a low level sample is analyzed after a high level sample, the analysis results may be affected
by carryover within the range of the carryover rate indicated in the table.

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Mode Comparison
For evaluating Mode Comparison, peripheral blood samples have been analyzed on an XR-Series device.
A linear regression analysis has been performed to judge the comparability of the different measurement modes
on an XR-Series instrument.

[Whole Blood] mode versus [Pre-Dilution] mode

Parameter Units Correlation coefficient (r) Average bias (%)
WBC-N x 103/µL 0.90 or more ±10
WBC-D x 103/µL 0.90 or more ±10
6
RBC x 10 /µL 0.95 or more ±5
HGB g/dL 0.95 or more ±5
HCT % 0.90 or more ±10
PLT-I x 103/µL 0.95 or more ±15
PLT-O* x 103/µL 0.95 or more ±15
PLT-F* x 103/µL 0.95 or more ±10
RDW-SD fL 0.90 or more ±20
RDW-CV % 0.90 or more ±15
MicroR % 0.60 or more ±50
MacroR % 0.60 or more ±100
PDW fL 0.70 or more ±30
P-LCR % 0.80 or more ±30
PCT % 0.80 or more ±20
NRBC% % 0.40 or more ±80
NEUT% % 0.90 or more ±8
LYMPH% % 0.90 or more ±10
MONO% % 0.70 or more ±15
EO% % 0.90 or more ±15
BASO% % 0.40 or more ±80
IG% % 0.40 or more ±80
AS-LYMP%* % 0.40 or more ±150
RE-LYMP%* % 0.40 or more ±150
NEUT-RI* FI 0.70 or more ±20
NEUT-GI* SI 0.60 or more ±10
RET%* % 0.90 or more ±30
IRF* % 0.70 or more ±60
LFR* % 0.70 or more ±20
MFR* % 0.60 or more ±50
HFR* % 0.40 or more ±100
RET-He* pg 0.70 or more ±20
RBC-He* pg 0.70 or more ±10
HYPO-He* % 0.70 or more ±100
HYPER-He* % 0.70 or more ±150

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Parameter Units Correlation coefficient (r) Average bias (%)

IPF* % 0.80 or more ±100

* The availability of these functions depends on your system configuration.

[Whole Blood] mode versus [Low WBC] mode

Parameter Units Correlation coefficient (r) Average bias (%)
WBC-D x 103 /µL 0.90 or more ±10
NEUT% % 0.90 or more ±8
LYMPH% % 0.90 or more ±10
MONO% % 0.70 or more ±15
EO% % 0.90 or more ±15
BASO% % 0.40 or more ±80
IG% % 0.40 or more ±80
AS-LYMP%* % 0.40 or more ±100
RE-LYMP%* % 0.40 or more ±100
NEUT-RI* FI 0.70 or more ±10
NEUT-GI* SI 0.70 or more ±10

* The availability of these functions depends on your system configuration.

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Method Comparison
For evaluating Method Comparison, peripheral blood samples have been analyzed on XR-Series and
XN series.
A linear regression analysis has been performed to judge the comparability of two methods.

Parameter Units Correlation coefficient (r) Average bias (%)

WBC-N x 103/µL 0.95 or more ±8
WBC-D x 103/µL 0.95 or more ±8
6
RBC x 10 /µL 0.95 or more ±5
HGB g/dL 0.95 or more ±5
HCT % 0.95 or more ±8
PLT-I x 103/µL 0.95 or more ±10
PLT-O x 103/µL 0.95 or more ±20
PLT-F x 103/µL 0.95 or more ±10
RDW-SD fL 0.90 or more ±10
RDW-CV % 0.90 or more ±15
MicroR % 0.60 or more ±50
MacroR % 0.60 or more ±60
PDW fL 0.80 or more ±20
P-LCR % 0.80 or more ±30
PCT % 0.80 or more ±10
NRBC% % 0.40 or more ±80
NEUT% % 0.90 or more ±8
LYMPH% % 0.90 or more ±15
MONO% % 0.70 or more ±30
EO% % 0.90 or more ±15
BASO% % 0.40 or more ±80
IG% % 0.40 or more ±80
AS-LYMP% % 0.40 or more ±150
RE-LYMP% % 0.40 or more ±150
NEUT-RI FI 0.70 or more ±20
NEUT-GI SI 0.70 or more ±10
RET%* % 0.90 or more ±30
IRF* % 0.70 or more ±60
LFR* % 0.70 or more ±20
MFR* % 0.60 or more ±50
HFR* % 0.40 or more ±100
RET-He* pg 0.70 or more ±20
RBC-He pg 0.70 or more ±10
HYPO-He % 0.70 or more ±100
HYPER-He % 0.70 or more ±100
IPF* % 0.80 or more ±100
WBC-BF* x 103/µL 0.90 or more ±30

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Parameter Units Correlation coefficient (r) Average bias (%)

6
RBC-BF* x 10 /µL 0.80 or more ±30
3
TC-BF#* x 10 /µL 0.90 or more ±30
MN%* % 0.40 or more ±50
PMN%* % 0.40 or more ±50
HPC% % 0.80 or more ±150

* The availability of these functions depends on your system configuration.

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Sample Stability with Changes after blood is taken are shown below.
Time after Blood
Collection
8 hours HCT within +5.0 %
MCV within +5.0 %
MicroR within ±36.0 % or ±2.0 MicroR (stored at 18 to 26 °C)
MacroR within ±36.0 % or ±2.0 MacroR (stored at 18 to 26 °C)

24 hours HCT within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)
MCV within +8.0 % (in a refrigerator), within +15.0 % (stored at 18 to 26 °C)
MicroR within ±36.0 % or ±2.0 MicroR (in a refrigerator)
MacroR within ±36.0 % or ±2.0 MacroR (in a refrigerator)
NRBC% within ±10.0 % or ±3.0 / 100 WBC
IG% within ±2.0 IG%
RET%* within ±20.0 % or ±0.3 RET%
RET#* within ±20.0 % or ±0.015 x 106/µL
IRF* within ±30.0 % or ±10.0 IRF
LFR* within ±30.0 % or ±10.0 LFR
MFR* within ±30.0 % or ±10.0 MFR
HFR* within ±30.0 % or ±5.0 HFR
RET-He* within ±8.0 % (RET# 0.0100 x 106/µL or more)
RBC-He* within ±8.0 %
Delta-He* RET-He, RBC-He within ±8.0 % (RET# 0.0100 x 106/µL or more)
AS-LYMP#* within ±40.0 %
AS-LYMP%* within ±5.0 AS-LYMP%
RE-LYMP%* within ±30.0 % or ±5.0 RE-LYMP%
NEUT-RI* within ±8.0 %
NEUT-GI* within ±8.0 %
IPF within ±30.0 % or ±2.0 IPF% (PLT 100 x 103/µL or more, IPF 2.0 %
or more)
IPF#* within ±30.0 % or ±20.0 x 103/µL (PLT 100.0 x 103/µL or more, IPF 2.0 %
or more)

36 hours NEUT% within ±8.0 NEUT%

LYMPH% within ±7.0 LYMPH%
MONO% within ±3.0 MONO%
EO% within ±3.0 EO%
BASO% within ±1.0 BASO%

48 hours PLT-I within ±10 % or ±30 x 103/µL

PLT-O* within ±15.0 %
PLT-F* within ±10.0 % or ±30 x 103/µL
NEUT% within ±8.0 NEUT%
LYMPH% within ±7.0 LYMPH%
MONO% within ±4.0 MONO%
EO% within ±3.0 EO%
BASO% within ±1.0 BASO%

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Sample Stability with

Time after Blood
Collection
72 hours WBC-N within ±10.0 %
WBC-D within ±10.0 %
RBC within ±5.0 %
HGB within ±5.0 %

* The availability of these functions depends on your system configuration.

Note:
• The data are the values when analyzing the samples stored at 18 to 26 °C or in a
refrigerator (2 to 8 °C). If the samples were refrigerated, they were restored to
room temperature before analyzing.
• If the method of collecting the samples and their management status are
inappropriate, the values may not fall within the above range.

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7.3 System limitations

7.3.1 Possible sample interferences

WBC
If any of the following is present, the system may erroneously report a low white blood cell count.
• Leukocyte aggregation

If any of the following are present, the system may erroneously report a high white blood cell count.
• Possibility of PLT clumps
• Cryoprotein
• Cryoglobulin
• Fibrin
• Giant platelets

RBC
Where the following are present, the system may erroneously report a low red blood cell count.
• Erythrocyte aggregation (Cold agglutinin)
• Microerythrocytes
• Possibility of fragmented RBCs

If any of the following are present, the system may erroneously report a high red blood cell count.
• Leukocytosis
• Giant platelets

HGB
If any of the following are present, the system may erroneously report a high hemoglobin concentration.
• Leukocytosis
• Lipemia
• Abnormal protein

HCT
If any of the following are present, the system may erroneously report a low hematocrit value.
• Erythrocyte aggregation (Cold agglutinin)
• Microerythrocytes
• Possibility of fragmented RBCs

If any of the following are present, the system may erroneously report a high hematocrit value.
• Leukocytosis
• Severe diabetes
• Uremia
• Spherocytosis

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PLT
If any of the following are present, the system may erroneously report a low platelet count.
• Possibility of PLT clumps
• Pseudothrombocytopenia
• Giant platelets

If any of the following are present, the system may erroneously report a high platelet count.
• Microerythrocytes
• Possibility of fragmented RBCs
• Fragmented leukocytes
• Cryoprotein
• Cryoglobulin

RET
If any of the following are present, the system may erroneously report a high reticulocyte count.
• Erythrocyte aggregation (Cold agglutinin)
• Giant platelets
• Possibility of PLT clumps
• Fragmented leukocytes
• Malaria
• Howell-Jolly body

WBC-BF
If any of the following are present, the system may erroneously report a high white blood cell count in body fluid
analysis.
• Bacterium
• Fungus
• Fragmented leukocytes
• Modified or broken down leukocytes (such as drainage or degeneration with time)
• Debris
• Crystals
• Excessive mixing of sample
• Fat globule
• Liposome preparation (cerebrospinal fluid)
• High viscosity synovial fluid

If any of the following are present, the system may erroneously report a low white blood cell count in body fluid
analysis.
• Broken down leukocytes
• Leukocytes contained in HF-BF (such as plasma cells)

RBC-BF
If any of the following are present, the system may erroneously report a high red blood cell count in body fluid
analysis.
• Bacterium
• Fungus
• Fragmented cells
• Damaged RBCs

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7.3.2 Effects of interference substances

Whole blood interference - EDTA-2K

Interfering substances studies for Bilirubin C, Bilirubin F, Hemolysis, Lipemia (Intralipos) and Chyle interferents
were performed on the XR-20 and XR-10 module.
A study of interference substances was conducted based on CLSI EP07-Ed3.

Whole blood EDTA-2K samples were collected from four donors for each interferent. Bilirubin C, Bilirubin F,
Hemolysis and Chyle interferents were diluted to 0 %, 20 %, 40 %, 60 %, 80 %, and 100 %, and Lipemia
(Intralipos) was diluted to 0 %, 1 %, 5 %, 10 %, 50 %, and 100 %. The tubes were mixed and measured four
consecutive times for WBC, RBC, HGB, HCT, PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF on the XR-20
and XR-10.

Bilirubin C interference
There was no significant Bilirubin C interference up to a concentration of 40 mg/dL for WBC, RBC, HGB, HCT,
PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF parameters.

Bilirubin F interference
There was no significant Bilirubin F interference up to a concentration of 40 mg/dL for WBC, RBC, HGB, HCT,
PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF parameters.

Hemolysis interference
There was no significant Hemolysis interference up to a concentration of 1,000 mg/dL for WBC, RBC, HGB,
HCT, PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF parameters.

Lipemia (Intralipos) interference

There was no significant Lipemia (Intralipos) interference up to a concentration of 2.00 g/dL for WBC, RBC,
HCT, PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF parameters. There was no significant Intralipos
interference up to a concentration of 0.20 g/dL for HGB parameter.

Chyle interference
There was no significant Chyle interference up to a concentration of 3,600 FTU for WBC, RBC, HGB, HCT,
PLT*1, PLT*2, RET%/#*3, IRF*3, RET-He*3 and IPF parameters.

Allowable change rate:

The Allowable change rate is the allowable bias for each measurand. Bias outside the ranges listed below is
considered an interference.
The concentration that showed no significant interference was judged by the change rate based on the criteria
from the CLSI document H26-A2 under Biological variation (%CV) for all listed parameters except for RET%/#*3,
IRF*3, RET-He*3 and IPF. For RET%/#*3, IRF*3, RET-He*3 and IPF, the change rate is determined by the
display value limits of XN CHECK Level2 corresponding to the normal range for human blood.

Parameter WBC RBC HGB HCT PLT*1,2 RET%*3 RET#*3 IRF*3 RET-He*3 IPF
Change within within within within within within within within within within
rate ±19.6 % ±6.1 % ±6.6 % ±6.4 % ±21.9 % ±20 % ±30 % ±36 IRF ±10 % ±5.0 IPF%

*1 PLT counted in the RBC/PLT channel (PLT particle size distribution).

*2 PLT counted in the PLT-F channel. This item does not appear with all analyzer types.
*3 These items do not appear with all analyzer types.

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7.4 ID Barcode specifications

Barcode labels can be affixed to sample tubes and racks to enable automatic reading of the ID by barcode reader.
This section explains the specifications of barcode labels that can be read by the barcode reader of this machine.

7.4.1 Acceptable barcodes

The bar code types that can be used and the corresponding check digits are as follows:

Caution!
Use check digits as much as possible when using sample barcodes.
Failure to use check digits may cause misreading of the barcode.

Sample number
Barcode type Check digit Number of digits

ITF Not used Max. 22 digits (sample ID)

Modulus 10 Max. 21 digits (sample ID) + 1 digit (check digit) = Max. 22 digits

CODABAR/NW7 Not used Max. 22 digits (sample ID)

Modulus 11 Max. 22 digits (sample ID) + 1 digit (check digit) = Max. 23 digits

Weighted Modulus 11

Modulus 16

CODE 39 Not used Max. 22 digits (sample ID)

Modulus 43 Max. 22 digits (sample ID) + 1 digit (check digit) = Max. 23 digits

JAN/EAN/UPC Modulus 10 12 digits (sample ID) + 1 digit (check digit)= 13 digits

ISBT 128 Modulus 103 Max. 22 digits (sample ID) + 1 digit (check digit) = Max. 23 digits

CODE 128 Modulus 103 Max. 22 digits (sample ID) + 1 digit (check digit) = Max. 23 digits

Information
• Do not use a rack ID barcode as a barcode for a sample ID.
• When using CODE 128, do not use the codes below.

Code CODE A CODE B Code CODE A CODE B

95 US DEL 101 FNC 4 CODE A
96 FNC 3 FNC 3 102 FNC 1 FNC 1
97 FNC 2 FNC 2 103 START(CODE A)
98 SHIFT SHIFT 104 START(CODE B)
99 CODE C CODE C 105 START(CODE C)
100 CODE B FNC 4

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Note:
In CODE 128, any one of the characters "A", "B", "C", "a", "b" or "c" can be used for the start/
stop code.

Rack number
Barcode type Check digit Number of digits

CODABAR/NW7 Modulus 16 6 digits (rack number) + 1 digit (check digit) = 7 digits

CODE 39 Modulus 43 6 digits (rack number) + 1 digit (check digit) = 7 digits

Information
Use either "D" or "d" for the start/stop code.

Quality control
Barcode type Check digit Number of digits

CODE 128 Modulus 103 3 digits (fixed character string "QC-") +

8 digits (lot number) + 1 digit (check digit) = 12 digits

Note:
The CODE 128 barcode for quality control is a special Sysmex code used for quality control
materials.

Dimensions of barcode elements

Narrow Element ≥ 190 µm
Wide Element ≤ 1.2 mm
Narrow Element ≤ GAP between characters ≤ Wide Element

Narrow/Wide ratio
For each character, the narrow/wide ratios must be as follows:
Narrow (Max) : Wide (Min) = 1 : 2.2 or more
Narrow (Min) : Narrow (Max) = 1 : 1.3 or less
Wide (Min) : Wide (Max) = 1 : 1.4 or less

PCS (Print Contrast Signal)

Reflectivity of white - Reflectivity of black
PCS=
Reflectivity of white

The measurement method conforms to JIS (Japanese Industrial Standards) x0501, "5.3 Optical Characteristics
of Bar Code Symbols".
Standard: PCS ≥ 0.45

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Print quality of barcode label

Use barcode labels of Label Grade C or higher of the ANSI standards.
Reading of laminated labels may not be possible.

Irregularity and roughness of printing

When a bar is magnified, it appears as shown at left.
MAX
Expressing the variation in the width of a bar as

MAX - MIN
MIN S= x 100 %
MAX

Bar S must be ≤ 20 %.

Dimensions of sample tube barcode label

41624269960424

a c a

Margin (Dimension a) 5 mm or more

Bar height (Dimension b) 10 mm or more

Effective barcode part (Dimension c) 48 mm or less

Narrow width - 0.19 mm or more

Dimensions of tube rack barcode label

b

a c a

Margin (Dimension a) 3 mm or more

Bar height (Dimension b) 8 mm or more

Effective barcode part (Dimension c) 45 mm or less

Label height (Dimension d) 15 mm or less

Narrow bar:Wide bar - 1:2.5

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7.4.2 Automatic assignment of sample ID and rack numbers

A sample ID number or rack number is automatically assigned to samples for which a barcode label read error
occurred or for which analysis started while the analysis order was still being downloaded.
An automatically assigned sample number starts with a symbol that distinguishes it from other sample numbers.

● Sample ID number
Number starting with [ERR] Assigned when a barcode label read error occurs.
A barcode label read error also occurs when a number includes characters
that cannot be used. When a serial number is assigned and the limit number
is exceeded, the number returns to [00....01].
Number starting with [QC] Assigned to a QC sample with a lot number or a QC file.
[BACKGROUNDCHECK] Assigned to a background check sample.
Number starting with Assigned to a precision check sample.
[PRE-CHK]
Number starting with Assigned to samples calibrated by calibrator calibration (parameters other
[CAL-CAL] than PLT-F).
Number starting with Assigned to samples calibrated by calibrator calibration (PLT-F).
[PF-CAL-CAL]

● Rack number
Automatically assigned rack numbers are 6 digits in length.

Number starting with [ERR] Assigned when a rack label read error occurs.
A barcode label read error also occurs when a number includes characters
that cannot be used.

Information
Sample numbers starting with [QC] whose lower four digits are one of the following numbers are
reserved.
• "1101", "1102", "1103": XN CHECK
• "1301", "1302": XN CHECK BF

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7.4.3 Check digits

To improve the reliability of ID reading, a check digit can be added.
Using the sample ID "258416" as an example, the procedures for calculating the check digits for modulus 11 and
weighted modulus 11 are explained below.

Modulus 11

1 Weight the value of each digit of "258416".

Digits and weightings are as follows.

Digit 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
Weighting 3 2 1 10 9 8 7 6 5 4 3 2 1 10 9 8 7 6 5 4 3 2

Calculate as follows.

Value of each digit 2 5 8 4 1 6

x x x x x x
Weighting 7 6 5 4 3 2
14 30 40 16 3 12

e.g: The first digit of "258416" is "6", and thus "6" is multiplied by "2", the weighting of the first digit.

2 Add all the values that result from the multiplications.

Let the result be S.

S = 14 + 30 + 40 + 16 + 3 + 12 = 115

3 Calculate the remainder when S is divided by 11.

Calculate the complement of the remainder.
The complement of 11 will be the check digit.

115/11 = 10, remainder 5

11 - 5 = 6

The check digit is 6.

Note:
Symbols and characters other than the numeric characters "0" to "9" are treated as "0". When
division of S by 11 results in a remainder of 0, or when calculation of the check digit results in 10,
0 is used for the check digit.

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Weighted modulus 11
Weighted modulus 11 has 2 sets of weightings for each digit. The check digit is first calculated with the first set
of weightings. If the resulting check digit is 10, the check digit is calculated again using the second set of
weightings. The result will always be a value from 0 to 9. Aside from the different weightings, the calculation
procedure is the same as for modulus 11.

1 Weight the value of each digit of "258416".

Digits and weightings are as follows.

Weighting W12 W11 W10 W9 W8 W7 W6 W5 W4 W3 W2 W1

1st set 6 3 5 9 10 7 8 4 5 3 6 2
2nd set 5 8 6 2 10 4 3 7 6 8 5 9

Calculate as follows.

Value of each digit 2 5 8 4 1 6

x x x x x x
Weighting 8 4 5 3 6 2
16 20 40 12 6 12

2 Add all the values that result from the multiplications.

Let the result be S.

S = 16 + 20 + 40 + 12 + 6 + 12 = 106

3 Calculate the remainder when S is divided by 11.

Calculate the complement of the remainder.
The complement of 11 will be the check digit.

106/11 = 9, remainder 7
11 - 7 = 4

The check digit is 4.

Note:
• Symbols and characters other than the numeric characters "0" to "9" are treated as "0". When
division of S by 11 results in a remainder of 0, or when calculation of the check digit results in
10, 0 is used for the check digit.
• In weighted modulus 11, weightings for digits after the 12th digit (13th and higher digits) are 0.
These are not included in the check digit calculation.

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7.5 Functional descriptions

This device performs hematology analyses according to the Hydrodynamically focussed DC detection method, flow
cytometry method (using a semiconductor laser), and SLS-hemoglobin method.

7.5.1 Analysis principles

Hydrodynamically focussed DC detection method

The RBC detector counts the RBC and PLT via the
Hydrodynamically focussed DC detection method. Front sheath
reagent Recovery tube
At the same time, the hematocrit (HCT) is calculated via the
RBC pulse height detection method.
Inside the detector, the sample nozzle is positioned in front of
the aperture and in line with the center. After the diluted
sample is forced from the sample nozzle into the conical
chamber, it is surrounded by the front sheath reagent and
passes through the aperture center.
After passing through the aperture, the diluted sample is sent
to the catcher tube. This prevents the blood cells in this area Sample Aperture
nozzle
from drifting back, and prevents the generation of false
platelet pulses. The Hydro Dynamic Focusing method
improves blood count accuracy and repeatability. And because the blood cells pass through the aperture in a
line, it also prevents the generation of abnormal blood cell pulses.

Flow cytometry method using semiconductor laser

Cytometry is used to analyze physiological and chemical
characteristics of cells and other biological particles. Flow Blood cell

cytometry is used to analyze those cells and particles as they

are passed through extremely small flow cells. Sheath reagent
A blood sample is aspirated quantitatively, diluted to the Sample
Flowcell
specified ratio, and stained. The sample is then fed into the nozzle
flow cells.
This Hydro Dynamic Focusing mechanism improves cell
count accuracy and repeatability. And since the blood cell particles pass in a line through the center of the flow
cell, the generation of abnormal blood pulses is prevented and flow cell contamination is reduced.

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A semiconductor laser beam (wavelength: 633 nm) is emitted to the blood cells passing through the flow cell.
The forward scattered light and side scattered light is captured by the photodiode, and the side fluorescent
light is captured by the avalanche photodiode. This light is converted into electrical pulses, thus making it
possible to obtain blood cell information.

Side Fluorescent Light System

Avalanche photodiode

Spectral filter

Dichroic mirror
Side Scattered Light System

Photodiode
Side light collector lens
Semiconductor laser Beam stopper

Photodiode

Collimator lens Condenser lens Flow cell

Beam Spot Generator System System Beam stopper Forward Scattered Light System

• Forward Scattered Light and Side Scattered Light

When obstacles pass through a light path, the light beam scatters from each obstacle in various directions.
This phenomenon is called light scattering. By detecting the scattered light, it is possible to obtain information
on cell size and material properties.
Likewise, when a laser beam is emitted to blood cell particles, light scattering occurs. The intensity of the
scattered light depends on factors such as the particle diameter and viewing angle. This device detects
forward scattered light, which provides information on blood cell size; and side scattered light, which provides
information on the cell interior (such as the size of the nucleus).

• Side Fluorescent Light

When light is emitted to fluorescent material, such as stained blood cells, light of longer wavelength than the
original light is produced. The intensity of the fluorescent light increases as the concentration of the stain
becomes higher. By measuring the intensity of the fluorescence emitted, you can obtain information on the
degree of blood cell staining. Fluorescent light is emitted in all directions; this device detects the fluorescent
light that is emitted sideways.

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SLS-Hemoglobin Method
In the past, the mainstream methods for automatically measuring hemoglobin were the cyanmethemoglobin
method and oxyhemoglobin method. But these methods have both advantages and disadvantages when they
are used with a large, fully automatic instrument such as this instrument.
The cyanmethemoglobin method was recommended by the International Committee for Standardization in
Hematology (ICSH) in 1966 as an international standard method. But since its hemoglobin conversion speed
is slow and multiple-sample processing is an assumed requirement, this method is not really appropriate for
automatic analysis. Moreover, since it uses cyanide compounds, which are poisonous as reagents, the liquid
waste must be treated, making the method undesirable from an environmental perspective.
Currently, this is not an appropriate analysis method, particularly as a large fully automatic instrument that
discharges large amounts of liquid waste.

In contrast, the hemoglobin conversion speed of the oxyhemoglobin method is fast, as blood hemoglobin is
instantly converted into oxyhemoglobin. And since it does not use poisonous substances such as cyanide, it is
a suitable method for performing automatic analysis. It cannot, however, convert methemoglobin into
oxyhemoglobin, which is not a problem for normal human blood, but will result in values that are lower than
the true values for samples that contain large amounts of methemoglobin, such as quality control materials.

The SLS-hemoglobin method is an analysis method that makes use of the advantages of the two
aforementioned methods.
As with the oxyhemoglobin method, the hemoglobin conversion speed of the SLS-hemoglobin method is fast
and the method does not use poisonous substances, making it a suitable method for automation.
Further, since methemoglobin can be analyzed, samples such as quality control material containing
methemoglobin can also be accurately analyzed.

7.5.2 Analysis parameters and channels

WBC analysis

WNR channel
The WNR channel is primarily a channel to count the white
blood cells and nucleated red blood cells. FSC
By flow cytometry method using a semiconductor laser, a Basophils
two-dimensional scattergram is plotted, with the X-axis Nucleated red
blood cells
representing the intensity of the side fluorescent light (SFL),
and the Y-axis representing the intensity of the forward
scattered light (FSC).
This scattergram displays groups of nucleated red blood Debris
cells, basophil, non-basophil white blood cells, and debris Lymphocytes+Monocytes+
Neutrophils+Eosinophils
(hemolyzed red blood cells and platelets).
SFL

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WDF channel
The WDF channel is primarily a channel for classifying white SFL
blood cells.
By flow cytometry method using a semiconductor laser, a
Monocytes
two-dimensional scattergram is plotted, with the X-axis Lymphocytes Immature
granulocytes
representing the intensity of the side scattered light (SSC)
and the Y-axis representing the intensity of the side Basophils + Neutrophils

fluorescent light (SFL). Eosinophils

This scattergram displays groups of lymphocytes,
monocytes, eosinophils, basophils + neutrophils, immature
granulocytes, and debris. SSC
Debris

WPC channel
The WPC channel is a channel for detecting immature cells Mature white blood cells
such as myeloblasts, and abnormal lymphocytes. SFL
By flow cytometry method using a semiconductor laser, a
two-dimensional scattergram is plotted, with the X-axis
representing the intensity of the side scattered light (SSC)
Immature cells,
and the Y-axis representing the intensity of the side Abnormal cells
fluorescent light (SFL).
This scattergram displays groups of immature cells, abnormal
cells, and mature white blood cells.

SSC

RBC/PLT analysis

Calculation of RBC constants

The red blood cell constants (mean cell volume, mean cell hemoglobin, and mean cell hemoglobin
concentration) are calculated from the RBC, HGB, and HCT.

● MCV (Mean cell volume)

The MCV is calculated from the RBC and HCT, using the following equation:

HCT (%)
MCV (fL) = x 10
RBC (x 106/µL)

● MCH (Mean cell hemoglobin)

The MCH is calculated from the RBC and HGB, using the following equation:

HGB (g/dL)
MCH (pg) = x 10
RBC (x 106/µL)

● MCHC (Mean cell hemoglobin concentration)

The MCHC is calculated from the HCT and HGB, using the following equation:

HGB (g/dL)
MCHC (g/dL) = x 100
HCT (%)

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RBC particle size distribution

The RBC (red blood count) is calculated as a particle count between two discriminators (lower discriminator
(LD) and upper discriminator (UD)), which are automatically set up in the ranges of 25 - 75 fL and 200 - 250 fL,
respectively.
The particle size distribution is checked for abnormal relative frequencies at each discriminator level,
existence of more than one peaks, and abnormal distribution width.
In this instrument, the RBC distribution width (RDW) is expressed in the following two ways.

● RDW-SD
With the peak height assumed to be 100 %, the distribution
width at the 20 % frequency level is RDW-SD.
100 %
The unit used is femtoliter (fL) (1 fL = 10-15 L).

20 %

RDW

● RDW-CV
With points L1 and L2 found at a frequency of 68.26 % of the 68.26 % of total distribution area
total distribution area, RDW-CV is calculated from the
following equation:

L2 - L1
RDW-CV (%) = x 100
L2 + L1

(L1) (L2)

PLT particle size distribution

The PLT (platelet count) is calculated as a particle count between two discriminators (lower discriminator (LD)
and upper discriminator (UD)), which are automatically set up in the ranges of 2 - 6 fL and 12 - 30 fL,
respectively.
PLT particle size distributions are checked for abnormalities, including abnormal relative frequencies at the
lower discriminator, abnormal distribution widths, and the existence of more than one peak.

● PDW (Calculated distribution width of platelets)

With the peak height assumed to be 100 %, the distribution
100 % P-LCR
width at the 20 % frequency level is PDW.
The unit used is femtoliter (fL) (1 fL = 10-15 L).

● P-LCR (Platelet-Large Cell Ratio)

The P-LCR is the ratio of large platelets from the 12 fL 20 %
discriminator or larger. It is calculated as a ratio comparing
the number of particles between the fixed discriminator and (LD) (12 fL) (UD)
UD, to the number of particles between LD and UD. PDW

● MPV (Mean Platelet Volume)

The MPV is calculated from the following equation:

PCT (%)
MPV (fL) = × 10,000
PLT (x 103/µL)

PCT: PCT is called the platelet hematocrit or platelet volume ratio, and is weighted toward the PLT frequency.

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Particle size distribution expression

The impression one receives of a particle size distribution can vary greatly, depending on the way in which it is
expressed. The width of a particle size distribution requires particular attention, because it can appear
completely different, depending on the expression used for the distribution.
The instrument utilizes a conventional particle size distribution expression (normal expression) and a particle
size distribution expression method that enables the user to obtain a large amount of information from the
particle size distribution intuitively (normal cell size range expression).

● Normal expression
With the peak of the particle size distribution set as full scale (maximum height when the particle size
distribution is displayed), this method of expression normalizes and expresses the distribution.

• Features: Patterns of particle size distributions whose counts are different can be viewed
on the same scale. Widths of particle size distributions can be compared
intuitively.
• Displays Supported area: RBC and PLT particle size distributions

RBC PLT

● Normal cell size range expression

This method of expression does not consider the peak of the particle size distribution as the full scale
(maximum height when the particle size distribution is displayed). Instead, it normalizes the distribution, with
the peak of the normal cell size range, which was calculated empirically, set as the full scale. At the same
time, this method overlays the normal range of the particle size distribution.
If, however, the peak of the particle size distribution is higher than the peak of the normal cell size range, the
expression is made with the distribution peak set as full scale. In this case, the normal cell size range is
proportionally smaller than the height of the particle size distribution peak.
A normal cell size range can be obtained by superposing the particle size distributions of a large number of
healthy people and then utilizing the region from the 10th percentile to the 90th percentile.

• Features: The viewer can intuitively see the size of the particle count from the particle size
distribution.
If the particle size distribution strays from the normal range, the viewer knows
instantly that the particle size distribution pattern is abnormal.
• Displays Supported area: RBC and PLT particle size distributions if settings are preset to normal range

RBC PLT

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PLT-F channel*
The PLT-F channel is for accurately measuring platelets, Red blood cells White blood cells
especially for low platelet counts.
FSC
By flow cytometry method using a semiconductor laser, a
scattergram is plotted, with the X-axis representing the intensity
of the side fluorescent light (SFL), and the Y-axis representing Debris
the intensity of the forward scattered light (FSC). This
scattergram displays groups of platelets, part of red blood cells, IPF

part of white blood cells, and debris.

The IPF is obtained as a ratio of platelet count in the area with Platelets
strong fluorescent light intensity in the PLT-F scattergram
(IPF zone), to the total platelet count. SFL

IPF (Immature Platelet Fraction):

Particle count in IPF zone

IPF= x 100
Particle count in the platelet zone

* Cannot be used depending on the analyzer type.

RET analysis

RET channel*
By flow cytometry method using a semiconductor laser, a FSC
Mature red blood cells
two-dimensional scattergram is plotted, with the X-axis
representing the intensity of the side fluorescent light (SFL),
and the Y-axis representing the intensity of the forward
scattered light (FSC).
This scattergram displays groups of reticulocytes, mature red
blood cells and platelets. Reticulocytes
Platelets

SFL

The scattergram is divided into three RET zones based on FSC

LFR MFR HFR
the intensity of the fluorescent light, and the ratio of the
reticulocytes in each zone to the total number of reticulocytes
is calculated.

SFL
* Cannot be used depending on the analyzer type.

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Reticulocyte Ratio:
Particle count in reticulocyte zone
RET% = x 100
Particle count in mature RBC zone + Particle count in reticulocyte zone

Reticulocyte Count:
RET% x RBC
RET# =
100

Low Fluorescence Ratio:

LFR = 100 - HFR - MFR

Middle Fluorescence Ratio:

Particle count in MFR zone
MFR = x 100
Particle count in reticulocyte zone

High Fluorescence Ratio:

Particle count in HFR zone
HFR = x 100
Particle count in reticulocyte zone

Immature Reticulocyte Fraction:

IRF = MFR + HFR

LFR: Low Fluorescence Ratio

MFR: Middle Fluorescence Ratio
HFR: High Fluorescence Ratio
IRF: Immature Reticulocyte Fraction

RET-He (Reticulocyte Hemoglobin equivalent) :

The RET-He is a unique parameter developed by Sysmex that is derived using the reticulocyte scattered light
signals and a proprietary Sysmex calculation equation.

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7.5.3 Electrical system of the analyzer

The control unit in the analyzer controls solenoid valves and master valves in the hydraulic system, thus, it
controls the flow of the sample, reagents, and waste fluid in the hydraulic system.
The electrical signals received from each detector are processed (waveform processing) in the analog unit, and
sent to the control unit. In the control unit, the analog signals are converted to digital signals, and arithmetic
processing is performed.

RBC and PLT cell signals are sent to the applicable waveform processing circuits of the analog unit, where
noise is eliminated and the required blood cell signals are picked up. The microcomputer unit converts the
analog-to-digital-converted cell signals into particle size distribution data and sends the data to the IPU.

HGB is calculated by subtracting the light absorbance of the diluent (background count) from the light
absorbance of the sample. As for this light absorbance, light that is passed through the liquid is received by the
photodiode, where it is photoelectrically converted. It is then converted from analog to digital signals, and sent to
the IPU.

The blood cell signals from the optical detector block (which analyzes WDF, WNR, WPC, PLT-F, and RET
channel) can be obtained by sending signals from the forward scattered light, side scattered light, and side
fluorescent light to the applicable waveform processing circuits of the analog unit, where noise is eliminated and
the required blood cell signals are picked up. The control unit converts the analog-to-digital-converted cell
signals into scattergram data and sends the data to the IPU.

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Chapter 8 Basic Operation

This chapter explains the basic operation of this instrument.

8.1 Overall flow of operation

The flow chart below is a general representation of the operation of this instrument.
Once you understand the overall flow, see each operation explained in detail in the following sections.

Power ON
➤P.114 "Chapter 8: 8.2 Start up"

Execute QC analysis
➤P.165 "Chapter 10: Performing Quality Control"

Process samples
➤P.196 "Chapter 11: 11.2 Prepare the sample"

Analysis
Manual analysis Sampler analysis

➤P.204 "Chapter 11: 11.6 Manual ➤P.218 "Chapter 11: 11.9 Sampler
analysis" analysis (XR-1000)"

Display/output analysis results

➤P.229 "Chapter 12: Checking Analysis

Data (Sample Explorer)"

Shutdown

➤P.121 "Chapter 8: 8.5 Shutdown"

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8.2 Start up

Note:
When using a PC for backup, you can start the instrument automatically at the specified date
and time. (➤ P.406 "Chapter 15: 15.6.1 Set the schedule")

8.2.1 Checks prior to turning power ON

Before turning ON the instrument's power, check the following.

Instrument inspection
• Check the connection of tubes and cables.
• Check if there are any bent tubes.
• Check if there is any object on top of the instrument.
• Check for any unremoved racks.
• Make sure that the network devices (hubs and network converters) are all powered ON.
• Discard any waste fluid in the waste container (if applicable).
For the details on discarding waste fluid, see Chapter 18. (➤P.447 "Chapter 18: 18.3.1 Replace the waste
container")

Reagent inspection
Make sure there are extra supplies of reagents for the number of samples to be processed on the day of
analysis. The amount of reagent needed varies with analysis mode. Therefore, check if enough reagent is
available for the daily routine analyses.
If a reagent runs out during the analysis, the instrument automatically stops. Replace the reagent at this time.
The analysis cannot resume until the replacement is complete.

Volume of reagent used per analyzed sample (in continuous analysis)

* The following are examples. For more information, please contact your authorized local Sysmex
representative.

Discrete mode
Reagent
CBC CBC+DIFF+WPC+RET+PLT-F

Total reagent volume Approx. 31.12 mL Approx. 63.35 mL

CELLPACK DCL Approx. 29.1 mL Approx. 54.2 mL

SULFOLYSER Approx. 0.5 mL Approx. 0.5 mL

Lysercell WNR Approx. 1.5 mL Approx. 2.5 mL

Fluorocell WNR Approx. 20 µL Approx. 20 µL

Lysercell WDF II - Approx. 1.5 mL

Fluorocell WDF - Approx. 20 µL

Lysercell WPC - Approx. 1.5 mL

Fluorocell WPC - Approx. 20 µL

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Discrete mode
Reagent
CBC CBC+DIFF+WPC+RET+PLT-F

CELLPACK DFL - Approx. 3.0 mL

Fluorocell RET - Approx. 20 µL

Fluorocell PLT - Approx. 20 µL

Volume of reagent used on instrument Volume of reagent used for rinsing

startup
Total reagent volume Approx. 281.5 mL Total reagent volume Approx. 276.2 mL

CELLPACK DCL Approx. 254.2 mL CELLPACK DCL Approx. 239.8 mL

SULFOLYSER Approx. 1.5 mL SULFOLYSER Approx. 2 mL

Lysercell WNR Approx. 7.5 mL Lysercell WNR Approx. 10 mL

Fluorocell WNR Approx. 60 µL Fluorocell WNR Approx. 80 µL

Lysercell WDF II Approx. 4.5 mL Lysercell WDF II Approx. 6 mL

Fluorocell WDF Approx. 60 µL Fluorocell WDF Approx. 80 µL

Lysercell WPC Approx. 4.5 mL Lysercell WPC Approx. 6 mL

Fluorocell WPC Approx. 60 µL Fluorocell WPC Approx. 80 µL

CELLPACK DFL Approx. 9 mL CELLPACK DFL Approx. 12 mL

Fluorocell RET Approx. 60 µL Fluorocell RET Approx. 80 µL

Fluorocell PLT Approx. 60 µL Fluorocell PLT Approx. 80 µL

* Analysis conditions:
At least 1 hour and no more than
24 hours after shutdown/cleaning.

Volume of reagent used on shutdown

process
Total reagent volume Approx. 85.6 mL

CELLPACK DCL Approx. 81.6 mL

CELLCLEAN AUTO Approx. 4 mL

(1 vial)

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8.2.2 Turn power ON

Follow the steps below to turn ON the instrument's power.

1 Make sure that the main power of each device connected to the instrument is
ON.
Check the power for the following devices. The power of the sampler and the analyzer is controlled by the IPU.
Therefore, you can keep the main power switches in the "ON" position at all times.
• Analyzer (➤P.39 "Chapter 3: Front interior")
• Sampler (➤P.41 "Chapter 3: 3.3 Sampler section")
• Display unit
• Printer (optional)

Information
Do not restart only the IPU (by restarting Windows) or log off (log off from Windows) while the
main power switch of the connected equipment is ON. After Windows restarts or you log off, the
equipment may not be able to reconnect with the IPU. If you need to restart or log off from
Windows, also switch off the main power switch of the equipment. Make sure that the IPU has
finished restarting before switching the main power switch back on.

2 Turn ON the IPU.

The power to the instrument turns ON, and the analyzer runs a self-check. Wait until the self-check is
completed. (➤P.118 "8.2.4 Execution of analyzer self-check")

If Auto Logon is disabled in the IPU, the Logon dialog box appears.
(➤P.117 "8.2.3 Log on to the IPU")

Note:
If an error occurs (e.g. if a reagent runs out) during startup, the operator must log on to the IPU
to resolve the error.

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8.2.3 Log on to the IPU

When turning ON the instrument's power, the following logon dialog box appears in the IPU*. Enter the required
information, or hold up the IC card to the IC card reader to log on.
* If Auto Logon is enabled in the IPU, the Logon dialog does not appear.

● Entering the required information

Enter your logon name and password, and click [OK]. If you click [Abort], logon is not performed, and the IPU
program exits. Contact your administrator for your logon name and password.

Information
• If in the factory default state, the administrator should promptly reset the default logon name
and password.
Also, add users and set their permissions for this instrument. For details, see the following:
(➤P.359 "Chapter 15: User information management (user administration)")
• If Auto Logon is enabled, keyboard entry may not be possible after the IPU starts. In this
event, briefly operate the menu screen with the mouse or touch panel, and then use the
keyboard.

● Using an IC card
If using the optional IC card reader, hold up the IC card to the IC card reader. Logon is automatically performed
after a successful reading.

Note:
• Before using an IC card, the IC card information needs to be registered from the user
information management setting. For details, see the following:
(➤P.359 "Chapter 15: User information management (user administration)")
• To stop the use of the IC card reader, change the connection settings of the IC card reader to
[Do not use]. (➤P.372 "Chapter 15: IC card reader connection")

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8.2.4 Execution of analyzer self-check

Once the power on the instrument turns ON, a self-test automatically runs for approximately 10 minutes, to
determine if there is any error in the analyzer. The self-check consists of the following tasks.

● Initialization of the mechanical parts

The mechanical parts move to their initial positions, and initialize/check the hydraulic parts.

● Rinse
Rinses the analyzer one to three times, depending on how long it has been since the last rinse.

● Waiting for temperature stabilization*

The dialog box on the right appears, and the system waits until the
temperatures are stable.
Once the temperatures are stable, the dialog box closes automatically.

Current Temp. (°C) Displays the current temperatures of each device.

Target (°C) Displays the target temperatures.

* Depending on the analyzer type, the following items do not appear in the
dialog box.
34°C Reaction Chamber, 34°C Reagent Heater

● Background check
Performs analysis without aspirating the samples to verify the effects of the auto rinse. This is repeated up to
3 times.
The analysis results can be checked in the Sample Explorer screen. Any item whose result is not within the
acceptable range is marked with a [!].

Parameters analyzed in background check and their acceptable values

Checked Parameter Acceptable Value Explanation

WBC-N 0.10 x 103/µL or less WBC counted in the WNR channel

WBC-D 0.10 x 103/µL or less WBC counted in the WDF channel

WBC-P*1 0.10 x 103/µL or less WBC counted in the WPC channel

RBC 0.02 x 106/µL or less -

HGB 0.1 g/dL or less*2 -

PLT-I 10 x 103/µL or less PLT counted in the RBC/PLT channel (PLT particle
size distribution)

PLT-O*1 10 x 103/µL or less PLT counted in the RET channel

PLT-F*1 3 x 103/µL or less PLT counted in the PLT-F channel

*1 These items do not appear with all analyzer types.

*2 In the case of Netherlands SI units, 0.1 mmol/L.

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If the results are still not within the acceptable range after 3 analyses, it will be considered a background check
error. Click [Execute] in the Help dialog box to execute Auto Rinse and Background Check again.
If the results are still not within the acceptable range, see Chapter 19. (➤P.515 "Chapter 19: 19.3 Error
message list")

Caution!
When the results are not within the acceptable range, you can still finish the check by clicking
[Close] on the Help dialog box. However, please note that the analysis results may be
unreliable.
Clicking [Close] does not clear the error.

Note:
The sample number for the background check data is [BACKGROUNDCHECK].

8.3 Log off from the IPU

To switch between users, follow the steps below to log off.

1 Click the [LOGOFF] icon in the Menu screen.

The dialog box on the right appears.

2 Click [Yes].
The user is logged off from the IPU.
After the logoff, the Logon dialog box appears. (➤P.117 "8.2.3 Log on to the IPU")

Note:
You cannot log off while the analyzer or the sampler is running.

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8.4 Operation lock function (Screen Lock)

When an operator needs to step away from the instrument, the IPU can be locked.
The operation lock is turned ON in the following cases. However, if a dialog or control menu appears, the operation
lock function will not operate.
• When the instrument has not been operated for a set length of time*
• When the operator turns ON the operation lock function directly by pressing Ctrl + L.
* You can set this between 15 to 60 minutes. For details, see the following:
(➤P.365 "Chapter 15: Security settings")

The following dialog box appears while the operation lock is enabled. To unlock the operation lock, enter the
password or hold up the IC card to the IC card reader.

[Logon Name] Displays the user name currently logged on.

[Password] Enter the password here to unlock.
[OK] Click this button after entering the password to unlock the operation lock.
[Log on as a different user] Log off the current user, and then click when logging on as a different user.

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8.5 Shutdown
This section describes the procedure for shutting down the instrument. When you finish analysis work for the day,
always turn OFF the analyzer and IPU.

8.5.1 Automatically shutting down the entire system (XR-1000)

The power of the entire system can be turned off automatically by placing a rack with CELLCLEAN AUTO.
Follow the steps below to shut down the entire system.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
until they are.

Status
indicator
LED

e.g. Sampler (SA-10)

2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is ejected out, press the mode button on the
analyzer.

Tube
holder

3 Place CELLCLEAN AUTO in the rack.

Place CELLCLEAN AUTO into the 10th position of the rack.

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4 Place the rack in the right sampler pool.

Slide the groove on the rack onto the protrusion on the right
side (when you face the analyzer), and start sampler analysis.

If the sampler auto-start function is ON on the

SA-10
Conveying automatically starts when the rack is placed.

If the SA-01 is used, or if the sampler auto start

Protrusion
function is OFF on the SA-10
Click the sampler analysis button in the control menu
and then click [Start].

5 Shutdown is performed automatically.

CELLCLEAN AUTO is aspirated and rinsing begins.
Shutdown takes about 15 minutes.
When all operations are finished, the instrument power turns OFF.
If automatic IPU backup schedule is set, the IPU backup will be performed automatically after shutdown.
(➤ P.127 "8.5.4 Perform automatic backup")

Information
• Use 1 vial of CELLCLEAN AUTO for each analyzer. CELLCLEAN AUTO that has already
been used cannot be reused.
• During the transition to shutdown, other sample tubes are not accepted.
• Do not use regular sample tubes together with CELLCLEAN AUTO in a same rack.

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8.5.2 Automatically shutting down the entire system (XR-2000)

The power of the entire system can be turned off automatically by placing a rack with CELLCLEAN AUTO.

Note:
After aspiration, CELLCLEAN AUTO is returned to the rack or the tube holder, depending on the
settings.
For the CELLCLEAN AUTO settings, see the following.
(➤P.342 "Chapter 15: 15.2.6 Sampler settings")

Follow the steps below to shut down the entire system.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
Status
until they are. indicator
LED

2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is ejected out, press the mode button on the
analyzer.
Tube
holder

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3 Place CELLCLEAN AUTO in the rack.

Place CELLCLEAN AUTO into the 9th position and 10th position of the
rack.

Note:
• If only 1 vial of CELLCLEAN AUTO is placed, only the analyzer corresponding to the
placement positions of CELLCLEAN AUTO is shut down. In that case, entire system shutdown
is not performed.
• The placement positions of CELLCLEAN AUTO correspond to the analyzers as follows:
- 9th: Analyzer (left)
- 10th: Analyzer (right)

4 Place the rack in the right sampler pool.

Slide the groove on the rack onto the protrusion on the right
side (when you face the analyzer), and start sampler analysis.

If the sampler auto-start function is ON

Conveying automatically starts when the rack is placed.

If the sampler auto-start function is OFF

Click the sampler analysis button in the control menu
and then click [Start]. Protrusion

5 Shutdown is performed automatically.

CELLCLEAN AUTO is aspirated in each analyzer and rinsing begins sequentially.
When all operations are finished, the instrument power turns OFF.
If automatic IPU backup schedule is set, the IPU backup will be performed automatically after shutdown.
(➤P.127 "8.5.4 Perform automatic backup")

Information
• Use 1 vial of CELLCLEAN AUTO for each analyzer. CELLCLEAN AUTO that has already
been used cannot be reused.
• During the transition to shutdown, other sample tubes are not accepted.
• Do not use regular sample tubes together with CELLCLEAN AUTO in a same rack.

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8.5.3 Shutting down the analyzer manually

If needed, you can shut down only the analyzer.
Follow the steps below to shut down the analyzer.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status indicator
LED

2 Click the Analyzer menu button on the control menu.

The menu on the right appears.

3 Click [Shutdown].
The window on the right appears.
If retracted, the tube holder slides out forward.

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4 Place the CELLCLEAN AUTO in the sample tube holder.

Place it in the front holder, when you face the analyzer.

5 Press the start switch on the analyzer.

The tube holder retracts into the analyzer and aspiration
begins.
When aspiration finishes, the tube holder automatically is
ejected out. Remove the CELLCLEAN AUTO.
If automatic IPU backup schedule is set, the IPU backup will be
performed automatically after shutdown. (➤P.127
"8.5.4 Perform automatic backup")

Start switch

Note:
• When [IPU Shutdown] is set to ON, the IPU shuts down automatically after all analyzers
connected to the IPU have shut down.
(➤P.358 "Chapter 15: IPU Shutdown setting")
• Shutdown takes about 15 minutes. Progress is shown as a progress bar on the screen. When
shutdown finishes, the tube holder automatically retracts into the analyzer.
• If the CELLCLEAN AUTO is not removed before shutdown finishes, a notice indicating that a
sample tube remains in the tube holder will appear at the next startup.

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8.5.4 Perform automatic backup

If an automatic backup schedule is set, the IPU backup will be performed automatically after the instrument
shuts down. (➤P.406 "Chapter 15: 15.6.1 Set the schedule")
Backup progress is shown as a progress bar.

● To abort backup
Click [Cancel] in the [Waiting to complete execution] dialog box. The IPU shuts down without backup.

Information
The IPU controls the power to the PC for backup (optional). Do not turn the PC for backup ON or
OFF.

Note:
The status of the PC for backup once backup is complete depends on the setting. (➤P.406
"Chapter 15: 15.6.1 Set the schedule")

If auto start of the instrument is enabled:

The IPU will shut down, but the PC for backup will remain turned ON. Do not turn OFF the power
to the PC for backup.
If auto start of the instrument is disabled:
The IPU and PC for backup automatically shut down once backup is complete.

8.5.5 Shutting down the IPU manually

If needed, you can shut down the IPU.
Follow the procedure below to turn off the power of the IPU.

1 Click [Exit IPU] in the menu screen.

The dialog box appears.

2 Click [Yes].
The IPU shuts down.

3 Shutdown Windows.
Your computer shuts down.

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8.6 Restart the analyzer

If [IPU Shutdown] is set to OFF, you can restart the analyzer by following the steps below.
If [IPU Shutdown] is set to ON, the IPU shuts down automatically after all analyzers connected to the IPU have shut
down. Therefore, the analyzers cannot be restarted.
(➤P.358 "Chapter 15: IPU Shutdown setting")

8.6.1 When using the XR-1000

1 Shut down the analyzer.

For the procedure for shutting down the analyzer, see the following.
(➤P.125 "8.5.3 Shutting down the analyzer manually")
When you shut down the analyzer, the dialog box appears.

2 Click [Restart] in the dialog box.

The power to the analyzer turns ON, and the analyzer runs a self-check. Wait until the self-check is completed.
(➤P.118 "8.2.4 Execution of analyzer self-check")

8.6.2 When using the XR-2000

1 Shutdown all analyzers connected to the IPU.

For the procedure for shutting down the analyzer, see the following.
(➤P.125 "8.5.3 Shutting down the analyzer manually")
When you shut down the analyzers, the restart all button appears in the control menu.

2 Click [Restart Analyzer] in the control menu.

The power to the analyzer turns ON, and the analyzer runs a self-check. Wait until the self-check is completed.
(➤P.118 "8.2.4 Execution of analyzer self-check")

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8.7 On-line manuals

For rapid access, the manual will be accessible through the IPU.
The following screen appears when [Instructions for Use] is clicked in the menu screen.

Toolbar

List display area Manual display area/operation buttons

Toolbar
The buttons of the following functions are displayed.

[Input]* Click this button to enter a comment when an item of [Error], [Flag], or
[Detailed procedure] is being displayed in the list display area.
[Validate]* Click this button to change the status of the displayed comment to approved
or unapproved. The approval status of a comment is differentiated as
follows:
White background: Approved
Gray background: Unapproved
[Validate All]* Click this button to collectively approve the unapproved comments.
(➤P.133 "8.7.4 Approving Unapproved Comments Collectively")
[Upper] Click to display the comment in the row above.
[Lower] Click to display the comment in the row below.
[File] Click to display a submenu. This can be used to save, restore, or initialize
data.
[Delete]* Click to display a dialog box that allows you to delete the selected comment.
[Close] Click to close the [Instructions for Use] screen.

* This is displayed only if the user who is logged in has the privileges to modify settings. For details on the
privileges to modify settings, see below.
(➤P.361 "Chapter 15: Change settings and add users")

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List display area

List display Comment display area

List switching buttons

During [Error] list display During error message display

List display Displays the item selected by the list switching buttons.
List switching buttons Used to switch the contents to be displayed in the list display area.
[Bookmark] Displays the table of contents of the manual. Click a chapter title to display
the topics in that chapter. Click a topic to display that topic in the screen.
[Error] Displays the list of errors occurring in this instrument. Click the error
category to display the category topics. Click a topic to display that topic in
the screen.
[Flag] Displays the IP message appended to the analysis data. Click the IP
message category to display the category topics. Click a topic to display
that topic in the screen.
[Detailed procedure] Displays a section of the "Instructions for Use" manual that explains the
procedure for troubleshooting the error occurring in this instrument. Click a
topic to display that topic in the screen.
[Back] Click to return the list display in the list display area to the uppermost
hierarchy.
Comment display area When you select an item from the lowermost hierarchy of [Error], [Flag], or
[Detailed procedure] in the list display area, the comment display area is
displayed, and you can check the comments. Double-click the area to
display the [Input Comment(s)] dialog box that allows you to enter or edit a
comment.
Comments can be entered or edited only if the privileges to modify settings
are available. For details on the privileges to modify settings, see below.
(➤P.361 "Chapter 15: Change settings and add users")
An approved comment is displayed with a white background, while an
unapproved comment is displayed with a gray background. If a comment
entered in a manual of a different version is restored, it is set to the
unapproved state even if it is approved, and is displayed with a gray
background.

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Manual display area/operation buttons

Manual display area Magnification button

Previous search/
next search buttons

Previous page/
next page buttons
First page/
last page buttons

Previous/next buttons

Manual display area Displays the manual.

[FIND] If you enter the characters to be searched and then click the previous
search/next search buttons, the manual being displayed is searched.
Previous search/ Click to search the page before or after the displayed page.
next search buttons
[Zoom] Changes the zoom
[+] Click to enlarge the view of the manual.
[-] Click to reduce the view of the manual.
Magnification button Select any magnification to change the view of the manual to that
magnification.
[Fit] Click to fit the view of the manual to the manual display area.
[Move Page] Use to move through the pages.
First page/ Click to move to the first page or the last page of the displayed manual.
last page buttons
Previous page/ Click to display the previous page or next page.
next page buttons
Previous/next buttons Click to move back to the previous page or forward to the next page.

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8.7.1 Saving Comments in CSV Format

You can save the comments as a CSV file.
Follow the steps below to save the comments in CSV format.

1 Click the [File] button - [Output in CSV Format] on the toolbar.

The [Save As] dialog box appears.

2 Specify or create the folder to save the comments into.

3 Enter the file name.

The file extension is ".csv".

Note:
The default file name of CSV format files is set to XR_software version_
XRMANUAL_COMMENT_destination_language_manual version.csv.
e.g. XR_00-01 (Build 2)_XRMANUAL_COMMENT_EU_EN_2108.csv

4 Click [Save].
The CSV data is saved.

8.7.2 Saving Comments (Backup)

You can save all of the added comments in one file.
Follow the steps below to save the comments.

1 Click the [File] button - [Backup] on the toolbar.

The [Save As] dialog box appears.

2 Specify or create the folder to save the comments into.

3 Enter the file name.

The file extension is ".cmt".

Note:
The default file name is set to [XR][Software version][ManualComment][Model name]
[Date of save_Time of save][Destination_Manual version].cmt.
e.g. [XR][00-01 (Build 2)][ManualComment][XR-2000][20210118_144511][EU_2108].cmt

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4 Click [Save].
All registered comments are saved.

8.7.3 Restoring Saved Comments

Saved comments can be restored.
Follow the steps below to restore comments.

1 Click the [File] button - [Restore] on the toolbar.

The [Open File] dialog box appears.

2 Select the name of the file you want to restore.

The file extension is ".cmt".

3 Click [Open].
Comments are restored.

Note:
If a comment entered in a manual of a different version is restored, it is set to the unapproved
state.

8.7.4 Approving Unapproved Comments Collectively

If there are several unapproved comments when comments are restored, the comments can be collectively
approved.
Follow the steps below to approve comments.

1 Click the [Validate All] button on the toolbar.

The dialog box on the right appears.

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2 Select the checkboxes for the comments you want to approve.

3 Click [OK].
All selected comments are approved.

8.7.5 Initializing Comments

The entered comments can be initialized.
Follow the steps below to initialize comments.

1 Click the [File] button - [Initialize] on the toolbar.

The dialog box on the right appears.

2 Select the checkboxes for the comments you want to initialize.

3 Click [OK].
The confirmation dialog box appears.

4 Click [OK].
Comments are initialized.

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Chapter 9 Preparing for Analysis (Registering

Information)
This chapter explains how to manually register the analysis order and the patient information before
performing an analysis.

9.1 Work List functions

The Work List functions allow you to display, register, modify and delete analysis orders. You can register analysis
information for up to 2,000 orders. You can sort, filter, search, save, and restore analysis order.

9.1.1 Work List screen

Clicking the [Work List] icon in the Menu screen displays the following screen. Alternatively, you can also click
the [Work List] button on the toolbar.
A maximum of 2,000 analysis orders can be stored.

Toolbar Font size button Order properties

Filter/sort
description

Order list

Patient information Display switching button

[Work List] screen

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the [Regist Order] dialog box.

[Modify] Click to display the [Modify Order] dialog box for the selected analysis order.
[Download] Click to download analysis orders from the host computer.
Entry is only possible when analysis ordering is set to [Rack No./Tube Pos.]. For the
analysis ordering setting, see the following. (➤P.373 "Chapter 15:
15.3.5 Automatic processing settings")
[Filter] Click to display a dialog box that allows you to set conditions for the data displayed in
the order list.
[Sort] Click to display a dialog box that allows you to set the sorting order for the data
displayed in the order list.

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[Output] Click to output the data of the selected analysis order.

[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[FIND] Click to display a dialog box that allows you to search data.
[Pending] Click to switch the display between pending orders only and all analysis orders.
[File] Click to display a submenu. This can be used to save and restore data.
[Delete] Click to display a dialog box that allows you to delete the selected analysis order.

● Order list
The main screen of the Work List screen.

[Status] Displays the status of the order.

[PEND.] Indicates that the order has been registered.
[COMP.] Indicates that the analysis has completed.
[ERR.] Indicates that an error has occurred.
[Priority Code] Displays the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[Registered date] Displays the date and time at which the order was registered.
[Rack] Displays the rack number.
[Position] Displays the sample tube position number when the sampler analysis was
performed.
[Sample No.] Displays the sample number.
The column to the right of the [Sample No.] column indicates how the sample
number was obtained.
[B]: Hand-held barcode reader input
[M]: Manually entered
[C]: Host computer queried
If you modify a sample number, an [M] is displayed.
[Discrete] Displays the discrete tests for the analysis parameters you specified in the [Work
List] screen or the host computer.
[Patient ID] Displays the patient ID.
[Patient Name] Displays the name of the patient (first name, last name).
[Sample Comment] Displays the status of the sample entered by the user and other information.

● Order properties
Displays the details of the analysis order selected in the order list.
It appears on the sub screen.

[ITEM] All analysis items are displayed.

[Order] The analysis parameters for the order selected in the list pane are marked with a
check mark ([V]).

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● Patient information
Displays the patient information of the analysis order selected in the order list.
It appears on the sub screen.

Patient Name Ward Name

Patient Comment Patient ID Date of birth, sex and age Doctor Name

Patient Name Displays the name of the patient (first name, last name).
Patient ID Displays the patient ID.
Date of birth, sex and age Displays the date of birth, gender, and age of the patient.
Ward Name Displays the patient's ward name or the name of the clinical service.
Doctor Name Displays the name of the doctor assigned to the patient.
Patient Comment Displays comments about the patient.

Note:
• For the details on registering each items, see below.
- Patient Name, Patient ID, Date of birth, sex, and age:
(➤P.154 "9.2.2 Registering and modifying patient information"
- Ward Name:
(➤P.161 "9.2.7 Registering and modifying ward names")
- Doctor Name:
(➤P.163 "9.2.9 Registering and modifying doctor names")
• Items that have not been filled will not be displayed.

● Filter/sort description
Shows what conditions were used to display the analysis orders. These are the conditions you specified in the
filter and sort settings.
For the details on the settings, see below.
(➤P.144 "9.1.3 Sorting analysis orders")
(➤P.145 "9.1.4 Specifying data display conditions (filter)")

The following symbols are used.

Symbol Analysis Method

[] Brackets The condition inside [ ] is considered one grouping. If there is a defined name, it is
shown in front of the brackets.
e.g. A filter called "Weekly Retests" that restricts by [Date]:
Weekly Retests[Date[2010/05/05~2010/06/06]]

, Comma The conditions before and after the comma are combined with a logical AND.
e.g. Orders restricted by [Date] AND [Order Type]:
[Date[2010/05/05~2010/06/06],Order Type[Rerun]]

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Symbol Analysis Method

| Pipe The conditions before and after the pipe are combined with a logical OR.
e.g. All orders whose [Order Type] is either [Rerun] OR [Reflex]:
[Order Type[Rerun|Reflex]]

: Colon Used between a setting and its value.

e.g. All orders whose [Print Graphic] setting under [Output Results] is
[Outputted]: [Output Results[Print Graphic:Outputted]]

() Parentheses Indicates [Asc.] or [Desc.].

e.g. All orders sorted by [Analysis Date] in ascending order:
[Analysis Date(Asc.)]

> Greater-than Indicates priorities between sort conditions.

symbol e.g. [Date] has higher priority than [Time]:
[Date(Desc.)]>[Time(Asc.)]

● Display switching button

You can click the display switching button to open/close the sub screens. Click to switch through the 4 patterns
in the order "sub-screen (right and bottom)" → "sub-screen (bottom)" → "no sub-screen" → "sub-screen (right)".

● Font size button

To change the size of the characters and the line height in the order list, click the font size button. To change the
size setting of the characters, see the following:
(➤P.367 "Chapter 15: 15.3.3 Display settings")

Note:
Multiple data can be selected as follows:
• Drag multiple consecutive rows while holding down the left button on the mouse
• While pressing Ctrl, click on the row that you want to select

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9.1.2 Registering and modifying analysis orders

This section explains how to register and modify an analysis order from the [Work List] screen.

Registering an analysis order

Click the [Regist.] button on the toolbar to display the following dialog box. The order selection area appears
when you click the select button on the right side of [Discrete].

Order
selection area

[Regist Order] dialog box

Modifying an analysis order

When you double-click on the table of orders in the [Work List] dialog, the [Modify Order] dialog appears.
Alternatively, you can also select the order you want to modify, and then click the [Modify] button on the
toolbar.
The fields in the [Modify Order] dialog box are the same as those of the above*. Please refer to it.
* [Rack unit registration] does not appear.

Note:
• If 2,000 analysis orders have been registered, the [Regist.] button on the toolbar is grayed
out and cannot be clicked. Delete old orders and then register a new analysis order.
• Analysis orders for which analysis has been completed cannot be modified.
• When registering an analysis order, if an order with the same entries for the items below has
already been registered, a dialog box will appear to confirm overwriting of the previous
order.
- [Sample No.]
- [Rack No.] and [Tube Pos.]

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Follow the steps below to register or modify an analysis order.

1 Populate the displayed fields.

[Sample No.] For new registrations, a sample number is automatically generated. Alternatively,
you can also assign an arbitrary sample number.
You can enter up to 22 characters.
An order can only be modified if analysis ordering is set to [Rack No./Tube
Pos.]*.
[Priority Code] Select the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[Rack No.] For new registrations, a rack number is automatically generated. Alternatively,
you can also assign an arbitrary number.
You can enter up to 6 characters. An order can only be modified if analysis
ordering is set to [Rack No./Tube Pos.]*.
In the Modify dialog box, [Rack No.] is grayed out and cannot be clicked.
[Tube Pos.] For new registrations, a tube position number is automatically generated.
Alternatively, you can also assign an arbitrary number.
Any number between 1 and 10 can be entered. An order can only be modified if
analysis ordering is set to [Rack No./Tube Pos.]*.
In the Modify dialog box, [Tube Pos.] is grayed out and cannot be clicked.
[Rack unit This can be selected to register orders by rack.
registration] If less than 10 orders can be registered, this is grayed out and cannot be
selected. Display is only possible when analysis ordering is set to [Rack No./
Tube Pos.]*.
[Discrete] Select the discrete test.
For the parameters included in each discrete test, see below.
(➤P.143 "Table of discrete tests and their corresponding analysis parameters")
[Sample Comment] Enter comments about the sample.
You can enter up to 40 characters.
[Patient ID] Enter the patient ID.
You can enter up to 16 characters.
When you enter a [Patient ID], a corresponding [Patient Information] is
automatically searched. If there is a match, the information is displayed.
This is displayed only if the user who is logged in has the privileges to display
and modify patient info.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

* For the analysis ordering setting, see Chapter 15. (➤P.373 "Chapter 15: 15.3.5 Automatic processing
settings")

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● [Patient Information]
The analysis order can be registered without entering any patient information.

* This is displayed only if the user who is logged in has the privileges to display and modify patient info.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

[Last Name] Enter the patient's last name.

You can enter up to 20 characters.
[First Name] Enter the patient's first name.
You can enter up to 20 characters.
[Birth] Enter the patient's date of birth. Enter it in the format "Year (4 digits)/Month
(2 digits)/Date (2 digits)".
If you click the button on the right edge of the input field, a calendar appears. You
can also enter the date by selecting from this calendar.
A delete button is displayed on the right side of [Birth] field.
Clicking it will clear the patient's date of birth.
[Age] Enter the patient's age. This is automatically displayed when [Birth] is entered.
[Sex] Select the patient's gender.
[Ward Name] Select the name of the patient's ward.
[Doctor Name] Select the name of the doctor assigned to the patient.
[Patient Comment] Enter any comment about the patient.
You can enter up to 100 characters.

Information
If a patient ID has not been entered, patient information cannot be entered.

Order selection area

● [Order]
Select the checkboxes to specify the parameters to analyze. The displayed analysis parameters vary
depending on the configuration of the connected analyzer.
If you have selected a [Discrete], the checkboxes for the corresponding parameters are selected.
If the selected parameter combination does not exist under [Discrete], [FREE SELECT] is displayed in the
[Discrete] field.
For discrete tests and analysis parameters, see below.
(➤P.143 "Table of discrete tests and their corresponding analysis parameters")

● [Channel]
[Analyze PLT-F Select this checkbox to enable the analysis of the PLT-F channel.
Channel] You can select this checkbox only when the order includes the PLT parameter.
[Analyze WPC Select this checkbox to enable the analysis of the WPC channel.
Channel] You can select this checkbox only when the order includes the DIFF parameter.

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2 Click [OK].
The dialog box closes and the analysis order is registered (or modified).
To register continuously, click [Continuous Registration].
* In the Modify dialog box, [Continuous Registration] does not appear.

[Continuous When [Rack unit registration] is not selected

Registration] The entered analysis order is registered and the next analysis order can be
registered.
When [Rack unit registration] is selected
The entered analysis order is registered as a [Tube Pos.] 1.
Repeat to register tube positions to [Tube Pos.] 10.
If tube positions are registered to [Tube Pos.] 10, the next [Regist Order] dialog
box appears.

Note:
If a discrete test in not selected under [Discrete], or if the [Sample No.] field is blank or set to
"0", the [OK] button and [Continuous Registration] button are grayed out and cannot be
clicked.

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Table of discrete tests and their corresponding analysis parameters

Analysis parameters

WBC RBC HGB HCT MCV MCH MCHC PLT*1 RDW-SD/ NRBC# NEUT%/LYMPH%/ RET%/RET#/ IPF/
Default Discrete Tests RDW-CV/ NRBC% MONO%/EO%/BASO%/ IRF/LFR/ IPF#
PDW/MPV/ NEUT#/LYMPH#/ MFR/HFR
P-LCR/PCT MONO#/EO# /
BASO#/IG#/IG%

CBC*2 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - - -
CBC+DIFF*2 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - -
3
CBC+DIFF+RET* ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ -
CBC+RET*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓ -
3

XR-1000/XR-2000 Instructions for Use

CBC+PLT-F* ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - - ✓
CBC+DIFF+PLT-F*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓
CBC+DIFF+RET+PLT-F*2,3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
CBC+RET+PLT-F*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓ ✓
CBC+DIFF+WPC*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - -
Chapter 9

CBC+DIFF+RET+WPC*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ -
CBC+DIFF+PLT-F+WPC*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓

CBC+DIFF+RET+PLT-F+WPC*3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

FREE SELECT If a combination other than the above default discrete tests is selected, [FREE SELECT] is displayed.
FREE SELECT+WPC This is displayed when the condition for [FREE SELECT] is met, and the [Analyze WPC Channel] checkbox is selected.

FREE SELECT+PLT-F This is displayed when the condition for [FREE SELECT] is met, and the [Analyze PLT-F Channel] checkbox is selected.
FREE SELECT+PLT-F+WPC This is displayed when the condition for [FREE SELECT] is met, and the [Analyze WPC Channel] and the [Analyze
PLT-F Channel] checkboxes are both selected.

*1 In addition, depending on the specified analysis conditions, the analysis results from [RBC/PLT], [PLT-F] or a combination of [RBC/PLT] and [RET]
channel will be used.
*2 During [Pre-Dilution] mode, you can use only these discrete tests. [RET] and [PLT-F] do not appear with all analyzer types.
*3 Cannot be used depending on the analyzer type.
Preparing for Analysis (Registering Information)

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9.1.3 Sorting analysis orders

You can sort analysis orders by the conditions that you specify.
Follow the steps below to sort analysis orders.

1 Click the [Sort] button on the toolbar.

The dialog box on the right appears.

2 Populate the displayed fields.

In fields [1st Key] through [4th Key], specify the sort conditions.
The sort conditions are prioritized from [1st Key] to [4th Key].
After selecting the keys, sort the alphanumeric in [Asc.] (0 to 9, A to Z) or [Desc.] (9 to 0, Z to A) order.

[Registered date] Sorts by date and time of registration.

[Sample No.] Sorts by sample number.
[Rack No.] Sorts by rack number.
[Tube Pos.] Sorts by sample tube position number.
[Priority Code] Sorts by priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[None] Condition not specified.

3 Click [OK].
The dialog box closes and sorting is applied.

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9.1.4 Specifying data display conditions (filter)

You can specify conditions for the data you want displayed.
Follow the steps below to specify conditions for the data you want displayed.

1 Click the [Filter] button on the toolbar.

The following dialog box appears.
If a pending order is displayed, the [Filter] button is grayed out and cannot be clicked.

2 Populate the displayed fields.

The following items appear in the dialog box.

[Use Filter] Selecting this checkbox will display only the orders that match the specified
conditions.
If you clear the checkbox, the settings will be grayed out and cannot be
selected.
[Specify Date] Select this checkbox to restrict the data to display by date.
[Starting Day] / Click to select [Today], [Yesterday] or [Specify].
[Ending Day] Selecting [Specify] allows you to specify the date. In the field below [Specify],
enter the date in the format "Year (4 digits)/Month (2 digits)/Date (2 digits)". If
you click the button on the right edge of the input field, a calendar appears.
You can also enter the date by selecting from this calendar.
[Specify Status] Select this checkbox to specify the status of the analysis order to be
displayed.
[PEND.] Select this checkbox to display orders that have not been analyzed.
[COMP.] Select this checkbox to display orders whose analysis have been completed.
[ERR.] Select this checkbox to display orders in which an analysis error has
occurred.
[Specify Priority Code] Select this checkbox to restrict the data to display by priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")

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3 Click [OK].
The dialog box closes and the specified data appear.

9.1.5 Searching analysis orders

You can search for a specific analysis order.
Follow the steps below to search for an analysis order.

1 Click the [FIND] button on the toolbar.

The dialog box on the right appears. Ward Name
When the dialog box is started, the input field
ward name / doctor name selection
field is not displayed.

Ward
selection
area

List of ward
names
Select
button

When the Ward selection area is displayed

Note:
The doctor selection area is similar to the above dialog box. Please refer to it.

2 Populate the displayed fields.

The following items appear in the dialog box.

● [Find Conditions]
[Sample No.] Enter the sample number.
You can enter up to 22 characters.
[Priority Code] Select the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[Patient ID] Enter the patient ID.
You can enter up to 16 characters.

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[Last Name] Enter the patient's last name.

You can enter up to 20 characters.
[First Name] Enter the patient's first name.
You can enter up to 20 characters.
[Ward Name] Displays the selected ward name.
Select button Clicking the button displays the ward selection area on the right side of the dialog
box.
[Doctor Name] Displays the selected doctor for the patient.
Select button Clicking the button displays the doctor selection area on the right side of the dialog
box.

● Ward / Doctor selection area

Ward name / Doctor Enter a condition to narrow down the ward names / doctor names.
name input field You can enter up to 20 characters.
List of ward names / Displays the ward names / doctor names that contain the condition that you entered.
doctor names Click to select the ward name / doctor name.
You can only select one ward name / doctor name.
[Clear] Click to clear the selected ward name / doctor name.

Note:
You can enter "?" and "*" as substitution characters in your search.
"?": A "?" is used in place of any 1 character.
e.g. If you search for "99?99", "99099", "99999", and "99A99" are all selected.
"*": A "*" is used in place of 0 or more characters.
e.g. If you search for "9*9", "909", "9119", and "99A99" are all selected.

3 Specify the search condition.

If you want to find orders that match the specified conditions exactly, select the [Find exact matches] checkbox.
If you clear the checkbox, it will also find orders that partially match the specified conditions.

4 Click [PREV.] / [NEXT].

An order that matches the search conditions is selected in the list pane.

[PREV.] Click to search up from the analysis order selected in the list pane.
[NEXT] Click to search down from the analysis order selected in the list pane.

5 Click [Close].
The dialog box closes.

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9.1.6 Saving pending order (backup)

You can save all of the registered pending orders in one file.
Follow the steps below to save pending analysis orders.

1 Click the [File] button - [Backup] on the toolbar.

The dialog box on the right appears.

Note:
If there are no pending orders, [Backup] is grayed out and cannot be clicked.

2 Click [OK].
The [Save As] dialog box appears.

3 Specify the save folder.

4 Enter the file name.

The file extension is ".odr".

Note:
The default file name is in the format [XR][Software version][Order]
[Date of save_Time of save].odr.
e.g. [XR][00-01 (Build 2)][Order][20210118_144511].odr

5 Click [Save].
All registered pending orders are saved.

Information
In the patient information that is associated with the order, only [Patient ID] is backed up
regardless of the setting. To back up other patient information, back up from patient registration.

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9.1.7 Restoring saved pending orders

You can restore saved pending orders.
Follow the steps below to restore saved pending orders.

1 Click the [File] button - [Restore] on the toolbar.

The [Open File] dialog box appears.

2 Select the name of the file you want to restore.

The file extension is ".odr".

3 Click [Open].
Pending orders are restored.

Note:
• Once the number of registered orders exceeds 2,000, any subsequent new registration will
overwrite the oldest registered order.
• If a registered data already exists with the same value for the items below, a dialog box
appears to confirm overwriting.
- [Sample No.]
- [Rack No.] and [Tube Pos.]
• Because of the analyzer's structure, the orders which cannot be registered are deleted when
the orders including the items that cannot be analyzed are restored.

9.1.8 Displaying only the pending orders

Displaying only pending analysis orders in the order list is possible.
Click the [Pending] button on the toolbar to display pending orders.

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9.1.9 Downloading analysis orders

Analysis orders can be downloaded from the host computer.
Follow the steps below to download analysis orders.

1 Click the [Download] button on the toolbar.

The dialog box on the right appears.

2 Enter the [Rack No.].

Enter the rack number of the analysis order you want to download.
You can enter up to 6 characters.
You can query up to 10 orders.

3 Click [OK].
The analysis orders are downloaded from the host computer using the rack number that you entered.

Note:
• If the host computer is not connected, if the order request item is set to [Sample No.], [OK] is
grayed out and cannot be clicked.
• Once the number of registered orders exceeds 2,000, any subsequent new orders will
overwrite the oldest registered order.
• If the [Patient ID], [Ward Name] and/or [Doctor Name] of a downloaded analysis order are the
same as an already registered order, they are overwritten.
• If a communication error occurs while downloading, the downloaded orders are registered.
Orders which do not finish downloading are not registered.
• If the downloaded analysis order and the already registered pending order have the same
[Rack No.] and [Tube Pos.], a dialog box appears to confirm overwriting.
• Because of the analyzer's structure, the orders which cannot be registered are deleted when
the orders including the items that cannot be analyzed are downloaded.

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9.1.10 Deleting analysis orders

Follow the steps below to delete the analysis orders selected in the order list.

1 In the list pane, click the order you want to delete.

The order is selected.
You can select multiple orders in the list.

2 Click the [Delete] button on the toolbar.

The dialog box on the right appears.

3 Click [Yes].
The dialog box closes and the order is deleted.

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9.2 Patient List functions

Use the Patient List functions to display, register, modify, save, restore and delete patient information, ward names,
and doctor names.

Opening / switching to [Patient List] screen

Clicking the [Patient List] icon in the Menu screen displays the [Patient List] screen.
Clicking the tab switches the view.
* The procedures for using the functions in the [Patient List] screen are same as the [Work List] screen. For
information on saving, restoring, and deleting patient information, see the procedures for using the [Work List]
screen.

● Saving patient information

You can back up all of [Patient Information], [Ward Name], and [Doctor Name] into a single file.
The file extension is ".pat". Refer to the following procedures in the [Work List] screen.
(➤P.148 "9.1.6 Saving pending order (backup)")

Note:
The default file name is in the format [XR][Software version][Patient][Date of save_Time of save].pat
e.g. [XR][00-01 (Build 2)][Patient][20210118_144511].pat

Information
If [Include patient information] is selected in [Security Settings], patient information is output to
the backup file. If [Output patient information] is selected, patient information is output to a CSV
file.
For details on security, see the following.
(➤P.365 "Chapter 15: Security settings")

● Restoring saved patient information

You can restore the [Patient Information], the [Ward Name], or the [Doctor Name] from the backup patient
information.
The file extension is ".pat". Refer to the following procedures in the [Work List] screen.
(➤P.149 "9.1.7 Restoring saved pending orders")

● Deleting patient information, ward name, and/or doctor name

Perform this operation while the screen corresponding to the item to be deleted is displayed. Refer to the
following procedures in the [Work List] screen.
(➤P.151 "9.1.10 Deleting analysis orders")

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9.2.1 Patient Information screen

Clicking the [Patient Information] tab displays the following screen.

In the [Patient Information] screen, you can sort, filter, search, save and restore patient information. You can
register patient information for up to 10,000 patients.

Toolbar

Patient
information
list

[Patient Information] screen

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the [Register Patient Information] dialog box.

[Modify] Click to display the [Modify Patient Information] dialog box for the selected patient
information.
[Filter] Click to display the dialog box that allows you to set the conditions for the data to be
displayed in the patient information list.
[Sort] Click to display the dialog box that allows you to set the sort order for the data to be
displayed in the patient information list.
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[FIND] Click to display a dialog box that allows you to search data.
[File] Click to display a submenu. This can be used to save and restore data.
[Delete] Click to display a dialog box that allows you to delete the selected patient
information.

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● Patient information list

Displays the registered patient information.

[Patient ID] Displays the patient ID.

[Patient Name] Displays the name of the patient (first name, last name).
[Sex] Displays the patient's gender.
[Birth] Displays the patient's date of birth.
[Age] Displays the patient's age.
[Ward Name] Displays the patient's ward name or the name of the clinical service.
[Doctor Name] Displays the name of the doctor assigned to the patient.
[Patient Comment] Displays comments about the patient.

9.2.2 Registering and modifying patient information

This section explains how to register and modify patient information.

Registering patient information

Click the [Regist.] button on the toolbar to display the following dialog box.

[Register Patient Information] dialog box

Modifying patient information

From the list pane, double-click the patient information you want to modify. The [Modify Patient Information]
dialog box appears. Alternatively, you can also select the patient information you want to modify, and then click
the [Modify] button on the toolbar.
The fields in the [Modify Patient Information] dialog box are the same as those in the [Register Patient
Information] dialog box*. Please refer to it.
Follow the steps below to register or modify patient information.
* [Continuous Registration] does not appear.

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1 Populate the displayed fields.

[Patient ID] For new registrations, you can enter the patient ID.
You can enter up to 16 characters.
The patient ID cannot be changed when modifying information.
[Last Name] Enter the patient's last name.
You can enter up to 20 characters.
[First Name] Enter the patient's first name.
You can enter up to 20 characters.
[Birth] Enter the patient's date of birth. Enter it in the format "Year (4 digits)/Month (2 digits)/
Date (2 digits)". If you click the button on the right edge of the input field, a calendar
appears. You can also enter the date by selecting from this calendar.
A delete button is displayed on the right side of the [Birth] field.
Clicking it will clear the patient's date of birth.
[Age] Enter the patient's age. This is automatically displayed once the date of birth is
entered.
[Sex] Select the patient's gender.

[Ward Name] Select the patient's ward name or the name of the clinical service.

[Doctor Name] Select the doctor assigned to the patient.

[Patient Comment] Input comments about the patient.

You can enter up to 100 characters.

2 Click [OK].
The dialog box closes and the patient information is registered (or modified).
Clicking [Continuous Registration] registers the [Patient Information] that you just entered, and allows you to
register the next [Patient Information]*.
* In the Modify dialog box, [Continuous Registration] does not appear.

Note:
Once the number of registered patient information exceeds 10,000, any subsequent new
registration will overwrite the oldest registered patient information.

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9.2.3 Sorting patient information

You can sort patient information by the condition that you specify.
Follow the steps below to sort patient information.

1 Click the [Sort] button on the toolbar.

The dialog box on the right appears.

2 Populate the displayed fields.

In fields [1st Key] through [5th Key], specify the sort conditions. The sort conditions are prioritized from [1st Key]
to [5th Key]. After selecting the keys, sort the alphanumeric in [Asc.] (0 to 9, A to Z) or [Desc.] (9 to 0, Z to A)
order.

[Patient ID] Sorts by patient ID.

[Last Name] Sorts by patient's last name.
[First Name] Sorts by patient's first name.
[Age] Sorts by patient's age.
[Sex] Sorts by patient's gender.
[None] Condition not specified.

3 Click [OK].
The dialog box closes and sorting is applied.

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9.2.4 Specify conditions for the patient information to display (filter)

You can specify conditions for the data you want displayed in the patient information list.
Follow the steps below to specify conditions for the data you want displayed.

1 Click the [Filter] button on the toolbar.

The following dialog box appears.
* When the dialog box is started, the ward name / doctor name selection field is not displayed.
Select button
Ward name
input field

Ward selection
area

List of ward
When the Ward name is displayed names

Note:
The doctor selection area is similar to the above dialog box. Please refer to it.

2 Populate the displayed fields.

The following items appear in the dialog box.

[Use Filter] Selecting this checkbox will display only the orders that match the specified
conditions.
If you clear the checkbox, the following settings will be grayed out and
cannot be selected.
[Specify Sex] Selecting this checkbox enables you to specify the patient's gender.
[Specify Ward] Selecting this checkbox enables you to specify the patient's ward.
Select button Clicking the button displays the ward selection area on the right side of the
dialog box.
[Specify Doctor Name] Selecting this checkbox enables you to specify the name of the patient's
doctor.
Select button Clicking the button displays the doctor selection area on the right side of the
dialog box.

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● Ward / Doctor selection area

Ward name / Doctor name Enter a condition to narrow down the ward names / doctor names.
input field You can enter up to 20 characters.
List of ward names / doctor Displays the ward names / doctor names that contain the condition that you
names entered.
Click to select the ward name / doctor name.
You can only select one ward name / doctor name.
[Clear] Click to clear the selected ward name / doctor name.

3 Click [OK].
The dialog box closes.
Only the patient information that match all of the specified criteria are displayed.

9.2.5 Searching for patient information

You can search for specific patient information.
Follow the steps below to search for patient information.

1 Click the [FIND] button on the toolbar.

The dialog box on the right appears.

2 Populate the displayed fields.

[Patient ID] Enter the patient ID.
You can enter up to 16 characters.
[Last Name] Enter the patient's last name.
You can enter up to 20 characters.
[First Name] Enter the patient's first name.
You can enter up to 20 characters.

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Note:
You can enter "*" and "?" as substitution characters in your search.
"?": A "?" is used in place of any 1 character.
e.g. If you search for "99?99", "99099", "99999" and "99A99" are all selected.
"*": A "*" is used in place of 0 or more characters.
e.g. If you search for "9*9", "909", "9119" and "99A99" are all selected.

3 Specify the search condition.

If you want to find patient information that matches the specified conditions exactly, select the [Find exact
matches] checkbox. If you clear the checkbox, it will also find patient informations that partially match the
specified conditions.

4 Click [PREV.] / [NEXT].

An patient information that matches the search conditions is selected in the list pane.

[PREV.] Click to search upward from the patient information selected in the list pane.
[NEXT] Click to search downward from the patient information selected in the list pane.

5 Click [Close].
The dialog box closes.

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9.2.6 Ward Name screen

Clicking the [Ward Name] tab displays the following screen.

In the [Ward Name] screen, you can sort and search ward names. You can register up to 200 ward names.
Toolbar

List of ward
names

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the [Register Ward Name] dialog box.

[Modify] Click to display the [Modify Ward Name] dialog box for the selected ward name.
[Sort] Click to display the dialog box that allows you to set the conditions for the data to be
displayed in the ward name list.
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[FIND] Click to display a dialog box that allows you to search data.
[Delete] Click to display a dialog box that allows you to delete the selected ward name.

● List of ward names

[No.] Displays the ward number.
[Ward Name] Displays the name of the ward.

Note:
For instructions on the following tasks in the [Ward Name] screen, see the procedures for the
[Patient Information] screen.
• Sorting ward names
(➤P.156 "9.2.3 Sorting patient information")
• Searching for a ward name
(➤P.158 "9.2.5 Searching for patient information")
• Deleting ward names
(➤P.151 "9.1.10 Deleting analysis orders")

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9.2.7 Registering and modifying ward names

You can register and modify ward names from the [Ward Name] screen.

Registering a ward name

Click the [Regist.] button on the toolbar to display the dialog
box on the right.

[Register Ward Name] dialog box

Modifying a ward name

From the list pane, double-click the ward name you want to modify. The [Modify Ward Name] dialog box
appears. Alternatively, you can also select the ward name you want to modify, and then click the [Modify] button
on the toolbar.
The fields in the [Modify Ward Name] dialog box are the same as those in the [Register Ward Name] dialog box.
Please refer to it.
Follow the steps below to register or modify a ward name.

1 Populate the displayed fields.

[No.] For new registrations, the minimum number that has not been registered is
automatically generated. You can change the displayed number. Any number
between 0 and 200 can be entered.
The number cannot be changed when modifying information.
[Ward Name] Enter the name of the ward.
You can enter up to 20 characters.

2 Click [OK].
The dialog box closes and the ward name is registered (or modified).
Clicking [Continuous Registration] registers the [Ward Name] that you just entered, and allows you to register
the next [Ward Name]*.
* In the Modify dialog box, [Continuous Registration] does not appear.

Note:
If 200 records have been registered, the [Regist.] button on the toolbar is grayed out and cannot
be clicked.

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9.2.8 Doctor Name screen

Clicking the [Doctor Name] tab displays the following screen.

In the [Doctor Name] screen, you can sort and search for doctor names. You can register up to 200 doctor names.

Toolbar

Doctor
name
list

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the doctor name registration dialog box.

[Modify] Click to display the Modify dialog box for the selected doctor name.
[Sort] Click to display the dialog box that allows you to set the conditions for the data to be
displayed in the doctor name.
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[FIND] Click to display a dialog box that allows you to search data.
[Delete] Click to display a dialog box that allows you to delete the selected doctor name
information.

● Doctor name list

[No.] Displays the doctor number.
[Doctor Name] Displays the doctor's name.

Note:
For instructions on the following tasks in the [Doctor Name] screen, see the procedures for the
[Patient Information] screen.
• Sorting doctor names
(➤P.156 "9.2.3 Sorting patient information")
• Searching for a doctor name
(➤P.158 "9.2.5 Searching for patient information")
• Deleting doctor names
(➤P.151 "9.1.10 Deleting analysis orders")

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9.2.9 Registering and modifying doctor names

You can register and modify doctor names from the [Doctor Name] screen.

Note:
The steps for registering and modifying a doctor name are the same as those for registering and
modifying a ward name.
(➤P.161 "9.2.7 Registering and modifying ward names")

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Chapter 10 Performing Quality Control

Chapter 10 Performing Quality Control

This chapter explains how to perform quality control tasks.

10.1 Introduction
Quality control is the routine monitoring of performance using commercial or patient controls.
Controls with known characteristics are analyzed and compared to the known characteristics using statistical methods.
This allows changes to performance to be detected and then action can be taken if these changes are significant.

10.1.1 Quality control workflow

Follow the steps below to perform quality control.

Configure quality control settings

➤P.167 "Chapter 10: 10.2 Configure quality
control settings"

Create QC file (input lot information)* QC File screen

➤P.168 "Chapter 10: 10.3 Registering and ➤P.180 "Chapter 10: 10.5.1 QC File
modifying a QC file (lot information input)" screen"

Perform QC analysis
➤P.175 "Chapter 10: 10.4.1 Performing ➤P.179 "Chapter 10: 10.4.2 Performing QC
QC analysis using manual analysis" analysis using sampler analysis"

Check QC results QC File screen

➤P.180 "Chapter 10: 10.5 Check quality control ➤P.180 "Chapter 10: 10.5.1 QC File
results" screen"

QC Chart screen
Troubleshoot any error that occurred ➤P.182 "Chapter 10: 10.5.2 QC Chart
screen"
➤P.191 "Chapter 10: 10.6 Troubleshoot quality
control errors"

Repeat QC analysis and check results

* This step is not necessary if you are using the automatic lot registration function.

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10.1.2 Types of quality control

The following types of quality control methods exist. Use the appropriate method according to your needs.

QC using quality control material

• X-bar Control: The quality control material is analyzed twice in succession, and the average of the 2 results
is used as the control data.
• L-J Control: Takes the data from a single analysis of quality control material and uses it as the control data.

QC using normal samples

X-barM Control: This program calculates a weighted average of batches of normal patient samples
(usually 20) and plots the resulting value as control data. The number of samples can be set
to any number.

10.1.3 About the timing of QC analysis

Quality control is performed in order to monitor an instrument's performance over time.
XN CHECK is the quality control material used to monitor the performance of the XR analyzer.
Quality control should be run according to licensing agency regulations.
It should be noted that for troubleshooting purposes, additional control runs may be necessary.

Note:
You can periodically display a message to prompt the user to perform quality control tasks
(quality control alarm).

10.1.4 Quality control materials

When performing X-bar control or L-J control, use dedicated quality control material.
● Types of quality control material
XN CHECK Level1
XN CHECK Level2
XN CHECK Level3
XN CHECK BF Level1
XN CHECK BF Level2

Information
• Only use the specified quality control material. Quality control material is specially designed to
the analysis technology of the instrument.
• To execute the quality control using an external QC sample or a residual sample (pooled
blood), set the [Material] to [Other].

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10.2 Configure quality control settings

Before performing quality control tasks, configure the following settings.
• Method of quality control (X-bar Control or L-J Control)
• Settings related to limits
• X-barM batch setting

For explanation on how to configure these settings, see the following.

(➤P.380 "Chapter 15: 15.3.8 QC settings")

10.2.1 Activating / deactivating X-barM Control

X-barM control is executed each time the analyzer is started. You can temporarily change this setting to not
execute control.
Follow the steps below to configure X-barM control settings.

1 Click the Analyzer menu button on the control menu.

The menu on the right appears.

2 Click [X-barM Setting].

The dialog box on the right appears.
Click [On] to perform X-barM Control, or [Off] to cancel X-barM
Control.

3 Click [OK].

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10.2.2 About X-barM control

The following analysis results are not controlled in X-barM control:
• Analysis results analyzed in a mode other than [Whole Blood] mode
• Analysis results with sample number "0"
• Calibration and QC analysis results
• Blank data and background check analysis results
• Analysis results including data outside the linearity range, low-reliability data, critical value, and data outside
the display range
• Analysis results that include data for which the data mask [ - - - - ] appears

10.3 Registering and modifying a QC file (lot information

input)
To perform quality control tasks, QC files must be registered.
You can register up to 94 QC files per analyzer.

Register lot information using one of the methods below.

• Manual lot registration (➤P.168 "10.3.1 Performing lot registration manually")
• Automatic lot registration (➤P.174 "10.3.2 Performing lot registration automatically")
• Modifying lot information (➤P.174 "10.3.3 Modifying lot information")

10.3.1 Performing lot registration manually

Follow the steps below to perform lot registration.

1 Click the [QC File] icon in the Menu screen.

The [QC File] screen appears.

2 When using the XR-2000, click a tab and select an analyzer.

QC files are managed for each analyzer. Select the analyzer that you want to register.
For the tabs, see below.
(➤P.180 "10.5.1 QC File screen")

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3 Select a QC file with no registered lots, and click the [Regist.] button on the
toolbar.
The following dialog box appears.

Clear Date
button

[Input Lot Information] dialog box

4 Enter lot information.

● [Lot Information]
This section explains lot information settings.

[Material] Select the type of quality control material.

[Lot No.] Enter the lot number.
You can enter up to 8 alphanumeric characters.
[Exp. Date] Displays the currently set date. You can also click and
directly enter the date.
Clear Date button: Click to clear the displayed date.

Information
If you modify the [Material], the values in the list of setting parameters in step 5 are reset to the
values that appear when the [Input Lot Information] dialog box is opened.

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● [Read Assay File]

Reads the lot information from the CD-ROM that came with the quality control material, or from the specified
folder.
Clicking [Read Assay File] will display the following dialog box.

Source directory field

List of files

Source directory field Displays the folder from which the file list will be imported. You can also specify the
import destination by manual entry.
[Browse] Click to display the dialog box for specifying the folder.
[Select Lot] Displays the list of files on the CD-ROM. Select the file that you want to register.
[Read targets/limits] Select this checkbox if you want to read the target / limit of the selected QC item. If
the checkbox is not checked, the target/limit values are reset to their default values
which are shown when the dialog box is opened.

Note:
The lot number is registered as shown below in the assay file*.
• XN CHECK Level1: QC-XXXX1101
• XN CHECK Level2: QC-XXXX1102
• XN CHECK Level3 QC-XXXX1103
• XN CHECK BF Level1: QC-XXXX1301
• XN CHECK BF Level2: QC-XXXX1302
* A number for each lot appears in XXXX.

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5 Set target and limit values.

List of setting
parameters

● List of setting parameters

This section explains how to edit target values and limit values.

[Item] The QC item name is displayed.

[Lower Limit] The lower limit value is displayed.
[Target] You can enter the target value. If left blank, a variable target is used, same as when
you enter "0".
[Upper Limit] The upper limit value is displayed.
[Unit] The units of the QC item are displayed.

● [Manual Settings]
You can manually set the target and limit values for the selected QC item.

[Item] Displays the name of the item currently selected in the list.
[Target] Click to enter the target value of the item that is selected in the list.
[Limit Range (#)] / Click to enter the limit value of the item that is selected in the list.
[Limit Range (%)] Depending of the configuration, this is displayed as a numerical value (#), or a ratio
(%).

● [Variable Target]
Specify this to quality control the QC files with arbitrary target values.
A function that automatically calculates the target values using the control data in the file. This function activates
when the targets are set to blank for X-bar Control, L-J Control, and X-barM Control.

Click to designate the target value of the selected item as a variable.

Nothing will be displayed in the [Target] field of the applicable item. If a "0" is entered in the [Target], or if it is left
blank, it will be processed as a variable target.

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Note:
The average of the plots, excluding the latest plot, is set as the variable target.

The target values are calculated as follows:

If the number of plots is zero: 0*
If the number of plots is 1: value of the plot
If the number of plots is 2 or more: Average value (excluding the latest plot)
* If the limit setting is ratio, the limit range will be 100 % and the minimum number of digits will
be displayed on the grid for each QC item.

● [Auto Settings]
Automatically sets the target and limit values for the selected
QC item.
Click to display the dialog box on the right.

[Select Data] When the respective checkbox(es) is

selected, the value for [Target] and/or
[Limit] fields will be automatically
calculated.
[Lot Information] Displays the lot information.

Information
If the QC data or the selected range of plots contains less than 3 plots, statistical data cannot be
calculated for the limit, therefore the limit cannot be automatically set.

● [Read Assay Items]

Reads the assay targets and limits from the CD-ROM that
came with the quality control material, or from the specified
folder.
The file extension is ".qxr" or ".qbr".
Click to display the dialog box on the right.

[Browse] Click to display the dialog box for specifying the folder.
[Select Data] When the respective checkbox(es) is selected, the value for [Target] and/or [Limit]
fields will be read.
[Lot Information] Displays the lot information.

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● [Backup]
The [Save As] dialog box is displayed to let you save a target/limit backup file.

Note:
The Target/Limit values are saved as follows.
[Analyzer ID][Software version][QCTargetLimit][File No.][Material][Lot No.].tlf

● [Restore]
The [Open File] dialog is displayed to let you restore a target/limit backup file.

6 Click [OK].
The lot information is registered and the dialog closes.

Information
If lot information with a same number already exists in the analyzer for which you are registering
the lot information, registration cannot be performed.

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10.3.2 Performing lot registration automatically

When sampler analysis is performed, lot information is acquired immediately before analysis and registered in
the QC file. The assay file is read from the dedicated server or the CD-ROM, and the lot information is registered
in the QC file.
Lot information (expiration date, target/limit values) is acquired from the lot number.
If 94 QC files are already saved, saving a new file deletes the oldest file from the data base.
If the oldest file is in use, the next oldest file that is not in use is deleted.

Note:
• A backup is kept of the deleted file as shown below.
[Analyzer ID][Software version][QCFile][Date of save_Time of save][Material][Lot No.].qcf
• If the lot number after "QC-" is more than 8 digits long, registration will not be performed.

10.3.3 Modifying lot information

Follow the procedure below to modify lot information.

1 Click the [QC File] icon in the Menu screen.

The QC File screen appears.
For QC file, see below.
(➤P.180 "10.5.1 QC File screen")

2 Select the QC file to be modified and click the [Modify] button on the toolbar.
The [Input Lot Information] dialog box appears.
For details on the [Input Lot Information] dialog box, see below.
(➤P.168 "10.3.1 Performing lot registration manually")

The following items can be modified.

• Lot No.
• Exp. Date
• Target/Limit

Note:
[Material] cannot be modified, and thus the [Read Assay File] button is grayed out and cannot
be clicked.

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10.4 Perform QC analysis

This section explains how to perform QC analysis.

10.4.1 Performing QC analysis using manual analysis

To perform body fluid analysis QC or QC using an external QC sample or remaining sample (pooled blood),
perform manual analysis. To perform QC using an external QC sample or remaining sample (pooled blood), set
[Material] to [Other].
Follow the steps below to perform QC analysis using manual analysis.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green, wait until it is.

Status indicator
LED

2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

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3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.
If the sample is whole blood, select [Whole Blood] mode. For body fluid,
select [Body Fluid] mode.

4 Click [OK].
The dialog box closes.

5 Click the Analyzer menu button on the control menu.

The menu on the right appears.

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6 Click [QC Analysis].

The dialog box on the right appears.

List of
QC files

7 From the list of QC files, click the file you want to analyze and click [OK].
The dialog box on the right appears.

[Execute L-J] dialog box

8 Mix the quality control material.

Follow the instructions included in the package insert of the quality control material for information on the mixing
procedure.

9 Analyze the sample using manual analysis.

For procedures on analysis, see Chapter 11.
(➤P.204 "Chapter 11: 11.6 Manual analysis" Step 5 and following steps)
For the procedure for analyzing body fluid, see Chapter 11.
(➤P.209 "Chapter 11: 11.7 Body fluid analysis" Step 5 and following steps)

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10 Check the analysis results.

When the analysis finishes, the analysis results are
displayed in the [Execute L-J] dialog box.
File information

Error message

Shortcut buttons

Analysis results

Next button
Back button

File information The information about the analyzed QC file is displayed.

Error message A message is displayed when there is an anomaly in the analysis results.
[Check control chart]: Indicates that the analysis data exceeds the QC limit.
[Data error, repeat test]: Indicates that the analysis data exceeds the QC limit by
over three times. This is displayed in white font on red
background.
Shortcut buttons Click to display item screens that are not currently displayed. If the data in a screen
includes a warning, a warning mark appears.
Analysis results Displays the analysis results*.
For L-J Control, data will be displayed for 1 analysis only.
For X-bar Control, the sample is analyzed twice, and an average value is displayed.
If there was an abnormality in the analysis results, the corresponding cells are
highlighted in red.
* The dialog box above is for L-J Control.
Back button Click to display the previous screen.
Next button Click to display the next screen.
[Accept] Click to close the dialog and plot the analysis data onto QC charts.

For the details on checking your analysis results, see below.

(➤P.180 "10.5 Check quality control results")

11 Click [Accept].
The dialog box closes.

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10.4.2 Performing QC analysis using sampler analysis

When using a quality control material, you can perform L-J control by sampler analysis.
Follow the steps below to perform QC analysis using sampler analysis.

1 Mix the quality control material.

Follow the instructions included in the package insert of the quality control material for information on the mixing
procedure.

2 Place the quality control material in the rack.

When using a new lot of quality control material, you can automatically import QC file obtained from the
dedicated server.
If the instrument is not configured to allow connection with the dedicated server, or if no network connection is
available, insert the CD-ROM into the IPU before analyzing, import the assay values, and register the lot
information.
For importing assay values, see below.
(➤P.168 "10.3 Registering and modifying a QC file (lot information input)")

3 Analyze the sample using sampler analysis.

For procedures on analysis, see Chapter 11.
(➤P.218 "Chapter 11: 11.9 Sampler analysis (XR-1000)")

Once the analysis is finished, the QC results are displayed on the IPU's screen.
For procedures on checking the results, see below.
(➤P.180 "10.5 Check quality control results")

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10.5 Check quality control results

This section explains how to check the results from QC analysis.

10.5.1 QC File screen

In the [QC File] screen, you can check the latest QC results for the QC file that is selected in the list.
Clicking the [QC File] button on the toolbar, or the [QC File] icon on the Menu screen displays the following
screen.

Toolbar Radar charts

QC file list

Tabs

[QC File] screen Display switching button

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the [Input Lot Information] dialog box.

[Modify] Click to display the [Input Lot Information] dialog box in edit mode.
The displayed controls and fields are the same as when manually registering a new
QC file.
[QC Chart] Click to display the [QC Chart] screen.
[Filter] Click to display the submenu.
Select either [All Files] or [Lot registration exists].
[Sort] Sort the QC file list. Click to display the submenu.
[File No.] Click to sort by file number in ascending order.
[Analysis Date] Each time this is clicked, the sorting method changes in the following order: analysis
date/time descending order – registration date descending order – file number
ascending order.
[Sort]* Click to sort by the sorting condition set in [Modify Settings].
* The name of [Sort] in the sub-menu can be changed using [Sort Name] in [Modify
Settings].
[Modify Settings] Click to open a dialog that lets you set the sorting condition.
Select from [File No.], [Lot No.], [Regist.], or [Analysis Date].

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[Upper] Click to move the selection up by 1 row.

[Lower] Click to move the selection down by 1 row.
[File] Click to display a submenu. This can be used to save and restore data.
The submenus are not displayed when the X-barM chart is displayed.
[Delete] Click to display a dialog box that allows you to delete the selected QC file.

● QC file list
Displays a list of registered QC files.
If there is a problem with a QC data, "[ERROR]" is displayed in white font on red background, on the left side of
the list of QC files.

● Tabs
Click to show data for a specific analyzer, or for all analyzers. This can be displayed only when using the
XR-2000.

● Radar charts
Displays the latest plot data from the selected QC file on
Upper Limit Target
the radar charts.
If there is not a single plot in the selected QC file, only the
frame and the item name are displayed.
Any point exceeding the upper or lower limit is marked
with a red "X".

Lower Limit

Plot data

Title Displays the name of the analysis parameter (QC item). The displayed parameters
vary with the QC method used.
Any parameter exceeding the QC limit (upper or lower) will be highlighted in red.
Lower Limit Indicates the lower QC limit.
Upper Limit Indicates the upper QC limit.
Target Indicates the target value.
Plot data Indicates the plot data from the selected QC file.

● Display switching button

You can click the display switching button to open/close the Radar charts (sub screens).

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10.5.2 QC Chart screen

The [QC Chart] screen allows you to view detailed graph data of the QC file. Clicking the [QC Chart] on the [QC
File] screen's toolbar displays the following screen.

QC file information (main) Toolbar QC file information (reference)

Chart display area (Left) Chart display area (Center) Chart display area (Right)

[QC Chart] screen

● Toolbar
The buttons of the following functions are displayed.

[Regist.] Click to display the [Input Lot Information] dialog box.

This does not appear if a lot for the selected file has already been registered.
[Modify] Click to display the [Input Lot Information] dialog box in edit mode.
The displayed controls and fields are the same as when manually registering a new
QC chart.
[Manage] Click to display the [Cursor Data Management] dialog box, which allows you to set
the cursor data.
(➤P.186 "10.5.3 Configuring cursor data settings")
[Shift] You can set up a maximum of 3 work shifts.
This button switches the display between charts for each shift.
To apply display by shift, select any shift between [Shift 1] to [Shift 3].
Selecting [Shift All] displays all shifts.
[Sort] Click to display the sort dialog box.
You can change the order of quality control items.
This item does not appear when [Ref.] - [Compare Analyzers] is selected while using
the XR-2000.
[Output] Print the selected chart to various printers or a host computer. Click the [Output]
button to select [Host Computer (HC)], [Report (GP)] or [Ledger (LP)].
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.

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[Vial] You can display a vial line to indicate replacing of a vial with a new one.
While the analysis data from the new vial is selected, click [Vial] to draw the vial line.
Repeat the same procedure to delete the line.
This button cannot be used in X-barM control.
(➤P.187 "10.5.4 Displaying the vial line")
[Range] Click to display the QC chart in select range mode.
When the number of plots on the QC chart is 1 and a lot has not been registered on
the QC chart, the [Range] button cannot be selected.
(➤P.187 "10.5.5 Select range mode")
[Ref.] Click to display the submenu.
[None] Select this checkbox to cancel the reference function.
[Compare QC QC charts registered to the same analyzer are overlaid on top of each other for
Files] comparison. Compares the new lot with the current lot.
(➤P.189 "10.5.6 Compare QC Files")
[Compare Compares QC files for the same material but registered to other analyzers.
Analyzers] This can be displayed only when using the XR-2000.
(➤P.190 "10.5.7 Compare Analyzers (XR-2000)")
[File] Click to display a submenu. This can be used to save and restore data.
[Delete] Click to display a dialog box that allows you to delete the selected data point.

● QC file information
Apart from the main QC file, you can compare its information with two additional QC files.
The information from each QC file is displayed in different colors.

[Nickname] Displays the name of the analyzer for the QC chart.

[Material] Displays the material registered for the QC file.
[Regist.]* Displays the registration date of the material registered in the QC file.
[File No.] Displays the QC file number.
[Lot No.]* Displays the lot number registered for the QC file.
[Exp. Date]* Displays the expiration date of the quality control material for the QC file.
When it has expired, it is displayed in white font on red background.

* Not displayed if [File No.] is X-barM.

● Chart display area (Left)

[Item] Displays the name of the QC item.
[UL] Displays the upper control limit.
[Target] Displays the control target value.
[LL] Displays the lower control limit.

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● Chart display area (Center)

The analysis data are plotted cumulatively and displayed in the chart area as a line graph.
When comparing QC files, the line graphs are displayed in different colors for each QC file.

Comment display area

Comment mark

Plot

Vial line

Calibration-executed line

Main cursor

Analysis date

Comment display Displays comments.

area
Comment mark Displayed when a comment exists for a QC chart.
For the procedure for entering comments, see below.
(➤P.186 "10.5.3 Configuring cursor data settings")
Indicates a comment for the cursor data.
The comment is displayed in the comment display area.
Indicates a comment for data other than the cursor data.

Plot Displayed when the analysis data is within the range between the upper
and lower limits.
Displayed when the analysis data is outside the range between the upper
and lower limits.
Displayed when the analysis data is not managed. A
plot for a data that is not managed is not connected by
lines, as shown on the figure on the right.
A data that is not managed is displayed in this way
even if it is outside the range between the upper and lower limits.
For details on data that is not managed, see below.
(➤P.186 "10.5.3 Configuring cursor data settings")
Vial line Indicates that the vial was switched to a new one.

Calibration-executed A calibration-executed line (a line to indicate that a calibration was

line performed) is displayed to the left of the first plot after the calibration. The
calibration-executed line cannot be erased.
Main cursor Indicated the currently selected data.

Analysis date Displays the date and time of analysis for the data selected by the cursor.

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● Chart display area (Right)

[n=xx] Displays the total number of all managed plots that appear in the chart display area.
[Data] Displays the data specified by the main cursor. Values exceeding the [UL] value in
the chart display area (right) are indicated by a [+], and values that are under the [LL]
value are indicated by a [-].
[SD] Displays the standard deviation calculated from all managed plots that appear in the
chart display area.
[Mean] Displays the average value calculated from all managed plots that appear in the
chart display area.
[CV] Displays the coefficient of variation calculated from all managed plots that appear in
the chart display area.

Note:
• When the [QC Chart] screen is not in the range-selecting mode (when the only cursor
displayed is the main cursor), this is called single-cursor mode.
• Once the number of datapoints exceeds 300, any subsequent new plot will overwrite the
oldest data.
• If the displayed range of the QC chart contains plots that are not managed, the plots do not
connect to the plots outside the displayed range.

Current display range Current display range

Lines are not connected Lines are not connected Lines are not connected

• The plots of data for which the data mask [ - - - - ] (this means non-analyzable) appears are not
joined by the line.
For the data masks, see below.
(➤P.237 "Chapter 12: 12.1.4 Numerical data of the analysis results")

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10.5.3 Configuring cursor data settings

You can exclude the QC data selected by the cursor or add comments to it.
Follow the steps below to configure the cursor data settings.

1 Click the [Manage] button on the toolbar.

The following dialog box appears.

[Cursor Data Management] dialog box

[Specify Excluded] Specify whether a QC data should be excluded from quality control.
Use the cursor to select the QC data in question, and select whether or not they are to
be managed*.
If [Not Managed] is selected, the excluded data is not managed by the functions below.
• Statistical computations (SD, Mean, CV)
• Automatic limit computation
• Variable target computation
• Number of data points n
* In X-barM control, this is always managed.
[Comments A comment can be added to the QC data selected by the cursor.
Settings]
[None] Select this if you are not including any comment for the selected data.
[Input Any Select this if you want to type a comment.
Comment]
[Fixed Select this if you want to use a comment from a list of preset comments.
Comments] You can preset up to 10 user-defined comments.
(➤P.380 "Chapter 15: 15.3.8 QC settings")
[Any Comments] Select this when [Input Any Comment] is selected in [Comments Settings]. You can
enter up to 100 characters.

2 Click [OK].
The selected settings become reflected in each QC item.

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10.5.4 Displaying the vial line

The display of the vial line changes depending on the existence of a plot. The relationship between the vial line
and the plot is as follows.

If all plots before the vial line are If all plots between the vial lines If plots on both sides of the vial
deleted are deleted line are deleted
(1) (2)

Delete Delete
Delete

The vial line is (2)

hidden
The old The plots on
vial line is both sides of the
hidden deleted plots
are connected
by a line.

10.5.5 Select range mode

A main cursor and sub-cursor can be displayed on the QC chart, and the data between the two cursors can be
manipulated. You can compare the analysis results at the start point indicated by the sub-cursor, with the
statistics over any selected range. When modifying lot information in select range mode, you can automatically
configure target/limit settings for the plot of the selected range.

When you click on [Range] in the [QC Chart] screen, a

sub-cursor appears.
The sub-cursor is fixed at the position where the main
cursor was located.
The main cursor is used for scrolling to select a range,
and can be moved by clicking on the end point of the
range you want to select in the [QC Chart] screen.

Sub-cursor Displayed in range-selecting Sub-cursor

mode. It indicates the start
point of the selection.

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In the range-selecting mode, the functions of some buttons on the toolbar and the layout of the [QC Chart]
screen are different from the single-cursor mode.

● Toolbar
The buttons whose functions change are as follows.

[Shift] If [Shift] is changed, range selection mode is canceled.

[Sort] Sorts the displayed items.
[Manage] The [Manage] button cannot be used.
[Ref.] Range selection mode is canceled.
[Output] The selected range of data can be output to an output destination.
[Delete] The selected range of data can be deleted (only main chart data is deleted).
Range selection mode is canceled.

● Chart display area (Right)

[n=xx] Displays the number of managed plots within the range selected by the cursors.
[Data] The data at the sub-cursor (the original position) data is displayed.
[SD] Displays the standard deviation calculated from the managed plots within the range
selected by the cursors.
[Mean] Displays the average value calculated from the managed plots within the range
selected by the cursors.
[CV] Displays the coefficient of variation calculated from the managed plots within the
range selected by the cursors.

Note:
• To cancel select range mode, press the [Range] button on the toolbar again.
• When the QC charts are hidden, the range-selecting mode is automatically canceled.

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10.5.6 Compare QC Files

QC charts registered to the same analyzer are overlaid on top of each other for comparison. Compares the new
lot with the current lot.
X-barM data cannot be compared with other data.
Follow the steps below to compare QC files.

1 In the [QC Chart] screen, click the [Ref.] button on the toolbar.
The submenu on the right appears.

2 Click [Compare QC Files].

The dialog box on the right appears.

[Show Level Difference]

Not selected Only files with the same material
and same level as the main
chart are shown in the dialog
box.
Selected All files with the same material
as the main chart are shown in
the dialog box.

3 Select the QC files you want to overlay, and then click [OK].
The selected QC files are compared and displayed.
Only one QC file can be superimposed.

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10.5.7 Compare Analyzers (XR-2000)

Compares QC files for the same material but registered to other analyzers.
Follow the steps below to compare analyzers.

1 In the [QC Chart] screen, click the [Ref.] button on the toolbar.
The submenu on the right appears.

2 Click [Compare Analyzers].

The dialog box on the right appears.

3 Select the QC files you want to overlay, and then click [OK].
The selected QC files are compared and displayed.

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10.6 Troubleshoot quality control errors

This section explains how to troubleshoot errors that occur during quality control analysis.

● If a data exceeds the QC limit, and is highlighted in red,

check the analysis data in the Data Browser screen.

● Check parameters which have recorded errors on the radar

chart.

● Check detailed data from the line graph.

Note:
When performing manual QC analysis, if you click the [Cancel] button on the analysis screen,
the data will not be plotted to the QC file.

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10.7 Manage QC files

This section explains how to manage QC files.
Follow the steps below to modify, delete, save and restore QC files.

1 Click the [QC File] icon in the Menu screen.

The [QC File] screen appears.

2 Select the QC file you want to manage.

Modify
Click the [Modify] button on the toolbar to display the [Input Lot Information] dialog box.
The displayed controls and fields are the same as when manually registering a new QC file.
(➤P.168 "10.3 Registering and modifying a QC file (lot information input)")

Delete
Click the [Delete] button on the toolbar to delete the selected file.

Save QC file data

Click the [File] button - [Backup] on the toolbar to display the dialog box for confirming the file name and save
directory.

Note:
The following file is saved.
[Analyzer ID][Software version][QCFile][Date of save_Time of save][Material][Lot No.].qcf

Restoring saved data

Click the [File] button - [Restore] on the toolbar to display the dialog box for specifying the file to read.

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Chapter 11 Analyzing Samples

This chapter explains the preparation of analysis samples and the different analysis modes.

Caution!
• Please ensure that samples are mixed sufficiently before being placed on the analyzer. This is
especially important for samples from patients prone to high degrees of sedimentation or for
samples that have been refrigerated/transported in a cool environment.
• Do not analyze coagulated blood.
• The instrument is equipped with a Blood Aspiration Sensor. However, there is a possibility that
correct results may not be obtained if the sample volume is low and the sensor could not
detect a "Short Sample" or "Sample Not Asp Error".
• During analysis, do not turn OFF the main power switch of the instrument. Risk of corrupting
the information that is written to the reagent cartridge.

11.1 Types of analysis

This instrument supports the following analysis mode.

Manual analysis
In this analysis, the operator loads the sample tubes individually by hand. The operator also mixes the samples
by hand. Use this analysis for STAT sample analysis, or for analyzing special samples.

Micro analysis
This is a type of manual analysis. The analysis is performed without a cap on the sample tube, to reduce dead
volume. The conditions for micro analysis are as follows:
• When [Cap Open] is turned ON in the Manual Analysis menu
• When an analysis is performed in [Pre-Dilution] mode
• When a micro collection sample tube is used

RBT analysis
This is a type of manual analysis. The analysis is performed using Raised Bottom Tubes, to reduce dead
volume.

Body fluid analysis*1

This is a type of manual analysis. Use this analysis to measure body fluid.

HPC analysis*1
This is a type of manual analysis. Use this for the analysis of HPC-related parameters.

hsA analysis*1,2
This is a type of manual analysis. Use this for the analysis of low-concentration blood cell samples for research.

*1 The availability of these functions depends on your system configuration.

*2 For information on hsA analysis, see the following:
(➤P.580 "Appendix: hsA analysis")

Caution!
In manual analysis, Raised Bottom Tubes can only be used for RBT analysis.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.

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Sampler analysis
In this analysis, the operator loads the sample tubes into a rack, which is then automatically transported and
analyzed by the instrument.
XR-1000: You can place up to 50 samples at a time.
XR-2000: You can place up to 100 samples at a time.
To use Raised Bottom Tubes in sampler analysis, place the tubes in a rack for Raised Bottom Tubes (RBT rack).

Caution!
When using the SA-01 in the XR-1000, Raised Bottom Tubes and RBT racks cannot be used.
Risk of instrument failure.

Note:
Except when performing micro analysis, use the sample tube with the cap on.

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11.1.1 Analysis modes

In this instrument, you can select the analysis mode according to the different samples.
The following are characteristics of each analysis mode:

Analysis mode Description Remarks

[Whole Blood] mode Used for analyzing whole blood. • Anticoagulant added
• Manual analysis/Sampler analysis
• This mode is automatically
selected when performing a
Sampler analysis.

[Low WBC] mode Used for analyzing low WBC using • Anticoagulant added
whole blood. The count time of the • Manual analysis
WDF channel is set to 3 times that of • Sampler analysis (only for
[Whole Blood] mode to increase retesting and querying host)
white blood cell measurement
accuracy.
[Pre-Dilution] mode Used for analyzing a small amount of • 1:7 dilution
blood. • Manual analysis (micro analysis)
only
• Blood aspiration sensor not used

[Body Fluid] mode* Used for analyzing body fluid • Manual analysis only
(cerebrospinal fluid, serous • Blood aspiration sensor not used
(peritoneal and pleural), synovial
fluid, CAPD (Continuous ambulatory
peritoneal dialysis) fluid).

[HPC] mode* Used for the analysis of HPC-related • Anticoagulant added

parameters using whole blood. • Manual analysis only
• Blood aspiration sensor not used

[hsA] mode* Used for the analysis of parameters • Manual analysis only
of low-concentration blood cells for • Blood aspiration sensor not used
research.

* The availability of these functions depends on your system configuration.

Information
Results generated in hsA mode are for research purpose only.
Do not use the analysis results of these parameters for the diagnosis of patients.

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11.2 Prepare the sample

This section will explain how to prepare the sample for analysis.

11.2.1 Sample types and handling

Samples analyzed in each analysis mode are as follows:
• [Whole Blood]/[Low WBC]/[HPC] mode: Whole blood
• [Pre-Dilution] mode: Small amount of blood that has been diluted
• [Body Fluid] mode: Body fluid (cerebrospinal fluid, serous (peritoneal and pleural),
synovial fluid, CAPD (Continuous ambulatory peritoneal dialysis)
fluid)

Handling whole blood

Collect venous blood with anticoagulant (EDTA-2K, EDTA-3K, or EDTA-2Na). Draw the specified amount of
blood as per the package insert of the tube used.
The sample should be analyzed within 24 hours after collection*. If it is not possible to analyze the sample
within 24 hours, store it in a refrigerator at 2 to 8 °C until it can be analyzed. When analyzing a refrigerated
sample, take it out of the refrigerator at least 15 minutes prior to analysis, to bring it back to room temperature.
Once restored to room temperature, mix the blood sufficiently before performing analysis.
* Sample stability for each parameter is different. For details, see Chapter 7.
(➤P.92 "Chapter 7: Sample Stability with Time after Blood Collection")

Caution!
• Please ensure that samples are mixed sufficiently before being placed on the analyzer. Any
delay in processing after mixing may lead to the production of incorrect results.
This is especially important for samples from patients prone to high degrees of sedimentation
or for samples that have been refrigerated/transported in a cool environment.
• If analyzing in [HPC] mode, mix the sample gently and analyze promptly.
Mixing with excessive force may cause cellular degradation and/or activation of the sample
and should be avoided.
• Use only the specified anticoagulant.
Using a non-specified anticoagulant may result in hemolysis or platelet aggregation,
preventing correct analysis results.
• Please ensure that sample tubes are filled and used in accordance with the manufacturer's
package insert.
If a sample tube is filled in excess of the specified volume, accurate analysis cannot be
guaranteed. Overfilling can lead to insufficient mixing or inadequate sample anticoagulation.
Sample tubes are designed such that the normal filling allows an air gap at the top of the tube.
This air gap is crucial to mixing as without this the blood does not move when the tube is
inverted. Check the sample volume before mixing.

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Handling diluted blood

For diluted blood, dilute capillary or venous blood by a factor of 7. In the case of capillary blood, dilute by a
factor of 7 after collection by dispensing the blood directly into the diluent. Do not use any anticoagulants.
Alternatively, you can collect the blood in a micro collection tube, and dilute it later.
e.g.
1 Pour CELLPACK DCL into the diluent-dispensing container.
2 Dispense 120 µL of CELLPACK DCL into the micro collection tube.
3 Add 20 µL blood to the micro collection tube containing 120 µL CELLPACK DCL (dilution ration 1:7).
4 Cap the sample, mix well and analyze

Caution!
• Do not dilute to other than the specified dilution ratio.
Incorrect analysis results may be obtained.
• The sample should be analyzed immediately after dilution, as platelet aggregation can easily
occur in diluted samples.
In addition, the dispensed diluent can cause a margin of error in the analysis data due to
evaporation or contamination. Therefore, a new diluted blood sample should be prepared for
each analysis.
• After diluting the sample, mix gently and analyze promptly. If the sample is mixed excessively
after dilution, the results may not be accurate.
• It is OK to apply light pressure to collect the capillary blood sample. However, too much
pressure will squeeze out body fluid with the blood, which lowers the reliability of the analysis
results.

Handling body fluids

Upon the collection of body fluid, add an anticoagulant such as EDTA or heparin as needed.
Analyze as soon as possible after collecting the sample. Particularly in the case of cerebrospinal fluid (CSF), it
has been indicated that cell breakdown starts to occur within one hour after collection*.
* CLSI H56-A: Clinical and Laboratory Standards Institute H56-A

Caution!
Mix as gently as possible.
Excessive mixing of a body fluid sample may cause false WBC-BF and TC-BF# values.

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Sample volume
This section explains the required sample volume.

Manual Analysis Aspirated Required

Type of Sample Setting
Specimen Tube type Menu sample sample
analysis Position
[Cap Open] volume volume
Whole Closed tube Sampler rack - 88 µL 1 mL
Sampler
blood Raised Bottom RBT rack - 250 µL
analysis
Tube (closed)
Whole Closed tube Normal tube OFF 88 µL 1 mL
blood Open tube holder ON 300 µL
Open micro tube Micro tube - 160 µL
holder
Raised Bottom Normal tube OFF 250 µL
Tube (closed) holder
Diluted Open tube Normal tube ON 70 µL 300 µL
blood holder
Manual Open micro tube Micro tube - 140 µL
analysis holder
Body Closed tube Normal tube OFF 88 µL 1 mL
fluid*1 Open tube holder ON 300 µL
Open micro tube Micro tube - 160 µL
holder
Whole Closed tube Normal tube OFF 190 µL 1 mL
blood Open tube holder ON 400 µL
(HPC)*2
Open micro tube Micro tube - 260 µL
holder
*1 The body fluid analysis can only be performed if the license is activated.
*2 HPC analysis can only be performed if the license is activated.

(1) Normal sample (2) Micro collection

tube holder tube holder

(2)
(1)

Analyzer
Front side

Direction of movement of the tube holder

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11.3 Terms used in analysis

11.3.1 Sample No.

A sample number is a number and text string up to 22 digits in length that is assigned to a sample. Sample
numbers are used to identify samples.
Sample numbers can be acquired by any one of the following methods:
• Manual input
• Reading sample tube barcodes with a barcode reader
• Automatic assignment (when a barcode read error occurs, etc.)
• Inquiry to host computer

When the auto increment function is on, the number is automatically incremented by one and assigned to each
subsequent sample after the first sample number is set (during manual analysis).

11.3.2 Rack No./tube position

A rack number is a 6-digit number that identifies a rack.
Rack numbers can be acquired by any one of the following methods:
• Manual input
• Reading rack barcodes with a barcode reader
• Automatic assignment (when a barcode read error occurs, etc.)

The sample tube position is a two-digit number that defines the sample tube position in a rack. There are 10 sample
tube positions in a rack. Sample tube positions are assigned from the right side in the order "01, 02, 03, ...".

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11.4 Supported sample tubes and racks

This section explains the sample tubes and racks you can use with this instrument.

Risk of infection
Depending on the structure and material of the sample tube cap, the sample may ooze from the
pierced part of the cap.

Information
Do not use any sample tubes other than those of the specified dimensions.
Incorrect analysis results may be obtained.

11.4.1 Supported sample tubes

Normal sample tubes d

Sampler Manual analysis

analysis With a cap Without a cap
Diameter (a) φ11 to 15 mm φ11 to 16 mm
c b
Length (b) At least 57 mm At least 57 mm 57 to 85 mm b

Length 70 to 85 mm 70 to 85 mm -
including
the cap (c)
a a
Cap diameter (d) φ18 mm or less φ18 mm or less -

* Except for when performing micro analysis, use the tube with the cap on.

e.g. Tubes verified for proper operation

• VENOJECT II (Terumo)
• Hemogard (BD)
• VACUETTE (Greiner)
• Monovette (SARSTEDT)

Information
• Verification of tubes does not guarantee the durability (abrasion proofness) of piercers.
• When performing sampler analysis using the VENOJECT II (Terumo), fold the film seal so that
it does not protrude horizontally and then place in the rack.
Otherwise, there is a risk that the seal will interfere with an adjacent sample tube and cause it
to fall from the rack.
• Reusable caps cannot be used for VENOJECT II (Terumo).

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Micro collection sample tubes

Typical shapes of micro collection tubes are shown below.
Acceptable dimensions vary depending on the shape of the micro collection tube. The following are
guidelines. Verification using the actual micro collection tube is necessary.

Type A Type B Type C

φ13 mm or less φ13 mm or less φ13 mm or less

36 to 46 mm
28 to 48 mm
36 to 50 mm

At least 35 mm
At least 35 mm

At least 27 mm
φ8 mm or less

20 mm

8.5 mm
20 mm

φ9.8 to 10.8 mm φ10.0 to 11.0 mm

φ7.4 to 7.8 mm

* Cap not included in dimensions. Open the cap during analysis.

e.g. Sample tubes verified for proper operation

• BD Microtainer Tube with BD Microgard Closure 365974 (BD)
• CAPIJECT II CJ-2DK (Terumo)*
• MiniCollect 450532 (Greiner)*

* The analyzer needs an adjustment if using the CAPIJECT II and MiniCollect. Please contact your
authorized local Sysmex representative.

Raised bottom micro collection sample tube (RBT: Raised Bottom Tube)
A microtube that can be used in sampler analysis. Compatible dimensions are the same as regular sample
tubes.

e.g. Sample tubes verified for proper operation

• Microtainer MAP 363706 (BD)
• MiniCollect II Complete Type 450547 (Greiner)

Caution!
When using a Raised Bottom Tube, please contact your authorized local Sysmex
representative.

Note:
For information on using sample tubes not described here, please contact your authorized local
Sysmex representative.

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11.4.2 Supported racks

Only Sysmex 10-tube racks can be used with normal sample tubes.
If the diameter of the tube is φ14 mm or less, attach a dedicated adapter onto the rack. A dedicated adapter is
included with the instrument.

55 mm

200 mm

25 mm

Caution!
To use Raised Bottom Tubes, place the tubes in a dedicated Raised Bottom Tube rack (RBT
rack).
Please note the following.
• Do not insert a Raised Bottom Tube in anything other than an RBT rack.
• Do not insert a sample tube other than a Raised Bottom Tube in an RBT rack.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.

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11.5 Sample tube and rack barcode labels

In order to achieve optimum performance levels of the system, the laboratory must ensure that barcode labels are
properly applied to the sample tube as well as rack labels.
This section will provide the necessary information related to their application onto the sample tube and system rack.
For the specific information about barcode types, see the following.
(➤P.97 "Chapter 7: 7.4 ID Barcode specifications")

Caution!
During the attachment of the barcode labels pay attention to prevent misreading of barcodes or
mix-up of samples.
• Affix the label so that the lines of the barcode are run horizontally.
• Do not affix multiple labels.
• Label surfaces must not be wrinkled.
• Make sure that the label does not extend past the bottom of the sample tube.
• Make sure that no part of the barcode label is peeled off.
• Make sure that the labeled sample tubes can be inserted into and removed from the rack with
ease.
• Do not write any text in the margins of a barcode label.

11.5.1 Sample tube barcode labels (sample numbers)

Apply barcode label to the sample tube so that it is within
the indicated distance shown in the figure on the right.
At least 5 mm

48 mm
or less

At least 5 mm
At least
At least
21 mm
16 mm

11.5.2 Barcodes for tube racks (rack numbers)

2 labels with same barcode number will accompany your system. Affix the label with printed text to the side of
the rack for verification purposes.
9.5 mm 16 mm

3 mm

39 mm 45 mm

Barcode area Label area

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11.6 Manual analysis

This section explains how to analyze whole blood and diluted blood in manual analysis. The method for analyzing a
STAT sample is the same as the method for manual analysis.

Caution!
• Samples measured in the manual mode are not mixed by the instrument and therefore must
be mixed manually.
• A Raised Bottom Tube cannot be used in [Pre-Dilution] mode.

Follow the steps below to perform manual mode analysis.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.
This step is not necessary when analyzing a STAT sample.
Proceed to the next step.

Status indicator
LED

2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

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3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.

● Specifying the analysis mode

[Whole Blood] Select this when using whole blood as the
sample.
[Low WBC] Select this to perform low WBC analysis when
using the whole blood as the sample.
[Pre-Dilution]* Select this when using 1:7 diluted blood as the
sample.

* When changing to [Pre-Dilution] from a different mode, the switching will

take some time. Please wait a while.

4 Click [OK].
The dialog box closes.

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5 Click on the Manual Analysis button on the control menu.

A dialog box corresponding to the selected mode appears.
● In [Whole Blood] mode / [Low WBC] mode:
[Sample No.]* Input is not necessary if the [Read ID] checkbox
is selected. If you will not scan a barcode, enter
the sample number manually in the input field.
[Read ID] Select this checkbox if barcode labels on sample
tubes will be scanned using the analyzer's built-
in barcode reader. This cannot be selected if
sample tube barcode reading is not enabled in
the analyzer settings.
[Patient ID] Enter the patient ID in the input field.
[Discrete] Select the check marks for the discrete tests you
want performed. In [Low WBC] mode, [DIFF]
cannot be changed.
[Cap Open] Select the check mark to perform a micro blood
analysis. This enables you to analyze the
sample without a cap on the sample tube, to
minimize dead volume.
[Query to Host] This only appears if real-time query is set to ON
in the analyzer settings. Select this checkbox to
query the host for analysis information.
This cannot be selected when the [Read ID]
checkbox is selected.
[Aspiration Sensor] Enables/disables the Blood Aspiration Sensor.
[Raised Bottom Tube] Select the check mark to perform RBT analysis.
This enables you to analyze the sample by using
a Raised Bottom Tube, to minimize dead
volume. This enables you to analyze the sample
with the cap on the sample tube.

* You can also use the hand-held barcode reader to input the sample number.

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● In [Pre-Dilution] mode:
[Cap Open], [Aspiration Sensor] and [Raised Bottom Tube] are not
displayed. In addition, the discrete tests are different. Other settings are
the same as the [Whole Blood] mode.

Note:
• The instrument is equipped with a Blood Aspiration Sensor. However, there is a possibility that
correct results may not be obtained if the sample volume is low and the sensor could not
detect a "Short Sample" or "Sample Not Asp Error".
• If you know in advance that the blood sample has a very low hemoglobin (e.g. blood from a
dialysis patient), disable the Blood Aspiration Sensor.
(➤P.351 "Chapter 15: 15.2.12 Analyzer settings")

6 Click [OK].
The dialog box closes.

7 Mix the sample tube as shown.

e.g. Normal sample tube

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8 Place the sample tube in the tube holder.

There are 2 sample tube holders.
When inserting a micro collection tube, insert the tube all the way in so that the bottom of the tube contacts the
base of the holder.

(2) Micro collection

(1) Normal sample
tube holder
tube holder

(2)
(1)

Analyzer
Front side

Direction of movement of the tube holder

● When performing micro analysis

Place the sample tubes after removing the cap.
When removing the cap, use caution to prevent the sample from splattering.

● When performing RBT analysis

Place the Raised Bottom Tube in the normal sample tube holder.

9 Press the start switch on the analyzer.

The tube holder slides in, and the aspiration of the sample begins.
Once the analysis finishes, the tube holder slides out.

Start switch

e.g. When a normal tube is set

10 Remove the sample tube.

To analyze another sample, repeat steps 3 through 10.

11 Press the mode switch on the analyzer.

The tube holder slides into the analyzer.
For the details on checking the analysis results, see Chapter 12. (➤P.229 "Chapter 12: 12.1 Sample Explorer functions")

Information
If a message appears during analysis to ask for reagent replacement, replace the reagent
concerned. If the reagent is replaced when the reagent level is low, bubbling could occur, which
would raise the blank value.

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11.7 Body fluid analysis

This section explains samples and analysis items for body fluid analysis.
* The availability of this function depends on your system configuration.

Caution!
A Raised Bottom Tube cannot be used for body fluid analysis.

Follow the steps below to perform body fluid analysis.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status indicator
LED

2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

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3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.

4 Click [Body Fluid].

5 Click [OK].
The dialog box will close, and the background check will start.
If the background values that result from the background check are under the allowable values, the Status
indicator LED lights green and the analyzer enters the body fluid analysis preparation done state.
Checked Acceptable Value Remarks
parameters
WBC-BF 0.001 x 103/µL or less White blood cell count in body fluid obtained from the WDF channel.
RBC-BF 0.003 x 106/µL or less Red blood cell count in body fluid obtained from the RBC/PLT
channel.
For details on background check, see Chapter 8.
(➤P.118 "Chapter 8: ●Background check")

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6 Click on the Manual Analysis button on the control menu.

The dialog box on the right appears.

[Sample No.]* Input is not necessary if the [Read ID] checkbox is

selected. If you will not scan a barcode, enter the sample
number manually in the input field.
[Read ID] Select this checkbox if barcode labels on sample tubes
will be scanned using the analyzer's built-in barcode
reader. This cannot be selected if sample tube barcode
reading is not enabled in the analyzer settings.
[Patient ID] Enter the patient ID in the input field.
[Cap Open] Select the check mark to perform a micro blood analysis.
This enables you to analyze the sample without a cap on
the sample tube, to minimize dead volume.
[Query to Host] This only appears if real-time query is set to ON in the
analyzer settings. Select this checkbox to query the host
for analysis information. This cannot be selected when
the [Read ID] checkbox is selected.
[Tube Sensor] Remove the check mark when performing blank analysis.
* You can also use the hand-held barcode reader to input the sample number.

Note:
Immediately after the analysis type is changed to [Body Fluid], [Cap Open] is in the selected state.
If you will perform closed analysis using regular sample tubes, remove the [Cap Open] checkmark.

7 Click [OK].
The dialog box closes.

8 Mix the sample tube as shown.

e.g. Normal sample tube

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9 Place the sample tube in the tube holder.

There are 2 sample tube holders.
When inserting a micro collection tube, insert the tube all the way in so that the bottom of the tube contacts the
base of the holder.

(1) Normal sample (2) Micro collection

tube holder tube holder

(2)
(1)

Analyzer
Front side

Direction of movement of the tube holder

● When performing micro analysis

Place the sample tubes after removing the cap.
When removing the cap, use caution to prevent the sample from splattering.

Caution!
When [Cap Open] is ON, be sure to open the sample tube cap before inserting the sample tube in
the tube holder. You can check whether the [Cap Open] setting is ON in the control menu.
If the sample is analyzed with the cap closed, correct analysis results may not be obtained.

10 Press the start switch on the analyzer.

The tube holder slides in, and the aspiration of the sample
begins.
Once the analysis finishes, the tube holder slides out.

Start switch

e.g. When a normal tube is set

11 Remove the sample tube.

To analyze another sample, repeat steps 3 through 10.

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12 Press the mode switch on the analyzer.

The tube holder slides into the analyzer.
For the details on checking the analysis results, see Chapter 12. (➤P.229 "Chapter 12: 12.1 Sample Explorer
functions")

Information
If a message appears during analysis to ask for reagent replacement, replace the reagent
concerned. If the reagent is replaced when the reagent level is low, bubbling could occur, which
would raise the blank value.

Note:
If instrument aspiration does not work well with a highly viscous sample such as synovial fluid,
the aspiration may be improved by diluting the fluid or performing enzyme treatment. For details,
refer to the guidelines on various body fluids.

11.8 HPC analysis

This section explains the procedure for performing HPC analysis.
* The availability of this function depends on your system configuration.

Caution!
A Raised Bottom Tube cannot be used for HPC analysis.

Follow the steps below to perform HPC analysis.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status indicator
LED

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2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.

4 Click [HPC].

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5 Click [OK].

6 Click on the Manual Analysis button on the control menu.

The dialog box on the right appears.

[Sample No.]* Input is not necessary if the [Read ID] checkbox is

selected. If you will not scan a barcode, enter the
sample number manually in the input field.
[Read ID] Select this checkbox if barcode labels on sample tubes
will be scanned using the analyzer's built-in barcode
reader. This cannot be selected if sample tube barcode
reading is not enabled in the analyzer settings.
[Patient ID] Enter the patient ID in the input field.
[Cap Open] Select the check mark to perform a micro blood analysis.
This enables you to analyze the sample without a cap on
the sample tube, to minimize dead volume.
[Query to Host] This only appears if real-time query is set to ON in the
analyzer settings. Select this checkbox to query the host
for analysis information. This cannot be selected when
the [Read ID] checkbox is selected.
* You can also use the hand-held barcode reader to input the sample
number.

7 Click [OK].
The dialog box closes.

8 Mix the sample tube as shown.

e.g. Normal sample tube

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9 Place the sample tube in the tube holder.

There are 2 sample tube holders.
When inserting a micro collection tube, insert the tube all the way in so that the bottom of the tube contacts the
base of the holder.

(1) Normal sample (2) Micro collection

tube holder tube holder

(2)
(1)

Analyzer
Front side

Direction of movement of the tube holder

● When performing micro analysis

Place the sample tubes after removing the cap.
When removing the cap, use caution to prevent the sample from splattering.

10 Press the start switch on the analyzer.

The tube holder slides in, and the aspiration of the sample
begins.
Once the analysis finishes, the tube holder slides out.

Start switch

e.g. When a normal tube is set

11 Remove the sample.

To analyze another sample, repeat steps 3 through 10.

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12 Press the mode switch.

The tube holder slides into the analyzer.
For the details on checking the analysis results, see Chapter 12. (➤P.229 "Chapter 12: 12.1 Sample Explorer
functions")

Information
If a message appears during analysis to ask for reagent replacement, replace the reagent
concerned. If the reagent is replaced when the reagent level is low, bubbling could occur, which
would raise the blank value.

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11.9 Sampler analysis (XR-1000)

Sampler analysis can be started in 2 ways.
• Start analysis automatically by placing a rack on the sampler (sampler auto-start function)*.
• Start the analysis from the information processing unit.
* Only when using the sampler (SA-10)

Caution!
• Correct analysis results may not be obtained due to insufficient mixing if the sample is left for
more than 4 hours and the cells/plasma have separated.
Therefore, in case of analyzing such samples, make sure to mix the samples thoroughly
before setting them on the sampler.
• Sample tubes are designed such that the normal filling allows an air gap at the top of the tube.
This air gap is crucial to mixing as without this the blood does not move when the tube is inverted.
Check the sample volume before mixing.
• Please ensure that sample tubes are filled and used in accordance with the manufacturer's
package insert.
If a sample tube is filled in excess of the specified volume, accurate analysis cannot be
guaranteed. Overfilling can lead to insufficient mixing or inadequate sample anticoagulation.

11.9.1 If the sampler auto-start function is ON (SA-10 only)

If the sampler auto-start function is turned on in the sampler (SA-10), follow the steps below to perform sampler
analysis.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
until they are.

Status
indicator
LED

2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is retracted, it means that the sampler
analysis is enabled.
If the tube holder is ejected out, press the mode button on the
analyzer.

Tube
holder

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3 Click on the Sampler Analysis button on the control menu.

The dialog box on the right appears. Check the settings.
This step is not required if you are using barcodes. Proceed to the next step.

[Sample No.]* Enter the sample number in the input field.

[Rack No.]* Enter the rack number in the input field.
[Starting Tube Specify the position of the sample tube where
Position] analysis should start.
[Discrete] Select the check marks for the discrete tests you
want performed.

* You can also use the hand-held barcode reader to input the sample and
rack numbers.

4 Click [OK].
The dialog box closes.

5 Place the rack in the right sampler pool.

Slide the groove on the rack into the protrusion on the right
side (when you face the analyzer). A maximum of 5 racks can
be placed. Once the rack is set in place, the sampler analysis
automatically starts.

● To abort the sampler analysis before it is finished:

Click the sampler analysis button in the control menu,
and then click [Yes] in the dialog that appears.

Protrusion

Caution!
• When using raised bottom micro collection sample tubes, insert the tubes in the dedicated RBT rack.
Please note the following.
- Do not insert a Raised Bottom Tube in anything other than an RBT rack.
- Do not insert a sample tube other than a Raised Bottom Tube in an RBT rack.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.
• Set the racks horizontally as far to the left edge and towards
the front as possible. Correct operation is not guaranteed if
the racks are set diagonally.

Note:
If the instrument has been set to perform a retest on a sample, it will automatically perform the
analysis multiple times on the sample.

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6 Remove the rack after the analysis is finished.

The finished racks are transported to the left sampler pool.
Check that the protrusion has cleared the groove, and then
remove the rack.
For procedures on checking the analysis results, see Chapter
12.
(➤P.229 "Chapter 12: 12.1 Sample Explorer functions")

11.9.2 Start sampler analysis manually

If the sampler auto-start function is turned OFF in the sampler (SA-10), or if the sampler (SA-01) is used, follow
the steps below to perform sampler analysis.
The sampler (SA-10) is used as an example in the following procedure.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
until they are.

Status
indicator
LED

e.g. Sampler (SA-10)

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2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is retracted, it means that the sampler
analysis is enabled.
If the tube holder is ejected out, press the mode button on the
analyzer.
Tube
holder

3 Place the rack in the right sampler pool.

Slide the groove on the rack into the protrusion on the right
side (when you face the analyzer). A maximum of 5 racks can
be placed.

Protrusion

Caution!
• When using raised bottom micro collection sample tubes, insert the tubes in the dedicated
RBT rack.
Please note the following.
- Do not insert a Raised Bottom Tube in anything other than an RBT rack.
- Do not insert a sample tube other than a Raised Bottom Tube in an RBT rack.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.
• Set the racks horizontally as far to the left edge and towards
the front as possible. Correct operation is not guaranteed if
the racks are set diagonally.

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4 Click on the Sampler Analysis button on the control menu.

The dialog box on the right appears. Check the settings.
The setting below is not required if you are using barcodes. Proceed to the
next step.

[Sample No.]* Enter the sample number in the input field.

[Rack No.]* Enter the rack number in the input field.
[Starting Tube Specify the position of the sample tube where
Position] analysis should start.
[Discrete] Select the check marks for the discrete tests you
want performed.
[Start] Click to start the analysis of the sample.

* You can also use the hand-held barcode reader to input the sample and
rack numbers.

5 Click [Start].
The dialog box closes, and the sampler analysis starts.

● To abort the sampler analysis before it is finished (SA-10 only):

Click the sampler analysis button in the control menu, and then click [Yes] in the dialog that appears.

Note:
If the instrument has been set to perform a retest on a sample, it will automatically perform the
analysis multiple times on the sample. (Only when using the sampler (SA-10))

6 Remove the rack after the analysis is finished.

The finished racks are transported to the left sampler pool.
Check that the protrusion has cleared the groove, and then
remove the rack.
For the details on checking the analysis results, see Chapter
12.
(➤P.229 "Chapter 12: 12.1 Sample Explorer functions")

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11.10 Sampler analysis (XR-2000)

Sampler analysis can be started in 2 ways.
• Start the analysis automatically by placing a rack on the sampler (sampler auto-start function).
• Start the analysis from the information processing unit.

Caution!
• Correct analysis results may not be obtained due to insufficient mixing if the sample is left for
more than 4 hours and the cells/plasma have separated.
Therefore, in case of analyzing such samples, make sure to mix the samples thoroughly
before setting them on the sampler.
• Sample tubes are designed such that the normal filling allows an air gap at the top of the tube.
This air gap is crucial to mixing as without this the blood does not move when the tube is inverted.
Check the sample volume before mixing.
• Please ensure that sample tubes are filled and used in accordance with the manufacturer's
package insert.
If a sample tube is filled in excess of the specified volume, accurate analysis cannot be
guaranteed. Overfilling can lead to insufficient mixing or inadequate sample anticoagulation.

11.10.1 If the sampler auto-start function is ON

Follow the steps below to perform sampler mode analysis.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
Status
until they are.
indicator
LED

2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is retracted, it means that the sampler
analysis is enabled.
If the tube holder is ejected out, press the mode button on the Tube
holder
analyzer.

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3 Click on the Sampler Analysis button on the control menu.

The dialog box on the right appears. Check the settings.
This step is not required if you are using barcodes. Proceed to the next step.

[Sample No.]* Enter the sample number in the input field.

[Rack No.]* Enter the rack number in the input field.
[Starting Tube Specify the position of the sample tube where
Position] analysis should start.
[Discrete] Select the check marks for the discrete tests you
want performed.

* You can also use the hand-held barcode reader to input the sample and
rack numbers.

4 Click [OK].
The dialog box closes.

5 Place the rack in the right sampler pool.

Slide the groove on the rack into the protrusion on the right
side (when you face the analyzer). A maximum of 10 racks can
be placed. Once the rack is set in place, the sampler analysis
automatically starts.

● To abort the sampler analysis before it is finished:

Click the sampler analysis button in the control menu,
and then click [Yes] in the dialog that appears.

Protrusion

Caution!
• When using raised bottom micro collection sample tubes, insert the tubes in the dedicated RBT rack.
Please note the following.
- Do not insert a Raised Bottom Tube in anything other than an RBT rack.
- Do not insert a sample tube other than a Raised Bottom Tube in an RBT rack.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.
• Set the racks horizontally as far to the left edge and towards
the front as possible. Correct operation is not guaranteed if
the racks are set diagonally.

Note:
If the instrument has been set to perform a retest on a sample, it will automatically perform the
analysis multiple times on the sample.

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6 Remove the rack after the analysis is finished.

The finished racks are transported to the left sampler pool.
Check that the protrusion has cleared the groove, and then
remove the rack.
For procedures on checking the analysis results, see Chapter
12.
(➤P.229 "Chapter 12: 12.1 Sample Explorer functions")

11.10.2 If the sampler auto-start function is OFF

Follow the steps below to perform sampler mode analysis.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait
Status
until they are. indicator
LED

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2 Make sure that the tube holder is retracted into the analyzer.
If the tube holder is retracted, it means that the sampler
analysis is enabled.
Tube
If the tube holder is ejected out, press the mode button on the holder
analyzer.

3 Place the rack in the right sampler pool.

Slide the groove on the rack into the protrusion on the right
side (when you face the analyzer). A maximum of 10 racks can
be placed.

Protrusion

Caution!
• When using raised bottom micro collection sample tubes, insert the tubes in the dedicated
RBT rack.
Please note the following.
- Do not insert a Raised Bottom Tube in anything other than an RBT rack.
- Do not insert a sample tube other than a Raised Bottom Tube in an RBT rack.
Otherwise, the tip of the needle could hit the bottom of the sample tube, which may lead to
damages of the piercer or other instrument failures.
• Set the racks horizontally as far to the left edge and towards
the front as possible. Correct operation is not guaranteed if
the racks are set diagonally.

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4 Click on the Sampler Analysis button on the control menu.

The dialog box on the right appears. Check the settings.
The setting below is not required if you are using barcodes. Proceed to the
next step.

[Sample No.]* Enter the sample number in the input field.

[Rack No.]* Enter the rack number in the input field.
[Starting Tube Specify the position of the sample tube where
Position] analysis should start.
[Discrete] Select the check marks for the discrete tests you
want performed.
[Start] Click to start the analysis of the sample.

* You can also use the hand-held barcode reader to input the sample and
rack numbers.

5 Click [Start].
The dialog box closes, and the sampler analysis starts.

● To abort the sampler analysis before it is finished:

Click the sampler analysis button in the control menu, and then click [Yes] in the dialog that appears.

Note:
If the instrument has been set to perform a retest on a sample, it will automatically perform the
analysis multiple times on the sample.

6 Remove the rack after the analysis is finished.

The finished racks are transported to the left sampler pool.
Check that the protrusion has cleared the groove, and then
remove the rack.
For procedures on checking the analysis results, see Chapter
12.
(➤P.229 "Chapter 12: 12.1 Sample Explorer functions")

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Chapter 12 Checking Analysis Data (Sample Explorer)

This section explains how to check the analysis data.

12.1 Sample Explorer functions

The Sample Explorer's functions allow you to display, delete, validate, and output analysis data that are saved on the
IPU. You can display the analysis data for up to 100,000 samples. In addition, you can sort, filter, search, save, and
restore analysis results.

12.1.1 Sample Explorer screen

Clicking the [Sample Explorer] icon in the Menu screen displays the following screen.
Alternatively, you can also click the [Explorer] button on the toolbar.

Toolbar Font size button Analysis data

Filter/sort
description

Analysis
data list

Tab

Patient
information
Display switching button

[Sample Explorer] screen

Toolbar
The buttons of the following functions are displayed.

[Modify] Click to display the dialog box for modifying the selected data in the analysis data list.
[Validate] Click to validate the selected analysis data in the analysis data list. If the list was already
validated, clicking in the list resets the validation status.
[Filter] Click to display the submenu that allows you to set the conditions for the data to be
displayed in the analysis data list.
[Sort] Click to display the submenu that allows you to set the sort order for the data to be
displayed in the analysis data list.
[Output] Click to display the submenu for selecting the output destinations.

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[Upper] Click to move the selection up by 1 row.

[Lower] Click to move the selection down by 1 row.
[FIND] Click to display a dialog box that allows you to search data.
[Last 20] Click to display the analysis data for the last 20 samples in the analysis data list window. In
the filter/sort description box, [Last 20] is displayed.
The analysis data are sorted by analysis date in descending order. Toggle off the [Last 20]
view to return to the original setting. When a new analysis data is saved, the list is
automatically updated.
If the last 20 data are already displayed, clicking [Last 20] displays all samples.
[File] Click to display a submenu that allows you to save and restore data.
[Delete] Click to display the dialog box for deleting the selected data in the analysis data list.

Analysis data list

Displays the analysis data selected in the analysis data list.
It appears on the sub screen.
For details, see the following:
(➤P.237 "12.1.4 Numerical data of the analysis results")

Tab
You can switch between the screens by clicking the tab.

Patient information
Displays the information on the patient selected in the analysis data list.
It appears on the sub screen.

Patient
category icon Patient Name Ward Name

Patient Comment Patient ID Date of birth, sex and age Doctor Name

Patient category Displays an icon. Below the icon is the category number of the patient. If there is no
icon corresponding category, no number is displayed.

Category number

Patient Name Displays the name of the patient (first name, last name).
Patient ID Displays the patient ID.
Date of birth, sex Displays the date of birth, gender, and age of the patient.
and age
Doctor Name Displays the name of the doctor assigned to the patient.
Ward Name Displays the patient's ward name or the name of the clinical service.
Patient Comment Displays comments about the patient.

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Note:
• Items that have not been filled will not be displayed.
• If the currently logged on user does not have privileges to display patient information, only the
patient category icon is displayed.

Filter/sort description
Shows what conditions were used to display the analysis data list. These are the conditions you specified in
the filter and sort settings.
For the details on how to read the symbols, see Chapter 9.
(➤P.135 "Chapter 9: 9.1.1 Work List screen" (●Filter/sort description))

Display switching button

You can click the display switching button to open/close the sub screens. A sub-screen is a screen that is
displayed to the right or below the list of analysis data, that can be opened and closed. Click to switch through
the 4 patterns in the order "sub-screen (right and bottom)" → "sub-screen (bottom)"→"no sub-screen" →
"sub-screen (right)".

Font size button

To change the size of the characters and the line height in the analysis data list, click the font size button.
To change the size setting of the characters, see the following:
(➤P.367 "Chapter 15: 15.3.3 Display settings")

Navigating the screen

For the details on changing the displayed items, see the following.
(➤P.259 "12.11 Change layout of analysis data list")

Note:
Multiple data can be selected as follows:
• Drag multiple consecutive rows while holding down the left button on the mouse
• While pressing Ctrl, click on the row that you want to select

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12.1.2 Analysis data list

The analysis data list displays common items and selection-based items. Common items are items displayed on
all tabs.
Selection-based items differ depending on the tab that is selected.
Once the number of stored items exceeds 100,000, each new item that is stored overwrites the item with the
oldest analysis date and time.

Information
Analysis results of research parameters are indicated by a gray background to distinguish them
from report analysis results. Research items are the parameter for research. Analysis results for
these parameters must not be used for diagnosis of patients.

Common items
Common items are displayed in the left section of the analysis data list.

[V] (Validate) A [V] will appear for validated samples. If a sample has not been validated, nothing
is displayed.
[Priority Code] Displays the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[Sample No.] Displays the sample number.
(Analysis mode) The column to the left of the [Sample No.] column shows the analysis mode for
each sample.
[WB]: Whole blood
[LW]: Low WBC
[PD]: Pre-Dilution
[BF]*: Body fluid
[HPC]*: HPC
[hsA]*: hsA
* The availability of these functions depends on your system configuration. If body
fluid analysis is performed without clearing the error after an [Analysis result is
high] error message is displayed, the background appears in red.
For information on [hsA] mode, see the following.
(➤P.582 "Appendix: Checking analysis data")
(Sample information) The column to the right of the [Sample No.] column indicates how the sample
number was obtained.
[A]: Automatically incremented
[B]: ID barcode scanned
[M]: Manually entered
[C]: Host computer queried
[Output] Displays the output status of the analysis results.
[D]: Indicates that the analysis results have not been output to Ticket
printer (DP).
[G]: Indicates that the analysis results have not been output to Graphic
printer (GP).
[H]: Indicates that the analysis results have not been output to Host
computer (HC).
It takes a maximum of 40 seconds for an output result to be reflected.

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[P/N] Displays whether an analysis result is Positive or Negative.

[D]: Diff. Positive
[M]: Morph. Positive
[C]: Count Positive
On Negative samples no (D), (M), or (C) are indicated at all.
[Action] Displays an action message, if one exists.
[Check] Displayed when the sample needs to be checked.
[Review] Displayed when channel difference has occurred, for example, and the analysis
results need to be reviewed.
[Retest] Displayed when the analysis mode, the order and the status of the sample need to
be reviewed, and then need to be re-analyzed.
[Order Type]* Displays the type of order of the analyzed sample.
[Initial] Analysis order processed for the first time.
[Initial/Repeat] An order that resulted in an error on the first test for sample analysis and was re-
analyzed.
[Rerun] An order that is automatically triggered to rerun a sample with the same discrete
test profile as the initial analysis.
[Reflex] An order that is automatically triggered to rerun a sample with additional discrete
test profiles.
[Rerun/Repeat] An order that was re-analyzed after the [Rerun] resulted in an error.
[Reflex/Repeat] An order that was re-analyzed after the [Reflex] resulted in an error.
[Manual] An order that was analyzed manually.
[Manual (Open)] An order that was analyzed by cap open analysis.
[ERR.] Displays the errors that occurred during the analysis.
[Result] One of the following errors has occurred: [Blood cannot be aspirated.], [Insufficient
blood volume], [Low count error], [Sample cannot be aspirated.].
[Func.] An error other than [Result] and Barcode Reader errors has occurred.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

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Selection-based item
Selection-based items are displayed in the right section of the analysis data list.

● [Sample Info] display screens

If a pending analysis, not all items are displayed.

[Date] Displays the date when the analysis result was made available.
[Time] Displays the time when the analysis result was made available.
[Seq.] Displays the sequential number for each analyzer of the analysis day that the IPU
was turned on.
[Reception Date] Displays the date and time when the first test was received for the sample.
[Rack] Displays the rack number of the sample (for sampler analysis).
For all except sampler analysis, nothing is displayed.
[Position] Displays the sample tube position number of the sample (for sampler analysis).
For all except sampler analysis, nothing is displayed.
[Distribution] Displays abnormal distribution.
[R]: Abnormal RBC distribution
[P]: Abnormal PLT distribution
[IP (WBC)] Displays the flag number of the WBC IP message.
For details, see the following:
(➤P.296 "Chapter 13: Table of IP message details")
[IP (RBC)] Displays the flag number of the RBC/RET IP message.
For details, see the following:
(➤P.296 "Chapter 13: Table of IP message details")
[IP (PLT)] Displays the flag number of the PLT IP message.
For details, see the following:
(➤P.296 "Chapter 13: Table of IP message details")
[Discrete] Displays the test profile.
For details on discrete tests, see Chapter 9.
(➤P.143 "Chapter 9: Table of discrete tests and their corresponding analysis
parameters")
[Rule Result]* Displays the results of the first test, determined according to the rules.
Some rules will display the number of comments in parentheses after the
determined result.
e.g. [Reflex] with 1 comment: [Reflex(1)]
[Repeat] The analysis must be repeated due to an error in the first test.
[Rerun] Analysis must be repeated for the same item as in the first test.
[Reflex] Analysis must be performed with additional items.
[QueryToHost] A host inquiry is necessary.
[None] It is not necessary to make a host inquiry or repeat analysis.
[Sample Comment] Displays the comment entered when the sample was registered.
[Validator] If validation was done manually, this field displays the login name of the user. For
auto validation, [(Auto Validate)] is displayed.
[Analyzer Nickname] Displays the name of the analyzer that was used for the analysis of the sample.
[Analyzer ID] Displays the ID number of the analyzer that was used for the analysis of the sample.

* When using the sampler (SA-01) in the XR-1000, [Comment] will appear when a rule judgment is made. The
number of comments is indicated in parentheses at the end.

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● [CBC]/[DIFF]/[RET]* / [PLT-F]* display screens

Displays the data relevant to the selected tab.
Some data may have a mark in the next column.
For details, see the following:
(➤P.237 "12.1.4 Numerical data of the analysis results")
* These items do not appear with all analyzer types.

Screen and display items

Screen Display items

[CBC] WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MicroR,
MacroR, PDW, MPV, P-LCR, PCT, NRBC#, NRBC%

[DIFF] NEUT#, LYMPH#, MONO#, EO#, BASO#, NEUT%, LYMPH%, MONO%, EO%,
BASO%, AS-LYMP#*, AS-LYMP%*, RE-LYMP#*, RE-LYMP%*, NEUT-RI*, NEUT-GI*,
IG#, IG%

[RET] RET%, RET#, IRF, LFR, MFR, HFR, RET-He, RBC-He, Delta-He, HYPO-He,
HYPER-He

[PLT-F] IPF, IPF#

* The availability of these functions depends on your system configuration.

● [Patient Information] display screen

Displays the patient information registered for the analyzed sample.
Patient ID, patient name, gender, date of birth, ward, doctor, and comments are displayed.

● [Reagent] display screen

Displays the lot number of the reagent that was used at the time the sample was analyzed. If the lot number is
not registered, nothing is displayed.
If the RU-20 is not connected, CELLPACK DST does not appear.
For the details on reagents, see Chapter 5.
(➤P.63 "Chapter 5: Reagents")

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12.1.3 Check Body fluid analysis data in Sample explorer

Click the [Body Fluid] tab* in the [Sample Explorer] screen to view a list of the body fluid analysis data. The sub
screen shows the items analyzed ([ITEM]), numerical data ([DATA]), marks, and the units ([UNIT]) of the sample
selected in the analysis data list.
* The body fluid analysis can only be performed if the license is activated.

The following items are displayed in the [Body Fluid] display screen.
Some data may have a mark in the next column.
For details, see the following:
(➤P.237 "12.1.4 Numerical data of the analysis results")

Screen and display items

Screen Display items

[Body Fluid] WBC-BF, RBC-BF, MN#, PMN#, MN%, PMN%, TC-BF#

For details on items for research, see the following.

(➤P.578 "Appendix: Body fluid items for research")

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12.1.4 Numerical data of the analysis results

The analysis data pane of the [Sample Explorer] screen displays the analysis parameters ([ITEM]), their
numerical values ([DATA]), marks, and the units ([UNIT]) for the sample that is currently selected in the analysis
data list. It appears on the sub screen.

Notations for abnormal data

If there is an abnormality in the analysis data, it is represented by the following masks and marks.

Data masks
Notation Meaning Description

[----] Analysis impossible Indicates that an analysis error or a parsing error has
occurred and the value cannot be displayed.

[++++] Out of range Indicates that the data cannot be displayed because the
value exceeds the display limit.

[ ] No order Indicates that the analysis order does not exist.

Marks*1,2
Notation Meaning Description

[*] Low reliability Indicates that the reliability of the data is low.

[@] Out of range Indicates that the data is outside the linearity limits.

[!] Exceeds upper critical limit/ Indicates that the value is higher than or less than the clinical
Below lower critical limit panic value. Also indicates that the value is higher than the
Exceeds upper acceptable allowed value for a background check.
background check value limit

[+] Exceeds upper limit Indicates that the value is higher than the reference interval.

[-] Exceeds lower limit Indicates that the value is less than the reference interval.

*1 Only 1 mark can be appended per data value. If multiple abnormalities apply to an analysis result, whichever
abnormality has the highest priority is notated. Priorities are assigned to the marks in the order they appear
in the table above ([*]).
*2 The priority levels of [*] and [@] are changed in the service settings.

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12.2 Validate analysis results

To validate analysis results means to accept them so that they can be output externally for reporting purposes*.
* You cannot validate any results while the last 20 samples are displayed.

Follow the steps below to validate the analysis results.

1 In the list pane, click the analysis result you want to validate.
The analysis result is selected.
You can select multiple items.

2 Click the [Validate] button on the toolbar.

A [V] appears on the left end of the analysis data list.
If multiple lines of analysis results are selected, the validation state of the active (reverse-displayed) line of the
analysis result is applied to the entire selection. For example, when you validate the active (reverse-displayed)
analysis results, other analysis results in the selection also become validate.

Note:
After validating, you cannot change any sample information, such as the sample number. If you
need to change any information, click [Validate] to reset the validation status.

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12.3 Sort analysis data list

You can sort the analysis data list by the conditions that you specify*.
The specified conditions are displayed in the filter/sort description box.
* You can sort the results by [Asc.] or [Desc.] of [Analysis Date] only, while the last 20 samples are displayed.

Follow the steps below to sort the list.

1 Click the [Sort] button on the toolbar.

The submenu on the right appears.

2 Click the conditions by which you want to sort the list.

The submenu closes, and the list is sorted.

[Analysis Date] Click to sort first by [Date], then by [Time]. You can select between [Asc.] and [Desc.]
using the button on the right. The ascending order/descending order setting is applied
to both [Date] and [Time].
[Reception Date] Click to sort first by [Reception Date], then by [Analysis Date]. You can select between
[Asc.] and [Desc.] using the button on the right. The ascending order/descending
order setting is applied to both [Reception Date] and [Analysis Date].
[Sample No.] Click to sort first by [Sample No.], then by [Date] in [Desc.] order, then by [Time] in
[Desc.] order. You can select between [Asc.] and [Desc.] using the button on the right.
The ascending order/descending order setting is applied to [Sample No.]. Regardless
of the setting, [Date] and [Time] is always descending order.
[Sort 01], [Sort 02] Click to sort by the criteria specified in [Sort 01] or [Sort 02].
[Modify Settings] Click to change the settings for [Sort 01] or [Sort 02].

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Modify Settings
You can change the settings for [Sort 01] and [Sort 02].
Follow the steps below to change the settings.

1 Click [Modify Settings].

The dialog box on the right appears.

2 Populate the displayed fields.

You can specify a [Sort Name]. You can enter up to 20 characters.
In fields [1st Key] through [5th Key], specify the sort conditions.
The sort conditions are prioritized from [1st Key] to [5th Key].
After selecting the keys, sort the alphanumeric in [Asc.] (0 to 9, A to Z) or [Desc.] (9 to 0, Z to A) order.

[Date] Sorts by date of analysis.

[Time] Sorts by time of analysis.
[Sample No.] Sorts by sample number.
[Rack No.] Sorts by rack number.
[Tube Pos.] Sorts by sample tube position number.
[Sequence No.] Sorts by the serial number, incremented the analysis day.
[Reception Date] Sorts by the date and time when the sample's first test was received.
[Priority Code] Sorts by priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[None] Condition not specified.

3 Click [OK].
The dialog box closes and sorting is applied.

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12.4 Specify data display conditions

You can specify conditions for the samples you want displayed in the analysis data list*.
* You cannot specify any conditions while the last 20 samples are displayed.

Follow the steps below to specify conditions for the data you want displayed.

1 Click the [Filter] button on the toolbar.

The submenu on the right appears.

2 Click the display conditions.

The submenu closes, and the samples that match the conditions are displayed in the list.

[No filter] Click to display all sample information.

If the filter was applied, this removes the filter.
[Filter01] to Click to display samples that match the conditions set in the corresponding filter.
[Filter05]
[Modify Settings] Click to change the setting for the corresponding filter.

Note:
If the data is selected with display conditions specified and a condition is no longer satisfied due
to the date being changed or other reason, the selected state cannot be maintained. A dialog
that notifies you of the change of selection range appears.

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Modify settings
You can change the settings for [Filter 01] through [Filter 05].
Follow the steps below to change the settings.

1 Click [Modify Settings].

The following dialog box appears.

For XR-1000

For XR-2000

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2 Populate the displayed fields.

[Filter Name] You can change the filter name.
You can enter up to 20 characters.

● Date
[Date] Select this checkbox to specify the samples you want displayed by their dates of
analysis.
The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Click to select [Today], [Yesterday] or [Specify].
Selecting [Specify] allows you to specify the date. In the
field below [Specify], enter the date in the format "Year
(4 digits)/Month (2 digits)/Date (2 digits)". If you click the
button on the right edge of the input field, a calendar
appears. You can also enter the date by selecting from this
calendar.

● Validate
[Validate] Select this checkbox to specify the samples you want displayed by whether or not
they have been validated. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Select [Validated] or [Not Validated].

● Error
[Error] Select this checkbox to specify the samples you want displayed by their error
statuses. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the
right.
Select [Error Occurred], [Error Did Not
Occur], [Set separately].
If you select [Set separately], specify [ID
Read Error] and/or [Analysis Error] by
selecting the corresponding
checkbox(es). Select [Occurred] or [No
Occurrence] for the error(s) you specified.

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● Positive/Negative
[Judgment] Select this checkbox to specify the samples you want displayed by their Positive/
Negative results. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the
right.
You can select [Positive], [Negative], or
[Set separately].
If you select [Set separately], specify
[Diff.], [Count], and/or [Morph.] by
selecting the corresponding
checkbox(es). Select [Positive] or
[Negative] for the items you specified.

● Analyzer*
[Analyzer] Select this checkbox to specify the samples you want displayed by the analyzer(s)
that was used for the analysis. The setting appears on the right side of the button.
This is displayed only if multiple analyzers are connected to the IPU.
[Modify] Click to display the dialog box on the right.
The connected Instrument Nickname(s) are
displayed as buttons.
Select the checkbox(es) to specify the analyzer(s)
of the samples you want displayed.

* This can be displayed only when using the XR-2000.

● Output
[Output] Select this checkbox to specify the samples you want displayed by their output
destinations. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the
right.
You can specify [Host Computer (HC)],
[Report (GP)], and/or [Ticket (DP)] by
selecting the corresponding checkboxes,
and select [No output] or [Outputted] for
each item.

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● Reference Interval
[Reference Select this checkbox to specify the samples you want displayed by whether or not
Interval] they are within the reference interval. The setting appears on the right side of the
button.
[Modify] Click to display the dialog box on the right.
Select [Inside Reference Interval] or [Outside
Reference Interval].

● QC
[QC Sample] Select this checkbox to specify the samples you want displayed by their QC status.
The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Select [QC Displayed] or [QC Not Displayed].

● Patient ID*
[Patient ID] Select this checkbox to specify the samples you want displayed by their patient IDs.
The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Enter the [Patient ID]. You can enter up to
16 characters.
Enter the [Patient ID] and click [OK] to display
samples that partially match the entered Patient ID.
To display samples that match the entered Patient
ID exactly, select the checkbox [Filter exact
matches].

* This is displayed only if the user who is logged in has the privileges to display and modify patient info.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

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● Priority code*
[Priority Code] Select this checkbox to specify the samples you want displayed by their priority codes.
The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the
right.
The enabled priority codes are displayed
as buttons.
Select the checkbox(es) to specify the
priority code(s) of the samples you want
displayed. When you select the [Through]
checkbox, you can specify the samples for which the priority code is not set.

* For details on priority codes, see the following.

(➤P.384 "Chapter 15: 15.3.9 Priority code settings")

● Discrete
[Discrete] Select this checkbox to specify the samples you want displayed by the status of their
discrete tests. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the
right*.
Specify the discrete tests by selecting
the corresponding checkbox(es).
When you select the [Specify discretes]
checkbox, the filter will include the
selected discrete test.
If you select [Other], the selectable
discrete tests will be filtered out.
When you select the [Filter using
conditions that include the selected
discretes] checkbox, the filter will include
any discrete tests that partially match the
selected discrete test.
For details on discrete tests, see
Chapter 9. (➤P.143 "Chapter 9: Table of
discrete tests and their corresponding
analysis parameters")
* These items do not appear with all analyzer types.

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● Analysis mode
[Measurement Select this checkbox to specify the samples you want displayed by their analysis
Mode] modes. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Select the checkbox to set [WB] ([Whole Blood]
mode), [LW] ([Low WBC] mode), [PD]
([Pre-Dilution] mode), [BF] ([Body Fluid]
mode)*, [HPC] ([HPC] mode)*, and [hsA] ([hsA]
mode)*.

* The availability of these functions depends on your system configuration.

● Order type*
[Order Type] Select this checkbox to specify the samples you want displayed by their order types.
The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
You can specify [Initial], [Initial/Repeat], [Rerun/
Repeat], [Rerun], [Reflex], [Reflex/Repeat],
[Manual], and/or [Manual (Open)] by selecting the
corresponding checkbox(es).

* When using the sampler (SA-01) in the XR-1000, this does not appear.

● Background check
[Background Select this checkbox to specify the samples you want displayed by their background
check] check status. The setting appears on the right side of the button.
[Modify] Click to display the dialog box on the right.
Select [Background check displayed] or [Background
check not displayed].

3 Click [OK].
The dialog box closes and the filter settings change.

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12.5 Search for a sample

You can search the analysis data list for a specific sample*.
* You cannot search for any samples while the last 20 samples are displayed.

Follow the steps below to search for a sample.

1 Click the [FIND] button on the toolbar.

The following dialog box appears.
In the following dialog box, the ward selection area appears*.
* In the default setting, the ward selection area does not appear.

Ward name
input field

Ward selection
area

List of ward names

Select button

Note:
The doctor name selection area is similar to the ward name selection area. Use the above dialog
box as a reference for the doctor selection area.

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2 Populate the displayed fields.

● [Find Conditions]
The specified items are used as search conditions.

[Sample No.] Enter the sample number. You can enter up to 22 characters.
[Priority Code] Select the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[Patient ID] Enter the patient ID. You can enter up to 16 characters.
[Last Name] Enter the patient's last name. You can enter up to 20 characters.
[First Name] Enter the patient's first name. You can enter up to 20 characters.
[Ward Name] Displays the selected ward name.
Select Clicking the button displays the ward selection area on the right side of the dialog box.
button
[Doctor Name] Displays the selected doctor for the patient.
Select Clicking the button displays the doctor selection area on the right side of the dialog box.
button

● Ward / Doctor selection area

Ward name / Enter a condition to narrow down the ward names / doctor names.
Doctor name You can enter up to 20 characters.
input field
List of ward Displays the ward names / doctor names that contain the condition that you entered.
names / doctor Click to select the ward name / doctor name. You can only select one ward name / doctor
names name.
[Clear] Click to clear the selected ward name / doctor name.

Note:
You can enter "*" and "?" as substitution characters in your search.
"?": A "?" is used in place of any 1 character.
e.g. If you search for "99?99", "99099", "99999", and "99A99" are all selected.
"*": A "*" is used in place of 0 or more characters.
e.g. If you search for "9*9", "909", "9119" and "99A99" are all selected.

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3 Set the search conditions for a match.

If you want to find analysis data that match the specified conditions exactly, select the [Find exact matches]
checkbox. If you clear the checkbox, it will also find samples that partially match the specified conditions.

4 Click [PREV.] / [NEXT].

A sample that matches the search conditions is selected in the list pane.

[PREV.] Click to search up from the analysis result selected in the list pane.
[NEXT] Click to search down from the analysis result selected in the list pane.

5 Click [Close].
The dialog box closes.

12.6 Modify sample information

You can modify the sample information from the analysis data list*.
When sample information is modified, the identification of analysis data changes. Exercise this operation very
carefully.
* If the selected sample in the analysis data list is validated, or if the analysis data list for the last 20 samples is
displayed, you cannot modify any sample information.

Follow the steps below to modify sample information.

1 In the list pane, click the sample you want to modify.

The sample information is selected.

2 Click the [Modify] button on the toolbar.

The dialog box on the right appears.

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3 Populate the displayed fields.

[Sample No.] Displays the sample number. You cannot modify it without entering the sample No.
You can enter up to 22 characters.
[Priority Code] Select the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
[P/N] Displays the Positive/Negative result of the sample.
You can modify a Positive result to Negative.
If the result is Negative, the setting is grayed out and cannot be modified. However, if it is a
Negative result with [Diff.], [Morph.], or [Count], then the setting can be modified.
[Sample Inf.] Displays the sample number attribute. You can select from [Manual Setting (M)], [Auto
Increment (A)], [ID Barcode Reader (B)], or [Host Setting (C)]
[Patient ID]* Displays the [Patient ID].
You can enter up to 16 characters.
[Patient Name] Displays the patient name retrieved by [Patient ID].
You cannot modify it.
[Sample Displays comments about the sample.
Comment] You can enter up to 40 characters.

* If the patient ID was changed, delta check is performed.

4 Click [OK].
The modified sample information is saved.

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12.7 Print analysis data

From the analysis data list in the [Sample Explorer] screen, you can print the analysis data for the selected sample to
various output destinations*.
Up to 300 samples can be output at once.
* The analysis data cannot be printed in the following cases.
• If the sample has not been validated.
• If the analysis data list for the last 20 samples is displayed.
• If you are not connected to any host computer or printers.

12.7.1 Output to host computer or printer

Follow the steps below to output to the host computer or the printer.

1 In the list pane, click the sample you want to output.

The sample information is selected.
You can select multiple items.

2 Click the output destination from the [Output] button on the toolbar.
The analysis data is output to the specified destination*.
* Destinations that are not connected are grayed out and cannot be clicked.

[Host Computer (HC)] Outputs to the host computer.

[Ticket (DP)] Prints to a ticket printer.
[Report (GP)] Prints to a graphic printer in report format.
[Ledger (LP)] Prints to a ledger printer.
[Report for Lab Use Only] Prints to a graphic printer for laboratory use only.

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12.7.2 Save in CSV/FCS format

You can select any analysis data in the [Sample Explorer] or [Data Browser] screen, and save it in CSV / FCS
format. However, you cannot save while the last 20 samples are displayed.

Information
When saving in CSV format, use caution on the following:
• IP messages are intended for use only in the clinical laboratory and are not for patient
diagnosis. IP messages provide notification of the possibility of a specific sample abnormality
based on examination of the analysis data.
• Do not use analysis results of any research parameter for the patient diagnosis.

Note:
When saving in CSV format, use caution on the following:
• The order of the saved parameters cannot be changed.
• Headers of research parameters are enclosed in [ ].
• Scattergrams and particle size distributions are saved individually as image files*.
• If the analysis data exceeds 256 parameters, 256 columns of data are saved as 1 file*.
* Depends on the configuration of IPU. For details, see the following:
(➤P.365 "Chapter 15: CSV output settings")

Follow the steps below to save the analysis data in CSV/FCS format.

1 In the analysis data list pane, click the sample you want to save.
The sample information is selected.
You can select multiple items.

2 Click the [File] button - [Output in CSV Format]/[Output in FCS Format] on the
toolbar.
The [Save As] dialog box appears.

3 Specify the folder to save to, or create a new folder.

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4 Enter the file name.

● CSV format
The file extension is ".csv".
The extension for scattergrams and other image files is ".bmp" or ".png".

● FCS format
The file extension is ".fcs".

Note:
• The default file name of CSV format is set to XR_software version_SAMPLE.csv.
e.g. XR_00-01 (Build 2)_SAMPLE.csv
• The default name of CSV format for the image file is set to Analyzer ID_software
version_analysis date_analysis time_sample number_image name.png (or bmp).
e.g. XR-20^11001_00-01 (Build 2)_20210118_144511_test01_RBC.png
• The default file name of FCS format is set to [Analyzer ID][software version][Fcs]
[analysis date_analysis time][sample number][Channels].fcs
e.g. [XR-20^11001][00-01 (Build 2)][Fcs][20210118_144511][test01][WNR].fcs
• If a character that cannot be used in a file name in Windows (\/:*?”<>|) is included in a sample
number, the character is automatically converted to a space.

5 Click [Save].
The data is saved in the specified format.

Note:
If you selected multiple data for save, the data will be saved in order from the top of list.

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12.8 Save analysis data

You can save analysis data*.
Up to 1,000 entries of analysis data can be saved.
* You cannot save any analysis data while the last 20 samples are displayed.

Follow the steps below to save analysis data to a file.

1 In the list pane, click the sample you want to save.

The sample information is selected.
You can select multiple items.

2 Click the [File] button - [Backup] on the toolbar.

The [Open] dialog box appears.

3 Specify or create the folder to save the sample data into.

4 Check the file name.

The file extension is ".smp".

Note:
• The file name is set to Analyzer ID_software version_Sample_analysis date_analysis
time_sample number.smp.
e.g. [XR-20^11001]_[00-01(Build15)]_[Sample]_[20100505_080808]_[1234].smp
• If a character that cannot be used in a file name in Windows (\/:*?”<>|) is included in a sample
number, the character is automatically converted to a space.

5 Click [OK].
A dialog that allows you to check progress appears.
When saving is finished, the dialog box closes.
The data are saved to the specified file*.
* Whether or not the backup data includes patient information depends on the IPU security settings. For details
on security, see the following.
(➤P.365 "Chapter 15: Security settings")

Note:
If you selected multiple samples, all selected data are backed up to multiple single smp files.

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12.9 Restore saved analysis data

You can restore saved analysis data*.
Up to 1,000 entries of analysis data can be restored.
* You cannot restore any analysis data while the last 20 samples are displayed.

Follow the steps below to restore saved analysis data.

1 Click [File] - [Restore] on the toolbar.

The [Open File] dialog box appears.

2 Select the name of the file you want to restore.

The file extension is ".smp".
You can select multiple items.

3 Click [Open].
A dialog that allows you to check progress appears.
When restoring is finished, the dialog closes.
The analysis data is restored*.
* If the user who is logged in does not have the privileges to display and modify patient info, a dialog box
appears to warn the user that patient info cannot be restored.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

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● If a data entry with the same [Patient ID] already exists

If the same [Patient ID] as the data you are restoring has already been registered in patient registration, the
following dialog box is displayed*.
* If the patient informations matches to the registered informations exactly, this dialog does not appear.

Follow the steps below to specify the patient's ID and information.

1 Specify patient ID.

Select [Overwrite] or [Register in different ID].
You can enter up to 16 characters in the [Register in different ID] field.

2 Specify patient information.

Select which items of the patient information you want to use.
If you want to select all items in [Registered patient information] or [Patient information in file], click [Always
use registered patient information] or [Always use patient information in file].

3 Click [Overwrite with above settings].

The patient ID and the patient information are overwritten.

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12.10 Delete analysis data

You can delete the selected analysis data from the analysis data list*.
* You cannot delete any analysis data while the last 20 samples are displayed.

Follow the steps below to delete analysis data.

1 In the list pane, click the analysis data you want to delete.
The sample information is selected.
You can select multiple items.

2 Click the [Delete] button on the toolbar.

The dialog box on the right appears.

3 Click [Yes].
The selected analysis data is deleted from the analysis data list.

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12.11 Change layout of analysis data list

You can change the layout of the analysis data list in the [Sample Explorer] screen.
Follow the steps below to change the layout of the analysis data list.

1 Right click on the tab or the analysis data list of the [Sample Explorer] screen.
A context menu opens.

2 Click the item you wish to change.

You can populate the displayed fields.

● [Property]
The following dialog box appears.
Select tabs

Common Displayed Displayed Items list

Items list

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Common Displayed Item Settings

[Selectable Items] Displays the items that can be set as common items and all items for research*.
[Selected Item(s)] The items in this list will be displayed in the analysis data list as common displayed
items.
[Insert] Click to move the selected item from Common Displayed Items list to the Items list,
above the selected item.
[Add] Click to move the item you selected in the Common Displayed Items list to the
bottom of the Displayed Items list.
[Move Up] Click to move up the selection in the Displayed Items list by 1 item.
[Move Down] Click to move down the selection in the Displayed Items list by 1 item.
[Delete] Click to move the item you selected in the Displayed Items list to the bottom of the
Common Displayed Items list.

* To display the items for research, the IPU setting is required. For details, see the following:
(➤P.361 "Chapter 15: Change settings and add users") The items for research are displayed on gray
background.

Tab Item Setting*

[Add Tab] Click to add a new tab to the right of the rightmost tab in the select tabs. The name of
the new tab is "Tab", and nothing is displayed in the Displayed Items list.
If the maximum number of tabs (20) is reached, this button is grayed out and cannot
be clicked.
[Delete Tab] Click to delete the tab that is currently displayed in the analysis data list.
Select tabs Allows you to change the individual items for the tab you clicked.
[Tab Caption] Allows you to change the caption displayed on the tab.
You can enter up to 20 characters.
[Move Left] Click to move the tab selection to the left by 1 tab.
[Move Right] Click to move the tab selection to the right by 1 tab.
* The functions of the [Insert], [Add], [Move Up], [Move Down], and [Delete] buttons are the same as described
in the "Common Displayed Item Settings" section.

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● [Layout backup]
Click to display the [Save As] dialog box. Enter a file name and click [OK] to save the layout. The file extension
is ".elf".

Note:
The default file name is set to [XR][software version][ExplorerLayout].elf.

● [Layout restore]
Click to display the dialog box. Select a file name and click [OK] to restore a layout. The file extension is ".elf".

● [Layout initialize]
Click to display the dialog box for confirming reset the layout of the screens to factory setting. Click [Yes] to have
the layout initialized.

3 Click [OK].
The dialog box closes and the layout of the analysis data list changes.

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Chapter 13 Checking Detailed Analysis Information (Data Browser)

Chapter 13 Checking Detailed Analysis Information

(Data Browser)

This section explains how to check detailed information on analysis data.

13.1 Data Browser screen

In the [Sample Explorer] screen, double-clicking a sample data displays the [Data Browser] screen.
Alternatively, you can also display the screen by selecting the sample you want to display, and clicking the [Data
Browser] icon on the Menu screen, or the [Browser] button on the toolbar.

Sample Patient
Action Error Rule result information information Toolbar Sample link

Positive/
Negative
Validation
Tabs

Analysis data

Instructions for
Use Icon

[Data Browser] screen

Toolbar
The buttons below only appear in the [Data Browser] screen.

[Output] - Click to output cumulative data from the graphic printer.

[Cumulative Report] For the output procedure, see Chapter 12.
(➤P.252 "Chapter 12: 12.7.1 Output to host computer or printer")

* Only appears in the following cases:

• A graphic printer (GP) is connected.
• The user has permission to display and edit patient information.
• The user has permission to display and output research items.
• The user has permission to perform external output.
• There is data to be printed.
• The most recent 20 samples are not displayed.
• Analysis data of [Whole Blood]/[Low WBC]/[Pre-Dilution]/[HPC] mode are shown.
For details on permission to display and edit patient information, permission to display and output research
items, and permission to perform external output, see the following.
(➤P.361 "Chapter 15: Change settings and add users")
The functions in the toolbar of Data Browser are similar to the toolbar of Sample Explorer. For details, see
Chapter 12. (➤P.229 "Chapter 12: 12.1.1 Sample Explorer screen" (Toolbar)) However, the function of [File] is
only [Output in CSV Format]. You cannot backup and restore the file.

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Navigating in the screen

You can switch between the screens by clicking the tab.

13.1.1 Common displayed items

This section explains the common items that are displayed on all tabs, in the top section of the [Data Browser]
screen.

Tabs

Click to switch to a different analysis data display. When the analysis data is from [Body Fluid], [HPC] or [hsA]
mode, the contents of the displayed tabs change.
* The availability of these functions depends on your system configuration.
For information on [hsA] mode, see the following.
(➤P.582 "Appendix: Checking analysis data")
When the analysis data is from [HPC] mode, the [HPC] tab appears in place of the [Cumulative] tab.

Positive/Negative, Validation
Displays the Positive/Negative result, and validation status.

Positive/Negative result
If the Positive/Negative result cannot be determined, the background becomes gray and nothing is displayed.
If there are no samples, or if the Positive/Negative result has not been determined, nothing is displayed.

[Positive] This is displayed in white letters on red background, if there were any abnormalities in
the blood cell count or blood cell morphology. The following Positive results are displayed
under [Positive].
[Diff.] Indicates an abnormal blood cell differentiation value.
[Morph.] Indicates an abnormal cell morphology.
[Count] Indicates an abnormal blood cell count.
[Negative] [Negative] is displayed if the sample had no errors.

Validation
If there are no samples, nothing is displayed.

[Validated] This is displayed to indicate that the analysis data has been validated.
[Not Validated] This is displayed to indicate that the analysis data has not been validated.

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Action, Error, Rule result

Displays the determined actions, errors, and rules.

Action
Nothing is displayed if there are no action messages or no samples. The details of the action message are
displayed in the [Action] field in the analysis data pane.

[Action]* If there is an action message, it is displayed in white letters on red background. The
details appear below.
[Check] There may be a mix-up of samples. Otherwise, there is a significant difference in the
analysis results. Check the sample.
[Review] Channel difference has occurred. Check the analysis results.
[Retest] Check the analysis mode, the order and the status of the sample, and then re-analyze.

* Use the analysis results only for testing in the clinical laboratory. They are not intended for patient diagnosis.

Error
If an analysis error occurred, [Error] is displayed in white letters on red background. Nothing is displayed if
there are no errors. The details of the error message are displayed in the [Error/Rule Comments] field in the
analysis data pane.

[Func.] An analysis error other than the ID barcode read error or [Result] has occurred.
[Result] One of the following analysis errors has occurred: [Blood cannot be aspirated.],
[Insufficient blood volume], [Low count error], [Sample cannot be aspirated.].

Rule result
Nothing is displayed if there are no samples.
If there are any comments, the comment icon and the number of comments are displayed on the right side of
[Rule Result]. The details of the comment are displayed in the [Error/Rule Comments] field in the analysis data
pane.
* When using the sampler (SA-01) in the XR-1000, only the number of comments is displayed. The
background color varies depending on the judgment result. When there are multiple comments, the
background color of the most important comment appears.
• Black Low importance
• Orange Medium importance
• Red High importance

[Repeat] The analysis must be repeated due to an error in the first test.
[Rerun] Analysis must be repeated for the same item as in the first test.
When using the XR-2000, the analyzer to be used for re-analysis is displayed on the right.
[Different]* Analysis must be performed using a different analyzer than that of the first test.
[Same] Perform the analysis using the same analyzer as the first test.
[Any]* It does not matter which analyzer you use for the analysis.
[Reflex] Due to the results from the first test, analysis must be performed with additional items.
The discrete test to be added is displayed on the right. If [LW-DIFF] was added, [LW] and
[DIFF] are displayed.
[Query to HOST] A host inquiry is necessary.
[None] The result is that it is not necessary to make a host inquiry or repeat analysis.
* This can be displayed only when using the XR-2000.

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Sample information
Displays the sample information of the analysis data.

Priority code Sample No.

Analysis sample icon

Comments Analysis date Rack No. Sample tube position

Analysis sample An icon is displayed to indicate the analysis sample. [WB] (Whole Blood sample) / [LW]
icon (Low WBC sample) / [PD] (Pre-diluted sample) / [BF] (Body Fluid sample)* / [HPC] (HPC
analysis sample)* / [hsA] (hsA analysis sample)* are displayed.
Priority code Displays the priority code.
For details on priority codes, see the following.
(➤P.384 "Chapter 15: 15.3.9 Priority code settings")
Sample No. Displays the sample number.
Analysis date Displays the date when the analysis result was made available.
Rack No. Displays the rack number of the analyzed sample.
Sample tube Displays the sample tube position number of the analyzed sample.
position
Comments Displays comments about the sample.

* The availability of these functions depends on your system configuration. If you performed body fluid analysis
without clearing a [Analysis result is high], "BF" will be displayed in white on a red background and the body
fluid icon will appear darker.

Patient information
Displays the patient information of the analysis data.

Sample link
The order type of the displayed analysis sample and the analyzer used for analysis are
displayed in buttons in the selected state. If the sample has [Initial], [Repeat], [Rerun], or
[Reflex] information, corresponding buttons appear. Information on the same analyzer
appears.
Click the sample link button to display the applicable analysis data in the [Data Browser]
screen.

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13.1.2 Display analysis data

The analysis data pane displays the details of the data selected in the analysis data list. The method of
displaying the data differs depending on the selected tab.

Information
Analysis results of research parameters are indicated by a gray background to distinguish them
from report analysis results. Research items are the parameter for research. Analysis results for
these parameters must not be used for diagnosis of patients.

Instructions for Use icon ( )

If a flag or error comment is displayed in the display field with an icon displayed at the top right, double-click the
displayed item to view the corresponding page in Instructions for Use.

Notations for abnormal data

If there is an abnormality in the analysis data, it is represented by the following masks and marks.
For the details on masks and marks, see Chapter 12.
(➤P.237 "Chapter 12: 12.1.4 Numerical data of the analysis results")

13.2 Check all information

You can check all information about the analysis data in the [Main] and [Graph] screens.

13.2.1 Main screen

Clicking the [Main] tab displays the following screen.

[Whole Blood] / [Low WBC] / [Pre-Dilution] / [HPC]* mode

When displaying analysis data, the following items are displayed in the main screen: Analysis parameters, all
reportable numerical data, flag information, SD Bar, action, rule comment and error message.
* The availability of the HPC analysis function depends on your system configuration. When the analysis data
is [HPC] mode data, the [HPC] tab appears.

[Main] screen

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[Item]*1,2 Displays analysis parameters.

[Data]*2 Displays the numerical data for each parameter.
If there is an abnormality in the data, [*] will appear after the value. For the
details on marks, see Chapter 12.
(➤P.237 "Chapter 12: 12.1.4 Numerical data of the analysis results")
[Unit]*2 Displays the unit of each parameter.
[LL UL]*2 For each parameter, the SD Bar displays its deviation from the normal range.
A green dot in the SD Bar turns red if the upper or lower limit is exceeded.
However, if the analysis result is not applicable for a reference interval
judgment, or the lower limit is set higher than the higher limit, nothing is
displayed.
Normal range: A green dot is displayed inside the upper/lower limits.

Abnormal range: Red dots are displayed at the upper/lower limits.

[WBC Flag(s)] Displays WBC IP messages, if one exists. The messages are displayed in the
order of abnormal messages, then suspect messages.
Double-click an IP message to display a section of the "Instructions for Use"
manual that explains the selected IP message. (➤P.286 "13.6 IP Messages")
[RBC Flag(s)] Displays RBC IP messages, if one exists. The messages are displayed in the
order of abnormal messages, then suspect messages.
Double-click an IP message to display a section of the "Instructions for Use"
manual that explains the selected IP message. (➤P.286 "13.6 IP Messages")
[PLT Flag(s)] Displays PLT IP messages, if one exists. The messages are displayed in the
order of abnormal messages, then suspect messages.
Double-click an IP message to display a section of the "Instructions for Use"
manual that explains the selected IP message. (➤P.286 "13.6 IP Messages")
[Action] Displays an action message, if one exists.
[Error/Rule Comments] Displays the error message and/or rule comment, if one exists.
The rule comments are sorted by priority with the highest priority on top, and
then by rule number in ascending order.
Double-click an error to display a section of the "Instructions for Use" manual
that explains the selected error. (➤P.525 "Chapter 19: 19.4 Causes of errors
and remedial actions")

*1 These items do not appear with all analyzer types.

*2 The items for research are displayed on gray background.

Note:
The action message [Suspect sample, check the sample.] appears when it is suspected that the
sample was not sufficiently mixed before being placed in the analyzer.
This message may also appear when there is an extended time between mixing and analysis,
when the sample has a high degree of sedimentation, when the sample has been refrigerated/
transported in a cool environment, or when the sample has a high RBC count or high HCT
value. If this message appears, check the sample.

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[Body Fluid] mode*

When displaying analysis data, the following items are displayed in the main screen: Analysis parameters, all
numerical data, flag information, action, rule comment and error message.
* The body fluid analysis can only be performed if the license is activated.

[Main] screen

[Item]* Displays analysis parameters.

[Data]* Displays the numerical data for each parameter. If there is an abnormality in the
data, [*] will appear after the value.
[Unit]* Displays the unit of each parameter.
[WBC Flag(s)] The WBC IP messages are displayed in the order of abnormal messages, then
suspect messages.
[Action] Displays an action message, if one exists.
[Error/Rule Comments] Displays the error message and/or rule comment, if one exists.
The rule comments are sorted by priority with the highest priority on top, and
then by rule number in ascending order.
* The items for research are displayed on gray background.

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13.2.2 Graph screen

Clicking the [Graph] tab displays the following screen.

[Whole Blood] / [Low WBC] / [Pre-Dilution] / [HPC]* mode

When displaying analysis data, the following items are displayed in the [Graph] screen: Analysis parameters,
all reportable numerical data, flag information, distribution data, and scattergram.
* The availability of the HPC analysis function depends on your system configuration. When the analysis data
is [HPC] mode data, the [HPC] tab appears.

Distribution data display area Scattergram display area

[Graph] screen
The display of [Item], [Data], [Unit] and flag informations are same to the [Main] screen.
See the [Main] screen explanation of whole blood or diluted sample as a reference for the [Graph] screen.
(➤P.267 "13.2.1 Main screen")
Distribution data display Displays the distributions for [RBC] and [PLT]. Double-click to display an
area enlarged view in a new window.
Scattergram display area Displays 2-dimensional distributions (scattergrams) for [WDF], [WNR],
[WPC]*1, 2, [RET]*1, [PLT-F]*1 and [PLT-O]*1.
Double-click for a 3D display of the scattergram. (➤P.272 "13.2.3 Check
scattergram in 3D display")
In the case of HPC analysis, you can right-click on the WPC scattergram to set
the scattergram that appears to [All plots] or [HPC only].

*1 These items do not appear with all analyzer types.

*2 For HPC analysis, [WPC(SSC-FSC)] is displayed.

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[Body Fluid] mode*

When displaying analysis data, the following items are displayed in the graph screen: Analysis parameters, all
reportable numerical data, flag information, distribution data, and scattergram.
* The body fluid analysis can only be performed if the license is activated.

Distribution data display area Scattergram display area

[Graph] screen

The display of [Item], [Data], [Unit] and flag informations are same to the [Main] screen.
See the [Main] screen explanation of body fluid sample as a reference for the [Graph] screen. (➤P.269 "[Body
Fluid] mode*")
Distribution data display Displays the distributions for [RBC].
area Double-click to display an enlarged view in a new window.
Scattergram display area Displays 2-dimensional distributions (scattergrams) for [WDF].
Double-click for a 3D display of the scattergram. (➤P.272 "13.2.3 Check
scattergram in 3D display")

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13.2.3 Check scattergram in 3D display

A scattergram can be viewed in 3-dimensional display. In addition to 3D scattergram, 2D scattergram and
surface plot can also be checked.
Double-click one of [WNR], [WDF], [RET], [PLT-F], [WPC], or [WDF] (body fluid mode) scattergram on the
[Graph] screen to display a dialog box with a 3D scattergram of the selected item.

Note:
• If the analysis data list for the last 20 samples is displayed in the [Data Browser] screen, a 3D
scattergram cannot be displayed.
• The 3D scattergram can only be displayed on the [Graph] screen. (➤P.299 "Chapter 13:
13.7 Change layout of screen")

3D scattergram

Analysis sample
icon
Up/down button

Display item
selection area

2D scattergram/
Surface plot

Axis selection
area

3D scattergram Displays a 3D scattergram. Click and drag to rotate the scattergram. Double-click
to reset the displaying angle to the state when the dialog box is opened.
You can fix the direction of scattergram rotation by the following operations:
• Drag while holding Ctrl: Rotates vertically
• Drag while holding Shift: Rotates horizontally
Analysis sample icon Displays an icon to indicate the analysis sample. [WB] (Whole Blood sample) /
[LW] (Low WBC sample) / [PD] (Pre-diluted sample) / [BF] (Body Fluid sample)*
are displayed.
Display item selection Items to display on the scattergram can be selected. Items with no particle to
area display cannot be selected.
Axis selection area Items to be used as X, Y, and Z axes of the scattergram can be selected. Text
color of each axis corresponds to axis colors of 3D scattergram, 2D scattergram,
and surface plot.

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[Switch Display] Click to switch between display of 2D scattergram and surface plot.
Up/down button Click to display the previous or next sample.
2D scattergram/surface Displays 2D scattergrams or surface plots.
plot Same as the 3D scattergram, surface plot display can be rotated individually.
Double-click to reset the displaying angle to the state when the dialog box is
opened.

2D scattergram Surface plot

* The availability of these functions depends on your system configuration.

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13.3 Check data by time ([Whole Blood] / [Low WBC] /

[Pre-Dilution] mode)

The [Cumulative] screen displays the change in the analysis data over time*. The analysis data for a specific patient
is restored by [Patient ID], and displayed cumulatively on the screen. [Displayed Items] and [Display Method] can be
selected.
* The analysis results below are not shown.
• [Body Fluid] mode analysis, [HPC] mode analysis
• Analysis error
• [Patient ID] is not registered
If there are multiple analysis results with the same reception date, only the result with the most recent analysis date
and time is displayed.

Clicking the [Cumulative] tab displays the following screen.

The [Cumulative] screen only appears if the user who is logged in has permission to display and modify patient information.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

Analysis
date

[Cumulative] screen

Note:
Displays the past 7 analysis results going backward in time from the selected analysis result. Data of
newer samples will not be displayed even if they are included in the analysis data list of the [Sample
Explorer] screen.

Common Displayed Items

This section explains the common items displayed in the [Cumulative] screen.
In the above screen, [Numerical] is selected. The common displayed items are the same when [Graph] or
[Scattergram] is selected.

● [Displayed Items]
For the discrete tests and their corresponding analysis parameters, see Chapter 9.
(➤P.143 "Chapter 9: Table of discrete tests and their corresponding analysis parameters")

[CBC] Click to display the report analysis item corresponding to the [CBC] discrete.
[DIFF] Click to display the report analysis items corresponding to WBC and [DIFF] discrete.
[RET/PLT-F]* Click to display the report analysis items corresponding to RBC, PLT, and [RET/PLT-F]
discrete.
* These items do not appear with all analyzer types. Either [RET] or [PLT-F] only appears.

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● [Display Method]
[Numerical] Click to display the numerical data cumulatively.
[Graph] Click to display cumulative line graphs.
[Scattergram] Click to display scattergrams and distributions cumulatively.

● Analysis date
[Date] Displays the date on which the data was analyzed.
[Hour(s)] Displays the time at which the data was analyzed.

13.3.1 Cumulative numerical display

Clicking [Numerical] displays the following screen.

The analysis data of 7 past analyses, with the selected analysis data as the most recent data, are displayed as
a numerical list.

Analysis parameters Analysis data

● Analysis data
Analysis Displays analysis parameters of the selected [Displayed Items].
parameters
Analysis data Displays the analysis parameter data in numerical values.

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13.3.2 Cumulative graph display

Clicking [Graph] displays the following screen.

The analysis data of 7 past analyses, with the selected analysis data as the most recent data, are displayed as
a line graph.

Analysis parameters Analysis data

● Analysis data
Analysis Displays analysis parameters of the selected [Displayed Items].
parameters
Analysis data Displays the analysis parameter data as line graphs.

● Maximum and minimum values

[Max] Displays the maximum value of each parameter.
[Min] Displays the minimum value of each parameter.

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13.3.3 Cumulative scattergram display

Clicking [Scattergram] displays the following screen.

The analysis data of 7 past analyses, with the selected analysis data as the most recent data, are displayed as
a scattergram and distribution.

Analysis parameters Analysis data

● Analysis data
Analysis Displays the channels of the selected [Displayed Items].
parameters
Analysis data Displays the analysis parameter data as scattergrams and distributions.
The displayed channels in the scattergrams and distributions change according to the
selected [Displayed Items].

Information
• The scattergram in the [Cumulative] screen is shown at low resolution.
• The scattergram does not display enlarged view by double-clicking.

● [Displayed Items] and Scattergram

Displayed Items Scattergram

[CBC] [WNR], [RBC] (histograms), [PLT] (histograms)

[DIFF] [WDF], [WNR], [WPC]*

[RET/PLT-F] [RET], [PLT-F]* / [PLT-O]*

* These items do not appear with all analyzer types.

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13.4 Check data by time ([HPC] mode)

The [HPC] screen displays the change in the analysis data over time*. The screen appears only for an analysis
sample in [HPC] mode. The analysis data for a specific patient is restored by [Patient ID], and displayed cumulatively
on the screen. [Display Method] can be selected.
* The analysis results below are not shown.
• [Whole Blood] / [Low WBC] / [Pre-Dilution] / [Body Fluid] mode analysis
• Analysis error
• [Patient ID] is not registered
If there are multiple analysis results with the same reception date, all are shown.

Clicking the [HPC] tab displays the following screen.

The [HPC] screen only appears if the user who is logged in has permission to display and modify patient information.
For details on privileges to display and modify patient info, see the following.
(➤P.361 "Chapter 15: Change settings and add users")

Information
Analysis
date

[HPC] screen

Common Displayed Items

This section explains the common items displayed in the [HPC] screen.
In the above screen, [Numerical] is selected. The common displayed items are the same when [Graph] or
[Scattergram] is selected.
• Numerical value / graph display: HPC#, WBC, NEUT#, and PLT are displayed.
• Scattergram display: WPC(SSC-FSC), WDF are displayed.

● [Display Method]
[Numerical] Click to display the numerical data cumulatively.
[Graph] Click to display cumulative line graphs.
[Scattergram] Click to display scattergrams and distributions cumulatively.

● Information
[Latest] Indicates the most recent data.
[Selecting] Indicates the currently displayed data.

● Analysis date
[Date] Displays the date on which the data was analyzed.
[Hour(s)] Displays the time at which the data was analyzed.

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13.4.1 Cumulative numerical display ([HPC])

Clicking [Numerical] displays the following screen.

The analysis data from the most recent 7 analyses, including the selected analysis data, are displayed as a
numerical list.

Analysis parameters Analysis data

● Analysis data
Analysis Displays analysis parameters.
parameters
Analysis data Displays the analysis parameter data in numerical values.

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13.4.2 Cumulative graph display ([HPC])

Clicking [Graph] displays the following screen.

The analysis data from the most recent 7 analyses, including the selected analysis data, are displayed as a line
graph.

Analysis parameters Analysis data

● Analysis data
Analysis Displays analysis parameters.
parameters
Analysis data Displays the analysis parameter data as line graphs.

● Maximum and minimum values

[Max] Displays the maximum value of each parameter.
[Min] Displays the minimum value of each parameter.

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13.4.3 Cumulative scattergram display ([HPC])

Clicking [Scattergram] displays the following screen.

The analysis data from the most recent 7 analyses, including the selected analysis data, are displayed as a
scattergram and distribution.

Analysis parameters Analysis data

● Analysis data
Analysis The channels used are displayed.
parameters
Analysis data Displays the analysis parameter data as scattergrams and distributions.

Information
• The scattergram in the [Cumulative] screen is shown at low resolution.
• The scattergram does not display enlarged view by double-clicking.

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13.4.4 Change layout of HPC screen

You can change the layout of the analysis data list in the [HPC] screen.
Follow the steps below to change the layout of the analysis data list.

1 Right click on the tab or the analysis data list of the [HPC] screen.
A context menu opens.

2 Click the item you wish to change.

You can populate the displayed fields.

● [Properties]
The following dialog box appears.

Row Displayed Displayed Items list

Items list

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Displayed Item Settings

[Selectable Items] Displays the items that can be set as row items and all items for research*.
[Selected Item(s)] The items in this list will be displayed in the analysis data list as row displayed items.
[Insert] Click to move the selected item from Row Displayed Items list to the Items list, above
the selected item.
[Add] Click to move the item you selected in the Row Displayed Items list to the bottom of
the Displayed Items list.
[Move Up] Click to move up the selection in the Displayed Items list by 1 item.
[Move Down] Click to move down the selection in the Displayed Items list by 1 item.
[Delete] Click to move the item you selected in the Displayed Items list to the bottom of the
Row Displayed Items list.

* To display the items for research, the IPU setting is required. For details, see Chapter 15.
(➤P.357 "Chapter 15: 15.3.2 System settings") The items for research are displayed on gray background.

● [Layout backup]
Click to display the [Open] dialog box. Enter a file name and click [OK] to save the layout. The file extension is
".hlf".

Note:
The default file name is set to [XR][software version][HPC Layout Files].hlf.

● [Layout restore]
Click to display the dialog box. Select a file name and click [OK] to restore the layout. The file extension is ".hlf".

● [Layout initialize]
Click to display the dialog box for confirming reset of the layout to factory setting. Click [Yes] to have the layout
initialized.

3 Click [OK].
The dialog box closes, and the layout of the analysis data list changes.

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13.5 Check data by Q-Flag

The [Q-Flag] screen displays the Positive/Negative levels for suspect IP messages, as a bar graph. The displayed
information corresponds to the sample you selected in the analysis data list of the [Sample Explorer] screen.
Clicking the [Q-Flag] tab displays the following screen.

● Suspect IP messages
For the details on IP message judgment conditions and judgment methods, see the following.
(➤P.288 "Chapter 13: 13.6.1 Targets of IP message judgment")

Q-Flag Message Meaning

WBC type [Blasts/Abn Lympho?] Possibility of blasts or abnormal lymphocytes

1
[Blasts?]* Possibility that blasts are present

[Left Shift?] Possibility of left shift

[Abn Lympho?]*1 Possibility abnormal lymphocytes

[Atypical Lympho?] Possibility of atypical lymphocytes

RBC type [RBC Agglutination?] Possibility of RBC agglutination

[Turbidity/HGB Interf?] Possibility of HGB interference by chylemia

[Iron Deficiency?] Possibility of iron deficiency anemia

[HGB Defect?] Possibility of HGB abnormality

[Fragments?] Possibility of fragmented RBCs

[iRBC?]*2,3 Possibility of red blood cell inclusion bodies*5

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Q-Flag Message Meaning

4
PLT type [PLT Clumps?]* Possibility of PLT clumps

[Giant Platelet?]*2 Possibility of giant platelets

*1 These items do not appear with all analyzer types.

*2 The availability of this function depends on your system configuration.
*3 If judged from the discrete [CBC+DIFF+RET], [R] appears after the message.
*4 The judged channel (WNR/WDF/PLT-F) is appended to the message.
*5 The flag indicates that red blood cell may be infected with either P. vivax or P. malariae – trophozoite,
schizont and gametocyte stages. This is only a suspect flag and NOT definitive or specific for malaria
infection.

● [Q-Flag]
In the bar graph, Negative results of the sample are displayed in green,
and Positive results are displayed in red.
The values are displayed below the bar graph. These values range
from 0 to 300, in increments of 10.
Values of 100 or more are determined as Positive. Boundary between
Positive and
Negative
In addition, the following may appear in the judgment value position. On or above this
Nothing is displayed on the bar graph. line: Positive
Below this line:
[Discrete]: Displayed in gray text. If the parameter used for
Negative
judgment has not been analyzed.
[Error]: If judgment impossible.
Blank: If prerequisite for judgment was not met. Also, if the suspect judgment was not performed due
to blank data, etc.

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13.6 IP Messages
When analysis data is analyzed in the IPU, information that supplements the Positive/Negative sample judgment
appears in the [Data Browser] screen.
Results without an error messages are classified into Positive/Negative based on the preset criteria. The system
bases its judgments on comprehensive surveys of numerical data, particle size distributions, scattergrams, and
provides easily-to-understand flags/messages indicating the instruments findings. These flags/messages are
referred to as "IP (Interpretive Program) messages."
IP messages appear on the sample information tab of the [Sample Explorer] screen, on the main tab of the [Data
Browser] screen, and the flag display area of the graph tab.

Caution!
• A [Positive] or [Error] judgment indicates the possibility of an abnormality. It is not a diagnosis
of the patient. If a [Positive] or [Error] judgment occurs, check the data and repeat the test or
examine carefully in accordance with the protocol of your laboratory.
• IP Messages are only intended for use in the clinical laboratory and are not for patient
diagnosis. IP messages provide notification of the possibility of a specific sample abnormality
based on examination of the analysis data.

Positive/Negative judgment Flag display area

The main tab of [Data Browser] screen

● Flag categories
[WBC Flag(s)] Shows IP message(s) for WBC. [NRBC Present] flag are also shown in here [WBC
Flag(s)].
[RBC Flag(s)] Shows IP message(s) for RBC/RET.
[PLT Flag(s)] Shows IP message(s) for PLT.

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● Message types
There are 2 types of IP messages, abnormal message and suspect message, that may be displayed for each of
WBC, RBC/RET, and PLT.

Abnormal message Indicates that the sample is clearly abnormal.

With some exceptions, the criteria for abnormal message judgment can be
preset. (➤P.348 "Chapter 15: 15.2.9 Flag settings")
Suspect message Indicates a possibility that the sample is abnormal.

● Positive/Negative judgment
[Positive] Indicates that an analysis value or cell morphology exceeds the preset criteria for
the IP message (abnormal sample).
Displayed on a red background.
A Positive judgment is classified into the 3 types shown below. The type appears
under [Positive].
[Diff.] Indicates an abnormal blood cell differentiation value.
[Morph.] Indicates an abnormal cell morphology.
[Count] Indicates an abnormal blood cell count.
[Negative] Indicates that there was no analysis error or abnormality, and that there is no IP
message (normal sample).
Displayed on a green background.

Note:
Only [Positive] judgment is performed for analysis in [Pre-Dilution] / [Body Fluid] / [HPC] mode.
[Negative] judgment is not performed.

● Marks / masks of data

When displaying IP messages, analysis results regarded as having low reliability due to abnormality are
displayed with a [*] mark attached on the right, or the data mask [----], which indicates that analysis is
impossible, is displayed. (➤P.293 "Marks / masks of data with IP message")

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13.6.1 Targets of IP message judgment

In the following cases, IP message judgment are not performed.
• QC analysis data
• Blank data
• Background check data
• Insufficient blood volume

● Blank data
Blank data is data that meets all of the following conditions:
• WBC < 1.00 x 103/µL
• RBC < 0.30 x 106/µL
• HGB < 1.0 g/dL
• PLT < 20 x 103/µL

● Judgment method
WBC < 0.50 x 103/µL The judgment for WBC suspect message ([Left Shift?]) is not performed.
(In [Low WBC] mode, when WBC < 0.20 x 103/µL)
RBC < 0.50 x 106/µL IP message judgment for RBC other than [RBC Abn Distribution] is not performed.
This is displayed as [RBC Abn Distribution], even if the analysis of RBC was not
indicated.

• If an error or other condition prevents an analysis item necessary for judgment from being calculated ("----"
or "++++" appears), judgments that include that analysis item will not be performed.
• Items for which the user has not specified that analysis be performed (blank " ") are not used for judgment.

● [Pre-Dilution] / [Body Fluid]* / [HPC]* mode

For IP messages judged in analysis of [Pre-Dilution] / [Body Fluid] / [HPC] mode, see the following.
(➤P.296 "Table of IP message details")
Only Positive judgment is performed; Negative judgment is not performed.
* The availability of these functions depends on your system configuration.

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13.6.2 Table of IP message

WBC Abnormal message

WBC Abn Scattergram

Description Abnormal WBC scattergram
• In modes other than body fluid mode
Clustering in the WNR or WDF scattergram is abnormal
• In body fluid mode
Clustering in the WDF scattergram is abnormal, or HF-BF is higher than the setting value
Default setting: HF-BF# > 999.999 [103/µL] or HF-BF% > 100.0 [/100WBC]

Neutropenia
Description Low neutrophil count
Neutrophil count is lower than the setting value
Default setting: NEUT# < 1.00 [×103/µL] or NEUT% < 0.0 [%]

Neutrophilia
Description High neutrophil count
Neutrophil count is higher than the setting value
Default setting: NEUT# > 11.00 [×103/µL] or NEUT% > 100.0 [%]

Lymphopenia
Description Low lymphocyte count
Lymphocyte count is lower than the setting value
Default setting: LYMPH# < 0.80 [×103/µL] or LYMPH% < 0.0 [%]

Lymphocytosis
Description High lymphocyte count
Lymphocyte count is higher than the setting value
Default setting: LYMPH# > 4.00 [×103/µL] or LYMPH% > 100.0 [%]

Monocytosis
Description High monocyte count
Monocyte count is higher than the setting value
Default setting: MONO# > 1.00 [×103/µL] or MONO% > 100.0 [%]

Eosinophilia
Description High eosinophil count
Eosinophil count is higher than the setting value
Default setting: EO# > 0.70 [×103/µL] or EO% > 100.0 [%]

Basophilia
Description High basophil count
Basophil count is higher than the setting value
Default setting: BASO# > 0.20 [×103/µL] or BASO% > 100.0 [%]

Leukocytopenia
Description Low leukocyte count
Leukocyte count is lower than the setting value
Default setting: WBC < 2.50 [×103/µL]

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Leukocytosis
Description High leukocyte count
Leukocyte count is higher than the setting value
Default setting: WBC > 18.00 [×103/µL]

NRBC Present
Description Nucleated red blood cells present
Nucleated red blood cell count is higher than the setting value
Default setting: NRBC% > 2.0 [%]

IG Present
Description Immature granulocyte present
Immature granulocyte count is higher than the setting value
Default setting: IG# > 0.10 [×103/µL] or IG% > 100.0 [%]

WBC suspect messages

Blasts/Abn Lympho?
Description Possibility that blasts or abnormal lymphocytes are present
Determined from the WDF scattergram

Blasts?
Description Possibility that blasts are present
Determined from the WDF and WPC scattergrams

Abn Lympho?
Description Possibility that abnormal lymphocytes are present
Determined from the WDF and WPC scattergrams

Left Shift?
Description Possibility of left shift
Determined from the WDF scattergram

Atypical Lympho?
Description Possibility that atypical lymphocytes are present
Determined from the WDF scattergram

RBC abnormal messages

RBC Abn Distribution

Description Abnormal RBC distribution

Dimorphic Population
Description Double-peak RBC distribution

Anisocytosis
Description RBC sizes are unequal
RDW-SD or RDW-CV has a value higher than the setting value
Default setting: RDW-SD > 65.0 [fL] or RDW-CV > 20.0 [%]

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Microcytosis
Description Microcytosis
MCV is lower than the setting value
Default setting: MCV < 70.0 [fL]

Macrocytosis
Description Macrocytosis
MCV is higher than the setting value
Default setting: MCV > 110.0 [fL]

Hypochromia
Description Hypochromic RBC
MCHC is lower than the setting value
Default setting: MCHC < 29.0 [g/dL]

Anemia
Description Anemia
HGB is lower than the setting value
Default setting: HGB < 10.0 [g/dL]

Erythrocytosis
Description High RBC count
RBC count is higher than the setting value
Default setting: RBC > 6.50 [106/µL]

RET Abn Scattergram

Description Abnormal RET scattergram
Clustering in the RET scattergram is abnormal

Reticulocytosis
Description High reticulocyte count
Reticulocyte count is higher than the setting value
Default setting: RET# > 0.2000 [106/µL] or RET% > 5.00 [%]

RBC suspect messages

RBC Agglutination?
Description Possibility of RBC agglutination
Judged from RBC distribution and HGB

Turbidity/HGB Interf?
Description Possibility of false high value of HGB due to chylemia
Judged from RBC distribution and HGB

Iron Deficiency?
Description Possibility of iron deficiency
Judged from RBC distribution and HGB

HGB Defect?
Description Possibility of HGB abnormality
Judged from RBC distribution

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Fragments?
Description Possibility that fragmented red blood cells are present
Judged from RBC distribution, PLT distribution and RET scattergram

iRBC?*
Description Possibility of red blood cell inclusion bodies
Determined from the WNR and WDF scattergrams
* The availability of these functions depends on your system configuration.

PLT abnormal messages

PLT Abn Distribution

Description Abnormal PLT distribution

Thrombocytopenia
Description Thrombocytopenia
Platelet count is lower than the setting value
Default setting: PLT < 60 [103/µL]

Thrombocytosis
Description Thrombocytosis
Platelet count is higher than the setting value
Default setting: PLT > 600 [103/µL]

PLT Abn Scattergram

Description Abnormal PLT-F scattergram
Clustering in the PLT-F scattergram is abnormal

PLT suspect messages

PLT Clumps?
Description Possibility of PLT clumps
Determined from the WNR, WDF, and PLT-F scattergrams

Giant Platelet?*
Description Possibility of giant platelets
Determined from the WNR scattergram
* The availability of these functions depends on your system configuration.

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13.6.3 Table of IP message details

Marks / masks of data with IP message

With respect to the following IP messages, when a sample judgment is Positive, the analysis results are
regarded as having low reliability due to the abnormality and "∗" (or "----" ) appears to the right of the data.

WBC IP messages
AS-LYMP# WBC-BF
AS-LYMP% TC-BF#
NRBC# NEUT# LYMPH# MONO# EO# BASO# IG# RE-LYMP# PMN#, PMN%
WBC NRBC% NEUT% LYMPH% MONO% EO% BASO% IG% RE-LYMP% MN#, MN%
WBC Abn Scattergram
Lymph, Mono(WDF) ∗ ∗ ∗
Neut, Eo(WDF) ∗ ∗ ∗
Lymph, Neut(WDF) ∗ ∗ ∗ ∗
Neut, Mono(WDF) ∗ ∗ ∗
Lymph, Baso(WDF) ∗ ∗ ∗ ∗
Lymph, Eo(WDF) ∗ ∗ ∗
Mono, Eo(WDF) ∗ ∗
Mono, Baso(WDF) ∗ ∗ ∗
Ghost, Neut(WDF) ∗*2 ∗*2 ∗ ∗ ∗ ∗ ∗*2 ∗ ∗
Ghost, Baso(WDF) ∗*2 ∗*2 ∗ ∗ ∗ ∗ ∗*2 ∗ ∗
Ghost, Lymph(WDF) ∗*2 ∗*2 ∗ ∗ ∗ ∗ ∗*2 ∗ ∗
Ghost, Eo(WDF) ∗*2 ∗*2 ∗ ∗ ∗ ∗ ∗*2 ∗ ∗
Ghost, WBC(BF)*3
Ghost or other
∗
interference with WBC
in body fluid analysis
4DIFF, Baso(WNR) ∗ ∗ ∗
1
4DIFF, Nrbc(WNR) ∗* ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗
Ghost, 4DIFF(WNR) ∗*1 ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗
Ghost, Nrbc(WNR) ∗*1 ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗
Nrbc, WBC(WNR) ---- ---- ---- ---- ---- ---- ---- ---- ----
WBC calculation
----*1 ---- ----*1 ----*1 ----*1 ----*1 ----*1 ----*1
not possible(WNR)
Abnormal 5DIFF
∗ ∗ ∗ ∗ ∗ ∗
distribution shape
5DIFF data calculation
---- ---- ---- ---- ---- ----
not possible
IG fraction ∗
HF-BF high value
NRBC Present
Blasts/Abn Lympho? ∗ ∗ ∗ ∗ ----

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AS-LYMP# WBC-BF
AS-LYMP% TC-BF#
NRBC# NEUT# LYMPH# MONO# EO# BASO# IG# RE-LYMP# PMN#, PMN%
WBC NRBC% NEUT% LYMPH% MONO% EO% BASO% IG% RE-LYMP% MN#, MN%
Blasts?*4 ∗ ∗ ∗ ∗ ----
4
Abn Lympho?* ∗ ∗ ∗ ∗ ----
Left Shift? ∗ ∗ ∗
Atypical Lympho? ∗ ∗ ∗ ∗ ∗
*1 WBC in the WNR channel.
*2 WBC in the WDF channel.
*3 The body fluid analysis can only be performed if the license is activated.
*4 These messages do not appear with all analyzer types.

RBC/RET IP messages
RET%,
IRF,
RBC, LFR,
HCT, MCH, MFR,
MCV MCHC HGB RDW-SD RDW-CV HFR PLT RET-He RET#
RBC Abn Distribution
MP-Flag ∗ ∗ ---- ---- ∗
Abnormal RDW-SD ∗ ∗ ---- ∗ ∗
Other abnormal
∗ ∗ ∗ ∗ ∗
distribution
Dimorphic Population ---- ----
RET Abn Scattergram*1
RET abnormal fraction
∗ ∗*2 ∗ ∗
(Deformation)
Other than above (RET
∗ ∗ ∗
zone error)
Foreign particles mixed
in PLT zone ----*2
(High impact)
Foreign particles mixed ∗*2
in PLT zone
RBC Agglutination? ∗ ∗ ∗
Turbidity/HGB Interf? ∗ ∗
Iron Deficiency?
HGB Defect?
Fragments?
iRBC?*3
*1 This message does not appear with all analyzer types.
*2 PLT in the RET channel.
*3 The availability of this function depends on your system configuration.

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PLT IP messages
PDW
MPV
P-LCR IPF#,
PLT PCT IPF
PLT Abn Distribution
Abnormal PDW ----
Other abnormal
∗
distribution
PLT Abn Scattergram*4 ∗*3 ∗
PLT Clumps?
PLT-F not analyzed ∗*1, 2 ∗
PLT-F analyzed ∗*3 ∗ ∗
5
Giant Platelet?* ∗ ∗
*1 PLT in the PLT channel.
*2 PLT in the RET channel.
*3 PLT in the PLT-F channel.
*4 This message does not appear with all analyzer types.
*5 May not appear depending on your system configuration.

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WBC IP messages
Chapter 13

Flag category of Detection Analysis mode Target table of flag judgment to discrete test
Message No.*1 Positive/Negative
channel CBC+DIFF CBC+DIFF CBC+DIFF
judgment [LW] [PD] [BF]*2 [HPC]*2 CBC CBC+DIFF CBC+RET +PLT-F
+RET +WPC +RET+WPC

WBC Abn Scattergram 1 Morph. WNR, WDF ✓ ✓ ✓ ✓ Δ ✓ ✓ Δ ✓ ✓ x

Neutropenia 2 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

WBC IP messages

Neutrophilia 3 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Lymphopenia 4 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Table of IP message details

Lymphocytosis 5 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Monocytosis 6 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Eosinophilia 7 Diff. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Basophilia 8 Diff. WNR ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Leukocytopenia 9 Count. WNR, WDF x x

Abnormal messages
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Leukocytosis A Count. WNR, WDF ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

NRBC Present E Morph.+Count. WNR ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

IG Present F Morph.+Count. WDF ✓ ✓ x ✓ x ✓ ✓ x ✓ ✓ x

Blasts/Abn Lympho? 7 Morph. WDF ✓ x x ✓ x ✓ ✓ x x x x

Blasts?*3 1 Morph. WDF+WPC ✓ x x x x x x x ✓ ✓ x

Abn Lympho?*3 A Morph. WDF+WPC x x x x x x x x

Checking Detailed Analysis Information (Data Browser)

✓ ✓ ✓

Suspect
Left Shift? 3 Morph. WDF ✓ x x ✓ x ✓ ✓ x ✓ ✓ x

messages
Atypical Lympho? 4 Morph. WDF, WDF+WPC ✓ x x ✓ x Δ Δ x ✓ ✓ x

✓ : Judgment enabled. (For [WBC Abn Scattergram], [Body Fluid] mode and other modes are judged with different rules.)
Δ : Partial judgment enabled. (Rules that use channels that are not analyzed are not judged.)
× : Judgment disabled.
*1 Message in the Explorer screen (Flag No.)
*2 The availability of these functions depends on your system configuration.
*3 These messages do not appear with all analyzer types.

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RBC/RET IP messages

Flag category of Detection Analysis Mode Target table of flag judgment to discrete test
Message No.*1 Positive/Negative
channel CBC+DIFF CBC+DIFF CBC+DIFF
judgment [LW] [PD] [BF]*2 [HPC]*2 CBC CBC+DIFF CBC+RET +PLT-F
+RET +WPC +RET+WPC

RBC Abn Distribution 1 Morph. RBC ✓ Δ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

Dimorphic Population 2 Morph. RBC ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
RET Abn Scattergram*3 9 Count. RET ✓ x x ✓ x x ✓ ✓ x ✓ x
Reticulocytosis*3 A Count. RET ✓ ✓ x ✓ x x ✓ ✓ x ✓ x
Anisocytosis 3 Morph. RBC ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
RBC/RET IP messages

Microcytosis 4 Morph. RBC ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

XR-1000/XR-2000 Instructions for Use

Macrocytosis 5 Morph. RBC ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
Hypochromia 6 Morph. RBC+HGB ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

Abnormal messages
Anemia 7 Count. HGB ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
Erythrocytosis 8 Count. RBC ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
Chapter 13

RBC Agglutination? 1 Count. RBC+HGB ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

Turbidity/HGB Interf? 2 Count. RBC+HGB ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
Iron Deficiency? 3 Morph. RBC+HGB ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x
HGB Defect? 4 Morph. RBC ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

Suspect
Fragments? 5 Morph. RBC, PLT, RET x x x

messages
✓ ✓ Δ Δ ✓ ✓ Δ ✓
iRBC?*2 6 Morph. WNR, PLT, ✓ ✓ x ✓ Δ Δ ✓ Δ Δ ✓ x
WDF, RET

✓ : Judgment enabled. (For [WBC Abn Scattergram], [Body Fluid] mode and other modes are judged with different rules.)
Δ : Partial judgment enabled. (Rules that use channels that are not analyzed are not judged.)
× : Judgment disabled.
*1 Message in the Explorer screen (Flag No.)
*2 The availability of these functions depends on your system configuration.
*3 These messages do not appear with all analyzer types.
Checking Detailed Analysis Information (Data Browser)

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Chapter 13

Flag category of Detection Analysis Mode Target table of flag judgment to discrete test
Message No.*1 Positive/Negative
channel CBC+DIFF CBC+DIFF CBC+DIFF
judgment [LW] [PD] [BF]*2 [HPC]*2 CBC CBC+DIFF CBC+RET +PLT-F
+RET +WPC +RET+WPC

PLT Abn Distribution 1 Morph. PLT ✓ x x ✓ ✓ ✓ ✓ ✓ ✓ ✓ x

PLT Abn Scattergram*3 4 Count. PLT-F ✓ ✓ x ✓ x x x x x x ✓
PLT IP messages

Thrombocytopenia 2 Count. PLT, RET, PLT-F ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Abnormal
messages
Thrombocytosis 3 Count. PLT, RET, PLT-F ✓ ✓ x ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
WNR, WDF,
PLT Clumps? 1 Count. ✓ x x ✓ Δ Δ Δ Δ Δ Δ Δ
PLT-F

Giant Platelet?*2 3 Morph. WNR x x x

Suspect
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

messages
✓ : Judgment enabled. (For [WBC Abn Scattergram], [Body Fluid] mode and other modes are judged with different rules.)
Δ : Partial judgment enabled. (Rules that use channels that are not analyzed are not judged.)
× : Judgment disabled.
*1 Message in the Explorer screen (Flag No.)
*2 The availability of these functions depends on your system configuration.
*3 These messages do not appear with all analyzer types.
Checking Detailed Analysis Information (Data Browser)

XR-1000/XR-2000 Instructions for Use

Chapter 13 Checking Detailed Analysis Information (Data Browser)

13.7 Change layout of screen

You can change the layout for [User] and [Lab. Only] screens.

[User] screen
This screen allows the user to set any layout. Items that can be set are reportable items on your analyzer.
This appears when the [User] tab is clicked.

[Lab. Only] screen

This screen allows the user to set any layout. Items that can be set are reportable items on your analyzer and
research items*.
This appears when the [Lab. Only] tab is clicked.
* Research items only appear when the user has permission for [Display and Output of Research Items].
For details on permission for [Display and Output of Research Items], see the following.
(➤P.361 "Chapter 15: Change settings and add users")

When you right-click on the screen, a menu is displayed, allowing you to change the settings. The items you can
configure change according to what part of the screen you right-click.

Right-clicking on the desired display-switching button:

The following context menus are displayed.

[Change Name] Click to display the dialog for renaming the button.
Up to 12 characters can be entered.
[Layout backup] Clicking this item opens the [Save As] dialog box. Enter a file name and click [Save] to
save the screen layout that is currently displayed.
The file extension is ".blf".
The default file name is set to [XR][software version][BrowserLayout].blf.
[Layout restore] Clicking this item opens the [Open File] dialog box. You can restore a screen layout. The
file extension is ".blf". Select a file and click [Open] to display the overwrite confirmation
dialog box. Clicking [OK] overwrites the screen layout and the dialog box closes.
[Layout initialize] Click to display the dialog box for confirming reset the layout of the screens to factory
setting. Click [Yes], you can reset the layout of the screen that is currently displayed to
factory setting.

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Right-clicking inside the desired screen:

[Add Item] Click to display the dialog box on the right.
Clicking a button places the item on the screen. A table,
a scattergram, a list box, a distribution, or a pie chart can
be placed. Simultaneously, a setting dialog box for each
item is displayed. Displayed item, name, color, types of
scattergram and distribution, and types of IP message,
error/rule comment and action can be set.

Right-clicking on an item in the screen:

[Move] Click this menu selects the right-clicked item, and its coordinates appear on the top right
corner of the screen.
In this state, you can drag to move the item to any position.
Moreover, you can resize the item by dragging its vertex or one of the four corners.
Displayed Item of coordinates
[X]: The horizontal coordinate of the top left corner of the item, with the top left
corner of the screen as the origin.
[Y]: The vertical coordinate of the top left corner of the item, with the top left corner
of the screen as the origin.
[W]: The length of the item.
[H]: The height of the item.
[x]: The horizontal coordinate of cursor, with the top left corner of the screen as the
origin.
[y]: The vertical coordinate of cursor, with the top left corner of the screen as the
origin.
[Delete] Click to delete the selected item.
[Properties] Click to display the Property dialog box for the selected item. You can configure its
advanced settings of following items from this dialog box.
[Grid] You can set items ([Item], [Data], [Unit] and [SD-Bar]) and analysis items to display in a
table. The items for research can be set to display*.
[Text Box] You can specify the analysis parameters, units, and display data to display. In addition,
you can set the font and background colors for entering free text. The items for research
can be set to display*.
[Scattergram] You can specify the type of scattergram you want to display.
[List Box] You can specify the type of IP messages, the list of Error / Rule comment and the display
of action comment you want to display.
[Distribution] You can specify the type of distribution and normal range you want to display.
[Pie Chart] You can set the analysis items you want to display in the pie chart and their colors.
[Group] You can specify the group name for each item you want to display.

* To display the items for research, the IPU setting is required. For details, see the following:
(➤P.361 "Chapter 15: Change settings and add users") The items for research are displayed on gray
background.

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Chapter 14 Performing Calibration

Chapter 14 Performing Calibration

This chapter explains how to perform calibration.

14.1 Introduction
Calibration is performed to ensure accuracy of the system.

About calibration
For this instrument, you can use a dedicated calibrator to calibrate the instrument (calibrator calibration).
The instrument automatically analyzes the same calibrator 11 times consecutively, and the repeatability and
accuracy of the analysis parameters are checked.
At the same time, the compensation rate can be updated.

There are 2 types of calibrator calibration, as follows.

• Calibrator calibration: Calibration of parameters other than PLT-F
• Calibrator calibration (PLT-F)*: Calibration of PLT-F
The calibrator used for each calibration is different.
* Calibration cannot be used with all analyzer types.

In addition, precision check function is available for checking only the instrument's repeatability by using a
normal sample.

Note:
For calibrator calibration and precision check, please note the following.
• Repeat, Rerun, and Reflex are not performed.
(➤P.413 "Chapter 16: 16.1 Types of rules")
• Identification of samples by barcode reader is not performed.
The following sample numbers are automatically assigned by the analyzer.
- Calibrator calibration: CAL-CAL-01 to CAL-CAL-11
- Calibrator calibration (PLT-F): PF-CAL-CAL-01 to PF-CAL-CAL-11
- Precision check: PRE-CHK-01 to PRE-CHK-11

Before Performing Calibration

Before performing calibration, check the remaining amount of the reagent connected to the instrument.
If the reagent runs out, the calibration stops.
If it stops, cancel the calibration. After replacing the reagent, restart the operation from the beginning.

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14.1.1 Calibration practice standards

The initial calibration is done by your authorized local Sysmex representative, at the time of installation.
Perform calibration as needed, e.g., when the QC data is fluctuating. However, if the abnormality in the QC
analysis data was caused by an error in the analyzer, degradation of the reagent, or degeneration of the quality
control material, do not perform calibration.

14.1.2 Calibrators and samples to be used

Use the following calibrators and samples for calibrator calibration and precision check.

Calibrator calibration
XN CAL: Use for the calibration of the analyzer for WBC, RBC, HGB, HCT, PLT, and RET.

Calibrator calibration (PLT-F)

XN CAL PF: Use for the calibration of the analyzer for PLT-F (Platelet count analyzed by the PLT-F
channel).

Precision check
For precision check, use one sample of fresh normal blood per analyzer that meets the following requirements.
• Blood of a healthy person who is not taking any medicine;
• Blood added with an appropriate amount of anticoagulant;
• Whole blood volume in each sample is at least 2.5 mL.

Information
When performing calibrator calibration, use a calibrator specified by Sysmex, and do not use
quality control materials. Quality control materials are intended for quality control, not for
calibration.

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14.2 About Calibrator Calibration

Calibrator calibration is performed by manual analysis.
The discrete tests to be analyzed are specified automatically, and cannot be changed. In addition, different discrete
tests are specified depending on the type of analyzer that is connected. For details, see the following:

Discrete test

Discrete test
Analyzer
Calibrator calibration Calibrator calibration (PLT-F)

XR-20[A1] CBC+DIFF+RET+WPC CBC+PLT-F

XR-20[A2] CBC+DIFF+RET+WPC -

XR-10[B1] CBC+DIFF+RET CBC+PLT-F

XR-10[B2] CBC+DIFF CBC+PLT-F

XR-10[B3] CBC+DIFF+RET -

XR-10[B4] CBC+DIFF -

14.2.1 Performing Calibrator Calibration

Follow the steps below to perform calibrator calibration for parameters other than PLT-F.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status
indicator
LED

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2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.
In calibrator calibration, select [Whole Blood] mode.

4 Click [OK].
The dialog box closes.

5 Click the Analyzer menu button on the control menu.

The menu on the right appears.

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6 Click [Calibration] - [Calibrator Calibration].

The dialog box on the right appears.
Shortcut buttons

Calibration
parameters

Data display area

Back button
Next button

[Calibrator Calibration]
analysis dialog box

Shortcut buttons Click to display calibration item screens that are not currently displayed. If the data in
a screen includes a warning, a warning mark appears.
Data display area
Calibration The analysis parameters to be calibrated are displayed. Different parameters are
parameters displayed depending on the type of analyzer that is connected.
[No.1] - [No.11] For each calibration parameter, the analysis results are displayed for the 11 repeated
analysis cycles. A strike-through is displayed for the results for [No. 1] since it is not
reflected in [Mean Value], [SD], and [CV (%)].
[Mean Value] For each calibration parameter, the mean value of the analyzed values from [No. 2]
to [No. 11] is displayed.
[SD] For each calibration parameter, the standard deviation of the analyzed values from
[No.2] to [No.11] is displayed. If the [Mean Value] is 0, [----] is displayed.
[CV (%)] Displays the coefficient of variation for the analysis result for each calibration
parameter. After the 11th analysis is complete, if the coefficient of variation is greater
than the [Limit (%)], then it is displayed in white font on red background.
[Limit (%)] Displays the standard value (acceptable value) for the coefficient of variation of each
calibration parameter.
Back button Click to display the previous screen.
Next button Click to display the next screen.
[Calibration] When clicked, the [Calibrator Calibration] data confirmation dialog box is displayed.

7 Mix the Calibrator.

Mix the Calibrator properly by following the instructions included in the package insert of the Calibrator.

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8 Place the vial in the sample tube holder.

9 Press the start switch on the analyzer.

Once the manual analysis starts, the analysis is performed
11 times consecutively, with the tube holder pulled into the
analyzer.
Once the analysis finishes, the tube holder slides out.
Wait until all analyses are complete.

Start switch

Information
If an error occurs during an analysis, and the analysis can no longer continue, stop the calibrator
calibration. Once the error is cleared, redo the manual analysis.

10 Redo the manual analysis.

The results from the analysis in step 9 are displayed in the [Calibrator Calibration] analysis dialog box.
When the analysis results do not satisfy the conditions below, the test numbers of tests that must be repeated
are displayed in the [Calibrator Calibration] analysis dialog box. Select and redo the manual analysis.

• All analysis results are normal.

• All calibration parameters are below the [Limit (%)] value.

When the analysis results satisfy the conditions, [Calibration] can be clicked in the [Calibrator Calibration]
analysis dialog box. Proceed to the next step.

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11 Click [Calibration] on the [Calibrator Calibration] analysis dialog box.

The dialog box on the right appears.

Shortcut buttons

Data display area

Back button
Next button

[Calibrator Calibration] data

confirmation dialog box

[Analysis Result] When clicked, the [Calibrator Calibration] analysis dialog box is displayed.
[Read targets] Use this to read the target value for each calibration parameter from the server.
[Lot No.] Enter and search the lot number of the calibrator (XN CAL).
[Read] When clicked, the target value is read.
Shortcut buttons Click to display calibration item screens that are not currently displayed. If the
data in a screen includes a warning, a warning mark appears.
Data display area
[Target] Enter the target value for each calibration parameter.
The input methods are as follows.
• Referring to the target sheet supplied with the XN CAL, enter the values
manually.
• Read the target values from the medium supplied with the calibrator.
[Range Value] Displays the difference between the maximum and the minimum values for each
calibration parameter.
If this is greater than the maximum range, it is displayed in white font on red
background.
[Max Range] When the target value is entered, a value that is equal to "Target value x Fixed
ratio for each calibration parameter" is displayed.
[Mean Value] Displays the average value of the analysis data.
[Delta Percent (%)] When the target value is entered, a value that is equal to "|Target value - Mean
Value|/Mean Value x 100 (%)" is displayed.
If this value is greater than the Acceptable Limit and less than the Service Limit,
the background is displayed in yellow. If this is greater than the Service Limit, it is
displayed in white font on red background.
[Acceptable Limit Displays a numeric value for determining whether calibration is necessary. If the
(%)] Delta Percent is less than this value, no calibration is necessary.

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[Service Limit (%)] Displays the maximum Delta Percent when performing calibrator calibration. If the
Delta Percent is greater than this value, calibration cannot be performed for that
parameter.
[Current Rate (%)] Displays the compensation rate for each calibration parameter before calibrator
calibration.
[New rate] Displays the new compensation rate, which is calculated from "Target value x
Current Rate/Mean Value". This value is displayed once [Target] and [Mean
Value] are displayed.
Back button Click to display the previous screen.
Next button Click to display the next screen.

12 Click [OK].
The dialog box on the right appears*.
* The display will vary depending on the type of
analyzer that is connected.

Calibrator parameter
checkboxes

Modify
checkboxes

Back button
Next button

[Calibrator Calibration]
execution dialog box

Calibrator parameter Select the checkbox to include the calibration parameter in the calibrator calibration.
checkboxes Clear the checkbox to exclude it from calibrator calibration.
If a calibration parameter meets all of the conditions below, the checkbox for that
parameter is automatically selected when the screen appears. In addition, you can
select or clear the checkboxes manually.
1) 80 % ≤ New Rate ≤ 120 %
2) New Rate - Current Rate ≤ ±5 %*
3) Range Value ≤ Max Range
4) Acceptable Limit ≤ Delta Percent ≤ Service Limit
If a calibration parameter meets all of the conditions from 1) to 3), and the Delta
Percent is less than the Acceptable Limit, it is excluded from calibration, as there is
no need for calibration.
If a calibration parameter does not meet all of the conditions from 1) to 3) and the
Delta Percent is greater than the Acceptable Limit, calibration cannot be performed.
Calibration is performed with this calibration parameter excluded.
* When the RBC checkbox is selected, condition 2) of HCT changes to "New Rate -
Current Rate ≤ ±12.5 %".

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[Current Rate (%)] Displays the compensation rate for each calibration parameter before calibrator
calibration.
[New rate] Displays the new compensation rate calculated by the system.
Modify checkboxes Selecting the checkbox enables you to manually enter a value in [New rate]. You
can enter a value within the range of 80 to 120 %.
However, the checkbox cannot be selected for any calibration parameter with "Delta
Percent > Acceptable Limit". In addition, calibration parameters with manually
entered values will be displayed with an asterisk (∗) in the calibrator calibration
history.
When the checkbox is cleared, you will not be able to manually enter a value in
[New rate]. Any values that were manually entered prior to clearing the checkbox
will revert to the system-calculated values.
Back button Click to display the previous screen.
Next button Click to display the next screen.

13 Click Next button.

The dialog box on the right appears.
The contents of the dialog box are the same as in
Calibrator parameter
step 12. checkboxes

Modify
checkboxes

Back button
Next button

14 Click [OK].
The compensation rates are updated, and this calibration process is logged in the calibrator calibration history.
For details on calibration history, see below.
(➤P.316 "14.3 Manage Calibration History")

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14.2.2 Performing calibrator calibration (PLT-F)

Follow the steps below to perform calibrator calibration for PLT-F.
This function may not be available depending on the configuration of the instrument you are using.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status
indicator
LED

2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.
In calibrator calibration (PLT-F), select [Whole Blood] mode.

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4 Click [OK].
The dialog box closes.

5 Click the Analyzer menu button on the control menu.

The menu on the right appears.

6 Select [Calibration] - [Calibrator Calibration(PLT-F)].

The dialog box on the right appears.

Data display area

[Calibrator Calibration(PLT-F)]
analysis dialog box

Data display area

[No.1] - [No.11] The analysis results for PLT-F are displayed for the 11 repeated analysis cycles. A
strike-through is displayed for the results for [No. 1] since it is not reflected in [Mean
Value], [SD], and [CV (%)].

[Mean Value] The mean value of the analyzed data from [No. 2] to [No. 11] is displayed.

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[SD] The standard deviation of the analyzed data from [No. 2] to [No. 11] is displayed.
If the [Mean Value] is 0, [----] is displayed.

[CV (%)] Displays the coefficient of variation for the analysis result. After the 11th analysis is
complete, if the coefficient of variation is greater than the [Limit (%)], then it is
displayed in white font on red background.

[Limit (%)] Displays the standard value (acceptable value) for the coefficient of variation of
PLT-F.

[Calibration] When clicked, the [Calibrator Calibration(PLT-F)] data confirmation dialog box is
displayed.

7 Mix the Calibrator.

Mix the Calibrator properly by following the instructions included in the package insert of the Calibrator.

8 Place the vial in the sample tube holder.

9 Press the start switch on the analyzer.

Once the manual analysis starts, the analysis is performed
11 times consecutively, with the tube holder pulled into the
analyzer.
Once the analysis finishes, the tube holder slides out.
Wait until all analyses are complete.

Start switch

Information
If an error occurs during an analysis, and the analysis can no longer continue, stop the calibrator
calibration (PLT-F). Once the error is cleared, redo the manual analysis.

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10 Redo the manual analysis.

The results from the analysis in step 9 are displayed in the [Calibrator Calibration(PLT-F)] analysis dialog box.
When the analysis results do not satisfy the conditions below, the test numbers of tests that must be repeated
are displayed in the [Calibrator Calibration(PLT-F)] analysis dialog box. Select and redo the manual analysis.

• All analysis results are normal.

• All calibration parameters are below the [Limit (%)] value.

When the analysis results satisfy the conditions, [Calibration] can be clicked in the [Calibrator Calibration(PLT-F)]
analysis dialog box. Proceed to the next step.

11 Click [Calibration] in the [Calibrator Calibration(PLT-F)] analysis dialog box.

The dialog box on the right appears.

Data display area

[Calibrator Calibration(PLT-F)]
data confirmation dialog box

[Analysis Result] When clicked, the [Calibrator Calibration(PLT-F)] analysis dialog box is displayed.
[Read targets] Use this to read the PLT-F target value from the server.
[Lot No.] Enter and search the lot number of the calibrator (XN CAL PF).
[Read] When clicked, the target value is read.
Data display area
[Target] Enter the target value for PLT-F.
The input methods are as follows.
• Referring to the target sheet supplied with the XN CAL PF, enter the values
manually.
• Read the target values from the medium supplied with the calibrator.
[Range Value] Displays the difference between the maximum and the minimum values of PLT-F.
If this is greater than the maximum range, it is displayed in white font on red
background.
[Max Range] When the target value is entered, a value that is equal to "Target value × Fixed
ratio for PLT-F" is displayed.
[Mean Value] Displays the average value of the analysis data.

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[Delta Percent (%)] When the target value is entered, a value that is equal to "|Target value - Mean
Value|/Mean Value x 100 (%)" is displayed.
If this value is greater than the Acceptable Limit and less than the Service Limit,
the background is displayed in yellow. If this is greater than the Service Limit, it is
displayed in white font on red background.
[Acceptable Limit Displays a numeric value for determining whether calibration is necessary. If the
(%)] Delta Percent is less than this value, no calibration is necessary.
[Service Limit (%)] Displays the maximum Delta Percent when performing calibrator calibration
(PLT-F). If the Delta Percent is greater than this value, calibration cannot be
performed for that parameter.
[Current Rate (%)] Displays the compensation rate for PLT-F before the calibrator calibration (PLT-F).
[New rate] Displays the new compensation rate, which is calculated from "Target value x
Current Rate/Mean Value". This value is displayed once [Target] and [Mean Value]
are displayed.

12 Click [OK].
The dialog box on the right appears.

Calibrator parameter
checkboxes

Modify
checkboxes

[Calibrator Calibration(PLT-F)]
execution dialog box

Calibrator parameter Select the checkbox to include the calibration parameter in the calibrator
checkboxes calibration (PLT-F). Clear the checkbox to exclude it from calibrator calibration
(PLT-F).
If the conditions below are met, the checkbox for PLT-F is automatically selected
when the screen appears. In addition, you can select or clear the checkboxes
manually.
1) 80 % ≤ New Rate ≤ 120 %
2) New Rate - Current Rate ≤ ±5 %
3) Range Value ≤ Max Range
4) Acceptable Limit ≤ Delta Percent ≤ Service Limit
If all of the conditions from 1) to 3) are met, and the Delta Percent is less than the
Acceptable Limit, it is excluded from calibration, as there is no need for calibration.
If not all of the conditions from 1) to 3) are met or the Delta Percent is greater than
the Acceptable Limit, calibration cannot be performed.

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[Current Rate (%)] Displays the compensation rate for PLT-F before the calibrator calibration (PLT-F).
[New rate] Displays the new compensation rate calculated by the system.
Modify checkboxes Selecting the checkbox enables you to manually enter a value in [New rate].
You can enter a value within the range of 80 to 120 %.
However, the checkbox cannot be selected if "Delta Percent > Acceptable Limit".
In addition, manually entered values will be displayed with an asterisk (∗) in the
Calibrator Calibration History.
When the checkbox is cleared, you will not be able to manually enter a value in
[New rate]. Any values that were manually entered prior to clearing the checkbox
will revert to the system-calculated values.

13 Click [OK].
The compensation rates are updated, and this calibration process is logged in the calibrator calibration history.
For details on calibration history, see below.
(➤P.316 "14.3 Manage Calibration History")

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14.3 Manage Calibration History

Up to 20 records can be saved in the calibrator calibration history. When using the XR-2000, up to 20 records can be
saved for each analyzer. Any record after the 20th record overwrites the existing records, starting from the oldest. A
calibration history can be displayed, output, saved, restored, and deleted.

14.3.1 Calibration screen

Clicking the [Calibration] icon in the Menu screen displays the following screen.

Data display area Toolbar Calibration parameters Font size button

Common
Items

Tab Display switching button

[Calibration] screen

Toolbar
The buttons of the following functions are displayed.

[Output] When clicked, the selected calibration history data is output.

[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[File] Click to display a submenu that allows you to save and restore data.
[Delete] When clicked, a dialog box appears that allows you to delete the selected
calibration history.

Common Items
[Nickname] Displays the name of the analyzer for which calibration was performed.
[Calibration Date] Displays the date and time when the calibration was performed.
[Logon Name] Displays the name of the user who was logged on to the IPU, at the time of
calibration.
Tab Click to switch the display per analyzer, or to display all data together. This can be
displayed only when using the XR-2000.

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Data display area

The content displayed depends on the type of calibration history. Clicking on a displayed history data switches it.

[Material] Displays the name of the calibrator. (XN CAL, XN CAL PF)
[Lot No.] Displays the lot number of the calibrator.
Calibration parameters The analysis parameters to be calibrated are displayed. Different parameters
names are displayed depending on the type of analyzer that is connected.

● Calibrator calibration history

When you click the display switching button, the following screen is displayed. This is the same as parameters
displayed in the calibrator calibration (PLT-F) history.
Calibration parameter units
Calibration parameters

Calibration parameters* The analysis parameters to be calibrated are displayed.

Calibration parameter Displays the units of the calibration parameters.
units*
[Target] Displays target values for the calibrator.
[No.2] - [No.11] For each calibration parameter, the analysis results are displayed for the
11 repeated analysis cycles.
[Range Value] Displays the difference between the maximum and the minimum values of the
analysis data. If this is greater than the maximum range, it is displayed on red
background.
[Max Range] Displays a value calculated from the [Target] that was entered.
[Mean Value] Displays the average value of the analysis data.
[Delta Percent (%)] A value that is equal to "|Target value - Mean Value|/Mean Value x 100 (%)" is displayed.
If this value is greater than the Acceptable Limit and less than the Service Limit, the
background is displayed in yellow. If this is greater than the maximum allowed error
rate, it is displayed on red background.
[Acceptable Limit (%)] Displays a numeric value for determining whether calibration is necessary.
[Service Limit (%)] Displays the maximum Delta Percent that allows calibration.
[Current Rate (%)] Displays the compensation rate for each analysis parameter before calibration.
[New Rate (%)] Displays the compensation rate for each analysis parameter after calibration.
Analysis parameters with an asterisk (∗) next to its value are parameters that were
manually entered in calibrator calibration.

* The display will vary depending on the type of analyzer that is connected.

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Display switching button

Click the display switching button to open and close the sub-screens. A sub-screen is a screen that is displayed
to the right of the list of analysis data, that can be opened and closed.

Font size button

To change the size of the characters and the line height in the list, click the font size button. To change the size
setting of the characters, see the following:
(➤P.367 "Chapter 15: 15.3.3 Display settings")

Note:
Multiple data can be selected as follows:
• Drag multiple consecutive rows while holding down the left button on the mouse
• While pressing Ctrl, click on the row that you want to select

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14.3.2 Outputting calibration history

You can save and output the data of the selected calibration history as a CSV file, or print to a connected printer
as a list (ledger printing).
Follow the steps below to output calibration history.

1 Click the [Calibration] icon in the Menu screen.

The [Calibration] screen appears.

2 Select the calibration history to output.

3 Select the format and output.

● Outputting in CSV format

On the toolbar, click the [File] button - [Output in CSV Format], then name and save the file.
The file extension is ".csv".

● Printing to a Ledger
On the toolbar, click the [Output] button, and then [Ledger (LP)].

14.3.3 Saving a calibration history (backup)

You can save the calibration history as a file.
Follow the steps below to save the calibration history.

1 Click the [Calibration] icon in the Menu screen.

The [Calibration] screen appears.

2 Select the history you want to save.

3 On the toolbar, click the [File] button, then click [Backup].

A folder selection dialog box appears, for specifying the folder to which you want to save the file.

4 Select the folder to which you want to save the file.

The file extension is ".cad".
You cannot change the file name.

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14.3.4 Restoring a saved calibration history (Restore)

You can restore saved calibration history.
Follow the steps below to restore a saved calibration history.

1 Click the [Calibration] icon in the Menu screen.

The [Calibration] screen appears.

2 On the toolbar, click the [File] button, then click [Restore].

A dialog box for selecting the file to restore is displayed.

3 Select to open the file you want to restore.

The file extension is ".cad".

Information
In the following cases, the saved history cannot be restored.
• If the history is for a parameter that cannot be analyzed with the analyzer that is connected.
• If a history exists with the same date and time as the history being restored.

14.3.5 Deleting a calibration history

You can delete a calibration history.
Follow the steps below to delete calibration history.

1 Click the [Calibration] icon in the Menu screen.

The [Calibration] screen appears.

2 Select the calibration history to delete.

3 Click the [Delete] button on the toolbar.

The dialog box on the right appears.

4 Click [Yes].
The selected history is deleted.

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14.4 Perform a precision check

The precision check is performed by manual analysis. The discrete tests to be analyzed are specified automatically
by the system, and cannot be changed. In addition, different discrete tests are specified depending on the type of
analyzer that is connected. For details, see the following:

Discrete test

Analyzer Discrete test

XR-20[A1] CBC+DIFF+RET+PLT-F+WPC

XR-20[A2] CBC+DIFF+RET+WPC

XR-10[B1] CBC+DIFF+RET+PLT-F

XR-10[B2] CBC+DIFF+PLT-F

XR-10[B3] CBC+DIFF+RET

XR-10[B4] CBC+DIFF

Follow the steps below to perform precision check.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green or orange, wait until it
is.

Status
indicator
LED

2 If the tube holder has not ejected out, press the mode switch.
The tube holder slides out forward.

Mode switch

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3 Click the Change Analysis Mode button on the control menu.

The dialog box on the right appears.
In precision check, select [Whole Blood] mode.

4 Click [OK].
The dialog box closes.

5 Click the Analyzer menu button on the control menu.

The menu on the right appears.

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6 Click [Calibration] - [Precision Check].

The dialog box on the right appears.

Shortcut buttons

Calibration parameters

Data display area

Back button
Next button

[Precision Check] analysis

dialog box

Shortcut buttons Click to display calibration item screens that are not currently displayed. If the data
in a screen includes a warning, a warning mark appears.
Data display area
Calibration parameters The analysis parameters to be calibrated are displayed. Different parameters are
displayed depending on the type of analyzer that is connected.
[No.1] - [No.11] For each calibration parameter, the analysis results are displayed for the
11 repeated analysis cycles.
A strike-through is displayed for the results for [No. 1] since it is not reflected in
[Mean Value], [SD], and [CV (%)].
[Mean Value] For each calibration parameter, the mean value of the analyzed values from [No.
2] to [No. 11] is displayed.
[SD] For each calibration parameter, the standard deviation of the analyzed values from
[No.2] to [No.11] is displayed.
If the [Mean Value] is 0, [----] is displayed.
[CV (%)] Displays the coefficient of variation for the analysis result for each calibration
parameter.
After the 11th analysis is complete, if the coefficient of variation is greater than the
[Limit (%)], then it is displayed in white font on red background.
[Limit (%)] Displays the standard value (acceptable value) for the coefficient of variation of
each calibration parameter.
Back button Click to display the previous screen.
Next button Click to display the next screen.

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7 Mix the vial containing the sample as shown.

8 Place the vial in the sample tube holder.

9 Press the start switch on the analyzer.

Once the manual analysis starts, the analysis is performed
11 times consecutively, with the tube holder pulled into the
analyzer.
Once the analysis finishes, the tube holder slides out.
Wait until all analyses are complete.

Start switch

Information
If an error occurs during an analysis, and the analysis can no longer continue, stop precision
check. Once the error is cleared, redo the manual analysis.

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10 Redo the manual analysis.

The results from the analysis in step 9 are displayed in the [Precision Check] analysis dialog box.
When the analysis results do not satisfy the conditions below, the test numbers of tests that must be repeated
are displayed in the [Precision Check] analysis dialog box. Select and redo the manual analysis.

• All analysis results are normal.

• All calibration parameters are below the [Limit (%)] value.

When the analysis results satisfy the conditions, [OK] can be clicked in the [Precision Check] analysis dialog
box. Proceed to the next step.

11 Click [OK] on the [Precision Check] analysis dialog box.

The dialog box on the right appears.

12 Click [Yes].
The results are added to the precision check history.
For details on precision check history, see below.
(➤P.326 "14.5.1 Precision Check screen")

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14.5 Manage the Precision Check History

Up to 20 records can be saved in the precision check history. For XR-2000, up to 20 records can be saved for each
analyzer. Any record after the 20th record overwrites the existing records, starting from the oldest.
Each history can be output, saved, restored, and deleted.

14.5.1 Precision Check screen

Clicking the [Precision Check] icon in the Menu screen displays the following screen.

Data display area Toolbar Calibration parameters Font size button

Common
Items

Tab Display switching button

[Precision Check] screen

Toolbar
The buttons of the following functions are displayed.

[Output] When clicked, the selected precision check history data is output.
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[File] Click to display a submenu that allows you to save and restore data.
[Delete] When clicked, a dialog box appears that allows you to delete the selected precision
check history.

Common items
[Nickname] Displays the name of the analyzer for which precision check was performed.
[Execution Date] Displays the date and time that the result of the precision check was recorded.
[Logon Name] Displays the name of the user who was logged on to IPU, at the time of precision
check.

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Data display area

When you click the display switching button, the following screen is displayed.
Calibration parameter units
Calibration parameters

Calibration The analysis parameters to be calibrated are displayed.

parameters*
Calibration parameter Displays the units of the calibration parameters.
units*
[No.2] - [No.11] For each calibration parameter, the analysis results are displayed for the 11 repeated
analysis cycles.
[Mean Value] Displays the average analyzed value for each calibration parameter.
[SD] Displays the standard deviation of the analyzed values for each calibration
parameter.
[CV (%)] Displays the coefficient of variation for each calibration result.
[Limit (%)] Displays the standard repeatability value for each calibration parameter.

* The display will vary depending on the type of analyzer that is connected.

Note:
The [Precision Check] screen has similar functions as the [Calibration] screen. For the operation
of the following, see the procedures for the [Calibration].
(➤P.316 "14.3.1 Calibration screen")
• Tabs (When using the XR-2000)
• Display switching button
• Font size button
• Selecting multiple precision check history data

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14.5.2 Outputting precision check history

You can save the selected precision check history as a CSV file, or print to a connected printer as a list (ledger
printing).
Follow the steps below to output the precision check history.

1 Click the [Precision Check] icon in the Menu screen.

The [Precision Check] screen appears.

2 Select the precision check history to output.

3 Select the format and output.

● Outputting in CSV format

On the toolbar, click the [File] button - [Output in CSV Format], then name and save the file.
The file extension is ".csv".

● Printing to a Ledger
On the toolbar, click the [Output] button, and then [Ledger (LP)].

14.5.3 Saving a precision check history (backup)

You can save a precision check history as a file.
Follow the steps below to save a precision check history.

1 Click the [Precision Check] icon in the Menu screen.

The [Precision Check] screen appears.

2 Select the history you want to save.

3 On the toolbar, click the [File] button, then click [Backup].

A folder selection dialog box appears, for specifying the folder to which you want to save the file.

4 Select the folder to which you want to save the file.

The file extension is ".pre".
You cannot change the file name.

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14.5.4 Restoring a saved precision check history (Restore)

You can restore saved history.
Follow the steps below to restore a saved precision check history.

1 Click the [Precision Check] icon in the Menu screen.

The [Precision Check] screen appears.

2 On the toolbar, click the [File] button, then click [Restore].

A dialog box for selecting the file to restore is displayed.

3 Select to open the file you want to restore.

The file extension is ".pre".

Information
In the following cases, the saved history cannot be restored.
• If the history is for a parameter that cannot be analyzed with the analyzer that is connected.
• If a history exists with the same date and time as the history being restored.

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14.5.5 Deleting a precision check history

You can delete a precision check history.
Follow the steps below to delete a precision check history.

1 Click the [Precision Check] icon in the Menu screen.

The [Precision Check] screen appears.

2 Select the precision check history to delete.

3 Click the [Delete] button on the toolbar.

The dialog box on the right appears.

4 Click [Yes].
The selected history is deleted.

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Chapter 15 Instrument Setup

This chapter explains how to configure analyzer and IPU settings.

15.1 Open the settings

The instrument settings consist of [Analyzer Settings] for the specific analyzer type, and [IPU Setting] for configuring
IPU application settings. The settings are configured from the [Analyzer Settings] and [IPU Setting] dialog boxes.
For the details on the settings and their default values, see Appendix. (➤P.584 "Appendix: Default settings")

Open the analyzer settings

Click the [Analyzer Setting] icon to display the following dialog box.

Setting menu tree Setting screen area

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Open the IPU settings

Click the [IPU Setting] icon to display the [IPU Setting] dialog box.
The configuration of the [IPU Setting] dialog box is similar to the [Analyzer Settings] dialog box.

Setting menu tree

This shows the settings. Click an item to open a setting screen for that item on the right.

Setting screen area

The setting screen for the item selected in the setting menu tree appears.

[OK] Save changed settings and close the dialog box.

[Cancel] Close the dialog box without saving changed settings.
[Apply] Save and immediately apply changed settings. The dialog box does not close.

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15.2 Analyzer settings

The analyzer settings are used to configure analyzer settings, sampler system settings, and flag settings.
The items shown below, which appear in the setting menu tree of the [Analyzer Settings] dialog box, can be
configured*.
* The displayed parameters vary depending on the instrument configuration.

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Note:
• When using the XR-2000, right and left is indicated next to [Analyzer].
e.g. [Analyzer (right)] and [Analyzer (left)]
• When using the XR-1000, left and right are not indicated next to [Analyzer].
• When using the XR-1000, [CELLCLEAN AUTO Settings] does not appear.

15.2.1 Manage settings

Settings can be managed.

[Backup]*1 The settings can be saved to a file.

(➤P.335 "Save settings")
[Restore]*2 Settings saved in a file can be restored (they will replace the current settings).
(➤P.336 "Restore settings")
[Set Default]*2 The settings can be returned to the default settings.
(➤P.336 "Initialize settings")
[Print Settings]*1 The settings in all analyzers and samplers connected to the IPU can be printed.
(➤P.337 "Print settings")
[Export]*1 Analyzer settings can be saved as a master file.
(➤P.337 "Save master settings")
[Import]*2 Analyzer settings can be imported from a master file.
(➤P.338 "Import master settings")

*1 Only displayed when setting changes have been applied. After changing a setting, click [Apply] to apply the
setting.
*2 Only the [Built-in User] registered at the factory can be executed.

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Click [Manage Settings] in the [Analyzer Settings] tree to display the items below.

Save settings
The settings in all analyzers and samplers connected to the IPU can be saved to a file.
Follow the steps below to save the settings.

1 Click [Backup].
The [Save As] dialog box appears.

2 Specify or create the folder to save the analyzer/sampler settings into.

3 Enter the file name.

The extension of a file is ".ini".

Note:
The default file name will be
[XR][Software Version][AnalyzerSetting][Date of save_Time of save].ini.

4 Click [Save].
The settings are saved.

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Restore settings
Settings can be imported from a saved file. These will replace the current settings.
Follow the steps below to restore settings.

1 Click [Restore].
The dialog box on the right appears.

2 Click [Yes].
The [Open File] dialog box appears.

3 Select the file that you wish to restore.

The extension of a file is ".ini".

4 Click [Open].
The settings are restored.

Initialize settings
The settings in all analyzers and samplers connected to the IPU can be returned to the default settings.
Follow the steps below to initialize the settings.

1 Click [Set Default].

The dialog box on the right appears.

2 Click [Yes].
The settings are initialized.

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Print settings
Click [Print Settings]. The settings will be printed.
The print format is ledger format. The settings are printed in 2 columns, with the first column showing the setting
name and the second column showing the setting.

Save master settings

Analyzer settings can be exported as a master file. Note that identification settings will not be exported.
Follow the steps below to save the master settings.

1 Click [Export].
The [Save As] dialog box appears.

Note:
When using the XR-2000, if the left and right
analyzers have different settings for [Aspiration
Sensor] and [Leak Sensor], the dialog box on
the right appears.
If the [Aspiration Sensor] is to be used in the
master settings, select the checkbox. To
continue using [Leak Sensor] when a water leak
is detected, select the checkbox. Click [OK] to
close the dialog box. The [Save As] dialog box
appears.

2 Specify the folder to save to, or create a new folder.

3 Enter the file name.

The extension of a file is ".smf".

Note:
The default file name is in the format
[XR][Software Version][AnalyzerSettingMaster][Date of save_Time of save].smf.

4 Click [Save].
The master settings are saved.

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Import master settings

When master settings are imported, the same settings are applied to all analyzers connected to the IPU.
Follow the steps below to import master settings.

1 Click [Import].
The dialog box on the right appears.

2 Click [Yes].
The [Open File] dialog box appears.

3 Select the file that you wish to open.

The extension of a file is ".smf".

4 Click [Open].
The settings are replaced.

Information
After importing the master settings, check [Sampler Discrete Settings] and [Manual Discrete
Settings], and set manually if needed.
If the analyzer into which the settings will be imported is a different type than the master instrument
analyzer, [Sampler Discrete Settings] and [Manual Discrete Settings] may not be replaced by the
master settings.

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15.2.2 Alarm sound setting

Set the alarm sound that notifies the operator when an error has occurred. The alarm sound can be set
separately for each analyzer.
Click [Alarm Sound] in the [Analyzer Settings] tree.

Play button Stop button

[Alarm Type] Set the alarm type. Select from 3 types.

[Warning] Set the alarm sound that notifies the operator when a warning error has occurred.
[No Alarm], [Once], or [Loop] can be selected.
[Stops Analysis] Set the alarm sound that notifies the operator when an analysis stop error has
occurred. [No Alarm], [Once], or [Loop] can be selected.
Play button Click to sound the selected alarm sound.
Stop button Click to stop the alarm sound.

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15.2.3 Smart Indicator settings

Set the color of the LED of the external indicator light (SI-14) when an error has occurred. Colors can be set
separately for each error.
Click [Smart Indicator] in the [Analyzer Settings] tree.

Error group

[LED] Displays the currently set LED color.

[Error] Displays the list of errors that LED colors can be set for.
[LED Select the LED color for the error selected on the list from [Green]/[Orange]/[Red]. When an
settings] error group is selected, LED color can be set for all errors in the selected group.

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15.2.4 Raised Bottom Tube samples setting

When analyzing samples using Raised Bottom Tubes, specify whether or not to perform [Repeat] analysis /
[Rerun] analysis / [Reflex] analysis.
Click [Raised Bottom Tube sample setting] in the [Analyzer Settings] tree*.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

[Repeat/Rerun/Reflex Raised You can specify whether or not to perform [Repeat] analysis / [Rerun]
Bottom Tube sample] analysis / [Reflex] analysis for samples analyzed using Raised Bottom
Tubes.
If you clear the checkbox, samples analyzed using Raised Bottom Tubes
are not retested, regardless of the setting for the rule. Also, no query is
sent to the host computer regarding the need to perform [Rerun] analysis
and [Reflex] analysis.

15.2.5 Reagent unit (RU-20) name setting

Set a name for the reagent unit (RU-20). The chosen name will appear in the RU area of the control menu and
in the RU history screen.
Click [RU Name Settings] in the [Analyzer Settings] tree.

[RU Name] Enter a name for the reagent unit.

You can enter up to 8 characters.

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15.2.6 Sampler settings

Sampler settings can be configured.

[Blood Sensor] Specify whether or not the [Blood Sensor] is used. When used, the sensor detects
whether or not there is blood in the sample tube.
(➤P.342 "Blood Sensor setting")
[Sampler Analysis Specify whether or not analysis is started automatically.
Start Settings]*1 (➤P.343 "Analysis Start Setting")
[Sampler Analysis Set the conditions for stopping analysis.
Stop] (➤P.343 "Analysis Stop setting")
[Repeat Setting]*1 Specify whether [Repeat] analysis is performed.
(➤P.344 "Repeat setting")
[Rerun/Reflex Specify whether or not [Rerun] analysis / [Reflex] analysis is performed.
Setting]*1 (➤P.344 "Rerun/Reflex setting")
[Sampler Discrete Set the discrete used for sampler analysis. This is the startup default setting.
Settings] (➤P.344 "Discrete settings during sampler analysis")
[CELLCLEAN AUTO Select the method used for returning CELLCLEAN AUTO from the analyzer when
Settings]*2 placing CELLCLEAN AUTO in a rack and only shutting down one of the two
analyzers.
(➤P.344 "CELLCLEAN AUTO Settings")

*1 When using the sampler (SA-01) in the XR-1000, this does not appear.
*2 When using the XR-1000, this does not appear.

Blood Sensor setting

Click [Sampler] - [Blood Sensor] in the [Analyzer Settings] tree.

[Use] Select the checkbox to have blood volume monitored

during sampler analysis.

Caution!
Not using the [Blood Sensor] may affect analysis results. For [Whole Blood] mode analysis,
select [Use].

Information
When a Raised Bottom Tube (RBT) is used, set the [Blood Sensor] to [Use]. In the event that the
rack barcode on the RBT rack cannot be read, the RBT rack is automatically detected.

Note:
If you know in advance that a blood sample will have a very low hemoglobin (such as that of a
dialysis patient), deactivate the [Blood Sensor].

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Analysis Start Setting

Click [Sampler] - [Sampler Analysis Start Settings] in the [Analyzer Settings] tree*.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

[Sampler analysis starts Select this checkbox to have sampler analysis automatically start when a rack is
when rack is placed in placed on the rack feed-in table.
sampler]

Analysis Stop setting

Click [Sampler] - [Sampler Analysis Stop] in the [Analyzer Settings] tree.
Select the checkboxes of events that will stop sampler analysis.

[ID Read Error] Unable to read the barcode label on the sample tube.
[Rack number read Unable to read the barcode label on the rack.
error]*
[Blank Data] When the count is abnormally low.
[Critical Value When the value is outside the set range.
Data] (➤P.350 "15.2.10 Critical Value Settings")
[Aspiration Error] When aspiration does not take place or the amount is
not sufficient.
This can be set when the [Aspiration Sensor] is used.
(➤P.351 "Blood aspiration sensor settings")
[Inadequate When there is no blood.
Sample] This can be set when the [Blood Sensor] is used.
(➤P.342 "Blood Sensor setting")
[QC Alarm] When the QC alarm sounds.
This can be set when the QC alarm is used.
(➤P.381 "QC alarm settings")
[X-barM Limit When an X-barM control error occurs in QC.
Error]
[L-J Limit Error] When an L-J control or X-bar control error occurs in
QC.
[Control Expired When the registered quality control material has
Error] expired.
[Unregistered When an unregistered quality control material is
Control] used.
[Reagent Expired When an expired reagent is used.
Error]
[Invalid analysis An order that cannot be analyzed was specified.
order]
[Command not to When not-aspirated is specified in the host computer
aspirate] or [Work List] screen.

* When using the sampler (SA-01) in the XR-1000, this does not appear.

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Repeat setting
Click [Sampler] - [Repeat Setting] in the [Analyzer Settings] tree*.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

[Repeat] Select this checkbox to perform [Repeat] analysis.

When this function is off, [Repeat] analysis will not be
performed even if a rule is set.

Rerun/Reflex setting
Click [Sampler] - [Rerun/Reflex Setting] in the [Analyzer Settings] tree*.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

[Rerun/Reflex] Select this checkbox to perform [Rerun]/[Reflex] analysis.

When this function is off, [Rerun]/[Reflex] analysis will not be
performed even if a rule is set.

Discrete settings during sampler analysis

Click [Sampler] - [Sampler Discrete Settings] in the [Analyzer Settings] tree.

[Discrete when last Select to use the discrete* set at the end of the
ended] previous sampler analysis.
[Specified discrete] Select to specify a discrete.
* Discretes set in [Reflex] analysis are not included.

CELLCLEAN AUTO Settings

Click [Sampler] - [CELLCLEAN AUTO Settings] in the [Analyzer Settings] tree*.
* When using the XR-1000, this does not appear.

[Return to rack] Select to have CELLCLEAN AUTO returned to the rack

after aspiration.
[Return to tube Select to have CELLCLEAN AUTO returned to the tube
holder] holder after aspiration.

Information
When Analyzer (left) and Analyzer (right) are shut down, CELLCLEAN AUTO is always returned
to the rack, regardless of this setting .

Note:
If [Return to tube holder] is selected, CELLCLEAN AUTO is returned to the tube holder after
aspiration, not to the rack. You can start sampler analysis immediately without the need to wait
for the analyzer to complete the shutdown cycle.

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15.2.7 Barcode reader setting

Specify whether or not a barcode reader is used. Advanced settings for barcode reading can be configured.
This barcode read setting is a shared setting for the overall analyzer. The setting is applied to the barcode
readers of both the analyzer and the sampler.
Click [Barcode Reader] in the [Analyzer Settings] tree.

[Barcode Reader Connection] Select the checkbox to turn on the barcode reader function.
When not selected, the items below are all grayed out and cannot be set.
[Read Tube ID] Select this checkbox if sample tube barcode labels will be read.
When selected, reading settings can be configured.
[Specify Sample No. Set whether or not the number of digits read is specified. If specified, enter
Length] the number of digits (1 to 22 digits).
If a number of digits other than the specified number is read, a reading error
will occur. However, quality control ([QC-]) and rinse ([RN-]) sample
numbers reserved in the system are not subject to the digit number check.
[Check Digits Conditions] Select the read code checkbox to set a code. A check digit can also be set.
[ITF] [Modulus-10]/[Through]
[CODABAR/NW7] [Modulus-11]/[W-Modulus-11]/[Modulus-16]/[Through]
[CODE39] [Modulus-43]/[Through]
[JAN/EAN/UPC] Select the checkbox to automatically set the check digit to be [Modulus-10].
[ISBT128] Select the checkbox to automatically set the check digit to be [Modulus-103].
[CODE128] Select the checkbox to automatically set the check digit to be [Modulus-103].

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[Rack number]* Select this checkbox if the rack barcode label will be read.
When selected, reading settings can be configured.
[Check Digits Select the read code checkbox to set a code. A check digit can also be set.
Conditions]
[CODABAR/NW7] Select the checkbox to automatically set the check digit to be [Modulus-16].
The start/stop characters are [/D(d)-D(d)]. Use either "D" or "d" for the
start/stop code.
[CODE39] Select the checkbox to automatically set the check digit to be [Modulus-43].
[Setting for Order Key This can be set when the sample tube label or rack label read function is on.
Read Error] Specify whether or not a sample for which an ordering key read error occurs
is analyzed.
* When using the sampler (SA-01) in the XR-1000, this does not appear.

Warning!
When using the hand-held barcode reader, use the barcode check digit function. There is a
higher potential for read errors when a check digit is not used.

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15.2.8 System settings

A system name and analyzer names can be set. The name and ID of the sampler and the analyzer can be
checked.

Analyzer name settings

Click [System] - [Identification] in the [Analyzer Settings] tree.

[Instrument Name] An instrument name can be entered. The instrument name set here will appear as
an error location in the error log screen.
You can enter up to 11 characters.
[Sampler Name]* The name of the sampler appears. Detailed information is displayed to the right.
By the default setting, "S" (sampler) appears. The information can be changed. You
can enter up to 2 characters.
[Sampler ID]* The sampler ID number appears.
The sampler ID appears in the format "Product Name^Serial Number".
This cannot be changed.
[Analyzer (left)] / The analyzer name and analyzer ID appear.
[Analyzer (right)] When using the XR-1000, only [Analyzer] appears.
[Nickname] The name of the analyzer appears. This is a number that is automatically assigned
to devices connected to [Instrument Name] and the IPU. This cannot be changed.
Detailed information on the right. The default values are as follows:
[-A]: Analyzer of the XR-1000
[-L]: Analyzer on the left side of the XR-2000
[-R]: Analyzer on the right side of the XR-2000
The above information can be changed:
You can enter up to 2 characters.
[Analyzer ID] The [Analyzer ID] of the analyzer appears.
The Analyzer ID appears in the format "Instrument Product Name^Serial Number".
This cannot be changed.

* When using the sampler (SA-01) in the XR-1000, this does not appear.

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15.2.9 Flag settings

Flag settings can be configured. When the data meets specified conditions due to a specific abnormal blood
conditions, an abnormal IP message will appear.
* This function is not available for hsA analysis results.
Settings can be configured for [WBC], [RBC], [PLT], and [WBC (Body Fluid Analysis)]*1.
For the details on flags and the values*2 that can be entered, see Chapter 13.
(➤P.288 "Chapter 13: 13.6.1 Targets of IP message judgment")
*1 The availability of this function depends on your system configuration.
*2 The decimal point symbol set in Windows is displayed in this instrument.
The only decimal point symbols displayed are "." (period) or "," (comma).

WBC flag settings

Set values that determine the display of WBC abnormal IP messages.
Click [Flag] - [WBC] in the [Analyzer
Settings] tree.
Select the checkbox of a flag to have the
flag judgment performed. The judgment
values of the flag judgment items can
also be set.

RBC flag settings

Set values that determine the display of RBC abnormal IP messages.
Click [Flag] - [RBC] in the [Analyzer
Settings] tree.
Select the checkbox of a flag* to have the
judgment performed.
* [Reticulocytosis] does not appear with
all analyzer types.

PLT flag settings

Set values that determine the display of PLT abnormal IP messages.
Click [Flag] - [PLT] in the [Analyzer
Settings] tree.
Select the checkbox of a flag to have the
flag judgment performed. The judgment
values of the flag judgment items can
also be set.

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WBC flag settings (body fluid)

Set values that determine the display of WBC abnormal IP messages (body fluid).
Click [Flag] - [WBC (Body Fluid Analysis)]
in the [Analyzer Settings] tree.
Select the checkbox of a flag to have the
flag judgment performed. The judgment
values of the flag judgment items can
also be set.

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15.2.10 Critical Value Settings

Upper and lower limit values can be set for each item. The set upper and lower limit values are called "critical
values".
Analysis data that are outside the intervals set here are displayed with an exclamation mark "!". Sampler
analysis can be set to stop when there is data with "!".
Click [Critical Value Setting] in the [Analyzer Settings] tree.
* This function is not available for hsA analysis results.

Limit setting list

Limit setting list Click to select an item.

[Critical Value The settings for the item selected in the limit setting list appear.
Setting]
[Item] The item selected in the limit setting list appears. This cannot be entered.
[Lower Limit]*, An upper limit and a lower limit can be entered. If [Critical Value Setting] in the analyzer
[Upper Limit]* stop conditions is used, analysis will stop if a value is outside the set upper and lower
limit range.

* The decimal point symbol set in Windows is displayed in this instrument.

The only decimal point symbols displayed are "." (period) or "," (comma).

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15.2.11 Sample number auto increment setting

Click [Sample No. Auto Increment] in the [Analyzer Settings] tree.

[Automatically increment Sample Select this checkbox to have the sample number automatically
No. (manual mode)] assigned as a sequential number when manual analysis is
performed.

15.2.12 Analyzer settings

Analyzer settings can be configured.

Blood aspiration sensor settings

Specify whether or not the [Aspiration Sensor] is used. When used, the sensor detects if the required sample
was aspirated.
* During [Pre-Dilution] / [Body Fluid] / [HPC] / [hsA] mode analysis, the blood aspiration sensor is always off,
regardless of the setting.

Click [Analyzer] - [Aspiration Sensor] in the [Analyzer Settings] tree.

[Use] Select the checkbox to use the [Aspiration

Sensor].

Caution!
Not using the [Aspiration Sensor] may affect test results. For [Whole Blood] mode analysis,
select [Use].

Note:
If you know in advance that a blood sample will be very thin (such as that of a dialysis patient),
deactivate the [Aspiration Sensor].

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Water leak sensor settings

Specify whether use of the analyzer is continued when a water leak is detected.

Click [Analyzer] - [Leak Sensor] in the [Analyzer Settings] tree.

[Continue using analyzer When the checkbox is selected, use of the analyzer can be continued when a
when leak is detected] water leak is detected.

Caution!
Unless otherwise directed by your authorized local Sysmex representative, keep the setting set
to OFF. If use is continued with the setting set to ON, the instrument and other devices may be
damaged if leakage occurs.

Discrete settings during manual analysis

Set the discrete used for manual analysis. This is the startup default setting.

Click [Analyzer] - [Manual Discrete Settings] in the [Analyzer Settings] tree.

[Discrete when last ended] Select to use the discrete set at the end of the previous manual analysis.
[Specified discrete] Select to specify a discrete.

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15.3 IPU settings

The system settings of the IPU, external device connection settings, and automatic processing settings can be
configured in the IPU settings.
The items shown below, which appear in the setting menu tree of the [IPU Setting] dialog box, can be configured.
(➤P.332 "Open the IPU settings")

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15.3.1 Manage settings

Settings can be managed.

[Backup]*1 The current settings in the IPU can be saved to a file.

(➤P.354 "Save settings")
[Restore]*2 Settings saved in a file can be restored (they will replace the current settings).
(➤P.355 "Restore settings")
[Set Default]*2 The settings in the IPU can be returned to the default settings.
(➤P.356 "Initialize settings")
[Print Settings]*1 The settings in the IPU can be printed.
(➤P.356 "Print settings")
*1 Only displayed when setting changes have been applied. After changing a setting, click [Apply] to apply the
setting.
*2 Only the [Built-in User] registered at the factory can be executed.

Click [Manage Settings] in the [IPU Setting] tree to display the screen below*.
* When a user other than the [Built-in User] registered at the factory is logged on, [Restore] and [Set Default]
are grayed out and cannot be selected.

Save settings
Follow the steps below to save the settings.

1 Click [Backup].
The [Save As] dialog box appears.

2 Specify or create the folder to save the IPU settings into.

3 Enter the file name.

The extension of a file is ".ini".

Note:
The default file name will be [XR][Software Version][IPUSetting][Date of save_Time of save].ini.

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4 Click [Save].
The settings are saved.

Restore settings
Follow the steps below to restore settings to the IPU.

1 Click [Restore].
The [Open File] dialog box appears.

2 Select the file that you wish to open.

The extension of a file is ".ini".

3 Click [Open].
The dialog box on the right appears.

4 Click [Yes].
The settings are replaced.

Information
When settings are restored, the user information settings are also replaced by the restored data.
Note that the [admin] (administrator) password is also replaced by the restored data.

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Initialize settings
Follow the steps below to initialize the settings in the IPU.

1 Click [Set Default].

The dialog box on the right appears.

2 Click [Yes].
The settings are initialized.

Information
When the settings are initialized, the user information settings are also initialized. Note that the
[admin] (administrator) password also returns to the default setting.

Print settings
Click [Print Settings]. The IPU settings will be printed.
The print format is ledger format. The settings are printed in 2 columns, with the first column showing the setting
name and the second column showing the setting.

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15.3.2 System settings

System settings can be configured.

[Facility Information] Set the name of the facility that is using the system. The set facility name is used
when analysis data is printed out. (➤P.357 "Facility information setting")
[System Language] Set the language that is used in the system and the language that is used in
printing. (➤P.358 "Change the display language (basic system language)")
[IPU Shutdown] Specify whether or not the IPU is automatically shut down when all devices
connected to the IPU are shut down.
(➤P.358 "IPU Shutdown setting")
[Date Format] Set the format of the date that is printed and displayed on the IPU.
(➤P.358 "Date format setting")
[User Administration] Register and delete users of the instrument. User permissions can also be set.
(➤P.359 "User information management (user administration)")
[CSV Output] Specify whether image data is output when analysis data is output to CSV. If image
data is output, select the output format ([BMP] or [PNG]) and the background color
([BLACK] or [WHITE]). In addition, specify whether the analysis data is divided into
multiple files when the data exceeds 256 columns. (➤P.365 "CSV output settings")
[Security] Configure patient information and screen locking settings.
(➤P.365 "Security settings")
[Screen Keyboard] Set whether or not the screen keyboard is used.
(➤P.366 "Screen keyboard setting")
[Patient ID Display] Set the display position of the patient ID. (➤P.366 "Patient ID display setting")
[Notification of Set whether or not you are notified of program updates. (➤P.366 "Program Update
Program Updates] Notification Setting")

Facility information setting

Click [System] - [Facility Information] in the [IPU Setting] tree.

[Facility Name] The [Facility Name] can be entered.

You can enter up to 32 characters.

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Change the display language (basic system language)

Click [System] - [System Language] in the [IPU Setting] tree.
Changed settings will be applied the next time startup or logon is performed.

[Language] The language displayed in the system can be set. [English], [German], [Italian],
[Spanish], [Portuguese], [Russian], [French], [Greek], [Chinese], [Traditional
Chinese], [Korean], or [Portuguese-Brazilian] can be selected.
[Print Language] The language used for printing can be set.
Languages that can be selected are the same as in [Language].
[Instructions for Use The language for the on-line manual can be set.
Language]

IPU Shutdown setting

Click [System] - [IPU Shutdown] in the [IPU Setting] tree.

[Automatically Shut Select the checkbox to have the IPU shut down automatically.
Down IPU]

Date format setting

Click [System] - [Date Format] in the [IPU Setting] tree.

[General Date Format] Select one of the following date formats.

[YYYY/MM/DD] Year 4 digits/Month 2 digits/Day 2 digits
[MM/DD/YYYY] Month 2 digits/Day 2 digits/Year 4 digits
[DD/MM/YYYY] Day 2 digits/Month 2 digits/Year 4 digits

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User information management (user administration)

Click [System] - [User Administration] in the [IPU Setting] tree.

Registered
user list

Number of
registered users

[Logon Name] The user name of the user logged onto the IPU appears.
[Auto Logon] Select the user for auto logon.
When [Same as OS Account Name] is selected, logon takes place using the same
name as the OS account name when the IPU is started. If the same name cannot
be found, auto logon does not take place.
Registered user list The registered users are displayed. [Logon Name], [Operator Name] and
[Operator Info.] appear.
[Built-in User], which appears in [Operator Info.], indicates a factory registered
user. A built-in user cannot be deleted or changed.
Number of registered The number of registered users is displayed.
users
[Change Password] Click to display the dialog for changing the password.
(➤P.360 "Change the password")
[Modify Settings] Click to display the dialog for changing user settings*.
(➤P.361 "Change settings and add users")
[Add User] Click to display the dialog for adding a user. When the maximum number of users
(101) have been registered, a user cannot be added.
(➤P.361 "Change settings and add users")
[Delete User] Click to delete a user. [admin] (instrument administrator) cannot be deleted.
(➤P.363 "Delete a user")
[Register IC card] Click to display a dialog box that allows you to register/reset an IC card for logon.
(➤P.363 "Register or change an IC card information", P.364 "Reset an IC card
information")
* You can also double-click the user you want to change in the registered user display list to open a dialog box.

Information
The factory default password for [admin] (instrument administrator) is "admin".
Change the password before using the instrument.

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Change the password

Follow the steps below to change the password.

1 Click [Change Password].

The dialog box on the right appears.

Note:
• The logged on user can change his or her password.
• Users with [All Administrators] authority can change the passwords of other users. For
permission settings, see the following section:
(➤P.361 "Change settings and add users")

2 Populate the displayed fields.

[Current Password] Enter the current password.
A user with [Built-in User] or [All Administrators] authority does not need to
enter the password.
[New Password] Enter the new password.
You can enter up to 20 characters.
[Re-enter New Re-enter the new password for confirmation.
Password]

3 Click [OK].
The password is changed.

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Change settings and add users

Follow the steps below to change settings or add a user.

1 Click [Modify Settings] or [Add User].

The following dialog box appears.

Note:
The maximum number of users that can be registered is 100. This does not include factory
registered users.

2 Populate the displayed fields.

● Set basic user information.

[Logon Name] Enter the logon name of the user.
You can enter up to 6 characters.
If the dialog box is opened from [Modify Settings], this cannot be modified.
[Operator Name] Enter the name of the logon user.
You can enter up to 20 characters.
[Operator Info.] Enter additional information related to the user.
You can enter up to 100 characters.
[Language] Select the language that is displayed for the user. For the languages that
are available, see the following.
(➤P.358 "Change the display language (basic system language)")
[Instructions for Use Select the language for the on-line manual.
Language]

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● Set user permissions.

[All Administrators] Select to give the user all permissions below.
[Set separately] Select to separately specify the items below.
[Order Registration] Select this checkbox to permit order registration.
If not selected, the user cannot open the [Work List] screen.
[Instrument Analysis] Select this checkbox to permit analysis of samples.
If not selected, the user cannot perform analysis.
[Modify / Delete Select this checkbox to permit modification/deletion of analysis results.
Results]
[Validate] Select this checkbox to permit validation of results.
[Display and Output of Select this checkbox to grant authority to display items for research in the
Research Items] [Data Browser] screen and the [Sample Explorer] screen, and to grant
authority to output externally (csv output, graphic printer (GP) printing).
[Input and delete QC Select this checkbox to permit input and deletion of QC sample lot
Lot Information, information, plot operation, and [Cursor Data Management]. You can
Operate plot] specify permission details. Select [All operations] or [Only QC Plot
operation].
If [Only QC Plot operation] is selected, permission is only given for plot
operation and [Cursor Data Management]. QC sample lot information
cannot be entered or deleted.
[Calibration] Select this checkbox to permit calibration.
[Modify Settings] Select this checkbox to permit modification of settings.
[Display and Modify Select this checkbox to permit display and modification of patient
Patient Info.] information. [Patient Information] can be included in the saved data of
Sample Explorer and in CSV file output. However, this must also be set in
[Security]. (➤P.365 "Security settings")
[Output Results] Select this checkbox to permit external output.

● Set shift.
[Shift] Select the shift. QC result plots can be viewed for each shift.

3 Enter the password.

Enter the new password (twice).
If settings are being modified, the dialog box on the
right does not appear. Go to the next step.

4 Click [OK].
The dialog box closes, the settings are changed or the users are added.

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Delete a user
Follow the steps below to delete a user.

1 Click the user that you wish to delete in the list.

The user is selected.

Note:
• Users with [All Administrators] authority can delete other users.
• A [Built-in User] cannot be deleted.

2 Click [Delete User].

The dialog box on the right appears.

3 Click [Yes].
The selected user will be deleted.

Register or change an IC card information

Follow the steps below to register or change an IC card information.

1 Select the user for registration or change of IC card information from the
list.
The user is selected.

2 Click [Register IC card].

The dialog box on the right appears.

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3 Hold up the IC card to be registered or changed to the IC card reader.

The IC card information is registered, and [****************] is displayed.

4 Click [OK].
The dialog box closes.

Reset an IC card information

Follow the steps below to reset an IC card information.

1 Select the user for reset of IC card information from the list.
The user is selected.

2 Click [Register IC card].

The dialog box on the right appears.

3 Click [Reset].
A confirmation dialog box appears.

4 Click [OK].
The dialog box closes and the IC card information is deleted.

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CSV output settings

Click [System] - [CSV Output] in the [IPU Setting] tree.

[Image File Output] Select the checkbox to have an image output when data is saved in CSV
format. The image format ([PNG]/[BMP]) and background color
([BLACK]/[WHITE]) can be selected.
[Output sub scattergrams.] Select the checkbox to output the sub scattergrams.
[If output items exceed 256 Select the checkbox to divide into multiple files if the output items exceed
columns, data will be divided 256 columns.
into multiple files.]

Security settings
Click [System] - [Security] in the [IPU Setting] tree.

[Include patient Select the checkbox to include [Patient Information] when saving analysis data.
information]
[Output patient Select the checkbox to include [Patient Information] when outputting analysis data to
information] a CSV file.
[Use screen lock Select the checkbox to turn on the screen lock timer.
timer] When the screen lock timer is used, the IPU screen will lock and operation will not be
possible if the mouse or keyboard of the IPU is not used for the time set with the timer.
[Time until screen The time until the screen is locked by the screen lock timer can be set. The time can
locks] be set from 15 to 60 minutes in increments of 1 minute.

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Screen keyboard setting

Click [System] - [Screen Keyboard] in the [IPU Setting] tree.

[Use screen keyboard] Select the checkbox to enable use of the screen
keyboard. Click an input box to display the screen
keyboard.
The screen keyboard is a Windows function.

Patient ID display setting

Click [System] - [Patient ID Display] in the [IPU Setting] tree.

[Patient ID Display Set patient ID display to [Right-justified] or [Left-justified]*.

Settings]
* The patient ID displayed in the patient information area is always left-justified,
regardless of the setting.

Program Update Notification Setting

Click [System] - [Notification of Program Updates] in the [IPU Setting] tree.

[Notify when ready to Select to be notified when program

install program updates are ready to be installed.
update]

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15.3.3 Display settings

Display settings can be configured.

[Data Grid] A data grid (line height and character size of lists) can be set.
(➤P.367 "Data grid setting")
[Scattergram] The background color of a scattergram can be set.
(➤P.367 "Scattergram setting")

Data grid setting

Click a font size button on the list screen of each Font size button
screen to change the data grid.

Click [Displayed] - [Data Grid] in the [IPU Setting] tree, and then set each item to change the data grid.

[Setting] The numbers displayed on the font size button of the list screen of each screen appear.
[Line Height] The line height can be set. Set to a height from 20 to 50 pixels in increments of 1 pixel.
[Font Size] The size of characters displayed on the screen can be set. Set to a size from 11 to 30
points in increments of 1 point.

Scattergram setting
Click [Displayed] - [Scattergram] in the [IPU Setting] tree.

[Background Color] The background color ([BLACK]/[WHITE]) of a scattergram can be selected.

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15.3.4 Connection settings

Connection settings can be configured.

[Host Computer] Configure host computer connection and communication settings.

(➤P.368 "Host computer connection")
[Ticket Printer (DP)] Set the ticket printer connection and print display format.
(➤P.370 "Ticket printer (DP) connection")
[Ticket Printer (DP) Set the items printed by the ticket printer and the print positions.
Print Format] (➤P.371 "Ticket (DP) print format settings")
[Printer] Set connection of the graphic printer and list printer.
(➤P.372 "Graphic printer (GP)/List printer (LP) connection")
[Device] Set connection of the IC card reader.
(➤P.372 "IC card reader connection")

Note:
Only when a host computer and printers are connected, the output destinations of the [Output]
button on the toolbar will be displayed.

Host computer connection

Click [Connect] - [Host Computer] in the [IPU Setting] tree.

Selection tabs

[Host Computer Select the checkbox to enable connection to a host computer.

Connection] When this is not selected, interface settings cannot be configured.
[Current Connection] Select [Host Computer 1] or [Host Computer 2].
Connection is only possible to 1 host computer. Up to 2 host computers can be
registered.
Selection tabs Click to display the connection settings of [Host Computer 1] or [Host Computer 2].

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[Host Computer Name] Enter the name of the host computer. The name entered here will appear in the
host menu.
You can enter up to 8 characters.
[Serial Connection] Select to connect to the host computer by serial connection. Detailed
parameters can be configured.
[Port Setting] Select the port used for the host computer connection. A serial port can be
selected.
[Port Settings] The following settings are available.
[Baud Rate] Select the transmission speed.
[Code] Select the data bit length.
[Stop Bit] Select the stop bit length.
[Parity Bit] Select the parity check method.
[Interval] Select the interval for transmission to the host computer.
[Format] Select the serial communication format.
[XR-Series Sysmex Standard] or [XR-Series ASTM] can be selected*.
When [XR-Series ASTM] is selected, the class cannot be selected.
[Class] Select the transmission method.
[TCP/IP Connection] Select to connect to the host computer by TCP/IP. Detailed parameters can be
configured.
[Host IP Address] Set the IP address of the host computer.
[Port No.] Set the port number of the host computer.
A value from 0 to 65535 can be entered.
[Format] Select the communication format for TCP/IP.
[XR-Series Sysmex Standard] or [XR-Series ASTM] can be selected*.
* To use format other than the above, service settings are required.

Note:
The host computer to which the system connects can be changed in the host menu. Click
[HOST] in the host computer area of the analyzer control menu to display the host menu.

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Ticket printer (DP) connection

Click [Connect] - [Ticket Printer (DP)] in the [IPU Setting] tree.

[DP Connection] Select to connect to the ticket printer (DP).

When not selected, the items below are grayed out and cannot be set.
[Select Printer] Select the printer to be connected. Only the [TM-U295] can be selected.
Connect the printer to the IPU with a parallel cable.
In some cases it is possible to connect to other than the above printer by means
of a model change.
[Print Format] The print format can be set.
[Sample No. Set the number of sample number digits that are printed. Any number from 1 to
Length] 22 can be selected.
[Date Print Type] Set the format of the printed date. [YYMMDD], [MMDDYY], [DDMMYY],
[DDMM], or [MMDD] can be selected.
Y: Year (2 digits), M: Month (2 digits), D: Day (2 digits).
[Delimiter of Date] Select the delimiter ([/], [Space], or [No Space]) used in the printed date.
e.g: May 5, 2010
Slash: 10/05/05
Space: 10 05 05
No space: 100505
[Print Decimal Specify whether decimal points in data are printed.
Point]
[Top Margin] Set the margin between the top of the ticket and the print start position in the
indicated inch-based units. A value from 8 to 255 can be set.
[Char. Pitch] Set the character pitch in dots. A value from 5 to 21 can be set.
[Line Pitch] Set the line pitch in the indicated inch-based units. A value from 8 to 255 can be
set.
[Inverted printing] Specify whether headstand printing is performed.

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Ticket (DP) print format settings

Click [Connect] - [Ticket Printer (DP) Print Format] in the [IPU Setting] tree.
* This function is not available for hsA analysis results.

Print Format Setting

List

Print Format Setting List Click the items that you wish to print.
Displays only the reportable items.
In date data, allowance must be made for any print spaces specified in Date
Print Type and Delimiter of Date. In sample numbers, allowance must be made
for any print spaces specified in Sample No. Length. Make sure the print spaces
of items do not overlap.
[Printed] Select the checkbox to have the item printed. Print details can be set.
[Print Condition] Select the samples to be printed. For items with "&" after the item name, [All
Samples] is always selected.
[Print Start Position] [Auto] or [Manual] can be selected.
When [Manual] is selected, set [Row] or [Column] for the print start position. A
value from 0 to 255 can be entered.
Set the column based on the print position of the most significant digit of each
analysis item.
[Import] A saved ticket (DP) print format can be imported.
The extension of a file is ".dpf".
The default file name is [XR][Software version][DPFormat].dpf.
The procedure is the same as for importing master settings.
(➤P.338 "Import master settings")
[Export] The current ticket (DP) print format settings can be saved to a file.
The extension of a file is ".dpf".
The procedure is the same as for exporting master settings.
(➤P.337 "Save master settings")

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Information
If the row or column setting is incorrect, some analysis results may not be printed or printing will
not be complete. Set the row and column to the correct position.
Depending on the state of adjustment of the printer and the length of the paper, printing may not
take place correctly even if the content is within the possible layout range.

Graphic printer (GP)/List printer (LP) connection

Click [Connect] - [Printer] in the [IPU Setting] tree.

[Report (GP) Connect] Select the checkbox to connect to a graphic printer.

[Ledger (LP) Connect] Select the checkbox to connect to a list printer.

IC card reader connection

Click [Connect] - [Device] in the [IPU Setting] tree.

[Serial port] Select the serial port to connect the IC card reader.

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15.3.5 Automatic processing settings

Automatic processing settings can be configured.

[Auto Validate] Specify whether validation takes place automatically. Set the samples to be
validated. (➤P.373 "Auto validate settings")
[Auto Output] Specify whether output takes place automatically. Set the output destination.
(➤P.374 "Auto output settings")
[Analysis Ordering] Set the keys and method used to query the host computer for analysis information.
(➤P.375 "Analysis ordering")
[Delta Check] Specify whether delta check is performed.
(➤P.376 "Delta check settings")

Auto validate settings

Click [Auto Process] - [Auto Validate] in the [IPU Setting] tree.

[Auto Validate] Select the checkbox to have samples automatically validated. Select whether
validation conditions are set in the rule screen or using the simple settings.
[Set in rule view] Select to enable the settings in [Validation Rule] in the rule screen.
[Use simple Select to enable the simple settings. Select samples to be validated.
settings]* When [Use simple settings] is selected, the settings in the rule screen are disabled.
* Only when setting the delta check, the items including "Delta Check Negative" are displayed. (➤P.376 "Delta
check settings")
When auto validated samples are [All Samples], samples are validated regardless of the analysis mode.

Note:
An analysis result which has been validated only can be output.

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Auto output settings

Click [Auto Process] - [Auto Output] in the [IPU Setting] tree.

Output
conditions
Output
destination

[Auto Output] Select to have validated samples automatically output. The following settings are
available.
[Set in rule view] Select to enable the settings in the rule screen. Analysis data will be automatically
output based on [Validation Rule] and [Output Rule].
[Use simple Select to set [Error Data Output Conditions] and [Auto Output Destination and
settings] Output Conditions].
When [Do not automatically output data with errors] is selected, data with errors are
not output to any of the output destinations, regardless of the output conditions.
Output Set the auto output destination.
destination
[DP] Select the checkbox to enable output from the ticket printer. Output conditions can
be selected.
[GP] Select the checkbox to enable output from the graphic printer. Output conditions can
be selected.
[HC] Select the checkbox to enable output from the host computer. Output conditions can
be selected.
Output conditions Set the output conditions.
[Negative When this is selected, data with neither any items judged abnormal nor any analysis
Data] errors are selected.
[Diff. pos.] When this is selected, sample data with abnormal blood cell differentiation are selected.
[Morph. pos.] When this is selected, sample data with abnormal blood cell morphology are selected.
[Count Posi.] When this is selected, sample data with abnormal blood cell counts are selected.

Note:
Data that have already been transmitted are not output by auto output.

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Analysis ordering
Click [Auto Process] - [Analysis Ordering] in the [IPU Setting] tree.

[Key Setting] Select [Sample No.] or [Rack No./Tube Pos.].

When there are pending orders in the [Work List] screen, the order key cannot be
changed. When [Rack No./Tube Pos.] is selected, sample tube labels are not read.
[Realtime Host Order Specify whether real-time queries are sent to the host computer when [Manual
Setting] Analysis] or [Sampler Analysis] is performed.
[Manual Analysis] Select to have host ordering performed during manual analysis. The order key is the
sample number.
[Sampler Select to have host ordering performed during sampler analysis. The order key is the
Analysis] key set in [Key Setting].

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Delta check settings

Click [Auto Process] - [Delta Check] in the [IPU Setting] tree.

[Perform Delta Check] Select the checkbox to have delta check

performed.

● Delta check

Purpose Detects the possibility of the following errors:

• Possibility of sample mix-up.
• Possibility of a sample or instrument problem

Method The difference between the data being judged and the previous analysis data is
obtained using the [Patient ID] as a keyword.

Checked parameters WBC, HGB, MCV, PLT.

If the previous analysis was performed more than four days earlier, WBC judgment
is not performed.
* Analysis data from [Body Fluid] / [HPC] / [hsA] mode are not checked by delta
check.

Display [Check] is displayed in the [Action] column of the [Sample Explorer] screen and in
the Action field of the [Data Browser] screen. The following Delta check details can
be viewed in the [Data Browser] screen.
• [The sample might be wrong. Check the sample.]
• [Significant change in WBC. Check the sample.]*
* The analysis parameter is an example. WBC, HGB, MCV, or PLT may appear,
depending on the judgment.

Note:
Using the patient ID as a keyword, delta check compares the most recent analysis data with the
previous analysis data and judges if the data is abnormal based on any changes in the data.
If you are using multiple analyzers, you can compare data with a same patient ID across
analyzers.

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15.3.6 Reference interval settings

The reference interval settings can be configured.

[Category] Set the patient categories by age and gender. (➤P.377 "Category settings")
[Reference Interval] Set the values based on which abnormal judgments are made. (➤P.378
"Reference interval settings")

Category settings
Click [Reference Interval] - [Category] in the [IPU Setting] tree.

[Category 1] to Select the category to be used.

[Category 7]
[Lower Age Limit], Enter values in [Year], [Month], and [Week].
[Upper Age Limit] [Year], [Month], and [Week] of [Lower Age Limit] and [Upper Age Limit] are the time
elapsed after birth, not a date.
[Sex] The gender can be specified.

Note:
If there is no information on the age or gender, or there is no applicable category, the limits of the
universal category are automatically used.

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Reference interval settings

Click [Reference Interval] - [Reference Interval] in the [IPU Setting] tree.
* This function is not available for hsA analysis results.

List of reference
interval values

[Specify Patient Set the patient category. One of categories 1 to 7, or category 8 (the universal
Category] category), can be selected.
[Age Range] The age range of the selected patient category appears.
[Sex] The gender of the selected patient category appears.
List of reference Click to select an item. Settings for the selected item can be configured in [Setting
interval values Reference Interval] at the right.
All items cannot be displayed at once. Scroll the screen to display items that do not
appear.
[Unit] cannot be changed in this dialog box. To set the units, see the following section:
(➤P.379 "15.3.7 Unit settings (Unit)")
[Setting Reference The current settings of the item selected in the list appear.
Interval] An abnormal judgment of analysis data is made based on this reference interval.
[Item] The selected item appears. This cannot be entered.
When multiple analyzers are connected to the IPU, analyzable items can be set for any
of the analyzers.
[Lower Limit]*, The lower limit and upper limit for judging abnormalities can be entered.
[Upper Limit]* You can enter up to 6 characters.
If a reference interval is not needed, set the lower limit to [0] and the upper limit to a
high value such as 999.9.
* The decimal point symbol set in Windows is displayed in this instrument.
The only decimal point symbols displayed are "." (period) or "," (comma).

Note:
When the analysis data of an item exceeds the upper or lower limit, "+" or "-" will appear to the
right of the data.

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15.3.7 Unit settings (Unit)

Click [Unit] in the [IPU Setting] tree.

List of units

List of units Click to select an item. Settings for the selected item can be configured in [Unit
Setting] at the right.
[Item Unit Setting] The current settings of the item selected in the list appear.
[Item] The item selected in the list appears. This cannot be changed.
[Data Format]* The data format of the item selected in the list is indicated using [*] and [.]. This
cannot be changed.
When multiple analyzers are connected to the IPU, analyzable items can be set for
any of the analyzers.
[Unit] Click to set the units.
The units that can be selected vary depending on the item.
When the units are changed, the displayed data format changes accordingly.
* The decimal point symbol set in Windows is displayed in this instrument.
The only decimal point symbols displayed are "." (period) or "," (comma).

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15.3.8 QC settings
Quality control settings can be configured.

[QC Setting] Set the quality control method and other basic settings.
(➤P.380 "QC settings")
[QC Alarm] Configure settings for alarms that prompt you to perform QC.
(➤P.381 "QC alarm settings")
[QC Chart Fixed Set fixed comments that can be added to plots in QC charts.
Comment] (➤P.382 "QC chart fixed comment settings")
[QC Data Auto Specify whether or not the plot data is output to a host computer when QC data is
Output] plotted on a QC chart.
(➤P.383 "QC data auto output settings")

QC settings
Click [QC] - [QC Setting] in the [IPU Setting] tree.

[QC Method Setting] Select the QC method.

[Limit Setting] Specify whether the QC limit value is
calculated from the average (target) using the
[Differential (#)] method ([SD]) or the [Ratio
(%)] method ([CV]) .
[Auto Limit Setting] Specify whether the limit used for auto limit is
twice [SD] or [CV] ([2SD]) or 3 times [SD] or
[CV] ([3SD]).
[X-barM Batch Set the number of samples (batches) per
Setting]* X-barM QC plot for each discrete item.
Any number from 0 to 99 can be set.

* These discrete samples do not appear with all analyzer types.

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QC alarm settings
Click [QC] - [QC Alarm] in the [IPU Setting] tree.

[QC Alarm Setting] Settings for alarms that prompt you to perform QC can be configured. 3 alarms can
be registered.
[Alarm 1] to [Alarm 3] When selected, the set alarm will sound.
If the checkmark is removed, the time and day cannot be set. The settings will be
grayed out and cannot be clicked.
[Time] Set the time that the alarm will sound.
Hour: A value from 00 to 23 can be set.
Minute: A value from 00 to 59 can be set.
[Repeating Day Set the day that the alarm will sound. [Everyday] or [Specify Day] can be selected.
Specification]

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QC chart fixed comment settings

Click [QC] - [QC Chart Fixed Comment] in the [IPU Setting] tree.

QC chart fixed
comment list

QC chart fixed Displays the [ID] and [Comment Body] of each QC chart fixed comment.
comment list
[Edit Comment] A comment selected in the list can be edited.
[ID] ID numbers from 01 to 10 appear. They cannot be changed.
[Comment Body] A comment can be entered. If a comment cannot be fully displayed, [...] appears at
the end.
You can enter up to 100 characters.

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QC data auto output settings

Click [QC] - [QC Data Auto Output] in the [IPU Setting] tree.

[QC Chart Screen] Automatic output settings can be configured. When selected, [QC Files (Excluding
X-barM)] and [X-barM Files] output can be set.
To output QC chart data, a connection to a host computer is required. (➤P.368 "Host
computer connection")
When the checkmark is removed, all items are grayed out and cannot be clicked.
[Explorer Screen] The output destination for analysis results of sample numbers beginning with "QC-"
that are received in the Explorer screen can be set. Select the checkbox to output
from the [Graphic Printer (GP)], [Host Computer (HC)], or [Ticket Printer (DP)].

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15.3.9 Priority code settings

Click [Priority Code] in the [IPU Setting] tree.

Priority code Priority code list

setting area

Priority code list Click to select an item.

Priority code setting Displays whether the priority code is enabled ([ ]) or disabled ([ ]).
area
[No.]* Displays numbers from 01 to 15. They cannot be changed.
[Code] Select the priority code. If you select a priority code other than "blank", the code is
enabled.
[Back Color] Select [No back color] or [Select back color]. Select [Select back color] to set the
background color for the priority code.
[Description] A comment can be entered.
You can enter up to 50 characters.

* This does not indicate the priority level.

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15.4 Graphic printer print settings (GP customize)

Analysis data, cumulative data, QC charts, and other data can be printed graphically from a graphic printer. The GP
customize function can be used to configure the print settings of the graphic printer.

Warning!
• The data output in the lab format is for research purposes. Do not use for the diagnosis of patients.
• When report format is displayed in the layout screen, items for research cannot be displayed in the
template.

15.4.1 GP customize function

Setting the text to be printed and the image format

The following print settings can be configured.
• Text
• Line
• Image format (BMP)
• Table

Printing analysis data

The data below can be printed in a specified color at a specified location.
• Sample information
• Analysis data
• Reference intervals for abnormality judgments
• Scattergrams*1
• Distributions*1
• IP messages
• Q-Flag*2
• Quality control chart
*1 Colors cannot be specified.
*2 Lab format only.

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Outputting print information

The print date and time, user name, software version, facility name, instrument name and other print-related
information can be output.

Printing from a graphic printer

Analysis data, scattergrams, QC charts, and other information can be printed from a graphic printer.

[Report Format] Select the [Output] button on the toolbar and click [Report (GP)].
[Lab Format] Select the [Output] button on the toolbar and click [Report for Lab Use Only].

15.4.2 GP customize screen

The content printed by the graphic printer can be set in the GP customize screen.
Click the [GP Customize] icon in the menu screen to display the [GP Customize] screen.
To exit, click [File] - [Exit] on the menu bar.
The screen consists of the following parts.

Shared
properties

Specific
properties

Selection palette Layout screen Property display area

Toolbar
The buttons of the following functions are displayed.

[New] Click to open a dialog for creating a new layout.

[Save] This can be clicked when the layout has been changed.
This temporarily saves the layout of the current layout screen.
[Select All] Click to select all objects in the layout screen.
[Delete] This can be clicked when an object is selected.
Click to delete an object selected in the layout screen.
[Copy] This can be clicked when an object is selected.
Click to copy an object selected in the layout screen.

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[Paste] Click to paste a copied object on the layout screen.

[Order] This can be clicked when an object is selected.
Clicking this displays a list of sorting options. A sorting option can be selected to
change the order of the objects. [Move Forward], [Move Backward], [Move to
Front] or [Move to Back] can be selected.
[Align] This can be clicked when an object is selected.
Clicking this displays a list of alignment options. Select an alignment option to
align the objects. [Left Aligned], [Right Aligned], [Top Aligned], [Bottom Aligned],
[Justify Vertically], [Justify Horizontally], [Center Vertically], [Center Horizontally],
[Center Vertically in Rectangle] or [Center Horizontally in Rectangle] can be
selected.
[Undo] Click to undo the previous operation.
[Redo] Click to cancel [Undo].
[Backup] The print layout of the current layout screen can be saved.
(➤P.392 "15.4.3 Save layout")
[Restore] Replaces the current layout screen with the layout of the file that is opened.
(➤P.393 "15.4.4 Restore saved layout")
[Cancel Template] Click to clear an object in a template. Table edit items cannot be cleared.
[Image] Any image can be added to the layout screen. A dialog box for selecting the
image file appears. The image format is BMP in which images are saved in the
24-bit bitmap format.
[Table] A table can be added to the layout screen. Click to open a dialog for setting the
table.
[Rectangle Display] Click to show edit frames around each item on the layout screen. Edit frames
allow you to check for overlapping items.
[Grid] Click to show/hide the grid on the layout screen. Showing the grid makes it easier
to check the size and position of objects.
[Zoom] Click to change the zoom of the layout image.
100 %, 150 %, or 200 % can be selected.

Selection palette
Select the template and the items to be printed. (➤P.388 "Selection palette")
The selected content appears in the layout screen.

Layout screen
Shows the print layout.
Use the tabs to switch between [Report Format] and [Lab Format].
(➤P.389 "●Tabs", ➤P.389 "Layout screen")

Property display area

This shows the items selected in the layout screen and the template properties. The properties can be set.
(➤P.389 "Properties")

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Selection palette
The following items are shown in the selection palette.

[Select] Click to change the layout screen to selection mode.

● Text and lines

Details for each edit item are displayed in the specific properties.
An item on the selection palette can also be clicked to display the item on the layout screen. A displayed item
can be clicked to edit the item from the properties display area.

[Free Text] Click to set the character size, color, and other settings. When the layout screen is
clicked, a text frame appears. A text frame can also be displayed by dragging on the
layout screen.
[Text Data] The text data of a set item can be edited. When the layout screen is clicked, a text
frame appears. A text frame can also be displayed by dragging on the layout screen.
[Line] Click to configure line settings.

● Template
Sample information and analysis items are arranged in sets of names and values. Frequently used
combinations of edit items are pre-grouped in a template.
Click the [New] button on the toolbar to open a dialog for selecting the template. A template can be selected
from the list that appears in the dialog.
To cancel a template, click the [Cancel Template] icon on the toolbar. Table edit items cannot be canceled.
The size of a template cannot be changed.

[Sample Info] Click to set the sample information template.

[Analysis items] Click to set the analysis items template.
[Scattergram] Click to set the scattergram template.
[Distribution] Click to set the distribution template.
[IP Message] Click to set the IP message template.
[Reference Interval] Click to set the reference interval template.
[Q-Flag] Click to set the Q-Flag template.

Note:
• Up to 15 edit items can be placed in the selection palette.
• If the layout screen is switched to a different format, the edit item palette changes to the state
in which [Select] is selected.

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Layout screen
The layout screen shows the print image.
The selected edit items and template appear in the layout.
The layout area is 196 x 259 mm. The print size is A4 (210 x 297 mm).

Note:
A dummy image will appear in the layout screen.

● Tabs
The print format is changed using the tabs. Click to select the print format.

[Report Format] Click to select report format.

Sample information and report items are printed. Only validated data can be
printed.
[Lab Format] Click to select lab format.
Sample information, report items, and research items are printed. Samples that
have not been validated can also be printed.
Printed with "Lab Use Only" on a gray background.

Properties
The properties of the item that is selected in the layout screen are displayed. Details can be set for each item.
When an item is not selected on the layout screen, the properties do not appear.

● Shared properties
Detailed information common to all edit items is displayed.

[Name] The name of the item. Immediately after an item is selected for editing, the default
name ("Item" + "Serial number") appears. This name can be changed.
You can enter up to 32 characters.
[X] The X coordinate of the item on the layout screen. This can be entered within the
range 0 to 555 pt.
[Y] The Y coordinate of the item on the layout screen. This can be entered within the
range 0 to 733 pt.
[Width] The width of the item.
This can be entered within a range up to 556 pt. The lower limit of the range varies
depending on the object.
[Height] The height of the item.
This can be entered within a range up to 734 pt. The lower limit of the range varies
depending on the object.

Note:
The position of the X and Y coordinates is displayed based on the point at the top left of the item.

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● Specific properties
Specific details are shown for each edit item. The settings can be changed by selecting items and entering
numerical values.

List of specific property edit items

Selection item/
template Edit item Description
in layout screen
Free text ([Free Text]) [Text] Shows the text string. The text string can be entered and edited.
[Font] The text font can be selected.
[Font Size] The text size can be entered and edited.
[Color] Shows the current text color. [Select] can be clicked to open the
color selection dialog and change the text color.
[Align] The text alignment can be selected.
Item name, numerical [Field ID] Type Selection: [Item Name], [Data], [Mark] or [Unit] can be
value, mark, units selected.
([Text Data]) Item Selection: Shows selection items based on the type. The
items that can be selected vary depending on
whether the format is report or lab.
[Font] The text font can be selected.
[Font Size] The text size can be entered and edited.
[Color] Shows the current text color. [Select] can be clicked to open the
color selection dialog and change the text color.
[Align] The text alignment can be selected.
Any image ([Image]) [File Name] Shows the image file path. Click the button to select an image.
[Fix Aspect Select to fix the aspect ratio of the image.
Ratio]
[Width Ratio] The image width can be set as a percentage. When [Fix Aspect
Ratio] is ON, links with the [Height Ratio] value.
[Height Ratio] The image height can be set as a percentage. When [Fix Aspect
Ratio] is ON, links with the [Width Ratio] value.
Scattergram, [Field ID] Type Selection: [Scattergram] or [Distribution] can selected.
distribution image Item Selection: Shows selection items based on the type. The
("[Image Field]") items that can be selected vary depending on whether the format
is report or lab.
[Width Ratio] The image width can be set as a percentage. Links with the
[Height Ratio] value.
[Height Ratio] The image width can be set as a percentage. Links with the
[Width Ratio] value.
Line ([Line]) [LineStyle] The line style can be selected.
[LineWidth] The line width can be selected.

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Selection item/
template Edit item Description
in layout screen
Table ([Table]) [LineStyle] The table line style can be selected.
[LineWidth] The table line width can be selected.
[Rows] The number of rows in the table can be set.
[Cols] The number of columns can be entered.
[MarginX] The left and right margin of text in table cells can be set.
[MarginY] The margin above and below text in table cells can be set.
Table cell ([Table Cell]) [Text] Shows the text string in the cell. The text string can be entered
and edited.
[Font] The text font can be selected.
[Font Size] The text size can be entered and edited.
[Color] Shows the current text color. [Select] can be clicked to open the
color selection dialog and change the text color.
[Align] The text alignment can be selected.
Sample information [Item Name] Sample information can be selected.
template
Analysis item template [Item Name] An analysis item can be selected.
Scattergram template [Item Name] A scattergram can be selected.
Distribution template [Item Name] A distribution can be selected.
IP message template [Item Name] An IP message can be selected.
Reference interval [Item Name] An analysis item that allows selection of a reference interval can
template be selected.
Q-flag template [Item Name] A suspect message can be selected.

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15.4.3 Save layout

The print layout that currently appears in the layout screen can be saved.
Follow the steps below to save the layout.

1 Click the [Backup] button on the toolbar.

The [Save As] dialog box appears.

2 Specify or create the folder to save the layout into.

3 Enter the file name.

The extension for a file is ".gpf".

Note:
The default file name is in the following format:
• Report Format: [XR][Software version][GPFormat(Report)].gpf
• Lab Format: [XR][Software version][GPFormat(LabOnly)].gpf

4 Click [Save].
The layout is saved.

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15.4.4 Restore saved layout

Saved layout can be restored.
Follow the steps below to restore saved layout.

1 Click the [Restore] button on the toolbar.

The [Open File] dialog box appears.

2 Select the file that you wish to open.

The extension for a file is ".gpf".

3 Click [Open].
The layout selected for the layout screen is displayed.

Combinations of restorable files

Combinations of restorable files are as follows. The background image of the lab format will not be restored.

Restore location display

File to be restored
For report use For lab use
For report use ✓ ✓
For lab use - ✓

15.4.5 Initialize layout

Layout that have been set can be initialized.
Follow the steps below to initialize layout.

1 Click the [File] - [Initialize Layout] button on the menu bar.

An initialization confirmation dialog box appears.

2 Click [Yes].
The display of the layout screen is initialized.

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15.5 RU-20 Reagent Unit Settings

This section explains how to configure the settings on the RU-20 Reagent Unit.
When the RU-20 is used, the settings can be changed from the RU area of the control menu.
When the power switch on the main unit is switched on, the RU-20 starts up.
The RU-20 dilutes concentrated reagent (CELLPACK DST) with purified water (RO water) and supplies the prepared
reagent to a connected hematology analyzer or hematology slide preparation unit.
For details on the RU-20, see the RU-20 "Instructions For Use".
* The initial settings for the RU-20 are sent from the main unit.

15.5.1 Reagent Expiration Stop and Alarm Settings

The RU-20 settings dialog can be used to configure reagent expiration stop and alarm settings.

Follow the steps below to configure the settings.

1 Click the RU menu button in the control menu.

The dialog box on the right appears.

Submenu
button

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2 Click the submenu button.

The submenu on the right appears.

3 Click [Setting].
The dialog box on the right appears.

Adjustment
buttons

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4 Populate the displayed fields.

The following items appear.
[Stop when reagent Stops reagent preparation when the reagent expires.
expires] [Yes] or [No] can be selected.
[Alarm Sound Alarm activation can be restricted to a set time period.
Restriction] [Yes] or [No] can be selected.
If you selected [Yes], click the adjustment buttons to set the [Alarm Start] time and
[Alarm End] time. Alarms will only sound during the specified time period.

5 Click [OK].
The settings are changed.

15.5.2 Temporarily use CELLPACK DCL

When the RU-20 cannot be used due to a failure or other problem, you can temporarily use CELLPACK DCL.
When temporarily using the CELLPACK DCL, reconnect the cubitainer spout kit connected to the RU-20 supply
tank to the CELLPACK DCL.

During normal operation When a problem occurs

Cubitainer spout kit

Cubitainer spout kit

RU-20 Supply tank CELLPACK DCL

Information
• Temporary use of CELLPACK DCL is an emergency measure that is to be employed in the
event that a problem occurs on the RU-20. If a problem occurs on the RU-20, please contact
your authorized local Sysmex representative as soon as possible.
• When CELLPACK DCL is used on a temporary basis, the aspiration intake of the dispensing
kit will not reach the bottom of the reagent container, and thus it will not be possible to use all
the CELLPACK DCL in the container.
• If the CELLPACK DCL runs out or drops to a level that cannot be aspirated during temporary
use of CELLPACK DCL, [CELLPACK DCL aspiration error] will appear. Replace the
CELLPACK DCL container and then click [Execute] in the help dialog box to replenish the
reagent. After replenishing of the reagent is completed, execute reagent replacement from the
[Replace Reagent] dialog box and register the reagent. This will take longer than regular
reagent replacement.
After reagent replacement, execute automatic rinsing and make sure that each parameter is
below the allowed blank value.

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Follow the steps below to configure the settings.

1 Install the CELLPACK DCL near the RU-20 supply tank, and turn the cap to
remove it.

CELLPACK DCL
Supply tank

Information
Do not throw removed caps.
After reconnecting the cubitainer spout kit, use it as the cap of the supply tank.

2 Remove the cover from the RU-20 supply tank.

This step is not required if you are not using the cover. Proceed to step 3.

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3 Turn and remove the cap from the RU-20 supply tank, and then pull out the
cubitainer spout kit.

Cubitainer spout kit

Caution!
Do not touch the aspiration nozzle of the cubitainer spout kit. In addition, exercise care so that
the nozzle does not come into contact with foreign objects.
Incorrect analysis results may be obtained.

4 Insert the cubitainer spout kit into the prepared CELLPACK DCL and turn the
cap to attach it.

5 Attach the cap removed in step 1 to the RU-20 supply tank.

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6 Click the RU menu button in the control menu.

The dialog box on the right appears.

Submenu
button

7 Click the submenu button.

The submenu on the right appears.

8 Click [RU->DCL].
The confirmation dialog box appears.

9 Click [OK].

10 Select [Register CELLPACK DCL] in the error message list and click
[Execute].
The [Replace Reagent] dialog box appears. Register the CELLPACK DCL.

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15.5.3 End temporary use of CELLPACK DCL

To reset the RU-20, reconnect the cubitainer spout kit connected to the CELLPACK DCL to the RU-20 supply
tank, and end the temporary use of the CELLPACK DCL.

When a problem occurs During normal operation

Cubitainer spout kit

Cubitainer spout kit

RU-20 Supply tank CELLPACK DCL

1 Turn and remove the cap attached to the RU-20 supply tank.

Cap

2 Turn and remove the cap from the CELLPACK DCL, and then pull out the
cubitainer spout kit.

Cubitainer spout kit

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Caution!
Do not touch the aspiration nozzle of the cubitainer spout kit. In addition, exercise care so that
the nozzle does not come into contact with foreign objects.
Incorrect analysis results may be obtained.

3 Insert the cubitainer spout kit into the RU-20 supply tank, and turn the cap to
attach it.

Cap

Information
Do not directly connect the cubitainer spout kit to the CELLPACK DST.

CELLPACK DST

4 Turn and attach the cap removed from the RU-20 supply tank in step 1 to
CELLPACK DCL.

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5 Attach the cover to the RU-20 supply tank.

This step is not required if you are not using the cover. Proceed to step 6.

6 Click the RU menu button in the control menu.

The dialog box on the right appears.

Submenu
button

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7 Click the submenu button.

The submenu on the right appears.

8 Click [DCL->RU].
The confirmation dialog box appears.

9 Click [OK].
The alarm temporarily sounds.
End temporary use of CELLPACK DCL, and use RU-20.

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15.6 Schedule settings

If a schedule is set, the data stored in the IPU is backed up to the specified storage destination when the IPU is shut
down on the specified date. When using a PC for backup, you can start the instrument automatically at the specified
date and time.
The types of IPU backup are as follows:
• Using a PC (optional) for backup
• Using external media or internal storage

Available functions are different depending on the saving destination of backup files.

Saving destination Automatic backup Automatic startup

PC for backup ✓ ✓

External media/internal storage ✓ -

● When using a PC (optional) for backup

Back up the data saved in the IPU in a PC for backup. Your authorized local Sysmex representative will install
and make the initial configuration for the PC for backup.

Switching in case of IPU failure

In case of IPU failure, delay in analysis can be minimized by switching from IPU to the PC for backup.
(➤P.559 "Chapter 19: 19.5 Switching the PC in case of IPU failure")

During normal operation When a problem occurs

PC for backup IPU

Instrument automatic startup

When using a PC for backup, you can start the instrument automatically at the specified date and time.
(➤P.406 "15.6.1 Set the schedule")

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● When using external media or internal storage

In case of IPU failure, delay in analysis can be minimized by installing a new IPU and restoring from the backup
data. Your authorized local Sysmex representative will install a new IPU and restore data from the backup.

When using an external media

Back up the data saved in the IPU in an external media such as a USB memory stick. Use external media in
NTFS format.

During normal operation When a problem occurs

New IPU

IPU

When using an internal storage

Back up the data in a designated folder in the computer used as an IPU.

During normal operation When a problem occurs

New IPU

IPU

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15.6.1 Set the schedule

Set an automatic backup/automatic startup schedule. You can set [Automatic start] only when using a PC for
backup. For automatic backup, see the following:
(➤P.127 "Chapter 8: 8.5.4 Perform automatic backup")

1 Click [Schedule settings].

The following dialog box appears.

Setting item switching tabs

2 Populate the displayed fields.

The following items appear in the dialog box.

● To set automatic backup

Select [Automatic backup] on the setting item switching tab to set the below items.

[Latest backup date] Displays date and time of the last backup attempt.
[Latest successful date] Displays date and time of the last successful backup.

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[Schedule] Schedules automatic backup.

[Set on selected date] Schedules automatic backup on the date selected on the calendar.
[Reset selected date] Resets the scheduled automatic backup on the date selected on the calendar.
[Set on all days] Schedules automatic backup on all days.
[Reset all days] Resets all scheduled automatic backup.
[Set on selected Schedules automatic backup on the days selected in [Select day of the week].
days]
[Reset selected days] Resets the scheduled automatic backup on the days selected in [Select day of
the week].
[Select day of the week] Check to select specific days for [Set on selected days] or [Reset selected days].

● To set automatic start

Select [Automatic start] on the setting item switching tab to set the below items.

[Latest backup date] Displays date and time of the last backup attempt.
[Latest successful date] Displays date and time of the last successful backup.
[Start time] The time for automatic start can be set.
[Schedule] Schedules automatic startup.
[Set on selected Schedules automatic startup on the date selected on the calendar.
date]
[Reset selected date] Resets the scheduled automatic startup on the date selected on the calendar.
[Set on all days] Schedules automatic startup on all days.
[Reset all days] Resets all scheduled automatic startup.
[Set on selected Schedules automatic startup on the days selected in [Select day of the week].
days]
[Reset selected Resets the scheduled automatic startup on the days selected in [Select day
days] of the week].
[Select day of the week] Check to select specific days for [Set on selected days] or [Reset selected
days].

3 Click [OK].

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15.6.2 Set the backup method

You can set the information to be backed up and the folder to save to.

1 Click [Schedule settings].

The following dialog box appears.

2 Click [Backup settings].

The dialog box on the right appears.

Saving destination
configuration area

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3 Populate the displayed fields.

The following items appear in the dialog box.

[Include measurement Select the checkbox to include analysis data to the backup data.
results]
[Include patient Select the checkbox to include patient information to the analysis data.
information]
Saving destination The saving destination can be specified. If you need to change the settings, please
configuration area contact your authorized local Sysmex representative.

Information
• Do not change the settings for the saving destination.
If changed, the backup may not be performed normally.
• Only the last backup data is saved. If backup is taken by removing the check mark for [Include
measurement results], the previously backed up analysis data is cleared.

Note:
If the backup data contains analysis results, backup takes time to complete.

4 Click [OK].

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15.6.3 Take manual backup

You can take a backup of the IPU at any optional timing.

1 Make sure that the analyzer and the sampler are in READY state.
If the Status indicator LEDs are not lit green or orange, wait Status
until they are. indicator
LED

2 Click [Schedule settings].

The following dialog box appears.

3 Click [Backup].
The confirmation dialog box appears.

4 Click [OK].
The PC for backup automatically starts and backup begins. The IPU automatically shuts down and restarts once
backup is complete. After that, the PC for backup automatically shuts down.

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● To abort backup
Click [Cancel] in the [Waiting to complete execution] dialog box. The IPU shuts down without backup.

Caution!
If backup is aborted or if data is backed up on external media or internal storage, the IPU will not
restart automatically. Turn it ON manually. (➤P.116 "Chapter 8: 8.2.2 Turn power ON")

Information
The IPU controls the power to the PC for backup. Do not turn the PC for backup ON or OFF.

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Chapter 16 Rules Setup

Chapter 16 Rules Setup

This chapter explains the procedures for setting rules to have the analyzer automatically perform a
subsequent operation based on the results of the first analysis.

16.1 Types of rules

Rules
Rules can only be displayed and set for the [Built-in User] registered at the factory.
The analysis data are judged by setting rules. The results of judgment can be reviewed in the [Sample Explorer] and
[Data Browser] screens. Up to 100 rules can be setup for each condition indicated below*.
A rule-based judgment is performed on the results of the first analysis. Based on the result of the rule-based
judgment, [Repeat] analysis, [Rerun] analysis, [Reflex] analysis, comment adding, validation, or output is performed.
[Repeat], [Rerun], and [Reflex] judgments will be performed for the second analysis results, but not for the third
analysis results.
* [Rerun/Reflex/Comment Rule], [Validation Rule] or [Output Rule] only.

Analysis
[Repeat] analysis: Repeats the first analysis.
[Rerun] analysis: Repeats analysis of a sample while holding the results of the first analysis.
[Reflex] analysis: Tests additional parameters due to the results of the first analysis.

Information
If you desire a rule change, registration, deletion or copy, please contact your authorized local
Sysmex representative.

Note:
The rules are not applied to the results of analysis for maintenance (QC), analysis of sample
number "0", and analysis that resulted in a barcode reader read error.

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In this instrument, the following types of rules can be set.

16.1.1 Repeat rule

[Repeat] means to do [Repeat] analysis if an error occurs in the first analysis*.
If an error occurs in the first analysis, a [Repeat] analysis is performed automatically. A [Repeat] rule is set for
each error message. The settings can be checked in the rule setting area of the [Repeat Rule] screen. (➤P.419
"Repeat Rule")
[Repeat] judgment is only performed when the analyzer setting is ON. For details, see Chapter 15. (➤P.344
"Chapter 15: Repeat setting")
* When using the sampler (SA-01) in the XR-1000, the [Repeat] rule does not work.

Note:
In the case of samples analyzed using Raised Bottom Tubes, [Repeat] analysis is only
performed when the analyzer setting is enabled. When the setting is disabled, only rule-based
judgment is performed. (➤P.341 "Chapter 15: 15.2.4 Raised Bottom Tube samples setting")

e.g. Error message: [0.25 MPa pressure error]

Action: [Repeat]
Explanation: If a [0.25 MPa pressure error] occurs, a [Repeat] analysis is automatically
performed.

For a list of error messages, see the following*.

(➤P.515 "Chapter 19: 19.3 Error message list")
* The error messages below are [BlockRepeat (Fixed)], and are not displayed in the screen.
• [41°C reagent heater thermistor error]
• [34°C reagent heater thermistor error]
• [41°C FCM reaction chamber thermistor error]
• [34°C FCM reaction chamber thermistor error]
• [FCM detector thermistor error]
• [FCM sheath thermistor error]
• [Ambient thermistor error]
• [APD thermistor error]
• [Laser output error]

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16.1.2 Rerun/Reflex/Comment rule

The result of the first analysis is judged, and a [Rerun] analysis, [Reflex] analysis, or addition of a comment is
automatically performed. You can set the judgment conditions for [Rerun] analysis, [Reflex] analysis, and comments.
[Rerun/Reflex/Comment Rule] do not function if an error occurs in the first analysis.
[Rerun] judgment and [Reflex] judgment are only performed when the analyzer setting is ON. For details, see
Chapter 15. (➤P.344 "Chapter 15: Rerun/Reflex setting")
* When using the sampler (SA-01) in the XR-1000, the [Rerun] / [Reflex] rule does not work. Only the Comment
rule works.

Note:
In the case of samples analyzed using Raised Bottom Tubes, [Rerun] analysis and [Reflex]
analysis are only performed when the analyzer setting is enabled. When the setting is disabled,
only rule-based judgment is performed. (➤P.341 "Chapter 15: 15.2.4 Raised Bottom Tube
samples setting")

Rerun
[Rerun] is used to judge the analysis result and automatically rerun the test.
The result of the first analysis is judged, and a [Rerun] analysis is automatically performed. When there are
multiple analyzers, you can specify which analyzer is used to perform [Rerun] analysis. However, if the specified
analyzer does not have the [Rerun] analysis function, [Rerun] analysis is performed using the same analyzer as
the initial analysis. You can set the judgment condition under which a [Rerun] analysis is performed.

e.g. Conditional Expression: [IPMessage] ([RBC Abn Distribution]) [OR] [IPMessage] ([Dimorphic Population])
Action: [Rerun] ([SameModule])
Explanation: If the judgment displays an IP message [RBC Abn Distribution] (RBC abnormal
particle size distribution) or [Dimorphic Population] (dimorphic population), [Rerun]
analysis is performed automatically using the same analyzer as the initial analysis.

Reflex
[Reflex] is a setting that is used to judge analysis results and automatically perform analysis with additional
discrete items not analyzed in the initial analysis.
The result from the first analysis is judged, and a [Reflex] analysis is performed to generate the additional
parameters that are different from the first test. You can set the judgment conditions for performing a [Reflex]
analysis of the initial analysis.

e.g. Conditional Expression: [IPMessage]([PLT Abn Distribution])

Action: [Reflex]([DIFF+RET+PLT-F+WPC])
Explanation: If the judgment shows the IP message [PLT Abn Distribution] (abnormal
platelet particle size distribution), a [Reflex] analysis is performed on discrete
parameters [DIFF+RET+PLT-F+WPC].

Comment
A comment is a setting that judges the analysis result and automatically displays a comment.
If [None] is selected for the action, a conditional expression that only sets a comment can be set.

e.g. Conditional Expression: [ItemValue](HGB[***.* g/dL]) < 8.0

Action: [None]
Comment: Contact doctor
Explanation: When HGB is less than 8.0 g/dL, "Contact doctor" appears in the comment
column.

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16.1.3 Validation rule

To validate means to approve the output of the analysis data for reporting. The [Validation Rule] sets the
judgment condition under which validation is automatically performed.
Analysis result that has been already judged by the [Repeat Rule] or the [Rerun/Reflex/Comment Rule] is
judged, and validation is automatically performed.

e.g. Conditional Expression: [ResultFlag]([Negative])

Action: [Validate]
Explanation: If an analysis data flag judgment result was Negative based on the [Rerun/
Reflex/Comment Rule], validation is performed automatically.

16.1.4 Output rule

The [Output Rule] sets the judgment condition for automatically outputting the analysis result.
Analysis result that has been already validated is judged and automatically output. You can also set the output
destination.

e.g. Conditional Expression: [ResultFlag] ([Negative])

Action: [ReportTo] ([HC])
Explanation: If the Positive/Negative judgment is [Negative] the analysis data is
automatically output to the host computer.

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16.2 Rule screen

Click the [Rule] icon in the menu screen to display the following screen.

Toolbar

Rule
execution
order area

Tabs Open/close
button

[Rule] screen

Toolbar
The buttons of the following functions are displayed.

[Enable]*1, 2 Click to enable selected rule(s) in the [Rule] screen. If the rule was already enabled,
clicking in the list disables the rule.
[Sort] Click to display the dialog box for sorting rules in the [Rule] screen.
[Output] Click to display the submenu for printing displayed rules in ledger format.
[Upper] Click to move the selection up by 1 row.
[Lower] Click to move the selection down by 1 row.
[File] Click to display the submenu for saving, restoring or initializing the rules.
[Close] Click to close the [Rule] screen.
*1 When [Repeat Rule] is [BlockRepeat(Fixed)], the settings cannot be changed.
*2 The setting of a rule that is valid only can be enabled.

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Rule Execution Order

The order of execution of the rules is shown.
Click the open/close button to open/close the Rule Execution Order display area.

[Repeat Rule], [Rerun/Reflex/Comment Rule]

If the [Repeat] or [Rerun/Reflex] checkbox is not selected in the analyzer settings, the setting in the rule screen
will not be valid. For details, see Chapter 15.
(➤P.344 "Chapter 15: Repeat setting", ➤P.344 "Chapter 15: Rerun/Reflex setting")

[Validation Rule], [Output Rule]

The status of the rule appears below the rule name. If the rule in the rule screen is in
effect, the status does not appear.
When a rule is set in the IPU settings, [Use Rule ####### Simple Setting] appears.
If the rule is OFF, the background is gray and [Rule ####### Disabled] appears.

Tabs
Click a tab to change the displayed rule screen list. The [Repeat Rule], [Rerun/Reflex/Comment Rule],
[Validation Rule], and [Output Rule] tabs appear.
* The tabs that appear vary depending on the instrument that is used.

Note:
You can select multiple data in the rule screen list as follows:
• Drag multiple consecutive rows while holding down the left button on the mouse
• While pressing Ctrl, click on the row that you want to select

Open/close button
Click to open/close the rule execution order area.

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16.2.1 Rule screens

Repeat Rule
Click the [Repeat Rule] tab to display the following screen*.
* Errors that do not occur due to the instrument configuration are not displayed. For other errors that are not
displayed, see below.
(➤P.414 "16.1.1 Repeat rule")
When using the sampler (SA-01) in the XR-1000, the screen below does not appear.

Rule setting area Rule supplementary explanation area

[Repeat Rule] screen

Rule setting area Displays whether the rule is ON ( ), OFF ( ) or invalid ( ).

[No.] The unique number assigned to the error for which the [Repeat Rule] is applied is
displayed.
[Error Code] The error code is displayed.
[Error Message] The error message is displayed.
[Action] The following actions are displayed.
[None] [Repeat] is not performed.
[BlockRepeat] [Repeat] is not performed. Even if other errors occur that have [Repeat] set for the
action, if an error occurs that has [BlockRepeat] set, [BlockRepeat] is given
priority. [BlockRepeat] disables the [Repeat Rule]. It does not disable [Rerun] or
[Reflex].
[Repeat] [Repeat] is performed.
[BlockRepeat(Fixed)] Displayed when the action is fixed at [BlockRepeat].
[Update Date] The date and time the rule was registered or last modified is displayed.
Rule supplementary A supplementary explanation of the rule is displayed.
explanation area

Note:
[Repeat Rule] is applied when an error occurs in the result of the first analysis and when an error
occurs in the result of [Rerun], [Reflex]. [Repeat] analysis is not possible for some errors.

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Rerun/Reflex/Comment Rule
Click the [Rerun/Reflex/Comment Rule] tab to display the following screen*.
* When using the sampler (SA-01) in the XR-1000, this is displayed as the [Comment Rule] screen.

Rule setting area Rule supplementary explanation area

[Rerun/Reflex/Comment Rule] screen

Rule setting area Displays whether the rule is ON ( ), OFF ( ), or invalid ( ).

[No.] The rule number appears. If a number greater than "100" (the maximum number
that can be registered) is entered, the number will be displayed in red.
[Name] The name of the rule appears. If not entered, nothing appears.
[Conditional Expression] Displays the conditional expression for whether [Rerun], [Reflex] is performed.
[Action] The following actions are displayed.
[None] [Rerun], [Reflex] is not performed.
[BlockRerunReflex] [Rerun], [Reflex] is not performed. Even if there are other conditions with [Rerun]
or [Reflex] set for the action that are satisfied, if a condition with
[BlockRerunReflex] set is satisfied, [BlockRerunReflex] is given priority.
[Rerun] [Rerun] analysis is performed. If multiple analyzers are used, the analyzer to be
used for [Rerun] analysis can be specified.
[Reflex] [Reflex] analysis is performed. The discrete item of the added channel appears in
( ). Even when the judgment is [Reflex], if the analysis items belonging to the
discrete to be added and all channels were analyzed in the initial analysis,
[Reflex] analysis will not be performed.
[QueryToHost]* The host computer is queried if [Rerun], [Reflex] is necessary.
[Rule comment] The comment to be added to the analysis data is displayed. Nothing appears if no
comments have been entered. The display color varies depending on the
importance of the comment.
[Low] Displays in black characters on a white background.
[Medium] Displays in black characters on an orange background.
[High] Displays in white characters on a red background.
[Update Date] The date and time the rule was registered or last modified is displayed.
[Description] A description of the rule appears. If not entered, nothing appears.
Rule supplementary A supplementary explanation of the rule is displayed.
explanation area
* Only when IPU service settings are being configured, this will appear.

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Note:
• The result of a [Rerun] or [Reflex] analysis cannot be consolidated with or compared to the
result of the first analysis.
• The [Rerun] / [Reflex] rule is applied when there is no error in the first analysis results and
when there is no error in the [Initial/Repeat] result.
• In the case of samples analyzed using Raised Bottom Tubes, [QueryToHost] is only performed
when the analyzer setting is enabled. (➤P.341 "Chapter 15: 15.2.4 Raised Bottom Tube
samples setting")

Validation rule
Click the [Validation Rule] tab to display the following screen.

Rule setting area Rule supplementary explanation area

[Validation Rule] screen

Rule setting area Displays whether the rule is ON ( ), OFF ( ), or invalid ( ).

[No.] The rule number appears. If a number greater than "100" (the maximum number
that can be registered) is entered, the number will be displayed in red.
[Name] The name of the rule appears. If not entered, nothing appears.
[Conditional Expression] Displays the conditional expression for whether validation is performed.
[Action] The following actions are displayed.
[BlockValidate] Validation is not performed. Even if there are other conditions with [Validate] set
for the action that are satisfied, if a condition with [BlockValidate] set is satisfied,
[BlockValidate] is given priority.
[Validate] Validation is performed.
[Update Date] The date and time the rule was registered or last modified is displayed.
[Description] A description of the rule appears. If not entered, nothing appears.
Rule supplementary A supplementary explanation of the rule is displayed.
explanation area

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Output Rule
Click the [Output Rule] tab to display the following screen.

Rule setting area Rule supplementary explanation area

[Output Rule] screen

Rule setting area Displays whether the rule is ON ( ), OFF ( ), or invalid ( ).

[No.] The rule number appears. If a number greater than "100" (the maximum number
that can be registered) is entered, the number will be displayed in red.
[Name] The name of the rule appears. If not entered, nothing appears.
[Conditional Expression] Displays the conditional expression for output.
[Action] The following actions are displayed.
[BlockReport] Data is not output. Even if there are other conditions with [ReportTo] set for the
action that are satisfied, if a condition with [BlockReport] set is satisfied,
[BlockReport] is given priority.
[ReportTo] Data that has been validated is output. The output destination appears in ( ).
[Update Date] The date and time the rule was registered or last modified is displayed.
[Description] A description of the rule appears. If not entered, nothing appears.
Rule supplementary A supplementary explanation of the rule is displayed.
explanation area

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16.3 Enable/Disable rules

The enable/disable setting of each rule in the rule screen can be changed*.
* The setting of a rule that is valid only can be changed. The settings of a rule that is fixed to [BlockRepeat] cannot
be changed.
Follow the steps below to enable/disable a rule.

1 Click the rule that you wish to enable or disable.

The rule is selected.
You can select multiple rules in the list.

2 Click the [Enable] button on the toolbar.

The rule is enabled/disabled.
When multiple lines of rules are selected, the enable/disable selection of the highlight-selected rule will apply to
all selected rules.
For example, when the highlight-selected rule is enabled, all other selected rules are enabled.

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16.4 Sort rules

The rules can be sorted in the order of a specified keyword.
Sorting conditions can be set separately for each tab.
Follow the steps below to sort the rules.

1 Click the tab of the rules you wish to sort.

2 Click the [Sort] button on the toolbar.

The dialog box on the right appears.

3 Populate the displayed fields.

Sorting conditions can be set by clicking the sort key.
When a keyword is set, the numbers or letters can be sorted in [Asc.] order (0 to 9/A to Z) or [Desc.] order (9 to
0/Z to A).

[No.] Sort by rule number.

[Name]*1 Sort by rule name.
2
[Error Code]* Sort by error code.
2
[Error Message]* Sort by error message.
[Update Date] Sort by update date.
*1 [Rerun/Reflex/Comment Rule], [Validation Rule] or [Output Rule] only.
*2 [Repeat Rule] only.

4 Click [OK].
The dialog box closes and sorting is applied.

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16.5 Print rules

Rules that have been registered can be printed as a list.
Follow the steps below to print rules.

1 Click the tab of the rules that you wish to print.

The rules appear.

2 Click the [Output] - [Ledger (LP)] button on the toolbar.

The displayed rules will be printed as a list.

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16.6 Save rules

The various rules that have been registered can be saved to a single file.
Follow the steps below to save the rules.

Note:
• As part of good laboratory practices, rules should be saved during initial installation of
instrument and any time there are updates or changes to rules.
• Saved file should be stored in a location so it is readily accessible.

1 Click the [File] - [Backup] button on the toolbar.

The [Save As] dialog box appears.

2 Specify or create the folder to save the rules into.

Note:
Even if the simple settings are used for the [Validation Rule] or [Output Rule], any content
registered in the rule screen will be saved.

3 Check a file name.

The file extension is “.rule".

Note:
The default file name is "[XR][Software version][Rule][Date of save_Time of save].rule".
e.g.: [XR][00-01 (Build 2)][Rule][20210118_144511].rule

4 Click [Save].
All registered rules are saved.

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16.7 Restore saved rules

Saved rules can be restored.
Follow the steps below to restore saved rules.

1 Click the [File] - [Restore] button on the toolbar.

The dialog box on the right appears.
* The rules that appear vary depending on the instrument
that is used.

2 Select the checkboxes of the rules that you wish to restore.

3 Click [OK].
The [Open File] dialog box appears.

4 Select the file that you wish to restore.

The file extension is ".rule".

5 Click [Open].
The dialog box on the right appears.

6 Click [Yes].
The rules are restored.

Note:
Rule sorting settings and simple settings are retained even when rules are restored.

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16.8 Initialize rules

Rules that have been set can be initialized.
Follow the steps below to initialize rules.

1 Click the [File] - [Initialize] button on the toolbar.

The dialog box on the right appears.
* The rules that appear vary depending on the instrument
that is used.

2 Select the checkboxes of the rules that you wish to initialize.

3 Click [OK].
An initialization confirmation dialog box appears.

4 Click [Yes].
The rules are initialized.

Note:
Rule sorting settings and simple settings are retained even when the rules are initialized.

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Chapter 17 Checking the History

17.1 About the history screen

Clicking the [History] icon in the Menu screen displays the following screen.
In the following screen, the error log tab appears.

Toolbar

Font size
button

History
list

Display-switching tabs
[History] screen

Toolbar
[Input] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted.
If there is an existing comment, any new comments entered are appended after the
previously entered comment.
[Filter] Click to display a dialog that allows you to specify the conditions for the data you
want displayed in the history list.
[Output] Click to display a submenu that allows you to specify the output destination.
[Upper] Click to move up one data.
[Lower] Click to move down one data.
[File] Click to display a submenu that allows you to save and restore data.
[Close] Click to close the [History] screen.

Font size button

To change the size of the characters and the line height in the history list, click the font size button.
To change the size setting of the characters, see the following:
(➤P.367 "Chapter 15: 15.3.3 Display settings")

Navigating the screen

You can switch between the screens by clicking the display-switching tab.

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17.1.1 About the history list

The items in the history list change depending on which tab is selected.

● Operation history screen

Displays a history of operations performed in the device.
A maximum of 5,000 entries are stored and displayed in the operation history. The operation history tab is
similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.429 "17.1 About the history screen")

[Date] Displays the date and time at which the history data was registered.
[Logon Name] Displays the user name that was logged in when the history data was registered.
[Operation Name] Displays the name of the operation performed.
[Details] Displays the details of the operation performed.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

The history list displays the following operators under respective conditions.

Operator Display condition

[Logon] When a user logs on.

[Logoff] When a user logs off.

[Modify Sample No.] When the sample number of an analysis data is modified.

[Modify Pos. -> Neg.] When the judgment of an analysis data is changed from Positive to Negative.

[Modify Neg. -> Pos.] When the judgment of an analysis data is changed from Negative to Positive.

[Modify Sample Inf.] When the sample information of an analysis data is modified.

[Modify Patient ID] When the patient ID of an analysis data is modified.

[Delete Analysis Data] When an analysis data is deleted*1.

[Register QC File] When a QC file is registered.

[Modify QC Lot] When QC lot attributes (expiration date and lot number) are changed.

[Modify QC Target/ When a QC target is changed.

Limit]

[Delete QC File] When a QC file is deleted.

[Delete QC Plot] When a QC plot is deleted.

[Delete Analysis When an analysis order is deleted*1.

Registration]
[Execute Calibration] When a compensation rate is changed.
[Change Settings] When a setting is changed in the [IPU Setting] or [Analyzer Settings] dialog box,
and when the [Backup settings] are changed in the [Schedule settings] dialog box.
[Restore Settings] When a saved setting is restored in the [IPU Setting] or [Analyzer Settings] dialog box.

[Input Comment(s)] When a comment is entered in an on-line manual.

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Operator Display condition

[Delete Comment(s)] When a comment is deleted from an on-line manual.

[Validate Comment(s)] When a comment is approved in an on-line manual.

[Initialize Comment(s)] When a comment is initialized in an on-line manual.

[Restore Comment(s)] When a saved comment is restored to an on-line manual.

[Initialize Settings] When a setting is initialized in the [IPU Setting] or [Analyzer Settings] dialog box.

[Register Rule] When a rule is registered in the rules screen.

[Modify Rule] When a rule is modified in the rules screen.

[Delete Rule] When a rule is deleted in the rules screen.

[Restore Rule] When a saved rule is restored in the rules screen*2.

[Initialize Rule] When a rule is initialized in the rules screen.

[Enable Rule Settings] When a setting for a rule is enabled.

[Disable Rule Settings] When a setting for a rule is disabled.

*1 A deletion is not logged if a data was automatically deleted because the maximum number of registered data
was exceeded.
*2 The history is displayed by rule type.

● Error Log screen

A history of errors that occurred is displayed with information at the time of occurrence and clearance. Double-
click the error history to display a section of the "Instructions for Use" manual that explains the selected error.
(➤P.525 "Chapter 19: 19.4 Causes of errors and remedial actions")
A maximum of 5,000 entries are stored and displayed in the error log. For the details on the display of the error
log tab, see below.
(➤P.429 "17.1 About the history screen")

[Date] Displays the date and time at which the history data was registered.
[Logon Name] Displays the user name that was logged in when the history data was registered.
[Location] Displays the name of location where the error occurred.
[Status] Displays the status of the error that occurred.
[Occurred]: Error
[Clear]: Error cleared
[ERR.] Displays the message of the error that occurred.
[Error Code] Displays the error code of the error that occurred.
[Parameter 1] / Displays parameter 1 to 4 of the error that occurred.
[Parameter 2] / Depending on the type of error, this field may be blank.
[Parameter 3] /
[Parameter 4]
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

For details on errors, see Chapter 19.

(➤P.511 "Chapter 19: Troubleshooting")

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● Reagent Replacement Log screen

Displays a history of reagent replacement, and any information that was entered at the time of replacement.
A maximum of 5,000 entries are stored and displayed in the reagent replacement log. The reagent replacement
log tab is similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.429 "17.1 About the history screen")

[Date] Displays the date and time at which the history data was registered.
[Logon Name] Displays the user name that was logged in when the history data was registered.
[Analyzer Nickname] Displays the name of the analyzer for which the reagent was replaced.
[Reagent] Displays the name of the replaced reagent.
[Lot No.] Displays the lot number of the replaced reagent.
[Serial No.] The serial number within the lot of the replaced reagent appears.
[Exp. Date] Displays the expiration date of the replaced reagent.
[Shelf life after Displays the shelf life of the replaced reagent after it has been opened.
opening]
[Capacity] If a diluent or a hemolytic agent was replaced, the amount of the replaced reagent is
displayed.
If a dye was replaced, the number of tests for the replaced reagent is displayed.
[Entry Type] Displays the method of input for the replaced reagent.
[Manual]: Manual
[Barcode]: Barcode reader
[RFID]: ID reader of the dye
[ProductCode] Displays the entered part code.
[Manufacturer] Displays the entered manufacturer.
[Address] Displays the entered manufacturer's address.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

For details on replacing reagents, see the following:

(➤P.475 "18.4 Replace reagents")

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● Maintenance Log screen

Displays a history of maintenance tasks executed with information at the time of execution.
A maximum of 5,000 entries are stored and displayed in the maintenance log. The maintenance log tab is
similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.429 "17.1 About the history screen")

[Date] Displays the date and time at which the history data was registered.
[Logon Name] Displays the user name that was logged in when the history data was registered.
[Analyzer Nickname] Displays the name of the analyzer for which the maintenance task was executed.
[Maintenance] Displays the name of the maintenance task executed.
[Maintenance Displays the attributes of the maintenance task executed.
Property]
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

A maintenance log entry is registered when the following maintenance task is performed.
The following are the maintenance tasks and attributes displayed.

Maintenance Task Maintenance Attributes

Auto Rinse As needed

Cleaning As needed

Shutdown Daily

Drain Waste Chamber As needed

Rinse Waste Chamber As needed

Remove Flowcell Air Bubbles As needed

Rinse Flowcell As needed

Drain Reaction Chamber As needed

Drain RBC Isolation Chamber As needed

Remove Clogs As needed

Reagent Replenishment As needed

Drain Reagent As needed

Adjust Pressure As needed

For details on maintenance, see the following:

(➤P.443 "18.1.1 List of maintenance items")

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17.1.2 Specify conditions for the history to display (filter)

You can specify conditions for the log entries you want displayed in the history list.
Follow the steps below to specify conditions for the log entries you want displayed.

1 Click the [Filter] button on the toolbar.

The following dialog box appears.

Condition specification area

e.g. Filter of Error log

2 Populate the displayed fields.

The following items are displayed in the dialog box.

[Use Filter] Selecting this checkbox will display only the log entries that match the specified
conditions.
If you clear the checkbox, the settings will be grayed out and cannot be selected.
[Specify Date] Select this checkbox to restrict the data to display by date.
[Starting Day] / Click to select [Today], [Yesterday] or [Specify].
[Ending Day] Selecting [Specify] allows you to specify the date. In the field below [Specify],
enter the date in the format "Year (4 digits)/Month (2 digits)/Date (2 digits)". If you
click the button on the right edge of the input field, a calendar appears. You can
also enter the date by selecting from this calendar.
[Specify Logon Name] Select this checkbox to specify the data to display by logon name.
Click to select the logon name to display. You can only select one user.
Condition specification The displayed buttons are different depending on the displayed screen.
area By selecting the checkbox displayed at the top, you can use the condition
displayed on the button.
Below each button, items that can be selected by each condition are displayed.
[Specify Displayed when the operation history screen is open.
Operation] Select this checkbox to restrict the data to display by operation name.
Selecting the checkbox below the button displays the selected operation name.
You can select multiple operators.

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[Specify Displayed when the error history screen is open.

Location] Select this checkbox to restrict the data to display by location.
Selecting the checkbox below the button displays the selected location. You can
select multiple locations.
[Specify Error] Displayed when the error history screen is open.
Select this checkbox to restrict the data to display by error type.
Selecting the checkbox below the button displays the selected error type. You can
select multiple error types.
[Specify Displayed when the reagent replacement screen or maintenance log screen is
Analyzer] open.
Select this checkbox to restrict the data to display by analyzer.
Selecting the checkbox below the button displays the selected analyzer. You can
select multiple analyzers.
[Specify Displayed when the Reagent Replacement Log screen is open.
Reagent] Select this checkbox to restrict the data to display by reagent.
Selecting the checkbox below the button displays the selected reagent. You can
select multiple reagents.
[Specify Displayed when the Maintenance Log screen is open.
Maintenance] Select this checkbox to restrict the data to display by maintenance type.
Selecting the checkbox below the button displays the selected maintenance type.
You can select multiple maintenance types.

3 Click [OK].
The dialog box closes.
The log entries that match the specified conditions are displayed in the history list.

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17.1.3 Output history to a printer

You can output the history list to a connected printer.
Click the [Output] button - [Ledger (LP)] on the toolbar. The history list is output from the ledger printer.

17.1.4 Save history in CSV format.

You can save the history list as a CSV file.
Follow the steps below to save the history in CSV format.

1 Click the [File] button - [Output in CSV Format] on the toolbar.

The [Save As] dialog box appears.

2 Specify the folder to save to, or create a new folder.

3 Enter the file name.

The file extension is ".csv".

4 Click [Save].
The CSV data is saved.

Note:
When the dialog box opens, the files names are pre-entered as follows:
• XR_SoftwareVersion_AUDITLOG.csv (Operation history)
• XR_SoftwareVersion_ERRORLOG.csv (Error Log)
• XR_SoftwareVersion_REAGENTLOG.csv (Reagent Replacement Log)
• XR_SoftwareVersion_MAINTENANCELOG.csv (Maintenance Log)

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17.2 About the RU history screen

Clicking the [RU Log] icon in the Menu screen displays the following screen.
In the following screen, the error log tab appears.

Toolbar
Font size
button

RU
history
list

Display-switching tabs
[RU Log] screen

Toolbar
[Input] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.
[Filter] Click to display a dialog that allows you to specify the conditions for the data you
want displayed in the RU history list.
[Output] Click to display the submenu for selecting the output destinations.
[Upper] Click to move up one data.
[Lower] Click to move down one data.
[File] Click to display a submenu that allows you to save and restore data.
[Close] Click to close the [RU Log] screen.

Font size button

To change the size of the characters and the line height in the RU history list, click the font size button.
To change the size setting of the characters, see the following:
(➤P.367 "Chapter 15: 15.3.3 Display settings")

Navigating the screen

You can switch between the screens by clicking the display-switching tab.

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17.2.1 About the RU history list

The items in the RU history list change depending on which tab is selected.

● Preparation history screen

Displays a history of reagent preparation performed on the RU and related information.
A maximum of 2,000 entries are stored and displayed in the preparation history. The preparation history log tab
is similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.437 "17.2 About the RU history screen")

[RU Name] Name of the RU for which the history was stored*.
[Result] Shows the result of reagent preparation as [OK] or [Fail].
[Temperature] Temperature when reagent preparation was completed.
[Conductivity] Conductance when reagent preparation was completed.
[Reference Value] AD value of the reference voltage when reagent preparation was completed.
[Electrode Value] AD value of the electrode voltage when reagent preparation was completed.
[Thermistor Value] AD value of the thermistor voltage when reagent preparation was completed.
[Date] Date when the history was stored.
[Time] Time when the history was stored.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

* The name set in [RU Name Settings] appears.

For the details on the settings, see below.
(➤P.341 "Chapter 15: 15.2.5 Reagent unit (RU-20) name setting")

● RO water history screen

Displays a history of RO water analysis performed on the RU and related information.
A maximum of 2,000 entries are stored and displayed in the RO water history. The RO water history log tab is
similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.437 "17.2 About the RU history screen")

[RU Name] Name of the RU for which the history was stored*.
[Result] Result of RO water analysis.
[OK]: Normal
[WA]: Warning value
[Fail]: Abnormal value
[Temperature] Temperature when the history was stored.
[Conductivity] Conductance when the history was stored.
[Reference Value] AD value of the reference voltage when the history was stored.
[Electrode Value] AD value of the electrode voltage when the history was stored.
[Thermistor Value] AD value of the thermistor voltage when the history was stored.

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[Type] Conditions when the history was stored.

[Start Supply]: First measurement value when supply to RO water chamber started
(the valve was switched).
[End Supply]: Last measurement value when supply to RO water chamber ended
(the valve was switched).
[Fixed Period]: Measurement values every 5 minutes when the time from start to
end of supply exceeds 5 minutes.
[Range Error]: First measurement value outside the monitor level (two types:
abnormal range / warning range) during supply.
[Restore]: First measurement value that returned to the monitor level (two
types: abnormal range / warning range) during supply.
[Supply Direction] RO water supply direction when the history was stored.
[Chamber]: Measurement value during supply to RO water chamber.
[Drain]: Measurement value during draining from RO water chamber.
[Supply Direction] is shown as [---] when the [Result] is [Fail] or [WA] and the [Type]
is [Range Error].
[Date] Date when the history was stored.
[Time] Time when the history was stored.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.
* The name set in [RU Name Settings] appears.
For the details on the settings, see below.
(➤P.341 "Chapter 15: 15.2.5 Reagent unit (RU-20) name setting")

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● Error Log screen

A history of errors that occurred is displayed with information at the time of occurrence and clearance.
A maximum of 2,000 entries are stored and displayed in the error log. For the details on the display of the error
log tab, see below.
(➤P.437 "17.2 About the RU history screen")

[RU Name] Name of the RU for which the history was stored*.
[Date] Date when the history was stored.
[Time] Time when the history was stored.
[Status] Displays the status of an error that occurred.
[ERR.]: Error has occurred.
[Restore]: System restored from error.
[Error] Displays the description of the error.
[Error Code] Displays the error code of the error that occurred.
[Parameter 1] / Displays parameter 1 and parameter 2 of the error that occurred.
[Parameter 2] Depending on the type of error, this field may be blank.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

* The name set in [RU Name Settings] appears.

For the details on the settings, see below.
(➤P.341 "Chapter 15: 15.2.5 Reagent unit (RU-20) name setting")

For details on errors, see Chapter 19 or the RU-20 "Instructions for Use".
(➤P.511 "Chapter 19: Troubleshooting", RU-20 Instructions for Use "Chapter 7 Troubleshooting")

● Reagent Replacement Log screen

Displays a history of reagent replacement, and any information that was entered at the time of replacement.
A maximum of 200 entries are stored and displayed in the reagent replacement log. The reagent replacement
log tab is similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.437 "17.2 About the RU history screen")

[RU Name] Name of the RU for which the history was stored*.
[Reagent] Displays the name of the replaced reagent.
[Lot No.] Displays the lot number of the replaced reagent.
[Serial No.] The serial number within the lot of the replaced reagent appears.
[Exp. Date] Displays the expiration date of the replaced reagent.
[Shelf life after opening] Displays the shelf life of the replaced reagent after it has been opened.
[Capacity] The amount of the replaced reagent is displayed.
[Input Method] Displays the method of input for the replaced reagent.
[Manual]: Manual
[Barcode]: Barcode reader
[ProductCode] Displays the entered part code.
[Manufacturer] Displays the entered manufacturer.
[Address] Displays the entered manufacturer's address.
[Date] Date when the history was stored.

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[Time] Time when the history was stored.

[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.
* The name set in [RU Name Settings] appears.
For the details on the settings, see below.
(➤P.341 "Chapter 15: 15.2.5 Reagent unit (RU-20) name setting")

For details on replacing reagents, see the following:

(➤P.480 "18.4.4 Replace with new CELLPACK DST")

● Part Replacement Log screen

This displays the part replacement log.
A maximum of 200 entries are stored and displayed in the part replacement history. The part replacement
history tab is similar to the error log tab. For the details on the display of the error log tab, see below.
(➤P.437 "17.2 About the RU history screen")

[RU Name] Name of the RU for which the history was stored*.
[Description] Information on replaced parts appears.
[Filter], [DP1], [DP2] and [Reagent Conductivity Calibration] appear.
[Date] Date when the history was stored.
[Time] Time when the history was stored.
[Comments] Click to display a dialog box that allows you to enter a comment.
You can enter up to 50 characters. Once the comment is entered, it cannot be edited
or deleted. If there is an existing comment, any new comments entered are
appended after the previously entered comment.

* The name set in [RU Name Settings] appears.

For the details on the settings, see below.
(➤P.341 "Chapter 15: 15.2.5 Reagent unit (RU-20) name setting")

For details on part replacement, see the RU-20 "Instructions for Use".
(➤RU-20 Instructions for Use "Chapter 6: 6.4.2 Replacing a maintenance part")

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17.2.2 Output RU history to a printer

You can output the RU history list to a connected printer.
Click the [Output] button - [Ledger (LP)] on the toolbar. The RU history list is output from the ledger printer.

17.2.3 Save RU history in CSV format.

You can save the RU history list as a CSV file.
Follow the steps below to save the RU history in CSV format.

1 Click the [File] button - [Output in CSV Format] on the toolbar.

The [Save As] dialog box appears.

2 Specify the folder to save to, or create a new folder.

3 Enter the file name.

The file extension is ".csv".

4 Click [Save].
The CSV data is saved.

Note:
When the dialog box opens, the files names are pre-entered as follows:
• XR_SoftwareVersion_RU_QUALITYLOG.csv (Preparation Log)
• XR_SoftwareVersion_RU_ROWATERLOG.csv (RO water Log)
• XR_SoftwareVersion_RU_ERRORLOG.csv (Error Log)
• XR_SoftwareVersion_RU_REAGENTLOG.csv (Reagent Replacement Log)
• XR_SoftwareVersion_RU_PARTSLOG.csv (Part Replacement Log)

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Chapter 18 Performing Maintenance of Instrument and

Replacing Supply Parts

This chapter explains an overview of the maintenance tasks for the instrument and explains how to perform
those tasks, including the replacement of reagents and supply parts.

18.1 Introduction
Regular maintenance is necessary to keep the instrument in the most optimal condition. Please perform the
appropriate maintenance tasks according to this chapter. In addition, whenever you perform a maintenance task, log
it in the maintenance inspection checklist. (➤P.497 "18.6 Maintenance inspection checklist")
To perform maintenance, the analyzer and the sampler must be in READY state. Otherwise, maintenance cannot be
performed. In addition, analysis is not possible during maintenance.

18.1.1 List of maintenance items

Maintenance tasks can be categorized into daily tasks, and tasks that are performed on an as need-basis.
Below is a list of maintenance tasks.

Daily maintenance tasks

• Shutdown (➤P.447 "18.2.1 Shutting down the instrument")

Maintenance tasks performed as needed

• Replacing waste container (➤P.447 "18.3.1 Replace the waste container")
• Automatic rinsing (➤P.449 "18.3.2 Perform auto rinse")
• Cleaning (➤P.451 "18.3.3 Perform cleaning")
• Remove an RBC detector clog (➤P.453 "18.3.4 Clog removal from the RBC detector")
• Cleaning RBC detector aperture (➤P.454 "18.3.5 Rinse the RBC detector aperture")
• Draining the waste chamber (➤P.458 "18.3.6 Drain the waste chamber")
• Rinsing the waste chamber (➤P.458 "18.3.7 Rinse the waste chamber")
• Removing flowcell air bubbles (➤P.460 "18.3.8 Remove air bubbles from flowcell")
• Rinsing flowcell (➤P.461 "18.3.9 Rinse flowcell")
• Draining reaction chamber (➤P.463 "18.3.10 Drain the reagent from the reaction chamber")
• Draining RBC isolation chamber (➤P.463 "18.3.11 Drain the reagent from the RBC isolation chamber")
• Adjusting the pressure (0.25 MPa) (➤P.464 "18.3.12 Adjust the pressure (0.25 MPa)")
• Adjusting the pressure (0.16 MPa) (➤P.466 "18.3.13 Adjust the pressure (0.16 MPa)")
• Adjusting the pressure (0.07 MPa) (➤P.468 "18.3.14 Adjust the pressure (0.07 MPa)")
• Discarding sample residue from the sample tube holder (➤P.471 "18.3.15 Discard sample residue from the
sample tube holder")
• Draining the pneumatic trap chamber (➤P.472 "18.3.16 Drain the pneumatic trap chamber")
• Replacing piercer (➤P.474 "18.3.17 Replace the piercer")
• Draining the reagent (➤P.488 "18.4.7 Drain the reagent")

Caution!
Always use CELLCLEAN AUTO for all cleaning and maintenance tasks that require a cleaning
agent, and do not use any other cleaning agent.
Failure to do so could result in insufficient cleaning effect.

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Replacing reagents and supply parts

• Replacing reagents (➤P.475 "18.4.1 List of reagents", P.475 "18.4.2 About [Reagent Replacement] dialog
box")
• Replacing a new dilution/hemolytic agent
(➤P.477 "18.4.3 Replace a new dilution/hemolytic agent", P.480 "18.4.4 Replace with new CELLPACK
DST")
• Replacing a new dye (➤P.483 "18.4.5 Replace a new dye")
• Replenishing reagents (➤P.486 "18.4.6 Replenish reagents")
• Reagent replacement history (➤P.490 "18.4.8 Check the reagent replacement history")
• Replacing fuse (➤P.490 "18.5 Replace the fuse")

Time required (per analyzer)

The time guidelines for the procedure of maintenance are as shown below.

Maintenance Task Time

Shutdown About 15 minutes

Cleaning About 20 minutes

Rinsing the waste chamber About 15 minutes

Rinsing flowcell About 10 minutes

18.1.2 Maintenance menu

Analyzer Maintenance menu

You can perform specific maintenance tasks, operation checks, and operation test, using the Maintenance
menu.
Follow the steps below to display the Maintenance menu.

1 Click the Analyzer menu button on the control menu.

The menu on the right appears.

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2 Click [Maintenance].
The submenu on the right appears.

Note:
• For the details on operation checks, see Chapter 18. (➤P.505 "18.8 Check the status of the
device")
• For the details on operation test, see Chapter 18. (➤P.498 "18.7 Test proper operation of the
device")

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RU-20 Maintenance menu

When using the RU-20, special maintenance and settings can be performed in the RU-20 Maintenance menu.
Follow the steps below to display the RU-20 Maintenance menu.

1 Click the RU menu button on the control menu.

The dialog box on the right appears.

Submenu
button

2 Click the submenu button.

The submenu on the right appears.

Note:
For the details on the settings, see below.
(➤P.394 "Chapter 15: 15.5 RU-20 Reagent Unit Settings")

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18.2 Daily maintenance tasks

18.2.1 Shutting down the instrument

Turn OFF each analyzer after rinsing. Be sure to perform shutdown once a day and turn OFF the analyzer and
IPU.
For details, see Chapter 8.
(➤P.121 "Chapter 8: 8.5 Shutdown")

18.3 Maintenance tasks performed as needed

If an error occurs that requires maintenance, the help dialog box appears in the IPU screen. Perform the necessary
maintenance tasks according to the message shown in the action field in the help dialog box.
For the details on the help dialog box, see Chapter 19.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")

18.3.1 Replace the waste container

If you are using waste tank full sensor and waste container becomes full, the help dialog box appears in the IPU
screen.

Risk of infection
Use caution to prevent waste from splattering.

Caution!
• Install the waste tank below the bottom of the analyzer.
• When automatic startup is enabled, discard the waste fluid in the waste tank at the end of
analysis of the day.
Otherwise, waste fluid may overflow at the time of automatic startup.

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Follow the steps below to replace the waste container.

1 Prepare an empty waste container and remove the cap.

2 Loosen the cap on the waste container you want to exchange by turning it in
the direction of the arrow.

3 Lift the cap straight up with the tube connected.

For disposing a waste container, see Chapter 2. (➤P.27
"Chapter 2: 2.9 Disposal of materials")

4 Insert the cap straight into the new waste container, with the tube connected.

5 Attach the cap by turning it in the direction that is opposite of the direction in
step 2.

6 Click [Accept] in the help dialog box.

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18.3.2 Perform auto rinse

Automatic analyzer rinse

You can automatically perform rinsing of the analyzer and the post-rinse background check.
If a background check error occurs, a help dialog will appear on the IPU screen.
Follow the procedure below to perform automatic rinsing.

1 Click the Analyzer menu button on the control menu.

The menu on the right appears.

2 Click [Auto Rinse].

The menu automatically closes, [Auto Rinse] appears in the control menu
and auto rinse starts. Progress is shown as a progress bar on the screen.
Wait until it is complete. Once complete, [Auto Rinse] disappears and the
background check begins.
For the details on background check, see Chapter 8.
(Background check ➤P.118 "Chapter 8: 8.2.4 Execution of analyzer self-check")

In [Body Fluid] mode, the background check for body fluid analysis starts*.
For the details on background check of body fluid mode, see Chapter 11.
(➤P.209 "Chapter 11: 11.7 Body fluid analysis")
* The body fluid analysis can only be performed if the license is activated.

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Automatic RU-20 rinse

When using the RU-20, follow the steps below to perform automatic rinsing.
In the event that a reagent preparation problem occurs, the partially prepared reagent can be drained and the
interior of the RU-20 automatically rinsed.
When automatic rinsing is performed, the prepared reagent in the supply tank is not drained.
Follow the procedure below to perform automatic rinsing.

1 Display the RU-20 Maintenance menu.

(➤P.446 "RU-20 Maintenance menu")

2 Click [Auto Rinse].

The dialog box on the right appears.

3 Click [Execute].
The dialog box automatically closes, [Maintenance in progress] appears in the operation status display area of
the help dialog box, and automatic rinsing begins. For the operation status display area, see Chapter 19.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")
Wait until it is complete. When it is complete, [Maintenance in progress] disappears.

4 Click [Cancel].
The dialog box closes.

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18.3.3 Perform cleaning

If the error is not cleared after automatic rinsing is performed, perform cleaning. In addition, when analysis is
performed 1,000 times since the last cleaning or shutdown, and cleaning is required, a help dialog box will
appear on the IPU screen.
You can clean the optical detector block and hydraulic circuit with CELLCLEAN AUTO.
Follow the steps below to perform cleaning.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green, wait until it is.

Status
indicator
LED

2 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

3 Click [Cleaning].
The window on the right appears.

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4 If the tube holder is not ejected, press the mode switch on the analyzer.
The tube holder slides out forward.

Mode switch

5 Place the CELLCLEAN AUTO in the sample tube holder.

Place it in the front holder, when you face the analyzer.

6 Press the start switch on the analyzer.

The tube holder retracts into the analyzer and aspiration begins.
Wait until it is complete.
When the process ends, cleaning starts and the tube holder is
ejected.
Cleaning takes about 20 minutes. Progress is shown as a
progress bar on the screen. Wait until it is complete.

Start switch

7 Remove the CELLCLEAN AUTO.

8 Press the mode switch on the analyzer.

The tube holder slides into the analyzer.
Once cleaning is complete, auto rinse starts automatically. (➤P.449 "18.3.2 Perform auto rinse")
Wait until it is complete. When it is complete, the window closes automatically.

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18.3.4 Clog removal from the RBC detector

If the RBC detector is clogged or air bubbles have formed, a help dialog will appear on the IPU screen.
Follow the procedure below to remove the clog from the RBC detector.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Remove RBC Detector Clog].

The window appears, and the removal of the clog starts. Progress is shown as a progress bar on the screen.
Wait until it is complete. When it is complete, the window closes automatically.

Note:
If the clog cannot be removed with this operation, see below.
(➤P.454 "18.3.5 Rinse the RBC detector aperture")

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18.3.5 Rinse the RBC detector aperture

If the removing the clog from the RBC detector does not remove all the clog or clear the error, rinse the RBC
detector aperture.

Warning!
Never touch the detector when the power of the Main Unit is turned ON.
An electrical shock could occur.

Caution!
• When closing the detector cover, take care not to kink the tube.
Otherwise, it may lead to incorrect analysis.
• When rinsing the detector aperture, use the supplied unclogging brush and lightly tap on the
detector aperture.
Excessive force will damage the detector aperture.

Follow the steps below to rinse the RBC detector aperture.

1 Open CELLCLEAN AUTO with the special CELLCLEAN AUTO opener.

With CELLCLEAN AUTO held straight as shown, press down the opener until Opener
you hear a "pop" sound.
Keep the opener attached, and remove immediately before you use
CELLCLEAN AUTO.

Caution!
• When opening CELLCLEAN AUTO, be sure to wear adequate personal protective equipment,
such as protective gloves, a protective mask, protective eyewear, and a lab coat.
• Press down slowly so that the content fluid does not splash.
• Store opened CELLCLEAN AUTO standing on the rack with the opener attached.
If CELLCLEAN AUTO is tilted, the content fluid may leak even when the opener is attached.

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2 Shutting down analyzer for maintenance.

Shut down the instrument and switch off the main power switch.
For analyzer shutdown procedures, see Chapter 8.
(➤P.125 "Chapter 8: 8.5.3 Shutting down the analyzer manually")

Note:
When [IPU Shutdown] is set to ON, the IPU shuts down automatically after all analyzers
connected to the IPU have shut down. If you do not want to shut down the IPU, set [IPU
Shutdown] to OFF before executing shutdown.

3 Open the top front cover.

Open to the highest point. It may move down.

4 Loosen the screw that is holding the detector cover in place.

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5 Remove the detector cover.

Lift it temporarily, and pull it out toward you.

Detector cover
Detector cover

6 Pull out the lid of the detector chamber by turning it in the direction of the arrow.

Detector chamber

7 Soak the supplied unclogging brush in the content fluid of

CELLCLEAN AUTO, and wash the detector aperture by lightly tapping it.

Note:
If fluid spills, wipe off the spilled fluid with a piece of tissue paper.

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8 Insert the detector chamber cap straight in, and turn in the direction of the arrow.
Insert the detector chamber cap all the way in and
attach in the position as shown in the diagram to the
right.

Caution!
If the detector chamber cover is not properly attached, correct analysis results will not be obtained.
There is also a risk of instrument damage due to fluid leakage.

9 Attach the detector cover and secure with the screw.

10 Close the top front cover.

11 Turn ON the analyzer's power.

For procedures to restart the analyzer, see Chapter 8. (➤P.128 "Chapter 8: 8.6 Restart the analyzer")

Note:
• Wash the brush and opener well and store in a clean state.
Risk of instrument malfunctioning if there are small particles or other contaminants on the
brush or opener.
• CELLCLEAN AUTO used for rinsing can be used for shutdown that day. To do so, remove the
opener from the CELLCLEAN AUTO, place in the sample tube holder, and shut down
manually.
For details, see Chapter 8. (➤P.125 "Chapter 8: 8.5.3 Shutting down the analyzer manually")

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18.3.6 Drain the waste chamber

If the waste tube from the waste chamber is clogged, a help dialog will appear on the IPU screen.
Follow the procedure below to drain waste fluid that has collected in the waste chamber.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Drain Waste Fluid Chamber].

The menu closes automatically, [Drain Waste Fluid Chamber] appears in the
control menu, and draining begins.
Wait until it is complete. When it is complete, [Drain Waste Fluid Chamber]
disappears.

Note:
If the error cannot be cleared with this operation, see below.
(➤P.458 "18.3.7 Rinse the waste chamber")

18.3.7 Rinse the waste chamber

If the error is not cleared after waste fluid is drained from the waste chamber, rinse the waste chamber. You can
clean the waste chamber with CELLCLEAN AUTO.
Follow the steps below to rinse the inside of the waste chamber.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green, wait until it is.

Status
indicator
LED

2 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

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3 Click [Rinse Waste Fluid Chamber].

The window on the right appears.

4 If the tube holder is not ejected, press the mode switch on the analyzer.
The tube holder slides out forward.

Mode switch

5 Place the CELLCLEAN AUTO in the sample tube holder.

Place it in the front holder, when you face the analyzer.

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6 Press the start switch on the analyzer.

The tube holder retracts into the analyzer and rinsing starts.
Rinsing takes about 15 minutes. Progress is shown as a
progress bar on the screen. Wait until it is complete.
When the process ends, the tube holder is ejected.

Start switch

7 Remove the CELLCLEAN AUTO.

8 Press the mode switch on the analyzer.

The tube holder slides into the analyzer.

18.3.8 Remove air bubbles from flowcell

If air bubbles have formed in the Flowcell, a help dialog will appear on the IPU screen.
Follow the procedure below to remove the air bubbles from the inside of the Flowcell.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Remove Flowcell Air Bubbles].

The window appears, and the removal of air bubbles starts. Wait until it is complete. Progress is shown as a
progress bar on the screen. When it is complete, the window closes automatically.

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18.3.9 Rinse flowcell

If the Flowcell is clogged or dirty, a help dialog will appear on the IPU screen.
Follow the procedure below to rinse the inside of the Flowcell.

1 Check the Status indicator LED on the analyzer.

If the Status indicator LED is not lit green, wait until it is.

Status
indicator
LED

2 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

3 Click [Rinse Flowcell].

The window on the right appears.

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4 If the tube holder is not ejected, press the mode switch on the analyzer.
The tube holder slides out forward.

Mode switch

5 Place the CELLCLEAN AUTO in the sample tube holder.

Place it in the front holder, when you face the analyzer.

6 Press the start switch on the analyzer.

The tube holder retracts into the analyzer and rinsing starts.
Rinsing takes about 10 minutes. Progress is shown as a
progress bar on the screen. Wait until it is complete.
When the process ends, the tube holder is ejected.

Start switch

7 Remove the CELLCLEAN AUTO.

8 Press the mode switch on the analyzer.

The tube holder slides into the analyzer.

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18.3.10 Drain the reagent from the reaction chamber

If the drain tubing in the RBC/HGB reaction chamber is clogged, the help dialog box appears in the IPU screen.
Follow the procedure below to drain reagent that has collected in the reaction chamber.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Drain Reaction Chamber].

The window appears, and draining starts. Wait until it is complete. When it is complete, the window closes
automatically.

18.3.11 Drain the reagent from the RBC isolation chamber

If the density of the reagent is inconsistent, [PLT sampling error] appears on a help dialog of the IPU screen. If
the error appears after clearing it, drain the reagent from the RBC isolation chamber.
Follow the steps below to drain the reagents that have accumulated in the RBC isolation chamber.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Drain RBC Isolation Chamber].

The window appears, and draining starts. Progress is shown as a progress bar on the screen. Wait until it is
complete. When it is complete, the window closes automatically.

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18.3.12 Adjust the pressure (0.25 MPa)

A 0.25 MPa pressure is applied to operate the master valves.
If an error message for pressure abnormality is displayed, first check the tubes to see if there is any air leakage.
If there is no abnormality in the tube, display the [Pressure Adjustment] window and adjust the pressure by
checking the numeric values.

Information
If the pressure is too high, first decrease it below the specified value, and then increase to adjust
it.

Follow the steps below to adjust the 0.25 MPa pressure. The adjustment is done in the pneumatic unit.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Pressure Adjustment].

The window on the right appears.
Each monitored pressure and its current value are displayed.

[0.25MPa] Shows the value read for 0.25 MPa.

[0.16MPa] Shows the value read for 0.16 MPa.
[0.07MPa] Shows the value read for 0.07 MPa.
[-0.04MPa] Shows the value read for -0.04 MPa. This cannot be
adjusted.

[Pressure Adjustment] window

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3 Loosen the fastening screw for the 0.25 MPa regulator on the front of the
pneumatic unit.
For the location of the regulator, see Chapter 3.
(➤P.40 "Chapter 3: 3.2 Pneumatic unit")
Loosen

Fastening
screw

4 Adjust the pressure by turning the knob on the 0.25 MPa regulator.
While checking the pressure displayed in the [Pressure
Adjustment] window, adjust the pressure to the specified Low
High
value (0.25 ± 0.04 MPa). Turn the knob clockwise to
increase the pressure, and counter-clockwise to decrease
the pressure.

Adjustment
knob

Note:
When using the RU-20, you can also check the pressure indication in the [Show Status] window
while adjusting the pressure.
(➤P.470 "Adjust the pressure of the RU-20")

5 Tighten the fastening screw of the 0.25 MPa regulator, without turning the
adjustment knob.

6 Click [Close] in the [Pressure Adjustment] window.

The window closes.

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18.3.13 Adjust the pressure (0.16 MPa)

A 0.16 MPa pressure is applied to the optical detection block to supply the sheath fluid.
If an error message for pressure abnormality is displayed, first check the tubes to see if there is any air leakage.
If there is no abnormality in the tube, display the [Pressure Adjustment] window and adjust the pressure by
checking the numeric values.

Information
If the pressure is too high, first decrease it below the specified value, and then increase to adjust
it.

Follow the steps below to adjust the 0.16 MPa pressure. The adjustment is done in the main unit.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Pressure Adjustment].

The [Pressure Adjustment] window appears. ([Pressure Adjustment] window ➤P.464 "18.3.12 Adjust the
pressure (0.25 MPa)")

3 Open the top front cover.

Open to the highest point. It may move down.

Caution!
During analysis and other times when the analyzer is in operation, never open the top front
cover.

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4 Pull out the adjustment knob on the 0.16 MPa regulator to unlock it.
For the location of the regulator, see Chapter 3.
(➤P.37 "Chapter 3: 3.1 Analyzer")

Adjustment
knob

5 Adjust the pressure by turning the knob on the 0.16 MPa regulator.
While checking the pressure displayed in the [Pressure
Low High
Adjustment] window, adjust the pressure to the specified value
(0.16 ± 0.016 MPa). Turn the knob clockwise to increase the
pressure, and counter-clockwise to decrease the pressure.

6 Push the adjustment knob on the 0.16 MPa regulator to lock it.

7 Close the top front cover.

8 Click [Close] in the [Pressure Adjustment] window.

The window closes.

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18.3.14 Adjust the pressure (0.07 MPa)

A 0.07 MPa pressure is applied to drain waste and mix the samples.
If an error message for pressure abnormality is displayed, first check the tubes to see if there is any air leakage.
If there is no abnormality in the tube, display the [Pressure Adjustment] window and adjust the pressure by
checking the numeric values.

Information
If the pressure is too high, first decrease it below the specified value, and then increase to adjust
it.

Adjust the pressure of the analyzer

Follow the steps below to adjust the 0.07 MPa pressure. The adjustment is done in the main unit.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Pressure Adjustment].

The [Pressure Adjustment] window appears.
([Pressure Adjustment] window ➤P.464 "18.3.12 Adjust the pressure (0.25 MPa)")

3 Open the top front cover.

Open to the highest point. It may move down.

Caution!
During analysis and other times when the analyzer is in operation, never open the top front
cover.

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4 Pull out the adjustment knob on the 0.07 MPa regulator to unlock it.
For the location of the regulator, see Chapter 3.
(➤P.37 "Chapter 3: 3.1 Analyzer")

Adjustment
knob

5 Adjust the pressure by turning the knob on the 0.07 MPa regulator.
While checking the pressure displayed in the [Pressure
Adjustment] window, adjust the pressure to the specified value
(0.07 ± 0.01 MPa). Turn the knob clockwise to increase the
pressure, and counter-clockwise to decrease the pressure. Low High

6 Push the adjustment knob on the 0.07 MPa regulator to lock it.

7 Close the top front cover.

8 Click [Close] in the [Pressure Adjustment] window.

The window closes.

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Adjust the pressure of the RU-20

Follow the steps below to adjust the pressure. The adjustment is done on the RU-20.

1 Display the RU-20 Maintenance menu.

(➤P.446 "RU-20 Maintenance menu")

2 Click [Show Status].

The window on the right appears.
Each monitored pressure and its current value are displayed.

[0.25 MPa] Displays the source pressure of the pneumatic unit.

[0.07 MPa]* Displays the pressure value inside the instrument.
[-0.04 MPa] Displays the vacuum value inside the instrument.

* [0.07 MPa] or [0.09 MPa] appears, depending on your conditions of use.

[Show Status] window

3 Adjust the pressure.

For the detailed procedure, see the RU-20 "Instructions for Use".
(➤RU-20 Instructions for Use, "Chapter 6: 6.2.2 Adjusting the air pressure" Step 2 and following steps)

4 Click [Close] in the [Show Status] window.

The window closes.

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18.3.15 Discard sample residue from the sample tube holder

Risk of infection
Always wear adequate personal protective equipment, such as protective gloves, a protective
mask, protective eyewear, and a lab coat when performing this work. Also, wash your hands
after completing the process.
Failure to do so may result in infection by pathogens and other infectious substances.

1 If the sample tube holder is not ejected, press the mode switch.
The tube holder slides out forward.

Mode switch

2 Remove the sample residue container from the sample tube holder.
To prevent spillage, lift up the sample residue container
straight.

Sample
residue
container

3 Discard contents of the sample residue container.

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4 Install the sample residue container to the sample tube holder in the direction
shown in the figure.

18.3.16 Drain the pneumatic trap chamber

If the pneumatic trap chamber becomes full of water, a help dialog will appear on the IPU screen.
Check if the trap chamber is full of water, and drain as needed.

Caution!
If water accumulates daily, the analyzer may have malfunctioned.
Please contact your authorized local Sysmex representative.

Follow the steps below to drain the pneumatic trap chamber.

1 Open the top front cover.

Open to the highest point. It may move down.

Caution!
During analysis and other times when the analyzer is in operation, never open the top front
cover.

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2 Remove the pneumatic trap chamber by rotating it in the direction of the

arrow.

Pneumatic trap chamber

Loosen

3 Discard water that has collected in the chamber.

4 Remove the float, and place it in the pneumatic trap chamber.

Hold the removed float in the same orientation and put it
Float
straight into the pneumatic trap chamber.

5 Attach the pneumatic trap chamber by turning it in the direction that is

opposite from step 2.

6 Close the top front cover.

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18.3.17 Replace the piercer

When the piercing count exceeds 120,000, a help dialog box will appear in the IPU screen. Promptly contact
your authorized local Sysmex representative to have the piercer replaced. Replacement will be performed by
your Sysmex service representative.
Continuing to use the old piercer will cause needle tip wear and may result in blood aspiration errors, inaccurate
data, and needle breakage.

Note:
Depending on the condition in which the device is used or the sample tube to be used, the
piercer may wear down or may be damaged before 120,000 counts of piercing. If the piercer is
damaged in any way, replace it immediately.

18.3.18 View the maintenance log

The maintenance log can be viewed. The log data shows maintenance execution information, and comments
can be entered. The log can be printed or output as a file in CSV format.
For details, see the following:
(➤P.429 "Chapter 17: 17.1 About the history screen", P.437 "Chapter 17: 17.2 About the RU history screen")

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18.4 Replace reagents

This section explains how to replace reagents.

18.4.1 List of reagents

The following reagents are used in this device. For details on each reagent, see Chapter 5.
(➤P.63 "Chapter 5: Reagents")

Product Product
Description Volume Description Volume
Code Code

DCL-300A CELLPACK DCL 20 L WNR-210A Lysercell WNR 5L

DCL-310A CELLPACK DCL 10 L WDT-200A Lysercell WDF II 4L

DST-300A CELLPACK DST 20 L WDT-210A Lysercell WDF II 5L

DST-310A CELLPACK DST 10 L WPC-200A Lysercell WPC 1.5 L

DST-320A CELLPACK DST 4L WNR-800A Fluorocell WNR 82 mL

DFL-300A CELLPACK DFL 1.5 L WDF-800A Fluorocell WDF 42 mL

DFL-310A CELLPACK DFL 1L WDF-810A Fluorocell WDF 22 mL

SLS-220A SULFOLYSER 5L WPC-800A Fluorocell WPC 12 mL

SLS-210A SULFOLYSER 500 mL RET-800A Fluorocell RET 12 mL

PLT-800A Fluorocell PLT 12 mL

Available reagent package sizes may vary in some regions. For more details please contact your local
Sysmex representative.

18.4.2 About [Reagent Replacement] dialog box

The [Reagent Replacement] dialog box allows you to check the remaining volume for reagents and replace
them.
If a reagent runs out during an analysis, the analysis is paused, and an error message appears in the analyzer
area of the Control menu. Display the [Reagent Replacement] dialog box to replace the reagent.
When using the RU-20, a help dialog box appears when CELLPACK DST runs low. See below for the procedure
for replacing CELLPACK DST.
(➤P.480 "18.4.4 Replace with new CELLPACK DST")

Note:
Even when an error message does not appear, the steps below can be used to open the
[Reagent Replacement] dialog box.
• Click the analyzer menu button in the control menu, and click [Reagent Replacement].
• Click the reagent level display in the control menu.

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Follow the steps below to display the [Reagent Replacement] dialog box.

1 Click the help button on the control menu.

Help dialog box appears.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")

2 Click [Execute].
The following dialog box appears, and the reagent remaining volume indicator appears.

Barcode reader icon

Shared reagent icon

Shelf life after
opening
Lot No.
Remaining
volume graph
Reagent state
Reagent name

Barcode reader Indicates that the Reagent Code (barcode) can be scanned to enter reagent information.
icon
Shared reagent Indicates that the reagent is shared. The icon is displayed when the reagent is shared by
icon 2 analyzers on the XR-2000.
Shelf life after Display the shelf life of the reagent after opening. This is not displayed if the reagent has not
opening been registered. When the shelf life after opening has expired, it is displayed in white letters
on a red background.
Lot No. Displays the lot number of the reagent.
Reagent state Displays the remaining number of tests for the reagent. (Only the remaining level of
[CELLPACK DCL] reagent will be displayed.)
The remaining number of tests is only an approximation. It can change with use conditions.
This is not displayed if the reagent has not been registered. When the reagent runs low, the
background becomes yellow. During diluent or hemolytic agent replacement, progress is
indicated as "0 to 100 %".
Reagent name Displays the reagent name.
Remaining Displays the remaining volume of the reagent as a graph. This is not displayed if the
volume graph reagent has not been registered, or if the reagent has run out.

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18.4.3 Replace a new dilution/hemolytic agent

This section explains how to replace the following reagents.

• CELLPACK DCL, CELLPACK DFL

• SULFOLYSER
• Lysercell WNR, Lysercell WDF II, Lysercell WPC

See below for the procedure for replacing CELLPACK DST.

(➤P.480 "18.4.4 Replace with new CELLPACK DST")
For cautions while replacing reagents, see Chapter 5. (➤P.63 "Chapter 5: Reagents")

Caution!
• Install the reagent at a height no more than 1 meter above or below the bottom of the analyzer.
Do not put reagents on top of the instrument.
• The new reagent must to be left for at 24 hours at room temperature (15 to 30 °C).
• If reagent spills, immediately wipe it off using wet cloth or the like.

Note:
When using the XR-2000, the reagent shared by 2 analyzers is called a shared reagent. If the
shared reagent is replaced in one of the analyzers, the reagent is automatically replaced in the
other analyzer.

If a dedicated wagon is used, the reagent for the analyzer is stored in the area below. When replacing the
reagent pull out the reagent storage slowly.

SULFOLYSER,
Lysercell WPC,
CELLPACK DFL

CELLPACK DCL Lysercell WNR,

Reagent storage Lysercell WDF II

e.g. XR-2000

* The above diagram is an example.

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Warning!
• Open and close the storage using the handle on the dedicated wagon.
• When opening or closing the storage, watch your fingers.
• Because the dedicated wagon is carrying the reagent, it is very heavy. When pulling out and
pushing in the storage, do so slowly with care.

Follow the steps below to replace the reagent.

1 Display the [Reagent Replacement] dialog box.

(➤P.475 "18.4.2 About [Reagent Replacement] dialog box")

2 Turn and remove the cap from the new reagent container.
Check that the reagent has not expired.

3 Input the reagent code (barcode).

When you enter the Reagent Code (barcode), the [Reagent Replacement] dialog box will display [Received].
When using the XR-2000, if the [Received] reagent contains a shared reagent, all the [Received] reagents in the
2 analyzers will be replaced when you click [Execute]. Set all reagents you want to replace in the 2 analyzers to
[Received].

Input by barcode scanning

Scan the reagent code (barcode) on the outer box of the
new reagent with hand-held barcode reader.
Reagent Code (barcode) is as shown the right illustration.

Manual input
Click the name of the reagent to be replaced in the [Reagent Replacement] dialog box.
Enter the reagent code (barcode) and click [OK].

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4 Turn and remove the cap from the old reagent container.

e.g. CELLPACK DCL (20 L)

5 Pull out the dispensing set straight up.

6 Insert the dispensing set straight into the new reagent container.

7 Turn and attach the cap.

8 Click [Execute].
The replacement of the reagent starts. Wait until it is complete. When it is complete, the dialog box closes
automatically.
The time guidelines for replacement of the reagent are as shown below.

Reagent name Time Time*

CELLPACK DCL About 1 and a half minutes Maximum 7 and a half minutes
SULFOLYSER About 2 minutes
CELLPACK DFL About 1 minute
Lysercell WPC
About 3 minutes
Lysercell WDF II
About 1 and a half minutes
Lysercell WNR

* When using the reservoir tank.

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18.4.4 Replace with new CELLPACK DST

This section explains the procedure for replacing the CELLPACK DST when using the RU-20.
For cautions while replacing reagents, see Chapter 5. (➤P.63 "Chapter 5: Reagents")

Caution!
• Install the reagent at a height no more than 1 meter above or below the bottom of the analyzer.
Do not put reagents on top of the instrument.
• The new reagent must to be left for at 24 hours at room temperature (15 to 30 °C).
• If reagent spills, immediately wipe it off using wet cloth or the like.

If a dedicated wagon is used, the CELLPACK DST is stored in the area below. When replacing the
CELLPACK DST pull out the reagent storage slowly.

CELLPACK DST

Reagent storage

e.g. XR-2000

* The above diagram is an example.

Warning!
• Open and close the storage using the handle on the dedicated wagon.
• When opening or closing the storage, watch your fingers.
• Because the dedicated wagon is carrying the reagent, it is very heavy. When pulling out and
pushing in the storage, do so slowly with care.

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Follow the steps below to replace the reagent.

1 Display the RU-20 Maintenance menu.

(➤P.446 "RU-20 Maintenance menu")

2 Click [Replace Reagent].

The following dialog box appears and displays the remaining level of CELLPACK DST reagent.

Barcode reader icon

Shelf life after opening

Lot No.
Reagent state
Remaining
volume graph

RU-20 [Replace Reagent] dialog box

Barcode reader Indicates that the Reagent Code (barcode) can be scanned to enter reagent information.
icon
Shelf life after Display the shelf life of the reagent after opening. This is not displayed if the reagent has not
opening been registered. When the shelf life after opening has expired, it is displayed in white letters
on a red background.
Lot No. Displays the lot number of the reagent.
Reagent state Displays the remaining reagent as a percentage. When the reagent runs low, the
background becomes yellow.
Remaining Displays the remaining volume of the reagent as a graph. This is not displayed if the
volume graph reagent has not been registered, or if the reagent has run out.

3 Turn and remove the cap from the new reagent container.
Check that the reagent has not expired.

4 Input the reagent code (barcode).

Input by barcode scanning
Scan the reagent code (barcode) on the outer box of the
new reagent with hand-held barcode reader.
Reagent Code (barcode) is as shown the right illustration.
Manual input
Click the name of the reagent to be replaced in the
[Replace Reagent] dialog box.
Enter the reagent code (barcode) and click [OK].

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5 Turn and remove the cap from the old reagent container.

6 Pull out the dispensing set straight up.

7 Insert the dispensing set straight into the new reagent container.

8 Turn and attach the cap.

9 Click [Execute].
The replacement of the reagent starts. Wait until it is complete. When it is complete, the dialog box closes
automatically.

Note:
The RU-20 [Replace Reagent] dialog box can also be displayed by the method below.
• Click [OK] in the Help dialog that appears when insufficient CELLPACK DST remains.
• Click the reagent level display in the RU area of the control menu.

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18.4.5 Replace a new dye

This section explains how to replace the following reagents.

• Fluorocell WNR, Fluorocell WDF, Fluorocell WPC

• Fluorocell RET
• Fluorocell PLT

For cautions while replacing reagents, see Chapter 5. (➤P.63 "Chapter 5: Reagents")
Install the dye cartridge in its corresponding dye cartridge holder. The dye cartridge that can be installed will vary
depending on the analyzer types. The position of each dye cartridge holder is shown below.

WNR WDF RET PLT WPC WNR WDF RET PLT

XR-20 XR-10

Follow the steps below to replace the reagent.

1 Display the [Reagent Replacement] dialog box.

(➤P.475 "18.4.2 About [Reagent Replacement] dialog box")

2 Prepare the new reagent cartridge.

Check that the reagent has not expired.
For the details on new reagent cartridges, see below.
(➤P.475 "18.4.1 List of reagents")

e.g. Fluorocell WDF

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3 Open the top front cover.

Open to the highest point. It may move down.

Caution!
During analysis and other times when the analyzer is in operation, never open the top front
cover.

4 Pull up the cover from the reagent that is to be replaced.

Pull firmly until all the way up.

e.g. XR-20

Note:
When the dye solution cover is pulled up, a Help dialog box appears in the IPU screen. Proceed
to the next step. When the dye solution cover is pushed down in step 7, the Help dialog box
closes.

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5 Remove the old reagent cartridge from its holder.

6 Install the new reagent cartridge into the holder.

Make sure that the color of the label on the new reagent
cartridge matches the color of the dye cover, and install as
shown on the right.
The analyzer beeps.

Caution!
• If you install a different reagent, the analyzer beeps repeatedly and Help dialog box appears in
the IPU screen.
• If dye solution spills, immediately wipe it off using wet cloth or the like.
Otherwise, the coated surface of the instrument could be stained.

7 Pull down the cover on the reagent.

Pull down until you hear a "click" sound.
The ID of the new reagent is read automatically, and the information is registered.

8 Close the top front cover.

The replacement of the reagent starts. Wait until it is complete. When it is complete, the window closes
automatically.

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18.4.6 Replenish reagents

Replenish analyzer reagents

If you encounter an error with the dye solution, or if you set the wrong reagent, you can replenish the reagent.
Follow the steps below to replenish the reagent.

1 Make sure that the reagent you want to replenish is connected.

2 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

3 Click [Reagent Replenishment].

The dialog box on the right appears.

4 Click the name of the reagent to replenish, and click [Execute].

The replenishing of the reagent begins. Progress is shown as a progress bar on the screen. Wait until it is
complete. When it is complete, the dialog box closes automatically.

Note:
Multiple reagents can be replenished at once.

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Replenish the reagent in the RU-20 (Replacing the reagent in the RU-20 instrument and
supply tank)
When using the RU-20, follow the steps below to replace the reagent in the RU-20.
Perform this procedure if the expiration date of the concentrated reagent in the RU-20 has passed or the
wrong reagent was accidentally connected.
This procedure can be used to drain the concentrated reagent from the RU-20 and replace it with new
CELLPACK DST, and drain the prepared reagent from the supply tank and replace it with reagent prepared
using new CELLPACK DST.
Follow the steps below to replenish the reagent.

1 Make sure that the reagent you want to replenish is connected.

2 Display the RU-20 Maintenance menu.

(➤P.446 "RU-20 Maintenance menu")

3 Click [Reagent Replenishment].

The dialog box appears.

4 Click [Execute].
The dialog box automatically closes, [Maintenance in progress] appears in the operation status display area of
the help dialog box, and reagent replacement begins. For the operation status display area, see Chapter 19.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")
Wait until it is complete. Reagent replacement takes about 4 to 6 hours. When it is complete, [Maintenance in
progress] disappears.

5 Click [Cancel].
The dialog box closes.

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18.4.7 Drain the reagent

Draining analyzer reagent

If the reservoir tank is being used, reagent can be drained and the reservoir tank automatically cleaned in the
event that the reagent in the tank has expired or the wrong reagent was taken in.
Follow the procedure below to drain the reagent.

1 Make sure that the reagent you want to reconnect is connected.

2 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

3 Click [Drain Reagent].

The dialog box on the right appears.

4 Click the name of the reagent that you wish to drain and click [Execute].
Draining starts. Progress is shown as a progress bar on the screen. Wait until it is complete. When it is
complete, the dialog box closes automatically.

Note:
Multiple reagents can be drained at once.

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RU-20 reagent draining (Replacing the reagent in the RU-20 instrument)

When using the RU-20, follow the steps below to replace the reagent in the RU-20.
If the concentrated reagent in the RU-20 has expired or the wrong reagent was accidentally connected, the
concentrated reagent in the RU-20 can be drained and replaced with new CELLPACK DST.
Follow the procedure below to drain the reagent.

1 Make sure that the reagent you want to reconnect is connected.

2 Display the RU-20 Maintenance menu.

(➤P.446 "RU-20 Maintenance menu")

3 Click [Drain Reagent].

The dialog box appears.

4 Click [Execute].
The dialog box automatically closes, [Maintenance in progress] appears in the operation status display area of
the help dialog box, and reagent draining begins. For the operation status display area, see Chapter 19.
(➤P.511 "Chapter 19: 19.1.1 Help dialog box")
Wait until it is complete. Reagent draining takes about 1 hour. When it is complete, [Maintenance in progress]
disappears.

5 Click [Cancel].
The dialog box closes.

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18.4.8 Check the reagent replacement history

The history of reagent replacements can be viewed. The log data shows the information entered at the time of
replacement, and comments can be entered. The log can be printed or output as a file in CSV format.
For details, see the following:
(➤P.429 "Chapter 17: 17.1 About the history screen", P.437 "Chapter 17: 17.2 About the RU history screen")

18.5 Replace the fuse

If a fuse blows, replace the fuse. The replacement procedure varies depending on the device.

Warning!
• Make sure to unplug the power cable when replacing a fuse.
This is to avoid the risk of electrical shock.
• Make sure to only use a fuse of the specified type and rating.
This is to avoid the risk of fire.

To replace the fuse for an analyzer

Follow the steps below to replace the fuse in the analyzer.

1 Open the top front cover.

Open to the highest point. It may move down.

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2 Turn OFF the Main power switch of the analyzer.

OFF

3 Unplug the power cable from the rear side of the main unit.
For locations of the power cable plug and the fuse on each
device, see Chapter 3.
(➤P.37 "Chapter 3: 3.1 Analyzer")

4 Remove the old fuse.

1 On the rear of the unit, pinch the tabs of the
fuse holder and pull out forward.
2 Remove the old fuse from the fuse holder. Fuse holder

Fuse

Tab

5 Set the new fuse into the fuse holder, and insert it into the unit.

Note:
The fuse orientation in the fuse holder is not specified.

6 Plug in the power cable.

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7 Turn ON the Main power switch of the analyzer.

ON

8 Close the top front cover.

9 Turn ON the power to the device.

For the details on starting the device, see Chapter 8. (➤P.114 "Chapter 8: 8.2 Start up")

To replace the fuse for a pneumatic unit

Follow the steps below to replace the fuse in the pneumatic unit.

1 Turn OFF the power to the entire device.

For shutdown procedures, see Chapter 8. (➤P.121 "Chapter 8: 8.5 Shutdown")

2 Unplug the power cable from the rear side of the main unit.
For locations of the power cable plug and the fuse on each
device, see Chapter 3.
(➤P.40 "Chapter 3: 3.2 Pneumatic unit")

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3 Remove the old fuse.

1 On the rear of the unit, pull out the fuse holder
Fuse
forward.
Use a flathead screwdriver to push up on the hook part of
the fuse holder and withdraw the fuse holder.
Fuse holder
2 Remove the old fuse from the fuse holder.

Tab

4 Set the new fuse into the fuse holder, and insert it into the unit.

Note:
The fuse orientation in the fuse holder is not specified.

5 Plug in the power cable.

6 Turn ON the power to the device.

For the details on starting the device, see Chapter 8. (➤P.114 "Chapter 8: 8.2 Start up")

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When using the sampler (SA-10) (XR-1000)

Follow the steps below to replace the fuse in the sampler (SA-10).

1 Turn OFF the power to the entire device.

For shutdown procedures, see Chapter 8. (➤P.121 "Chapter 8: 8.5 Shutdown")

2 Turn OFF the Main power switch of the sampler.

For the location of the main power switch, see Chapter 3.
(➤P.41 "Chapter 3: 3.3 Sampler section")

3 Unplug the power cable from the rear side of the main unit.
For locations of the power cable plug and the fuse on each
device, see Chapter 3.
(➤P.41 "Chapter 3: 3.3 Sampler section")

4 Remove the old fuse.

1 On the rear of the unit, pinch the tabs of
the fuse holder and pull out forward.
Fuse holder
2 Remove the old fuse from the fuse holder.
Fuse

Tab

5 Set the new fuse into the fuse holder, and insert it into the unit.

Note:
The fuse orientation in the fuse holder is not specified.

6 Plug in the power cable.

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7 Turn ON the Main power switch of the sampler.

8 Turn ON the power to the device.

For the details on starting the device, see Chapter 8. (➤P.114 "Chapter 8: 8.2 Start up")

When using the sampler (SA-20) (XR-2000)

Follow the steps below to replace the fuse in the sampler (SA-20).

1 Turn OFF the power to the entire device.

For shutdown procedures, see Chapter 8. (➤P.121 "Chapter 8: 8.5 Shutdown")

2 Turn OFF the Main power switch of the sampler.

For the location of the main power switch, see Chapter 3.
(➤P.41 "Chapter 3: 3.3 Sampler section")

3 Remove the protective cover.

4 Remove the sampler cover.

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5 Unplug the power cable from the rear side of the main unit.
For locations of the power cable plug and the fuse on each
device, see Chapter 3.
(➤P.41 "Chapter 3: 3.3 Sampler section")

6 Remove the old fuse.

1 On the rear of the unit, pinch the tabs of the fuse Fuse
holder and pull out forward.
2 Remove the old fuse from the fuse holder.
Fuse holder

Tab

7 Set the new fuse into the fuse holder, and insert it into the unit.

Note:
The fuse orientation in the fuse holder is not specified.

8 Plug in the power cable.

9 Set the sampler cover.

10 Set the protective cover.

11 Turn ON the Main power switch of the sampler.

12 Turn ON the power to the device.

For the details on starting the device, see Chapter 8. (➤P.114 "Chapter 8: 8.2 Start up")

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e.g.
Yr. Month 18.6
Daily Maintenance Tasks
Day
Maintenance task 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Shutdown

Signed

Maintenance Tasks to Be Performed as Needed Replacing reagents and supply parts

Month/Day Month/Day Month/Day Month/Day
Maintenance task Signed Signed Maintenance task Signed Signed
Chapter 18

Replacing reagents (CELLPACK DCL)

XR-1000/XR-2000 Instructions for Use

Automatic rinsing
Cleaning Replacing reagents (CELLPACK DST)
Replacing waste container Replacing reagents (CELLPACK DFL)

Draining waste chamber Replacing reagents (SULFOLYSER)

Removing an RBC detector clog Replacing reagents (Lysercell WNR)

Replacing reagents (Lysercell WDF II)
Cleaning RBC detector aperture
Rinsing the waste chamber Replacing reagents (Lysercell WPC)

Removing flowcell air bubbles Replacing reagents (Fluorocell WNR)

Maintenance inspection checklist

Rinsing flowcell Replacing reagents (Fluorocell WDF)

Draining reaction chamber Replacing reagents (Fluorocell WPC)

Replacing reagents (Fluorocell RET)
Draining RBC isolation chamber
Replacing reagents (Fluorocell PLT)
Adjusting the pressure (0.25 MPa)
Replacing fuses
Adjusting the pressure (0.16 MPa)
Adjusting the pressure (0.07 MPa)
Discarding sample residue from the
sample tube holder
Draining the chamber

Draining the reagent

Performing Maintenance of Instrument and Replacing Supply Parts

* We recommend that our customers prepare a checklist that suits their operating environment.

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18.7 Test proper operation of the device

You can perform various tests to verify proper operation of each unit, or to identify the cause of an error that occurred
in the analyzer.
To perform the tests, the analyzer and the sampler must be in READY state. Otherwise, the tests cannot be
performed. Analysis is not possible during the test process.
If the test did not complete successfully, the help dialog box appears in the IPU. Troubleshoot according to the
message displayed in the action field in the help dialog box.

18.7.1 An operation test on the barcode reader

You can perform an operation test on the barcode reader on the analyzer or the sampler.

Analyzer barcode reader operation test

Follow the procedure below to test the operation of the analyzer barcode reader.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Analyzer BR Test].

The dialog box on the right appears. Read result display area

[Sample No.] Displays the sample number that was read from the
barcode.
[CD] Displays the check digit of the barcode.
[Type] Displays the type of barcode.
Read result Displays the result from the read operation. One of
display area the following symbols is displayed, depending on
the result. If there was no problem with reading,
nothing is displayed.
[E]: Barcode reader reading error or invalid check
digit.
[+]: The value that was read is longer than the
specified number of digits.
[-]: The value that was read is shorter than the
specified number of digits.

3 Set the sample tube into the tube holder, with the barcode affixed.

4 Click [Start].
The read test starts. If a previous test result was displayed, it is cleared when the test begins.
Wait until it is complete. Once the read operation completes, the result is displayed.

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Sampler barcode reader operation test

When using the sampler (SA-10/SA-20), follow the steps below to test the operation of the sampler barcode
reader.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Sampler BR Test].

The dialog box on the right appears. Read result display area

[Sample No.] Displays the sample number that was read from the
barcode.
[CD] Displays the check digit of the barcode.
[Type] Displays the type of barcode.
Read result Displays the result from the read operation. One of
display area the following symbols is displayed, depending on
the result.
If there was no problem with reading, nothing is
displayed.
[E]: Barcode reader reading error or invalid check
digit.
[+]: The value that was read is longer than the
specified number of digits.
[-]: The value that was read is shorter than the
specified number of digits.

3 Insert the sample tubes into the rack, with the barcodes affixed. Place the
rack on the analysis line.

4 Click [Start].
The read test starts. If a previous test result was displayed, it is cleared when the test begins.
Wait until it is complete. Once the read operation completes, the result is displayed.

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18.7.2 An operation test on the WB aspiration motor

Follow the steps below to perform an operation test on the WB aspiration motor.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Whole Blood Aspiration Motor Test].

The window appears, and the WB aspiration motor test begins. Wait until it is complete. Once the test is
completed successfully, the window closes automatically.

18.7.3 An operation test on the sheath motor

Follow the steps below to perform an operation test on the sheath motor.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Sheath Motor Test].

The window appears, and the sheath motor test begins. Wait until it is complete. Once the test is completed
successfully, the window closes automatically.

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18.7.4 An operation test on the aspiration unit motor

Follow the steps below to perform an operation test on the aspiration unit motor.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Aspiration Unit Motor Test].

The window appears, and the aspiration unit motor test begins. Wait until it is complete. Once the test is
completed successfully, the window closes automatically.

18.7.5 An operation test on the tube holder motor

Follow the steps below to perform an operation test on the tube holder motor.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Tube Holder Motor Test].

The window appears, and the tube holder motor test begins. Wait until it is complete. Once the test is completed
successfully, the window closes automatically.

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18.7.6 An operation test on the sampler

Operation tests vary depending on the type of sampler.

When using the sampler (SA-10/SA-20)

You can test the operation of the two belts that transport the racks horizontally on the analysis line. Facing the
sampler, the belt that is closer to the sampler is the front belt, and the belt that is furthest out from the sampler
is the back belt.
Follow the steps below to perform an operation test on the sampler.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Sampler Operation Test].

The dialog box on the right appears.

3 Set the rack on the analysis line.

4 Click the operation you want to test.

A window appears, and the test for the clicked belt begins. Once the test is completed successfully, the window
closes automatically.

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When using the sampler (SA-01)

You can test rack feed-in from the sampler to the analysis line, rack shifting on the analysis line, and rack feed-
out from the analysis line to the sampler.
Follow the steps below to perform an operation test on the sampler.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Sampler Operation Test].

The dialog box on the right appears.

3 Place the rack in the sampler or on the analysis line.

To test [Rack feed-in], place the rack in the sampler. To test [Rack shift] or [Rack feed-out], place the rack on the
analysis line.

4 Click the operation you want to test.

A window appears, and the test for the clicked belt begins. Once the test is completed successfully,
the window closes automatically.

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18.7.7 An operation test on the tube grabber

Follow the steps below to perform an operation test on the tube grabber.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Hand Test].

The window appears, and the operation test of the tube grabber begins. Wait until it is complete. Once the test is
completed successfully, the window closes automatically.

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18.8 Check the status of the device

You can check the operation or the operation count of each unit.

18.8.1 Test proper operation of the device (sensor)

You can verify the temperature, pressure, and the operation status of each unit. The data display is updated
every 0.5 seconds.

Sensor screen for the analyzer

Follow the steps below to display the sensor screen for the analyzer.

1 Display the Maintenance menu.

(➤P.444 "Chapter 18: 18.1.2 Maintenance menu")

2 Click [Analyzer Sensor Display].

The dialog box on the right appears.

Shortcut The buttons of the dialogs that appear in the Shortcut

buttons analyzer sensor display screen are displayed. buttons
Click a button of a dialog that does not
currently appear to display the dialog.
[Pressure (units: Displays the pressure for each unit.
MPa)]
[Temperature Displays the temperatures of each unit within
(units: °C)] the instrument as well as the ambient
temperature. The items that are displayed
vary depending on the analyzer that is
connected.
[HGB] Displays the conversion value for hemoglobin.
Nothing is displayed during analysis.
Next
[Aspiration Displays the conversion value for the blood
button
Sensor] aspiration sensor. Nothing is displayed during
analysis.
[Laser Current] Displays the output current of the laser. [Sensor 1] dialog box
Next button Click to display the [Sensor 2] dialog box.

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3 Click Next button.

The dialog box on the right appears.
Shortcut buttons

Sensor
operation status
display area

Back button

[Sensor 2] dialog box

Shortcut buttons The buttons of the dialogs that appear in the analyzer sensor display screen are
displayed.
Click a button of a dialog that does not currently appear to display the dialog.
Sensor operation Displays the operation status of each sensor. Sensors that are ON are displayed in
status display area red, and those that are OFF are displayed in white.
Below is a list of sensor numbers and sensor names.

Sensor Number Sensor Name

[01] Float switch 1 status (WC1)
[02] Float switch 2 status (WC2)
[03] Float switch 3 status (FCM)
[04] Float switch 4 status (DIL)
[05] Float switch 5 status (RBC)
[06] Float switch 6 status
[07] Start switch
[08] Mode switch
[09] FCM cover
[10] Front cover sensor 1
[11] Front cover sensor 2
[12] RBC detector cover sensor
[13] Water leak detecting sensor 1
[14] Water leak detecting sensor 2
[15] Water leak detecting sensor 3
[16] Waste tank sensor
[17] Dye cartridge holder monitor 1 (WNR)

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[18] Dye cartridge holder monitor 2 (WDF)

[19] Dye cartridge holder monitor 3 (WPC)
[20] Dye cartridge holder monitor 4 (RET)
[21] Dye cartridge holder monitor 5 (PLT)
[25] Sample tube identification sensor
[26] Hand Z-axis tube holder catch position
[27] Hand Z-axis sampler catch position
[28] Sample tube presence sensor
[29] Sample tube stabilizing unit initial position
[38] Water leak sensor error monitor 1
[39] Water leak sensor error monitor 2
[40] Water leak sensor error monitor 3
[41] Prism sensor (CELLPACK DCL)
[43] Prism sensor (SULFOLYSER)
[44] Prism sensor (Lysercell WNR)
[45] Prism sensor (Lysercell WDF II)
[46] Prism sensor (CELLPACK DFL)
[47] Prism sensor (Lysercell WPC)
[49] Prism sensor (Fluorocell WNR)
[50] Prism sensor (Fluorocell WDF)
[51] Prism sensor (Fluorocell WPC)
[52] Prism sensor (Fluorocell DFL)
[53] Prism sensor (Fluorocell PLT)
[61] Micro collection sample tube monitor
[62]* Blood presence monitor
[65] Reservoir tank: Float switch 1 status (CELLPACK DCL high)
[66] Reservoir tank: Float switch 2 status (CELLPACK DCL low)
[67] Reservoir tank: Float switch 3 status (CELLPACK DFL)
[68] Reservoir tank: Float switch 4 status (Lysercell WPC)
[69] Reservoir tank: Float switch 5 status (SULFOLYSER)
[70] Reservoir tank: Float switch 6 status (Lysercell WDF II)
[71] Reservoir tank: Float switch 7 status (Lysercell WNR)
[75] Reservoir tank: Prism sensor (CELLPACK DCL1)
[81] Reservoir tank: Prism sensor (CELLPACK DCL2)
Back button Click to display the [Sensor 1] dialog box.

* Only when using the sampler (SA-01) in the XR-1000

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Sensor screen for the sampler

When using the sampler (SA-10/SA-20), follow the steps below to display the sampler sensor screen.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Sampler Sensor Display].

The window on the right appears.

Sensor operation status display area

Sensor operation Displays the operation status of each sensor. Sensors that are ON are displayed in
status display area red, and those that are OFF are displayed in white.
Below is a list of sensor numbers and sensor names.
Sensor Number Sensor Name
[03] Sample tube monitoring sensor
[04] Left sampler pool rack full sensor
[05] Return prevention stopper monitoring sensor
[06] Rack feed-in arrival monitoring sensor
[07] Blood monitoring sensor
[08] Right sampler pool rack detecting sensor
[09] Analysis line termination monitoring sensor

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18.8.2 Check operation count (counter)

You can check the analysis count for each analysis mode/channel, or the operation count of each unit (or
oscillation time of the laser).
Follow the steps below to check the counters.

1 Display the Maintenance menu.

(➤P.444 "18.1.2 Maintenance menu")

2 Click [Counter].
The dialog box on the right appears.
Shortcut
Shortcut The buttons of the dialogs that appear in the buttons
buttons operation counter screen are displayed.
Click a button of a dialog that does not currently
appear to display the dialog.
[Mode] Displays the name of the analysis mode.
[WB] : Whole blood analysis
[PD] : Dilution analysis
[BF]* : Body fluid analysis
[HPC]* : HPC analysis
[hsA]* : hsA analysis
[QC] : Quality control analysis
[Maintenance]: Background check
(Includes a background check Next
for body fluid and hsA analysis*) button
[Total]: All analysis
[Counter] Displays the analysis count by analysis mode.
[Measurement Mode Counter]
[Test] Displays the name of the test. dialog box
[Total] Displays the total analysis count by discrete test.
[Rerun] Displays for each discrete test the number of
reruns of an analysis with the same parameters as
the first test.
[Reflex] Displays for each discrete test the number of
analysis with additional parameters after the first
test.
[Repeat] Displays for each discrete test the number of
retries of an analysis due to an error in the first
test.
Next button Click to display the [Pump Counter] dialog box.
* The availability of these functions depends on your system configuration.

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3 Click Next button.

The dialog box on the right appears.

Shortcut The buttons of the dialogs that appear in the Shortcut

buttons operation counter screen are displayed. buttons

Click a button of a dialog that does not currently

appear to display the dialog.
[Pump] Displays the name of the pump.
[Counter] Displays the operation count by pump.
Back button Click to display the [Measurement Mode Counter]
dialog box.
Next button Click to display the [Unit Counter] dialog box.

Next
button
Back
button

[Pump Counter] dialog box

4 Click Next button.

The dialog box on the right appears.

Shortcut The buttons of the dialogs that appear in the Shortcut

buttons operation counter screen are displayed. buttons
Click a button of a dialog that does not currently
appear to display the dialog.
[Unit] Displays the unit name for which the operation
count is being taken.
[Counter] Displays the operation count of each unit (for
laser, displays the oscillation time).
Back button Click to display the [Pump Counter] dialog box.
[Save] Click to store the counter value before it is reset to
zero in the analyzer memory.

Back
button

[Unit Counter] dialog box

5 Click [Close].
The dialog box closes.

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Chapter 19 Troubleshooting

Chapter 19 Troubleshooting

This chapter explains the errors that may occur in the instrument and how to troubleshoot them.

19.1 Introduction

19.1.1 Help dialog box

When a specific error occurs, or a maintenance task or cleaning becomes necessary, the following help dialog
box appears on the IPU. Respond to the error message according to the message shown in the action field.
(➤P.525 "19.4 Causes of errors and remedial actions")

Action
Information
on the sample
with error

When [Detailed procedure] When information on sample

is displayed with error is displayed

[Mute alarm] Click to stop the alarm.

[Error Message List] Displays a list of current errors. If multiple errors exist, errors that have higher
priority are displayed at the top.
Action Displays the troubleshooting action(s) for the selected error. Depending on the
type of error, this field may be blank.

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Information on sample Information on the sample that was being analyzed when the error occurred or
with error the sample that caused the error is displayed. If the same error occurs in multiple
samples, the information on the sample in which the error occurred first is
displayed, and (+) is displayed after the sample information. Check the
information on the second and subsequent samples and the sample information
of the cleared errors on the error log screen. (➤P.429 "Chapter 17: 17.1 About
the history screen")
: The rack number and tube position number of the sample is displayed.
This is not displayed when there is no rack information, such as during
manual analysis.
: Displays the sample number.
[Detailed procedure] Click to display a section of the "Instructions for Use" manual that explains the
procedure for troubleshooting the selected error. This button cannot be selected
if there are no relevant sections.
[Instruction manual] Click to display a section of the "Instructions for Use" manual that explains the
selected error. (➤P.525 "19.4 Causes of errors and remedial actions")
This button cannot be selected if there are no relevant sections.
[Execute]/[Accept] Depending on the error type, either the [Execute] button or the [Accept] button
appears.
Clicking the [Execute] button performs the action displayed in the Action field.
Clicking the [Accept] button clears the error.
[Close] Click to close the help dialog box.

Note:
• When there is an error, the help dialog box can be displayed.
Click the help button on the control menu.
• All alarms sounding on the IPU will stop when you click any button in the Help dialog box or
press any key on the keyboard.

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When using the RU-20, if a specific error occurs on the RU-20 or a maintenance task or cleaning task becomes
necessary, the help dialog box below appears on the IPU. Respond to the error message according to the
message shown in the [Action] field.
(➤RU-20 Instructions for Use "Chapter 7: 7.3 Causes of errors and remedial action")

Operation status
display area

Submenu
button

Operation status display The status of the RU-20 appears.

area [Resetting in progress]: The RU-20 unit is resetting.
[Maintenance in progress]: The RU-20 unit is executing maintenance operation.
[Stop Alarm] Click to stop the alarm.
[Error Message List] Displays a list of current errors. If multiple errors exist, errors that have higher
priority are displayed at the top.
[Action] The corrective action for the highest priority error appears. Depending on the
type of error, this field may be blank.
[Instruction manual] Click to display a section of the "Instructions for Use" manual that explains the
selected error. This button cannot be selected if there are no relevant sections.
[Detailed procedure] Click to display a section of the "Instructions for Use" manual that explains the
procedure for troubleshooting the selected error. This button cannot be selected
if there are no relevant sections.
Submenu button Click to display a submenu for RU-20 maintenance operations and settings.
For details on maintenance, see Chapter 18.
(➤P.443 "Chapter 18: Performing Maintenance of Instrument and Replacing
Supply Parts")
For the details on the settings, see below.
(➤P.394 "Chapter 15: 15.5 RU-20 Reagent Unit Settings")
[OK] Click to execute the action or clear the error displayed in the action field.
[Cancel] Click to close the help dialog box.

Note:
• The RU menu button in the control menu can be clicked to display the help dialog box.
• All alarms sounding on the IPU will stop when you click any button in the Help dialog box or
press any key on the keyboard.

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Chapter 19 Troubleshooting

19.2 Check the error log

19.2.1 Display the error log

The history of error occurrences can be viewed. The log data shows the information regarding the occurrence
and the clearing of each error, and comments can be entered. The log can be printed or output as a file in
CSV format.
For details, see Chapter 17.
(➤P.429 "Chapter 17: 17.1 About the history screen", P.437 "Chapter 17: 17.2 About the RU history
screen")

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19.3 Error message list

19.3.1 Error message list (in alphabetical order)

Below is an alphabetical list of error messages related to the analyzer/sampler/IPU.
-0.04 MPa pressure error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.07 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.16 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.25 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
34°C FCM reaction chamber temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C FCM reaction chamber temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C FCM reaction chamber thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
34°C reagent heater temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C reagent heater temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C reagent heater thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
41°C FCM reaction chamber temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C FCM reaction chamber temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C FCM reaction chamber thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
41°C reagent heater temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C reagent heater temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C reagent heater thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
A sample other than CELLCLEAN AUTO has been placed. . . . . . . . . . . . . . . . . . 555
Abnormal pressure loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
Ambient temperature is high. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Ambient temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Ambient thermistor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Analysis item not specified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Analysis result is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Analyzer barcode reader communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
APD thermistor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Aspiration Sensor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 533
Aspiration Sensor is OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Aspiration unit left-right motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
Aspiration unit up-down motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
Background check error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
Backup could not be executed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Blood cannot be aspirated.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Bubbles in RBC detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Cannot recognize CELLCLEAN AUTO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
Cannot recognize Fluorocell PLT information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell RET information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WDF information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WNR information . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WPC information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
CELLCLEAN AUTO has already been used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
CELLCLEAN AUTO has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
CELLCLEAN AUTO is not placed correctly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 555
CELLPACK DCL aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
CELLPACK DCL has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
CELLPACK DFL has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
CELLPACK DST has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Check Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Cleaning is required (warning) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Cleaning is required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Communication error during sampler analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Completed sampler analysis stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Control has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Control is not registered. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552

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Data Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547

Ejection table is full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Ejection table is full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 541
Ejection table stopper position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Failed to read rack number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Failed to read sample number (analyzer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to read sample number (sampler). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to read sample number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to register the automatic startup schedule . . . . . . . . . . . . . . . . . . . . . . . . . 558
FCM cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
FCM detector temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM detector temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM detector thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
FCM sheath aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
FCM sheath motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
FCM sheath temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM sheath temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM sheath thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Feed-in table stopper position error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Fluorocell PLT aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell PLT cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell PLT has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell PLT has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell PLT is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell PLT RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell RET aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell RET cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell RET has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell RET has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell RET is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell RET RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell WDF aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WDF cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WDF has already been used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WDF has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WDF is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WDF RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell WNR aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WNR cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WNR has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WNR has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WNR is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WNR RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell WPC aspiration error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WPC cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WPC has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WPC has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WPC is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WPC RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Front cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
Front cover open error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
Hand open/close error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Hand up-down error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
HGB error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
Host computer communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Instrument communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Insufficient blood volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Insufficient blood volume (short sample) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Internal Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551

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Invalid analysis item is specified. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544

Invalid analysis item is specified (sampler analysis) . . . . . . . . . . . . . . . . . . . . . . . 545
Laser life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Laser output error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Leak sensor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
L-J Control Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Low count error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Lysercell WDF II has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Lysercell WNR has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Lysercell WPC has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Mixing error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
No Analysis Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
No analyzer is ready. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
No tubes are in tube holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Out of CELLPACK DCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of CELLPACK DFL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of diluted CELLPACK DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Out of Fluorocell PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell RET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WNR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WDF II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WNR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of SULFOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Piercer replacement is required. Contact your local Sysmex representative. . . . . 555
PLT channel error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
PLT sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
PLT-F channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
PLT-F sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
PLT-F Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Positive ID check error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Press Start SW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 555
QC not executed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Rack feed-in error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack feed-in error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack feed-in home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack feed-in home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack feed-out error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack feed-out error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack feed-out home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack feed-out home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack move error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack move error (back belt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack move error (front belt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack move home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack move mechanism initialization error (back belt) . . . . . . . . . . . . . . . . . . . . . . 538
Rack move mechanism initialization error (front belt). . . . . . . . . . . . . . . . . . . . . . . 538
Rack not placed on feed-in table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack not placed on feed-in table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
RBC channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
RBC cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
RBC detector clog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
RBC sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
RBC sheath fluid aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
RBC sheath motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
RBC/HGB chamber not draining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Register CELLPACK DCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531

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Reservoir tank is empty (CELLPACK DCL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530

Reservoir tank is empty (CELLPACK DFL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WDF II) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WNR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (SULFOLYSER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
RET channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
RET sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
RET Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
RFID communication error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
RU-20 has stopped supplying reagent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Sample cannot be aspirated. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Sample number not input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Sampler analysis stop error has occurred. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Sampler barcode reader communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Sampler belt error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Sampler belt error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
SULFOLYSER has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Temperature stabilizing error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
The IPU switching has been completed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
The sample must be remixed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Tube holder move error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube pickup error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube presence verification home position error. . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Tube remains in tube holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube return error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Two tubes are in tube holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Unable to correctly detect CELLCLEAN AUTO. . . . . . . . . . . . . . . . . . . . . . . . . . . 555
Waste chamber 1 not draining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Waste chamber 2 not draining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Waste container is full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Water leak detected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
WB aspiration motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
WDF channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
WDF sampling error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WDF Scattergram sensitivity error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
WNR channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
WNR sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WNR Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
WPC channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
WPC sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WPC Scattergram sensitivity error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Wrong reagent installed in Fluorocell PLT holder . . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell RET holder . . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell WDF holder . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell WNR holder . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell WPC holder . . . . . . . . . . . . . . . . . . . . . . . . 557
X-bar control error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
X-barM control error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552

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19.3.2 Error message list by function

Analyzer/sampler/IPU

Errors related to pressure

-0.04 MPa pressure error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.07 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.16 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
0.25 MPa pressure error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
Abnormal pressure loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526

Errors related to temperature

34°C reagent heater temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C reagent heater temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C FCM reaction chamber temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C FCM reaction chamber temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C reagent heater temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C reagent heater temperature is low. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C FCM reaction chamber temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . 526
41°C FCM reaction chamber temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM detector temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM detector temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM sheath temperature is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
FCM sheath temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
34°C reagent heater thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
34°C FCM reaction chamber thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
41°C reagent heater thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
41°C FCM reaction chamber thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
APD thermistor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
FCM detector thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
FCM sheath thermistor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Ambient thermistor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Ambient temperature is high. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Ambient temperature is low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
Temperature stabilizing error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527

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Errors related to reagents and chambers

CELLPACK DCL aspiration error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
FCM sheath aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
RBC sheath fluid aspiration error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WNR aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WDF aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell WPC aspiration error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell RET aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Fluorocell PLT aspiration error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 528
Out of CELLPACK DCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of SULFOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WNR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WDF II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Lysercell WPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of CELLPACK DFL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WNR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell WPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell RET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Out of Fluorocell PLT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 529
Reservoir tank is empty (CELLPACK DCL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (SULFOLYSER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WNR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WDF II) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (Lysercell WPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Reservoir tank is empty (CELLPACK DFL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Out of diluted CELLPACK DST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
RU-20 has stopped supplying reagent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
RBC/HGB chamber not draining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 530
Waste chamber 1 not draining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Waste chamber 2 not draining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Waste container is full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Water leak detected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Water leak detected (analysis not possible) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Leak sensor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531
Register CELLPACK DCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531

Errors related to motors

FCM sheath motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
RBC sheath motor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
Aspiration unit up-down motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
Aspiration unit left-right motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532
WB aspiration motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 532

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Errors related to blood aspiration

Blood cannot be aspirated.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 533
Aspiration Sensor error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 533
Insufficient blood volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Insufficient blood volume (short sample) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Aspiration Sensor is OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
Sample cannot be aspirated. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534

Errors related to sampler analysis (SA-10/SA-20)

Feed-in table stopper position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Completed sampler analysis stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Tube presence verification home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . 536
Sampler belt error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Ejection table is full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Ejection table stopper position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack feed-in home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack feed-in error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack not placed on feed-in table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 537
Rack feed-out error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack feed-out home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack move mechanism initialization error (front belt). . . . . . . . . . . . . . . . . . . . . . . 538
Rack move mechanism initialization error (back belt) . . . . . . . . . . . . . . . . . . . . . . 538
Rack move error (front belt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Rack move error (back belt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538
Sampler analysis stop error has occurred. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 538

Errors related to sampler analysis (SA-01)

Rack feed-in error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack feed-in home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack move error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack move home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
Rack feed-out error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack feed-out home position error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Sampler belt error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Rack not placed on feed-in table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540
Ejection table is full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 541

Errors related to the tube grabber and tube holder

Mixing error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Two tubes are in tube holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube remains in tube holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
No tubes are in tube holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube pickup error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube holder move error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Tube return error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Hand up-down error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Hand open/close error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
The sample must be remixed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543

Errors related to sample number and rack number

Failed to read sample number (sampler).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to read sample number (analyzer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to read sample number.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Positive ID check error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
Failed to read rack number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Sample number not input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544

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Errors related to orders

No Analysis Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Analysis item not specified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Invalid analysis item is specified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
Invalid analysis item is specified (sampler analysis) . . . . . . . . . . . . . . . . . . . . . . . 545
No analyzer is ready. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545

Errors related to analysis

PLT sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
RBC sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
PLT-F sampling error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
RET sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WDF sampling error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WNR sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WPC sampling error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 545
WDF channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
PLT-F channel error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
WNR channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
WPC channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
PLT channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
RBC channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
RET channel error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
HGB error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
RBC detector clog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Bubbles in RBC detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Low count error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Data Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Analysis result is high . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Background check error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548

Errors related to covers

Front cover open error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
Front cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
FCM cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
RBC cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WNR cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WDF cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell WPC cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell RET cover is open. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Fluorocell PLT cover is open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549

Errors related to the laser

Laser output error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Laser life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550

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Errors related to the system

Analyzer barcode reader communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Sampler barcode reader communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Communication error during sampler analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
RFID communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Instrument communication error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Internal Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Host computer communication error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551

Errors related to quality control

L-J Control Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
X-barM control error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
X-bar control error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Control has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Control is not registered. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
QC not executed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
WNR Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
WDF Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
WPC Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
RET Scattergram sensitivity error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
PLT-F Scattergram sensitivity error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Check Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553

Errors related to user maintenance and warnings

Cleaning is required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
Cleaning is required (warning) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
CELLPACK DCL has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
SULFOLYSER has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Lysercell WNR has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Lysercell WDF II has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Lysercell WPC has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
CELLPACK DFL has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WNR has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WDF has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell WPC has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell RET has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Fluorocell PLT has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
CELLPACK DST has expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 554
Piercer replacement is required. Contact your local Sysmex representative. . . . . 555
Press Start SW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 555
CELLCLEAN AUTO is not placed correctly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 555
A sample other than CELLCLEAN AUTO has been placed. . . . . . . . . . . . . . . . . . 555
Unable to correctly detect CELLCLEAN AUTO.. . . . . . . . . . . . . . . . . . . . . . . . . . . 555
CELLCLEAN AUTO has already been used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
Cannot recognize CELLCLEAN AUTO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
CELLCLEAN AUTO has expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556

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Errors related to the dye cartridge holder

Wrong reagent installed in Fluorocell WNR holder . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell WDF holder . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell WPC holder . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell RET holder . . . . . . . . . . . . . . . . . . . . . . . . . 557
Wrong reagent installed in Fluorocell PLT holder . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WNR is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WDF is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WPC is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell RET is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell PLT is not installed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WNR has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WDF has already been used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WPC has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell RET has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell PLT has already been used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WNR information . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WDF information . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell WPC information . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell RET information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Cannot recognize Fluorocell PLT information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Fluorocell WNR RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell WDF RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell WPC RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell RET RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Fluorocell PLT RFID tag error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558

Errors related to the IPU

Backup could not be executed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558
Failed to register the automatic startup schedule . . . . . . . . . . . . . . . . . . . . . . . . . 558
The IPU switching has been completed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 558

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19.4 Causes of errors and remedial actions

If an error occurred, refer to the causes and actions below and take appropriate action.
If the error persists after taking the suggested action, or if a malfunction or any other damage occurs, please contact
your authorized local Sysmex representative.

19.4.1 Analyzer/sampler/IPU

Errors related to pressure

Error messages -0.04 MPa pressure error

Probable Cause 1) There is a foreign object pressing on the tubing connected to the pneumatic unit,
or there is a kink in the tubing.
2) The nipple on the pneumatic unit is loose.
3) Water has accumulated in the anti-backflow chamber.

Actions 1) Remove the object that is pressing on the tubing, and straighten the tubing.
2) Connect the nipple securely.
3) Drain water from the pneumatic trap chamber. For the details on draining water
from the pneumatic trap chamber, see Chapter 18.
(➤P.472 "Chapter 18: 18.3.16 Drain the pneumatic trap chamber")

Error recovery condition The pressure returns within the monitored range.

Error messages 0.07 MPa pressure error

0.16 MPa pressure error
0.25 MPa pressure error

Probable Cause 1) The pressure value has fallen out of the monitored range.
2) The power to the pneumatic unit is OFF.
3) There is a foreign object pressing on the tubing connected to the pneumatic unit,
or there is a kink in the tubing.
4) The nipple on the pneumatic unit is loose.
5) There is an abnormality in the regulator.

Actions 1) Click [Execute] in the help dialog box.

While checking the displayed [Pressure Adjustment] dialog box, adjust the
pressure. For the details on adjusting the pressure, see Chapter 18.
(➤P.464 "Chapter 18: 18.3.12 Adjust the pressure (0.25 MPa)", P.466 "Chapter
18: 18.3.13 Adjust the pressure (0.16 MPa)", P.468 "Chapter 18:
18.3.14 Adjust the pressure (0.07 MPa)")
2) Securely plug in the power cable of the pneumatic unit, and then turn ON the
power switch.
3) Remove the object that is pressing on the tubing, and straighten the tubing.
4) Connect the nipple securely.
5) The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition The pressure returns within the monitored range.

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Error messages Abnormal pressure loss

Probable Cause The power to the pneumatic unit shut OFF while running.

Actions Securely plug in the power cable of the pneumatic unit, and then turn ON the power
switch. Remove the sample tubes from the device, and then click [Execute] in the
help dialog box. Restart the device.

Error recovery condition Restart the device.

Errors related to temperature

Error messages 34°C reagent heater temperature is high
34°C reagent heater temperature is low
34°C FCM reaction chamber temperature is high
34°C FCM reaction chamber temperature is low
41°C reagent heater temperature is high
41°C reagent heater temperature is low
41°C FCM reaction chamber temperature is high
41°C FCM reaction chamber temperature is low
FCM detector temperature is high
FCM detector temperature is low
FCM sheath temperature is high
FCM sheath temperature is low

Probable Cause The temperature of the unit has fallen out of the monitored range.

Actions Click [Execute] in the help dialog box. While checking the displayed [Sensor 1] dialog
box, wait for the temperature to return within the monitored range.
Click [Cancel] to close the dialog box.
For details on the [Sensor 1] dialog box, see the following.
(➤P.505 "Chapter 18: 18.8.1 Test proper operation of the device (sensor)")
If the error has not cleared after 30 minutes, please contact your authorized local
Sysmex representative.

Error recovery condition The temperature returns within the monitored range.

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Error messages 34°C reagent heater thermistor error

34°C FCM reaction chamber thermistor error
41°C reagent heater thermistor error
41°C FCM reaction chamber thermistor error
APD thermistor error
FCM detector thermistor error
FCM sheath thermistor error
Ambient thermistor error

Probable Cause The thermistor in the unit has malfunctioned, or there is a break in its connection.

Actions Remove the sample tubes and racks from the device, and then turn OFF the main
power to the system.
The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition -

Error messages Ambient temperature is high

Ambient temperature is low

Probable Cause The ambient temperature of the device has fallen out of the usable range.

Actions Click [Execute] in the help dialog box. While checking the displayed [Sensor 1] dialog
box, wait for the temperature to return within the monitored range.
Click [Cancel] to close the dialog box.
For details on the [Sensor 1] dialog box, see the following.
(➤P.505 "Chapter 18: 18.8.1 Test proper operation of the device (sensor)")

Error recovery condition The temperature returns within the monitored range.

Error messages Temperature stabilizing error

Probable Cause The temperature of the unit is not stabilizing.

Actions Remove the sample tubes and racks from the device, and then turn OFF the main
power to the system.
The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition -

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Errors related to reagents and chambers

Error messages CELLPACK DCL aspiration error
FCM sheath aspiration error
RBC sheath fluid aspiration error

Probable Cause 1) The tubing connected to the reagent container is clogged.

2) There is a foreign object pressing on the tubing connected to the reagent
container, or there is a kink in the tubing.

Actions 1) Click [Execute] in the help dialog box, and then replenish the reagent. For the
details on replenishing a reagent, see Chapter 18.
(➤P.486 "Chapter 18: 18.4.6 Replenish reagents")
2) Remove the object that is pressing on the tubing, and straighten the tubing.

Error recovery condition Replenish the reagent.

Error messages Fluorocell WNR aspiration error

Fluorocell WDF aspiration error
Fluorocell WPC aspiration error
Fluorocell RET aspiration error
Fluorocell PLT aspiration error

Probable Cause 1) Air bubbles have formed in the tubing connected to the reagent container.
2) The dye cover opened.

Actions 1) Click [Execute] in the help dialog box, and then replenish the reagent. For the
details on replenishing a reagent, see Chapter 18.
(➤P.486 "Chapter 18: 18.4.6 Replenish reagents")
2) Close the dye cover.

Error recovery condition 1) Replenish the reagent.

2) Close the dye cover.

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Error messages Out of CELLPACK DCL

Out of SULFOLYSER
Out of Lysercell WNR
Out of Lysercell WDF II
Out of Lysercell WPC
Out of CELLPACK DFL

Probable Cause 1) The remainder of the reagent has run out.

2) There is a foreign object pressing on the tubing connected to the reagent
container, or there is a kink in the tubing.

Actions 1) Click [Execute] in the help dialog box, and then replace the reagent with a new
one. For the details on replacing a reagent, see Chapter 18.
(➤P.477 "Chapter 18: 18.4.3 Replace a new dilution/hemolytic agent")
2) Remove the object that is pressing on the tubing, and straighten the tubing.

Error recovery condition Replace the reagent.

Error messages Out of Fluorocell WNR

Out of Fluorocell WDF
Out of Fluorocell WPC
Out of Fluorocell RET
Out of Fluorocell PLT

Probable Cause The remainder of the reagent has run out.

Actions Replace the reagent with a new one. For the details on replacing a reagent, see
Chapter 18. (➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Replace the reagent.

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Error messages Reservoir tank is empty (CELLPACK DCL)

Reservoir tank is empty (SULFOLYSER)
Reservoir tank is empty (Lysercell WNR)
Reservoir tank is empty (Lysercell WDF II)
Reservoir tank is empty (Lysercell WPC)
Reservoir tank is empty (CELLPACK DFL)

Probable Cause 1) The remainder of the reagent has run out.

2) There is a foreign object pressing on the tubing connected to the reagent
container, or there is a kink in the tubing.

Actions 1) Click [Execute] in the help dialog box, and then replace the reagent with a new
one. For the details on replacing a reagent, see Chapter 18.
(➤P.477 "Chapter 18: 18.4.3 Replace a new dilution/hemolytic agent")
2) Remove the object that is pressing on the tubing, and straighten the tubing.

Error recovery condition Replace the reagent.

Error messages Out of diluted CELLPACK DST

RU-20 has stopped supplying reagent.

Probable Cause The CELLPACK DST has run out.

Actions Click [Execute] in the help dialog box of the RU menu, and replace CELLPACK DST.
For the procedure for replacing CELLPACK DST, see Chapter 18.
(➤P.480 "Chapter 18: 18.4.4 Replace with new CELLPACK DST")

Error recovery condition Replace the CELLPACK DST.

Error messages RBC/HGB chamber not draining

Probable Cause The drain tubing of RBC/HGB is clogged.

Actions Click [Execute] in the help dialog box and drain the reagent from the reaction
chamber.
For the procedure for draining reagent from the reaction chamber, refer to Chapter
18.
(➤P.463 "Chapter 18: 18.3.10 Drain the reagent from the reaction chamber")

Error recovery condition The draining by the device finishes successfully.

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Error messages Waste chamber 1 not draining

Waste chamber 2 not draining

Probable Cause The drain tubing is clogged.

Actions Click [Execute] in the help dialog box and drain waste fluid from the waste chamber.
For the procedure for draining waste fluid from the waste chamber, refer to Chapter 18.
(➤P.458 "Chapter 18: 18.3.6 Drain the waste chamber")

Error recovery condition The draining by the device finishes successfully.

Error messages Waste container is full

Probable Cause The waste container is full.

Actions Replace the waste container, and then click [Accept] in the help dialog box.
For the details on replacing the waste container, see Chapter 18.
(➤P.447 "Chapter 18: 18.3.1 Replace the waste container")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Water leak detected

Water leak detected (analysis not possible)

Probable Cause There is a water leak inside the analyzer.

Actions Turn OFF the main power to the system. The device needs to be serviced. Please
contact your authorized local Sysmex representative.

Error recovery condition -

Error messages Leak sensor error

Probable Cause The water leak sensor has malfunctioned.

Actions Remove the sample tubes from the device, and then turn OFF the main power to the
system. The device needs to be serviced. Please contact your authorized local
Sysmex representative.

Error recovery condition -

Error messages Register CELLPACK DCL

Probable Cause CELLPACK DCL is enabled instead of RU-20.

Actions Insert the dispensing set that you removed from the RU-20 supply tank straight into
the CELLPACK DCL, and execute reagent replacement.

Error recovery condition Click [Execute] in the help dialog box.

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Errors related to motors

Error messages FCM sheath motor error
RBC sheath motor error

Probable Cause FCM sheath motor or RBC sheath motor is malfunctioned.

Actions Click [Execute]. The motor operation test begins. If the error has not cleared, please
contact your authorized local Sysmex representative.

Error recovery condition The test operation by the device finishes successfully.

Error messages Aspiration unit up-down motor error

Probable Cause Aspiration unit up-down motor is malfunctioned.

Actions Remove the sample tubes from the device, and then click [Execute]. Restart the
device. If the error has not cleared, please contact your authorized local Sysmex
representative.

Error recovery condition Restart the device.

Error messages Aspiration unit left-right motor error

Probable Cause Aspiration unit left-right motor is malfunctioned.

Actions Click [Execute]. The motor operation test begins. If the error has not cleared, please
contact your authorized local Sysmex representative.

Error recovery condition The test operation by the device finishes successfully.

Error messages WB aspiration motor error

Probable Cause WB aspiration motor is malfunctioned.

Actions Click [Execute]. The motor operation test begins. If the error has not cleared, please
contact your authorized local Sysmex representative.

Error recovery condition The test operation by the device finishes successfully.

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Errors related to blood aspiration

Error messages Blood cannot be aspirated.
Probable Cause 1) The density of the sample is inconsistent.
2) The piercer or the tubing of the WB aspiration line is clogged.
3) The blood aspiration sensor has malfunctioned.
4) Low hemoglobin value.
Actions 1) Click [Accept] in the help dialog box, mix the sample well, and then re-analyze.
2) Click [Accept] in the help dialog box. Once the device is in READY state, perform
an auto rinse. If the error persists, perform cleaning. If the error still persists, the
piercer must be replaced. Please contact your authorized local Sysmex
representative.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
For the details on cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")
3) The device needs to be serviced. Please contact your authorized local Sysmex
representative.
4) Check the blood volume and whether the blood has coagulated, and click
[Accept] in the help dialog box. If the blood volume is sufficient but there is no
coagulation, a low hemoglobin value is possible. Disable the Blood Aspiration
Sensor and repeat analysis using manual analysis.
Error recovery condition Click [Accept] in the help dialog box.

Error messages Aspiration Sensor error

Probable Cause The blood aspiration sensor has malfunctioned.

Actions The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Insufficient blood volume

Probable Cause 1) The sensor could not detect the specified amount of blood.
2) Blood volume is insufficient.
3) The piercer or the tubing of the WB aspiration line is clogged.

Actions 1) Repeat the analysis by manual or micro analysis.

2) Repeat the analysis by manual or micro analysis.
3) Click [Accept] in the help dialog box. Once the device is in READY state, perform
an auto rinse. If the error persists, perform cleaning. If the error still persists, the
piercer must be replaced. Please contact your authorized local Sysmex
representative.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
For the details on cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Insufficient blood volume (short sample)

Probable Cause 1) The sensor could not detect the specified amount of blood.
2) Blood volume is insufficient.
3) The piercer or the tubing of the WB aspiration line is clogged.
4) Low hemoglobin value.

Actions 1) Repeat the analysis by manual or micro analysis.

2) Repeat the analysis by manual or micro analysis.
3) Click [Accept] in the help dialog box. Once the device is in READY state, perform
an auto rinse. If the error persists, perform cleaning. If the error still persists, the
piercer must be replaced. Please contact your authorized local Sysmex
representative.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
For the details on cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")
4) Check the blood volume and whether the blood has coagulated, and click
[Accept] in the help dialog box. If the blood volume is sufficient but there is no
coagulation, a low hemoglobin value is possible. Disable the Blood Aspiration
Sensor and repeat analysis using manual analysis.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Aspiration Sensor is OFF

Probable Cause The Blood Aspiration Sensor is disabled.

Actions Enable the Blood Aspiration Sensor.

Error recovery condition Enable the Blood Aspiration Sensor.

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Error messages Sample cannot be aspirated.

Probable Cause Sample analysis was attempted on sample tubes with the cap still on, while micro
analysis or [Cap Open] was set to ON.

Actions Remove the cap from the tube and reanalyze the sample. If the error persists, please
contact your authorized local Sysmex representative.

Error recovery condition Click [Accept] in the help dialog box.

Errors related to sampler analysis (SA-10/SA-20)

● When using the sampler (SA-10) in the XR-1000
The names and positions of the sensors attached to the sampler (SA-10) are shown below.

Sample tube monitoring sensor Tube rotation mechanism

Analysis line termination

monitoring sensor
Analysis line Blood monitoring sensor Rack feed-in arrival
(Rack horizontal-feed unit) monitoring sensor

Left sampler pool

return prevention stopper
Right sampler pool
Left sampler pool (Rack feed-in table) Right sampler pool return
prevention stopper

Left sampler pool rack full Right sampler pool

sensor rack detecting sensor
The structure of a sampler

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● When using the XR-2000

The names and positions of the sensors attached to the sampler are shown below.

Analysis line termination Sample tube monitoring sensor Tube rotation mechanism
monitoring sensor
Rack feed-in arrival
monitoring sensor
Blood monitoring sensor

Right sampler
pool return
Analysis line prevention
(Rack horizontal-feed unit) Left sampler pool stopper
return prevention
stopper
Right sampler pool
Left sampler pool Left sampler pool (Rack feed-in table)
rack full sensor

Right sampler pool

The structure of a sampler rack detecting sensor

Error messages Feed-in table stopper position error

Probable Cause There is a foreign object in the movement path of the return prevention stopper in the
right sampler pool.

Actions Remove the foreign object away from the return prevention stopper.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Completed sampler analysis stop

Probable Cause When aborting sampler analysis, this message appears after the abort operation has
completed.

Actions -

Error recovery condition Click [Accept] in the help dialog box.

Error messages Tube presence verification home position error

Probable Cause 1) There is a foreign object in the movement path of the tube rotation mechanism.
2) The sample tube monitoring sensor is not operating correctly due to dust and/or
other particles.

Actions 1) Remove the foreign object away from the tube rotation mechanism.
2) Remove the dust and/or other particles.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Sampler belt error

Probable Cause A rack was detected on the analysis line while initializing the analysis line.

Actions Remove the rack from the analysis line.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Ejection table is full

Probable Cause 1) The left sampler pool is full with racks.

2) There is a foreign object in the movement path of the racks in the left sampler pool.
3) The left sampler pool rack full sensor is not operating correctly due to dust and/or
other particles.

Actions 1) Remove the racks.

2) Remove the foreign object from the left sampler pool.
3) Remove the dust and/or other particles.

Error recovery condition Perform the above actions. (Automatically cleared)

Error messages Ejection table stopper position error

Probable Cause There is a foreign object in the movement path of the return prevention stopper in the
left sampler pool.

Actions Remove the foreign object away from the return prevention stopper.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Rack feed-in home position error

Rack feed-in error
Probable Cause 1) There is a foreign object in the movement path of the racks in the right sampler pool.
2) The rack is not placed properly.
3) The rack detecting sensor in the right sampler pool is not operating correctly due
to dust and/or other particles.
Actions 1) Remove the foreign object from the right sampler pool.
2) Reposition the rack, and then perform sampler analysis.
3) Remove the dust and/or other particles.
Error recovery condition Click [Accept] in the help dialog box.

Error messages Rack not placed on feed-in table

Probable Cause 1) The rack is not placed properly.

2) The rack detecting sensor in the right sampler pool is not operating correctly due
to dust and/or other particles.

Actions 1) Reposition the rack, and then perform sampler analysis.

2) Remove the dust and/or other particles.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Rack feed-out error

Rack feed-out home position error

Probable Cause 1) There is a foreign object in the movement path of the rack feed-out lever.
2) There is a foreign object in the movement path of the racks in the left sampler
pool.
3) The feed-out movement of the rack was blocked.
4) The rack is not moving properly because the table surface of the left sampler pool
is dirty.

Actions 1) Remove the foreign object from the rack feed-out lever.
2) Remove the foreign object from the left sampler pool.
3) Reposition the rack, and then perform sampler analysis.
4) Clean the table surface of the left sampler pool.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Rack move mechanism initialization error (front belt)

Rack move mechanism initialization error (back belt)
Rack move error (front belt)
Rack move error (back belt)

Probable Cause 1) There is a foreign object in the movement path of the rack on the sampler's
analysis line.
2) The rack is not placed properly.

Actions 1) Remove the foreign object from the analysis line.

2) Reposition the rack, and then perform sampler analysis.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Sampler analysis stop error has occurred.

Probable Cause An interruption error occurred during sampler analysis.

Actions Clear all errors and then click [Accept] in the help dialog box.

Error recovery condition Click [Accept] in the help dialog box.

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Errors related to sampler analysis (SA-01)

The names and positions of the sensors attached to the sampler (SA-01) are shown below.

Rack feed-out initial position sensor Sample tube monitoring sensor

Analysis line
(Rack horizontal-feed Blood monitoring sensor Rack shift initial position sensor
unit)

Right sampler pool

rack feed-in end sensor

Right sampler pool

rack feed-in position sensor

Right sampler pool

Left sampler pool
(Rack feed-in table)

Left sampler pool rack Rack shift monitor sensor Right sampler pool rack
full sensor feed-in initial position sensor
The structure of a sampler

Error messages Rack feed-in error

Rack feed-in home position error

Probable Cause 1) There is a foreign object in the movement path of the racks in the right sampler
pool.
2) The rack is not placed properly.

Actions 1) Remove the foreign object from the right sampler pool.
2) Reposition the rack, and then perform sampler analysis.

Error recovery condition Click [Execute] in the help dialog box.

Error messages Rack move error

Rack move home position error

Probable Cause 1) There is a foreign object in the movement path of the rack on the sampler's
analysis line.
2) The rack is not placed properly.

Actions 1) Remove the foreign object from the analysis line.

2) Reposition the rack, and then perform sampler analysis.

Error recovery condition Click [Execute] in the help dialog box.

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Error messages Rack feed-out error

Rack feed-out home position error

Probable Cause 1) There is a foreign object in the movement path of the rack feed-out lever.
2) There is a foreign object in the movement path of the racks in the left sampler
pool.
3) The feed-out movement of the rack was blocked.
4) The rack is not moving properly because the table surface of the left sampler pool
is dirty.

Actions 1) Remove the foreign object from the rack feed-out lever.
2) Remove the foreign object from the left sampler pool.
3) Reposition the rack, and then perform sampler analysis.
4) Clean the table surface of the left sampler pool.

Error recovery condition Click [Execute] in the help dialog box.

Error messages Sampler belt error

Probable Cause A rack was detected on the analysis line while initializing the analysis line.

Actions Remove the rack from the analysis line.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Rack removed

Probable Cause When the hand unit was holding a sample tube during sampler analysis, the rack was
removed from the analysis line.

Actions Remove the sample tube from the hand unit and return it to the rack. Reposition the
rack, and then perform sampler analysis.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Rack not placed on feed-in table

Probable Cause 1) The rack is not placed properly.

2) The rack feed-in position sensor in the right sampler pool has malfunctioned due
to dust or other particulate matter.

Actions 1) Reposition the rack, and then perform sampler analysis.

2) Remove the dust and/or other particles.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Ejection table is full

Probable Cause 1) The left sampler pool is full with racks.

2) There is a foreign object in the movement path of the racks in the left sampler
pool.
3) The left sampler pool rack full sensor is not operating correctly due to dust and/or
other particles.

Actions 1) Remove the racks.

2) Remove the foreign object from the left sampler pool.
3) Remove the dust and/or other particles.

Error recovery condition Perform the above actions. (Automatically cleared)

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Errors related to the tube grabber and tube holder

Error messages Mixing error

Probable Cause 1) There is a foreign object in the movement path of the tube grabber in the sampler.
2) The sample tube is not set properly.

Actions 1) Remove the foreign object from the movement path of the tube grabber.
2) Reposition the sample tube, and then perform sampler analysis.

Error recovery condition The test operation by the device finishes successfully.

Error messages Two tubes are in tube holder

Probable Cause Both the normal sample tube and the micro collection sample tubes were set for
manual analysis.

Actions Remove the sample tube that does not need to be analyzed.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Tube remains in tube holder

Probable Cause When the analysis was switched from manual to sampler, a sample tube was found
left in the tube holder.

Actions Remove the sample tube from the tube holder.

Error recovery condition Click [Accept] in the help dialog box.

Error messages No tubes are in tube holder

Probable Cause Neither a normal sample tube nor a micro collection sample tube was placed for
manual analysis.

Actions Place the sample tube to be analyzed.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Tube pickup error

Tube holder move error
Tube return error

Probable Cause 1) There is a foreign object in the movement path of the tube holder.
2) The sample tube is not set properly.

Actions 1) Remove the foreign object from the tube holder.

2) Reposition the sample tube, and then perform sampler analysis.

Error recovery condition The test operation by the device finishes successfully.

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Error messages Hand up-down error

Hand open/close error

Probable Cause 1) There is a foreign object in the movement path of the tube grabber in the sampler.
2) The sample tube is not set properly.

Actions 1) Remove the foreign object from the movement path of the tube grabber.
2) Reposition the sample tube, and then perform sampler analysis.

Error recovery condition The test operation by the device finishes successfully.

Error messages The sample must be remixed.

Probable Cause The set time (60 seconds) elapsed after an analysis information query was sent to
the host computer during manual analysis.

Actions Re-agitate the sample. Click [Accept] in the help dialog box and then repeat analysis.

Error recovery condition Click [Accept] in the help dialog box.

Errors related to sample number and rack number

Error messages Failed to read sample number (sampler).
Failed to read sample number (analyzer).
Failed to read sample number.

Probable Cause 1) The barcode label on the sample is dirty.

2) The print quality of the barcode label on the sample is poor.
3) The position of the barcode label on the sample is off.

Actions Check the position and cleanliness of the barcode label.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Positive ID check error

Probable Cause 1) The barcode read by the sampler was different from that read by the analyzer.
2) There is a foreign object in the device.

Actions 1) Reposition the sample, and then perform sampler analysis.

2) Remove the foreign object from the device.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Failed to read rack number

Probable Cause 1) The barcode label on the rack is dirty.

2) The print quality of the barcode label on the rack is poor.
3) The position of the barcode label on the rack is off.

Actions Check the position and cleanliness of the barcode label.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Sample number not input

Probable Cause No sample number was specified at the time of manual analysis.

Actions Enter the sample number, and then perform the analysis.

Error recovery condition Click [Accept] in the help dialog box.

Errors related to orders

Error messages No Analysis Orders

Probable Cause 1) When sampler analysis stop by not-aspirated command is set and either of the
following two conditions occurs:
- A sample not-aspirated command has been received from the host computer.
- An order has not been registered for the sample in the [Work List] screen.
2) When sampler analysis stop by not-aspirated command is not set, and a not-
aspirated command and a command for display of this error message are both
received from the host computer.

Actions Check if the order is registered in the host computer or [Work List] screen.
Error recovery condition Click [Accept] in the help dialog box.

Error messages Analysis item not specified

Probable Cause No analysis parameter was specified at the time of manual analysis.

Actions Enter the analysis parameter, and then perform the analysis.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Invalid analysis item is specified

Probable Cause An analysis parameter was specified that cannot be analyzed in manual analysis.

Actions Change the analysis parameter, and then perform the analysis.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages Invalid analysis item is specified (sampler analysis)

Probable Cause An analysis parameter was specified that cannot be analyzed in sampler analysis.

Actions Check the analysis parameter and click [Accept] in the help dialog box.
The analysis of the sample is skipped, and the sampler analysis continues.
Error recovery condition Click [Accept] in the help dialog box.

Error messages No analyzer is ready.

Probable Cause The sample could not be analyzed due to the status of the analyzer.

Actions 1) Change the analyzer to sampler analysis.

2) Cancel sampler analysis from the menu.

Error recovery condition Change the analyzer's settings to match the sample.

Errors related to analysis

Error messages PLT sampling error
RBC sampling error

Probable Cause 1) The density of the sample is inconsistent.

2) The detector suddenly became clogged.

Actions 1) Click [Accept] in the help dialog box, mix the sample well, and then re-analyze.
2) Click [Accept] in the help dialog box. Once the device is in READY state, remove
the clog from the RBC detector. For the details on removing a clog from the RBC
detector, see Chapter 18.
(➤P.453 "Chapter 18: 18.3.4 Clog removal from the RBC detector")

Error recovery condition Click [Accept] in the help dialog box.

Error messages PLT-F sampling error

RET sampling error
WDF sampling error
WNR sampling error
WPC sampling error

Probable Cause 1) The density of the sample is inconsistent.

2) The flowcell has suddenly become clogged.

Actions 1) Click [Accept] in the help dialog box, mix the sample well, and then re-analyze.
2) Click [Accept] in the help dialog box. Once the device is in READY state, rinse the
flowcell. For the details on rinsing the flowcell, see Chapter 18. (➤P.461 "Chapter
18: 18.3.9 Rinse flowcell")

Error recovery condition Click [Accept] in the help dialog box.

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Error messages WDF channel error

PLT-F channel error
WNR channel error
WPC channel error
PLT channel error
RBC channel error

Probable Cause 1) The density of the sample is inconsistent.

2) Because of external noise, the number of particles has exceeded the limit of
display range.

Actions 1) Click [Accept] in the help dialog box, mix the sample well, and then re-analyze.
2) Keep the noise source away from the Main Unit. Click [Accept] in the help dialog
box, and then re-analyze.

Error recovery condition Click [Accept] in the help dialog box.

Error messages RET channel error

Probable Cause 1) The density of the sample is inconsistent.

2) The flowcell is clogged.
3) The flowcell is dirty.
4) Air bubbles have formed in the flowcell.

Actions 1) Click [Accept] in the help dialog box, mix the sample well, and then re-analyze.
2) Click [Accept] in the help dialog box. Once the device is in READY state, rinse the
flowcell. For the details on rinsing the flowcell, see Chapter 18. (➤P.461 "Chapter
18: 18.3.9 Rinse flowcell")
3) Click [Accept] in the help dialog box. Once the device is in READY state, rinse the
flowcell. For the details on rinsing the flowcell, see Chapter 18. (➤P.461 "Chapter
18: 18.3.9 Rinse flowcell")
4) Click [Accept] in the help dialog box. Once the device is in READY state, remove
the air bubbles from the flowcell. For the details on removing air bubbles from the
flowcell, see Chapter 18.
(➤P.460 "Chapter 18: 18.3.8 Remove air bubbles from flowcell")

Error recovery condition Click [Accept] in the help dialog box.

Error messages HGB error

Probable Cause The HGB background value or the HGB sample value has fallen out of the specified
range.

Actions Click [Accept] in the help dialog box, and then re-analyze.

Error recovery condition Click [Accept] in the help dialog box.

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Error messages RBC detector clog

Bubbles in RBC detector

Probable Cause 1) The detector is clogged.

2) Air bubbles have formed in the detector.

Actions Click [Execute] in the help dialog box, and then remove the clog from the RBC
detector. For the details on removing a clog from the RBC detector, see Chapter 18.
(➤P.453 "Chapter 18: 18.3.4 Clog removal from the RBC detector")

Error recovery condition The clog is successfully removed from the RBC detector.

Error messages Low count error

Probable Cause The piercer or the tubing of the WB aspiration line is clogged.

Actions Click [Accept] in the help dialog box. Once the device is in READY state, perform an
auto rinse. If the error persists, perform cleaning. If the error still persists, the piercer
must be replaced. Please contact your authorized local Sysmex representative.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
For the details on cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Data Errors

Probable Cause The analyzed value has fallen out of the specified range of upper/lower limits.

Actions Check the analyzed data, and revise the specified upper and lower limits.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Analysis result is high

Probable Cause When body fluid analysis was performed, analysis data with high values that may
affect the next analysis results were obtained*.
* The availability of this function depends on your system configuration.

Actions Remove the sample tube from the device. Click [Execute] in the help dialog box to
perform a background check.
For the details on background check, see Chapter 11.
(➤P.209 "Chapter 11: 11.7 Body fluid analysis")

Error recovery condition The background check completes successfully.

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Error messages Background check error

Probable Cause 1) Air bubbles have formed in the detector.

2) The detector is clogged.
3) The detector is dirty.
4) The reagent is defective.

Actions 1) Click [Execute] in the help dialog box, and then perform an auto rinse.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
2) Click [Execute] in the help dialog box, and then perform an auto rinse.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
3) Click [Execute] in the help dialog box, and then perform an auto rinse.
For the details on auto rinse, see Chapter 18.
(➤P.449 "Chapter 18: 18.3.2 Perform auto rinse")
4) Replace the reagent with a new one.
For the details on replacing a reagent, see Chapter 18.
(➤P.475 "Chapter 18: 18.4 Replace reagents")

Error recovery condition The value of the background check is within the acceptable range.

Errors related to covers

Error messages Front cover open error

Probable Cause The top bottom cover opened during analysis.

Actions Remove the sample tubes from the device, and then close the bottom front cover.
Click [Execute] in the help dialog box. Restart the device.

Error recovery condition Restart the device.

Error messages Front cover is open

Probable Cause 1) The bottom front cover opened.

2) The sensor on the bottom front cover is malfunctioned.

Actions 1) Close bottom front cover.

2) The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition 1) Close the bottom front cover.

2) -

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Error messages FCM cover is open.

Probable Cause 1) The FCM cover is open.

2) The sensor on the FCM cover is malfunctioned.

Actions Please contact your authorized local Sysmex representative.

Error recovery condition -

Error messages RBC cover is open.

Probable Cause 1) The RBC cover is open.

2) The sensor on the RBC cover is malfunctioned.

Actions 1) Close the RBC cover.

2) The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition 1) Close the RBC cover.

2) -

Error messages Fluorocell WNR cover is open

Fluorocell WDF cover is open
Fluorocell WPC cover is open
Fluorocell RET cover is open
Fluorocell PLT cover is open

Probable Cause 1) The dye cover opened during analysis.

2) The sensor on the dye cover is malfunctioned.

Actions 1) Close the dye cover.

2) The device needs to be serviced. Please contact your authorized local Sysmex
representative.

Error recovery condition 1) Close the dye cover.

2) -

Errors related to the laser

Error messages Laser output error

Probable Cause The laser output has exceeded the control range.

Actions Remove the sample tubes and racks from the device, and then turn OFF the main
power to the system. The laser needs to be replaced. Please contact your authorized
local Sysmex representative.

Error recovery condition -

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Error messages Laser life

Probable Cause It is time to replace the laser.

Actions The laser needs to be replaced. Please contact your authorized local Sysmex
representative.

Error recovery condition -

Errors related to the system

Error messages Analyzer barcode reader communication error

Probable Cause There was a communication error between the analyzer and the barcode reader.

Actions Remove the sample tubes and racks from the device, and then turn OFF and ON the
main power to the system. If the error persists, please contact your authorized local
Sysmex representative.

Error recovery condition -

Error messages Sampler barcode reader communication error

Probable Cause There was a communication error between the sampler and the barcode reader.

Actions Remove the sample tubes and racks from the device, and then turn OFF and ON the
main power to the system. If the error persists, please contact your authorized local
Sysmex representative.

Error recovery condition -

Error messages Communication error during sampler analysis.

Probable Cause Communication with the analyzer has been disconnected in sampler analysis.

Actions Remove the sample tubes and racks from the device, check the connection with the
analyzer.

Error recovery condition Click [Accept] in the help dialog box.

Error messages RFID communication error

Probable Cause Communication with the RFID unit has been disconnected.

Actions Remove the sample tubes and racks from the device, and then turn OFF and ON the
main power to the system. If the error persists, please contact your authorized local
Sysmex representative.

Error recovery condition -

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Error messages Instrument communication error

Probable Cause There was a communication error between the device and the IPU.

Actions Remove the sample tubes and racks from the device, and then turn OFF and ON the
main power to the system.

Error recovery condition Power OFF

Error messages Internal Error

Probable Cause An error occurred in the operation of the program.

Actions Turn OFF the main power.

Please contact your authorized local Sysmex representative.

Error recovery condition -

Error messages Host computer communication error

Probable Cause 1) Host computer program is not functioning normally.

2) The connection settings with the host computer do not match.
3) The connection cable to the host computer is disconnected.

Actions 1) Confirm that the host computer is functioning.

2) Confirm that the connection settings with the host computer are matching.
3) Confirm that the connection cable to the host computer is connected.

Error recovery condition Click [OK] in the dialog box.

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Errors related to quality control

Error messages L-J Control Error
X-barM control error
X-bar control error

Probable Cause An abnormality was detected in the quality control data.

Actions In the QC chart, check the parameter that exceeded the QC limits, and then click
[Accept]. Perform calibration as necessary. For details on QC charts, see Chapter 10.
(➤P.182 "Chapter 10: 10.5.2 QC Chart screen")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Control has expired.

Probable Cause The quality control material has expired.

Actions Replace the quality control material with a new one. Register the lot information, and
then click [Accept] in the help dialog box. For the details on registering lot information,
see Chapter 10.
(➤P.168 "Chapter 10: 10.3 Registering and modifying a QC file (lot information
input)")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Control is not registered.

Probable Cause Quality control material with an unregistered lot number was used.

Actions Register the lot information of the quality control material and then click [Accept] in
the help dialog box. For the details on registering lot information, see Chapter 10.
(➤P.168 "Chapter 10: 10.3 Registering and modifying a QC file (lot information
input)")

Error recovery condition Click [Accept] in the help dialog box.

Error messages QC not executed.

Probable Cause It is time to perform QC analysis.

Actions Perform QC analysis, and then click [Accept] in the help dialog box.
For the details on quality control, see Chapter 10.
(➤P.175 "Chapter 10: 10.4 Perform QC analysis")

Error recovery condition Click [Accept] in the help dialog box.

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Error messages WNR Scattergram sensitivity error

WDF Scattergram sensitivity error
WPC Scattergram sensitivity error
RET Scattergram sensitivity error
PLT-F Scattergram sensitivity error

Probable Cause A numerical value for a parameter in the scattergram is outside the specified range.

Actions Check the scattergram.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Check Measurement Mode

Probable Cause The analysis mode and the type of quality control material are not compatible.

Actions Check the type of analysis mode and quality control material.

Error recovery condition Click [Accept] in the help dialog box.

Errors related to user maintenance and warnings

Error messages Cleaning is required.

Probable Cause It is time to perform cleaning.

Actions Perform cleaning, and then click [Accept] in the help dialog box. For the details on
cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Cleaning is required (warning)

Probable Cause Cleaning needs to be performed.

Actions Click [Execute] in the help dialog box, and then perform cleaning.
For the details on cleaning, see Chapter 18.
(➤P.451 "Chapter 18: 18.3.3 Perform cleaning")

Error recovery condition Cleaning completes successfully.

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Error messages CELLPACK DCL has expired

SULFOLYSER has expired
Lysercell WNR has expired
Lysercell WDF II has expired
Lysercell WPC has expired
CELLPACK DFL has expired

Probable Cause The reagent has expired.

Actions Click [Execute] in the help dialog box, and then replace the reagent with a new one.
For the details on replacing a reagent, see Chapter 18.
(➤P.477 "Chapter 18: 18.4.3 Replace a new dilution/hemolytic agent")

Error recovery condition Replace the reagent.

Error messages Fluorocell WNR has expired

Fluorocell WDF has expired
Fluorocell WPC has expired
Fluorocell RET has expired
Fluorocell PLT has expired

Probable Cause The reagent has expired.

Actions Replace the reagent with a new one. For the details on replacing a reagent, see Chapter 18.
(➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Replace the reagent.

Error messages CELLPACK DST has expired

Probable Cause The CELLPACK DST has expired.

Actions Replace the CELLPACK DST with a new one. For the details on replacing a
CELLPACK DST, see Chapter18.
(➤P.480 "Chapter 18: 18.4.4 Replace with new CELLPACK DST")

Error recovery condition Replace the CELLPACK DST.

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Error messages Piercer replacement is required. Contact your local Sysmex representative.

Probable Cause It is time to replace the piercer.

Actions The piercer must be replaced. Please contact your authorized local Sysmex
representative.

Error recovery condition Replace the piercer.

Error messages Press Start SW

Probable Cause The set time (5 hours) has elapsed since the analyzer entered the standby state.

Actions Press the start switch.

Error recovery condition Press the start switch.

Error messages CELLCLEAN AUTO is not placed correctly

Probable Cause The CELLCLEAN AUTO is not placed correctly.

Actions Place the CELLCLEAN AUTO in the specified position again.

(➤P.121 "Chapter 8: 8.5 Shutdown")

Error recovery condition Click [Accept] in the help dialog box.

Error messages A sample other than CELLCLEAN AUTO has been placed.

Probable Cause A sample other than CELLCLEAN AUTO is placed in a rack in which
CELLCLEAN AUTO is placed in the specified position.

Actions Remove sample tubes that are not CELLCLEAN AUTO from the rack and place the
rack again. (➤P.121 "Chapter 8: 8.5 Shutdown")

Error recovery condition Click [Accept] in the help dialog box.

Error messages Unable to correctly detect CELLCLEAN AUTO.

Probable Cause The CELLCLEAN AUTO information read by the sampler does not match the
CELLCLEAN AUTO information read by the analyzer.

Actions Place the CELLCLEAN AUTO again.

(➤P.121 "Chapter 8: 8.5 Shutdown")

Error recovery condition Click [Accept] in the help dialog box.

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Error messages CELLCLEAN AUTO has already been used.

Probable Cause A used CELLCLEAN AUTO has been installed.

Actions Replace the CELLCLEAN AUTO with a new one.

Error recovery condition Click [Accept] in the help dialog box.

Error messages Cannot recognize CELLCLEAN AUTO

Probable Cause 1) The barcode label on the CELLCLEAN AUTO is dirty.

2) The position of the barcode label on the CELLCLEAN AUTO is off.

Actions Check the position and cleanliness of the barcode label.

Error recovery condition Click [Accept] in the help dialog box.

Error messages CELLCLEAN AUTO has expired.

Probable Cause The CELLCLEAN AUTO has expired.

Actions Replace the CELLCLEAN AUTO with a new one.

Error recovery condition Click [Accept] in the help dialog box.

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Errors related to the dye cartridge holder

Error messages Wrong reagent installed in Fluorocell WNR holder
Wrong reagent installed in Fluorocell WDF holder
Wrong reagent installed in Fluorocell WPC holder
Wrong reagent installed in Fluorocell RET holder
Wrong reagent installed in Fluorocell PLT holder

Probable Cause The dye cartridge holder and the dye that was installed are different.

Actions Set a correct reagent. For the details on replacing a reagent, see Chapter 18.
(➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Set a correct reagent.

Error messages Fluorocell WNR is not installed

Fluorocell WDF is not installed
Fluorocell WPC is not installed
Fluorocell RET is not installed
Fluorocell PLT is not installed

Probable Cause The dye has not been installed in the dye cartridge holders.

Actions Set a reagent. For the details on replacing a reagent, see Chapter 18.
(➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Set a reagent.

Error messages Fluorocell WNR has already been used

Fluorocell WDF has already been used
Fluorocell WPC has already been used
Fluorocell RET has already been used
Fluorocell PLT has already been used

Probable Cause A used dye has been installed.

Actions Replace the reagent with a new one. For the details on replacing a reagent, see
Chapter 18. (➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Set a new reagent.

Error messages Cannot recognize Fluorocell WNR information

Cannot recognize Fluorocell WDF information
Cannot recognize Fluorocell WPC information
Cannot recognize Fluorocell RET information
Cannot recognize Fluorocell PLT information

Probable Cause The ID of the dye is damaged.

Actions Click [Execute] in the help dialog box, click the reagent name, and register the
reagent information.

Error recovery condition Register reagent information.

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Error messages Fluorocell WNR RFID tag error

Fluorocell WDF RFID tag error
Fluorocell WPC RFID tag error
Fluorocell RET RFID tag error
Fluorocell PLT RFID tag error

Probable Cause Cannot write any data to the dye ID.

Actions Replace the reagent that has the correct ID. For the details on replacing a reagent,
see Chapter 18. (➤P.483 "Chapter 18: 18.4.5 Replace a new dye")

Error recovery condition Set the reagent that has the correct ID.

Errors related to the IPU

Error messages Backup could not be executed

Probable Cause 1) If the saving destination is the PC for backup, the connection cable to the PC for
backup is disconnected.
2) If the saving destination is an external media, the external media is not
connected.
3) If the saving destination is an external media, the capacity of the external media is
insufficient.

Actions 1) Confirm that the connection cable to the PC for backup is connected.
2) Confirm that the external media is connected.
3) Check the capacity of the external media.

Error recovery condition Click [OK] in the dialog box.

Error messages Failed to register the automatic startup schedule

Probable Cause The connection cable to the PC for backup is disconnected.

Actions Confirm that the connection cable to the PC for backup is connected.

Error recovery condition Click [OK] in the dialog box.

Error messages The IPU switching has been completed

Probable Cause This message is displayed when IPU switching is complete.

Actions -

Error recovery condition Click [OK] in the dialog box.

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19.5 Switching the PC in case of IPU failure

In case of IPU failure, you can continue to use this instrument by switching connection of each instrument to the PC
(optional) for backup.

During normal operation When a problem occurs

PC for backup

LIS LIS

Peripheral Peripheral
device, device,
Network Network
IPU
server server

Information
• Switching to the PC for backup is an emergency measure at the event of IPU failure.
Since restoration of the system to the normal status is necessary, please contact your
authorized local Sysmex representative promptly.
• The IPU controls the power to the PC for backup. Do not turn the PC for backup ON or OFF
except when indicated in the steps below.

1 If the IPU is running, shut it down.

(➤P.127 "Chapter 8: 8.5.5 Shutting down the IPU manually")

2 Unplug the LAN cable connecting the IPU and the PC for backup.

3 Reconnect the USB cable and HDMI cable connected to the IPU with the PC
for backup.
Reconnect all cables to the terminals in the same way as they were on the IPU.

4 Confirm that nothing is connected to the LAN port of the PC for backup.

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5 Start the PC for backup.

The dialog box on the right appears.
This step is not required if the PC for backup is already
started. Proceed to the next step.

Caution!
When starting the PC for backup, do not operate the PC until the Setting screen appears. If any
other dialog boxes are displayed, close them.

6 Click [Set Routine PC].

The PC for backup automatically shuts down.

7 Reconnect the LAN cable connected to the IPU with the PC for backup.
The LAN cable connecting the IPU and the PC for backup that was removed in step 2 needs not be connected.

Caution!
Be sure to connect the LAN cable to the same place as it was on the IPU.
If not connected in the same places, communication cannot be performed properly.

8 Again start the PC for backup.

The IPU in which the backup data is applied starts and the analyzer can be used. This step is not required if the
PC for backup is already started. Proceed to the next step.

9 Log on to the started IPU.

A log on dialog box appears.

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10 Check the [Date/time of recovered data] displayed in the dialog box.

Recovery of the backup data at [Date/time of recovered data] and
IPU switching are complete.

Caution!
• Register the reagents again after switching the IPU. However, stain solutions do not require
registration.
• The reagent remaining volume of the dilution/hemolytic agent may not be displayed correctly
as the reagent consumption from the time the backup was last performed until the IPU is
switched is not reflected. The correct reagent remaining volume is displayed by replacing with
a new reagent after switching the IPU.

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Appendix

Appendix

This chapter explains service and research data.

Check service data (service)

The service data of the sample selected in the list in the [Sample Explorer] screen can be checked on the [Service]
tab of the [Data Browser] screen*.
* Even when the data is masked in other confirmation screens, the value is displayed. When analysis is not
performed on the channel for which the displayed item is calculated, the data is not displayed.

Information
Data displayed on the Service screen is for the purpose of monitoring the status of the instrument.
These data must not be used for diagnosis of patients.

Click the [Service] tab in the [Data Browser] to display the following screen.

Service data display

selection area

Service data display Click to display the respective service data.

selection area [RBC/PLT], [WNR], [WDF], [RET]*, [PLT-F]*, [WPC]*, [HARDWARE] or
[ADJUSTMENT] can be selected.
* These items do not appear with all analyzer types.

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RBC/PLT service data

Click [RBC/PLT] to display the following screen.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the RBC/PLT channel measured at fixed intervals appears in the column below [RBC] and [PLT].
• The data of a maximum of 32 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.

● [Reference Data]
[R-MFV] Most frequently occurring value for the red blood cell volume. (units: fL)
[P-MFV] Most frequently occurring value for the platelet volume. (units: fL)
[S-RBC] The RBC count of the smaller red cell distribution out of the 2 peak RBC distributions.
[L-RBC] The RBC count of the larger red cell distribution out of the 2 peak RBC distributions.
[S-MCV] MCV of the smaller red cell distribution out of the 2 peak distributions.
[L-MCV] MCV of the larger red cell distribution out of the 2 peak distributions.
[PLT-I] The PLT count calculated from the RBC/PLT channel (PLT distributions).

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● [Discri]
[RBC-LD] The position of the lower limit discriminator of the RBC distribution (Numerical value from
0 to 49 with 49 full scale.).
[RBC-MD] The position of the discriminator that separates the 2 peak RBC distribution into a
distribution with a lower limit MCV and a distribution with a higher limit MCV (Numerical
value from 0 to 49 with 49 full scale.).
[RBC-UD] The position of the higher limit discriminator of the RBC distribution (Numerical value
from 0 to 49 with 49 full scale.).
[PLT-LD] The position of the lower limit discriminator of the PLT distribution (Numerical value from
0 to 39 with 39 full scale.).
[PLT-UD] The position of the higher limit discriminator of the PLT distribution (Numerical value from
0 to 39 with 39 full scale.).

● [HGB]
Hemoglobin values appear in 3 formats in the left column.

[Sample] Optical density of the sample converted by A/D conversion.

[Blank] Optical density of a blank sample converted by A/D conversion.

● [Distribution]
[RBC] If the RBC distribution is abnormal, abnormal distribution information will be displayed.
[PLT] If the PLT distribution is abnormal, abnormal distribution information will be displayed.

● [RBC]
[Clog] Electronically detected numerical value indicating the amount of clogging in the RBC
detector.
[Bubble] Electronically detected numerical value indicating the amount of air bubbles in the RBC
detector.

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WNR service data

Click [WNR] to display the following screen.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the WNR channel measured at fixed intervals appears in the column below [WNR].
• The data of a maximum of 16 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.

● [Scattergram Sensitivity]
[WNR-X] The fluorescent light intensity of the WBC area on the WNR scattergram.
[WNR-Y] The forward scattered light intensity of the WBC area on the WNR scattergram.
[WNR-WX] The fluorescent light distribution width index of the WBC area on the WNR scattergram.
[WNR-WY] The forward scattered light distribution width index of the WBC area on the WNR
scattergram.
[NRBC-X] The fluorescent light intensity of the NRBC area on the WNR scattergram.
[NRBC-Y] The forward-scattered light intensity of the NRBC area on the WNR scattergram.

● [Reference Data]
[WBC-N] The WBC count calculated from the WNR channel.
[TNC-N] The total nucleated cell count(WBC+NRBC) calculated from the WNR channel.
[iRBC-WNR#]* The iRBC count calculated from the WNR channel.
[Cell 1] Total count measured in the WNR channel.

* The availability of this function depends on your system configuration.

● [Laser Current]
[LD driver] The current of the LD driver.

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WDF service data

Click [WDF] to display the following screen.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the WDF channel measured at fixed intervals appears in the column below [WDF].
• The data of a maximum of 16 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.
• In the case of analysis data of [hsA] mode, 2 cycles of data appear.
* The availability of this function depends on your system configuration.

● [Scattergram Sensitivity]
[WDF-X] The lateral scattered light intensity of the WBC area on the WDF scattergram.
[WDF-Y] The fluorescent light intensity of the WBC area on the WDF scattergram.
[WDF-WX] The lateral scattered light distribution width index of the WBC area on the WDF
scattergram.
[WDF-WY] The fluorescent light distribution width index of the WBC area on the WDF scattergram.
[NE-SSC] The lateral scattered light intensity of the NEUT area on the WDF scattergram.
[NE-SFL] The fluorescent light intensity of the NEUT area on the WDF scattergram.
[LY-X] The lateral scattered light intensity of the LYMPH area on the WDF scattergram.
[LY-Y] The fluorescent light intensity of the LYMPH area on the WDF scattergram.
[WBC-FX] The WBC(FSC) distribution average value of the WBC area.

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● [Reference Data]
[WBC-D] The WBC count calculated from the WDF channel.
[DLT-WBCD The ratio of the white blood cell count (WBC-D) in the WDF channel to the white blood
[WBC-D/WBC]] cell count (WBC) in the WNR channel.
[TNC-D] The total nucleated cell count (WBC+NRBC) calculated from the WDF channel.
[iRBC-WDF#]* The iRBC count calculated from the WDF channel.
[Cell 1] Total count calculated from the WDF channel.
[Cell 2] Count plotted in the WDF scattergram.

* The availability of this function depends on your system configuration.

● [Laser Current]
[LD driver] The current of the LD driver.

RET service data

Click [RET]* to display the following screen.

* This screen does not appear with all analyzer types.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the RET channel measured at fixed intervals appears in the column below [RET].
• The data of a maximum of 16 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.

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● [Scattergram Sensitivity]
[RET-RBC-X] The fluorescent light intensity of RBC (mature red blood cells) area on the RET
scattergram.
[RET-RBC-Y] The forward scattered light intensity of RBC (mature red blood cells) area on the RET
scattergram.
[RET-RBC-WX] The fluorescent light distribution width index of RBC (mature red blood cells) area on the
RET scattergram.
[RET-RBC-WY] The forward scattered light distribution width index of the RBC (mature red blood cell)
area of the RET scattergram.
[RET-X] The fluorescent light intensity of the RET area on the RET scattergram.
[RET-Y] The forward scattered light intensity of the RET area on the RET scattergram.

● [Reference Data]
[RBC-O] RBC count calculated from the RET channel.
[PLT-O] PLT count calculated from the RET channel.
[DLT-RBC The ratio of the RBC count (RBC-O) in the RET channel to the RBC count (RBC) in the
[RBC-O/RBC-I]] RBC/PLT channel (RBC distribution).
[DLT-PLTO The ratio of the platelet count (PLT-O) in the RET channel to the platelet count (PLT-I) in
[PLT-O/PLT-I]] the RBC/PLT channel (PLT distribution).
[Unclassified] Count appearing in the area of the low value of the forward scattered light signal and the
high value of side fluorescent light on the RET scattergram.
[Cell Total] Total count measured in the RET channel.

● [Laser Current]
[LD driver] The current of the LD driver.

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PLT-F service data

Click [PLT-F]* to display the following screen.

* This screen does not appear with all analyzer types.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the PLT-F channel measured at fixed intervals appears in the column below [PLT-F].
• The data of a maximum of 16 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.

● [Scattergram Sensitivity]
[PLT-F-RBC-X] The fluorescent light intensity of the RBC area on the PLT-F scattergram.
[PLT-F-RBC-Y] The forward scattered light intensity of the RBC area on the PLT-F scattergram.
[PLT-F-RBC-WX] The fluorescent light distribution width index of the RBC area on the PLT-F scattergram.
[PLT-F-RBC-WY] The forward scattered light distribution width index of the RBC area on the PLT-F
scattergram.
[PLT-F-X] The fluorescent light intensity of the PLT area on the PLT-F scattergram.
[PLT-F-Y] The forward scattered light intensity of the PLT area on the PLT-F scattergram.

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● [Reference Data]
[AREA-F#] The count of AREA-F of the PLT-F scattergram.
[DLT-PLT-F [PLT-F/ The ratio of the platelet count (PLT-F) calculated from the PLT-F channel to the platelet
PLT-I]] count (PLT-I) calculated from the PLT channel.
[AREA#] The count of AREA1 of the PLT-F scattergram.
[Cell 1] Count measured in the PLT-F channel over an interval of 16.1 seconds.
[Cell 2] Count plotted on the PLT-F scattergram over an interval of 16.1 seconds.
[Cell 3] Count counted in the PLT-F channel over an interval of 16.1 seconds and having a
certain signal intensity.
[Cell 4] Count counted in the PLT-F channel in the 0.5 second interval after 16.1 seconds and
having a certain signal intensity.

● [Laser Current]
[LD driver] The current of the LD driver.

WPC service data

Click [WPC]* to display the following screen.

* This screen does not appear with all analyzer types.

● [Sampling Data]
This sampling data can indicate the occurrence of disturbing background noise. If the difference between the
maximum value and the minimum value constitute a proportion of the total sampling value that exceeds the
specified range, a sampling error will occur.
• The count of the WPC channel measured at fixed intervals appears in the column below [WPC].
• The data of a maximum of 16 measurements is displayed.
• The total count appears at the bottom of the table.
• The total cell count is calculated by a multiple of the value in the parentheses so that the total particle count
falls into the range of 0 to 9,999.
• In the case of analysis data of [HPC] mode, 4 cycles of sampling data appear*.
* The HPC analysis can only be performed if the license is activated.

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● [Scattergram Sensitivity]
[WPC-X] The lateral scattered light intensity of the WBC area on the WPC scattergram.
[WPC-Y] The fluorescent light intensity of the WBC area on the WPC scattergram.

● [Reference Data]
[WBC-P] WBC count calculated from WPC channel.
[DLT-WBCP The ratio of the white blood cell count (WBC-P) calculated from the WPC channel by the
[WBC-P/WBC]] white blood cell count (WBC) calculated from the WNR channel.
[TNC-P] The total nucleated cell count (WBC+NRBC) calculated from the WPC channel.
[Cell 1] Total count calculated from the WPC channel.
[Cell 2] Count plotted in the WPC scattergram.
[AREA1#] The count in AREA1 on the WPC scattergram.
[AREA2#] The count in AREA2 on the WPC scattergram.
[AREA3#] The count in AREA3 on the WPC scattergram.

● [Laser Current]
[LD driver] The current of the LD driver.

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HARDWARE service data

Click [HARDWARE] to display the following screen.

● [Unit Counter]
The operation count of each unit is displayed*.
* [Total] shows the operation count of the overall analyzer. [Piercer] displays the previous operation count after
piercer replacement.

● [Temperature]
The temperature of each part is displayed*1, 2.
*1 [Ambient Temp.] is the surrounding temperature.
*2 [34°C Reagent Heater] and [34°C FCM Reaction Chamber] do not appear with all analyzer types.

● [Pressure]
Displays pressure data at any set monitor timing.

● [Aspiration Sensor]
In the case of analysis data of [HPC] mode, 2 cycles of data appear.

[blank] Data used for monitoring of blood aspiration is displayed.

[sample] Data used for monitoring of blood aspiration is displayed.
* The HPC analysis can only be performed if the license is activated.

● [RBC/HGB Drain Sensor]

[blank] Data used for monitoring of RBC/HGB analysis sample discharge is displayed.
[sample] Data used for monitoring of RBC/HGB analysis sample discharge is displayed.

● [Laser]
The sum of the laser oscillation time appears.

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ADJUSTMENT service data

A list of the items used for sensitivity adjustment appears in the [ADJUSTMENT] screen.
For items that are the same as in other screens, the same data is displayed.

Click [ADJUSTMENT] to display the following screen*1, 2.

*1 The scattergram is not displayed in enlarged view by double-clicking.
*2 [WPC(SSC-FSC)] does not appear with all analyzer types.

● [WDF]
[WDF-X] The lateral scattered light intensity of the WBC area on the WDF scattergram.
[WDF-Y] The fluorescent light intensity of the WBC area on the WDF scattergram.
[WDF-Z] The forward scattered light intensity of the WBC area on the WDF scattergram.
[LY-X] The lateral scattered light intensity of the LYMPH area on the WDF scattergram.

● [WNR]
[WNR-X] The fluorescent light intensity of the WBC area on the WNR scattergram.
[WNR-Y] The forward scattered light intensity of the WBC area on the WNR scattergram.
[WNR-Z] The lateral scattered light intensity of the WBC area on the WNR scattergram.

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● [WPC]*
[WPC-X] The lateral scattered light intensity of the WBC area on the WPC scattergram.
[WPC-Y] The fluorescent light intensity of the WBC area on the WPC scattergram.
[WPC-Z] The forward scattered light intensity of the WBC area on the WPC scattergram.

* This area does not appear with all analyzer types.

● [RET]*
[RET-RBC-X] The fluorescent light intensity of the RBC (mature red blood cells) on the RET
scattergram.
[RET-RBC-Y] The forward scattered light intensity of the RBC (mature red blood cells) on the RET
scattergram.
[RET-RBC-Z] The lateral scattered light intensity of the RBC (mature red blood cells) on the RET
scattergram.

* This area does not appear with all analyzer types.

● [PLT-F]*
[PLT-F-X] The fluorescent light intensity of the PLT area on the PLT-F scattergram.
[PLT-F-Y] The forward scattered light intensity of the PLT area on the PLT-F scattergram.
[PLT-F-Z] The lateral scattered light intensity of the PLT area on the PLT-F scattergram.
[PLT-F-RBC-X] The fluorescent light intensity of the RBC area on the PLT-F scattergram.
[PLT-F-RBC-Y] The forward scattered light intensity of the RBC area on the PLT-F scattergram.
[PLT-F-RBC-Z] The lateral scattered light intensity of the RBC area on the PLT-F scattergram.

* This area does not appear with all analyzer types.

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Check items for research

Settings can be configured in the [Sample Explorer] or the [Data Browser] to display items for research. Items for
research are displayed on a gray background.
For the setting, see the following:
(➤P.259 "Chapter 12: 12.11 Change layout of analysis data list", P.299 "Chapter 13: 13.7 Change layout of
screen")

Information
Analysis results of research parameters are indicated by a gray background to distinguish them from
report analysis results. Research items are the parameter for research. Analysis results for these
parameters must not be used for diagnosis of patients.

WBC items for research

The WBC items for research below can be set to be displayed.

● Items
TNC The total nuclear cell count(WBC#+NRBC#).
TNC-N The total nuclear cell count(WBC#+NRBC#) calculated from the WNR channel.
BA-N# The basophil counts calculated from the WNR channel.
BA-N% The basophil percent calculated from the WNR channel.
TNC-D The total nuclear cell count(WBC#+NRBC#) calculated from WDF channel.
NEUT#& The number of particles obtained by subtracting the IG count from the NEUT count.
NEUT%& The ratio of the count obtained by subtracting IG# from NEUT# to the WBC count.
LYMP#& The number of particles obtained by subtracting the HFLC count from the LYMPH count.
LYMP%& The ratio of the count obtained by subtracting HFLC# from LYMPH# to the WBC count.
HFLC# The count of the upper LYMPH area of the WDF scattergram.
HFLC% The ratio of the count of the upper LYMPH area of the WDF scattergram to the WBC count.
AS-LYMP%L* The ratio of the AS-LYMP count to the lymphocyte count.
RE-LYMP%L* The ratio of the RE-LYMP count to the lymphocyte count.
BA-D# The basophil counts calculated from the WDF channel.
BA-D% The basophil percent calculated from the WDF channel.
NE-SSC The lateral scattered light intensity of the NEUT area on the WDF scattergram.
NE-SFL The fluorescent light intensity of the NEUT area on the WDF scattergram.
NE-FSC The forward-scattered light intensity of the NEUT area on the WDF scattergram.
LY-X The lateral scattered light intensity of the LYMPH area on the WDF scattergram.
LY-Y The fluorescent light intensity of the LYMPH area on the WDF scattergram.
LY-Z The forward-scattered light intensity of the LYMPH area on the WDF scattergram.
MO-X The lateral scattered light intensity of the MONO area on the WDF scattergram.
MO-Y The fluorescent light intensity of the MONO area on the WDF scattergram.
MO-Z The forward-scattered light intensity of the MONO area on the WDF scattergram.
NE-WX The lateral scattered light distribution width index of the NEUT area on the WDF
scattergram.

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NE-WY The fluorescent light distribution width index of the NEUT area on the WDF scattergram.
NE-WZ The forward-scattered light distribution width index of the NEUT area on the WDF scattergram.
LY-WX The lateral scattered light distribution width index of the LYMPH area on the WDF scattergram.
LY-WY The fluorescent light distribution width index of the LYMPH area on the WDF scattergram.
LY-WZ The forward-scattered light distribution width index of the LYMPH area on the WDF scattergram.
MO-WX The lateral scattered light distribution width index of the MONO area on the WDF scattergram.
MO-WY The fluorescent light distribution width index of the MONO area on the WDF scattergram.
MO-WZ The forward-scattered light distribution width index of the MONO area on the WDF scattergram.
WBC-P* WBC count calculated from WPC channel.
TNC-P* The total nuclear cell count (WBC#+NRBC#) calculated from WPC channel.

* These items do not appear with all analyzer types.

RBC/PLT items for research

The RBC/PLT items for research below can be set to be displayed.

● Items for research

RBC-O* RBC count calculated from the RET channel.
RET-Y* The forward-scattered light intensity of the RET area on the RET scattergram.
RET-RBC-Y* The forward-scattered light intensity of RBC (mature red blood cells) area on the RET
scattergram.
IRF-Y* The forward-scattered light intensity of the IRF area on the RET scattergram.
FRC#* The absolute count calculated from the count in a specific area below the RBC area in the
RET scattergram.
FRC%* The ratio calculated from the count in a specific area below the RBC area in the RET
scattergram.
RPI* Reticulocyte Production Index.
RET-UPP* The count appearing in the UPP area of the RET scattergram.
RET-TNC* The count appearing in the TNC area of the RET scattergram.
HGB-O* Hemoglobin concentration calculated from the RET channel.
MCHC-O* MCHC-O is calculated by the equation HGB-O / HCT.
Delta-HGB* Delta-HGB is calculated by the equation HGB - HGB-O.
H-IPF* The ratio to the total platelet count of the count of platelets that appear in the area of
stronger fluorescent light intensity within the IPF area of the PLT-F scattergram.
PLT-F2* The platelet count with a minimum number digits of 100/µL calculated from the PLT-F
channel.

* These items do not appear with all analyzer types.

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Body fluid items for research

The Body fluid items for research below can be set to be displayed*.
* The body fluid analysis can only be performed if the license is activated.

● Items for research

HF-BF# The count in the area with stronger fluorescence than the WBC-BF area of the
WDF scattergram.
HF-BF% HF-BF count divided by WBC-BF and expressed as a percentage.
NE-BF# The count appearing in the NEUT area of the WDF scattergram.
NE-BF% NE-BF count divided by WBC-BF and expressed as a percentage.
LY-BF# The count appearing in the LYMPH area of the WDF scattergram.
LY-BF% LY-BF count divided by WBC-BF and expressed as a percentage.
MO-BF# The count appearing in the MONO area of the WDF scattergram.
MO-BF% MO-BF count divided by WBC-BF and expressed as a percentage.
EO-BF# The count appearing in the EO area of the WDF scattergram.
EO-BF% EO-BF count divided by WBC-BF and expressed as a percentage.
RBC-BF2 RBC in the body fluid with a minimum number digits of 100/µL.

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hsA items for research

The hsA items for research below can be set to be displayed.
* The availability of the function depends on your system configuration.

● Items for research

WBC* WBC counted in the WDF channel.
RBC* RBC used from RBC-I or RBC-O.
RBC-I RBC counted in the RBC/PLT channel (RBC distribution).
RBC-O RBC counted in the RET channel.
NEUT#* The count in the NEUT area of the WDF scattergram.
LYMPH#* The count in the LYMPH area of the WDF scattergram.
MONO#* The count in the MONO area of the WDF scattergram.
EO#* The count appearing in the EO area of the WDF scattergram.
NEUT%* NEUT count divided by WBC and expressed as a percentage.
LYMPH%* LYMPH count divided by WBC and expressed as a percentage.
MONO%* MONO count divided by WBC and expressed as a percentage.
EO%* EO count divided by WBC and expressed as a percentage.
MN#* The count in the mononuclear area of the WDF scattergram.
PMN#* The count in the polynuclear area of the WDF scattergram.
HF# The count in the area with stronger fluorescence than the WBC area of the WDF
scattergram.
MN%* MN count divided by WBC and expressed as a percentage.
PMN%* PMN count divided by WBC and expressed as a percentage.
HF% HF count divided by WBC and expressed as a percentage.
TC# Total nuclear cell count calculated from WDF channel.

* These parameter names are the same as the analysis parameters in [Whole Blood] / [Low WBC] /
[Pre-Dilution] / [Body Fluid] / [HPC] modes. In places where a parameter should be distinguished as an [hsA]
mode parameter for research, its name will be appended with "(hsA)".
e.g. [WBC] analyzed in [hsA] mode: [WBC(hsA)]

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hsA analysis
This section explains the hsA analysis.
* hsA analysis can only be performed if the license is activated.
• Types of analysis: ➤P.193 "Chapter 11: 11.1 Types of analysis"
• Analysis modes: ➤P.195 "Chapter 11: 11.1.1 Analysis modes"

Sample volume
The required sample volume is as follows.

Type of Sample Setting Manual Analysis Menu Aspirated Required

Tube type
analysis Position [Cap Open] sample volume sample volume
Closed tube Normal tube OFF 200 µL 1 mL
Manual Open tube holder ON 400 µL
analysis Open micro Micro tube - 260 µL
tube holder

Information
Results generated in hsA mode are for research purpose only.
Do not use the analysis results of these parameters for the diagnosis of patients.

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hsA analysis
Before performing the operation, change to manual analysis mode. For details, see steps 1 through 3 of the
body fluid analysis procedure see Chapter 11.
(➤P.209 "Chapter 11: 11.7 Body fluid analysis")

1 In the [Change Measurement Mode] dialog box, select [hsA] and click [OK].
The dialog box will close, and the background check will start.
If the background values that result from the background check are under the allowable values, the Status
indicator LED lights green and the analyzer enters the analysis preparation done state.
Checked
Acceptable Value Remarks
Parameter
WBC 0.0010 x 103/µL or less WBC counted in the WDF channel
6/µL or
RBC-I 0.0030 x 10 less RBC counted in the RBC/PLT channel (RBC distribution)
6/µL
RBC-O 0.000100 x 10 or less RBC counted in the RET channel
For details on background check, see Chapter 8.
(➤P.118 "Chapter 8: 8.2.4 Execution of analyzer self-check")

Note:
Immediately after the analysis type is changed to [hsA], [Cap Open] is in the selected state. If
you will perform closed analysis using regular sample tubes, remove the [Cap Open]
checkmark.

2 Analyze the sample using manual analysis.

For details, see steps 6 through 12 of the body fluid analysis procedure in Chapter 11.
(➤P.209 "Chapter 11: 11.7 Body fluid analysis")

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Checking analysis data

Settings can be configured in the [Sample Explorer] screen or the [Data Browser] screen to display the analysis
parameters for [hsA] mode. In the [Sample Explorer] screen, they are displayed by adding the analysis
parameters for the [hsA] mode in the [Property] dialog box. In the [Data Browser] screen, they are displayed by
adding the analysis parameters for the [hsA] mode in the [User] and [Lab. Only] tabs.
For the setting, see the following:
(➤P.259 "Chapter 12: 12.11 Change layout of analysis data list", P.299 "Chapter 13: 13.7 Change layout of
screen")
The analysis parameters in [hsA] mode are for research purpose only. For details on the analysis parameters,
see the following:
(➤P.579 "hsA items for research")

Information
• Analysis results of research parameters are indicated by a gray background to distinguish them
from fully validated, diagnostic analysis results. Do not use the analysis results of parameter for
research for the diagnosis of patients.
• RBC-O in [hsA] mode has been designed especially for the analysis of samples with very low RBC
concentrations. For samples with RBC-O that exceeds 0.200001 x 106/µL, we recommend that
you refer to RBC-I.

Sample Explorer

● [hsA] screen
Click the [hsA] tab in the [Sample Explorer] screen to view a list of hsA analysis data. The sub screen shows
the parameters analyzed ([ITEM]), numerical data ([DATA]), marks, and the units ([UNIT]) of the sample
selected in the analysis data list. If there is an abnormality in the analysis data, it is represented by masks and
marks.
* For details on the Sample Explorer's functions, see Chapter 12.
(➤P.229 "Chapter 12: Checking Analysis Data (Sample Explorer)")

● Other screens
In the [Sample Explorer] screen, from the analysis data list, select a sample analyzed in [hsA] mode to view
the hsA analysis data listed in the analysis data area.

Data Browser
In the [Sample Explorer] screen, double-clicking a sample analyzed in [hsA] mode displays the [Data Browser]
screen. The [Data Browser] screen can be displayed on the [Main] / [Graph] / [Lab. Only] / [User] tabs.
* For details on the Data Browser's functions, see Chapter 13.
(➤P.263 "Chapter 13: Checking Detailed Analysis Information (Data Browser)")

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Program version

• To find out the version of your current program of the IPU, click the [Version Information] icon in the Menu screen.
• When using the RU-20, the current RU-20 program version can be checked by clicking the [Show Status] button in
the RU menu.

Interface Protocol
Data can be output in various formats via the serial interface. For details, please contact your authorized local
Sysmex representative.

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Default settings
Analyzer setting names and default settings

Sampler
Setting name Default setting

Blood Sensor Use

1
Sampler Analysis Start Settings* Sampler analysis starts when
rack is placed in sampler

Sampler Analysis Stop ID Read Error Stop Sampler Analysis

Rack number read error*1 Stop Sampler Analysis

Blank Data Stop Sampler Analysis

Critical Value Data Stop Sampler Analysis

Aspiration Error Stop Sampler Analysis

Inadequate Sample Stop Sampler Analysis

QC Alarm Do Not Stop Sampler Analysis

X-barM Limit Error Stop Sampler Analysis

L-J Limit Error Stop Sampler Analysis

Control Expired Error Stop Sampler Analysis

Unregistered Control Do Not Stop Sampler Analysis

Reagent Expired Error Do Not Stop Sampler Analysis

Invalid analysis order Stop Sampler Analysis

Command not to aspirate Do Not Stop Sampler Analysis

Repeat Setting*1 Repeat

Rerun/Reflex Setting*1 Rerun/Reflex

Sampler Discrete Settings Specified discrete

CELLCLEAN AUTO Settings*2 Return to rack

*1 When using the sampler (SA-01) in the XR-1000, this does not appear.
*2 When using the XR-1000, this does not appear.

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Barcode Reader
Setting name Default setting

Barcode Reader Connection Connect Barcode Reader

Read Tube ID Read Tube ID

Specify Sample No. Length No

Check Digits ITF Use ITF

Conditions
Check digit Modulus-10

CODABAR/NW7 Use CODABAR/NW7

Check Digit Modulus-16

CODE39 Use CODE39

Check Digit Modulus-43

JAN/EAN/UPC Use JAN/EAN/UPC

Check digit Modulus-10

ISBT128 Do Not Use ISBT128

CODE 128 Use CODE128

Check Digit Modulus-103

Rack number* Do Not Read Rack ID

Check Digits Conditions (when read) CODABAR/NW7

Start-Stop Character/D(d)-D(d)
Modulus 16

Setting for Order Key Read Error Analyzed

* When using the sampler (SA-01) in the XR-1000, this does not appear.

Alarm
Setting name Default setting

Warning Loop

Stops Analysis Loop

Smart Indicator
Setting name Default setting

LED settings Orange

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Raised Bottom Tube sample settings*

Setting name Default setting

Raised Bottom Tube Sample Settings Repeat/Rerun/Reflex analyses

are not performed for samples
analyzed using Raised Bottom
Tubes

* When using the sampler (SA-01) in the XR-1000, this does not appear.

RU name setting
Setting name Default setting

RU-1 RU-1

RU-2 RU-2

System
Setting name Default setting

Identification Instrument XR-1000 XR-1000-#

Name*

XR-2000 XR-2000-#

Sampler Name Suffix -S

Analyzer Name XR-1000 -A

Suffix

XR-2000 Left Analyzer: -L

Right Analyzer: -R

* "#" at the end of the instrument name and instrument abbreviation indicates a serial number appended to an
instrument that connects to the IPU. Numbers 1 to 3 are assigned by the system.

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Flags
Flag Judgment Judgment value setting*1

WBC Abnormal Flags

Neutropenia Judge NEUT# < 1.00 [x10^3/uL] or NEUT% < 0.0 [%]

Neutrophilia Judge NEUT# > 11.00 [x10^3/uL] or NEUT% > 100.0 [%]

Lymphopenia Judge LYMPH# < 0.80 [x10^3/uL] or LYMPH% < 0.0 [%]

Lymphocytosis Judge LYMPH# > 4.00 [x10^3/uL] or LYMPH% > 100.0 [%]

Monocytosis Judge MONO# > 1.00 [x10^3/uL] or MONO% > 100.0 [%]

Eosinophilia Judge EO# > 0.70 [x10^3/uL] or EO% > 100.0 [%]

Basophilia Judge BASO# > 0.20 [x10^3/uL] or BASO% > 100.0 [%]

Leukocytopenia Judge WBC < 2.50 [x10^3/uL]

Leukocytosis Judge WBC > 18.00 [x10^3/uL]

NRBC Present Judge NRBC% > 2.0 [%]

IG Present Judge IG# > 0.10 [x10^3/uL] or IG% > 100.0 [%]

RBC Abnormal Flags

Reticulocytosis Judge RET# > 0.2000 [x10^6/uL] or RET% > 5.00 [%]

Anisocytosis Judge RDW-SD > 65.0 [fL] or RDW-CV > 20.0 [%]

Microcytosis Judge MCV < 70.0 [fL]

Macrocytosis Judge MCV > 110.0 [fL]

Hypochromia Judge MCHC < 29.0 [g/dL]

Anemia Judge HGB < 10.0 [g/dL]

Erythrocytosis Judge RBC > 6.50 [x10^6/uL]

PLT Abnormal Flags

Thrombocytopenia Judge PLT < 60 [x10^3/uL]

Thrombocytosis Judge PLT > 600 [x10^3/uL]

WBC Abnormal Flag (Body Fluid Analysis)*2

WBC Abn Scattergram Do Not HF-BF# > 999.999 [x10^3/uL] or HF-BF% > 100.0/
Judge 100WBC

*1 The decimal point symbol set in Windows is displayed in this instrument.

The only decimal point symbols displayed are "." (period) or "," (comma).
*2 The body fluid analysis can only be performed if the license is activated.

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Critical Value
Setting name Default setting

Critical Value Setting Item WBC

Lower Limit WBC Lower Limit

Upper Limit WBC Upper Limit

Item Lower limit* Upper limit* Unit

WBC 0.00 999.99 x10^3/uL

RBC 0.00 99.99 x10^6/uL

HGB 0.0 999.9 g/dL

HCT 0.0 999.9 %

MCV 0.0 999.9 fL

MCH 0.0 999.9 pg

MCHC 0.0 999.9 g/dL

PLT 0 9999 x10^3/uL

RDW-SD 0.0 999.9 fL

RDW-CV 0.0 999.9 %

PDW 0.0 999.9 fL

MPV 0.0 999.9 fL

P-LCR 0.0 999.9 %

PCT 0.00 99.99 %

NRBC# 0.00 999.99 x10^3/uL

NRBC% 0.0 9999.9 %

NEUT# 0.00 999.99 x10^3/uL

LYMPH# 0.00 999.99 x10^3/uL

MONO# 0.00 999.99 x10^3/uL

EO# 0.00 999.99 x10^3/uL

BASO# 0.00 999.99 x10^3/uL

NEUT% 0.0 999.9 %

LYMPH% 0.0 999.9 %

MONO% 0.0 999.9 %

EO% 0.0 999.9 %

BASO% 0.0 999.9 %

IG# 0.00 999.99 x10^3/uL

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Item Lower limit* Upper limit* Unit

IG% 0.0 999.9 %

AS-LYMP# 0.00 999.99 x10^3/uL

AS-LYMP% 0.0 999.9 %

RE-LYMP# 0.00 999.99 x10^3/uL

RE-LYMP% 0.0 999.9 %

NEUT-RI 0.0 999.9 FI

NEUT-GI 0.0 999.9 SI

MacroR 0.0 999.9 %

MicroR 0.0 999.9 %

RET% 0.00 99.99 %

RET# 0.0000 0.9999 x10^6/uL

IRF 0.0 999.9 %

LFR 0.0 999.9 %

MFR 0.0 999.9 %

HFR 0.0 999.9 %

RET-He 0.0 999.9 pg

RBC-He 0.0 999.9 pg

Delta-He -999.9 999.9 pg

HYPO-He 0.0 999.9 %

HYPER-He 0.0 999.9 %

IPF 0.0 999.9 %

IPF# 0.0 999.9 x10^3/uL

* The decimal point symbol set in Windows is displayed in this instrument.

The only decimal point symbols displayed are "." (period) or "," (comma).

Sample number auto increment

Setting name Default setting

Sample No. Auto Increment Setting Do not automatically increment

(manual mode)

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Analyzer
Setting name Default setting

Aspiration Sensor Use

Leak Sensor When a water leak is detected,

do not continue analysis.

Manual Discrete Settings Discrete when last ended

IPU setting names and default settings

System
Setting name Default setting

Facility Information Facility Name None

System Language Language English

Print Language English

IPU Shutdown Automatically Shut Down IPU

General Date Format YYYY/MM/DD

User Administration Auto Logon Do Not Output

CSV Output Setting Image File Output Do Not Output Image File

Image Format (when PNG

output)

Background Color (when BLACK

output)

Output sub scattergrams. Do Not Output

If output items exceed 256 Divide Files

columns, data will be
divided into multiple files.
(when output)

Security Settings Analysis Data Backup Data Do not include patient

information

CSV File Do not output patient

information

Screen lock Do Not Use

Screen Keyboard Settings Do Not Use

Patient ID Display Settings Right-justified

Program Update Notification Setting Do Not Use

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Display
Setting name Default setting

Data Grid Line Height Setting 1 20 px

2 22 px

3 (default) 27 px

4 32 px

5 50 px

Font Size Setting 1 11 pt

2 13 pt

3 (default) 16 pt

4 19 pt

5 26 pt

Scattergram Background Color BLACK

settings

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Connection
Setting name Default setting

Host Computer Connection Do not connect to host

Current Connection Host Computer 1

(when host computer connection is ON)

Serial Connection OFF

(when host computer connection is ON)

Port Settings Port Setting COM1

Baud Rate 9600

Code 8-Bit

Stop Bit 1-Bit

Parity Bit None

Interval 2

Class Class B

Format XR-Series Sysmex Standard

TCP/IP Connection (when host computer connection ON

is ON)

Host IP Address IPv4 (1.1.1.1)

Port No. 5000

Format XR-Series Sysmex Standard

Ticket (DP) DP Connection Do not connect to DP

Setting
Select Printer (when DP connection is ON) TM-U295

Print Format Sample No. 15

Length

Date Print Type YYMMDD

Delimiter of Date /

Print Decimal Printed

Point

Top Margin 16 1/60 inch (8 - 255)

Char. Pitch 7 dot (5 - 21)

Line Pitch 8 1/60 inch (8 - 255)

Inverted printing No

Ticket (DP) Print Item Printed Varies by item.

Format Setting Conditions
Print Condition Varies by item. (All Samples/
Negative)

Print Start Position Manual

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Setting name Default setting

Printer Report (GP) Connect Connect to GP

Connection
Ledger (LP) Connect Connect to LP
Settings

IC Card Reader Serial port Do not use

Connection
Settings

Automatic processing
Setting name Default setting

Auto Validate Conditions Do Not Auto Validate

Auto Validate Setting Procedure Use simple settings

(when auto validate is ON)

Auto Validate Sample All Samples

(when simple settings are used)

Auto Output Conditions Do Not Auto Output

Auto Output Setting Procedure Use simple settings

(when auto output is ON)

Error Data Output Conditions Do not automatically output

data with errors

Auto Output Destination and Output Do Not Use

Conditions

Analysis Ordering Key Setting Sample No.

Realtime Host Order Setting Realtime Request: No

Delta Check Setting Do Not Use

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Reference interval
Setting name Default setting

Patient Category Settings Use Category

Lower Age Limit Upper Age Limit

Year Month Week Year Month Week Sex

Category 1 0 0 0 0 0 1 Both

Category 2 0 0 1 0 1 0 Both

Category 3 0 1 0 1 0 0 Both

Category 4 1 0 0 12 0 0 Both

Category 5 12 0 0 60 0 0 Male

Category 6 12 0 0 60 0 0 Female

Category 7 60 0 0 999 0 0 Both

Item Lower limit* Upper limit* Unit

WBC 3.00 15.00 x10^3/uL

RBC 2.50 5.50 x10^6/uL

HGB 8.0 17.0 g/dL

HCT 26.0 50.0 %

MCV 86.0 110.0 fL

MCH 26.0 38.0 pg

MCHC 31.0 37.0 g/dL

PLT 50 400 x10^3/uL

RDW-SD 37.0 54.0 fL

RDW-CV 11.0 16.0 %

PDW 9.0 17.0 fL

MPV 9.0 13.0 fL

P-LCR 13.0 43.0 %

PCT 0.17 0.35 %

NEUT# 1.50 7.00 x10^3/uL

LYMPH# 1.00 3.70 x10^3/uL

MONO# 0.00 0.70 x10^3/uL

EO# 0.00 0.40 x10^3/uL

BASO# 0.00 0.10 x10^3/uL

NEUT% 37.0 72.0 %

LYMPH% 20.0 50.0 %

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Item Lower limit* Upper limit* Unit

MONO% 0.0 14.0 %

EO% 0.0 6.0 %

BASO% 0.0 1.0 %

IG# 0.00 7.00 x10^3/uL

IG% 0.0 72.0 %

AS-LYMP# 0.00 999.99 x10^3/uL

AS-LYMP% 0.0 999.9 %

RE-LYMP# 0.00 999.99 x10^3/uL

RE-LYMP% 0.0 999.9 %

NEUT-RI 0.0 999.9 FI

NEUT-GI 0.0 999.9 SI

MacroR 0.0 999.9 %

MicroR 0.0 999.9 %

RET% 0.00 99.99 %

RET# 0.0000 0.9999 x10^6/uL

IRF 0.0 100.0 %

LFR 0.0 100.0 %

MFR 0.0 100.0 %

HFR 0.0 100.0 %

RET-He 0.0 99.9 pg

RBC-He 0.0 999.9 pg

Delta-He 0.0 999.9 pg

HYPO-He 0.0 999.9 %

HYPER-He 0.0 999.9 %

IPF 0.0 99.9 %

IPF# 0.0 999.9 x10^3/uL

* The decimal point symbol set in Windows is displayed in this instrument.

The only decimal point symbols displayed are "." (period) or "," (comma).

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Units
Item Units Format*1

WBC 10^3/uL ***.**

RBC 10^6/uL **.**

HGB g/dL ***.*

HCT % ***.*

MCV fL ***.*

MCH pg ***.*

MCHC g/dL ***.*

PLT 10^3/uL ****

RDW-SD fL ***.*

RDW-CV % ***.*

PDW fL ***.*

MPV fL ***.*

P-LCR % ***.*

PCT % **.**

DIFF# 10^3/uL ***.**

DIFF% % ***.*

NEUT-RI*2 FI ***.*
2
NEUT-GI* SI ***.*

HPC#*2 10^3/uL **.***

RET#*3 10^6/uL 0.****

RET%*3 % **.**

IRF*3 % ***.*

IPF*3 % ***.*

NRBC% % ****.*

WBC-BF*2 10^3/uL ***.***

RBC-BF*2 10^6/uL **.***

*1 The decimal point symbol set in Windows is displayed in this instrument.

The only decimal point symbols displayed are "." (period) or "," (comma).
*2 The availability of these functions depends on your system configuration.
*3 These items do not appear with all analyzer types.

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Quality control
Setting name Default setting

QC Setting QC Method Setting L-J

Limit Setting Differential (#)

Auto Limit Setting 2SD

X-barM Batch Number of CBC Samples 20

Setting
Number of DIFF Samples 20

Number of RET Samples* 20

Number of PLT-F Samples* 20

Number of WPC Samples* 20

QC Alarm Setting Do Not Use Alarm

QC Chart Fixed Comment Do Not Use

QC Chart Data QC Chart Screen Automatically QC Files

Auto Output output plot data (Excluding X-barM)
Setting to host
X-barM Files
computer.

Explorer Screen Output analysis Graphic Printer No output

results of sample (GP)
numbers starting
Host Computer No output
with QC to location
(HC)
below.
Ticket Printer No output
(DP)

* These items do not appear with all analyzer types.

Priority code
Setting name Default setting

No. Code Back Color Description

1 S No back color STAT

2 R No back color Routine

3 T No back color Timed

4 to 15 Blank No back color Blank

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Index

Numerics Calibrator (XN CAL/XN CAL PF)...............302

3D scattergram ......................................... 272 Calibrator calibration
Backup history ......................................319
A Deleting history .....................................320
About Calibrator Calibration...................... 303 History management.............................316
Calibrator calibration............................. 303 Outputting history..................................319
Calibrator calibration (PLT-F) ............... 310 Restoring history...................................320
About the RU history list ........................... 438 Screen ..................................................316
Acceptable barcodes .................................. 97 Category....................................................377
Activating / deactivating X-barM Control... 167 Causes of errors and remedial actions .....525
Additional components................................ 61 CELLCLEAN AUTO Settings ....................344
Adjusting the air pressure ......................... 464 CELLPACK DCL .........................................63
Alarm......................................................... 339 Character size ...........................................367
Analysis data list ....................................... 232 Check Digit................................................101
Analysis ordering ...................................... 375 Checking the research parameters ...........576
Analysis start............................................. 343 Cleaning ....................................................451
Analysis stop............................................. 343 Cleaning the flow cell ................................461
Analyzer ...................................................... 37 Cleaning the waste fluid chamber .............458
Analyzer name .......................................... 347 Common displayed items..........................264
Analyzer settings...............................333, 351 Computer viruses ........................................29
Aspiration Sensor...................................... 351 Connection
Auto output................................................ 374 Graphic printer (GP) .............................372
Auto Rinse ................................................ 449 Host computer ......................................368
Auto validate ............................................. 373 IC card reader.......................................372
Automatic assignment numbers................ 100 Items .....................................................368
Automatic processing settings .................. 373 List printer (LP) .....................................372
Automatic startup ...................................... 404 Ticket Printer (DP) ................................370
Avoiding infections ...................................... 26 Critical Value .............................................350
CSV Output ...............................................365
B
Barcode D
Dimensions of label ................................ 99 Data browser
Irregularity and roughness of printing ..... 99 Change layout.......................................299
Quality control......................................... 98 Checking data.......................................263
Rack number .......................................... 98 Cumulative screen ................................274
Sample ID number.................................. 97 Display analysis data ............................267
Barcode label ............................................ 203 Main screen ..........................................267
Barcode Reader........................................ 345 Data grid....................................................367
Basic principles of technology................... 103 Date Format ..............................................358
Basic system language ............................. 358 Default setting
Blood Sensor ............................................ 342 Analyzer................................................584
Body fluid analysis .................................... 209 IPU........................................................590
Delta check ...............................................376
C Discrete settings during
Calibration................................................. 301
manual analysis .....................................352
Introduction........................................... 301
Discrete settings during
Practice standards................................ 302
sampler analysis ....................................344

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Display and Modify Patient Info.................361 Information Processing Unit (IPU)

Display and Modify Research Items..........361 Basic screen ...........................................46
Disposal of materials...................................27 Operation ................................................46
Doctor Name Installation ...................................................65
Register/Edit .........................................163 Interface Protocol ......................................583
Screen ..................................................162 Introduction....................................................9
Draining the pneumatic trap chamber of IP messages
the pneumatic unit..................................472 Details ...................................................296
Draining the sample from Displayed Items ....................................286
the RBC isolation chamber ....................463 Meaning ................................................289
Draining the sample from Type ......................................................289
the reaction chamber .............................463 IPU (Information processing unit)................45
Draining waste fluid...................................458 IPU backup......................................... 45, 404
Automatic backup .................................404
E Manual backup......................................410
Electromagnetic compatibility (EMC) ..........25
Schedule setting ...................................404
Error Log ...................................................514
Setting...................................................408
Error message list
Switching IPU........................................559
(in alphabetical order) ............................515
IPU settings ...............................................353
Error message list by function...................519
Items for research
F Body fluid ..............................................578
Facility Information ....................................357 hsA........................................................579
Flag settings..............................................348 RBC/PLT...............................................577
Flags WBC type..............................................576
PLT .......................................................348
L
RBC ......................................................348
Lab format .................................................389
WBC .....................................................348
Laser ...........................................................27
WBC (body fluid)...................................349
Leak Sensor ..............................................352
G List of maintenance items..........................443
GP customize List of menu items .......................................52
Function ................................................385 List printer (LP) connection .......................372
Screen ..................................................386 Logging on.................................................117
Graphic printer (GP) connection ...............372 LOGOFF....................................................119
Graphic printer print setting.......................385 Lot information
Automatic registration ...........................174
H Manual registration ...............................168
History list..................................................430 Modifying...............................................174
Host computer connection ........................368 Overview ...............................................168
HPC analysis.............................................213
hsA analysis ..................................... 580, 581 M
Maintenance inspection checklist..............497
I Maintenance menu....................................444
IC card information Maintenance Task .......................................27
Add .......................................................363 Manage settings
Reset ....................................................364 Analyzer ................................................334
IC card reader connection.........................372 IPU ........................................................354
ID Barcode specifications............................97 Manual analysis.........................................204
Markings......................................................31

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N QC Chart ...................................................182
Notification of Program Updates ............... 366 Q-Flag .......................................................284
Numerical data of the analysis results ...... 237 Quality control ...........................................165
Chart (QC chart) ...................................182
O Comparing analyzers............................190
Open the settings Comparing QC files ..............................189
Analyzer................................................ 331 Cursor data settings..............................186
IPU........................................................ 332 Files (QC files) ......................................180
Operation lock function ............................. 120 Manage QC files ...................................192
Operators .................................................... 29 Select range mode................................187
Output Rule............................................... 416 Timing ...................................................166
Overview of the system............................... 11 Troubleshooting ....................................191
Type......................................................166
P
Vial line .................................................187
Parameters ................................................. 14
Quality control materials............................166
Part Names and Functions ......................... 37
Patient ID display ...................................... 366 R
Patient list Rack number.............................................100
Filter...................................................... 157 RBC detector aperture cleaning................454
Function................................................ 152 Reagent................................................ 63, 65
Register/Edit ......................................... 154
Checking replacement history ..............490
Screen .................................................. 153
List ........................................................475
Search .................................................. 158
Reagent volume used...........................114
Sorting .................................................. 156
Replacing a dilution/hemolytic agent ....477
Performance characteristics ....................... 72
Replacing the stain solution..................483
Performance/specifications......................... 69
Replenish..............................................486
Pneumatic Unit............................................ 40
Reference interval .....................................378
Precision check......................................... 321
Remove Flowcell Air Bubbles....................460
Backup history ...................................... 328
Remove RBC Detector Clogs ...................453
Deleting history..................................... 330
Repeat rule................................................414
History management ............................ 326
Repeat setting ...........................................344
Outputting history ................................. 328
Replace the fuse
Restoring history................................... 329
Analyzer................................................490
Screen .................................................. 326
Pneumatic unit ......................................492
Preparing the Instrument ............................ 65
Sampler ....................................... 494, 495
Print format ............................................... 389
Replacing piercer ......................................474
Printed items ............................................. 388
Replacing waste container ........................447
Priority code .............................................. 384
Report format ............................................389
Program version........................................ 583
Rerun/Reflex setting..................................344
Prohibited acts ............................................ 21
Rerun/Reflex/Comment Rule ....................415
Q Restarting..................................................128
QC RU-20..........................................................50
Alarm .................................................... 381 RU-20 name setting ..................................341
Chart fixed comment ............................ 382 RU-20 reagent switching
Data auto output ................................... 383 Reset the RU-20 ...................................400
Setting ..........................................167, 380 Temporary use of CELLPACK DCL......396
QC analysis
Manual analysis.................................... 175
Sampler analysis .................................. 179

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Rule screens Service data ..............................................563

Display ..................................................419 ADJUSTMENT......................................574
Output Rule...........................................422 HARDWARE .........................................573
Repeat rule ...........................................419 PLT-F ....................................................570
Rerun/Reflex/Comment Rule................420 RBC/PLT...............................................564
Validation rule .......................................421 RET.......................................................568
Rules WDF......................................................567
Disable..................................................423 WNR .....................................................566
Enable...................................................423 WPC......................................................571
Execution Order....................................418 Shutdown ......................................... 358, 447
Initialize.................................................428 Shutting down
Print ......................................................425 Shutting down the entire instrument .....121
Save......................................................426 Smart Indicator ..........................................340
Screen ..................................................417 Starting the Instrument ..............................114
Sort .......................................................424 Symbols used in the manual .......................19
Type......................................................413 Symbols used on the labels ........................20
System Language .....................................358
S System limitations .......................................94
Safety Information .......................................23
System settings
Sample
Analyzer ................................................347
Types and collection requirements .......196
IPU ........................................................357
Sample explorer ........................................229
Reagent Unit (RU-20) ...........................394
Backup..................................................255
Change layout.......................................259 T
CSV Output...........................................253 Targets of IP message judgment
Delete ...................................................258 Judgment conditions .............................288
Filter......................................................241 Judgment method .................................288
Modify ...................................................250 Technical Information ..................................69
Output ...................................................252 Test operation
Restore .................................................256 Aspiration unit motor .............................501
Search ..................................................248 Barcode Reader....................................498
Sort .......................................................239 Counter .................................................509
Sample ID number ....................................100 Sampler.................................................502
Sample number auto increment ................351 Sensor...................................................505
Sample tubes ............................................200 Sheath motor ........................................500
Sampler.......................................................41 Tube grabber ........................................504
Sampler analysis.............................. 218, 223 Tube holder motor.................................501
Sampler rack .............................................202 WB aspiration motor .............................500
Sampler settings .......................................342 Ticket (DP) printer format ..........................371
Screen keyboard .......................................366 Ticket printer (DP) connection ...................370
Screen Lock ..............................................120 Troubleshooting.........................................511
Screen lock timer ......................................365 Turning the power ON ...............................116
Security .....................................................365 Type of analysis.........................................193
Self-check .................................................118
U
Unit setting ................................................379
Unpacking checklist.....................................53

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User information
Add ...............................................359, 361
Change the password........................... 360
Delete ................................................... 363
Management......................................... 359
Modify settings...................................... 361
User permission ........................................ 361

V
Validation .................................................. 238
Validation rule ........................................... 416

W
Ward Name
Register/Edit ......................................... 161
Screen .................................................. 160
Warranty ..................................................... 68
Work list
Backup.................................................. 148
Delete ................................................... 151
Displaying the pending orders .............. 149
Download.............................................. 150
Filter...................................................... 145
Register/Edit ......................................... 139
Restoring .............................................. 149
Screen .................................................. 135
Search .................................................. 146
Sorting .................................................. 144

X
X-barM excluded data............................... 168
XN CAL/XN CAL PF.................................. 302
XN CHECK ............................................... 166
XR-10/XR-20............................................... 11

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Legal information

Legal information
Importer to EU

Sysmex Europe SE

Bornbarch 1, 22848 Norderstedt, Germany

Phone: +49 40 5 27 26-0 / Fax: +49 40 5 27 26-100
www.sysmex-europe.com

Responsible person for United Kingdom of Great Britain and Northern Ireland

Sysmex UK Ltd

Sysmex House, Garamonde Drive,

Wymbush, Milton Keynes, MK8 8DF, United Kingdom

The system described in this manual is compliant with the Medical Devices
Regulations 2002.