REFERENCE

MANUAL

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FOR ANY INFORMATION, PLEASE CALL

(NAME AND ADDRESS OF THE SUPPLIER):

Diagnostica Stago S.A.S - 9, rue des Frères Chausson - 92600 Asnières sur Seine (France) 27638
www.stago.fr- email: [email protected] - RCS Nanterre - N° B 305 151 409 0931047D
Information contained in this document, in particular data, pictures, information, trademarks and logos are
protected by copyrights and other intellectual property rights ©2009, Diagnostica Stago, all rights reserved - 07/
2009.
Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and would be
considered a violation of Diagnostica Stago’s copyrights and other intellectual property rights.
REFERENCE MANUAL

Revision Table

Reference Date Software List of Modifications

manual version
version

V 1.A0 January 98 1.63 Preliminary Version 1

V 1.B0 July 98 1.63 Preliminary Version 2

V 1.0 July 98 1.63 Original Version

V 1.1 Sept 98 1.63 Revision Table

Front Page: Modification of the reference
0931047A → 0931047B
Modified Version
Chapter No.1 - Page 10
Note: Conformity with UL 3101-1 Standard

V 1.2 Dec 2003 2.40 Compliance with IVD directive

0931047B => 0931047C

V 1.3 July 2009 2.40 Compliance with EN Standard 61326-2-6 (Class

A)
0931047C → 0931047D
Modification of analyzer name:
STart®4 → STart®

V1.3 July 2009

REFERENCE MANUAL

V1.3 July 2009

REFERENCE MANUAL
Table of contents

1 Warnings and symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 Meaning of the symbols used in STart® . . . . . . . . . . . . . . . . . . 1-1
1.2 General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 Warnings regarding the handling of biological products . . . . 1-2
1.4 Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.5 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.6 Warnings regarding the STart® system . . . . . . . . . . . . . . . . . . . 1-4
1.7 Warnings regarding the analyzer disposal . . . . . . . . . . . . . . . . . 1-5

2 System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Keyboard description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.3 Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.4 Consumables and spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.4.1 Thermal paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.4.2 Cuvette strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4.3 Ball dispenser and ball vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4.4 Magnetic stir-bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4.5 The cabled pipette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4.6 Pipette thermal conductors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.4.7 Reagent-vial reduction rings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.4.8 Ball remover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.5 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1 Installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Unpacking the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Installation procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

4 Principle of clot determination . . . . . . . . . . . . . . . . . . . . . . 4-1

5 Test parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1 Test parameter access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Test parameter description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.3 To edit test parameter(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

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5.4 To modify the units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

6 Test mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 Access to the working screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1.1 Identification: Manual mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.1.2 Identification: Automatic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Description of the working screen . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3 Assay procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.4 Other functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.4.1 Access to these functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.4.2 Change of pipette mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.4.3 Reprint of the last results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.4.4 Insertion of new patient ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.4.5 Display of test parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

7 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 Calibration menu access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Calibration menu description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3 Calibration procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

8 System check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.1 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 Diagnostic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

9 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1 Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1.1 Daily maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1.2 Weekly maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1.3 Half-yearly maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.1.4 Decontamination of the STart® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.2 Component replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.2.1 Thermal paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.2.2 Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.1 Messages: printed or displayed . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.2 Observed problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

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REFERENCE MANUAL 1
Warnings and symbols

1 Warnings and symbols

1.1 Meaning of the symbols used in STart®

On the analyzer

Alternating current Direct current

Protection earth Warning, consult the

accompanying documents

Off (turn current off) On (turn power on)

Biohazardous element Dangerous voltage

Medical equipment for in vitro Name and address of

diagnosis manufacturer

Separate collection: do not

discard with other waste.
Product put on the market
after 13/08/2005a

a.See chap. 1.7 for additional information about the disposal procedure.

On the consumables

Use once only Keep away from magnetic

fields

Disposable gloves mandatory Mask and goggles must be

worn

Temperature limits for

preservation

In the documentation

Danger for the user or for the Risk of damaging the analyzer
patient (risk of injuries or of
incorrect results)

Complementary information Result of an action

" Action to be performed Initial situation

2

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1.2 General warnings

The use of the STart® requires a training provided either by Diagnostica Stago or by one of its official
distributors.
In order to ensure the correct operation of the STart® system, it is imperative to acknowlege and to
comply with any and all of the analyzer warnings, instructions and procedure contained in this
manual.
The compliance with any and all local legislations, regulations and norms related to biological acts
and/or to medical biology laboratories applicable in the territory where the STart® system is installed
is required and in particular, for France, the GBEA (Guide to Correct Performance of Medical Biology
Analyses) published in its most recent version, the decree of April 26th, 2002 (JO [Journal Officiel]
May 4th, 2002 n°104) and, for the United States the CLIA-88 in the most recent version (Clinical
Laboratory Improvement Act of 1988).
All Information, warnings, instructions and procedures contained in this manual and/or in all later
versions updated by Diagnostica Stago as well as all legislation, regulations and norms relating to the
use of medical in vitro diagnostic equipment in force and applicable for users locally (by"local", we
understand the territory in which the STart® system is installed) are hereafter collectively referred
to as the "Recommendations".
Under no circumstances Diagnostica Stago, its employees, its suppliers or a third party mentioned in
the manual shall be liable whether in contract, tort including, but not limited to negligence or
otherwise for any special or consequential damages, damages or losses that result from the security
and the efficacy of the STart® system as well as any damage whatever, direct, indirect, material or
immaterial, incidental or accessory, or of any nature whatever or of any prejudice, in the non
restrictive cases listed hereunder:
I) in case of non respect of the recommendations described in this manual as well as the use of
procedures that are not set forth by Diagnostica Stago,
II) in case of use of reagents other than those manufactured by Diagnostica Stago even if the use of
said reagents associated with the STart® system is specified in an adaptation protocol,
III) in case of use of washed and/or re-used cuvettes, the reacting cuvettes being consumables
intended for a single use, as well as cuvettes other than those manufactured by Diagnostica Stago and
commercialized by Diagnostica Stago and/or by its official distributors,
IV) in case of non-performance of the current and regular maintenance operations, calibration and
support operations set forth in the present manual and permanently required to ensure the correct
functioning and security of the STart® system,
V) in case the STart® system is not decontaminated in accordance with the decontamination
procedures set forth in chapter 9.1.4 of this manual.

1.3 Warnings regarding the handling of biological products

For the handling of reagents, calibration plasmas, control plasmas and patient’s plasma (hereafter
referred to as “Products”), read carefully the inserts provided with each product.
Before any intervention on the STart® system, to ensure the safety of the staff working in contact
with biohazardous products, and to allow a proper execution of the biological assays, please observe
the following instructions:
I) Respect all recommendations,
II) Make sure that the STart® is decontaminated in conformity with the decontamination procedures
described in chapter 9.1.4 of this manual,

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III) Observe all norms and safety measures imposed on laboratories for the execution of biological
analyses involving biohazardous products in accordance with the regulations in effect locally.
For instance, the following precautions must be observed:
- Do not eat, drink or smoke in places where these products are handled,
- Immediately consult a physician if any of these products is ingested or comes in contact with
mucous membranes or skin lesions (wounds, cuts, etc.),
- Use disposable gloves and handle all products as potential sources of infections,
- Eliminate all products as if they were infected in accordance with the law and the regulations
locally in effect.

1.4 Warnings regarding test settings

Not following the conditions regarding test settings may have consequences on the
reliability of the results as well as on the execution of any biological analysis on the STart®
system, therefore the following conditions must be observed:

ˆ Pre-analytic conditions regarding samples

In order to ensure the activity of various coagulation factors, samples must be drawn with care
following the recommended standards for sample collection; only tubes with proper citrate
concentration should be used.
The quality of the centrifugation and the storage temperature of samples should also be carefully
ensured before the analysis:
- Hemolized and partially coagulated plasma (presence of micro-clots), plasma that was damaged
by temperature changes or plasma with bubbles on its surface may cause inaccurate results.
- Plasma that has been frozen may contain sediments when thawed. These sediments should be
removed before measurement.

ˆ Pre-analytic conditions regarding products and reagents

The laboratory must strictly comply with the instructions provided by the manufacturer in the
product and reagent inserts. Poor preparation of the reagent regarding reconstitution volume,
stabilization time, stirring, presence of bubbles, forgetting or inappropriately leaving a magnetic stir
bar may lead to incorrect results.
The ISI value of the thromboplastin used for the determination of the prothrombin time should be
the one indicated on the assay value insert. Any change in lot - like any intervention- should give rise
to verification of the ISI value.

ˆ Configuration and condition of the analyzer

The laboratory must make sure that the test settings comply with the manufacturer’s prescriptions
for reagents, especially regarding volumes to be used, incubation times, rinsing solutions, buffers, etc.
The analyzer gives results from biological material and although this material is used and measured
by highly sophisticated computer-controlled automated systems in order to optimize reliability and
safety, it is impossible to guarantee an error rate of zero.
The results produced by the analyzer must always be analyzed according to the patient’s history, the
clinical examination and any other biological results.
The laboratory must ensure that the maintenance of the analyzer is performed on a regular basis and
in conformity with the recommendations given in this manual.

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ˆ Conditions regarding the validation of methods and of techniques

The test settings provided by Diagnostica Stago have been validated individually for the STart®
analyzer.
Each laboratory must, considering the regulations applicable in each country, the specificities and the
population of the laboratory patients and the nature of each test, select and validate the test method
used. If the laboratory decides to use other lines of reagents and test settings that have not been
validated by Diagnostica Stago as compatible with the STart® analyzer, a validation of this new
system will be required. This validation will ensure that the characteristics of the method are verified
(see references, 2nd reference).

1.5 References
1 KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B. :
“A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests”.
Am. J. Clin. Pathol., 102, 2, 242-246, 1994.

2 VASSAULT A. et al. :
“Protocole de validation de techniques”. Ann. Biol. Clin., 44, 686 - 745, 1985.

1.6 Warnings regarding the STart® system

The STart® may only be installed by personnel duly authorized by Diagnostica Stago or by its official
distributors.
In order to avoid any risk of electric shocks, it is essential that the procedures described in this manual
are scrupulously observed.
Install the STart® on a stable support that is insensitive to vibrations.
Make sure that the STart® is positioned in such a way that it can be easily unplugged.
Do not obstruct air vents.
Once the STart® has been turned off, wait for 30 seconds, at least, before turning it back on.
The STart® was made and tested according to the CISPR 11 (International Special Commitee On
Radio Interference) for class A equipment. In a domestic environment, the STart® may cause radio
interferences. In this case, measures will have to be taken to reduce these interferences.
The analyzer conforms to the EN 61326-2-6:2006 standard.
The electromagnetic environment should be evaluated before turning on the analyzer.
Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones,
unprotected sources of radiofrequency...) as they may interfere with the operating conditions of the
analyzer.

In order to ensure a proper working of the analyzer, some components of the STart® have to
remain at their initial location:
- the cuvette distributor,
- the pipette.
a

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Follow the safety precautions for the handling of biohazardous materials in accordance with the local
regulations in effect: use disposable gloves.

1.7 Warnings regarding the analyzer disposal

Waste Electrical and Electronic Equipment (WEEE).

The use of this symbol implies that the analyzer must not be disposed of with
household waste; that it must be subject to separate collection and that it has been
put on the market after 13 August 2005.

In accordance with Directive 2002/96/EC of January 27th, 2003 relating to WEEE, the producers of
WEEE are financially liable for the collection, treatment, recovery and environmentally sound
disposal of WEEE resulting from the equipment put on the market after 13 August 2005, unless other
agreements have been concluded between the producer and the user or the distributor, planning
ahead for either a partial or total transfer of producer’s obligations and liabilities either to user or
distributor.
For more information concerning the correct disposal of the STart®, please contact your distributor.

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System description

2 System description
Introduction
The STart® analyzer is a compact 4-channel coagulation instrument to run in vitro assays.
Its main items are :
ˆ built-in plasma and reagent incubation zones.
ˆ an integrated thermal printer.
ˆ a calculator.
ˆ four independent timers for incubation.
ˆ four measurement channels.
The calibration curves are all stored in memory, each calibration curve graph can be printed.
A cabled pipette is connected at the rear of the analyzer. It allows automatic start of measurement
with the addition of reagent.
An unique detection system based on electromagnetic sensors allows to detect all types of clots, even
if weak.

2.1 Front view

Fig. 1 - Global View

Legend:

1 Back light liquid crystal display (4 lines of 40 characters).

2 Incubation area (4 columns of 4 cells) thermostated at 37 °C.

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3 Control keys for incubation timers A to D: :

4 Control key for pipette - either to enable it when using a cabled reservoir pipette or to
start the timers for clot detection when using an ordinary pipette.

5 Measurement area thermostated at 37 °C.

6 Numerical keyboard (chapter 2.2).

7 Two reagent storage positions and 37 °C thermostated pipette tips - the position identified by
is equipped with a stirring motor.

8 Single storage position for the ball dispenser.

The ball dispenser must not be positionned in one of the reagent storage positions (area 7). That
would cause the magnetization of the balls which would affect the results.

9 Thermal printer (40 columns).

When handling the analyzer, the paper cutter must be protected in order to avoid any gash.

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System description

2.2 Keyboard description

0, 1, 2 to 9 Numerical keys which allow the selection of the different menus or the
and z modification of the displayed data.

Enter
Confirmation key. If information is not confirmed, it is not stored in
memory (access to a menu or data modification, for example). In some
menus (Calibration, Test Parameters, System Check), the key
allows the cursor movement on the following line.

Escape
Escape or cancel key. This key allows to exit a menu, or not to confirm
some information (for example, data modification).

Paper advance
This key should imperatively be used to advance paper; never pull the
paper, it will damage the printer.

Cursor movement keys

or
Depending on the menus, these keys allow cursor movement on a given
line (so, it is possible to modify numerical data).
In the following menus (Calibration, Test Parameters, System

Check), the key allows the cursor to move back on the previous
line. In the menus (System Check and Test Parameters ) and in the
UTILITIES screen, the key is used to modify non numerical data.

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2.3 Rear view

Legend:

1 Fuses.

2 Socket for power cable.

3 ON/OFF turn.

4 Plug to connect the cabled pipette.

5 See the following chapter before:

- Turning ON the analyzer: chapter 3.3,
- Changing the fuses: chapter 9.2.2,
- Connecting a cabled pipette: chapter 6.4.2.

6 Connection with PC (interface RS232).

7 Identification Label.

8 “Fuse / Input Volt.” Label.

Reminder of the values for the:
- Fuses,
- Voltage range.

2.4 Consumables and spare parts

2.4.1 Thermal paper

Thermal paper is for the analysis results. It is to be installed in the thermal printer (chapter 9.2.1).

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System description

2.4.2 Cuvette strip

The cuvette strip can be divided as needed.

The cuvettes should not be washed and reused. Diagnostica Stago will not guarantee the exactitude
of results obtained while using disposable cuvettes which have been washed and reused.

2.4.3 Ball dispenser and ball vial

The ball dispenser is such designed that the ball vial (to recharge the dispenser) can be screwed on
to the dispenser without any transfer.

2.4.4 Magnetic stir-bars

Magnetic stir-bars can be used to assure correct homogeneity of the reagents, i.e.:

one reagent position (identified by the sign) is equipped with magnetic stirring motor.

Never place the ball dispenser in this position. It would cause the magnetization of the balls which
would affect the results.

2.4.5 The cabled pipette

The cabled pipette which is supplied with the STart® analyzer is a Finnpipette®. Diagnostica Stago
has modified it to include a reagent distribution detection system and a cable to transmit the
distribution information. With this cabled pipette, measurement can be started automatically while
dispensing the reagents. The color of the Finnpipette® does not have any repercussion on its
functioning.
To avoid contamination between reagents, it is mandatory to change the tip of the pipette each time
the reagent changes.
As for the volumes distributed, the principle is: volume distributed = minimum volume indicated on
tip (1 = XX μl) x position on the volume selection dial.

For example: to distribute 100μl,

if the volume written on the tip is 25 μl select 4 with the volume selection dial

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System description

2.4.6 Pipette thermal conductors

The thermal conductors must be positionned to ensure good heat transfer for the tip of the pipette.
The color of the thermal conductors does not have any repercussion on their functioning. Thermal
conductors are interchangeable.

2.4.7 Reagent-vial reduction rings

To assure good heat transfer characteristics, three types of reagent vial reduction rings can be
supplied. Thus, 18-mm and 22-mm diameter vials, as well as 13-mm diameter tubes (5-ml standard
test tubes), can be used to store the reagents.

2.4.8 Ball remover

The magnetic end of this ball remover allows removal of a ball which has fallen inside a measurement
or incubation well.

2.5 Technical specifications

Standards EC marking (in accordance with the european directive 98/79/EC)

- IEC 61010-1
- IEC 61010-2-101
- EN 61326-2-6 (Class A)
- UL : UL61010A-1 (Underwriters Laboratory)
All the devices connected to the STart® must comply with the IEC
60950 and the EN 55022 (class A) standards.

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System description

Dimensions Depth : 420 mm (16.5 in.)

Width : 410 mm (16.1 in.)
Height : 120 mm (4.7 in.)

Weight 5.7 kg ~ (12.54 Lbs)

Power Supply Class 1.

Installation class: 2.
Voltage: 100-230V (± 10 %).
Frequency: 50-60 Hz.
Power: 110 W max.

Pollution Degree 2.

Heat generated at an For 230 V : 32.2 Btu/h.

ambient tempera-
ture of 20°C

Operating - Room temperature: + 15°C to + 32°C (+ 59°F to + 89.5°F)

Condition - Relative humidity without condensation: 20 to 80 %
- Altitude < 2000 m (indoor use only).

Measurement Electromagnetic sensor.

Principle Plasma or whole blood.
Automatic (with electronically connected pipette) or manual start
of measurement.

Test Performance Intra-assay Reproducibility:

with Normal Plasma Pathological Plasma
Diagnostica Stago
PT (sec) <1,5% < 2%
Products
APTT (sec) <1,5% < 2%
Fibrinogen (sec) < 4% < 5%

Data - Backlighted liquid crystal display (4 lines of 40 characters).

Management
- Integrated thermal printer of 40 columns.
- 21 numerical and function control keys.
- Results in seconds and in various units (%, ratio, INR, g/l, mg/dl,
IU/ml).
- RS232 interface.

Samples and Rea- - Incubation and measurement wells at 37 °C ± 0.5 °C with:

gents
. 16 incubation positions for samples (4 cells x 4 columns);
Handling
. 4 measurement channels (one column);
. 2 positions for reagents (one with magnetic stirrer) with 2 pipette
wells.

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System description

Incubation time han- - 4 independent built-in timers for incubation.

dling
- Incubation control with audible alarm.
- 1 storage position for Ball dispenser.

Test Cuvettes Divisible cuvette strips.

Patented design.

Heating Time 30 min.

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REFERENCE MANUAL 3
Installation

3 Installation

3.1 Installation requirements

STart® dimensions:
- Depth: 420 mm (16.5 in.)
- Width: 410 mm (16.1 in.)
- Height: 120 mm (4.7 in.)

Install the STart® on a stable support that is insensitive to vibrations.

Make sure that the STart® is positioned in such a way that it can be easily unplugged.

Electrical power supply

- Voltage and tolerances: 100-230V (±10%)
- Frequency and tolerance: 50/60Hz
- Power: 110 W maximum.

3.2 Unpacking the analyzer

Open the box with the top side up and check the components :
- 1 STart® coagulation analyzer.
- 1 Protective blanket.
- 1 Roll of thermal paper.
- 2 Pipette thermal conductors.
- 1 Power cable.
- 1 Reference manual (bilingual French/English)(27638).
- 1 Booklet on operating procedures (26987).
- 2 x 18-mm Reduction rings for reagent vials.
- 2 x 22-mm Reduction rings for reagent vials.
- 2 Reduction rings for 13-mm diameter test tubes.
- 1 Ball remover.
- 2 Magnetic stir-bars.
- 1 Finnpipette® cabled.
- 1 Box of 1,25 ml Finntips®
- 1 Box of cuvette strips.

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3 REFERENCE MANUAL
Installation

- 1 Ball dispenser.
- 1 Vial containing approx. 1 850 balls.
- 10 Fuses (T3,15A).
- 1 CD ROM of documentation.

Make sure the analyzer has not been damaged during the transportation.
Keep the original packaging.

3.3 Installation procedure

Make sure there is a minimum space around the analyzer. For optimum convenience, Diagnostica
Stago recommends :

- Width: 600 mm (23.6 in.)

- Depth: 700 mm (27.6 in.)

" Plug in the power cable and turn the STart® analyzer ON.
A self-check is immediately performed by the STart®. When the self-check is completed, the screen
displays the message:

End of self-check: OK
Press a key to continue

" Press any key to continue.

The main menu is displayed.
" Check the System Parameters (see procedure in chapter 8.1).
" Install the paper as explained in chapter 9.2.1.

Access to Test Mode is not accepted by the STart® until it has reached the working temperature
of 36.5°C.
Wait 30 minutes after turning ON the analyzer to reach the required temperature.

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REFERENCE MANUAL 4
Principle of clot determination

4 Principle of clot determination

The principle consists in measuring the variations of the ball oscillation amplitude through inductive
sensors.
The ball has a pendular movement obtained thanks to:
- the two curvated rail tracks of the cuvettes (patented design),
- an alternate electro-magnetic field created by two independent coils.
The oscillation amplitude is constant when the environment has a constant viscosity.
The oscillation amplitude decreases when the environment viscosity increases.

Fig. 1 - Physical principle of the measurement system

The intensity of magnetic field can be varied depending on the tests to be carried out (PT, APTT...)
and on the expected clot.
The detection system of the oscillation amplitude variations is based on two measurement coils.
The tranmitting coil emits an electro-magnetic field. The signal received by the receiver coil depends
on the ball position in the cuvette.
An algorithm uses these magnetic field variations to determine the oscillation amplitude and the
clotting time.

Fig. 2 - Shema: ball movement

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Principle of clot determination

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REFERENCE MANUAL 5
Test parameters

5 Test parameters
In this menu are stored the parameters for each test. All the parameters are stored in memory and
can be modified.
For the settings recommended by Diagnostica Stago, please see the booklet “Operating Procedures”
delivered with the analyzer (26987).

5.1 Test parameter access

From the main menu:

Diagnostica Stago
1 : Test Mode 2 : Calibration
3 : Test Parameters 4 : System Check
Enter Code Number :

" Press the 3 key on the keyboard. Test Parameters is clearly displayed beside Enter Code
Number on the last line.
" Press to confirm.
The first list of available tests is displayed :

1 : PT 2 : APTT
3 : Fibronogen 4 : Factors
5 : Heparin 6 : Others
Enter Code Number :

" Choose the desired test by pressing the key corresponding to its code number (for example, 2
for APTT). In some cases, you have to make consecutive choices (for example for factor X, press
first the 4 key then the 5 key).
The name of the test is clearly displayed beside Enter Code Number on the last line of the screen.
" If a test does not appear on this first list, press the 6 key to display the second list of available
tests.

1 : Inhibitors 2 : TCT 3 : Lupus

4 : SPA 5 : Others
Enter Code number :

" Choose the desired test by pressing the key corresponding to its code number.
" Confirm the final choice with

Max. Time : 110 s

Incubation Times T2 : 120 s T1 : 0 s
Single/Duplicate : Duplicate ( = Chgt)
Precision : 5 %
The first parameters are displayed.
" Press the key to confirm each parameter and to display the following page.

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Test parameters

" At any time, the key allows to return to the main menu.

5.2 Test parameter description

ˆ Max Time: 110 s
ˆ Incubation Times T2: 120 s T1: 0 s
ˆ Single/Duplicate: Duplicate
ˆ Precision: 5 %
ˆ Unit (1 to 8): %

Max. time Maximum time for an analysis.

Above this time, the given result is >xx.

Incubation STart® can control two incubation times for each test: a pre-incubation time
Times: T1 and an incubation time T2. At the incubation time minus 10 seconds, the
T1 and T2 analyzer beeps during 5 seconds to warn the operator.

Single/ 2 possibilities:
Duplicate
- single determination,
- duplicate determination.

Precision Maximum difference allowed for a duplicate determination. It is expressed

in % and it is applied to the clotting times (sec.). This line is not displayed when
single determination is chosen.

Unit Results are always given in seconds and in the desired unit. The following units
can be selected by their code number.
Code Unit Definition
1 % Percentage
2 %-INR Percentage and
International Normalized Ratio
3 g/l Grams/liter
4 mg/dl Milligrams/deciliter
5 Ul/ml International Unit/milliliter
6 sec. Seconds (only)
7 Ratio Sample time/reference time ratio
8 Ratio-INR Sample time/reference time ratio and
International Normalized Ratio

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REFERENCE MANUAL 5
Test parameters

5.3 To edit test parameter(s)

When the cursor is over the desired information, use the numerical keys to enter the new data.
Confirm each modification with the key.
For the type of determination (single or duplicate), use the key to change from Single to
Duplicate or reversely, then confirm with the key.
To enter a new unit:
" Choose the desired unit among the list given at the bottom of the screen,
" Press the key (1 to 8) corresponding to the desired unit. The corresponding unit is displayed
beside Units.

Any unit change, other than % to %-INR, Ratio to Ratio-INR or reversely, automatically leads to the
deletion of the calibration curve which is stored in memory.

" Confirm the choice with

For INR unit, a new line is displayed to enter the ISI value (International Sensitivity Index).

Changing the concentration units in the Test Parameters menu does not lead to results
automatically given in the new unit. See the modification procedure described below.

5.4 To modify the units

To modify the units, three steps are necessary:
1 Run the standard plasmas in duplicate using the Test Mode menu (see chapter 6),

2 Change the unit code in the Test Parameters menu (see chapter 5.3),

3 Enter, for the desired test, in the Calibration menu, the standard values in accordance with
the new unit and for each standard, the time values as recorded during step 1 (see chapter 7).
Thus, a new calibration curve will be computed and the results will be given in the modified
unit.

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Test parameters

Any unit change, other than % to %-INR, Ratio to Ratio-INR or reversely, automatically leads to the
deletion of the calibration curve which is stored in memory.

The following table gives the different authorized units (X) in accordance with the chosen test. Any
other choice of units only involves the operator’s responsability.

Units

Test % %-INR g/l mg/dl UI/ml Sec Ratio Ratio-INR

PT X X X X X

SPA X X X

APTT X X

Fibrinogen X X X

Factor II X X

Factor V X X

Factors VII-X X X

Factor VII X X

Factor X X X

Factor VIII X X X

Factor IX X X

Factor XI X X

Factor XII X X

Unfract. Heparin X X

LMWH X X

Protein C X X

Protein S X X

Thrombin Time X

Reptilase Time X

Staclot LA X

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REFERENCE MANUAL 5
Test parameters

Units

Test % %-INR g/l mg/dl UI/ml Sec Ratio Ratio-INR

Staclot PNP X

Mode lin/lin X X X X X X X X

Mode lin/log X X X X X X X X

Mode log/log X X X X X X X X

Mode 1/C X X X X X X X X

Mode 1/(T-N) X X X X X X X X

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Test parameters

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REFERENCE MANUAL 6
Test mode

6 Test mode

For each test, it is mandatory to run quality controls before each series of analysis.There is no
specific management of quality controls in STart®.

The lab has to decide:

ˆ If the patient identification is manual or automatic,
ˆ If a cabled pipette or a not-connected pipette will be used.
Information are stored in the System Check menu as Setup parameters (see chapter 8).
The lab must also check that the test parameters are properly defined (see the booklet «Operating
Procedures» delivered with the analyzer 26987).

6.1 Access to the working screen

Diagnostica Stago
1 : Test Mode 2 : Calibration
3 : Test Parameters 4 : System Check
Enter Code number:

From the main menu:

" Press the 1 key on the keyboard. Test Mode is clearly displayed beside Enter Code Number.

" Confirm with key.

The first list of available tests is displayed:

1 : PT 2 : APTT
3 : Fibrinogen 4 : Factors
5 : Heparin 6 : Others
Enter Code number:

" Choose a test by pressing the key corresponding to its code number (for example 1 for PT). In
some cases, it is necessary to make consecutive choices (for example for factor X, press first
the 4 key then the 5 key).
The name of the test is clearly displayed beside Enter Code Number on the last line of the
screen.

" If a test does not appear on this first list, press the 6 key to display the second list of available
tests.

1 : Inhibitors 2 : TCT 3 : Lupus

4 : SPA 5 : Others
Enter Code number:

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6 REFERENCE MANUAL
Test mode

" Choose the desired test by pressing the key corresponding to its code number.

" Confirm with

If the temperature is lower than 36.5°C, the access to Test Mode menu is impossible.
Wait 30 minutes after turning ON the analyzer to reach the required temperature.

2 identification modes:
ˆ Manual mode,
ˆ Automatic mode.
The choice between the two identification modes is made in the System Check menu.

6.1.1 Identification: Manual mode

Pat ID#1 : Pat ID#5 :

Pat ID#2 : Pat ID#6 :
Pat ID#3 : Pat ID#7 :
Pat ID#4 : Pat ID#8 :

" Enter the patient identification numbers by using the numerical keyboard. Numbers must be
greater than or equal to 1 (7 digits maximum).

" Confirm each identification number with the key.

" If several patient ID# have to be modified, press as many times as necessary.

the key to move the cursor back on the line(s) to be corrected. The key allows to
return to the end of the list.

" When all identification numbers have been entered and confirmed, press the key: the
working screen is displayed and the list of patient identification numbers is printed.

6.1.2 Identification: Automatic mode

«First Patient ID» is displayed:

" Enter the first patient identification number by using the numerical keyboard. This number has
to be greater than or equal to 1 (7 digits maximum).
The next numbers are automatically incremented.

The patient ID# can be corrected with the key.

" Confirm with the key to display the working screen.

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REFERENCE MANUAL 6
Test mode

6.2 Description of the working screen

P.T. (1) Units : % (1)
(2) 1 (ID#(3)) : (4) (2) 3 (ID#(3)) : (4)
(2) 2 (ID# (3)) : (4) (2) 4 (ID# (3)) : (4)

000 (5) 000 (6) 000 (7) 000 (8) 37.0°C (9)

Legend:

(1) Name of the test and unit in which the result will be given; can be replaced by following
messages: «Next: xxx» or «Ready: PIP key».

(2) Channel number.

(3) Patient identification number.

(4) Measured times.

(5) Timer of the first incubation column.

(6) Timer of the second incubation column.

(7) Timer of the third incubation column.

(8) Timer of the fourth incubation column.

(9) Temperature measured by the thermal sensor of the incubation and measurement zones.

6.3 Assay procedure

" Prepare the reagents (see the booklet «Operating Procedures» delivered with the analyzer).

" Place the cuvettes for preheating in incubation zone (see chapter 2.1, number 2).

" Use the ball dispenser to dispense one ball in each cuvette.

" Place the reagents in the proper locations, thermostated to 37°C, with magnetic stir-bar, if
necessary (see chapter 2.1, number 7).
The liquid level in each vial must not be above the work zone surface.

" If the vial does not touch the storage zone walls the reagents will not be at the correct
temperature. Then, use the reduction ring.

" If a cabled reservoir pipette is used, place the appropriate tip on the pipette and set the
volume to be delivered. Place the pipette in the area reserved, next to the reagents, in order
the pipette is at the correct temperature.

" Display the working screen for the test to be carried out.
Example of PT determinations with a connected pipette, automatic patient identification
mode.

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Test mode

The working screen is displayed:

P.T Ready: PIP key

1( ): 3( ):
2( ): 4( ):

000 000 000 000 37.1°C

" Dispense the first sample in the top cuvette of the first strip placed in the incubation area
(cuvette #1 of the first strip).

To avoid risks of contamination between plasmas, it is mandatory to change the tip of the pipette.

" Start the timer corresponding to the incubation column by pressing the control key
(see chapter 2.1, number 3).
The timer starts from 0 and the time runs with the sign i displayed at the right of the timer.
" Dispense the other samples.
" Refill the pipette reservoir with the start reagent.
" Wipe off the tip.
" Replace the pipette in its storage well.
" When the analyzer starts to beep (10 seconds before the end of the incubation time), transfer
quickly the cuvette strip to the measurement area (see chapter 2.1, number 5).
" Prime the tip.

" Press the pipette control key (see chapter 2.1, number 4) to activate the pipette:

P.T. Units : %

1( 101) : 3( 102) :
2( 101) : 4( 102) : 16.2

058 i 000 000 000 37,1°C

The sign , which means «waiting for reagent distribution» is displayed beside position 1 on
the display. The patient identification numbers appear. The ball agitation starts.

" When the incubation time reaches the value stored in the menu Test Parameter
(see chapter 5), i.e. 5 seconds after the audible alarm stops, dispense the start reagent in the first
cuvette (the top one):

the sign moves beside position 2 on the display and the sign, which means «measurement
in progress», appears beside position 1. At the right of the timer appears the sign+, which means
that the incubation time is now over.

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REFERENCE MANUAL 6
Test mode

P.T. Units : %

1( 101) : 3( 102) :

2( 101) : 4( 102) :

062 + 000 000 000 37.1°C

" Dispense the start reagent in the second cuvette:

the sign moves beside position 3 on the display and the sign appears beside position 2
(measurement is in progress for position 2).

P.T. Units : %

1( 101) : 3( 102) :

2( 101) : 4( 102) :

066 + 000 000 000 37.1°C

" Dispense the start reagent in the third cuvette, then in the fourth cuvette. When the clotting
times are determined, they are displayed. Then, the results are printed in seconds in the desired
unit.

P.T. Ready: PIP key

1( 101) : 12.1 3( 102) : 16.0
2( 101) : 12.0 4( 102) : 16.2
100 + 000 000 000 37.1°C

If the pipette control key is not pressed, the results remain displayed.
Example of printout for results:
ˆ Automatic Identification Mode:

PT-End analysis at 10 : 40 AM.

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6 REFERENCE MANUAL
Test mode

Legend:

1 Type of analysis.

2 Date.

3 Time.

4 Reagent lot number(s).

5 Patient identification.

6 Channel number where the clotting time has been determined.

7 Result in second.

8 Result in unit.

9 Average in case of duplicate determination. This average is preceded by the sign * when the
calculated margin of the clotting times is greater than the given one in the Test parameters
menu.

ˆ Manual Identification Mode

Legend:
1 Type of analysis.

2 Date.

3 Time.

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REFERENCE MANUAL 6
Test mode

4 Reagent lot number(s).

5 Patient identification.

6 Channel number where the clotting time has been determined.

7 Result in second.

8 Result in unit.

9 Average in case of duplicate determination. This average is preceded by the sign * when the
calculated margin of the clotting times is greater than the given one in the Test parameters
menu.

" To get the working screen ready for the next samples, press the pipette control key (see
chapter 2.1, number 4).
The next patient identifications appear as well as the sign (which means «waiting for reagent
distribution») beside position 1. The ball agitation starts.

P.T Units : %
1( 103) : 3( 104) :
2( 103) : 4( 104) :

000 058 i 000 000 37.1°C

With a connected pipette, the pipette control key function (see chapter 2.1, number 4) is to
make operational the automatic start of measurement with the addition of reagent.

However, after having pressed this control key, it is possible to return with the key.
Then, it is possible to dispense reagent without starting any measurement. Thus, it is possible to

prime the pipette tip (if it has been forgotten) then to start again with the pipette control key .

" With a connected pipette or with a not-connected pipette, whatever the patient identification

mode, press the key to return to the main menu.

" With a not-connected pipette, whatever the patient identification mode:

The sign, which means «waiting for reagent distribution», is already displayed at the working

screen. In this case, the pipette control key (see chapter 2.1, number 4) is used to start each
measurement. So, for each reagent distribution, press the pipette control key as the same
time as the pipetting lever is pressed.

On the display, the sign means that the measurement is in progress. The sign which means
«waiting for reagent distribution» moves to the next position as when using a connected pipette.

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Test mode

General remarks:

With the manual patient identification mode, whatever the pipette type:
- After the 4 first measurements, the name of the test is replaced by «Next: xxx» where xxx is the
next patient ID#.
- At the end of the serie, the sign N is displayed beside the non-used measurement wells. The

pipette control key is no more available. Press the key to exit this menu.
To reset the timer, press once again its control key (see chapter 2.1, number 3). The four
timers are separately controlled.
With the automatic patient identification mode, whatever the pipette type, when less than four
samples have to be run (less than four measurement channels), use the procedure described
previously. The sign remains displayed beside the position of the first channel which has not
been dispensed. As soon as the clotting times of the dispensed channels have been determined, the
results are displayed and printed, the sign moves back beside position 1 (either automatically

when using a not-connected pipette or when the pipette control key is pressed when using a
connected pipette).
For duplicate assays, this is true only if the start reagent is dispensed for the two duplicates (2
measurement channels should be used).
In case of consecutive incubations, the timer starts from 0 and the time runs until the first incubation
time T1. Then the sign p is displayed at the right of the timer.
Once time T1 is reached, the timer is reset and the time runs indefinitely until the timer is reset.
From 0 to incubation time T2, the sign i is displayed at the right of the timer. Then, when the time
is greater than T2, the sign + is displayed at the right of the timer.

6.4 Other functions

When the working screen is displayed and no measurement is in progress, it is possible to access the
following functions:
- Change of pipette mode for the test in progress (connected to not connected or reversely).
- Reprint of last result.
- Insertion of new Patient identifications in case of manual identification mode.
- Display of the list of test parameters for the test in progress.

6.4.1 Access to these functions

The working screen is displayed and no measurement is in progress:

P.T. Ready: PIP key

1( 1) : 12.1 3( ) : 16.0
2( 1) : 12.0 4( ) : 16.2

000 025 000 000 37.0°C

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REFERENCE MANUAL 6
Test mode

" Press the key on the keyboard: the UTILITIES screen is displayed:

Utilities
1 : Pipette Mode 2 : Reprint
3 : Add ID# 4 : Parameters
Enter Code number:

6.4.2 Change of pipette mode

It can be necessary to change the pipette mode for the test in progress : for example, change from
a connected pipette mode to a not-connected pipette mode.
The pipette must be disconnected from the STart® to change into the not-connected pipette
mode.
From the Utilities screen (chapter 6.4.1):
" Press the 1 key on the keyboard (Pipette Mode):
The pipette mode is displayed on the last line, for example, connected pipette.

" Press the key on the keyboard:

The pipette mode changes, i.e.: connected pipette to not-connected pipette.
" Confirm with the key on the keyboard.

" Then, press the key to display the working screen back.

Leave the working screen to return to the main menu. Then the pipette mode becomes again
identical to the previous one programmed in the System check menu (chapter 8).

6.4.3 Reprint of the last results

From the Utilities screen, (chapter 6.4.1):

" Press the 2 key on the keyboard: the last results are reprinted.

6.4.4 Insertion of new patient ID#

This function can only be used if manual identification mode has been set.

From the Utilities screen (chapter 6.4.1).

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Test mode

" Press the 3 key on the keyboard (Add ID#’s): «Pat ID#x:» appears on the upper left corner of
the display; x is equal to the number of patients already tested+1.
" Enter with the numerical keyboard the patient identification numbers to be inserted.
" Confirm each patient ID# with the key.
When all identification numbers to be inserted have been entered and confirmed, press the
key; the UTILITIES screen is displayed and the list of identification numbers included the new
patient ID#’s is printed.

" Press the key: the working screen is dispayed with the next patient ID# equal to the first
identification number inserted.

6.4.5 Display of test parameters

From the UTILITIES screen (chapter 6.4.1):

" Press the 4 key on the keyboard (Parameters):

The list of parameters defined for the test in progress is displayed, i.e.:

Max. Time : 90 s (1)

Incubation Times T2 : 120 s T1 : 0 s (2)
Single/Duplicate: Duplicate (5 %) (3)
Unit: sec (4)

Legend:
(1) Max. reading time for a test.

(2) Incubation times T1 and T2.

(3) Determination mode. In case of duplicate determinations, the precision value is given in
parenthesis.

(4) Unit and ISI value, if necessary.

All these parameters have been defined in the Test Parameters menu (chapter 5).

" Press the key: the Utilities screen is displayed.

" Press the key to return to the working screen.

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REFERENCE MANUAL 7
Calibration

7 Calibration
The standards have to be run in duplicate as normal samples using the Test Mode menu. If necessary,
the unit is modified in the Test Parameters menu (see unit modification procedure chapter 5.4). Then,
the Calibration menu is used to enter the measured times and to determine the calibration curve.

7.1 Calibration menu access

From the main menu:

Diagnostica Stago
1 : Test Mode 2 : Calibration
3 : Test Parameters 4 : System Check
Enter Code number :

" Press the 2 key on the keyboard.

Calibration is displayed beside Enter Code Number on the last line.

" Confirm with

The first list of available tests is displayed:

1 : PT 2 : PT + APTT
3 : Fibrinogen 4 : Factors
5 : Heparin 6 : Others
Enter Code number :

" Choose the desired test by pressing the key corresponding to its code number (for example 1
for PT). In some cases, it is necessary to make consecutive choices (for example for factor X,
press first the 4 key then the 5 key).
The name of the test is clearly displayed beside Enter Code Number on the last line of the
screen.

" If a test doesn’t appear on this first list, press the 6 key to display the second list of available tests.

1 : Inhibitors 2 : TCT 3 : Lupus

4 : SPA 5 : Others
Enter Code number :

" Choose the desired test by pressing the key corresponding to its code number.

" Confirm the choice with

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Calibration

7.2 Calibration menu description

05/10/97 Factor VIII
Standard lot number : 971961
Start reagent lot number : 971982
R1 lot number : 971553
R2 lot number : 960383
STDI : 95.00 % = 82.3 s and 82.1 s
STD2 : 47.50 % = 91.3 s and 92.8 s
STD3 : 23.75 % = 103.2 s and 102.6 s
STD4 : 11.87 % = 113.6 s and 113.1 s
S = -6.439
Y0 = 14.317
R = -0.9994

Legend:

XXX lot number: The lot numbers of the reagents used to determine the calibration
curve are entered on these lines.
R1 and R2 lot number lines will only be displayed for the tests which
require these reagents.
The lot numbers will be recalled on the printings of the calibration
curve and on each result printout (maximum 9 digits).

STD1: X1 = t11 and t12 X1, X2, X3, X4, ... X8, are the values of the standards of the last
STD2: X2 = t21 and t22 calibration (maximum 8). They are stored in memory and recalled
STD3: X3 = t31 and t32 on this display. They can be edited.
STD4: X4 = t41 and t42 t11, t12 to t82 are the times measured for the standards. The times
... entered for the last calibration are stored in memory and recalled
STD8: X8 = t81 and t82 on this display. They can be edited.

S= Slope.

Y0 = Y intercept.

R= Regression coefficient.

When new time values are entered, the computer calculates the new calibration curve and displays
the curve parameters : slope, Y intercept and regression coefficient.

8 standards maximum can be entered. To use less than 8 standards, 0 has to be entered both for the
concentration and the time.

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Calibration

Special cases :
ˆ Ratio Mode (for example APTT): type of information where T1 and T2 are reference times.

05/10/97 A.P.T.T.
Standard lot number : POOL
Start reagent lot number : 971982
R1 lot number : 960383

T1 = 35.0 s
T2 = 35.4 s

ˆ SPA mode or user mode 5 (c = f (1/(T- n)) : the calibration is determined by 3 parameters A0, A1
and N and by the regression coefficient R.

7.3 Calibration procedure

Run in duplicate the number of standards indicated in the Test Parameters menu as samples (use
Test Mode menu). If necessary, modify the unit in the Test Parameters menu (chapter 5.4).

" Display the Calibration menu of the desired test (for example, PT) (chapter 7.1).

Standard Lot Number : 971204

Start Reagent Lot Number : 971741

For the first calibration in a given unit, all values are equal to zero. Otherwise, the values of the
previous calibration are displayed. Those values will be replaced by the new data if the new
calibration is confirmed.

The cursor is beside Standard Lot Number:

" Enter the standard lot number.
" Confirm with

The cursor is beside Start Reagent Lot Number:

" Enter the lot number of the start reagent.
" Confirm with

To override all these steps, use the key.

This screen is displayed:

Calibration: PT
Press a key to edit calibration data

" Press any key to proceed with the calibration data.

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STDI : 100.00 % = 12.0 s and 12.1 s

STD2 : 50.00 % = 15.9 s and 16.1 s
STD3 : 25.00 % = 23.8 s and 24.0 s
STD4 : 12.50 % = 39.7 s and 39.9 s

The cursor is beside STD1.

2 cases are possible :

a) The standard values have changed:

" Type the new standard value in accordance with the displayed unit.
" Confirm with the key.
The cursor moves over the first measured time.

b) The standard values are still the same:

" Move the cursor over the time value by pressing the key.
" Type the first measured time (obtained with the Test Mode menu).
" Confirm with the key.
The cursor moves over the second value.
" Type the second measured time (obtained with the Test Mode menu).

If one measured time is available, press the ↵ key: the first time will be doubled.

" Confirm with

" Go through the same procedure for all standards.
" If less than 8 standards are used: confirm with the key the entire line following the last
standard.

On this line and on the following lines, the concentration values and the time values have to be equal
to zero.

At the end of the process, the slope, the Y0 intercept and the regression coefficient are displayed.

S = -1.980
Y0 = -1.980
R = 0.9992
Press ENT to store data or ESC

" Confirm the calibration data with the key before exiting the Calibration menu. The
calibration data (date, type of assay, lot numbers, standard values, times, slope, y intercept and
regression coefficient) and the calibration curve graph are printed.

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Calibration

" When no data have been changed, exit the menu with the key.

For the Ratio and Ratio-INR units, no calibration curve graph is possible.

Example of a calibration printout:

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Calibration

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REFERENCE MANUAL 8
System check

8 System check

8.1 Setup
The Setup parameters define the date, the time, the type of patient identification, the type of pipette,
the STart® station number and if the control keys sound or not.
The main menu is displayed:

Diagnostica Stago
1 : Test Mode 2 : Calibration
3 : Test Parameters 4 : System Check
Enter Code number :

" Press the 4 key, then the key to change the Setup parameters.

System Check
1 : Setup
2 : Diagnostic Tests
Enter Code number :

" Press the 1 key, then the key.

Date : 18/01/98
Time : 03:01 PM
Patient ID# : Manual ( = Chg)

Connected Pipette ( = Chg)

" Enter the date: month/day/year.

" Confirm with the key.

" Enter the time: hour:minutes, then use the key to choose AM or PM identification.

" Confirm with the key.

" Choose automatic or manual patient identification mode with the key.

" Choose connected or not-connected pipette with the key. If the chosen mode is not

connected, the pipette must be physically disconnected from the STart®.

" Confirm each choice with the key. The cursor moves over the next parameter.

Sound : ON ( = Chg)
Station Number : 3

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" Choose Sound: ON or OFF with the key.

" Confirm the choice with the key. The cursor moves over the next parameter.
" If the STart® analyzer has to be connected to a host computer, enter the station number of the
analyzer and confirm with the key.
When the option Sound: ON is chosen, each time a key is selected, a beep sounds. This option does
not concern in any case the audible alarm generated at the end of the incubation times.
When no change is needed for a parameter, press the key to move the cursor over the next
parameter.
At any time, the key allows to return to the System Check menu.

In this case, any change not confirmed by the ↵ key is not saved in memory.

8.2 Diagnostic tests

These tests are used to determine if the analyzer is performing correctly or not.
The main menu is displayed:

Diagnostica Stago
1 : Test Mode 2 : Calibration
3 : Test Parameters 4 : System Check
Enter Code number :

" Press the key 4, then the key/

System Check
1 : Setup
2 : Diagnostic Tests
Enter Code number :

" Press the key 2, then the key. Then, press once again the key to start the self-test.
The following parts are tested one after each other:
- The printer: all the available characters are printed, as the example below.

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System check

- The keyboard: press each key one after each other. Start with the control key of the first timer
( ) on the left side (chapter 2.1, number 3).

- The RAM circuit (automatic).

- The NOVRAM circuit (automatic).
- The display: all dots should be black.
- The pipette (only if a connected pipette is used): press once the pipetting lever.
- The RS232 interface (automatic).
" After each test, and if this one is correct, Test OK is displayed. Press the key to start the next
one. If some test is not correct (no printing, no answer for one key of the keyboard, etc.), call
the Service Department.

It is possible to override the keyboard test with the key.

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REFERENCE MANUAL 9
Maintenance

9 Maintenance
In order to ensure a correct functionning of the STart®, it is imperative to follow the maintenance
described below.

9.1 Preventive maintenance

9.1.1 Daily maintenance

Observe the proper precautions for handling biohazardous materials in accordance with local
existing regulations. Use disposable gloves.

" Clean the thermal conductor of the pipette after used with swabs soaked in the decontamination
solution (see chapter 9.1.4).
" Rinse with purified water and dry with absorbent paper.

9.1.2 Weekly maintenance

Observe the proper precautions for handling biohazardous materials in accordance with local
existing regulations. Use disposable gloves.

" Clean the work surface and the reagent storage positions with absorbent paper soaked in the
decontamination solution (see chapter 9.1.4).
" Clean each measurement well, each incubation well and each pipette well with swabs soaked
with ethanol (concentration between 20% and 40%).

Do not drip product in the measurement wells.

" Clean each thermal conductor with a decontamination solution (see chapter 9.1.4).

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Maintenance

" Rinse with purified water and dry with absorbent paper.

If plasma or product vial (reagent, control, calibrator, dilution buffer) has been split or broken,
decontaminate the analyzer and the thermal conductors with a decontamination solution at 0.37%
of active chlorine, then rinse and dry them.

9.1.3 Half-yearly maintenance

" Run a self-test (chapter 8.2).

9.1.4 Decontamination of the STart®

Observe the proper precautions for handling biohazardous materials in accordance with local
existing regulations. Use disposable gloves.

If plasma or product vial (reagent, control) has been split or broken, or prior to any intervention by
a technician, decontaminate the analyzer and the thermal conductors with a decontamination
solution.
Prepare a decontamination solution at 0.37% of active chlorine.

To obtain a decontamination solution at 0.37% of active chlorine from a bleach solution and distilled
water at ambient temperature:
add N parts of water to 1 part of bleach according to the following formula:
B
N = ----------- – 1 where B = % of active chlorine in the bleach used.
0, 37

Examples:
- Bleach at 2.6% of active chlorine:
Mix 1 part of 2.6% active chlorine solution with 6 parts of water.
- Bleach at 5.25% of active chlorine:
Mix 1 part of 5.25% active chlorine solution with 14 parts of water.
- Bleach at 9.6% of active chlorine:
Mix 1 part of 9.6% active chlorine solution with 25 parts of water,
OR
Mix 1 part of bleach at 9.6% of active chlorine with 3 parts of water to obtain bleach at 2.6% of active

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Maintenance

chlorine. Then mix 1 part of bleach at 2.6% of active chlorine with 6 parts of water.

" Decontaminate the following parts:

- Work surface,
- Reagent storage positions,
- Pipette position.

" 15 minutes in contact.

To decontaminate a surface, make sure the decontamination solution is in contact with the surface
during 15 mn.

" Rinse and dry the analyzer and/or the thermal conductors.

9.2 Component replacement

9.2.1 Thermal paper

Cat. No.: 26649
" Tear, if necessary, the paper still in the printer.

" Press the key to disengage the paper still in the printer.

Do not pull on the paper, the printer could be damaged.

" Cut the paper to obtain a straight edge, as shown below:

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" Insert the paper as shown below:

" When inserted, press the key to feed the paper in the printer, as shown below:

Do not pull on the paper, the printer could be damaged.

" Press the key to obtain the proper insertion of the paper in the printer.

If the paper is badly positioned, press the key to ensure it is correctly repositioned.

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Maintenance

The paper is in place:

9.2.2 Fuses
Cat. No.: 39478 (packet of ten fuses rated at T3,15A).
The fuses are located at the back of the analyzer (see chapter 2.3, repair 1).

" Turn off the analyzer. " Remove the power cable.

" Unscrew the fuse holders with a flat " Remove the fuse holders.
screwdriver.

" Replace the old fuses by fuses with the same value.
" Place the fuse holders back in their proper positions.
" Plug in the line cable.
" Turn on the analyzer.

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Troubleshooting

10 Troubleshooting
10.1 Messages: printed or displayed

MESSAGE Warning: no stored calibration for unit #.

CAUSE For a given test, one unit has been chosen but no calibration in accordance with
this unit has been stored in memory. By default, all results are given in seconds.
Reminder: any unit change automatically leads to the deletion of the
calibration stored in memory.

SOLUTION - Run in duplicate the standards of reference plasmas by using the Test Mode
menu.
- Modify the unit in the Test Parameters menu (chapter 5.4).
- Store in memory the new calibration (in accordance with the desired unit) by
using the Calibration menu.

MESSAGE No graduation for this unit.

CAUSE For a given test, a non-authorized unit has been chosen (see the list of authorized
units, chapter 5.4). So, it is not possible to print the calibration curve graph.

SOLUTION - Choose an authorized unit for the given test (Test Parameters menu).
- Store in memory the correct calibration curve (Calibration menu).

MESSAGE No calibration possible for unit Sec.

CAUSE While the unit Seconds has been chosen or has been set by default (see message
: No stored calibration for unit #), the operator tries to store a calibration in
memory.

SOLUTION Modify the unit in the Test Parameters menu. Then, store in memory the
correct calibration (chapter 5.4).

MESSAGE Warning: invalid calibration.

CAUSE The operator tried to store in memory a calibration curve with invalid data such
as time values equal to zero.

SOLUTION Enter valid data for calibration curves:

- No concentration value (except for heparin) must be equal to zero.
- No time value must be equal to zero if the corresponding standard value is
different from 0.

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Troubleshooting

MESSAGE Calibration error.

CAUSE An internal error has been detected by one of the microprocessors

of the STart®.

SOLUTION
Press the key and perform again the operation in progress. If
this error is repeated, please call the technical service.

10.2 Observed problems

Observed problem(s) Probable cause(s) Possible solution(s)

Error is displayed and - No balls in the cuvette(s) or " Check the ball dispenser.
printed beside one or several in the same cuvette. " Call the technical service.
several position(s).
- No ball movement.

>>xx is displayed and is The clotting time is greater than " Modify the maximum time limit given
printed for one or the maximum time limit given in in the Test Parameters menu
several plasma(s). the test parameters. (chapter 5.2) and rerun the sample.

With the manual patient The serie is finished, the non- " Dispense the start reagent in the used
identification mode, N is used measurement wells are wells.
displayed. tagged with a N.

When duplicate The variance between the two " Check the reagents.
determination is used, values is greater than the " Check the disposable, the pipettes.
the sign * is printed variance in the Test
beside the average Parameters menu. " Check the measurement wells.
value.

The measured times are The calibration data are not " Enter in Calibration menu the
correct but not the correct. correct standard values in accordance
results in units. with the units and the corresponding
times.

Abberant results. - The cuvette is not properly " An object is fallen in the measurement
seated in the well. wells.
- When using a Finnpipette®, " Check the Finnpipette® volume
the volume selection dial is selection dial with respect of the type
not in the correct position. of tips.
- The test and incubation " Call the technical service.
zones are not at 37±0.5°C.
- The reagent storage zone is
not at 37±0.5°C.

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Troubleshooting

Observed problem(s) Probable cause(s) Possible solution(s)

The analyzer is turned - The power plug is out of " Plug the power cable at a different
on but does not start. service. outlet.
- The power cable is not " Plug the power cable.
plugged in. " Change the fuses (chapter 9.2.2).
- The fuses have burned out. " Call the technical service.
- The analyzer is out of
service.

No display. The display is out of service. " Call the technical service.

When printing, the Paper is not correctly engaged " Drive the paper by using the roller at
paper jams. in the printer. the right of the printer.
" If the trouble persists: Cut the paper
and engage it in the printer (chapter
9.2.1).

When printing, the Paper is not correctly engaged " Drive the paper by using the roller at
printer head jams. in the printer. the right of the printer.
" If the trouble persists: Cut the paper
and engage it in the printer (chapter
9.2.1).

No printing. The printer is out of service. " Note the clotting times as displayed
on the screen and call the technical
service.

The selected timers do The control keys or the system " Call the technical service.
not start. is out of service.

The selected keys of the Keyboard or system is out of " Call the technical service.
keyboard are not service.
functionning.

The connected pipette Cable is damaged. " Disconnect the pipette.

is not functionning.
" Modify the System check menu so
that a not- connected pipette can be
used (chapter 8.1) and call the
technical service.

No agitation on reagent The agitation motor do not " Turn off then on the analyzer (several
block (37°C). start. times if necessary) until agitation
starts.
" If the agitation does not start again, call
the technical service.

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