LABiTec LAbor BioMedical Technologies CoaLAB 6000 User manual

Operators Manual

CoaLAB 6000

For in-vitro diagnostic use only!

Order

Bedienungsanleitung CoaLAB 6000 Best. Nr.: 30.000.1615 German Version
Operators Manual CoaLAB 6000 Order No.: 30.000.1616 English Version

Revision History

Version Manual

Date

(mm/dd/yy)

Software-Version - Release -

Analyser

1.0 10/29/99 1.0 Final release Version

1.2 02/20/01 1.02a Software update

1.3 07/17/01 1.02d Software update/corrections

1.4 05/07/02 1.03 Software update/corrections

1.5 08/12/02 1.03 Corrections

1.6 02/06/03 1.04 Software update/corrections

1.7 08/21/03 1.04 IVD update

1.8 11/26/04 1.04 Updates/Corrections

Copyright of Software

All software by LABiTec LAbor BioMedical Technologies GmbH (in the following LABiTec-Software) is the
intellectual property of the LABiTec LAbor BioMedical Technologies GmbH. Intellectual property rights shall
remain with LABiTec LAbor BioMedical Technologies GmbH. You are entitled to use LABiTec-Software and
the printed accompanying material at a place of work that cannot be transferred. Any violation of property
rights or copyright or trademark or using conditions may be subject to legal action. LABiTec reserves the
rights to modify the software, documentation as well as this operator manual without prior written notice.

Your Distributor:

(Please do not hesitate to contact your local distributor if you have any questions or problems.)

CoaLAB 6000

The name and serial number of your system can be found on the plate located on the back of the instrument.

Legend:

1 Type
2 Product Identification
3 Input

- Voltage (V)

- Power consumption (VA)

- Frequency (Hz)

- Fuses

1
2

3

4

4 Serial Number coded*
5 IVD Manufacturer

5

* Serial number code:
e.g. C 28 2 0501

C Productions month
28 Production date
2 Production year
0501 consecutive instrument number

Please enter the following information:

Serial number: ____________________________

Type: CoaLAB 6000

P-ID: D6-99.0000

Input: 230-240V~150VA, 47/63Hz, Fuse: 4AT/250V

110-120V~150VA, 47/63Hz, Fuse: 4AT/125V

SN

90.000.0300

C 28 2 0501

LABiTec GmbH
22926 Ahrensburg, Germany

Made in Germany

IVD

Contents

Table of contents

1 INTRODUCTION................................................................. 3

1.1 Definitions..............................................................................4

1.2 Description of the system ....................................................5

1.3 Measuring principle ..............................................................9

1.4 Software Overview ................................................................ 9

2 HAZARD AND PRECAUTION.......................................... 11

3 WARRANTY ..................................................................... 15

4 SERVICE .......................................................................... 16

5 INSTALLATION ................................................................ 17

5.1 Unpacking and installation of the system ........................17

5.1.1 How to prepare the installation area .........................................17

5.1.2 Check Contents.........................................................................17

5.1.3 Unpacking the system...............................................................18

5.1.4 Assembly of the system ............................................................19

5.1.4.1 Mount the diluter syringe and tubes.......................................19

5.1.4.2 Connect the Liquid System Containers .................................21

5.1.4.3 Connect the Barcode Scanner (Optional)..............................22

5.1.4.4 Connect a HOST or Personal Computer to the System........22

5.1.4.5 Insert and change printer paper.............................................23

5.1.4.6 Mount the cuvette waste box.................................................24

5.2 Instrument control Card (ICC)............................................ 25

5.3 Language Setup ..................................................................25

6 OPERATION ..................................................................... 26

6.1 Routine Operation <1 ROUTINE MENU>...........................26

6.1.1 Switch ON the system...............................................................27

6.1.2 Rinsing with distilled water ........................................................27

6.1.3 Disinfection of waste tubing (Terralin), change of FW-Filter.....28

6.1.4 Rinsing with Washing Solution..................................................31

6.1.5 Loading and unloading reagents...............................................32

6.1.6 Delete joblist, delete samples ...................................................34

6.1.7 Enter a new joblist.....................................................................35

6.1.8 Handle the joblist.......................................................................37

6.1.9 Print of a joblist..........................................................................37

6.1.10 Start measuring, load cuvette bars ...........................................38

6.1.11 Interrupt a current run (User interrupt)......................................41

6.1.12 Print results, send results to HOST...........................................42

6.1.13 Refill liquids, clean containers...................................................43

6.1.14 Empty and clean the waste water container .............................44

6.2 Enter Test Parameter .......................................................... 45

6.2.1 Enter Reagent Specific Parameters..........................................45

6.2.1.1 Enter a reference curve (PT, for example) ............................45

CoaLAB 6000 – Operators Manual 1.8 Page 1

Contents

6.2.1.2 Enter ISI value .......................................................................47

6.2.1.3 Enter RATIO (APTT for example)..........................................49

6.2.1.4 Enter normal ranges (for example PT) ..................................50

6.2.2 Enter Method Parameter...........................................................52

6.2.2.1 Enter single or double determinations ...................................52

6.2.2.2 Enter PT Test Parameter.......................................................54

6.2.2.3 Enter APTT Test Parameter ..................................................58

6.2.2.4 Enter Fibrinogen Test Parameter ..........................................63

6.2.2.5 Print of Test Parameters (Fibrinogen for example) ...............67

6.2.3 Read ChipCARD to load a new test (Read test).......................69

6.2.4 Save Tests on a ChipCARD......................................................71

6.2.5 Print of Test Parameters (Print test)..........................................73

6.2.6 Delete Test ................................................................................74

6.3 STAT Management..............................................................75

6.4 General Setting (SETUP MENU)......................................... 81

6.4.1 Define Primary Tubes ...............................................................82

6.4.2 Define STAT positions in the sample rotor ...............................83

6.4.3 Date and Time...........................................................................84

6.4.4 Printer Setup .............................................................................85

6.4.5 Beeper Setup ............................................................................86

6.4.6 Set PIN Code ............................................................................87

6.4.7 Language ..................................................................................88

6.4.8 Print of Setup Parameters.........................................................89

6.5 Removing cuvette bars from the system..........................90

6.6 Switch OFF the system....................................................... 90

7 FAILURES ........................................................................ 92

7.1 Status Messages ................................................................. 93

7.2 Application Errors...............................................................94

7.3 Non-Fatal Errors..................................................................95

7.4 Fatal Errors.......................................................................... 96

7.5 Change fuses.......................................................................97

8 ANNEX.............................................................................. 99

8.1 Maintenance and Hygiene .................................................. 99

8.1.1 Cleaning and Disinfection of housing and waste box .............100

8.1.2 How to dispose of used disposables.......................................100

8.1.3 How to dispose the used system ............................................100

8.2 Protocol of Maintenance Check....................................... 101

8.3 Safety Specifications........................................................ 101

8.4 Technical Data................................................................... 101

8.5 Accessories and Consumables ....................................... 104

8.6 Mathematics ......................................................................106

8.7 Adaptation of coagulation reagents................................106

8.8 Packing of the system, preparation of transport ........... 107

CoaLAB 6000 – Operators Manual 1.8 Page 2

Introduction

1 Introduction

The instrument type CoaLAB 6000 (in the following titled as
analyzer/system) is a compact and automatic blood coagulation analyzer for
routine and STAT samples in the clinical laboratory.

For in-vitro diagnostic use only!

The system can perform 3 clotting tests such as PT / aPTT and Fibrinogen
simultaneously. It can perform additional tests such as Thrombin Time,
when the ChipCARD is used to replace any of the 3 standard tests. The
system can work in batch mode (individual test handling) or in random­access mode simultaneous test handling). In both cases the analyzer will
manage the results automatically.

The analyzer has 6 digital measuring channels based on the
turbodensitometric FIBRINTIMER

To avoid sedimentation a Teflon stirrer (2 stirrers are included) can be
added to the reagent. The reagent positions are always at room
temperature.

TM

measuring principle.

Purpose of this instruction manual

The instruction manual describes the system and is directed to all users of
the system.

This instruction manual gives all information necessary for the installation,
operation, maintenance, storing, packing, and transport of the system.
Service information is handled separately.

Careful observation of all information, especially of hazards and precautions
will ensure the correct and safe operation of the analyzer.

Therefore it is absolutely necessary to read the instruction manual
completely.

This instruction manual was prepared with greatest care. Should you have
any questions please refer to your distributor or to the manufacturer.

Validity of this instruction manual

All information in this instruction manual refers to this system:
For all requests please indicate type and serial number of your system
which can be found on the type plate on the back of the instrument or under
‘identification’ of this manual.

CoaLAB 6000 – Operators Manual 1.8 Page 3

Introduction

1.1 Definitions

Analyzer/System/ Instrument

Manufacturer

User

Personnel

In this manual the following terms are used:

This is the CoaLAB 6000.

The manufacturer according to IVD directive 98/79/EC is the
company/dealer who distributes the system within the respective country.

User is the current operator of the instrument.

Personnel are all people authorised to work with the system and meeting
the specifications required by the manufacturer for the operation of the
system.

Skilled personnel

All people who are especially qualified and authorised to handle specific
matters in connection with the instrument.

Life phases

All phases of the system from end of manufacture to disposal of the
instrument.

In this instruction manual all phases of the system will be mentioned.

QUALIFICATION OF PERSONNEL

The different life phases of the system require different qualifications of the personnel. The minimum
requirements for qualification are described at the beginning of each chapter or at the proper place in this
manual.

CoaLAB 6000 – Operators Manual 1.8 Page 4

Introduction

130-3-12-13

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rot
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1.2 Description of the system

The System

No additional equipment is necessary to operate the instrument. The
integrated module and system software controls the system and manages
all data. The system can be connected to a host computer for the
management of results. All measured results, reagent and test-specific data
can be printed on the internal thermal printer.

The system will be loaded with samples, reagents, and cuvette bars. The
samples in primary tubes (Becton Dickinson Vacutainer, Sarstedt
Monovette or specially designed sample cups) are loaded into the sample
rotor. At any time STAT samples can be loaded for priority handling. The
system can either work sample-orientated or test-selective.

Dilutor

Big loading lid

Printer

ChipCARD

F1

F2

F3

ESC

F4

Key pad

ENTER

7

8

4

0

9

5

1

6

2

3

Small loading lid

Figure 1 System Connections

1

rot

blau

schwarz

gr-n

gr-n

schwarz

rot

blau

schwarz

rot

gr-n

nc.

blau

weiss

1111

schwarz

rot

gr-n

nc.

blau

weiss

a3a2

TSG

130-3-12-13

50%

6a 6b 6c7

Figure 2 Modules

8

Connection of containers for
system liquids

Sensor connection
Dist. water (green)

Sensor connection
Waste water (red)

Pipettor with steel tubing and level
sensor with tubing connected to
dilutor

Barcode scanner
RS 232 interface
Power supply ON/OFF
Main plug
Cuvette waste box

2
3

4

9

8

7

ESC

0

R

E

T

N

E

F4F3F2F1

456

2

1

5

3

910

CoaLAB 6000 – Operators Manual 1.8 Page 5

Introduction

R5

13

14

15

16

17

18

1

2

3

4

5

6

7

8

9

10

11

12

R6

R1

R2

R3

R4

Reagent positions:

10 ml Adapter (white)*
4 ml Adapter (blue)*
* test specific

Sample positions:

1 - 18 for patient plasmas

Cuvette positions:

6 rials for cuvette bars

Rinsing station:

central station to rinse and
wash the pipettor steel tubing
and the level sensor

The sample rotor

Item Description

1. 37C temp. pipettor

2. Thermal printer

3. ChipCARD reader

4. Cuvette waste box

5. Keyboard
6a. Sample rotor
6b. Cuvette rail
6c. Reagent position

7. Dilutor

8. Washing position for pipettor

9. Incubation cell

10. Measuring cells (6 parallel)

The combined sample and reagent rotor consists of:

- 6 positions for the cuvette bars (6 cuvettes per bar).

- 6 numbered positions (R1 - R6) for the reagent vials.
Two different vials can be used:

- 4 ml plastic vial with blue adapter ring

- 10 ml plastic vial with white adapter ring

- 1 reagent stirrer position on which all 6 reagent positions can be stirred
just prior to sampling.

- 18 numbered sample positions

- rinsing station

Primary tubes

The following primary tubes can be selected in the Setup Menu under
< 1 Primary Tubes >:

- Sample cup

- 4.5 ml Beckton Dickinson Vacutainer (the short Vacutainer only)

- 3.0 ml Sarstedt Monovette

For further information refer to section 6.4.1 Define Primary Tubes.

CoaLAB 6000 – Operators Manual 1.8 Page 6

Figure 3 Sample rotor with positions

Introduction

The cuvette bar

The cuvette bar has 6 wells. Up to 6 bars (36 cuvettes) can be loaded onto
the sample rotor.

To ensure correct loading, the cuvette bar is designed so that it can only be

NOTE

inserted one way (with semi-round opening inserted first), see picture.
Remove metal foil before using the cuvette bar.

Each well of the bar contains a 1 x 3 mm stir bar. These stir bars are
necessary to obtain accurate measurements.

Ensure that only the original cuvette bars and stir bars provided by the
manufacturer are being use to operate the system otherwise the warranty
may become null and void.

Figure 4 Bar with loading direction

The keyboard

The keys are used for direct control of the system and lead you through the
operating software. The display informs you of the current operation mode
of the system.

ESC

7

8

9

456

1

2

F4F3F2F1

ENTER

0

3

Figure 5 The keyboard

Keys Meaning

Arrow Keys Function key to scroll through the menu

• The right arrow-key sets the decimal point.

• The left arrow-key deletes single characters.

ESC-key Function key to quit or confirm a certain menu point.
ENTER-key Function key to confirm and save menu information.
Number-keys Function keys to enter digits and enter or select special

menu points.

Function keys

(F1-F4)

Delete-key

(blank)

Function keys to select certain operation steps which
are displayed directly above.
Function key to delete Pat. ID or Lot-No completely or to
be used as line feed key.

CoaLAB 6000 – Operators Manual 1.8 Page 7

Introduction

RS232

Barcode

1 Fuses
2 Power switch
3 Mains connection
4 Barcode plug

5 Barcode socket
6 Interface RS232

Mains connection fuses and power
switch

The main connection fuses and power switch of the system are combined
and integrated into the right side of the instrument. There is also a socket
for a barcode scanner (optional) and for a connection to a host computer
(optional) via an RS 232 C interface. The connections are marked
accordingly.

Figure 6 Power filter with mains plug

The system is delivered without power supply cable. The cable must

NOTE

meet the local regulations. (e.g. IEC 320, VDE, CSA-C22.2, No. 21 and
No. 49).

The cable has to be designed with NYLHY. The recommended length
is 1.5 m, and the minimum cross section 3x 0.75 mm2. A cold device

plug is used at the system’s end.

Use only fuses recommended by the manufacturer. Observe the
instructions on the name plate located on the back side of the system.
The analyzer is set to 230V by the manufacturer, change fuses
(supplied in accessories) in power filter, if analyzer will be operated in
115V. See chapter 7.5 on changing fuses.

CoaLAB 6000 – Operators Manual 1.8 Page 8

Introduction

L

r

1.3 Measuring principle

The system operates according to the opto-mechanical measuring principle:
It is well suited for lipemic and icteric samples as well as reagents with
kaolin.

A light beam passes through the cuvette containing the test plasma onto a
photo-detector. Any change in intensity of the transmitted light, that is light
increase or decrease, is converted into an electric signal.

The period from adding the start reagent until clot formation is measured. It
can be converted into the appropriate units then (%, Ratio, INR, mg/dl, g/l).

Once the start reagent has been added the measuring channel is
repeatedly adjusted, that means the lamp intensity automatically adjusts to
the turbidity of the test sample. In this process the turbidity of the sample
plasma and the reagent are levelled out.

A stir bar in each cuvette provides homogeneity of the reagent-plasma
medium during the measuring process. At the same time a small whirl
emerges through the stir bar movement which assures that even the
smallest fibrin clot is formed in front of the photo-detector.

This stirring action combined with the optical measurement, constitute the
basic features of the patented „turbodensitometric measuring principle“.

Figure 7 Measuring principle

Test cuvette

amp

Stirrer - Motor

ELECTRONIC

DISPLAY

Detecto

perm. magnet

1.4 Software Overview

The software overview makes it easier to find the different functions desired.
After the instrument has been switched on, it will initialize and automatically
display the MAIN MENU.

MAIN MENU

< ROUTINE MENU >

By pressing the

• Arrow-keys right/left you can select a menu.

• ENTER-key opens a menu or selects a function.

• ESC-key steps back a level in the menu.

CoaLAB 6000 – Operators Manual 1.8 Page 9

Introduction

Initialising

MAIN MENU:

Analyzer Power ON

F4

user interrupt (ESC)

Yes No Stop STAT

Esc

< 5 Start measure >

Enter

< 5 UTILITY MENU >

Enter

< 4 SETUP MENU >

Enter

< 3 STAT MANAGEM. >

Enter

< 2 TEST MENU >

Enter

< 1 ROUTINE MENU >

UTILITY MENU:

< 1 Init Instrument >

PIN

SETUP MENU:

< 1 Primary Tube >

< 2 No of STAT pos >

STAT Measurement

Edit Ins Prnt Start

F1 F2 F3 F4

Enter

Select test:

PT aPTT FBG END

PIN

TEST MENU:

< 1 Modify test >

< 2 Read test >

ROUTINE MENU:

< 1 Erase joblist >

< 2 Insert sample >

< 3 Edit joblist >

< 4 Print j oblist >

< 3 Date / Time >

< 4 Printer setup >

< 5 Beeper Setup >

< 6 Modify PIN >

< 7 Language >

< 8 Print Setup >

Enter

Enter

F1 F2 F3 F4

PARAMETER

< 1 Replication > sngl / DBLE

< 2 Measurement > < Parameter >

Enter

< 3 Print test >

< 4 Erase test >

< 5 Write test >

< 5 Start measure >

< 6 Result managem. >

< 7 Load reagents >

< 8 Maintenance >

Maintenance

Enter

< 1 Sample volume >

< 2 Diluent >

< 3 Reagent 1 >

< 7 Incub. time >

< 8 Start reagent / Vol ume

/ Lot . No. / Bottle type >

< 9 max meas time >

Enter

Enter

< 3 Normal range >

< 4 1st Conversion > Reference curve /..

< 5 2nd Conversion > Ratio / INR

< 6 Print test >

wash FLUSH remov

Result Management

send disp. PRINT

CoaLAB 6000 – Operators Manual 1.8 Page 10

Hazard and Precaution

2 Hazard and Precaution

This section contains the safety regulations that must be observed by all
users of the system, to ensure safe and economic operation.

Importance of safety regulations

All safety instructions in this instruction manual must be observed to avoid
damage to persons, property and the environment.

All local safety and environmental regulations and guidelines must also be
observed.

Disregarding of safety regulations

Disregarding these safety regulations or technical specifications may result
in accidents with personnel or equipment, or environmental damages.

Hazards and Precautions

The system has been delivered by the manufacturer in a technically
flawless condition. In order to keep this condition the user must follow
the following safety regulations of this manual.

The system must be operated by skilled personnel only.

NOTE

Note introduces rules to be observed.

Warning signals

ATTENTION!

WARNING!

Two different warning signals with different meanings are used in this

section.

Potential danger may cause minor injury or equipment damage, if no
precautions are taken.

Potential danger may cause severe injury or death if no precautions are
taken.

CoaLAB 6000 – Operators Manual 1.8 Page 11

Hazard and Precaution

Electrical safety:

WARNING!

Ensure that the operating voltage is set correctly before the instrument is
connected to the main power supply.

Use only grounded sockets and extension cords when connecting the
instrument to a power supply. Never disconnect grounding contacts.

Never disconnect the grounding contacts intentionally.
There is the risk of an electrical shock if

- The protective conductor is interrupted within or outside the device

- The grounded contact has been disconnected from the line.

Never remove protective guards or secured components, since you
could expose electrically live parts. Even after the instrument has been
switched off, some parts may contain voltage due to electrical charge.

All current carrying parts are sources of danger for an electrical shock.

Never use the instrument on a moist surfaces (floor, worktable or
countertop), or place containers of liquids on top of the instrument. Liquids
spilled into the instrument may cause an electrical shock.

Switch off the instrument and disconnect it from all power sources

before performing maintenance or repair work. Perform only the
maintenance/repair work described in this manual; unauthorized work on
the instrument may cancel the warranty, and require expensive service
work.

All work which requires the instrument to be opened under voltage must
only be carried out by a technician who is familiar with the risks related
thereto.

Use only replacement fuses of the stated type and with the stated
minimum current;

- Never use ‘repaired’ fuses.

- Never short-circuit the fuse holder.

Fire and Explosion hazards:

WARNING!

Do not place the instrument near explosive mixtures of flammable
gases, such as oxygen or hydrogen; electrical sparks could cause fire or

explosions.

Mechanical Safety (system in
operation)

WARNING!

CoaLAB 6000 – Operators Manual 1.8 Page 12

Never remove housing parts while the instrument is on; moving parts
such as the fan or motor drives may cause injury.

Always close the sample rotor-loading inlet during operation, to avoid
contact with moving parts. The probe will not stop when the loading inlet
is open.

Ensure that the pipettor does not stop over the sample rotor or the
measuring block when the instrument is switched off.

Hazard and Precaution

- Use the protection cap for the pipettor if the system will not be operated
for a long time, to avoid damage and contamination.

- Do not open covers during a run, to avoid damaging the pipettor.

If safe operation of the instrument is not possible switch the
instrument off and secure it against use if:

- The instrument is damaged

- The instrument does not work properly

- The instrument has been stored / transported under adverse conditions

- The instrument has experienced severe temperature fluctuations

Samples, Reagents

WARNING!

Follow the instructions on the directional inserts for the correct use of
reagents.

Avoid skin contact with samples and/or test reagents, as well as those
instrument parts that touch samples and/or test reagents. All instrument

parts are potentially infectious, and reagents might irritate mucous
membranes and the skin. All liquid and waste containers which carry
sample and/or test reagents are marked with a biohazard symbol.

If sample material is spilled onto the instrument, wipe it off immediately and
decontaminate the affected surfaces.

Ensure that no foam or air bubbles are on the surface of reagents and
sample material prior to loading the system: their presence could influence
the measured results and the level detection of the needle. Ensure reagents
are used at room temperature only.

Before using sample cups and reagent vials make sure to remove all
covers/lids beforehand. Do not use organic solvents unless explicitly
authorized by the manufacturer, as their use may result in damage to
the cuvette bars, primary tubes, and waste water tubes.

Waste Liquids:

WARNING!

Dispose of waste liquids must be in compliance with applicable
regulations.

Accuracy and Precision of
Results:

WARNING!

CoaLAB 6000 – Operators Manual 1.8 Page 13

Measure control samples and ensure the instrument is operating
properly to obtain accurate results.

Inaccurate results may lead to a false diagnosis and endanger the patient.

Hazard and Precaution

User Qualification:

WARNING!

Barcode Scanner:

ATTENTION:

CAUTION

LASER LIGHT
DO NOT STARE INTO BEAM

670nm LASER DIODE

1.0 MILLIWATT MAX
CLASS II LASER PRODUCT

VORSICHT

LASERSTRAHLUNG, NICHT IN DEN LICHTSTRAHL BLICKEN,
SICHTBARE LASERSTRAHLUNG, LASERKLASSE 2

The system should be operated by trained personnel only.

Be careful when using the barcode scanner laser light.

- Avoid direct eye contact with the laser beam.

- Follow the manufacturer’s instructions.

- Ensure the scanner was tested and authorized for use by the
manufacturer.

Acoustic Signals

A beeper confirms all key strokes on the system keyboard. Thus, the user
can recognise, for example, the end of a run, possible failures during
operation, or the access to STAT mode without looking at the display.

CoaLAB 6000 – Operators Manual 1.8 Page 14

Warranty

3 Warranty

The representatives or authorised dealers warrant that the system does not
have any material or manufacturing damages after installation if the
instruction manual has been observed.

The warranty does not apply for damages which are caused

- By accidents, negligence, or non-observation of the instruction manual,

- By using inadmissible reagents or disposables, or

- By operating the instrument in an environment contradicting the
specifications of this instruction manual.

Repair and service work must be carried out by technicians who have been
authorised.

CoaLAB 6000 – Operators Manual 1.8 Page 15

Service

4 Service

The representatives or authorised dealers guarantee to carry out repair
work during the official working hours from Monday to Friday with the
exception of public holidays.

If you need service outside of that time contact our parent company or our
authorised dealer.

CoaLAB 6000 – Operators Manual 1.8 Page 16

Installation

5 Installation

This section describes how to unpack, install and prepare the instrument for
use.

Safety regulations

We assume that you have read chapter 2 Hazard and Precaution carefully.

5.1 Unpacking and installation
of the system

5.1.1 How to prepare the

installation area

Select a stable and level area for installation.

NOTE

Ensure the power cable will reach the outlet without
cords.

Ensure there is enough light for proper operation, but no direct sunlight.

Do not put the analyzer on a shelf or on a roll-desk. Protect from
direct sun light, significant temperature changes, humidity, and

Ensure there will be a cleared space of at least 12 inches (30 cm) to the

voltage variations.

sides and rear of the system, to allow easy access and air circuation.

Ensure the space above the system will be clear of equipment, supplies and
shelves.

using any extension

5.1.2 Check Contents

NOTE

The instrument weighs about 35 pounds (17 kg), and can be carried or
moved by one person. For the safety of the instrument and yourself,
however, you should move the instrument using a rolling cart of have
someone assist you.

Do not damage any packaging material, and keep them for possible
later use, including the transport protection devices. Store them
away from heat and humidity.

• Place box on the floor

• Remove all small parts from the box first, and ensure all accessories
and disposables listed in section 8.5 have been received.

CoaLAB 6000 – Operators Manual 1.8 Page 17

Installation

5.1.3 Unpacking the system

• Lift the system from the box (with assistant), and place on the installation
area.

• Remove the left (1) and right (2) foam inserts and set aside (See figure 8).

Pay attention to the pipettor!
Be careful not to damage the pipettor, flat cable, steel tubing or level sensor;
any damaged or defective parts must be replaced by a service technician
before operating.

• Place the system in the correct position on the table.

• Remove all tapes and transport protection devices (see figure 9).

1

2

1

2

Figure 8 The system with foam inserts

Transport protection devices are:

See figure 9.

1. Box insert: protects the pipettor from moving in X-direction.

2. Plastic plate with cable ties: protects the pipettor from moving in Z-

direction.

3. Red plastic screw on the steel tubing (top): protects from contamination.

4. Plastic protection cap on the steel tubing (bottom): protects from

contamination.

5. Empty cuvette rack between sample rotor and measuring block.

CoaLAB 6000 – Operators Manual 1.8 Page 18

Installation

2
t
P
c

. Transport protection of

he pipettor:

lastic with

able ties

3

2

1

4

5

System
sectional view

ROTOR

1. Transport protection of
pipettor with carton

1

2

F1

F2

F3

ESC

F4

ENTER

7

8

4

0

9

5

1

6

2

3

Figure 9 The system with transport protection devices

5.1.4 Assembly of the system

Before connecting the instrument to the main power supply, complete all
instructions in this section.

5.1.4.1 Mount the diluter
syringe and tubes

Mount the 250 µl dilutor syringe to the dilutor of the system according, see
figure 10. When properly mounted, the syringe should not be wedged, and
must be watertight.

CoaLAB 6000 – Operators Manual 1.8 Page 19

Installation

S

• Press the syringe piston completely into the dilutor syringe.

• Open the locking screw.

• Push the syringe holder at the dilutor downward.

• Place the opening of the syringe piston onto the syringe holder of the
dilutor.

• Screw the top of the syringe onto the adapter of the dilutor valve.

• Tighten the locking screw.

• Connect all tubing’s to the dilutor valve.

teel tubing

pipettor

Dist. water to

Dilutor valve

Top of syringe

Pipettor

Dist. water

Syringe piston

Syringe holder
Locking screw

Steel tubing
point and
level sensor

Figure 10 Diluter and syringe

Attach the tubes

The liquid system requires tubing between the diluter and pipettor. Connect
the tube as follows:

• Take the tubing out of its plastic accessory bag.

• Remove the red plastic screw at the steel tubing of the pipettor.

• Screw the tubing (white screw) onto the diluter valve until hand-tight.

• Run the other end of the tubing through the tubing guides on the back of
the instrument.

• Screw the end into the top of the arm (black screw). Make sure it fits
properly and watertight.

• Review the entire tube path to ensure the tubes will be neither bent nor
squeezed during instrument operation.

CoaLAB 6000 – Operators Manual 1.8 Page 20

Installation

5.1.4.2 Connect the Liquid
System Containers

• Place the distilled water container (with the green label) and the empty
waste water container (with the red label) to the left rear of the system. Fill
the distilled water container with at least 1 Liter of distilled water.

• Place the colour-coded sensors into the appropriate containers (green for
dist. water, red for waste water). Ensure there are no air bubbles in the
tubing of the distilled water container, or in the container itself.

• Plug the green and red colour-coded couplings into their matching sockets
on the back of the system (see figure 11). A „click“ indicates the proper
seating of the connectors.

The system will only function if the distilled and waste water tubes have
been connected properly to the system.

NOTE

The system is switched OFF.

The couplings are color-coded:

Red for
waste water

Green for

dist water

Green

Red

Figure 11 Connect the level sensor tubes to the system

< NOTE >

Decoupling of the tube adapter
Press on the metal shield to

release the tube adapter.

The distilled water container must have at least 1 Liter of distilled

NOTE

water. The waste water container should be emptied every day. Be
careful not to have air bubbles in the distilled water container as well
as in the tube.

CoaLAB 6000 – Operators Manual 1.8 Page 21

Installation

Container

Figure 12 Container for distilled water. Container and tubes are

Figure 13 Container for waste water. Container and tubes are coded

dist

water

coded with green.

waste

water

with red.

5.1.4.3 Connect the Barcode
Scanner (Optional)

5.1.4.4 Connect a HOST or
Personal Computer to
the System

NOTE

• Connect the optional barcode scanner to the system. Use the
recommended type only.

• Connect the barcode scanner data cable to the upper socket (marked
barcode) on the system (see figure 6).

• Plug the power supply into the socket next to it.

The system has an additional interface port (RS 232 C).The RS 232
interface is a uni-directional interface which allows the transfer of patient ID
and results to a connected HOST or PC. Due to many different used
HOST/LIS PC systems the interface protocol may vary, please ask your
distributor or the manufacturer for further information on transfer of data’s.

• Before switching on the computer, the PC must have been connected to
the external periphery instruments. Use the data cable recommended by

manufacturer or dealer only. Then connect the PC to the power supply.
Do not switch the computer on yet!

Now connect the data cable to the lower socket (marked RS 232) on the

right side of the system and to the interface port of your computer.

Before switching on the analyzer and before each re-initialisation,
pay attention that all cuvettes and vials have been removed from the
rotor and the measuring block.

• Now connect the system to the power supply. The ON/OFF switch is on
the right side of the instrument.

CoaLAB 6000 – Operators Manual 1.8 Page 22

Installation

• After complete installation the instrument and, possibly, the computer can
be switched on and off accordingly.

See figure 6 Power ON/OFF, Power filter.

5.1.4.5 Insert and change
printer paper

After switching on the system you can now insert the printer paper (see
accessories). The printer paper can be inserted only when the system is
switched on

.

• Lift the printer cover above the keyboard and remove the previous paper
roll holder, if necessary.

• Place the new paper roll with the paper roll holder into the correct position.
The unrolling paper must run towards the inside of the printer

Paper roll axis

paper insert slot

Figure 14 Printer housing

• Guide the paper - with a clear-cut end- into the paper slot of the printer.
Once the paper has been captured it will be advanced automatically.

• Guide the paper through the slot of the printer cover and re-install the
cover.

Use manufacturer’s printer paper only. Otherwise, the warranty

NOTE

may become void. Over time the text will fade. It is recommended
that all printouts be copied for storage purposes.

CoaLAB 6000 – Operators Manual 1.8 Page 23

Installation

5.1.4.6 Mount the cuvette waste
box

The cuvette waste box must be attached before using the instrument. The
cuvette bars which are automatically ejected from the measuring unit will be
collected.

Be careful that plasma as well as reagents can flow out from the cuvette
bars.

Therefore it is necessary to clean the box in regular intervals.

Mounting the waste box

See figure 15 next page

• Take the waste box out of the accessory box.

• As shown in the figure, press the box gently.

• Guide the waste box, gently pressed and slightly tipped, into the housing
space so that the locking devices on the inside prevent the box from
slipping.

Use caution, as the cuvette bars that are collected in the waste box,

NOTE

may leak plasma and reagents.

If mounted properly the nose of the waste box will be placed under the
measuring block and will collect used cuvette bars. It is recommended to
clean the waste box weekly using a 10% bleach solution.

Demounting the waste box

• Remove the box by pressing it gently and slightly tipping it.

• Dispose of the cuvette bars in compliance with biohazard regulations. •

Mount waste box

1. Press box gently
see arrows

2. Tip box slightly while
inserting it

Thermo block 37˚C
Movement direction
of the cuvette rack --->>>

waste box fixpoints

3. Bring box into proper
position as shown in
the sectional
view.

Figure 15 mounting the cuvette waste box

CoaLAB 6000 – Operators Manual 1.8 Page 24

Installation

5.2 Instrument control Card
(ICC)

The manufacturer recommends to fill in the Instrument Control Card (see
attachment) of each system after its initial installation and to return it to the
manufacturer within four weeks. With this Instrument Control Card the
manufacturer will register your system. The customer confirms proper
receipt, functioning and completeness of the delivered system.

The Instrument Control Card is the basis for any warranty claims.

NOTE

Possible claims can only be called for if the Instrument Control Card
had been returned to the manufacturer after the initial installation of
the system.

The document is enclosed.

5.3 Language Setup

The analyzer is pre-set to the English language.
If you want to change the language follow section 6.4.7 Language.

CoaLAB 6000 – Operators Manual 1.8 Page 25

Operation

6 Operation

Training

Safety precautions

6.1 Routine Operation

<1 ROUTINE MENU>

This section describes how to routinely operate the system as well as
information on quality control of coagulation measurements. Furthermore
you will find hints to possible failures and troubleshooting.

Onsite training courses are offered for this instrument. For additional
information contact your distributor.

Thoroughly review the Hazard and Precautions section of this manual
before proceeding.

The system will be ready for coagulation analysis after initial set-up has
been completed, see section 6.4 General Setting (SETUP MENU). The
following descriptions explain the ROUTINE MENU and give an insight into
safe coagulation analysis.

In the ROUTINE MENU you can select between three different methods.
You can use nearly all well-known PT / aPTT and Fibrinogen reagents on
the system. Please note that due to the large variety of coagulation
reagents on today’s markets only a certain number of reagents have been
checked and adjusted to the system. See section 8.7 Adaptation of
coagulation reagents for further information.

Preparing routine operation

white

blue

- The instrument is connected to the power supply.

- The distilled water container is filled with water (without bubbles) and
connected to the system.

- The waste water container is empty and connected to the system.

- The waste box is cleared of cuvette bars.

- All tubes have been properly connected, and are neither squeezed nor
bent.

- Sufficient printer paper has been inserted.

- The liquid system is filled and without bubbles.

Reagents for the tests will be reconstituted according to the package insert
and will be filled into the reagent vials. The delivered reagent vials have the
following dead volumes:

10 ml reagent vial

(white adapter)

4 ml reagent vial

(blue adapter)

without stir bar

with stir bar

without stir bar

with stir bar

dead volume: 1.5 ml
dead volume: 2.0 ml
dead volume: 0.5 ml
dead volume: 0.8 ml

CoaLAB 6000 – Operators Manual 1.8 Page 26

Operation

6.1.1 Switch ON the system

The instrument must be free of cuvette bars, sample and reagent

NOTE

vials.

• Switch the instrument on by setting the power switch to the position I =
ON.

The display shows the instrument name and checks all internal modules
automatically (the pipettor moves to the washing station).

Diverse displays ...

User dialogue display
of the system

Then all system modules will be initialised.

The following data will be printed:

C2820501 V1.04 04/22/02

07.05.2002 08:55

Ser. No. / SW-Version / Release
Date / Time

The instrument is ready for operation.

• Use the arrow keys (</>) to select <1 ROUTINE MENU> in the MAIN
MENU.

MAIN MENU:
< 1 ROUTINE MENU >

• Press the ENTER-key to confirm.

The following display appears:

MAIN MENU:
< 1 Erase joblist >

6.1.2 Rinsing with distilled
water

For transport protection reasons the system has been delivered in dry
condition, without any liquids. Before measuring with the system it is
necessary to perform a rinsing process and fill all system modules with
liquid (pumps, dilutor and tubing’s). This procedure also removes any air
bubbles from the tubing system and the dilutor tubing. You can now check
whether all tube and screw connections have been installed properly.
Should you notice any leaking, tighten the connections to the point that they
are watertight.

• Use the arrow keys (</>) to select < 8 Maintenance > in the ROUTINE
MENU.

ROUTINE MENU:
< 8 Maintenance >

• Press ENTER to confirm and rinse the pipetting system of the system.

CoaLAB 6000 – Operators Manual 1.8 Page 27

Operation

The following display appears:

Maintenance
wash FLUSH remov
F1 F2 F3 F4

= accompanying function keys

• Press function key F2.

The instrument will rinse the system with distilled water. After the initial
installation this procedure should be repeated until all tubes are filled with
liquid completely.

By Pressing F4 = remov cuvette bars will be ejected into the waste box.

During rinsing the following display appears:

Maintenance

Maintenance
wash FLUSH remov

• Leave the menu after rinsing by pressing ESC.

The following display appears:

ROUTINE MENU:
< 8 Maintenance >

Pressing ESC will take you back to the MAIN MENU.

After this procedure the instrument pipetting system has been rinsed with
distilled water. The manufacturer recommends repeating this procedure
after the initial installation several times to secure that no air bubbles are in
the pipetting tube and that no liquids containing thrombin, for example, will
remain in the liquid system (if system has already been used). Check the
system for leakage’s again and re-mount, if necessary, all connections and
tubes before repeating the rinsing cycle.

6.1.3 Disinfection of waste tubing
(Terralin), change of FW-Filter

It is necessary to disinfect and clean the liquid system, tubing’s at regular
intervals, see section 8.1 Maintenance and Hygiene to avoid reagent or
sample residues, possibly causing inaccurate results or improper functioning
of the analyzer. Therefore, regular disinfection and cleaning cycles must be
run to guarantee proper functioning of the system.

Follow the instructions for disinfection of the system tubing’s:

Clean the distilled water container
and change filter

1. Remove the Distilled Water Sensor (green mark) from the Distilled

Water Container.

2. Remove the white fresh water filter

from the end of the Distilled Water

Sensor and replace it with a new fresh water filter.

CoaLAB 6000 – Operators Manual 1.8 Page 28

Operation

3. Empty the Distilled Water Container and clean the inside using a 70%
alcohol solution.

4. Rinse the Distilled Water Container thoroughly with distilled water to
remove any traces of the alcohol solution.

5. Refill the Distilled Water Container and return the Distilled Water

Sensor to the container.

Disinfection of Wash Station and Waste
tubing with Cleaning Solution

6. Make a working solution of Cleaning Solution. Fill 2 Liters of distilled
water into the Cleaning Solution Container (white label) and add 20
ml of concentrated Cleaning Solution. Swirl gently.

7. Place the Waste Water Container carrying the Waste Level Sensor
(red label, sensor) beside or behind the analyzer on the same height
level. The container may not be

placed underneath the analyzer. Make
sure the waste tubing (red marked) and the electrical plug of the waste
tubing are correctly connected to the fluid panel of the back side of the
analyzer.

NOTE

Do not disconnect any of the level sensor tubing’s (red/green) and
electrical plugs at the fluid panel at the back side of the analyzer.

8. Take out 4ml of the diluted working Cleaning Solution from the
Cleaning Container using a standard commercial pipette, e.g.

Eppendorf.

9. Guide the pipette over the Wash Station, located in the center of the
reagent and sample rotor.

Make sure that neither the steel needle nor the level sensor of the

NOTE

probe will be damaged or bent during this operation. The system may
not be in operation, moving.

10. Dispense the diluted Cleaning Solution out of the pipette into the wash
station. Repeat this process until you have added 4ml into the Wash
Station. Leave the working Cleaning Solution in the Wash Station for
at least 2 min.

Make sure the Cleaning Solution inside the Wash Station remains on

NOTE

the same level. It may not disappear inside the Wash Station. In this
event place the Waste Water Container on a higher level, meaning
above the height of the wash station of the analyzer and repeat adding
the Cleaning Solution into the Wash Station. Further make certain not
to overflow the wash station to avoid any liquid flowing into the
sample/reagent rotor.

Flush after cleaning

After the disinfection/cleaning cycle with Cleaning Solution it is
absolutely necessary to rinse the liquid system with distilled water to
ensure that no Cleaning Solution may remain in the liquid system at
all.

CoaLAB 6000 – Operators Manual 1.8 Page 29

Operation

NOTE

NOTE

Follow the instructions to rinse the system with distilled water:

11. Make sure the Distilled Water Sensor is equipped with a NEW fresh

water filter and the Distilled Water Sensor is placed correctly in the
Distilled Water Container.

12. Run flush cycles with distilled water described as follows:

• Use the arrow keys (</>) to select <5 UTILITY MENU> in the MAIN

MENU.

MAIN MENU

< 5 UTILITY MENU >

• Press ENTER to confirm.

The following display appears:

UTILITY MENU

<1 Init Instrument>

• Press ENTER to confirm the message.

The following display appears:

Init Instrument

Init ... (ESC=Stop)

The motors and the diluter will be initialised. During this phase the cuvette
racks in the measuring block will be moved one position to the right and will
be ejected from the measuring block.

The following display appears:

Init Instrument

Flush... (ESC=Stop)

Then the liquid system will be initialised. Liquids are pumped into the
tubing’s. Press ESC if you want to finish initialisation.

This flush process should run a minimum 5-8 minutes or until no foam
residues of Cleaning Solution will remain in the liquid system, waste
tubing (red marked). Check if waste water runs through the waste
tubing into the Waste Water Container and no foam remains in the
waste tubing.

The manufacturer recommends repeating this procedure at least twice
a month. Once a year it is recommended to renew all liquid containing
parts of the system. Ask your local dealer
available maintenance/service kits.

or the manufacturer for

CoaLAB 6000 – Operators Manual 1.8 Page 30

Operation

6.1.4 Rinsing with Washing
Solution

In the ROUTINE MENU you can choose to clean the pipetting system of the
instrument with an extra Washing Solution. This is especially recommended
after the use of reagents containing thrombin, such as Fibrinogen. The
system disposes of an automatically wash cycle if Thrombin containing
reagents, e.g. Fibrinogen are being used. Once the reagents are
introduced, see section 6.1.5 and are requested to run in a joblist, section

6.1.7 the system automatically washes the system with washing solution
after the use of such thrombin containing reagents.

NOTE

This intensive washing cycle must be run daily after routine work in
order to avoid any residues of previous measurements.

Follow the instructions to wash the system:

• Use the arrow keys (</>) to select < 8 Maintenance > in the ROUTINE
MENU.

ROUTINE MENU
< 8 Maintenance >

• Press ENTER to confirm.

The following display appears:

Maintenance
WASH flush remov
F1 F2 F3 F4

• Press F1= WASH and follow the instructions of the display.

The following display appears:

1: washer:
LOAD 3.0ml skip
F1 F2 F3 F4

If no washing solution has been loaded the following display appears. Put
the white adapter ring into reagent position 1: = R1 extended automatically
and put the 10 ml reagent vial filled with min. 3 ml Washing Solution into the
reagent position. Confirm either with F1= Load or with ENTER.

Maintenance

To cancel this procedure press F4= skip. After having confirmed with F1 or
ENTER the analyzer will start an automatic wash cycle to clean the tubing’s

(consumption per wash cycle ca. 110 µl).

The next display appears:

Maintenance
WASH flush remov

• Press ESC to leave the menu.

CoaLAB 6000 – Operators Manual 1.8 Page 31

Operation

6.1.5 Loading and unloading
reagents

NOTE

The following display appears:

ROUTINE MENU
< 8 Maintenance >

The system has now been cleaned with Washing Solution. If necessary, this
procedure can be repeated. Press ESC to get back to the upper menu level.

Before entering a joblist it is possible to load and later unload reagents for
daily routine. Observe the following preconditions:

- All reagents must be reconstituted according to the package insert.

- The system is preset to the supplied reagent vial types. To avoid
inaccurate level detection you should use the reagent vials with the
adapter rings only. Make sure that only predefined reagent vial types (4 ml
or 10 ml) are positioned in the sample or reagent rotor. For definition of
reagent vial types see section 6.2.2 Enter Method Parameter for definition
of reagent vial types.

10 ml reagent vial

(white adapter)

4 ml reagent vial

(blue adapter)

without stir bar

with stir bar

without stir bar

with stir bar

dead volume: 1.5 ml
dead volume: 2.0 ml
dead volume: 0.5 ml
dead volume: 0.8 ml

The dead volumes mentioned above have been considered when the
volume is asked for.

Loading PT, aPTT and Fibrinogen reagent is described in the following
example.

Remember to use the provided adapter rings (4 ml vial = blue ring;
10ml vial = white ring). Always position the reagent vials with the
adapter rings into the correct reagent position in the sample rotor and
make sure to use predefined reagent vial types only to avoid
inaccurate level detection.

The system has an automatic reagent stir position in order to avoid
sedimentation’s. If reagents are stirred, Teflon stir bars must be put
into the reagent vials. To select reagent vial types, see section 6.2.2
Enter Method Parameter.

• Use the arrow keys (</>) to select <7 Load reagents> in ROUTINE
MENU.

ROUTINE MENU
< 7 Load reagents >

• Press ENTER to confirm.

The following display appears:

1: washer:
LOAD unload
F1 F4

CoaLAB 6000 – Operators Manual 1.8 Page 32

Operation

The reagent position for the Washing Solution will be extended
automatically. Should you have loaded Washing Solution already, the above
display appears.

• Press F1 to confirm loading.

By pressing F4 ‘remove’ you inform the system that you have
removed reagent and/or washing solution from the sample rotor.

NOTE

‘Remove’ will always be displayed if you have loaded the sample rotor
with reagents and/or washing solution beforehand. Once the sample
rotor has been loaded with reagents and/or washing solution ‘remove’
will be displayed to ‘unload’ the sample rotor.

If ‘skip’ is displayed instead of ‘remove’ you can press F4 to skip over
loading with reagent and/or Washing Solution. Remember however,
that the analyzer cannot run measurements or start cleaning cycles if
reagents and/or Washing Solution have not been loaded. This
message will always be displayed when no reagents and/or Washing
Solution have been loaded to the sample rotor.

The following display appears:

2: Buffer: 9999992
LOAD skip

The sample rotor position will be extended automatically. Load the sample
rotor with Buffer in position 2: = R2 and confirm with F1.

If you want to skip over this position and not load Buffer press F4.

The following display appears:

3: FBG 8888
LOAD skip

The sample rotor position will be extended automatically. Load the sample
rotor with Fibrinogen reagent in position 3: = R3 and confirm with F1.

If you want to skip over this position and not load Fibrinogen press F4.

The following display appears:

4: CaCl2 88888
LOAD skip

The sample rotor position will be extended automatically. Load the sample
rotor with Calcium Chloride in position 4: = R4 and confirm with F1.

If you want to skip over this position and not load Calcium Chloride press
F4.

The following display appears:

5: aPTT 99999995
LOAD skip

CoaLAB 6000 – Operators Manual 1.8 Page 33

Operation

The sample rotor position will be extended automatically. Load the sample
rotor with aPTT reagent in position 5: = R5 and confirm with F1.

If you want to skip over this position and not load aPTT reagent press F4.

The following display appears:

6: PT 88888
LOAD skip

The sample rotor position will be extended automatically. Load the sample
rotor with PT reagent in position 6: = R6 and confirm with F1.

If you want to skip over this position and not load PT reagent press F4.

After all reagents have been positioned on the sample rotor the following
display appears.

ROUTINE MENU
< 7 Load reagents >

• Press ESC to get back into the MAIN MENU.

6.1.6 Delete joblist, delete
samples

If you want to delete a joblist from the memory follow the instructions:

• Use the arrow keys (</>) to select <1 Erase joblist > in the ROUTINE
MENU.

The following display appears:

ROUTINE MENU
< 1 Erase joblist >

Press ENTER to confirm.

The following display appears:

Really erase joblist?
YES no

If you want to delete the joblist confirm with F1 = YES. If you do not want to
delete it, press F2 = NO. Confirm with F1.

The following display appears:

Remove samples 1-9
and close cover

• Remove primary tubes 1 to 9 from the sample positions extended
automatically and confirm with ENTER.

If more than 9 primary tubes are in the sample rotor the following message
appears:

Remove samples 10­and close cover

CoaLAB 6000 – Operators Manual 1.8 Page 34

Operation

• Remove the remaining primary tubes 10 - 18 and confirm with ENTER.

The following display appears:

ROUTINE MENU
< 1 Erase joblist >

• Press ESC to get back into the MAIN MENU.

6.1.7 Enter a new joblist

Before entering a joblist you must define whether single or double
determinations shall be made, see section 6.2.2.1

The following examples show how a joblist is to be entered:

Example 1:
01 = Sample 1 S-ID: 30001 = consecutive no. PT and APTT =

test to be measured
Example 2:
02 = Sample 2 S-ID: 30002 = consecutive no PT, APTT, FBG =

test to be measured
Example 3:

03 = Sample 3

S-ID: 123 = individual no PT =

test to be measured

Example 1:

• Use the arrow keys (</>) to select < 2 Insert sample > in the ROUTINE
MENU.

ROUTINE MENU
< 2 Insert sample >

• Press ENTER to confirm.

The following display appears:

01 S-ID: 30001
pt aptt fbg all
F1 F2 F3 F4

The sample rotor will automatically advance to the position to be loaded
with sample 1 (01 S-ID:). Load the sample rotor with the first primary tube
and select the tests with keys F1-F4. In this case the tests pt=F1 and
aptt=F2 have been selected.

The following display appears:

01 S-ID: 30001
pt APTT fbg all

After the tests have been selected they will appear in capital letters.

• Press ENTER to confirm.

CoaLAB 6000 – Operators Manual 1.8 Page 35

Operation

Example 2

Example 3

NOTE

The following display appears:

02 S-ID: 30002
pt aptt fbg all

The sample rotor will automatically advance to the position to be loaded
with sample 2 (02 S-ID:). Load the sample rotor with the second primary
tube and select the tests with keys F1-F4. In this case the tests pt, aptt and
fbg have been selected, i.e. all = F4.

• Press ENTER to confirm.

The following display appears:

03 S-ID: 123
pt aptt fbg all

The sample rotor will automatically advance to the position to be loaded
with sample 3 (03 S-ID:). Load the sample rotor with the third primary tube
and select the tests with keys F1-F4. In this case the test pt=F1 has been
selected. If you want to change the patient ID press the left arrow key (<)
until the patient ID is no longer displayed. You can now enter the individual
ID, here 123.

• Press ENTER to confirm.

The following display appears:

04 S-ID: 30003
pt aptt fbg all

The sample rotor will extend automatically the position to be loaded with
sample 4 (04 S-ID:). Repeat this procedure to insert more patient ID´s.
Press ESC to leave this Menu.

The analyzer offers two possibilities to enter patient ID’s. If no ID is entered
the system will automatically assign consecutive numbers.

1.) Enter the patient ID manually.

Using the number keys (0-9), enter the

patient ID up to 10 digits.

2) Enter the patient ID by using the barcode scanner.

Press the button on
the barcode scanner and direct the scanner window to the barcode
label of the primary tube. Continue pressing the button until a beep
confirms entry of ID.

A large number of barcodes can be used. If the system does not
accept a certain barcode contact the manufacturer or enter the patient
ID manually.

Press ESC to leave the Menu.

CoaLAB 6000 – Operators Manual 1.8 Page 36

Operation

The following display appears:

ROUTINE MENU
< 2 Insert sample >

The sample rotor has a maximum of 18 sample positions of which 15 can
be used for routine work. Up to 3 positions can be used for STAT
measurements. To load the sample positions repeat the procedures as
described in this chapter.

Press ESC to get back to the MAIN MENU.

6.1.8 Handle the joblist

After entering the joblist into the memory, entries may be reviewed for
accuracy or modification.

• Use the arrow keys (</>) to select <3 Edit joblist> in the ROUTINE MENU.

ROUTINE MENU
< 3 Edit joblist >

• Press ENTER to confirm.

The following display appears:

01 S-ID: 30001
PT APTT fbg all

The desired test of each sample is displayed in capital letters. All other tests
will be displayed in lowercase. By pressing the function keys F1-F4, tests
may be selected or deselected or further tests can be added.

With the up and down arrow keys you can select the next sample.

• Press ESC to leave this menu point.

The following display appears:

ROUTINE MENU
< 3 Edit joblist >

• Press ESC to get back to the MAIN MENU.

6.1.9 Print of a joblist

The description how to print a joblist follows in this section. The printed
joblist will provide an overview of the patient samples and methods.

• Use the arrow keys (</>) to select <4 Print joblist> in the ROUTINE
MENU.

ROUTINE MENU
< 4 Print joblist >

• Press ENTER to confirm.

CoaLAB 6000 – Operators Manual 1.8 Page 37

Operation

NOTE

The following display appears:

printing joblist

The joblist will be printed on the internal printer. After printing this function
will re-appear.

ROUTINE MENU
< 4 Print joblist >

• Press ESC to get back to the MAIN MENU.

Example of printed joblist.

C2820501 V1.04 04/22/02

07.05.2002 08:44
ROUTINE Joblist:
T1 = PT PT
T2 = APTT APTT
T3 = FBG Fibrinogen

No Sample-ID T1 T2 T3
1: 30001 x x
2: 30002 x x x
3: 123 x

------------------------------------------

Have the joblist printed after entry. Thus you can control whether it
contains all selected entries. See chapter 6.1.8 Handle the joblist if
you want to modify anything.

- Test name (short form)

- selected tests

6.1.10 Start measuring, load
cuvette bars

After printing the joblist start measurement. Follow the instructions in this
section to run measurements.

• Use the arrow keys (</>) to select <5 Start measure> in the ROUTINE
MENU.

ROUTINE MENU
< 5 Start measure >

• Press ENTER to confirm.

The following display appears:

Select test:
PT aPTT FBG all

CoaLAB 6000 – Operators Manual 1.8 Page 38

Operation

With the function keys F1-F3 below the display a single test will be run.
With the function key F4 = all, all three tests will be run automatically
(RANDOM ACCESS).

Example: PT = F1

The following display appears:

Prepare measure

The following display appears:

INFO
check waste box

The message ‘check waste box’ is displayed for a short moment every time
you enter a new joblist. Empty the waste box if used cuvette bars are still in.

The following message will be displayed:

Insert cuvette-bar
and close cover

The system will calculate according to the joblist how many cuvette bars are
needed. The sample rotor automatically advances to the next position for a
cuvette bar. Place the cuvette bar properly into its position.

This procedure will be repeated until all bars for the measurements have
been positioned.

• Press ENTER to confirm.

If no reagents are loaded the sample rotor will automatically advance to the
reagent position. Place the adapter ring and the predefined reagent vial of
the selected test (here PT) into it. See section, 6.2.2 Enter Method
Parameter.

The display will show the reagent volume necessary for the tests.

6: PT 123456789
LOAD 2.4ml skip

The displayed figure already considers the necessary dead volume of the
reagent vial.

Dead volumes:

10 ml reagent vial

(white adapter)

4 ml reagent vial

(blue adapter)

without stir bar

with stir bar

without stir bar

with stir bar

dead volume: 1.5 ml
dead volume: 2.0 ml
dead volume: 0.5 ml
dead volume: 0.8 ml

Having positioned the reagent vial with adapter into the sample rotor you
can confirm this in two ways:

F1 (load) or =
ENTER

The reagent has been loaded and the entry is
confirmed.

CoaLAB 6000 – Operators Manual 1.8 Page 39

Operation

F4 (skip) =

The reagent has not been loaded, the entry was not
confirmed.

• In this case press F1 or ENTER to confirm.

Remember that the supplied reagent vials consider sufficient dead
volume when calculating the reagent volume. Therefore the reagent

NOTE

volumes are larger than what is actually needed for the tests. Always
use the adapter rings and the pre-defined reagent vials as the volume
calculation of the reagent will be influenced negatively otherwise.

The instrument will check the reagents for sufficient volume. If reagents are
missing or the volume is insufficient the following display will appear:

For example:

6: PT 123456789
only x.xml of x.xml

Load the missing or insufficient reagent in position R6. Remember the
necessary dead volume.

• Press ENTER to confirm end of loading.

If you do not want to load the missing reagents press ESC. The analyzer
will measure as many samples as possible with the available reagents.
Samples not measured will be identified with a note on the printout.

By pressing ESC and thus refuse to load the missing reagents, not all
measurements will be worked off your joblist. The system will do all

NOTE

measurements possible with the reagent volume. Follow the steps in
this section to work off the remaining measurements.

The following display appears:

Pipettor M-Block

37.4 38.4

The message Pipettor / M-Block indicates the temperature of the measuring
block and the pipettor. This message will be displayed until the correct
temperature has been reached.

The following display appears:

4 PT Samples <
No Results available

The system will start measurements. The number (e.g. 4 PT samples) of
measurements for each method will be displayed. The results will
automatically be printed on the internal printer.

The display will show ‘no results available’.

The rotating symbol (<) in the upper right hand corner of the display means
that the instrument is measuring presently.

CoaLAB 6000 – Operators Manual 1.8 Page 40

Operation

At the completion of all tests a short beep will be heard and the following
message appears on the display:

STATE
Normal Termination

All cuvette bars that were not completely used will remain in the measuring
block, and be used in the next testing cycle.

Example of a printed result:

C2820501 V1.04 04/22/02

07.05.2002 08:44

Analyzer Mode : Batch
Research Mode : Off

Test PT 07.05.2002 10:30
No Sample-ID Result Cuv.
1: 123 online 01a
PT time1 15.4 sec
PT INR 1.74
PT conc 43.5 %

---------------------------------------------
Finished 07.05.2002 10:45
State: Normal Termination

6.1.11 Interrupt a current run
(User interrupt)

Follow the instructions in this section to interrupt a current run. The system
is measuring as described in section 6.1.10 Start measuring, load cuvette
bars.

The following display appears:

X PT Samples
03 123 --.--

• Press ESC to interrupt the run.

There may be a slight delay, before interruption of the current run is
confirmed on the display.

The following display appears:

User interrupt (ESC)
Yes no stop stat
F1 F2 F3 F4

Select the method of interruption by using the function keys F1-F4:

CoaLAB 6000 – Operators Manual 1.8 Page 41

Operation

Function

Instruction Meaning

key

F1 Yes The run will only be interrupted after all cuvette

bars in the measuring block have been
completed, and results are available. The
cuvette bars remaining in the sample rotor will
be used later.

F2 or No The run will not be interrupted.

F3 Stop The current run is interrupted immediately. The

cuvette bars in the incubation and measuring
position will not be used. The joblist will remain
active.

F4 Stat Places the instrument in STAT management

mode, see section 6.3 STAT Management.
Cuvette bars in the measuring block will be first
completed.

• Press F4 to get into the STAT measurement and follow the instructions as
indicated in section 6.3 STAT Management.

STAT Measurement
Edit Ins Prnt Start

• Press ENTER to run the selected tests.

6.1.12 Print results, send results
to HOST

This section describes how to print results or send to a HOST computer.
The system has an internal thermal printer to print all results, test and setup
parameters, and error messages. Moreover, results can be sent to a
connected HOST computer.

Use the RS 232C interface port to connect the HOST computer to the

NOTE

analyzer. The port is on the right side of the system below the socket
for the optional barcode scanner. The port is marked RS 232. For
further instructions, see section 5.1.4.4.

• Use the arrow keys (</>) to select <6 Result managem.> in the ROUTINE
MENU.

ROUTINE MENU
< 6 Result managem. >

• Press ENTER to confirm.

The following display appears:

Result managem.
send list PRINT
F1 F2 F3

Use F1 = send to send results to a HOST. To list the results in the display
press F2 = list. Use the arrow keys (</>) to select between the patients.
Use F3 = print to print the results on the internal printer.

CoaLAB 6000 – Operators Manual 1.8 Page 42

Operation

By pressing F1 = send the following message will appear on the display for
a short moment. The results and patient ID´s will be sent to the HOST
computer.

sending results

By pressing F2 = list the results of each patient and test will be displayed
accordingly. Using the arrow keys (</>) will display different patient results
per test. Using the arrow keys up/down will display different test results per
patient.

123 PT
1 result

After pressing F3 = print the following message will appear on the display
for a short moment. The results will be printed on the internal printer.

printing results

The following display appears:

ROUTINE MENU
< 6 Result managem. >

After sending or printing the ROUTINE MENU will appear again. Press ESC
to get back to the MAIN MENU.

6.1.13 Refill liquids, clean
containers

NOTE

It is absolutely necessary to check the level in the distilled water container
(green label) constantly and at the same time clean the waste water
container regularly. If possible, the distilled water container should have a
minimum of 1 litre. Always take care that no bubbles will be in the container.
The bubbles might get into the tubing system which would influence level
detection. Use Distilled Water (aqua dest.) only!

The containers should be checked every time before the system is switched
on, before the measurement run at the latest.

The waste water container should be cleaned in a regular cycle. See
section 8.1 Maintenance and Hygiene for further instructions.

The distilled water sensor (marked green) must be placed into the distilled
water container (green label) before using the system. This sensor monitors
the liquid level in the container and gives an error message if the level is too
low. The following error message will be displayed:

STATE
Out of system liquid

The current measurement will be interrupted if not enough liquid is in
the container during a measurement as the steel tubing cannot be
washed.

CoaLAB 6000 – Operators Manual 1.8 Page 43

Operation

The following error message will be printed:

Finished 07.05.2002 15:45
Status: no system liquid

To refill and clean the distilled water container follow the instructions below:

• Ensure that the system is not in a washing cycle or in menu
< 5 Start measure >.

• Remove the Distilled Water Sensor from the Distilled Water
Container.

• Empty the Distilled Water Container completely.

• Clean the inside of the container using a 70% alcohol solution and rinse it
with distilled water. Avoid any alcohol residues in the container.

• Refill the Distilled Water Container with demineralised or distilled water.
Do not use tap water.

• Place the Distilled Water Sensor into the container and continue with
routine measurements.

• Every time the Distilled Water Container is refilled the Waste Water
Container must be emptied.

Always check the liquid levels to avoid unintended interruption of runs.

6.1.14 Empty and clean the
waste water container

NOTE

It is absolutely necessary to check the level in the waste water container
(red label) constantly. The container should be checked every time before
the system is switched on, before the measurement run at the latest.

The waste water sensor (marked red) must be placed into the waste water
container (red label) before using the system. This sensor monitors the
liquid level in the container and gives an error message if the level is too
high. The following error message will be displayed:

STATE
Waste bottle full

The current measurement will be interrupted if the level is too high in
order to avoid an overflow.

The following error message will be printed:

Finished 07.05.2002 15:45
Status: Waste bottle full

To empty and clean the waste water container follow the instructions below:

• Make sure that the instrument is not in a washing cycle or in menu
< 5 Start measure >.

• Remove the Waste Water Sensor from the Waste Water Container.

• Empty the Waste Water Container completely. (See section Hazard and
Precaution)

CoaLAB 6000 – Operators Manual 1.8 Page 44

Operation

p

• Clean the inside of the Waste Water Container with 70% alcohol solution
and rinse it with distilled water. Avoid any alcohol residues in the
container.

• Return the Waste Water Sensor to the container and continue with
measurements.

NOTE

The waste water contains patient samples and test reagents and
must be treated potentially infectious. Avoid any direct skin contact.
Dispose of the waste water in compliance with biohazard and legal

rovisions.

6.2 Enter Test Parameter

Follow the instructions to change pre-defined test parameters. The
descriptions will lead you through the TEST MENU and will help you to
enter test parameters correctly.

6.2.1 Enter Reagent Specific
Parameters

In this chapter learn how to enter reagent-specific parameters.

6.2.1.1 Enter a reference curve

(PT, for example)

Follow the steps mentioned below to enter a reference curve. Here PT is
used as an example since the reference curves for all methods will be
entered in the same way. Therefore use the same steps to enter reference
curves for the other methods, if necessary.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

• Press ENTER to confirm.

NOTE

The following display appears:

• Enter the PIN code with the number keys (default=11111).

The following display appears:

MAIN MENU:
< 2 TEST MENU >

Before getting into the TEST MENU it is necessary to enter a number
code (PIN). The system number code is preset to 11111 by the
manufacturer. Change this code as described in section 6.4.6 Set PIN
Code. Remember to note the code down and keep it at a safe place. It
should be known to those users only who are authorised to operate
the instrument.

TEST MENU:
PIN

TEST MENU:
< 1 Modify test >

CoaLAB 6000 – Operators Manual 1.8 Page 45

Operation

NOTE

• To change or check test parameters press ENTER to confirm.

You can now select from the following display:

Select test:
PT aPTT FBG END

• Select method PT by pressing F1. To enter the reference curve for
Fibrinogen press F3 accordingly. Press F4 = END to leave the menu

without making any changes.

• Use the arrow keys (</>) until <4 1st Conversion> is displayed.

PT PARAMETER:
< 4 1st conversion >

• Press ENTER to confirm.

With the arrow keys (</>) choose between the following reference curve
types:

PT 1st Conversion: selection for:
< 1 None > no conversion
< 2 Curve regr.> regression
< 3 Curve interpol > interpolation

• Use the arrow keys (</>) until < 3 curve interpol > is displayed.

• Press ENTER to confirm.

The following display appears:

Time Val[%]
1 11.5 100.0

The displayed values can be overwritten directly. First enter the time. Press
the right arrow key (>) to set the decimal point. Press ENTER to confirm.

Enter the % - value with the number keys. Press ENTER to confirm. Use the
left arrow key (<) to delete or overwrite.

The system checks the reference curve points automatically whether they
are plausible, i.e. falling concentration/activity must have rising time values
and reverse. If the points are not plausible the system will beep.

The following display appears:

Time Val[%]
2 14.5 50.0

Enter the 2.reference curve point. Follow the instructions above. A minimum
of 2 points must be defined; a maximum of 9 points can be entered.

• Press ENTER to confirm the entry.

To enter any additional point after having entered the second or any
further point enter 0.0 s for the last time value. The remaining points
will not be displayed. To enter more points next time enter the actual
time value instead of 0.0 s and the remaining points will be displayed.

CoaLAB 6000 – Operators Manual 1.8 Page 46

Operation

The following display appears:

PT PARAMETER:
< 4 1st conversion >

• Press ESC to leave this menu point.

Select <1 none> in <1st Conversion> menu to enter no reference curve.

• Press ENTER to confirm <1 none> and to deactivate the reference curve.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC again to get back into the MAIN MENU.

6.2.1.2 Enter ISI value

Follow the instructions to enter the ISI value.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN

MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

Select test:
PT aPTT FBG END

• Press F1 to select method PT.

Press F4 = END to leave the menu without making any changes.

The following display appears:

• Use the arrow keys (</>) until <5 2nd Conversion> is displayed.

CoaLAB 6000 – Operators Manual 1.8 Page 47

Operation

PT PARAMETER:
< 5 2nd conversion >

• Press ENTER to confirm.

• Use the arrow keys (</>) until < 3 INR > is displayed.

The following display appears:

PT 2nd conversion
< 3 INR >

• Then press ENTER to confirm.

The following display appears:

INR:
100% = 11.5 s

• Enter the 100% reference value (in sec.). The 100% Value can be taken

from the tested calibration curve or from the used INR. INR is defined
through standard plasma with a given mean value of 6 determinations
definitions classification and the average value to be given in seconds.

The displayed value can be overwritten with the number keys. A maximum
of 3 digits before the decimal point can be entered. Press the right arrow
key (>) to set the decimal point.

Use the left arrow key (<) to delete or overwrite any entry.

• Press ENTER to confirm the entry.

The following display appears:

INR:
ISI: 1.100

Enter the ISI-value according to the package insert of the reagent
manufacturer. The displayed value can be overwritten with the number
keys. A maximum of 3 digits after the decimal point can be entered. Press
the right arrow key (>) to set the decimal point. Use the left arrow key (<) to
delete or overwrite any entry. After the ISI-value has been entered the
system will calculate the INR for each sample automatically.

• Press ENTER to confirm the entry.

The following display appears:

PT PARAMETER:
< 5 2nd conversion >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC again to get back into the MAIN MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 48

Operation

6.2.1.3 Enter RATIO (APTT for
example)

Follow the instructions to enter RATIO. Here aPTT is used as an example
however Ratio for all methods will be entered in the same way. Therefore
use the same steps to enter Ratio for the other methods, if necessary.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

Select test:
PT aPTT FBG END

• Press F2 to select method aPTT.

If you want to enter Ratio for one of the other methods press either F1 for
PT. Press F4 = END to leave the menu without making any changes.

• Use the arrow keys (</>) until <5 2nd Conversion> is displayed.

The following display appears:

aPTT PARAMETER:
< 5 2nd conversion >

• Press ENTER to confirm.

• Use the arrow keys (</>) until <2 RATIO> is displayed.

The following display appears:

aPTT 2nd conversion
< 2 RATIO >

• Press ENTER to confirm.

The following display appears:

CoaLAB 6000 – Operators Manual 1.8 Page 49

Operation

Ratio:
100% = 20.0s

• Enter Ratio in seconds.

The displayed value can be overwritten directly. Press the right arrow key
(>) to set the decimal point. Use the left arrow key (<) to delete or overwrite
any entry.

• Press ENTER to confirm the entry.

The following display appears:

aPTT PARAMETER:
< 5 2nd conversion >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC again to get back into the MAIN MENU.

6.2.1.4 Enter normal ranges
(for example PT)

Follow the instructions to enter the normal ranges. Here PT is used as an
example since the normal ranges for all methods will be entered in the
same way. Therefore use the same steps to enter the normal ranges for the
other methods, if necessary.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 50

Operation

The following display appears:

Select test:
PT aPTT FBG END

• Press F1 to select method PT.

To set the normal ranges for one of the other methods press F2 for aPTT or
F3 for Fibrinogen. Press F4 = END to leave the menu without making any
changes.

• Use the arrow keys (</>) until <3 Normal ranges> is displayed.

The following display appears:

PT PARAMETER:
< 3 Normal range >

• Then press ENTER to confirm.

The following display to the maximum %-value appears:

PT Normal range:
max: 130.0 %

• Use the number keys to enter the %-value.

Press the right arrow key (>) to set the decimal point. A maximum of 4 digits
before the decimal point can be entered. Use the left arrow key (<) to delete
or overwrite any entry.

• Press ENTER to confirm the entry.

The following display to enter the minimum %-value appears:

PT Normal range:
min: 70.0 %

• Use the number keys to enter the %-value

A maximum of 2 digits before the decimal point can be entered. Press the
right arrow key (>) to set the decimal point. Use the left arrow key (<) to
delete or overwrite any entry.

• Press ENTER to confirm the entry.

The following display appears:

PT PARAMETER:
< 3 Normal range >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC again to get back into the MAIN MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 51

Operation

6.2.2 Enter Method Parameter

This section describes how to enter the method parameters.

6.2.2.1 Enter single or double
determinations

Follow the instructions to enter single or double determinations. In the
following find two examples since the single and double determinations for
all methods will be entered in the same way. Therefore use the same
procedure accordingly.

Example 1

Set PT from double to single determination

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

• Press ENTER to confirm.

The following display appears:

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

• Press F1 to select method PT.

To set another method press F2 for aPTT or F3 for Fibrinogen. Use F4 =
END to leave the menu without making any changes.

• Use the arrow keys (</>) until <1 Replication> is displayed.

The following display appears:

• Then press ENTER to confirm.

MAIN MENU:
< 2 TEST MENU >

TEST MENU:
PIN

TEST MENU:
< 1 Modify test >

Select test:
PT aPTT FBG END

PT PARAMETER:
< 1 Replication >

CoaLAB 6000 – Operators Manual 1.8 Page 52

Operation

The following display appears:

PT Replication:
sngl DBLE
F1 F2

DBLE = double

• Press F1 to select single (sngl) determination. The determination
selected will be displayed in capital letters.

The following display appears:

PT PARAMETER:
< 1 Replication >

• Press ENTER again to get to <1 Replication >.

Here, you can check whether single determination was accepted. SNGL will
be displayed in capital letters.

• Press ESC to leave this menu point.

Example 2

Set APTT with 10% variation coefficient from single to double
determination

<1 Modify test> in the TEST MENU has been selected.

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm the selection.

The following display appears:

Select test:
PT aPTT FBG END

• Press F2 to select method aPTT.

To set another method, press either F1 for PT or F3 for Fibrinogen. Use F4
= END to leave the menu without making any changes

• Use the arrow keys (</>) until <1 Replication> is displayed.

The following display appears:

aPTT PARAMETER:
< 1 Replication >

• Press ENTER to confirm.

The following display appears:

aPTT Replication:
SNGL dble

SNGL = single

• Press F2 = dbl to select double determination. The determination selected
will be displayed in capital letters.

CoaLAB 6000 – Operators Manual 1.8 Page 53

Operation

The following display appears:

aPTT max. CV:
10%

Use the number keys to enter the variation coefficient. A maximum of 2
digits can be entered. With the left arrow key (<) you can delete or overwrite
your entry.

• Press ENTER to confirm.

The following display appears:

aPTT PARAMETER:
< 1 Replication >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC to get back into the MAIN MENU.

6.2.2.2 Enter PT Test Parameter

In the following we have described how to enter reagent-specific data for
PT.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN

MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

Enter the sample volume

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 54

Operation

The following display appears:

Select test:
PT aPTT FBG END

• Press F1 to select method PT.

Use F4 = END to leave the menu without making any changes.

• Use the arrow keys (</>) until <2 Measurement> is displayed.

PT PARAMETER:
< 2 Measurement >

• Press ENTER to confirm.

• Use the arrow keys (</>) until <1 Sample volume> is displayed.

The following display appears:

PT Measurement:
< 1 Sample volume >

• Press ENTER to confirm.

The following display appears:

PT Sample volume:
50 µl

• Use the number keys to change the sample volume.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter incubation time

• Use the arrow keys (</>) until <7 Incub. time> is displayed.

The following display appears:

PT Measurement:
< 7 Incub. Time >

• Press ENTER to confirm.

The following display appears:

PT Incubation:
70s

• Use the number keys to change the incubation time. A maximum of 3
digits can be entered. Use the left arrow key (<) to delete or overwrite any
entry.

• Press ENTER to confirm the entry.

CoaLAB 6000 – Operators Manual 1.8 Page 55

Operation

Enter start reagent volume and
the reagent lot number

• Use the arrow keys (</>) until <8 Start reagent> is displayed.

The following display appears:

PT Measurement:
< 8 Start reagent >

• Press ENTER to confirm.

The following display appears:

PT volume:
100 µl

• Use the number keys to change the volume of the start reagent.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter the reagent lot number

Select reagent vial types

The following display appears:

PT Lot No.:
8888

• Use the number keys to enter or change the lot number of each method.
Take the lot number from the package insert. A maximum of 9 digits can
be entered. Use the left arrow key (<) to delete or overwrite any entry.

• Press ENTER to confirm the entry.

The system has an integrated reagent stir position to avoid sedimentation of
the coagulation reagents. The reagents will be stirred immediately before
pipetting and automatically within a defined time frame. In order to inform
the system of the reagents to be stirred it is necessary to preset the reagent
vial type and the stir function.

The manufacturer offers two reagent vial types. You should use those
reagent vials only since the functionality of the system might be influenced
otherwise. A Teflon Stir Bar (supplied with the accessories) must be
placed into the reagent vials. Also the adapter rings (supplied with the
accessories) must be used.
The following display to select a reagent vial type appears:

PT Bottle type:
< 6 4ml bottle >

• Use the arrow keys (</>) to determine which reagent vial type shall be
used and whether the reagent shall be stirred.

CoaLAB 6000 – Operators Manual 1.8 Page 56

Operation

Which varieties can be selected shows the following list.

Displayed Meaning Adapter ring Teflon stir bar

<3 10ml bottle>
<4 10ml bottle-R>
<6 4ml bottle>
<7 4ml bottle-R>

10 ml reagent vial without stir bar white no
10 ml reagent vial with stir bar white yes
4 ml reagent vial without stir bar blue no
4 ml reagent vial with stir bar blue yes

Before positioning a reagent vial into the sample or reagent rotor
make sure that it has been predefined for the method. The reagent
vial types supplied by the manufacturer have different filling

NOTE

heights depending on their sizes (10 ml or 4ml). If you use the
wrong vial type the level might not be detected correctly or the
needle will touch the bottom of the wrong vial.

Enter maximum measuring time

If the vial type was selected the following display appears:

PT Measurement:
< 9 max meas time >

• Press ENTER to define the maximum measuring time.

The following display appears:

PT max. M-time:
80s

• Use the number keys to enter or change the maximum measuring time. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

The following display appears:

PT Measurement:
< 1 Sample volume >

• Press ESC to leave this menu point.

The following display appears:

PT PARAMETER:
< 2 Measurement >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

Press ESC to leave the menu without any further changes of method­specific data for other methods.

CoaLAB 6000 – Operators Manual 1.8 Page 57

Operation

To change more press ENTER and follow the instructions as per section

6.2.2.3

6.2.2.3 Enter APTT Test Parameter

The following describes how to enter method-specific data for aPTT.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN

MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

Enter the sample volume

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

Select test:
PT aPTT FBG END

• Press F2 to select method aPTT.

Press F4 = END to leave the menu without making any changes.

• Use the arrow keys (</>) until <2 Measurement> is displayed.

aPTT PARAMETER:
< 2 Measurement >

• Press ENTER to confirm.

• Use the arrow keys (</>) until <1 Sample volume> is displayed.

The following display appears:

aPTT Measurement:
< 1 Sample volume >

• Press ENTER to confirm.

CoaLAB 6000 – Operators Manual 1.8 Page 58

Operation

The following display appears:

aPTT Sample volume:
50 µl

• Use the number keys to enter or change the sample volume.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter 1. Reagent Volume

• Use the arrow keys (</>) until <3 Reagent 1> is displayed.

The following display appears:

aPTT Measurement:
< 3 Reagent 1 >

• Press ENTER to confirm.

The following display appears:

aPTT volume:
50 µl

• Use the number keys to change the reagent volume for APTT reagent.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter a Lot Number

The following display appears:

aPTT Lot No.:
123456789

• Use the number keys to enter or change the lot number.

You will find the number on the reagent package insert. A maximum of 9
digits can be entered. Use the left arrow key (<) to delete or overwrite any
entry.

• Press ENTER to confirm the entry.

Select reagent vial types

The system has an integrated reagent stir position to avoid sedimentation of
the coagulation reagents. The reagents will be stirred immediately before
pipetting and automatically within a defined time frame. In order to inform
the system of the reagents to be stirred it is necessary to predefine the
reagent vial type and the stir function.

CoaLAB 6000 – Operators Manual 1.8 Page 59

Operation

NOTE

The manufacturer offers two reagent vial types. You should use those
reagent vials only since the functionality of the system might be influenced
otherwise. A Teflon Stir Bar (supplied with the accessories) must be
placed into the reagent vials. Also the adapter rings (supplied with the

accessories) must be used.

The following display appears:

aPTT Bottle type:
< 6 4ml Bottle >

• Use the arrow keys (</>) to determine which reagent vial type shall be
used and whether the reagent shall be stirred.

Which varieties can be selected shows the following list.

Displayed Meaning Adapter ring Teflon stir bar

<3 10ml bottle>
<4 10ml bottle-R>
<6 4ml bottle>
<7 4ml bottle-R>

10 ml reagent vial without stir bar white no
10 ml reagent vial with stir bar white yes
4 ml reagent vial without stir bar blue no
4 ml reagent vial with stir bar blue yes

Before positioning a reagent vial into the sample or reagent rotor
make sure that it has been predefined for the method. The reagent
vial types supplied by the manufacturer have different filling
heights depending on their sizes (10 ml or 4ml). If you use the
wrong vial type the level might not be detected correctly or the
needle will touch the bottom of the wrong vial.

Enter incubation time

• Use the arrow keys (</>) until <7 Incub. time> is displayed.

The following display appears:

aPTT Measurement:
< 7 Incub. time >

• Press ENTER to confirm.

The following display appears:

aPTT Incubation:
120 s

• Use the number keys to enter or change the incubation time.

A maximum of 3 digits can be entered. Use the left arrow key (<) to delete
or overwrite any entry.

• Press ENTER to confirm the entry.

CoaLAB 6000 – Operators Manual 1.8 Page 60

Operation

Enter Start Reagent Volume

• Use the arrow keys (</>) until <8 Start reagent> is displayed.

The following display appears:

aPTT Measurement:
< 8 Start reagent >

• Press ENTER to confirm.

The following display appears:

CaCl2 volume:
50 µl

• Use the number keys to enter or change the reagent volume for Calcium
Chloride.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter a Lot Number

Select Reagent Vial Types

Displayed Meaning Adapter ring Teflon stir bar

<3 10ml bottle>
<4 10ml bottle-R>
<6 4ml bottle>
<7 4ml bottle-R>

The following display appears:

CaCl2 Lot No.:
123456789

• Use the number keys to enter or change the lot number.

The number is on the reagent package insert. A maximum of 9 digits can be
entered. Use the left arrow key (<) to delete or overwrite any entry.

• Press ENTER to confirm the entry.

Select the reagent vial type for calcium chloride and decide whether the
reagent shall be stirred. To change the setting for the reagent vial type
follow the instructions above.

The following display appears:

CaCl2 Bottle type:
< 6 4ml Bottle >

• Use the arrow keys (</>) to determine which reagent vial type shall be
used and whether the reagent shall be stirred.

Which varieties can be selected shows the following list.

10 ml reagent vial without stir bar white no
10 ml reagent vial with stir bar white yes
4 ml reagent vial without stir bar blue no
4 ml reagent vial with stir bar blue yes

CoaLAB 6000 – Operators Manual 1.8 Page 61

Operation

NOTE

Enter Maximum Measuring Time

The following display appears:

aPTT Measurement:
< 9 max meas time >

• Press ENTER to confirm the maximum measuring time.

The following display appears:

aPTT max M-time:
120 s

• Use the number keys to enter or change the maximum measuring time.

A maximum of 3 digits can be entered. Use the left arrow key (<) to delete
or overwrite any entry.

• Press ENTER to confirm the entry.

The following display appears:

aPTT Measurement:
< 1 Sample volume >

• Press ESC to leave this menu point.

The following display appears:

aPTT PARAMETER:
< 2 Measurement >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

Press ESC if no further change of method-specific data for other methods is
requested.
To change more parameters press ENTER and follow the instructions as
per section 6.2.2.4

Before positioning a reagent vial into the sample or reagent rotor
make sure that it has been predefined for the method. The reagent
vial types supplied by the manufacturer have different filling
heights depending on their sizes (10 ml or 4ml). If you use the
wrong vial type the level might not be detected correctly or the
needle will touch the bottom of the wrong vial.

CoaLAB 6000 – Operators Manual 1.8 Page 62

Operation

6.2.2.4 Enter Fibrinogen Test Parameter

Follow the instructions to enter test-specific parameters.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN

MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

Select test:
PT aPTT FBG END

• Select method FBG by pressing the function key F3. Press F4 = End to

leave this menu without making any changes.

• Use the arrow keys (</>) until <2 Measurement> is displayed.

The following display appears:

FBG PARAMETER:
< 2 Measurement >

• Press ENTER to confirm.

Enter the Sample Volume

• Use the arrow keys (</>) until <1 Sample volume> is displayed.

The following display appears:

FBG Measurement:
< 1 Sample volume >

• Press ENTER to confirm.

The following display appears:

FBG Sample volume:
100 µl

CoaLAB 6000 – Operators Manual 1.8 Page 63

Operation

• Use the number keys to enter or change the sample volume.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter 1. Reagent Volume (Dilution)

• Use the arrow keys (</>) until <2 Diluent> is displayed.

The following display appears:

FBG Measurement:
< 2 Diluent >

• Press ENTER to confirm.

The following display appears:

FBG Diluent 1 + n:

9.0

• Use the number keys to change the reagent volume (1+n) for the

Dilution (Buffer).

A maximum of 3 digits can be entered. Press the right arrow key (>) to set
the decimal point. Use the left arrow key (<) to delete or overwrite any entry.

• Press ENTER to confirm the entry.

Enter a Lot Number (Buffer)

Enter Incubation Time

The following display appears:

FBG Diluent Lot No.:
123456789

• Use the number keys to enter or change the lot number.

The number is on the reagent package insert. A maximum of 9 digits can be
entered. Use the left arrow key (<) to delete or overwrite any entry.

• Press ENTER to confirm the entry.

• Use the arrow keys (</>) until <7 Incub. time> is displayed.

The following display appears:

FBG Measurement:
< 7 Incub. time >

• Press ENTER to confirm.

The following display appears:

FBG Incubation:
90 s

CoaLAB 6000 – Operators Manual 1.8 Page 64

Operation

• Use the number keys to enter or change the incubation time.

A maximum of 3 digits can be entered. Use the left arrow key (<) to delete
or overwrite any entry.

• Press ENTER to confirm the entry.

Enter Start Reagent Volume

• Use the arrow keys (</>) until <8 Start reagent> is displayed.

The following display appears:

FBG Measurement:
< 8 Start reagent >

• Press ENTER to confirm.

The following display appears:

FBG volume:
50 µl

• Use the number keys to enter or change the reagent volume for
Fibrinogen.

Remember that the total test volume must be between 125µl and 250µl. A
maximum of 3 digits can be entered. Use the left arrow key (<) to delete or
overwrite any entry.

• Press ENTER to confirm the entry.

Enter a Lot Number

Select Reagent Vial Types

The following display appears:

FBG Lot No.:
123456789

• Use the number keys to enter or change the lot number of the method.

You will find the number on the reagent package insert. A maximum of 9
digits can be entered. Use the left arrow key (<) to delete or overwrite any
entry.

• Press ENTER to confirm the entry.

Select the reagent vial type for Fibrinogen and decide whether the reagent
shall be stirred. To change the setting for the reagent vial type follow the
instructions above.

The following display appears:

FBG Bottle type:
< 7 4ml Bottle-R >

• Use the arrow keys (</>) to determine which reagent vial type shall be
used and whether the reagent shall be stirred.

CoaLAB 6000 – Operators Manual 1.8 Page 65

Operation

Which varieties can be selected shows the following list.

Displayed Meaning Adapter ring Teflon stir bar

<3 10ml bottle>
<4 10ml bottle-R>
<6 4ml bottle>
<7 4ml bottle-R>

NOTE

Enter Maximum Measuring Time

• Use the arrow keys (</>) until <9 max meas time> is displayed.

The following display appears:

FBG Measurement:
< 9 max meas time >

• Press ENTER to confirm the maximum measuring time.

The following display appears:

FBG max M-time:
100 s

• Use the number keys to enter or change the maximum measuring time.

A maximum of 3 digits can be entered. Use the left arrow key (<) to delete
or overwrite any entry.

• Press ENTER to confirm the entry.

The following display appears:

FBG Measurement:
< 1 Sample volume >

• Press ESC to leave this menu point.

The following display appears:

FBG PARAMETER:
< 2 Measurement >

• Press ESC to leave this menu point.

The following display appears:

TEST MENU:
< 1 Modify test >

• Repeat pressing ESC until you are back in the MAIN MENU.

10 ml reagent vial without stir bar white no
10 ml reagent vial with stir bar white yes
4 ml reagent vial without stir bar blue no
4 ml reagent vial with stir bar blue yes

Before positioning a reagent vial into the sample or reagent rotor
make sure that it has been predefined for the method. The reagent
vial types supplied by the manufacturer have different filling
heights depending on their sizes (10 ml or 4ml). If you use the
wrong vial type the level might not be detected correctly or the
needle will touch the bottom of the wrong vial.

CoaLAB 6000 – Operators Manual 1.8 Page 66

Operation

6.2.2.5 Print of Test Parameters
(Fibrinogen for example)

The following describes how to print all reagent and method specific data
(Print test) of a method. Here Fibrinogen is used for example however the
other methods PT and APTT will be printed in the same way. Therefore
follow the same steps to print the other methods. To print all methods
together follow the instructions in section 6.2.5 Print of Test Parameters
(Print test).

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ENTER to confirm <1 Modify test> in the TEST MENU.

The following display appears:

Select test:
PT aPTT FBG END

• Select method FBG by pressing the function key F3.

If you want to print another method press either F1 for PT or F2 for APTT. If
you press F4 = End you can leave this menu without changing anything.

• Use the arrow keys (</>) until < 6 Print test > is displayed.

FBG PARAMETER:
< 6 Print test >

• Press ENTER to confirm.

‘Print test’ will be displayed for a short moment.

Print test

CoaLAB 6000 – Operators Manual 1.8 Page 67

Operation

The following display appears:

FBG PARAMETER:
< 6 Print test >

The reagent and method specific data will be printed automatically on the
internal printer.

• Press ESC to leave this menu after printing is completed.

The following display appears:

TEST MENU:
< 1 Modify test >

• Press ESC again in order to get back into the MAIN MENU.

Example of a test parameters print

C2820501 V1.04 04/22/02

07.05.2002 11:50

T3 = FBG Fibrinogen

--------------------------

Replication : Double
max. CV : 10
Sample volume : 100µl
Diluent : Bufer
999992 : 1 + 9.0
Incub. time : 90 s
Start reagent : FBG
8888 : 50 µl
4ml Bottle-R
Airgap volume : 5 µl
Waste volume : 5 µl
max meas time : 120 s
Normal range
150 -- 400 mg/dl
1st Convers. : Interpol

9.9 sec 518 mg/dl

12.8 sec 422 mg/dl

16.6 sec 299 mg/dl
Extrapolation range
25 -- 1200 mg/dl
2nd Convers. : None

CoaLAB 6000 – Operators Manual 1.8 Page 68

Operation

_

_

_

_

6.2.3 Read ChipCARD to load a new test

(Read test)

In the following you will find how to load method and reagent specific data
with a ChipCARD. Besides loading these data manually (see sections 6.2.1
and 6.2.2) you can use a ChipCARD. These ChipCARDs have been
programmed with the method and reagent specific data of each reagent.

Each system is preset by the manufacturer with the test settings for PT,
APTT and FIBRINOGEN. These test settings can be changed or overwritten
with a ChipCARD.

3 tests can be loaded on the system at one time, e.g. PT, APTT, and

NOTE

Fibrinogen. If you want to load a new test with changed settings
one test from the system will be overwritten, i.e. deleted.

CoaLAB 6000

Default ChipCard

PT

30.000.1196

P-ID G 15 2 0220

_____________________

To install, refer to operators manual prior to use.
Weitere Informationen zur Installation finden Sie im Benutzerhandbuch.
Reportez-vous au manuel d´utilisation pour l´installation.
Para la instalación, consultar antes el Manuel del usuario.
Per l´installazione, leggere Il manuale di instruzioni prima dell´utillizo.

_____________________

The ChipCARDs contain all reagent and test specific data such as lot no.,
reference curve, incubation or activating time, expiry date of the reagent,
ISI, etc. Once you have loaded a ChipCARD no further settings have to be
made at the system. All data which had been entered manually beforehand
will be overwritten with the data of the ChipCARD.

For further information regarding availability, prices and application of
ChipCARDs contact your distributor or manufacturer.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

LABiTec GmbH
22926 Ahrensburg, Germany

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Select <2 Read test> in the TEST MENU.

TEST MENU:
< 2 Read test >

• Lift the printer cover above the keyboard.
The ChipCARD reader is below the printer module.

• Insert the ChipCARD with the chip facing down into the slot of the
reading module. Leave the ChipCARD in the reader.

• Press ENTER to confirm.

CoaLAB 6000 – Operators Manual 1.8 Page 69

Operation

The following display appears:

ChipCARD

Keypad

Figure 15 How to load a ChipCARD

ChipCARD Reader

Printer unit

Overwrite test:

PT aPTT FBG END

• Use the function keys F1 - F3 to select the test to be overwritten by the
ChipCARD. By pressing F4 = End you can leave this menu without
making any change.

The following display appears:

Read test

‘Read test’ will be displayed for a short moment. The instrument reads the
ChipCARD.

The following display appears:

Test loaded:
Name of loaded test

A message follows that the test of the system was overwritten by the
ChipCARD test.

• Press ENTER to confirm.

If the ChipCARD was inserted wrong or not at all the following error
message will appear:

E R R O R

No CARD found

• Press ENTER to confirm this message and repeat the procedure.

CoaLAB 6000 – Operators Manual 1.8 Page 70

Operation

If you inserted a ChipCARD of which the test had been loaded already the
following error message will be displayed:

E R R O R

Test already loaded

• Press ENTER to confirm this message and repeat the procedure with
another ChipCARD.

Withdraw the ChipCARD from the reader and close the printer cover again.
If you want to overwrite more tests of the system repeat the above steps for
all new tests.

The following display appears:

TEST MENU:
< 2 Read test >

• Press ESC in order to get back into the MAIN MENU.

6.2.4 Save Tests on a
ChipCARD

Find below how to write test parameters, including calibration curve, to a
ChipCARD and how to save the data. Editable ChipCARDs can be bought
from the manufacturer, see Chapter 8.5 Accessories and Consumables.

It is possible to save test parameters for a specific reagent lot so that you
can use this test again when a reagent of the same lot is used. No
parameters have to be entered manually.

Since the procedure of saving test parameters on a ChipCARD is the same
for all tests we have taken the PT test as an example.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

The following display appears:

TEST MENU:
< 1 Modify test >

• Press the arrow keys (</>) until <5 Write test> is displayed.

TEST MENU:
< 5 Write test >

CoaLAB 6000 – Operators Manual 1.8 Page 71

Operation

NOTE

• Press ENTER to select the function.

• Insert the ChipCARD into the reader. Use either a blank CARD or an
already edited ChipCARD. If you select a used ChipCARD remember that
all data on the ChipCARD will be overwritten.

Be careful not to use and overwrite the Default ChipCARD (also
supplied in the accessories).

The following display appears:

Select test:
PT aPTT FBG END
F1 F2 F3 F4

• Select the test to be saved by pressing one of the function keys F1 - F3.
By pressing F4 = End you can leave this menu without making any
changes.

The following display appears:

Write test

‘Write test’ will be displayed while the data is written to the ChipCARD.

Test written:
Name of written test

An acoustic signal will be heard at the end of saving.

• Press ENTER to confirm.

• Remove the edited ChipCARD and write all test relevant information on it
for proper identification.

• Put the printer cover back into its position.

• Press ESC to get back into a higher menu level.

Error messages

If the ChipCARD has been inserted wrong or not at all the following
message will appear:

E R R O R

No CARD found

• Press ENTER to confirm and repeat the procedure after the ChipCARD
has been inserted.

If you used the Default CARD the following message will appear:

E R R O R

Write protected card

• Press ENTER to confirm and repeat the procedure with another
ChipCARD.

CoaLAB 6000 – Operators Manual 1.8 Page 72

Operation

If a defective ChipCARD was used the following message will appear:

E R R O R

No CARD found

• Press ENTER to confirm and repeat the procedure with a new ChipCARD.

6.2.5 Print of Test Parameters
(Print test)

Follow the instructions to print all reagents and test specific data (print test)
of a method. We have used Fibrinogen for example however the other
methods PT and APTT will be printed in the same way. Therefore follow the
same steps to print the other methods.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN
MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Use the arrow keys (</>) until <3 Print test> is displayed.

TEST MENU:
< 3 Print test >

• Press ENTER to confirm.

The following display appears:

Select test:
PT aPTT FBG END

• Select method FBG by pressing the function key F3. If you want to print
another method press either F1 for PT or F2 for APTT. If you press F4 =
End you can leave this menu without changing anything.

The following display appears:

Print test

The test specific data for Fibrinogen will be printed automatically on the
internal printer.

• Press ESC to get back into the MAIN MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 73

Operation

6.2.6 Delete Test

In the following we have described how to delete tests which are stored in
the system. Remember that all reagent and test specific data of this method
will be deleted completely.

• Use the arrow keys (</>) to select <2 TEST MENU> in the MAIN

MENU.

MAIN MENU:
< 2 TEST MENU >

• Press ENTER to confirm.

The following display appears:

TEST MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Use the arrow keys (</>) until <3 Print test> is displayed.

TEST MENU:
< 4 Erase test >

• Press ENTER to confirm.

The following display appears:

Select test:
PT aPTT FBG END

• Using the function keys F1 - F4 select the test to be deleted. By pressing
F4 = End you can leave this menu without making any changes.

The following display appears:

Really erase test?
YES no

You will be asked again whether you really want to delete the selected test.
Use either F1 = YES or F2 = NO.

TEST MENU:
< 4 Erase test >

• Confirm deletion by pressing F1 = YES.

• Press ESC to get back into the MAIN MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 74

Operation

6.3 STAT Management

In the following we have described the STAT management which explains
how to run emergency tests during routine operation.

Introduction

Up to 3 samples may be preset for STAT on the sample/reagent rotor, see
section 6.4.2 Define STAT positions in the sample rotor. If you want to run
STAT tests you can either:

1) Preset up to 3 samples on the rotor for STAT beforehand, see section

6.4.2. Positions 16 to 18 will be used on the rotor.

2) Or make no reservations of any special position on the rotor. The
system will position STAT tests automatically into the next available rotor
positions. If all sample rotor positions are occupied by routine
measurements and no STAT positions have been reserved you have to
clear the complete joblist first.

NOTE

We recommend to pre-set 1-3 positions for emergency measurements
to run STAT tests during routine operation.

Follow section 6.1.11 Interrupt a current run (User interrupt) run if you are in
routine operation and want to run a STAT test. All routine tests which have
not been worked off will remain in the joblist and will be measured after the
STAT test.

Follow the instructions for STAT measurements:

• Use the arrow keys (</>) to select <3 STAT MANAGEMENT> in the MAIN
MENU.

MAIN MENU:
< 3 STAT MANAGEMENT >

• Press ENTER to confirm.

The following display appears:

STAT MANAGEMENT:
Edit Ins Prnt Start

If you are in routine operation you can go directly into this method by
pressing F4 = STAT (see section 6.1.11 Interrupt a current run (User
interrupt). Before entering the STAT joblist the running measurements from
routine operation will be completed. Using the function keys F1 - F4 select
the desired action from the table:

Function key Order Meaning

F1 Edit If there is a joblist from routine operation you

can transfer patients from this list into the
STAT job list. Further you can edit or change
any existing STAT joblist.

F2 Ins To enter new emergency patients into the

STAT joblist. The routine joblist will not be
influenced, if free positions are available.

F3 Prnt To print the STAT joblist.

F4 Start To begin STAT measurements.

CoaLAB 6000 – Operators Manual 1.8 Page 75

Operation

Example F1 = Edit

• Change from ROUTINE into STAT operation:

• Press F1 for editing.

The following display appears:

01 S-ID: 30001
pt aptt fbg all

The first patient of your ROUTINE joblist will be displayed and can be
transferred into the STAT joblist. With the function keys F1-F4 you can
select the methods. The selected test will be displayed in big letters. With
the arrow keys up and down the next sample can be called for or skipped
over.

The patient samples that have been transferred from ROUTINE into the
STAT joblist will be deleted in the ROUTINE list. All patient samples which
have not been transferred into the STAT list will remain in the ROUTINE list
for later measurements.

• Press ENTER to confirm.

The following display appears:

STAT MANAGEMENT:
Edit Ins Prnt Start

If you want to print the STAT joblist press F3 = print. If you want to start
STAT measurements press F4 = Start. For further entry of new STAT
patients press F2 = Ins and follow the example below.

Example F2 = Insert

Enter new patient samples into the STAT joblist:

• Press F2 for inserting.

The following display appears:

05 S-ID: 30005
pt aptt fbg all

The system will extend the next available sample rotor position
automatically so that you can place the new primary tube. Press F1-F4 to
select the methods. If you want to change the patient ID press the left arrow
key (<) until the displayed ID is deleted. Now you can enter another ID with
the number keys.

• Press ENTER to confirm.

The following display appears:

06 S-ID: 30006
pt aptt fbg all

If you want to insert further patient samples into the STAT joblist follow the
steps as mentioned before. Press ESC to leave this menu.

CoaLAB 6000 – Operators Manual 1.8 Page 76

Operation

The following display appears:

STAT MANAGEMENT:
Edit Ins Prnt Start

Example F3 = Prnt

Print STAT joblist:

• Press F3 for printing.

The following display appears:

Printing joblist

The STAT job list will be printed automatically on the internal printer.

After the print the following message will be displayed:

STAT MANAGEMENT:
Edit Ins Prnt Start

Example of the printed STAT joblist:

C2820501 V1.04 04/22/02

07.05.2002 11:50

STAT Joblist
T1 = PT PT
T2 = APTT APTT
T3 = FBG Fibrinogen

No Sample-ID T1 T2 T3
1 30001 x x x
2 30002 x x x
3 30005 x x x

-------------------------

Example F4 = Start

Start the STAT joblist:

• Press F4 for start.

The following display appears:

Prepare measure…

The following display appears:

INFO
Check waste box

CoaLAB 6000 – Operators Manual 1.8 Page 77

Operation

‘Check waste box’ will be displayed for a short moment every time a job

list has been entered. If used cuvette racks are still in the waste box we
recommend to empty it.

The following display appears:

Insert cuvette bar
and close cover

The system calculates from the joblist automatically how many cuvette
racks will be needed. The sample rotor extends the next position
automatically to load a cuvette rack. This procedure will be repeated until all
cuvette racks necessary for the measurements have been positioned in the
sample rotor.

• Press ENTER to confirm.

The sample rotor will extend the next available reagent position
automatically. Insert the adapter ring and the reagent vial for the selected
method. Remember to use predefined reagent vial types only (see Chapter

6.2.2.2). If reagents are already loaded the analyzer will check reagent

volume and starts measurement automatically.

Test will not function without any reagents.

The necessary reagent volume will be displayed.

1: washer:
LOAD 0.5ml skip

If the reagent vial is in the sample rotor you can either select

F1 (load) or = the reagent has been loaded and confirmed.
ENTER

F4 (skip) = the reagent has not been loaded no entry confirmed

continue to next reagent.

• Press F1 or ENTER in this case to confirm.

The following display appears:

2: Buffer 9999992
LOAD 0.4ml skip

• The sample rotor position will be extended automatically. Load Buffer into
the sample rotor and confirm with F1.

If you want to skip over this position and not load Buffer press F4.

The following display appears:

3: FBG 8888
LOAD 0.3ml skip

• The sample rotor position will be extended automatically. Load

Fibrinogen into the sample rotor and confirm with F1.

If you want to skip over this position and not load Fibrinogen press F4.

CoaLAB 6000 – Operators Manual 1.8 Page 78

Operation

The following display appears:

4: CaCl2 12345678
LOAD 0.3ml skip

• The sample rotor position will be extended automatically. Load Calcium
Chloride into the sample rotor and confirm with F1.

If you want to skip over this position and not load Calcium Chloride press

F4.

The following display appears:

5: aPTT 999999995
LOAD 0.3ml skip

• The sample rotor position will be extended automatically. Load aPTT
reagent into the sample rotor and confirm with F1.

If you want to skip over this position and not load aPTT reagent press F4.

The following display appears:

6: PT 123456789
LOAD 0.3ml skip

• The sample rotor position will be extended automatically. Load PT reagent
into the sample rotor and confirm with F1.

If you want to skip over this position and not load PT reagent press F4.

The following display appears:

Prepare measure…

After having placed the last reagent into the sample rotor of the system will
check the reagents automatically. Especially the volume will be checked. If
reagents are missing or the volume is insufficient the following message will
be displayed:

6: PT 123456789
Only x.x of x.x ml

You can load the missing reagent now.

• Press ENTER to confirm.

The following display appears:

Pipettor M-Block

37.4 38.4

The message Pipettor / Tubing gives a short status on the temperature of
the measuring block and the pipettor. If the temperature is not correct, i.e.
37°C or 38°C, this message will be displayed until the temperature has
been reached.

CoaLAB 6000 – Operators Manual 1.8 Page 79

Operation

NOTE

The following display appears:

18 Samples
No Results available

The system starts measuring. The message displayed shows how many
samples still have to be worked off. The results will be printed automatically
on the internal printer.

If results are not available yet the message ‘No results available’ will be
displayed.

You can interrupt the STAT measurement by pressing the ESC-key.
Follow the instructions as per Chapter 6.1.11 Interrupt a current run
(User interrupt).

After the measurement has been completed a beep will be heard and the
following message will be displayed:

STATUS
Normal Termination

Example for a result print:

C2820501 V1.04 04/22/02

07.05.2002 11:50
Analyzer Mode : Batch
Research Mode : Off

**** STAT MANAGEMENT ****
Test PT 07.05.2002 15:10
No Sample-ID Result Cuv.
1 30001 online 01ab
PT time1 11.7 sec
PT time2 11.7 sec
PT mean 11.7 sec
PT INR 1.03
PT conc 93.75 %

Test aPTT 07.05.2002 15:17
No Sample-ID Result Cuv.
1 30001 online 01ef
aPTT time1 35.3 sec
aPTT time2 35.7 sec
aPTT mean 35.5 sec
aPTT Ratio 1.77

-------------------------­**END STAT MEAUREMENT**

Finished 07.05.2002 15:45
State: Normal Termination

CoaLAB 6000 – Operators Manual 1.8 Page 80

Operation

6.4 General Setting (SETUP
MENU)

Basic settings of the system

Before working with the system in routine operation several basic settings
must be entered. The following default parameters have been preset by the
manufacturer:

Standard settings of the
system

System parameters

Name Standard setting

Primary tube Sample Cup
Reserved STAT positions 0
Analyzer mode Batch
PIN code 11111
Language English
Printer mode list
Beeper Setup long

Reagent or Method Parameters:

Name Standard setting of reagent or method parameters

Determination double double double ­Variation coefficient 5% 5% 10% ­Sample volume 50 µl 50 µl 100 µl -

Reagent 1 / Diluent - APTT Bufer Washer

Reagent volume - 50 µl 1 + 9.0 ­Reagent vial type - 4 ml 4 ml 10 ml
Reagent stir function - inactive - ­Adapter ring - blue blue White
Teflon stir bar - no no No
Incubation time 70 sec 180 sec 90 sec -

Start reagent PT CaCl2 FBG -

Reagent volume 100 µl 50 µl 50 µl ­Reagent vial type 4 ml 4 ml 4 ml ­Reagent stir function active inactive inactive ­Adapter ring Blue blue blue ­Teflon stir bar Yes no yes ­Airgap volume 5 µl 5 µl 5 µl ­Waste volume 5 µl 5 µl 5 µl ­Max. meas. time 80 sec 120 sec 120 sec ­Normal range 7.0-13.0 sec 25-45 sec 150-400 mg/dl -

1. conversion none none regression -

dep. on lot. - dep. on lot. ­Extrapolation range - - 45-1000 mg/dl -

2. conversion none none none -

100% dep. on lot - - ­ISI dep. on lot - - -

PT aPTT Fibrinogen Washing Solution

CoaLAB 6000 – Operators Manual 1.8 Page 81

Operation

NOTE

6.4.1 Define Primary Tubes

NOTE

NOTE

If you do not wish to change any of the manufacturer’s preset default
settings continue with ROUTINE operation, see section 6.1.

If you want to change any of these settings follow the steps below:

Before entering a joblist in routine operation the primary tubes can be
selected. The system has a recommended number of different types. If you
use the Sample cup which is preset by the manufacturer you can ignore the
following instructions.

To secure perfect operation of the system only recommended primary
tubes should be used.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN
MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

Before getting access to the SETUP MENU a PIN code has to be
entered with the number keys. The preset code is 11111. You can
change this code by following the instructions as per chapter 6.4.6 Set
PIN Code. Remember to write this code down and keep it at a safe
place, accessible to authorised users only.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <1 Primary Tube> is displayed in the
SETUP MENU.

The following display appears:

SETUP MENU:
< 1 Primary Tube >

• Press ENTER to confirm.

The following display appears:

Primary Tube:
< 1 Sample Cup >

The displayed primary tube is the type entered last. By pressing the arrow
keys (</>) you can select another type.

CoaLAB 6000 – Operators Manual 1.8 Page 82

Operation

• Press ENTER to confirm.

The following list will give an overview of the primary tubes which can be
used on the system.

NOTE

Never go below the recommended dead volume or results may be
affected. Only one type can be used at a time. A mixture of tubes
may damage the pipettor.

Pos No. Primary Tube Dead volume Max. Volume Manufacturer

1 1 Sample Cup 150 µl 4.000 µl LABiTec
2 2 Vacutainer - 4.500 µl Beckton & Dickinson
3 3 Monovette - 3.000 µl Sarstedt

The following display appears:

SETUP MENU:
< 1 Primary Tube >

• Press ESC to get back into the MAIN MENU.

6.4.2 Define STAT positions in
the sample rotor

Follow the instructions to define or reserve STAT positions in the sample
rotor. A maximum of 3 positions may be reserved for STAT samples. If no
STAT positions have been reserved, the instrument will use the next free
position available.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN
MENU.

• Press ENTER to confirm.

The following display appears:

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <2 No of STAT pos.> is displayed in the

The following display appears:

• Press ENTER to confirm.

MAIN MENU:
< 4 SETUP Menu >

SETUP MENU:
PIN

SETUP MENU.

SETUP MENU:
< 2 No of STAT pos >

CoaLAB 6000 – Operators Manual 1.8 Page 83

Operation

6.4.3 Date and Time

The following display appears:

No of STAT pos
No of STAT pos: 0

The displayed number of reserved STAT positions is the number entered
last. By pressing the number keys (0-3) you can enter the selected number
of STAT positions.

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
< 2 No of STAT pos >

• Press ESC to get back into the MAIN MENU.

As the date and time are printed at the top of each run’s results, it is
important that they are entered accurately.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN
MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <3 Date / Time> is displayed in the
SETUP MENU.

The following display appears:

SETUP MENU:
< 3 Date / Time >

• Press ENTER to confirm.

The following display appears:

Date / Time:

17.04.2002 16:34:58

CoaLAB 6000 – Operators Manual 1.8 Page 84

Operation

• Use the number keys to enter the date and time. With the left arrow key
(<) you can delete or overwrite.

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
< 3 Date / Time >

• Press ESC to get back into the MAIN MENU.

6.4.4 Printer Setup

This section describes the printer configurations. You can set the operation
mode of the analyzer internal printer according to your requirements.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN

MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <4 Printer setup> is displayed in the
SETUP MENU.

The following display appears:

SETUP MENU:
< 4 Printer setup >

• Press ENTER to confirm.

Printer setup:
AUTO list on off
F1 F2 F3 F4

Using the function keys F1-F4, select the desired operation mode from the
table below. The activated operation mode will be displayed in bold letters.

NOTE

Please note, by using the function key F4 = off in general no print
out will be done by the internal printer.

CoaLAB 6000 – Operators Manual 1.8 Page 85

Operation

Function
key

F1 auto All printing orders will be transmitted to the internal printer.

F2 list All printing orders will be transmitted to the internal printer.

F3 on No online print of results. To print results, activate ‘print

F4 OFF Turns the internal printed off. No printing will occur.

6.4.5 Beeper Setup

Message

Meaning

displayed

The measurement results will be printed test oriented
(online), that means according to the availability of results.

The measurement results will be printed patient oriented,
that means once all results per patient are available.

results’ see section 6.1.12 Print results, send results to
HOST. All other printing orders will be executed.

The following display appears:

SETUP MENU:
< 4 Printer setup >

• Press ESC to get back into the MAIN MENU.

This section allows the user to set the length of the signals when a status
massage or error has occurred or testing is complete. See below the 3
basic signal tones you can choose from.

1.) Long, followed by repeatedly short tones warns of future action
necessary and can be switched off by acknowledging the action and
confirming it with the ENTER key. Same tones will also sound by
pressing a key on the keyboard to acoustically confirm the entry.

2.) Short, followed by a one-time signal tone, warns that the system
waits for the next command to complete the action and remains in this
position until the operator gives the next command and confirm it with
the ENTER key. Same tones will also sound by pressing a key on the
keyboard to acoustically confirm the entry.

3.) Off, no signal tones will be carried-out.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN
MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

CoaLAB 6000 – Operators Manual 1.8 Page 86

Operation

• Press the arrow keys (</>) until < 5 Beeper Setup > is displayed in the
SETUP MENU.

SETUP MENU:
< 5 Beeper setup >

• Press ENTER to confirm.

The following display appears:

Beeper setup:
long short off
F1 F2 F4

With the function keys F1 + F2 you can select the beeper mode. F4 will
deactivate the beeper. The activated mode will be displayed in big letters.

The following display appears:

SETUP MENU:
< 5 Beeper setup >

• Press ESC to get back into the MAIN MENU.

6.4.6 Set PIN Code

In the following we have explained how to change the PIN code of the
system. The PIN is preset to 11111 by the manufacturer and will be active
until modified by the user. The PIN code will be asked for before entering
the TEST MENU and the SETUP MENU.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN

MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <6 Modify PIN> is displayed in the

SETUP MENU.

The following display appears:

SETUP MENU:
< 6 Modify PIN >

• Press ENTER to confirm.

The following display appears:

CoaLAB 6000 – Operators Manual 1.8 Page 87

Operation

6.4.7 Language

Modify PIN
New PIN: 11111

The actual PIN code will be displayed. You can change it with the number
keys. A maximum of 5 numbers can be entered. The PIN code has to be
defined between 1 until 65535. Use the left arrow key (<) if you want to
delete or overwrite your entry.

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
< 6 Modify PIN >

• Press ESC to get back into the MAIN MENU.

Follow the instructions if you want to change the language in the system.
You can select between English and German.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN

MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <7 Language> is displayed in the

SETUP MENU.

The following display appears:

SETUP MENU:
< 7 Language >

• Press ENTER to confirm.

The following display appears:

Select language:
ENG deu end
F1 F2 F4

The activated language will be displayed in big letters. With the function
keys F1 = English and F2 = German you can select the desired language.
If you press F4 = end you will leave this menu without changing anything.

CoaLAB 6000 – Operators Manual 1.8 Page 88

Operation

The following display appears:

SETUP MENU:
< 7 Language >

• Press ESC to get back into the MAIN MENU.

6.4.8 Print of Setup
Parameters

Follow the instructions to print the parameters described in section 6.4
General Setting (SETUP MENU) on the internal printer. Printing the SETUP
parameters provides an overview of the general setup of the system.

• Use the arrow keys (</>) to select <4 SETUP MENU> in the MAIN
MENU.

MAIN MENU:
< 4 SETUP Menu >

• Press ENTER to confirm.

The following display appears:

SETUP MENU:
PIN

• Enter the PIN code with the number keys (default= 11111).

• Press the arrow keys (</>) until <8 Print Setup> is displayed in the
SETUP MENU.

SETUP MENU:
< 8 Print Setup >

• Press ENTER to confirm.

The following display appears:

Print Setup

The SETUP parameters will be printed on the internal printer.

The following display appears:

SETUP MENU:
< 8 Print Setup >

• Press ESC to get back into the MAIN MENU.

CoaLAB 6000 – Operators Manual 1.8 Page 89

Operation

6.5 Removing cuvette bars
from the system

In the following chapter we have described how to remove cuvette bars
from the measuring block.

• Use the arrow keys (</>) to select <5 UTILITY MENU> in the MAIN
MENU.

MAIN MENU
< 5 UTILITY MENU >

• Press ENTER to confirm.

The following display appears:

UTILITY MENU:
< 1 Init Instrument >

• Press ENTER to confirm the message.

The following display appears:

Init Instrument
Init ... (ESC=Stop)

The motors and the diluter will be initialised. During this phase the cuvette
racks in the measuring block will be moved one position to the right and will
be ejected from the measuring block.

The following display appears:

Init Instrument
Flush ... (ESC=Stop)

Then the liquid system will be initialised. Liquids are pumped into the
tubing’s.

• Press ESC if you want to finish initialisation.

The following display appears:

UTILITY MENU:
< 1 Init Instrument >

• Press ESC to get back into the MAIN MENU.

6.6 Switch OFF the system

Prior to switching off the system make sure the system is cleaned and
disinfected from all residues of reagent and sample material inside the liquid
system as well as from the outer side of the analyzer. Depending on how
long you would like to shut down the system it is necessary to follow
different wash/flush cycles to avoid any residues of reagents/samples will
remain in the liquid system.

To clean/disinfect the system follow the instructions as described in sections

6.1.2 Rinsing with distilled water, 6.1.3 Disinfection of waste tubing

(Terralin), change of FW-Filter or 6.1.4 Rinsing with Washing Solution.

CoaLAB 6000 – Operators Manual 1.8 Page 90

Operation

In case of a long term shut down it is recommended to also dry the system
completely. Follow the instructions in section 8.8 Packing of the system,
preparation of transport as described under 3. - 6. This procedure should be
done if the shut down time exceeds 4 weeks.

Remove all reagents must be removed from the sample/reagent rotor.
Follow the instructions in section 6.1.5 Loading and unloading reagents.

Remove all samples/cups from the sample/reagent rotor positions 1-18 by
erasing the joblist. Follow the instructions described in section 6.1.6 Delete
joblist, delete samples. Make sure all results of the current joblist are printed
out prior to erasing the joblist. Once the joblist has been deleted no results
will be available anymore.

Make sure that finally the instrument is free of cuvette bars, vials, cups and
adapter rings.

Now the system can be switched OFF by setting the power switch to the
position O = ON.

CoaLAB 6000 – Operators Manual 1.8 Page 91

Operation

7 Failures

Status messages:

Application errors:

Non-fatal errors:

Fatal errors:

Possible error messages, their causes and trouble shooting are described in
this section. These failures or status messages can be displayed as well as
printed. The messages will be differentiated according to the following
scheme:

System messages for the general information of the user. These are no
errors/failures.

Failures/errors to be corrected by the user.

Functional system errors to be corrected by the user.

Errors to be corrected by the technical customer service only. Contact your
authorised distributor or the manufacturer.

CoaLAB 6000 – Operators Manual 1.8 Page 92

Operation

7.1 Status Messages

Message

Module:<name> (<Adr>)
Timeout Req = <ID>

Example

Module: Control (07)
Timeout Req = 43

STATE
Out of system liquid

STATE
Waste bottle full

STATE
System liquid error

STATE
Missing reagent

STATE
User Interrupt

Cause Corrections

Message has no influence on
functions of the system.

Message only displayed and
printed out.

No influence on measurements.

The dist. water container is empty Fill water into the container see

chapter 6.1.13.

The waste water container is full. Empty the container see chapter

6.1.14.

The dist. water container is empty
and/or the waste water container

Fill dist. water container and/or

empty waste water container.
is full.
A reagent was not loaded or
positioned in the rotor

Measurement interrupted by the

Reload or position missing

reagent, see chapter 6.1.5.

See Chapter 6.1.11.
user.

STATE

A routine run was completed. Message for the user.

Normal Termination

INFO
No Space for new Sample

INFO
No samples loaded

More than 18 possible samples
were to be loaded
or
no further positions available due
to STAT positions reserved.
No joblist available, i.e. no
samples have been loaded.

Further samples must be

measured later.

Reserved STAT positions could

be reduced, see chapter 6.4.2.

Work out joblist and load

samples, see chapter 6.1.7

ERROR
Test volume too big

The permissible volume was
exceeded.

Check volume settings for sample

and reagent volume.

(Test volume 125 µl-250 µl)

ERROR
Test volume too low

The volume is too low. Check volume settings for sample

and reagent volume.

(Test volume 125 µl-250 µl).

No print out Printer is not active Switch on printer, refer to chapter

6.4.4Printer Setup

CoaLAB 6000 – Operators Manual 1.8 Page 93

Operation

7.2 Application Errors

Message

Module: Control (07)
Move Error Motor 0

Module: Control (07)
Move Error Motor 3

Module: Diluter (03)
Move Error Motor 0

ERROR
No chip card found

ERROR
Test already loaded

ERROR
Too many reagents

ERROR
Not enough sample

ERROR
Not enough reagent

ERROR
Incubation warning

ERROR
pipettor not conn.

fresh water sensor
No sensor 1 found

Waste water sensor
No sensor 2 found

ERROR
Level Sensor Error

STATE
Wash station full

STATE
Out of washer liquid

Cause Corrections

Cuvette rack or sample cup was
not positioned properly.

Cuvette rack in the rotor or in the
measuring block is not positioned
properly.

The syringe is not mounted
properly to the diluter or the space
below the syringe is too small.
A ChipCARD was not inserted
properly or not at all.

The selected test on the Chip­CARD had already been loaded.

The number of reagent positions
does not correspond to the
number of loaded methods.
Not enough samples for pipetting
or a wrong primary tube used.

Not enough reagents available or
a wrong reagent vial used.

The incubation time was
exceeded.

Flat cable to pipettor is not
connected properly or cable has
been damaged.
Fresh Water Sensor is not
connected.

Waste Water Sensor is not
connected.

Liquid between Level Sensor and
needle at the pipettor

Waste Water Tube is bended or
not connected to analyzer

Too less washing solution Refill washing solution to rotor

Check correct position of racks

and/or sample cups. Does this

error appear again, see fatal

errors!

Either remove rack with Init

Instrument (Chapter 6.5) or switch

Instrument off and remove cuvette

rack manually. Does this error

appear again, see fatal errors!

Check correct mounting of

syringes (Chapter 5.1.4.1) or clear

space below

Re-insert ChipCARD, repeat

procedure (Chapter 6.2.3).

No corrections necessary.

A method must be deleted

(Chapter 6.2.6).

Refill sample or replace primary

tube (Chapter 6.4.1).

Refill reagent or replace reagent

vial.

Check method parameters

regarding incubation times,

maximum measuring times and

activation times (reagent 3).

Check correct connection of

cable. Has cable been damaged

contact customer service.

Switch Instrument off. Connect

fresh water sensor. Re-start

system.

Switch Instrument off. Connect

waste water sensor. Re-start

system.

Remove liquid carefully, press

ENTER to confirm.

Check correct connection of tube;

refer to Fatal errors if problem still

exists!

position R1.

CoaLAB 6000 – Operators Manual 1.8 Page 94

Operation

7.3 Non-Fatal Errors

Message

ERROR
Write protected card

ERROR
No valid test card

ERROR
no writing

Module: <Name> (<Adr>)
ParBlock Error <Nr>

Example:

Module: Meas1 (0A)
ParBlock Error2

break bot lim

break top lim Sample is very light and cannot

Too dark Sample is too dark and cannot be

break drift The measuring signal could not

break noise strong noise during sample

break jump signal peak during measure

No clotting found No clotting was found during

Time Range error The permissible deviation of CV’s

Conc. Overflow The extrapolation range was

Conc. Underflow The extrapolation range was not

Normal Range The result is out of the normal

Cause Corrections

A protected ChipCARD was used
to save a method.

Repeat procedure with a non-

protected ChipCARD.

The ChipCARD is invalid. Repeat procedure with a valid

ChipCARD.

ChipCARD or reader is defective.
Chip CARD was insert wrong.

Use new ChipCARD or insert

correctly. Otherwise contact

customer service.
Check sum error in the memory. The system loads all default

parameters automatically. Check

method and instrument data.

Some parameters might have to

be redefined. See Chapter 6.2.1,

6.2.2, 6.4

Sample is too turbid, too dark and
cannot be measured.

Prepare new test and repeat

measurement. If this message

appears often contact the

customer service.

Prepare new test and repeat
be measured.

measurement. If this message

appears often contact customer

service.

Prepare new test and repeat
measured.

measurement. If this message

appears frequently contact the

customer service.

Check reagent and tubes for
be adjusted or is unsteady

particles.

Check for air bubbles or particles.
adjustment.

Check sample for air bubbles.

Check the max meas time. Dilute
maximum measuring time.

sample and repeat measurement.

Repeat measurement.
was exceeded.

Check reference curve and repeat
exceeded during conversion.

measurement. This message

does not necessarily mean a

wrong result.

Check reference curve and repeat
reached.

measurement. This message

does not necessarily mean a

wrong result.

Check normal ranges unless it is
range.

sure that the patient really is

outside the normal ranges.

CoaLAB 6000 – Operators Manual 1.8 Page 95

Operation

7.4 Fatal Errors

Message

Module: Control (07)
Move Error Motor 1

Module: Control (07)
Move Error Motor 2

Module: Diluter (03)
Move Error Motor 1

Module: <Name> (<Adr>)
Range Error Par <Nr>

Example:

Module: Meas1 (0A)
Range Error Par 1

mixer error One or more stir motors in the

Module: <Name>(<Adr>)
Syntax Error Par <Nr>

Example:

Module: Control (07)
Sytax Error 0

Module: <Name>(<Adr>)
Com. Error <Nr>

Example:

Module: Control (07)
Com. Error 0

Module: <Name>(<Adr>)
Command Error <Nr>

Example:

Module: Meas1 (0A)
Command Error 2

Module: <Name> (<Adr>)
Unknown Error

Example:

Module: Control (07)
Unknown Error

STATE
Wash station full

Temperature error The temperature is not stable

Cause Corrections

X-motor is blocked and/or does
not reach its normal value. X­motor is not connected properly or
can not reach its home-position.
Z-motor is blocked and/or does
not reach its normal value. Z­motor is not connected properly or
can not reach its home-position.
Functional failure at the diluter
valve.

Functional failure in the module
communication.

measuring cell are defective.

Functional failure in the module
communication.

Functional failure in the module
communication.

Functional failure in the module
communication.

Functional failure in the module
communication.

Waste water pump defective. Contact customer service, first

during the measurement.

Check whether the pipettor can

move freely from right to left

Otherwise contact customer

service.

Check whether the pipettor can

move freely up and down.

Otherwise contact customer

service.

Contact customer service.

Contact customer service.

Contact customer service.

Contact customer service.

Contact customer service.

Contact customer service.

Contact customer service.

refer to application errors!

Contact customer service.

CoaLAB 6000 – Operators Manual 1.8 Page 96

Operation

Message

Cause Corrections

Parameter error

Severe soft- or hardware failure. Contact customer service.

System stopped!

<Name>(<Adr>) not found

Severe soft- or hardware failure. Contact customer service.

System stopped!

Example:

Dilutor (03) not found
System stopped!

Module: Control (07)
Move Error Motor 0

Rotor motor does not reach
home-position or is not connected

Contact customer service, or see

application errors!
properly.

Module: Control (07)
Move Error Motor 3

M-Block motor does not reach
home-position or is not connected

Contact customer service, or see

application errors!
properly. Light barrier is
damaged.

7.5 Change fuses

Fuses may need to be changed if the system does not operate even though
it is properly connected.

Two fuses are required to operate the system:

230 VAC (Europe) 115 VAC (USA)

4 amp/250 V time lag
according to: IEC 60127-2/III

4 amp/125 V time lag
according to: UL 248-14

Proceed as follows to change fuses:

• Switch off system

• Disconnect system from power supply and remove cable.

• Carefully lift the housing cover open, pull 1 (see figure 16).

• A red fuse carrier (= voltage selector) becomes visible.

• Place the screwdriver in the upper slot of the fuse carrier, pull 2 (see
figure 16) and drive carrier out of the housing.

• Inspect fuses to see if wires have melted and replace accordingly.

• Insert fuse carrier into housing.

• Close cover of the fuse carrier.

• Reconnect the system to power supply and check proper operation.

Contact the authorised customer service if the exchange of fuses has been
unsuccessful.

CoaLAB 6000 – Operators Manual 1.8 Page 97