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
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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
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nc.
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weiss
1111
schwarz
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a3a2
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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
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