Labitec CoaDATA 501 Operator's Manual
Operators Manual
CoaDATA 501
For in-vitro diagnostic use only!
Order
Bedienungsanleitung CoaDATA 501 Order No.: 30.000.1613 German Version
Operators Manual CoaDATA 501 Order No.: 30.000.1614 English Version
Revision History
Version Manual
Date
(mm/dd/yy)
Changes
Software-Version
Print
1.0 June 2001 2.06 OM-CD501-2.PM6/PS
1.1 March 2003 2.06 OM-CD501a.p65
1.2 April 2003 2.10 OM-CD501b.p65
2.0 12/19/03 2.11 OM_CD501.doc
2.1 04/22/04 Corrections (2.11)
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.)
Contents
CoaDATA 501 –Operators Manual 2.1 Page 1
Contents
1 INTRODUCTION .................................................................3
1.1 Application.................................................................................... 3
1.2 Instrument Description................................................................ 3
1.3 Installation .................................................................................... 6
1.3.1 Connect an external printer............................................... 6
1.4 Measuring Principle.....................................................................7
1.5 Reagents ....................................................................................... 8
2 OPERATION........................................................................ 9
2.1 Steps for Instrument Operation.................................................. 9
2.1.1 Turn on analyzer ............................................................... 9
2.1.2 STANDBY ......................................................................... 10
2.1.3 How to measure................................................................11
2.1.4 How to change methods ................................................... 13
2.1.5 How to change methods with a ChipCARD ...................... 15
2.2 Method Parameterization ............................................................ 16
2.2.1 PT-parameterization ......................................................... 16
2.2.2 aPTT - parameterization ................................................... 22
2.2.3 Fibrinogen 1 [g/l] - parameterization ................................. 25
2.2.4 Fibrinogen 2 [mg/dl] - parameterization ............................ 28
2.2.5 Thrombin time parameterization ....................................... 28
2.2.6 Intrinsic Factor parameterization....................................... 28
2.2.7 Extrinsic Factor – parameterization ..................................28
2.2.8 Utilities............................................................................... 29
2.2.8.1 Menu printer.............................................................. 29
2.2.8.2 Menu computer............................................................ 30
2.2.8.3 Menu beeper ................................................................ 30
2.2.8.4 Menu clock .................................................................. 30
2.2.8.5 Menu calibrate temp .............................................. 31
2.2.8.6 Menu secret number................................................. 32
2.2.8.7 Menu cuvette test ................................................... 32
2.3 Printer............................................................................................ 33
2.3.1 Sample print-outs PT and calibration................................ 34
2.4 Errors ............................................................................................ 37
2.4.1 Application errors .............................................................. 37
2.4.2 Error Messages................................................................. 38
2.4.3 Errors during operation ..................................................... 39
2.4.4 Warnings ........................................................................... 39
2.4.5 How to change fuses ........................................................ 39
3 SOFTWARE ........................................................................40
3.1 Software overview ....................................................................... 41
3.2 Flow Chart of different application methods ............................ 42
3.3 Method Parameters...................................................................... 43
4 SAFETY ISSUES................................................................. 44
4.1 Hazard and Precautions .............................................................. 44
4.2 Maintenance and Hygiene........................................................... 46
4.2.1 Disposal of analyzer.......................................................... 46
Contents
CoaDATA 501 – Operators Manual 2.1 Page 2
5 APPENDIX .......................................................................... 47
5.1 Disposables .................................................................................. 47
5.2 Materials Supplied .......................................................................47
5.3 Technical Data.............................................................................. 48
5.4 Safety Specifications................................................................... 49
5.5 Mathematics .................................................................................50
5.6 Terminology.................................................................................. 52
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 3
1 Introduction
1.1 Application
The instrument type CoaDATA 501 (in the following titled as analyzer) as
described in this manual is an opto-mechanical coagulation analyzer which
applies the turbodensitometric measuring principle.
All routine coagulometric clotting tests such as Prothrombin time, activated
and partial Thromboplastin time, Fibrinogen, and single factor assays can
be performed with these types of instrument.
For in-vitro diagnostic use only!
1.2 Instrument Description
The analyzer is constructed in modular units. A liquid crystal display with
one row and 8 characters has been integrated for visual communication.
The arrow keys <-- / --> allow the operator to select the next step in the
menu. The numbers are for the entry of method parameters.
The Enter key is used to confirm an entry or a selection. The parameter
memory is accessed with the Mode-key. Any procedure can be cancelled or
stopped with the Esc-key.
The measuring channel is integrated into the 37.4°C incubation block with 1
position for reagent bottle and 4 positions for cuvettes.
Immediately after the analyzer has been switched on, an adjustment
provides cuvette detection. According to the instructions on the display
cuvette in or cuvette out, place a cuvette into the measuring channel or
remove a cuvette from the measuring channel.
The next step during a run is always shown in the display.
A measurement is automatically started by adding the reagent to a sample
cuvette.
Results can be printed via on optional, external printer or can be read from
the display.
At the left side of the analyzer is the connector for the external power
adapter located. The external power adapter can be connected to the mains
with a voltage range from 100V - 240V, 47 - 63Hz.
Via the connection to the main voltage the analyzer is automatically
switched on or off.
For data output an RS 232 C 6-pin interface is also located on the left side
of the analyzer.
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 4
Analyzer
Name plate (underneath)
ChipCARD Reader
at front side
Display 1 line, 8 Characters
Power and printer plugs
leftward
Membrane keypad with keys:
0 - 9, Mode, Enter, ESC, <--, -->.
Incubation block 37°C:
- 4 positions for cuvettes
T = position for temp. adjustment
- 1 position for reagent bottle
- 1 measuring channel with light
protection caps designed for
Thrombi-Tips
Membrane keypad with keys:
Reset and Start.
Figure 1 Analyzer
Mode
Esc
0
123
456
789
Enter
Reset
Start
Power connector
Printer connector
T
Made in Germany
Type: CoaDATA 501
Input: 12
VDC~9.6VA Fuse: 0,8AT
: XXXXXX
IVD
SN
A 00 0 0000
P-ID CD500-96.0000
- +
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 5
Description of keys
Figure 2 Membrane keypad
Arrow-key left, right
<- - select display to the left
-> - select display to the right, set decimal point
Esc-key
Switch from measuring to STANDBY
Exit a submenu
Enter-key
Confirm selection, advance printer paper
Number-keys
Enter parameters
0-key
A print-out of the respective parameters for the selected method is
generated by pressing 0 during measuring.
Mode-key
1. Calibration
2. Menu selection, analyzer settings, and method parameterization
3. Exit a menu and save entered or modified data.
Start-key: manual testing
- Start sample incubation timer
- Sample adjustment
- Manual test start
- Manual test stop
Reset-Key, reset testing,
Break of run, adjustment of sample
Mode
Esc
0
123
456
789
Enter
Reset
Start
Esc
Ente
r
123
Mode
Start
Reset
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 6
1.3 Installation
Remove the analyzer from its packaging and verify that the accessories kit
is complete. Please notify your distributor immediately in the event that the
shipment was incomplete. Refer also to Materials Supplied in chapter 5.2
Proceed as follows to install the analyzer:
• Prior to installation of the analyzer read the instructions under Hazard and
Precautions in chapter 4.1.
• Place the analyzer in a position that it is not exposed to excess humidity,
any explosive gases, or magnetic influences.
• Connect the power adapter between the analyzer and a power supply
(100V - 240V) free from interferences by large power users such as
elevators and centrifuges.
• Use only the included original AC power adapter.
• Use only original cuvettes and stir bars which will assure proper operation
of the instrument.
Switch on CoaDATA 501
• Connect the external power adapter with the analyzer
.
• Connect the external power adapter with the mains; automatically the
analyzer is switched on.
Figure 3 Analyzer connections
1.3.1 Connect an external printer
• Connect the data-cable between the analyzer and the printer. Ask your
dealer for recommended printer types.
• Connect the power adapter to the printer (see figure 3). The printer will be
set ON by connecting to the mains.
• Refer to chapter 2.2.8.1 for proper printer setting.
Never operate the printer without paper! Read the instructions
manual from the manufacturer of the printer for further details.
power supply
12 Volt, 0,8 Amp. 9,6VA
Printer
power supply
Mode
Esc
0
123
456
789
Enter
Reset
Start
D
ange
r!
NOTE
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 7
1.4 Measuring Principle
The analyzer operates according to the opto-mechanical measuring
principle. This measuring principle is especially suited for lipemic and/or
icteric colored 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 the intensity of the transmitted light, that is
light increase or decrease, is converted into an electric signal. Hence, even
the most unstable clot can be detected.
The period from adding the start reagent until clot formation is measured. It
then can be converted into the appropriate units (%, ratio, INR, mg/dl, g/l).
Once the start reagent has been added, the measuring channel is adjusted,
that is the lamp intensity automatically adjusts up or down depending on the
turbidity of the test sample. In this process the turbidity of the sample
plasma and the reagent are adjusted.
A mixer is located in the cuvette. During the measuring process the mixer
provides homogeneity of the reagent-plasma medium. At the same time a
small whirl emerges through the mixer 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 constitutes the
basic features of the patented "turbodensitometric measuring principle".
Figure 4 Measuring Principle
Test cuvette
Lamp
Detector
ELECTRONIC
DISPLAY
Stirrer - Motor
perm. magnet
Introduction
CoaDATA 501 – Operators Manual 2.1 Page 8
1.5 Reagents
For proper coagulation analysis we recommend to use reagents, controls
and buffers from well known reagent manufacturers.
Contamination
With the application of different reagents, and here especially reagents
containing thrombin, there is a danger of reagent carry-over.
When adding reagents the light protection cap is exposed to
reagents and hence a point of contamination.
This point of contamination must be cleaned with a suitable thrombin in
activator and a cotton swab after each method change.
Useful hints:
Use the pipettor supplied with the respective pipette tips (Thrombi-Tips).
In General: The analyzer is equipped with light protection caps for
Thrombi-Tips.
To guarantee perfect functioning of the system it is absolutely
necessary to use only the variable Thrombi-Pette and original
Thrombi-Tips. Please understand that warranty shall not apply to
instruments which have problems due to the use of other types of
pipettes or tips.
Make sure no air bubbles are generated during the pipetting process.
Read the reagent packaging insert prior to use and follow the instructions.
Only use original cuvettes and stir bars from the manufacturer which
are subject to strict quality control measures. Please understand
that the use of non-original cuvettes or instruments problems
caused by the use of non-original cuvettes may lead to the warranty
obligation become null and void.
Perform analytical quality controls on a regular basis.
NOTE
NOTE
20-200µl
200
NOTE
Operation
CoaDATA 501 – Operators Manual 2.1 Page 9
2 Operation
2.1 Steps for Instrument Operation
Communication with the analyzer is performed via the liquid crystal display.
We assume that you are familiar with the function of the individual keys as
described in chapter 1.2
2.1.1 Turn on analyzer
• Connect the analyzer power adapter to the mains, automatically it is
switched on.
The following text will appear in the display:
This sign <- informs of a floating text.
<- read param. .. analyzer name V X.xx (C)mm/dd/yy
LAbor GmbH
SELFTEST
Self test
ROM: ok
Testing of ROM
RAM: ok
Testing of RAM
WARM UP
Start of warning up
The changing display will show the
36.5oC
- actual temperature of the measuring block
14:26
- the remaining time of warm up phase.
The analyzer requires approximately 30 minutes to warm up the incubation
block to an operating temperature of 37.4°C (deg).
Use the warm-up phase to load the analyzer with cuvettes and reagents for
testing.
Each cuvette must be equipped with a stir bar.
• Comply with the instructions of the reagent manufacturer.
• Compare the method parameters with those stored in the analyzer.
• For your own safety follow instructions for hygiene.
As soon as the operating temperature has been reached, an adjustment for
automatic cuvette recognition will follow.
<- Remove cuv .. .ette, then press any key.
• Remove the existing cuvette from the measuring channel and close the
light protection caps.
• Press any key (e.g. Enter) for confirmation.
Operation
CoaDATA 501 – Operators Manual 2.1 Page 10
<-auto blanking .. keep channels clear.
The measuring channel will be adjusted for automatic cuvette detection.
(Time requirement: approximately 10 seconds).
No cuvettes must be in the measuring channels when saving the
blank values. Otherwise a wrong value is saved which might lead
to evaluation problems. Protect against external light as this might
have an impact on the blank value as well.
The method used last e.g. PT is selected.
< 1 PT >
Printer
If the printer is set to AUTO in the menu UTILITIES the parameterization of
the selected method as well as the result of the first measurement is printed
as soon as the first measurement is completed.
Additional results will be printed automatically upon completion of a
measurement.
2.1.2 STANDBY
< 1 PT >
The selected method will be displayed.
• Press Enter to access the measuring mode.
• Press Esc to return to STANDBY.
A request for sample incubation will be displayed.
cuv in
If there is no action the next 10 minutes, automatically the display will
change to the STANDBY mode and show the actual temperature.
37.4°C
NOTE
Operation
CoaDATA 501 – Operators Manual 2.1 Page 11
2.1.3 How to measure
One measuring channel is available for measuring.
The following description refers to a double determination of PT. The test
procedure varies depending on single or double determination. For
additional information please refer to chapter "3.2 Flow Chart of different
application methods".
Single/double determinations
The user can switch to single determination prior to or after a
measurement in the method menu <replication> (refer to chapter 2.2.1
PT-parameterization).
Sample incubation
Sample incubation is always performed in the measuring channel!
• Switch to measuring mode.
cuv in 1
• Open the light protection cap.
• Pipette 50 µl citrate plasma in a cuvette.
• Immediately place this cuvette into measuring channel.
• Close the light protection cap.
The analyzer automatically recognizes the cuvette and starts the timer for
sample incubation (timer count down). An acoustic signal indicates 5 sec
remaining incubation time.
incu 47
Timer count down
After sample incubation the measuring channel will be adjusted for sample.
(adjS = adjust Sample).
adj – S1
Sample adjustment
Once the sample has been adjusted the following display 100 ul alternately
GO – S1 appears:
100 ul
Request to add
GO – S1
add start reagent
• Aspirate 100 µl start reagent into the pipettor.
• Place the pipette vertically onto the light protection cap.
• The measurement is automatically started by pipetting the start reagent
into the sample cuvette.
1.2 s
current measurement in [sec]
An acoustic signal indicates the recognition of clotting in a measuring
channel and stops the timer.
t = 12.6 s
clot recognition in [sec]
Operation
CoaDATA 501 – Operators Manual 2.1 Page 12
<-cuv out, then .. press „Reset“
• Open the light protection cap.
• Remove cuvette out of the measuring channel.
• Press Reset-key.
cuv in 2
• Pipette 50 µl citrate plasma in a cuvette.
• Immediately place this cuvette into measuring channel.
• Close the light protection cap.
The analyzer automatically recognizes the cuvette and starts the timer for
sample incubation (timer count down). An acoustic signal indicates 5 sec
remaining incubation time.
incu 52
Timer count down
After sample incubation the measuring channel will be adjusted for sample.
(adjS = adjust Sample).
adj – S2
Sample adjustment
Once the sample has been adjusted the following display 100 ul alternately
GO – S2 appears:
100 ul
Request to add
GO – S1
add start reagent
• Aspirate 100 µl start reagent into the pipettor.
• Place the pipette vertically onto the light protection cap.
• The measurement is automatically started by pipetting the start reagent
into the sample cuvette.
6.9 s
current measurement in [sec]
An acoustic signal indicates the recognition of clotting in a measuring
channel and stops the timer.
<- mean time =
..
12.2 s clot recognition in [sec]
Once the second measured value has been obtained, the mean from the
measured values will be determined and converted into %, ratio, and INR
via the entered calibration curve.
Operation
CoaDATA 501 – Operators Manual 2.1 Page 13
The results will be displayed consecutively for duration of 5 sec. The printer
will automatically print the results. The last message cuv out then press
"Reset" will request the removal of the cuvettes from the measuring
channels.
<- mean time =
..
12.4s Display of mean value in [sec.]
% = 91.0
Display of activity in [%]
INR = 1.05
Display of INR
If ratio is selected under 2nd conversion, ratio will be displayed instead of
INR.
<-cuv out, then
.. press „Reset“
• Open the light protection cap.
• Remove cuvette from measuring channel and confirm by pressing Reset-
key (see chapter 3 Software).
The analyzer is now ready for additional measurements.
cuv in 1
Continue as described for additional measurements.
The timer can be started or stopped manually by pressing the
Start-key.
Refer to function keys in chapter 1.2
2.1.4 How to change methods
Methods can only be changed from STANDBY.
< 1 PT >
STANDBY
• Press Esc to switch to STANDBY.
• Press the right arrow; the next method aPTT is displayed as ready-to-
measure.
• Press the arrow-key --> (arrow-key <-- back); the following methods and
the UTILITIES Menu will be displayed:
< 1 PT >
< 2 aPTT >
< 3 Fib. 1 >
g/l
< 4 Fib. 2 >
mg/dl
< 5 Thrmb >
< 6 Intr. >
< 7 Extr. >
Can be overwritten by ChipCARD!
< UTILIT >
NOTE
Operation
CoaDATA 501 – Operators Manual 2.1 Page 14
• Select the desired method (1-7).
• Press Enter to confirm the method selection.
The new method has been initialized. Incubation of the first samples can
begin.
cuv in 1
Continue as described for PT in chapter 2.1.3
Operation
CoaDATA 501 – Operators Manual 2.1 Page 15
2.1.5 How to change methods with a ChipCARD
Unless a measurement is currently running, a ChipCARD can be inserted
into the adapter at any time for additional methods.
The method parameters will be loaded in memory 7 Extr. Factor. Once
another method is introduced, the method Extr. Factor will be overwritten
and can only be reloaded again using a ChipCARD for Extr. Factor.
The ChipCARD Reader can be accessed through a side opening
underneath the right membrane keypad.
The ChipCARD will be inserted into the ChipCARD reader with the contact
ahead and method description readable.
To load a method:
• Insert the ChipCARD with the selected method into the ChipCARD
Reader the method name and the lot-no. will be displayed automatically.
<-reading card
aPTT
Lot XXXXX
• Press Enter to confirm loading.
remove card
When remove card is displayed, remove the ChipCARD from the
ChipCARD Reader.
<-write param.
.. eter
When writing parameter to internal is displayed, the method parameters
will be stored in method memory 7.
Incubate next samples and continue as described above.
cuv in 1
UTILITIES
The menu Utilities is a group of menus in which instrument settings can be
performed after a "Secret no." (code number) has been entered.
The submenus are as follows: <printer>, <computer>, <beeper>, <clock>
<calibrate temp>, <secret number>, and <cuvette detect.>.
Refer to chapter 2.2.8 Utilities.
aPTT
Lot No.: 123456, Exper. Date 05/05
Insert ChipCARD
Reconstitute reagents according to
manufacturer information
TEST:
- pipette 50ul Plasma in cuvette
- add 50ul aPTT reagent
- 120s incubation time
- start with 50ul CaCl2
Operation
CoaDATA 501 – Operators Manual 2.1 Page 16
2.2 Method Parameterization
2.2.1 PT-parameterization
Method parameters in the analyzer have been preset by the manufacturer.
Prior to performing clotting analysis you must update the method parameter
for the reagent used.
• Set analyzer to STANDBY mode
< 1 PT >
STANDBY
• Press Mode. The analyzer will request you to enter an up to 5 digit long
secret number (factory setting: 11111). For additional information refer to
chapter 2.2.8.6 Menu secret number.
<- secret no.:
..
_________
If the wrong number was entered STANDBY will be displayed. As soon as
the correct number has been entered, the following display will appear:
<1.conv>
Press the arrow key -> to display the following menus: <1. conversion>,
<2. conversion>, <replication>, <measurement> and <cuv remove
detec.>.
Overview PT parameterization:
<1.conversion>
<curve>
input of a 9-point calibration curve under or
<quick>
to enter the 100%-value and slope or
<none>
for no conversion
<2.conversion>
<INR>
input of the ISI-value for INR or
<ratio>
input of normal value for ratio calculation or
<none>
for no conversion
<replication>
select single or double determination
<single>
and the coefficient of variation
<double>
(CV 1-20%).
<measurement>
start reagent volume, reagent lot. no.
and sample incubation time.
<cuv remove detect.>
refer to chapter 3 Software
<ON>
activates the automatic cuvette detection
<OFF>
deactivates the automatic cuvette detection.
(default)
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