Operators Manual: For In-Vitro Diagnostic Use Only!

Operators Manual
CoaDATA 501
For in-vitro diagnostic use only!
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Order
Bedienungsanleitung CoaDATA 501 Order No.: 30.000.1613 German Version
Operators Manual CoaDATA 501 Order No.: 30.000.1614 English Version
Revision History
Date Changes
Version Manual (mm/dd/yy) Print
Software-Version
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
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
CoaDATA 501 –Operators Manual 2.1 Page 1

Contents
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
CoaDATA 501 – Operators Manual 2.1 Page 2

Introduction
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
Analyzer
Made in Germany
Type: CoaDATA 501
SN A 00 0 0000 IVD
P-ID CD500-96.0000 - +
Input: 12VDC~9.6VA Fuse: 0,8AT
: XXXXXX
Name plate (underneath)
ChipCARD Reader at front side

Printer connector
Power connector
Display 1 line, 8 Characters
Power and printer plugs leftward

1 2 3
Mode 4 5 6 0
Esc 7 8 9 Enter 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
T
Membrane keypad with keys:

Reset Start Reset and Start.
Figure 1 Analyzer

Introduction
Description of keys
1 2 3
Mode 4 5 6 0
Esc 7 8 9 Enter
Reset Start
Figure 2 Membrane keypad
Arrow-key left, right

<- - select display to the left
-> - select display to the right, set decimal point
Esc-key
Esc
Switch from measuring to STANDBY
Exit a submenu
Enter Enter-key
Confirm selection, advance printer paper
1 2 3 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
Mode
1. Calibration
2. Menu selection, analyzer settings, and method parameterization
3. Exit a menu and save entered or modified data.
Start Start-key: manual testing

- Start sample incubation timer
- Sample adjustment
- Manual test start
- Manual test stop
Reset Reset-Key, reset testing,

Break of run, adjustment of sample

Introduction
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.
12 Volt, 0,8 Amp. 9,6VA

power supply
power supply
1 2 3
Mode 4 5 6 0
Esc 7 8 9 Enter
Danger!
Printer
Reset Start
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.
NOTE Never operate the printer without paper! Read the instructions
manual from the manufacturer of the printer for further details.

Introduction
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".
Test cuvette
Lamp Detector
perm. magnet
Stirrer - Motor
ELECTRONIC
DISPLAY
Figure 4 Measuring Principle

Introduction
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.
NOTE 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

NOTE 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
200
pipettes or tips.
20-200µl
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
NOTE
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.

Operation
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
<-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

NOTE 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

Operation
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
<-cuv out, then .. press „Reset“
• 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
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“

• 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.
NOTE 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 >

Operation
• 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
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.
aPTT
Lot No.: 123456, Exper. Date 05/05
Insert ChipCARD The method parameters will be loaded in memory 7 Extr. Factor. Once
Reconstitute reagents according to
manufacturer information another method is introduced, the method Extr. Factor will be overwritten
TEST:
- pipette 50ul Plasma in cuvette

and can only be reloaded again using a ChipCARD for Extr. Factor.
- add 50ul aPTT reagent
- 120s incubation time
- start with 50ul CaCl2
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.

Operation
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

<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)

Operation
Enter a calibration curve
1st conversion
curve
• Select 1. conversion and press Enter to confirm selection.
< curve >
A 9-point calibration curve can be entered with this menu.

Calibration curve points that are not to be used must have the entry 0.0 s.
For information of interpolation refer to chapter 5.5 Mathematics. The
system requires two points to be defined but we would recommend a
minimum of 3 points. You can exit the calibration curve menu with Esc if no
entry has been made. Once an entry has been made, all additional
calibration curve points must be retrieved and verified.
• Press Enter to type in the first calibration point. This point is defined as
point of greatest activity and shortest clotting time.
1.point
100.0 %
• Confirm the activity of 100.0 % by pressing Enter or overwrite the preset

entries by pressing the respective number keys. Confirm your entry with
Enter. The cursor switches to the time setting.
12.0 s
• Enter the clotting time for the respective activity of 100.0 %.
• Press Enter to confirm your entry.
The entry field for the next calibration curve point is displayed.
2.point
• Verify or update the second calibration curve point as described above.
• To enter additional calibration curve points follow the above instructions.
The following display appears once the last calibration curve point has been
confirmed:
<- select: ESC. .. = work ENTER= more parameters
• Press Esc to access the measuring mode or Enter to add or verify

additional parameters.

Operation
Quick
The curve for the PT calibration curve can be entered by typing in the 100
%-value and the factor for the slope of the calibration curve.
< quick >
• Press Enter to confirm selection.
<- 100 % Example!
= 11.6 s normal clotting time
factor = 54
Please use the value for factor as provided with the reagent package insert.
If you need to calculate the factor by yourself please refer to chapter 5.5.
If complete data has been entered for <curve> and <quick > the
NOTE calibration curve type selected last is active for con-versions in the
ready-to-measure mode. This is also valid for INR and ratio under
2nd conversion.

none
If < none > was selected no conversion will be performed.
2nd conversion
< 2.conv >
If a calibration curve has been entered in menu 1st conversion or if <none>

has been selected, the 2nd conversion can be used for INR or ratio.
INR
• Press Enter and the following display appears:
< INR >
• Press Enter to type in the ISI-value.
ISI= 1.05
ATTENTION: If <none> was selected under 1st conversion the 100 % sec
value, e.g. 100 % = 12,6 sec. will be requested.
• Enter the ISI-value provided on the reagent package insert.

• Press Enter to confirm the entry.

Operation

ratio
< ratio >
100% = 12.0 s Input of normal time for the 100 % value

none
If < none > was selected no conversion will be performed.
replication
In the menu "replication" you can select between "double" for double
determinations or "single" for single determinations by pressing the arrow
key.
< replic >
• Press Enter.
< double > Selection of double determination
• Press Enter to confirm the selection
Only if double determination has been selected the following display for
entry of the coefficient of variation of the individual values will be displayed.
If this value is exceeded the message "mean error" will appear in the display
and print-out.
<-coef variatio n = 10% possible entry range: 1% - 20%
• Enter the coefficient of variation



Operation
measurement
< measur >
• Press Enter
A display to type in the sample incubation time appears:
Incubation time
incubat.
= 60 s
• Enter the correct sample incubation time

• Press Enter to confirm the entry
A display which requests the entry of start reagent volume and lot number
appears.
Start reagent volume/

reagent lot number
<-Start Reagent
= 100 ul
• Enter the volume for the start reagent e.g. 100 µl

lot no.=
12345678 Example!
• Enter the reagent lot no.


cuvette remove detect.

< cuvdet >
• Press Enter-key to get the cuvette detection on the display.
< OFF >

Operation
By selecting:
- <ON> Cuvette detection occurs as soon as a cuvette is placed in the

measuring channel or removed from the measuring channel.
- <OFF> Cuvette detection occurs only when a cuvette is placed into

the measuring channel. The removal of cuvettes must be
confirmed by pressing the Reset-key.
• Select the desired cuvette detection.

• Press Enter-key to confirm entry.


Operation
2.2.2 aPTT - parameterization

• Change to STANDBY mode.
• Select method < 2 aPTT >
< 2 aPTT >
• Press Mode; and enter the secret no.
<- secret no.:
:_________ (Preset to 11111)
If you enter the wrong number STANDBY will appear.

The following dialog will appear as soon as the correct number has been
entered:
<2.conv>
The menus <2. conversion>, <replication>, <measurement> and <cuv

remove detec.> will be displayed by pressing the right arrow key.
Overview over aPTT parameterization
<2.conversion>
<ratio> input of normal value for ratio calculation or



(default)
2nd conversion
<2.conv> Selection Conversion
• Press Enter to confirm the selection.
ratio
< ratio >
100% = Example!

Operation
27.5 s Enter a normal value

replication
< replic >
< single > or <double> for double determination
and print-out.
<- coef. variat ion> possible entry range
n = 5% 1% - 20%

• Press Enter to add additional parameter or Esc to access the

measuring mode.
measurement
< measur >
<- incubat.
=120 s
• Enter the correct sample incubation time.

A dialog will request the entry of start reagent volume and

reagent lot no.:
<-Start Reagent

Operation
= 50 ul
• Enter the volume for start reagent.
lot. no. =
12345678


cuvette remove detection

< cuvdet >
< OFF >
By selecting:





Operation
2.2.3 Fibrinogen 1 [g/l] - parameterization

• Select method < 3 Fib. 1 >
< 3 Fib. 1 > Results will be calculated in [g/l]
• Press Mode; and enter the secret no.
<- secret no.:
: ______ (preset to: 11111)
If you enter the wrong number STANDBY will appear.

The following dialog will appear as soon as the correct number has been
entered:
< 1.conv >
The menus <1. conversion>, <replication>, <measurement> and <cuv

remove detec.> will be displayed by pressing the right arrow key.
Overview over Fibr. g/l parameterization
<1.conversion>
<none> no conversion



(default)
1st conversion
A 9-point calibration curve can be entered with this menu.
Calibration curve points that are not to be used must have the entry 0.0 s.
For information on interpolation refer to chapter 5.5 Mathematics. The
system requires two points to be defined but we would recommend a
minimum of 3 points. You can exit the calibration curve menu with Esc if no
entry has been made. Once an entry has been made, all additional
calibration curve points must be retrieved and verified.
< curve >
• Press Enter to enter the calibration curve.
1.point: Definition as:

Operation
5.28 g/l Point of greatest concentration and
6.4 s shortest clotting time!
• Enter the concentration and clotting time and confirm the entry with
Enter.
2.point:
2.53 g/l
11 s
• Enter the concentration and clotting time and confirm the entry with
Enter.
• Proceed as described to enter additional points on the calibration curve
The following display appears once the last calibration curve point has been
confirmed:

replication
< replic >
• Press Enter.
< double > Selection of double determination
• Press Enter to confirm the selection
and print-out.
<- coef. variat ion> Possible entry:
n = 10% 1% - 20%


Operation
• Press Enter to add additional parameter or Esc to access the

measuring mode.
measurement
< measur >
<- incubat.
= 60 s
• Enter the correct sample incubation time.

A dialog will request the entry of start reagent volume and reagent lot no.:
<-Start Reagent
= 100 ul
• Enter the volume for start reagent.
lot. no. =
12345678


cuvette remove detection

< cuvdet >
< OFF >
By selecting:


Operation



additional parameters
2.2.4 Fibrinogen 2 [mg/dl] - parameterization

<4 Fib.2> same as described under 2.2.3 Fibrinogen g/l <3Fib. 1>.
2.2.5 Thrombin time parameterization

<5Thrmb> same as described under 2.2.2 aPTT, but without 2nd
conversion possibility.
2.2.6 Intrinsic Factor parameterization

Intr. Factors <6 Intr. > (Factor VIII, Factor IX, Factor XI, or Factor XII) can
be parameterized with this menu. >intrinsic factors< = endogenous
clotting factors.
The following menus can be accessed under method parameters:
<1.conversion>



(default)
2.2.7 Extrinsic Factor – parameterization
<1.conversion>

and the coefficient of variation
<measurement> (CV 1-20%).
start reagent volume, reagent lot. no.

<cuv remove detect.> and sample incubation time.
<ON>
<OFF> refer to chapter 3 Software
activates the automatic cuvette detection

Operation
2.2.8 Utilities
To enter the Utilities Menu:
• finish an actual measurement
• change to the Standby-Mode
• press the left arrow-key
< UTILIT >
• Press Mode to confirm selection.
The following menus can be accessed under Utilities provided the secret
number (11111) has been entered: <printer>, <computer>, <beeper>,
<clock>, <calibrate-temp>, <secret no>, <cuvette test>.
Menu overview Settings

< printer > AUTO- MANUAL- parameter protocol - OFF
< computer > OFF - ON
< beeper > ON - OFF - CLICK
< clock > date and time
< calibrate temp > adjustment of temperature
< secret no > enter personal secret number
< cuvette test > test automatic cuvette detection
Use the left or right arrow-key to change the menu selection.
Each alteration in one of the menus is to be confirmed with the Enter- key.
The following display appears:
• Press Esc to access the measuring mode or press Enter to access

additional menu items.
2.2.8.1 Menu printer

< printer >
A selection between <AUTO>, <MANUAL>, <Par Pro>, and OFF for the
optional printer EPSON P40 can be made from this menu.
A print-out includes:
Test results, method parameters, complete parameter list, and error
messages.

Operation
If you select
- AUTO The results will be printed out immediately after

they have been obtained.
- MANUAL The results will be printed out after processing

results and pressing the Reset-key.
- OFF The print function is switched off.
- Par Pro All stored method parameters will be printed

out.
• Use the arrow keys to make a selection from the display.

• Press Enter to confirm a selection.
2.2.8.2 Menu computer

Change of the default parameters have only be done by the authorized
customer service of the distributor.
2.2.8.3 Menu beeper
< beeper >
The integrated beeper provides an acoustic signal

- during key strokes
- when an error occurs
- after sample incubation
- when clot recognition occurs
In this menu you can select between <ON>, <OFF>, and <CLICK>.
If you select:
- ON The beeper will be activated. Each action will

be confirmed by the beeper.
- OFF The beeper is deactivated.
- CLICK Only key strokes will be confirmed.
• Use the arrow keys to make a selection in the display.

• Press Enter to confirm a selection.
2.2.8.4 Menu clock

< clock >
You can enter the current date and time with this menu. Once a selection
has been made the following dialog will appear:
18.05.99 Day, Month, Year

Operation
The cursor (activated, highlighted field) is positioned on the field "day".

• Enter day, month, year and press enter after every input.
It is not necessary to enter a dot between the numbers.
Next the value of time will be displayed.
14:53:06 Hour, Minute, Second
• Enter the current hour, minute, and second and press Enter.
2.2.8.5 Menu calibrate temp

You can adjust the temperature of the incubation block with this menu. If
you have accessed the menu and you do not wish to adjust, press Esc to
exit the menu.
When does the temperature have to be readjusted? You must readjust

when the temperature of the incubation block deviates more than +/- 1°C
measured with a calibrated digital thermometer.
Position for adjustment:

The lower right cuvette position of the incubation block. Refer to chapter
1.2, figure 1, marked with "T". If you like to verify or adjust the temperature,
the cuvette at the position T must be filled with 400 µl bi-distilled water.
Measuring tools:
Digital multimeter with 4 1/2-digit display. For example Voltkraft M-4650B
and temperature measurement adapter for multimeter, e.g. Fluke 80T-
150U, output in °C.
To verify the temperature place the measuring sensor into position "T"
which is filled with bi-distilled water.
• Check the temperature after approx. 10 min.
If a temperature adjustment is necessary:

• Select <calib> and press Enter to confirm selection.
< calib >
The following display appears:
int 37.4 Example!
ext 37.4
• Wait until the temperature in the display has stabilized internally to 37.4
°C.
• Next enter the temperature displayed by the digital thermometer via the
numerical keypad. The entry will be displayed under extern.
• Wait until the temperature has stabilized at 37.4 °C on the display intern.

Operation
As soon as the temperature has stabilized at 37.4 °C on the display intern

the value must be compared with the value measured with the digital
multimeter. If the internal and external values are identical temperature
adjustment has been completed. Otherwise the procedure has to be
repeated.
• Press Esc. All values will be stored by the analyzer.
2.2.8.6 Menu secret number
< sec. no. >
In the menu <sec.no.> you are able to select a code number to restrict
access to the parameter menus.
A number in the range between 00001 and 65535 can be chosen.
Once a sec.no. has been selected the following display will appear:
<- enter new se .. cret no.
>11111< (0=none)
You can overwrite the number preset by the manufacturer.
• Press Enter to save the new number. A print-out of secret number as well
as serial number follows (printer mode: AUTO).
-----------------------------
Analyzer name
ser. no. C1770711 Sample print-out!
secret no=xxxxx x= number
-----------------------------
If zero is entered and saved instead of a number the secret number will not
be queried when a parameter menu has been selected.
The entry must be completed with Enter if a secret number shorter 5 digit is
stored.
Without entering a secret number the customer can:

- perform tests
- change the test method
without use of the secret number.
Once you have entered the secret number, you can

- perform calibration of tests
- perform settings and controls under UTILITIES and all its submenus.
2.2.8.7 Menu cuvette test
< cuvet. >

Operation
You can control the function of the automatic cuvette detection with this
menu.
CUV-TEST
cuv
If no cuvette is located in the measuring channel the display (-----) appears.
If a cuvette was placed in the measuring channel the display cuv appears.
The display will show the respective status once a cuvette is placed into or
removed from the analyzer.
• Press Enter to leave the menu.
2.3 Printer
It is possible to link an external printer (optional) to the analyzer, refer to
chapter 1.3.1 Connect an external printer. The connection to the printer
shall be done via the RS 232C interface of the analyzer. Ask your local
dealer for recommended printer models.

Operation
2.3.1 Sample print-outs PT and calibration
General print-outs
Once a method has been selected the programmed calibration curve
parameters will be printed followed by the results. The print-out is automatic
as soon as a result has been obtained by the measuring channel.
Print-out of all parameters

A print-out of all programmed test parameters can be generated as
described in chapter 2.2.8 Utilities.
=======================
PARAMETER-PROTOCOL
( 980 Bytes)
1-channel
V X.xx, mm/dd/yy
math-vers V XX.xx
actual date & time:

02.12.99, 14:44:00
[dd.mm.yy, hh.mm.ss]
-- device-specific: --
ser.no. j582074 Serial number of analyzer
secret no. = 11111
ntc_soll = 509
------- global: ------- Global Parameter

Analyzer name
Dealer name
parameter-ID: F1890078
Printer AUTO
computer OFF
Header OFF
Beeper ON
cuv detection ON
method 1 PT
--- method store 1 --- Stored method parameter

PT for PT
cuv remove detection OFF

filter.no. = 0
mode SINGLE
incubat = 60 s
start-reagent:
Lot 1
reagent = 100 ul
1st convers INTERPOLAT:

2nd convers INR
ISI = 1.05
100.0 % 11.6 s
50.0 % 17.7 s
25.0 % 29.9 s
10.0 % 66.6 s
---- method store 2 ----
aPTT

Operation
print-out of method parameters

If you press 0 when the analyzer is in the measuring mode, a parameter
print-out for the selected method is generated.
print-outs PT
PT Documentation
Example: Conversions via a 4-point calibration curve in % and INR.
--- method store 1 ---

PT
actual date 02.12.99
cuv remove detection OFF Automatic cuvette detection
mode DOUBLE Double determination

coef.var = 5 % Coefficient of variation
incubat = 60 s Sample incubation time
start-reagent:
Lot 101xxx Reagent lot no.
reagent = 100 ul Reagent start volume
1st convers INTERPOLAT. 1. conversion, calib. curve / interpolation

2nd convers INR 2. conversion INR
ISI = 1.05 ISI-constant
100.0%= 11.6 s Calibration curve points

50.0%= 17.7 s
25.0%= 29.9 s
10.0%= 66.6 s
-----------------------
results:
PT Method
patient _____________ Patient name
02.12.99, 10:52:55 Date, Time
time 1 = 12.0 s 1st measured time
time 2 = 12.8 s 2nd measured time
Mean = 12.4 s Mean of measured times
INR = 1.7 Conversion to INR
% = 88.4% Conversion to PT %

Operation
PT documentation
Example: Conversion via Factor calibration curve in % and INR.
--- method store 1 ---

PT
actual date 02.12.99
cuv remove detection OFF Automatic cuvette detection
mode DOUBLE Double determination

coef.var = 5 % Coefficient of variation
incubat = 60 s Sample incubation time
start-reagent:
Lot 101xxx Reagent lot no.
reagent = 100 ul Reagent start volume
1st convers QUICK FACTOR

2nd convers INR
100% = 11.8s
factor = 52
ISI = 1.05
-----------------------
results:
PT Method
patient _____________ Patient name
02.12.99, 12:58:38 Date, Time
time 1 = 11.7 s 1st measured time
time 2 = 12.1 s 2nd measured time
Mean = 11.9 s Mean of measured times
INR = 1.01 Conversion to INR
quick = 98.1% Conversion to PT %

Operation
2.4 Errors
Errors can be generated by the user and/or the system itself. The analyzer
displays error messages and warnings in the display. If the printer has been
activated these messages will be printed.
2.4.1 Application errors

Application errors may cause error messages. Possible causes are:
- Air bubbles were created during pipetting

- Pipetting was performed directly into the measuring channel without
cuvette
- The wrong pipette tips were used
- The pipetted volume is incorrect (for variable Pipets)
- The pipetting process was too slow and the angle incorrect
- The temperature of the start reagent deviates from 37°C
- The reagent has been placed incorrectly
- The sample or control is too old
- No stir bar has been placed into the cuvette
- Reagents have been carried over (PT or Fibrinogen reagent)
- A reagent with the wrong lot number has been used
Should any of these errors occur and they are recognized in time, they must
be remedied immediately.
Certain of these errors can only be recognized when determining control

plasmas.
As a result we recommend running control plasma on a daily basis prior to

running routine determinations.
Cancel incubation / measurement:
By pressing the Reset-key, any process on the measuring channel can be

cancelled.

Operation
2.4.2 Error Messages
Error message (Display) Cause Remedy

BREAK timeout the maximum measuring time has been possibly no clotting; optical test
exceeded for clots; repeat test.
BREAK dark preparation for measurement is too turbid dilute plasma or mix reagent.
BREAK top lim exceeded measuring range (too high) repeat test
possibly caused by air bubbles
BREAK bot lim exceeded measuring range (too low) repeat test
BREAK motor mixer motor error occurred contact technical service
BREAK noise loud noise after sample adjustment check for air bubbles or other
particles.
BREAK drift measured curve drifted after reagent has check sample for air bubbles
been added
break measurement cancelled with Reset caused by user!
break jump Measuring break because of a measuring repeat test and if necessary
value jump (no clotting) contact technical Service.
break readjust message is displayed if the light value is too Repeat test and dilute plasma if
dark during the adjustment phase necessary.
mg/dl <2.0 converted value is lower than the check analytical steps and the
parameterized minimum value. conversion parameter.
mg/dl <200.0 converted value is bigger than the see above (mg/dl <2.0)
parameterized maximum value.
Err div0 deviation through 0 during conversion check conversion parameter,

Err log0 comp. of the logarithm from a negat. Value if necessary, contact technical
Err over computation overflow. Service
SYSTEM FAILURE: EPROM check sum error contact technical Service

EPROM: Sxxxx S9999 xxxx=set value; yyyy=actual value
SYSTEM FAILURE: MPU-RAM on address Sxxxx in error contact technical Service

MPU-RAM: Sxxxx
SYSTEM FAILURE: external RAM on address Sxxxx in error contact technical Service
ext. RAM: Sxxxx
parameter-error! check sum error for parameters in EEPROM contact technical Service
press any key ...
ERROR/ERROR rekursiv software error contact technical Service
NOTE All errors will cancel the current measurement.

Operation
2.4.3 Errors during operation
Error Cause Remedy

Cannot start analyzer Main voltage failure? Fuse defect? Check if main voltage available
Is the power adapter accurate connected? and check power adapter
Analyzer fails during Main voltage failure? Fuse defect? Prüfung ob Netzspannung vor-
operation Is the power adapter accurately connected? handen, Prüfung d. Sicherungen
Measuring cell polluted Additional pipetting of plasma or reagent Remove liquid with pipettor, clean
with liquids into the measuring cell without cuvette with appropriate absorbent cloth,
refer to chapter 4.2
2.4.4 Warnings
Warning Meaning
Cool down This message will appear if the incubation block is too warm during a measuring
pause. No other measurements can be started during cool down.
TEM. WARN If during a measurement the temperature of the incubation block deviates
significantly from the set value, the measurement is not cancelled. Instead this
warning appears in the display and is also printed out via the active printer.
mean error Signals a wrong result after a double determination in relation to the coefficient.
max-time reached If a point of calibration curve meets the no more points maximum measured
- no more points time no additional points can be entered as they need to increase from point to
point. Input will be blocked when this message appears.
min-value reached During the input of the calibration curve, the range of values (%, g/l, mg/dl) is
- no more points limited for each method due to manufacturer’s settings. In addition the points
or must increase or decrease depending on the presetting. If the largest or smallest
max-value reached permitted value for a point has been entered, no additional points can be
- no more points entered. Input will be blocked when this message appears.
2.4.5 How to change fuses

Fuses can not be changed in the external power adapter or inside the
analyzer. Contact your distributor if problems occur with the power adapter
or the instrument itself.

Software
3 Software
The software for the analyzer is stored in a memory and will be activated as
soon as the analyzer is switched on. It controls the analyzer via start
functions for the analytic program.
Visual communication between the analyzer and the user is accomplished

via a liquid crystal display with one row and 8 characters.
The menu Utilities has been integrated into the method menu so that
system settings can be performed for the following menus <printer>,
<computer>, <beeper>, <clock>, <calibrate temp>, <secret number>, and
<cuvette test>.
The analyzer contains automatic cuvette detection. The following display

will appear after initialization:
<-auto blanking .. keep channels clear.
At this point the optical blank value will be determined and stored for the
measuring channel. No cuvettes may be located in the measuring channels
at this time!
Due to the optical change in the measuring channel, the analyzer

automatically recognizes whether a cuvette is placed in the measuring
channel or removed.
Storing of parameter
After a parameterization of an instrument or test-data, short information
"write parameter" will be shown on the display.

Software
3.1 Software overview
Analyzer name
Power ON
Initialising
WARM UP
Remove cuvettes
then press any key
auto blanking
keep channels clear
< 1 PT >
Method parameter Test steps (double determ.) Method list

secret no.: cuv in 1 < 1 PT >
< 1. conv > incu 47 < 2 aPTT >
< 2. conv > adj – S1 < 3 Fib 1>
< replic > GO-S1 < 4 Fib 2>
< measure > 100 ul < 5 Thrmb>
< cuvdet > 1.2 s < 6 Intr.>
t= 12.6 s < 7 Extr.>
cuv out,* < UTILIT >
cuv in 2 Mode
incu 52 secret no.:
adj – S2 < print >
GO - S2 < comput >
100 ul < beeper >
6.9 s < clock >
mean time= < calib. >
% = 91.0 < sec.no >
INR = 1.05 < cuvet. >
cuv out, *
* then press “Reset”
Figure 7 Software Overview

Software
3.2 Flow Chart of different application methods
Flow chart to set single or double determination at the analyzer.
Test steps for Test steps for

double determination single determination
cuv in 1 cuv in
incu 47 incu 47
adj – S1 adj – S
GO - S1 GO - S
100 ul 100 ul
1.2 s 1.2 s
t= 12.6 s time =…
cuv out,* = 12.6 s
cuv in 2 % = 91.0
incu 52 INR = 1.05
adj – S2 cuv out, *
GO - S2
100 ul
6.9 s
mean time=
% = 91.0
INR = 1.05
cuv out, *
* then press “Reset”
Figure 8 Test procedure for single and double determination

Software
3.3 Method Parameters

The settings on the analyzer are set by the manufacturer. Before routine
tests can be performed, the user must change certain reagent specific
parameters such as lot number and calibration curve parameter.
The following parameter settings are manufacturer’s settings.
Program Version: V X.xx Release mm.dd.yy

Printer: AUTO
Computer: OFF (only for service purposes!)
Beeper: ON
Secret no.: 11111
Cuvette detection: OFF
Single determination: for all methods
Method Parameters (factory settings)
Calibration curve P1 - P9
P1 P2 P3 P4 P5 P6 P7 P8 P9 Unit 100% ratio ISI Rea. Lot no.

1 PT Value 100 50 25 10 0,0 0,0 0,0 0,0 0,0 % 11,6 1 1.05 1
Time 11,6 17,7 29,9 66,6 0,0 0,0 0,0 0,0 0,0 sec
2 aPTT Value 0 0 0 0 0 0 0 0 0 27,5 0 1.05 -

time 0 0 0 0 0 0 0 0 0 sec
3 Fib.1 Value 8 4 2 1 0 0 0 0 0 g/l 0 0 0 2

Time 8,5 16,5 32 80 0 0 0 0 0 sec
4 Fib.2 Value 804 402 199 100 0 0 0 0 0 mg/dl 0 0 0 3

Time 8,5 16,5 32 80 0 0 0 0 0 sec
5 Thrmb Value 0 0 0 0 0 0 0 0 0 0 0 0 -
Time 0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 sec
6 Intr. Value 200 0,5 0 0 0,0 0,0 0,0 0,0 0,0 % 0 0 0 -

Time 5,0 150,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 sec
7 Extr. Value 200,0 0,5 0,0 0,0 0,0 0,0 0,0 0,0 0,0 % 0 0 0 -
Time 5,0 150,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0 sec
method store
max. 5 characters
method name
incub [sec] (0=off)
start-reagent [µl]
(quick)
1st conversion reference curve
1st conversion unit
decimal place
2nd conversion (INR/RATIO)
min value (conc)
max value (conc)
time (lin / log / rezi)
value (lin / log / rezi)
1 PT 60 100 curve % 1 INR 5 150 lin rezi

2 aPTT 120 50 - 0 Ratio 0 0 lin lin
3 Fib.1 60 100 curve g/l 1 - 0,2 10,0 log log
4 Fib.2 60 100 curve mg/dl 0 - 20 1000 log log
5 Thrmb 60 100 - 1 - 0 0 lin lin
6 Intr. 120 50 curve % 1 - 0,5 200 log log
7 Extr. 60 100 curve % 1 - 0,5 200 log log

Hazard and Precautions
4 Safety issues
4.1 Hazard and Precautions
The cautions and safety regulations in this instruction manual meet

international classifications:
Symbol warns of a risk of injury or of a risk to life (for example by electrical

Danger!
shock).
Symbol warns of a risk of injury or of the instrument being severely

damaged.
Caution!
NOTE Symbol introduces rules to be observed.
The following caution and safety regulations must be observed at all

times:
1. Electrical safety
Check that the operating voltage is set correctly before you connect the
device to the main power supply.
To connect the device to the power supply, use only sockets which are
grounded in order to keep the risk of an electrical shock as low as possible.
Danger! Use only grounded extension cables.
Never intentionally disconnect the grounding contacts.

There is the risk of electrical shock if
- the protective conductor is interrupted within or outside the device,
and/or
- the grounded contact has been disconnected from the line.
Never remove protective guards or secured components since you

could expose electrically live parts in this way.
Electrical connection contacts (plugs, sockets, etc.) can be electrically live.
Even after a device has been switched off, components (e.g.

capacitators) can be under voltage as the result of an electrical charge.
All current carrying parts are sources of danger for an electrical shock.
Surfaces (floors, work table) must not be moist when you are working with
any electrical device.
Carry out only the maintenance work and/or the replacement of parts
described in these operating instructions.

Unauthorized work on the device can lead to the guarantee obligation

becoming null and void with necessary expensive service work to correct it.
All work which requires the analyzer to be opened may 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 nominal
current.
Never use fuses which have been "repaired".
Never short-circuit the fuse holder.
There is a Lithium battery type Li-Mn CR 2430 on board which must be

replaced by the distributor every 5 years.
2. Fire and explosion hazards
Do not place any flammable or hazardous explosive material in the

proximity of the analyzer.
Caution! Electrical sparks could cause fire or explosions.
3. Mechanical safety
(Analyzer is operating)
Never open screw-attached housing parts while the instrument is ON. There
is a risk of injury due to moving parts (fan, motor, drives).
Caution!
Risk of infections
4. Samples
Avoid any direct contact with samples which are potentially infectious or
which may generate other risks to the human body.
If sample material is spilled onto the analyzer, wipe it off immediately and
decontaminate the surface. Refer to chapter 4.2.
5. Reagents
Observe the suggestions in the package inserts for a correct use of the
reagents.
Caution!
6. Accuracy and precision

of the measured results
In order to ensure a flawless operation of the analyzer measure control
samples and watch the function of the instrument closely.
Faulty measurement results may result in an incorrect diagnosis or range
danger for patient.
Caution!

7. Restrictions for samples

and reagents
For cuvettes no guarantee can be provided for any resistance against
organic solvents.
For this reason, do not use any organic solvents unless such solvents are
expressly indicated.
Caution!
8. Operator qualification
The analyzer should only be operated by trained personnel. Ask you local
dealer or distributor for further information on the availability of user
trainings.
Caution!
4.2 Maintenance and Hygiene
No organic acid based cleaning substances should be applied. Instead use

cleaner designed for cleaning and disinfecting laboratory instruments. Only
use a dampened cloth to clean the instrument. Never spray or pour cleaning
solution directly onto the instrument which may negatively impact the
Caution!
analyzer's functions significantly.
Keep the instrument clean and do not spill liquids onto the analyzer. To
protect the instrument from dust, cover it with the supplied dust cover or
store instrument in a cabinet when not in use.
In case liquids were spilled onto the instrument, immediately absorb liquid
with an appropriate cloth.
If liquid has accidentically run or was pipetted into the measuring channel,
remove liquid with a pipette and clean the measuring channel with a lint-free
cloth.
Contact Technical Service if your control measurements do not produce the

expected results.
4.2.1 Disposal of analyzer

The following features should be observed when disposing of the analyzer:
- The top and bottom housing are made of polyurethane foam.
- Mechanical parts are mostly made of aluminium and precious metals.
- Electronic parts must be disposed off in accordance with the guidelines for
the disposal of electronic parts
- Make sure that the analyzer has been decontaminated before disposal.

Appendix
5 Appendix
5.1 Disposables
Material Order number
Cuvettes
1 x Dispo-System micro 40.613.0002
500 cuvettes / stir bars 1,0 x 4,0 mm
1 x 500 cuvettes micro in plastic bag 40.612.0010
1 x 500 stir bars micro 1,0 x 4,0 mm 40.650.0021

in plastic vial
Thrombi-Tips
1 x Thrombi-Tips Racks, 16 x 144 Tips 40.673.0016
Manuals
Operators Manual CoaDATA 501 30.000.1613
(German Version)
Pipettes
Thrombi-Pette 20 - 200 µl 20.000.2712
Thrombi-Pette 20 µl 20.000.2713
200

20-200µl
5.2 Materials Supplied

Material
1 x CoaDATA 501
1 x 10 cuvettes + mixer, Dispo-System

2 x Plastic vials
1 x Power adapter 100V – 240 V (Europe) + 1 adapter
USA/Japan
1 x Operator Manual (English)
1 x Thrombi-Pette 20 - 200 µl adjustable (optional)
1 x 10 Thrombi-Tips (Only if Thrombi-Pette is supplied)
1 x Packaging
1 x Styropor inserts (set)
1x Analytical Protocol (copy)

Appendix
5.3 Technical Data
Instrument type Analyzer for determination of plasmic clotting.
Application coagulometric tests such as PT, aPTT, TZ,

Fibrinogen, single factors FII - FXII
Restrictions only for traditional, coagulometric clotting tests (no

chromogenic substrates).
Operation manual
Measuring principle turbodensitometric; opto-mechanical with

automatic zero adjustment and magnetic stir bar
for homogenizing of the test suspension and
increased sensitivity.
Sensitivity PT > 10% of norm
Test throughput PT 30/h, aPTT 15/h, +/- 10 tests/h
Cuvette volume min. 150 µl, max. 300 µl (test suspension)
Calibration manual input of calibration points, method

dependent
Software loaded in memory
Programmed PT, in sec, %, Ratio, INR (combinations)

methods aPTT, in sec, and Ratio
Fibrinogen, in sec, g/l,
Fibrinogen in sec, mg/dl
Thrombin T., in sec
Intr. Factor, in %
Extr. Factor, in %
Light source LED, light emitting diode
Display 1 lines with 8 characters, liquid crystal

Display
Processor 80552 (single chip microcontroller)
Incubation block controlled at 37.4°C +/- 0.3°C
Measuring channels 1
Light protection caps: for Thrombi-Tips

optional for yellow tips by Eppendorf
Reagent vials for 1 position, diameter 23.0 mm
Cuvette positions 4
Disposables cuvettes, paper for thermal printer, tips
Measuring timer max. 600 sec
Interfaces RS 232 C (optional printer) ChipCARD reader

Appendix
Printer memory 10 KByte
Operating voltage 12 V DC
Power consumption 9.6 VA
Environmental temperature: +10° - 30°C

conditions relative humidity: less than 85 %,
no condensation
System time real time clock for time and date
Dimensions 9,7 x 21,2 x 5,2 cm (WxDxH)
Weight 0,6 kg
Warranty
Warranty is granted for a period of 12 months starting from the date of
delivery.
5.4 Safety Specifications
The instruments conform to the relevant European regulations.

The instruments described in this manual bear a CE mark which confirms
the compliance with the essential requirements of the following European
IVD directives:
If the instrument's type plate bears an IVD symbol it complies with the
following directive:
- 98/79/EC in-vitro Diagnostics directive
If the instrument bears no IVD symbol on the type plate it complies with the
following directives:
- 73/23/EEC Low-voltage directive
- 89/336/EEC-EMC directive
The instrument was produced in accordance with EN 6110-1/A2:1995.
The instrument was checked according to EN 50081-1, EN 50082-2 and

geprüfte
Sicherheit
ENV 50140, IEC 1000-4-4 and ENV 50141 and meets the requirements of
limit value class B. The use of screened data cables is a precondition for
PRODUCT SERVICE
compliance with the relevant regulations. The user is responsible for

ensuring that screened data cables are used.

Appendix
5.5 Mathematics
Computation of Factor for

PT calibration curve:
Determine the 100 % value in s (e.g.12.2 sec) and the 25 % value in sec
(e.g.29.3 sec) from regular plasma in double determination and proceed as
follows:
Computation of Factor:
(25 % Value in sec) – (100 % Value in sec)
(1/25) – (1/100 %) = factor
Example:
( 29.3 – 12.2 ) 17.1

(1/25) – (1/100 %) = 0.04-0.01 = factor = 570
Please only enter the first two digits into the menu, as for example 57!
Computation of PT %
1
(( meas. time-100 % = PT %
Range for conversions:
Method Unit from to exceeded
PT: % 2,0 250 error

Ratio 0,1 10 Error
INR 0,1 10 error
Fibrinogen: g/l 0,4 9,999 error

mg/dl 40 999,9 error
Another limit is the lag phase of the method.
Computation of mean
If in a dual determination the individual results deviate to a larger extent
than permitted by the coefficient of variation, the error message mean error
will be displayed and printed-out.
Extrapolation
PT >100 % linear extrapolation over the last two higher points.
PT <10 % linear extrapolation over the last two lower points.
Fibrinogen: linear extrapolation respectively over the last two points.

Appendix
Calibration curve axes

PT: reciprocal/linear
Fibrinogen: log/log
Extr. Factor log/log
Intr. Factor log/log
Conversion to ratio
and INR:
ratio = measured clotting time / normal value
INR = RATIO ISI (International Normalized Ratio)
ISI = International Sensitivity Index according to package insert

Appendix
5.6 Terminology
A
adju = adjustment
B
break = cancel refer to chapter 2.4.2
break noisy =refer to chapter 2.4.2
break drift = refer to chapter 2.4.2
break dark = refer to chapter 2.4.2
break top lim = refer to chapter 2.4.2
break bot lim = refer to chapter 2.4.2
break jump = refer to chapter 2.4.2
break readjust = refer to chapter 2.4.2
break motor = refer to chapter 2.4.2
C
ChipCARD = memory card (size of a credit card)
clock = menu, date and time
curve = calibration curve
cal = calibration / adjustment
cuvette test = automatic cuvette detection
cuv lrn = blank value, cuvette detection
cool down = refer to chapter 2.4.4
E
ERROR = refer to chapter 2.4.2
err div0 = refer to chapter 2.4.2
err log0 = refer to chapter 2.4.2
err over = refer to chapter 2.4.2
F
Fib = Fibrinogen
G
Go = continue, next step
I
incu = incubate
INR = International Normalized Ratio / constant for Thromboplastin
J
K
L
lot/incu = lot number / incubation
Lo/IN = menu lot number / incubation
Lot = lot number
lrn = learn
M
meas = measuring
motor = refer to chapter 2.4.2
mg/dl <2.0 = refer to chapter 2.4.2
mg/dl <200.0 = refer to chapter 2.4.2

Appendix
P
PAR.TYPE = parameter type
Par Pro = parameter protocol
parameter error = refer to chapter 2.4.2
Q
R
S
Secret no. = security code number
T
THROMBIN T = Thrombin time
TIME = hour:minute:second
Temperat. warning = refer to chapter 2.4.4
SYSTEM FAILURE .... = refer to chapter 2.4.2
V, W
writing parameter to internal = parameter storage

Appendix


Operators Manual: For In-Vitro Diagnostic Use Only!

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Operators Manual

For in-vitro diagnostic use only!

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1.0 June 2001 2.06 OM-CD501-2.PM6/PS

2.0 12/19/03 2.11 OM_CD501.doc

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CoaDATA 501 –Operators Manual 2.1 Page 1

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CoaDATA 501 – Operators Manual 2.1 Page 2

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All routine coagulometric clotting tests such as Prothrombin time, activated

For in-vitro diagnostic use only!

1.2 Instrument Description

The Enter key is used to confirm an entry or a selection. The parameter

Immediately after the analyzer has been switched on, an adjustment

The next step during a run is always shown in the display.

A measurement is automatically started by adding the reagent to a sample

Via the connection to the main voltage the analyzer is automatically

CoaDATA 501 – Operators Manual 2.1 Page 3

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Input: 12VDC~9.6VA Fuse: 0,8AT

Name plate (underneath)

ChipCARD Reader at front side

Display 1 line, 8 Characters

Power and printer plugs leftward

Esc 7 8 9 Enter Membrane keypad with keys:

Incubation block 37°C:

Membrane keypad with keys:

CoaDATA 501 – Operators Manual 2.1 Page 4

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Figure 2 Membrane keypad

Arrow-key left, right

Start Start-key: manual testing

Reset Reset-Key, reset testing,

CoaDATA 501 – Operators Manual 2.1 Page 5

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Proceed as follows to install the analyzer:

• Place the analyzer in a position that it is not exposed to excess humidity,

• Use only the included original AC power adapter.

Switch on CoaDATA 501

12 Volt, 0,8 Amp. 9,6VA

Figure 3 Analyzer connections

1.3.1 Connect an external printer

• Refer to chapter 2.2.8.1 for proper printer setting.

CoaDATA 501 – Operators Manual 2.1 Page 6

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1.4 Measuring Principle

Figure 4 Measuring Principle

CoaDATA 501 – Operators Manual 2.1 Page 7

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NOTE When adding reagents the light protection cap is exposed to

This point of contamination must be cleaned with a suitable thrombin in

In General: The analyzer is equipped with light protection caps for

Perform analytical quality controls on a regular basis.

CoaDATA 501 – Operators Manual 2.1 Page 8

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2.1.1 Turn on analyzer

The following text will appear in the display:

<- read param. .. analyzer name V X.xx (C)mm/dd/yy