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Analyticon
Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com
Analyticon Biotechnologies AG makes no express or implied warranty regarding this manual, its quality,
performance, or appropriate use regarding any type of specific procedure. Furthermore, this manual may be
modified by Analyticon Biotechnologies AG without notice and without implying any obligation or liability on
the part of the company.
Software Copyrights
All software for the Coagulyzer 1 (in the following Analyzer-Software) is the user and instrument control
Software for the Coagulyzer 1 and is the intellectual property of the initial manufacturer. Intellectual property
rights shall remain with the initial manufacturer. Analyticon Biotechnologies AG is entitled to use the
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trademark or using conditions may be subject to legal action. The initial manufacturer reserves the rights to
modify the software, hardware and documentation without any prior written notice.
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Revision History
Analyser
Date
Version Manual Software-Version -
(mm/dd/yy)
Release -
Analyticon Biotechnologies AG
Am Mühlenberg 10
35104 Lichtenfels
Germany
User Manual Coagulyzer 1 Contents
TABLE OF CONTENTS
1 INTRODUCTION ....................................................................................... 2
1.1 Application ............................................................................................................... 2
1.2 Instrument Description ............................................................................................ 2
1.3 Hazard and Precautions .......................................................................................... 5
1.4 Standard Symbols ................................................................................................... 7
2 INSTALLATION ........................................................................................ 8
2.1 Connect an external printer ..................................................................................... 8
2.2 Measuring Principle ................................................................................................. 9
2.3 Reagents ............................................................................................................... 10
3 SOFTWARE ............................................................................................ 11
3.1 Software overview ................................................................................................. 12
3.2 Flow Chart of different application methods .......................................................... 13
3.3 Method Parameters ............................................................................................... 14
4 OPERATION ........................................................................................... 15
4.1 Steps for Instrument Operation ............................................................................. 15
4.1.1 Turn on analyser................................................................................................... 15
4.1.2 STANDBY ............................................................................................................ 16
4.1.3 How to measure ................................................................................................... 17
4.1.4 How to change methods ....................................................................................... 19
4.2 Method Parameterization ...................................................................................... 20
4.2.1 PT-parameterization ............................................................................................. 20
4.2.2 aPTT - parameterization ....................................................................................... 25
4.2.3 Fibrinogen G [g/l] - parameterization .................................................................... 28
4.2.4 Fibrinogen MG [mg/dl] - parameterization ............................................................ 31
4.2.5 Thrombin time parameterization ........................................................................... 31
4.2.6 Intrinsic Factor parameterization .......................................................................... 31
4.2.7 Extrinsic Factor – parameterization ...................................................................... 31
4.2.8 Utilities .................................................................................................................. 32
4.2.8.1 Menu printer ....................................................................................... 32
4.2.8.2 Menu computer ................................................................................... 33
4.2.8.3 Menu beeper ...................................................................................... 33
4.2.8.4 Menu clock ......................................................................................... 33
4.2.8.5 Menu calibrate temp ........................................................................... 34
4.2.8.6 Menu secret number ........................................................................... 35
4.2.8.7 Menu cuvette test ............................................................................... 35
4.3 Printer .................................................................................................................... 36
4.3.1 Sample print-outs PT and calibration.................................................................... 37
5 SAFETY IN OPERATION........................................................................ 40
5.1 Maintenance and Hygiene..................................................................................... 40
5.1.1 Disposal of the Analyser ....................................................................................... 40
5.2 Errors ..................................................................................................................... 41
5.2.1 Application errors.................................................................................................. 41
5.2.2 Error Messages .................................................................................................... 42
5.2.3 Errors during operation ......................................................................................... 43
5.2.4 Warnings .............................................................................................................. 43
5.2.5 How to change fuses ............................................................................................ 43
6 APPENDIX .............................................................................................. 44
6.1 Disposables ........................................................................................................... 44
6.2 Materials Supplied ................................................................................................. 44
6.3 Technical Data ...................................................................................................... 45
6.4 Safety Specifications ............................................................................................. 47
6.5 Mathematics .......................................................................................................... 48
1 INTRODUCTION
1.1 Application
The instrument type Coagulyzer 1 (in the following titled as analyser) as
described in this manual is an opto-mechanical coagulation analyser which
applies the turbodensitometric measuring principle.
The measuring channel is integrated into the 37.4°C incubation block with 1
position for reagent bottle and 4 positions for cuvettes.
Results can be printed via on optional, external printer or can be read from
the display.
The connector for the external power adapter is located at the back side of
the analyser. The external power adapter can be connected to the mains
with a voltage range from 100V - 240V, 47 - 63Hz.
For data output an RS 232 C 6-pin interface is also located on the back side
of the analyser.
The Analyser
No. Description
Description of keys
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, analyser 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
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.
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.
All work which requires the analyser to be opened may only be carried
out by a technician who is familiar with the risks related thereto.
3. Mechanical safety
(Analyser is operating)
Never open screw-fixed housing parts! There is always the risk of injury.
4. Samples/Reagents
Risk of infections
Avoid any contact between samples and/or test reagents with skin or
mucous membranes and any contact with parts of the instrument that come
into contact with samples/reagents. All consumables, e.g. cuvettes,
reagent vessels, pipette tips that may be used to transfer liquid
samples and reagents should be considered to be potentially infectious. If
specimens are spilled on the system, wipe them off at once and disinfect
the instrument (see Chapter 5.1 Maintenance and Hygiene). Reagents
may cause irritation to the skin and mucous membranes.
Dispose of spent samples and waste reagents and all consumables that
have come into contact with them after completion of the measurements
strictly in accordance with statutory directives and laboratory guidelines.
Wear gloves! There is the risk of infection.
7. User qualification
The analyser should only be operated by trained personnel. Ask you local
dealer or distributor for further information on the availability of user
trainings.
Fuse
2 INSTALLATION
Remove the analyser 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 chapter 6.2 Materials Supplied.
• Prior to installation of the analyser read the instructions under chapter 1.3
Hazard and Precautions.
• Connect the power adapter between the analyser and a power supply
(100V - 240V) free from interferences by large power users such as
elevators and centrifuges.
• Use only original cuvettes and stir bars which will assure proper operation
of the instrument.
• Connect the data-cable between the analyser 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.
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".
2.3 Reagents
For proper coagulation analysis we recommend the use of Analyticon
reagents, controls and buffers. Always read the information leaflet in the
pack and observe the instructions given by the reagent manufacturer.
Contamination
With the application of different reagents, and here especially reagents
containing thrombin, there is a danger of reagent carry-over.
If liquid residue or dried-on remnants can be seen on the rim of the opening of
the light protection cap, remove them with laboratory disinfectant solution and
cotton buds.
Only use pipettes which are being validated in regular intervals. Close
the light protection cap prior of each measurement.
Make sure that pipetting does not cause any air bubbles. Use a new
tip after every pipetting operation to prevent reagent/sample carry-
over.
Only use the original manufacturer’s cuvettes and mixers as they are
subject to strict quality control. The use of other makes of cuvette and
any associated instrument problems as a result, will invalidate your
guarantee.
3 SOFTWARE
The software for the analyser is stored in a memory and will be activated as
soon as the analyser is switched on. It controls the analyser via start
functions for the analytic program.
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>.
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!
Storing of parameter
After a parameterization of an instrument or test-data, short information
"write parameter" will be shown on the display.
Analyser name
Power ON
Initialising
WARM UP
Remove cuvettes
then press any key
auto blanking
keep channels clear
< 1 PT >
cuv in 2
cuv out, *
* then press “Reset”
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 in 2 % = 91.0
GO - S2
100 ul
6.9 s
mean time=
% = 91.0
INR = 1.05
cuv out, *
max. 5 characters
method name
start-reagent [µl]
(quick)
1st conversion reference curve
decimal place
4 OPERATION
4.1 Steps for Instrument Operation
Communication with the analyser 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 Instrument Description
Analyticon Manufacturer
Use the warm-up phase to load the analyser with cuvettes and reagents for
testing.
Each cuvette must be equipped with a stir bar.
• Remove the existing cuvette from the measuring channel and close the
light protection caps.
< 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.
4.1.2 STANDBY
< 1 PT >
cuv in
37.4°C
Single/double determinations
The user can switch to single determination prior to or after a measurement
in the method menu <replication>, refer to chapter 4.2.1 PT-
parameterization.
Sample incubation
Sample incubation is always performed in the measuring channel!
• Switch to measuring mode.
cuv in 1
The analyser automatically recognizes the cuvette and starts the timer for
sample incubation (timer countdown). An acoustic signal indicates 5 sec
remaining incubation time.
After sample incubation the measuring channel will be adjusted for sample.
(adjS = adjust Sample).
Once the sample has been adjusted the following display 100 ul alternately
GO – S1 appears:
• Press Reset-key.
cuv in 2
The analyser automatically recognizes the cuvette and starts the timer for
sample incubation (timer countdown). An acoustic signal indicates 5 sec
remaining incubation time.
After sample incubation the measuring channel will be adjusted for sample.
(adjS = adjust Sample).
Once the sample has been adjusted the following display 100 ul alternately
GO – S2 appears:
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.
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.
cuv in 1
• Press the right arrow; the next method aPTT is displayed as ready-to-
measure.
< 1 PT >
< 2 aPTT >
< 3 FibG > g/l
< 4 FibMG > mg/dl
< 5 Thrmb >
< 6 Intr. >
< 7 Extr. >
< UTILIT >
The new method has been initialized. Incubation of the first samples can
begin.
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 4.2.8 Utilities.
4.2.1 PT-parameterization
Method parameters in the analyser have been preset by the manufacturer.
Prior to performing clotting analysis you must update the method parameter
for the reagent used.
• Press Mode. The analyser will request you to enter an up to 5 digit long
secret number (factory setting: 11111). For additional information refer to
chapter 4.2.8.6 Menu secret number.
<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
<2.conversion>
<INR> input of the ISI-value for INR or
1st conversion
curve
• Select 1. conversion and press Enter to confirm selection.
• 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 %
12.0 s
The entry field for the next calibration curve point is displayed.
2.point
The following display appears once the last calibration curve point has been
confirmed:
<- select: ESC. .. = work ENTER= more parameters
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.
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 6.5
Mathematics.
If complete data has been entered for <curve> and <quick > the
calibration curve type selected last is active for conversions 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 >
INR
• Press Enter and the following display appears:
ISI= 1.05
ATTENTION: If <none> was selected under 1st conversion the 100 % sec
value, e.g. 100 % = 12, 6 sec. will be requested.
ratio
< ratio >
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.
• Press Enter.
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.
measurement
< measur >
• Press Enter
Incubation time
incubat.
= 60 s
A display appears which requests the entry of start reagent volume and lot
number.
= 100 ul
lot no.=
12345678 Example!
By selecting:
<2.conv>
<2.conversion>
<ratio> input of normal value for ratio calculation or
<none> for no conversion
(default)
2nd conversion
<2.conv> Selection Conversion
ratio
< ratio >
100% = Example!
replication
< replic >
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 printout.
n = 5% 1% - 20%
measurement
< measur >
=120 s
<-Start Reagent
= 50 ul
lot. no. =
12345678
By selecting:
<1.conversion>
<curve> input of a 9-point calibration curve under or
<none> no conversion
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 6.5 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.
• 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.
The following display appears once the last calibration curve point has been
confirmed:
replication
< replic >
• Press Enter.
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.
n = 10% 1% - 20%
measurement
< measur >
<- incubat.
= 60 s
A dialog will request the entry of start reagent volume and reagent lot no.:
<-Start Reagent
= 50 ul
lot. no. =
12345678
By selecting:
<1.conversion>
<curve> input of a 9-point calibration curve under or
<none> no conversion
<1.conversion>
<curve> input of a 9-point calibration curve under or
<none> no conversion
4.2.8 Utilities
To enter the Utilities Menu:
• finish an actual measurement
• change to the Standby-Mode
• press the left arrow-key
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>.
Each alteration in one of the menus is to be confirmed with the Enter- key.
The following display appears:
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.
If you select
In this menu you can select between <ON>, <OFF>, and <CLICK>.
If you select:
You can enter the current date and time with this menu. Once a selection
has been made the following dialog will appear:
• Enter the current hour, minute, and second and press Enter.
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 the cuvette
position which is filled with bi-distilled water.
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.
In the menu <sec.no.> you are able to select a code number to restrict
access to the parameter menus.
Once a sec.no. has been selected the following display will appear:
>11111< (0=none)
• Press Enter to save the new number. A print-out of secret number as well
as serial number follows (printer mode: AUTO).
-----------------------------
Analyser 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.
You can control the function of the automatic cuvette detection with this
menu.
CUV-TEST
cuv
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 analyser.
4.3 Printer
It is possible to link an external printer (optional) to the analyser, refer to
chapter 2.1 Connect an external printer. The connection to the printer
shall be done via the RS 232C interface of the analyser. Ask your local
dealer for recommended printer models.
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.
=======================
PARAMETER-PROTOCOL
( 980 Bytes)
1-channel
V X.xx, mm/dd/yy
math-vers V XX.xx
-- device-specific: --
ser.no. j582074 Serial number of analyser
secret no. = 11111
ntc_soll = 509
mode SINGLE
incubat = 60 s
start-reagent:
Lot 1
reagent = 100 ul
100.0 % 11.6 s
50.0 % 17.7 s
25.0 % 29.9 s
10.0 % 66.6 s
---- method store 2 ----
aPTT
print-outs PT
PT Documentation
Example: Conversions via a 4-point calibration curve in % and INR.
start-reagent:
Lot 101xxx Reagent lot no.
reagent = 100 ul Reagent start volume
PT Method
patient _____________ Patient name
08.05.08, 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 %
PT documentation
Example: Conversion via Factor calibration curve in % and INR.
start-reagent:
Lot 101xxx Reagent lot no.
reagent = 100 ul Reagent start volume
-----------------------
results:
PT Method
patient _____________ Patient name
08.05.08, 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 %
5 SAFETY IN OPERATION
Do not use organic acids for cleaning the instrument. Always use the
surface cleaning agents recommended by the specialist trade for this
purpose. Always use a moist cloth; do not spray on or pour on any liquids,
as they can affect the correct function of the instrument or damage it.
Keep the instrument free from dust and liquid spillages. When not used for a
prolonged period, place a dust cover over the instrument or place it in a
cabinet.
If liquid has been spilled on the instrument, remove the contamination with a
clean, absorbent non-woven cloth considering all applicable hygienic
requirements.
The analyser is fitted with a lithium battery type Li-Mn CR 2430 (life
approx. 5 years). It should be replaced by an authorised service operator
after 5 years at the latest. Otherwise a faultless operation cannot be
guaranteed.
– The upper and lower part of the housing is made of polyurethane foam.
– For the safety of the operating personnel make sure the analyser has
been disinfected before disposal.
5.2 Errors
Errors can be generated by the user and/or the system itself. The analyser
displays error messages and warnings in the display. If the printer has been
activated these messages will be printed.
Should any of these errors occur and they are recognized in time, they must
be remedied immediately.
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 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 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.
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 ...
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 5.1
5.2.4 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.
6 APPENDIX
6.1 Disposables
Cuvettes
Cuvettes FL45 in Dispo-System CG0451
5 x 100 Cuvettes / Mixer 1,0 x 4,0mm
1 x Coagulyzer 1 CG0001
1x 10 Cuvettes + mixer
1x Plastic vial
1x Power Supply 100V–240V (Europe/USA/Japan)
1x Operator Manual
Operation manual
Measuring channels 1
Cuvette positions 4
Operating voltage 12 V DC
Dimensions 19 x 13 x 6 cm (WxDxH)
Weight 0.7 kg
Warranty
The manufacturer, his agent or the authorised dealer warrants the proper
function of the instruments from the date of supply, provided they are
properly installed, used and with accessories and consumables in
accordance with these operating instructions.
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’s 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
EN61010-1:2001, EN61010-2-101:2002
6.5 Mathematics
Computation of PT %
1
(( meas. time-100 % time)/factor)+0.01) = PT %
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.
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