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User Manual

For in-vitro diagnostic use only!

Analyticon
Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com

agile - affordable - accurate


1
Liability Disclaimer

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
Analyzer-Software and the printed accompanying material. Any violation of property rights or copyright or
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.

Intellectual Property

Analyticon Biotechnologies AG Coagulyzer 1 is registered trademark of Analyticon Biotechnologies AG.

No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translation into any language (human or computer) in any form, or by any means whatsoever, without the
prior written permission of Analyticon Biotechnologies AG in behalf of the initial manufacturer.

Any reference to products, documentation, articles within this publication not expressly described as property
of the initial manufacturer and Analyticon Biotechnologies AG shall be considered as intellectual property of
the publishing company of this certain product, documentation and or article.

Revision History

Analyser
Date
Version Manual Software-Version -
(mm/dd/yy)
Release -

1.0 03/23/11 V2.14 Initial version

1.1 08/25/11 V2.14

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

Rev. 1.1 Page 1


User Manual Coagulyzer 1 Introduction

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.

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 analyser 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 analyser 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.

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.

Via the connection to the main voltage the analyser is automatically


switched on or off.

For data output an RS 232 C 6-pin interface is also located on the back side
of the analyser.

Page 2 Rev. 1.1


User Manual Coagulyzer 1 Introduction

The Analyser

Figure 1 The Analyser

No. Description

1 Power and printer interfaces in the back


2 Display 1 line, 8 Characters
Membrane keypad with keys:
3
Reset, Start, 0 - 9, Mode, Enter, ESC, ◄, ►.
Incubation block 37°C:
- 4 positions for cuvettes
4
- 1 position for reagent bottle
- 1 measuring channel with light protection cap
Name plate (underneath)

Rev. 1.1 Page 3


User Manual Coagulyzer 1 Introduction

Description of keys

Figure 2 Membrane keypads

Arrow-key left, right


◄ select display to the left
► select display to the right, set decimal point

Esc-key
Switch from measuring to STANDBY
Exit a submenu

Enter-key
Confirm selection, advance printer paper

Number-keys
Enter parameters

0-key
A print-out of the respective parameters for the selected method is
generated by pressing 0 during measuring.
Mode-key
1. Calibration
2. Menu selection, 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

Reset-Key, reset testing, Break of run, adjustment of sample

Page 4 Rev. 1.1


User Manual Coagulyzer 1 Introduction

1.3 Hazard and Precautions

The caution and safety regulations in this operator’s manual meet


international classification; see also Chapter 1.4 Standard Symbols.

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


shock).

Symbol warns of a risk of injury or of the instrument being severely


damaged.

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.

Use only grounded extension cables.

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 analyser to be opened may only be carried
out by a technician who is familiar with the risks related thereto.

2. Fire and explosion hazards

Do not place any flammable or hazardous explosive material in the


proximity of the analyser.

Rev. 1.1 Page 5


User Manual Coagulyzer 1 Introduction

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.

Always follow the manufacturer’s instructions for correct use given in


the literature accompanying the reagent.

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.

5. Accuracy and precision


of the measured results
In order to ensure a flawless operation of the analyser 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.

6. Restrictions for samples


and reagents
Resistance of cuvettes to organic solvents cannot be guaranteed. For this
reason, organic solvents should not be used unless they have been
expressly permitted. Only use the original manufacturer’s cuvettes and
mixers! Use cuvettes and mixers once only! Prior of each measurement
ensure a mixer is added to each cuvette.

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.

Page 6 Rev. 1.1


User Manual Coagulyzer 1 Introduction

1.4 Standard Symbols


A large number of symbols are used in this Operator’s Manual, on the
instrument itself, and on available accessories and consumables. Their
meanings are given below:

Manufacturer Order Number

In Vitro Diagnostic Medical Device Serial Number

CE Conformity Protect From Sunlight

Refer to Operators Manual Recyclable

Biological Risk Caution

Temperature Limitation Danger

Humidity Limitation Important Information

Separate collection, handling and


disposal for waste electrical and
Do Not Reuse
electronic equipment and its
components

Batch Code Electric Shock Warning

Fuse

Rev. 1.1 Page 7


User Manual Coagulyzer 1 Installation

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.

Proceed as follows to install the analyser:

• Prior to installation of the analyser read the instructions under chapter 1.3
Hazard and Precautions.

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


any explosive gases, or magnetic influences.

• 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 the included original AC power adapter.

• Use only original cuvettes and stir bars which will assure proper operation
of the instrument.

Switch on the analyser


• Connect the external power adapter with the analyser
.
• Connect the external power adapter with the mains; automatically the
analyser is switched on.

Figure 3 Analyser connections

2.1 Connect an external printer

• 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.

• Refer to chapter 4.2.8.1 Menu printer for proper printer setting.

Never operate the printer without paper! Read the instructions


manual from the manufacturer of the printer for further details.

Page 8 Rev. 1.1


User Manual Coagulyzer 1 Installation

2.2 Measuring Principle


The analyser operates according to the opto-mechanical measuring
principle. This measuring principle is especially suited for lipaemic and/or
icteric coloured samples as well as reagents with kaolin.

A light beam passes through the cuvette containing the test plasma onto a
photo detector. Any change in the intensity of the transmitted light, that is
light increase or decrease, is converted into an electric signal. Hence, even
the most unstable clot can be detected.

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

Once the start reagent has been added, the measuring channel is adjusted,
that is the lamp intensity automatically adjusts up or down depending on the
turbidity of the test sample. In this process the turbidity of the sample
plasma and the reagent are adjusted.

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

This stirring action combined with the optical measurement constitutes the
basic features of the patented "turbodensitometric measuring principle".

Figure 4 Measuring Principle

Rev. 1.1 Page 9


User Manual Coagulyzer 1 Installation

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.

Utilize reagents and controls only according to directions as provided


by the reagent manufacturer to avoid incorrect measuring results or
malfunctions of the analyser.

Contamination
With the application of different reagents, and here especially reagents
containing thrombin, there is a danger of reagent carry-over.

When adding reagents the light protection cap is exposed to


reagents and hence a point of contamination.

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.

Other things you may need to or


must take into consideration:
Only use the analyser according to the required ambient conditions.
Protect the measuring channels from direct sunlight or other light
sources.

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.

Always place a cuvette in the measuring tube before pipetting. Ensure


each cuvette is equipped with a mixer. Pipetting reagent or sample
into the measuring tube can significantly contaminate the analyser
and could even render it faulty, so that expensive cleaning or repair
might become necessary.

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.

Use cuvettes once only. Multiple use of cuvettes may produce


incorrect results; this in turn can become an indirect hazard for the
patient.

Perform regular quality control checks. Please refer to the guidelines


of use provided by the reagent manufacturer.

Page 10 Rev. 1.1


User Manual Coagulyzer 1 Software

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.

Visual communication between the analyser 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 analyser 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 analyser


automatically recognizes whether a cuvette is placed into the measuring
channel or being removed.

Storing of parameter
After a parameterization of an instrument or test-data, short information
"write parameter" will be shown on the display.

Rev. 1.1 Page 11


User Manual Coagulyzer 1 Software

3.1 Software overview

Analyser 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 FibG >

< replic > GO-S1 < 4 FibMG>

< measure > 100 ul < 5 Thrmb>

< cuvdet > 1.2 s < 6 Intr.>

t= 12.6 s < 7 Extr.>

cuv out,* < UTILIT >

cuv in 2

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 5 Software Overview

Page 12 Rev. 1.1


User Manual Coagulyzer 1 Software

3.2 Flow Chart of different application methods

Flow chart to set single or double determination at the analyser.

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 6 Test procedures for single and double determination

Rev. 1.1 Page 13


User Manual Coagulyzer 1 Software

3.3 Method Parameters


The following default settings are programmed set by the manufacturer.
Before performing routine tests, 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)


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 FibG 60 50 curve g/l 2 - 0.2 10.0 log log
4 FibMG 60 50 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

Page 14 Rev. 1.1


User Manual Coagulyzer 1 Operation

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

4.1.1 Turn on analyser


• Connect the analyser 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. .. analyser name V X.xx (C)mm/dd/yy

Analyticon Manufacturer

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 analyser 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 analyser 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 analyser.
• 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.

Rev. 1.1 Page 15


User Manual Coagulyzer 1 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


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.

4.1.2 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

Page 16 Rev. 1.1


User Manual Coagulyzer 1 Operation

4.1.3 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 4.2.1 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 analyser automatically recognizes the cuvette and starts the timer for
sample incubation (timer countdown). 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]

Rev. 1.1 Page 17


User Manual Coagulyzer 1 Operation

<-cuv out, then .. press „Reset“

• Open the light protection cap.

• Remove cuvette out of the measuring channel.

• Press Reset-key.

cuv in 2

• Pipette 50 µl citrate plasma in a cuvette.

• Immediately place this cuvette into measuring channel.

• Close the light protection cap.

The analyser automatically recognizes the cuvette and starts the timer for
sample incubation (timer countdown). 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.

Page 18 Rev. 1.1


User Manual Coagulyzer 1 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“

• Open the light protection cap.


• Remove cuvette from measuring channel and confirm by pressing Reset-
key (see chapter 3 Software).

The analyser is now ready for additional measurements.

cuv in 1

Continue as described for additional measurements.

The timer can be started or stopped manually by pressing the


Start-key.

Refer to function keys in chapter 1.2 Instrument Description.

4.1.4 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.

• By repeatedly pressing the arrow-key ► (arrow-key ◄ back) the following


methods and the UTILITIES Menu will be displayed one after the other:

< 1 PT >
< 2 aPTT >
< 3 FibG > g/l
< 4 FibMG > mg/dl
< 5 Thrmb >
< 6 Intr. >
< 7 Extr. >
< UTILIT >

Rev. 1.1 Page 19


User Manual Coagulyzer 1 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 4.1.3.

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 Method Parameterization

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.

• Set analyser to STANDBY mode

< 1 PT > STANDBY

• 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.

<- secret no.: .. _________

If the wrong number was entered STANDBY will be displayed. As soon as


the correct number has been entered, the following display will appear:

<1.conv>

Press the arrow key ► to display the following menus: <1. conversion>,
<2. conversion>, <replication>, <measurement> and <cuv remove
detec.>.

Overview PT parameterization:

<1.conversion>
<curve> input of a 9-point calibration curve under or
<quick> to enter the 100%-value and slope or

<none> for no conversion

<2.conversion>
<INR> input of the ISI-value for INR or

<ratio> input of normal value for ratio calculation or


<none> for no conversion

Page 20 Rev. 1.1


User Manual Coagulyzer 1 Operation

<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)

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 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.

• 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.

Rev. 1.1 Page 21


User Manual Coagulyzer 1 Operation

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.

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 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.

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

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

Page 22 Rev. 1.1


User Manual Coagulyzer 1 Operation

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.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

ratio
< ratio >

• Press Enter to confirm the entry.

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

• Press Enter to confirm the entry.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

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


• Press Enter to confirm the entry.

Rev. 1.1 Page 23


User Manual Coagulyzer 1 Operation

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

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 appears which requests the entry of start reagent volume and lot
number.

Start reagent volume/ reagent


lot number
<-Start Reagent

= 100 ul

• Enter the volume for the start reagent e.g. 100 µl


• Press Enter to confirm the entry

lot no.=

12345678 Example!

• Enter the reagent lot no.


• Press Enter to confirm the entry

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

cuvette remove detect.


< cuvdet >

• Press Enter-key to get the cuvette detection on the display.

< OFF >

Page 24 Rev. 1.1


User Manual Coagulyzer 1 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.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

4.2.2 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
<none> for no conversion

<replication> select single or double determination


<single> and the coefficient of variation
<double> (CV 1-20%).

<measurement> start reagent volume, reagent lot. no.


and sample incubation time.

<cuv remove detect.> refer to chapter 3 Software


<ON> activates the automatic cuvette detection
<OFF> deactivates the automatic cuvette detection.

Rev. 1.1 Page 25


User Manual Coagulyzer 1 Operation

(default)

2nd conversion
<2.conv> Selection Conversion

• Press Enter to confirm the selection.

ratio
< ratio >

• Press Enter to confirm the selection.

100% = Example!

27.5 s Enter a normal value

• Press Enter to confirm the entry.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

replication
< replic >

• Press Enter to confirm the selection.

< single > or <double> for double determination

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.

<- coef. variat ion> possible entry range

n = 5% 1% - 20%

• Enter the coefficient of variation


• Press Enter to confirm the entry

<- select: ESC. .. = work ENTER= more parameters

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


measuring mode.

measurement
< measur >

Page 26 Rev. 1.1


User Manual Coagulyzer 1 Operation

• Press Enter to confirm the selection.


<- incubat.

=120 s

• Enter the correct sample incubation time.


• Press Enter to confirm the selection.

A dialog will request the entry of start reagent volume and


reagent lot no.:

<-Start Reagent

= 50 ul

• Enter the volume for start reagent.

lot. no. =

12345678

• Enter the reagent lot no.


• Press Enter to confirm the selection.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

cuvette remove detection


< cuvdet >

• Press Enter-key to get the cuvette detection on the display.

< OFF >

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.

<- select: ESC. .. = work ENTER= more parameters

Rev. 1.1 Page 27


User Manual Coagulyzer 1 Operation

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.
4.2.3 Fibrinogen G [g/l] - parameterization
• Select method < 3 FibG >

< 3 FibG > 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>
<curve> input of a 9-point calibration curve under or
<none> no conversion

<replication> select single or double determination


<single> and the coefficient of variation
<double> (CV 1-20%).

<measurement> start reagent volume, reagent lot. no.


and sample incubation time.

<cuv remove detect.> refer to chapter 3 Software


<ON> activates the automatic cuvette detection
<OFF> deactivates the automatic cuvette detection.
(default)

• Press Enter to confirm the selection.

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.

< curve >

• Press Enter to enter the calibration curve.

Page 28 Rev. 1.1


User Manual Coagulyzer 1 Operation

1.point: Definition as:

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:

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

replication
< 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. variat ion> Possible entry:

n = 10% 1% - 20%

• Enter the coefficient of variation


• Press Enter to confirm the entry

Rev. 1.1 Page 29


User Manual Coagulyzer 1 Operation

<- select: ESC. .. = work ENTER= more parameters

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


measuring mode.

measurement
< measur >

• Press Enter to confirm the selection.

<- incubat.

= 60 s

• Enter the correct sample incubation time.


• Press Enter to confirm the selection.

A dialog will request the entry of start reagent volume and reagent lot no.:

<-Start Reagent

= 50 ul

• Enter the volume for start reagent.

lot. no. =

12345678

• Enter the reagent lot no.


• Press Enter to confirm the selection.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters.

cuvette remove detection


< cuvdet >

• Press Enter-key to get the cuvette detection on the display.

< OFF >

By selecting:

- <ON> Cuvette detection occurs as soon as a cuvette is placed in the


measuring channel or removed from the measuring channel.

Page 30 Rev. 1.1


User Manual Coagulyzer 1 Operation

- <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.

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or Enter to add or verify


additional parameters

4.2.4 Fibrinogen MG [mg/dl] - parameterization


<4 FibMG> same as described under 4.2.3 Fibrinogen G [g/l] -
parameterization <3 FibG>.

4.2.5 Thrombin time parameterization


<5Thrmb> same as described under 4.2.2 aPTT - parameterization, but
without 2nd conversion possibility.

4.2.6 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>
<curve> input of a 9-point calibration curve under or
<none> no conversion

<replication> select single or double determination


<single> and the coefficient of variation
<double> (CV 1-20%).

<measurement> start reagent volume, reagent lot. no.


and sample incubation time.

<cuv remove detect.> refer to chapter 3 Software


<ON> activates the automatic cuvette detection
<OFF> deactivates the automatic cuvette detection.
(default)

4.2.7 Extrinsic Factor – parameterization

<1.conversion>
<curve> input of a 9-point calibration curve under or
<none> no conversion

<replication> select single or double determination


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

Rev. 1.1 Page 31


User Manual Coagulyzer 1 Operation

4.2.8 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:

<- select: ESC. .. = work ENTER= more parameters

• Press Esc to access the measuring mode or press Enter to access


additional menu items.

4.2.8.1 Menu printer


< printer >

• Press Enter to confirm selection.

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

- 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.

Page 32 Rev. 1.1


User Manual Coagulyzer 1 Operation

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


• Press Enter to confirm a selection.

4.2.8.2 Menu computer


Changes of the default parameters have to be done by the authorized
customer service of the distributor.

4.2.8.3 Menu beeper


< beeper >

• Press Enter to confirm selection.

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.

4.2.8.4 Menu clock


< clock >

• Press Enter to confirm selection.

You can enter the current date and time with this menu. Once a selection
has been made the following dialog will appear:

18.05.08 Day, Month, Year

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.

Rev. 1.1 Page 33


User Manual Coagulyzer 1 Operation

4.2.8.5 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
Instrument Description, figure 1. If you like to verify or adjust the
temperature, the cuvette at this position 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 the cuvette
position 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.

• Press Enter to confirm the entry.

• Wait until the temperature has stabilized at 37.4 °C on the display intern.

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 analyser.

Page 34 Rev. 1.1


User Manual Coagulyzer 1 Operation

4.2.8.6 Menu secret number


< sec. no. >

• Press Enter to confirm selection.

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).

-----------------------------
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.

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.

4.2.8.7 Menu cuvette test


< cuvet. >

• Press Enter to confirm selection.

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.

Rev. 1.1 Page 35


User Manual Coagulyzer 1 Operation

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.

• Press Enter to leave the menu.

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.

Page 36 Rev. 1.1


User Manual Coagulyzer 1 Operation

4.3.1 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 4.2.8 Utilities.

=======================
PARAMETER-PROTOCOL
( 980 Bytes)

1-channel
V X.xx, mm/dd/yy
math-vers V XX.xx

actual date & time:


08.05.08, 14:44:00
[dd.mm.yy, hh.mm.ss]

-- device-specific: --
ser.no. j582074 Serial number of analyser
secret no. = 11111
ntc_soll = 509

------- global: ------- Global Parameter


Analyser 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

Rev. 1.1 Page 37


User Manual Coagulyzer 1 Operation

print-out of method parameters


If you press 0 when the analyser 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 08.05.08
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
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 %

Page 38 Rev. 1.1


User Manual Coagulyzer 1 Operation

PT documentation
Example: Conversion via Factor calibration curve in % and INR.

--- method store 1 ---


PT
actual date 08.05.08
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
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 %

Rev. 1.1 Page 39


User Manual Coagulyzer 1 Safety in Operation

5 SAFETY IN OPERATION

5.1 Maintenance and Hygiene

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.

If liquid has accidentally entered, or been pipetted into a measuring


channel, remove the liquid with a pipette and then clean the measuring
channel with a lint-free cloth. Please consider all applicable hygienic
requirements.

Contact our technical service if subsequent control measurements do not


produce the expected result.

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 light protection caps are considered to be potentially contaminated


therefore the manufacturer recommends to replace the light protection
caps once a year. Ask you local dealer or the manufacturer for further
information.

5.1.1 Disposal of the Analyser


The following must be considered when disposing of the analyser:

– The upper and lower part of the housing is made of polyurethane foam.

– Mechanical parts are predominantly made of aluminium and precious


metals.

– Electronic parts must be disposed of in accordance with national


directives for the disposal of electrical parts.

– For the safety of the operating personnel make sure the analyser has
been disinfected before disposal.

Page 40 Rev. 1.1


User Manual Coagulyzer 1 Safety in Operation

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.

5.2.1 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 Pipettes)
- 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
- The reagent has not been used according to the package insert
- The reagent used does not correspond to the method selected
- No or an incorrect calibration curve is available
- Errors appeared during the sample collection or centrifugation
- No stirrer is placed into the reagent vial
- Method parameters relevant for measuring are incorrect

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.

Rev. 1.1 Page 41


User Manual Coagulyzer 1 Safety in Operation

5.2.2 Error Messages

Error message (Display) Cause Remedy


BREAK timeout the maximum measuring time has been Probably no clotting found; optical
exceeded test 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 software error Contact technical Service


recursive

All errors will cancel the current measurement.

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User Manual Coagulyzer 1 Safety in Operation

5.2.3 Errors during operation

Error Cause Remedy


Cannot start analyser Main voltage failure? Fuse defect? Check if main voltage available
Is the power adapter correctly connected? and check power adapter
Analyser fails during Main voltage failure? Fuse defect? Check if main voltage is available
operation Is the power adapter correctly connected? and fuses working correct.

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.

5.2.5 How to change fuses


Do not change fuses in the external power adapter or inside the analyser.
Contact your distributor if problems occur with the power adapter or the
instrument itself.

Rev. 1.1 Page 43


User Manual Coagulyzer 1 Appendix

6 APPENDIX

6.1 Disposables

Material Order number

Cuvettes
Cuvettes FL45 in Dispo-System CG0451
5 x 100 Cuvettes / Mixer 1,0 x 4,0mm

Cuvettes FL45 in plastic bag CG0452


1x 500 Cuvettes + Mixer 1,0x4,0mm in plastic vial

Cuvettes FL45 in plastic bag CG0453


5x 500 Cuvettes + Mixer 1,0x4,0mm in plastic vial

6.2 Materials Supplied


Material Order number

1 x Coagulyzer 1 CG0001

1x 10 Cuvettes + mixer
1x Plastic vial
1x Power Supply 100V–240V (Europe/USA/Japan)
1x Operator Manual

Page 44 Rev. 1.1


User Manual Coagulyzer 1 Appendix

6.3 Technical Data

Instrument type Analyser 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 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)

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User Manual Coagulyzer 1 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 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.

Exclusions of manufacturer’s warranty:


• The use of none permitted peripheral devices, e.g. printer
• Improper use/operating faults and non-adherence to the user instructions
• Attempted repairs by the customer or third-parties without authorization by
manufacturer
• Defective maintenance by third parties
• Device defects due to power failure, heat losses or similar reasons
• Accidents, storms, lightening, fire, water/other liquids, other natural
catastrophes, theft, riots, plundering, the effects of war or other instances
of acts of god.
• Device caused by transportation/shipping.
• The use of third party components, unauthorized consumables or
accessories which do not comply to manufacturers specifications.
• Non-authorised system changes
• Resetting safety functions, deletion of passwords etc.
• Loss of customer data or software from repair and installation processes
• Improper use of machine capacity or output
• Inappropriate customer operating environment
• Products from which the category plates, serial numbers, part numbers on
the machine or machine parts have been removed or changed.
• Wear and tear appearances at components like for example LCD.
• Breaks and scratches, dirtying on e.g. LCD displays or dirtying of the
measuring channels.

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User Manual Coagulyzer 1 Appendix

6.4 Safety Specifications

This instrument conforms to the applicable European Directives.


The instruments described in this manual bear a CE mark which confirms
the compliance with the essential requirements of the following European
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’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

The instruments are produced in accordance with

EN55011:2007 + A2:2007, EN61326-2-6:2006, EN 61000-3-2:2006, EN


61000-3-3:1995 + A1:2001 + A2:2005, EN 61000-6-3:2007, EN 61000-6-
2:2005, EN60601-1-2:2007; EN591:2001

EN61010-1:2001, EN61010-2-101:2002

Rev. 1.1 Page 47


User Manual Coagulyzer 1 Appendix

6.5 Mathematics

Computation of PT %
1
(( meas. time-100 % time)/factor)+0.01) = 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.

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

Page 48 Rev. 1.1