User manual coagulyzer 1 GB v1 1

Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu

User Manual

For in-vitro diagnostic use only!

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

Version Manual Date

(mm/dd/yy)

Analyser Software-Version - Release -

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

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

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

INTRODUCTION

The Analyser

4

Incubation block 37°C:

- 4 positions for cuvettes

- 1 position for reagent bottle

- 1 measuring channel with light protection cap

Name plate (underneath)

Figure 1 The Analyser

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

Start-key: manual testing

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

INTRODUCTION

1.3 Hazard and Precautions

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

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

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

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:

Do Not Reuse

Separate collection, handling and disposal for waste electrical and electronic equipment and its components

Fuse

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

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

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

Other things you may need to or

must take into consideration:

Utilize reagents and controls only according to directions as provided

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

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

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 analyser according to the required ambient conditions Protect the measuring channels from direct sunlight or other light sources

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

SOFTWARE

3.1 Software overview

Figure 5 Software Overview

Analyser name Power ON Initialising WARM UP Remove cuvettes then press any key auto blanking keep channels clear

< 1 PT >

SOFTWARE

3.2 Flow Chart of different application methods

Figure 6 Test procedures for single and double determination

Flow chart to set single or double determination at the analyser

Test steps for double determination

Test steps for single determination

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

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

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

• 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

The changing display will show the

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 the existing cuvette from the measuring channel and close the light protection caps

• Press any key (e.g Enter) for confirmation

OPERATION

<-auto blanking keep channels clear

The measuring channel will be adjusted for automatic cuvette detection (Time requirement: approximately 10 seconds)

No cuvettes must be in the measuring channels when saving the 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

< 1 PT >

The selected method will be displayed

• Press Enter to access the measuring mode

• Press Esc to return to STANDBY

A request for sample incubation will be displayed

cuv in

If there is no action the next 10 minutes, automatically the display will change to the STANDBY mode and show the actual temperature

37.4°C

OPERATION

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 parameterization

PT-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

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:

• 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

An acoustic signal indicates the recognition of clotting in a measuring channel and stops the timer

OPERATION

• 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

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:

• 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

An acoustic signal indicates the recognition of clotting in a measuring channel and stops the timer

Once the second measured value has been obtained, the mean from the measured values will be determined and converted into %, ratio, and INR via the entered calibration curve

OPERATION

The results will be displayed consecutively for duration of 5 sec The printer

will automatically print the results The last message cuv out then press

"Reset" will request the removal of the cuvettes from the measuring

channels

If ratio is selected under 2nd conversion, ratio will be displayed instead of INR

• Open the light protection cap

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

Reset-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

Methods can only be changed from STANDBY

• Press Esc to switch to STANDBY

• Press the right arrow; the next method aPTT is displayed as

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

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

• 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

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>

<2 conversion>, <replication>, <measurement> and <cuv remove detec.>

Overview PT parameterization:

<1.conversion>

<2.conversion>

OPERATION

and sample incubation time

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

OPERATION

The following display appears once the last calibration curve point has been confirmed:

• 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

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

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

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

additional parameters

ratio

< ratio >

• Press Enter to confirm the entry

• Press Enter to confirm the entry

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

< replic >

• Press Enter

• 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

• Enter the coefficient of variation

• Press Enter to confirm the entry