manual coagulometer

USER MANUAL

Date: 2022.03.25. Version number: 1.0

Document Reference Number: 140500037AEN
The document corresponds to v1.0 software versions.
© 2020. ALL RIGHTS RESERVED. DIAGON Ltd. H-1047 Budapest, Baross u. 48-52.

2 Coag 4D Plus User Manual v 1.0

 Table of contents

Table of Contents
1. INTRODUCES AND .................................................................................................................................... 6
1.1. CONTACT ADDRESS ..................................................................................................................................... 6
1.2. LEGAL DECLARATION ................................................................................................................................... 7
1.3. LIMITED GUARANTEE ................................................................................................................................... 7
2. PACKAGE CONTENTS, ACCESSORIES ......................................................................................................... 8
3. SYMBOLS USED ON COAG 4D PLUS, ACCESSORIES AND PACKAGING ....................................................... 9
3.1. DATA TABLE MARKINGS................................................................................................................................ 9
3.2. MARKINGS ON THE COVER OF THE APPLIANCE................................................................................................. 10
3.3. MARKINGS ON ACCESSORIES ....................................................................................................................... 10
3.4. INDICATIONS FOR OUTER PACKAGING ............................................................................................................ 10
3.5. COMPUTER INTERFACE SIGNALS ................................................................................................................... 10
4. SAFETY REQUIREMENTS......................................................................................................................... 11
4.1. MARKINGS RELATED TO SAFETY REGULATIONS ................................................................................................ 11
4.2. NORMAL CONDITIONS OF USE ..................................................................................................................... 11
4.3. GENERAL INFORMATION FOR USE ................................................................................................................. 12
4.4. INSTALLATION OF THE COAG 4D PLUS COAGULOMETER ................................................................................... 12
4.5. USAGE INFORMATION ABOUT THE ELECTRICITY NETWORK ................................................................................. 13
4.6. ACCIDENT RISKS AND ACCIDENT PREVENTION.................................................................................................. 13
4.7. STOP THE WORKING IN EMERGENCY ............................................................................................................. 13
4.8. PRECAUTIONARY MEASURES ....................................................................................................................... 14
4.9. SAFE HANDLING OF REAGENTS ..................................................................................................................... 14
5. TECHNICAL DESCRIPTION ....................................................................................................................... 15
5.1. MEASUREMENT PRINCIPLE.......................................................................................................................... 16
5.1.1. COAGULOMETRIC MEASUREMENTS .......................................................................................................... 16
5.1.2. CHROMOGENICITY MEASUREMENTS ......................................................................................................... 16
5.1.3. IMMUNOLOGICAL MEASUREMENTS (LATEX AGGLUTINATION) ........................................................................ 16
5.2. DATA EVALUATION AND CONTROL PROCESSES ................................................................................................ 17
5.3. APPROPRIATE OPERATING CONDITIONS ......................................................................................................... 17
5.4. QUALITY CONTROL PROCESSES..................................................................................................................... 17
5.4.1. ELECTRONIC SELF-CHECKING FOR THE FOLLOWING FUNCTIONS....................................................................... 17
5.5. TECHNICAL DESCRIPTION ............................................................................................................................ 18
5.6. SAMPLES................................................................................................................................................. 18
5.7. ELECTROMAGNETIC COMPATIBILITY (EMC) ................................................................................................... 18
5.8. ELECTRONIC DEVICE SECURITY (2014/35/EU ANNEX I)................................................................................... 19
5.9. STORAGE AND TRANSPORT CONDITIONS ........................................................................................................ 19
6. PARTS OF THE COAG 4D PLUS COAGULOMETER .................................................................................... 20
6.1. POWER SUPPLY CONNECTION ...................................................................................................................... 20
6.2. USB AND ETHERNET CONNECTION ............................................................................................................... 21
6.3. REAGENT SPACE ....................................................................................................................................... 21
6.4. CELLULAR INCUBATOR ............................................................................................................................... 21
6.5. MEASURING SITES..................................................................................................................................... 21
6.6. USED CUVETTE MANAGEMENT .................................................................................................................... 21
6.7. LOCATION OF WARNING AND INFORMATION MARKINGS ON THE DEVICE ............................................................... 22
7. INSTALLATION OF COAG 4D PLUS .......................................................................................................... 22

Coag 4D Plus User Manual v 1.0 3

 7.1. OPERATING CONDITIONS ............................................................................................................................ 22
7.2. IMPORTANT OPERATIONAL INFORMATION...................................................................................................... 23
7.3. MOVING, UNPACKING AND PLACING THE COAG 4D PLUS ................................................................................. 23
7.4. PRINTER CONNECTION (OPTIONAL)............................................................................................................... 23
7.5. ONLINE CONNECTION ................................................................................................................................ 23
7.6. PROTECTING YOUR COAG 4D PLUS COMPUTER SECURITY ................................................................................. 24
8. OPERATING COAG 4D PLUS .................................................................................................................... 25
8.1. STARTING UP THE SYSTEM .......................................................................................................................... 25
8.2. DEVICE INTERFACE (INTERFACE) ................................................................................................................... 25
8.3. SWITCHING ON THE COAG 4D PLUS COAGULOMETER ...................................................................................... 26
8.4. STRUCTURE OF THE MAIN MENU .................................................................................................................. 27
8.5. FUNCTIONS OF THE MAIN MENU ................................................................................................................. 27
8.6. FUNCTIONS OF THE CONTROL LINE................................................................................................................ 28
8.7. SWITCH OFF............................................................................................................................................. 28
8.8. SPECIFYING A USER ................................................................................................................................... 29
8.9. SYSTEM .................................................................................................................................................. 30
9. REAGENT HOLDERS AND REAGENTS ...................................................................................................... 31
9.1. REAGENT HOLDER ..................................................................................................................................... 31
9.2. PLACEMENT OF REAGENTS .......................................................................................................................... 31
9.3. ADDING THE REAGENTS TO THE CATALOGUE ................................................................................................... 31
10. CATALOGUE MENU ............................................................................................................................ 34
10.1. FILTERING FOR DIFFERENT PRODUCT GROUPS ................................................................................................. 34
10.2. OTHER OPERATIONS IN THE CATALOGUE MENU .............................................................................................. 35
10.3. DELETE ................................................................................................................................................... 35
10.4. ADD A NEW PRODUCT................................................................................................................................ 35
11. TEST SETTINGS MENU ........................................................................................................................ 36
11.1. ANALYSIS ................................................................................................................................................ 36
11.2. REACTION ............................................................................................................................................... 37
11.3. CALIBRATION ........................................................................................................................................... 38
11.4. CONTROL ................................................................................................................................................ 39
11.5. OUTPUT FROM ......................................................................................................................................... 39
11.6. REPEAT................................................................................................................................................... 41
11.7. VIEW AND MODIFY THE PARAMETERS OF DEFINED TESTS ................................................................................... 41
11.8. DELETE DEFINED TEST ................................................................................................................................ 41
11.9. PRINT THE PARAMETERS OF THE DEFINED TESTS .............................................................................................. 41
12. CALIBRATION MENU .......................................................................................................................... 42
12.1. MASTER CALIBRATION ............................................................................................................................... 42
12.2. MANUAL CALIBRATION .............................................................................................................................. 42
12.3. PRINT CALIBRATION DATA ........................................................................................................................... 43
12.4. CLEAR CALIBRATION DATA .......................................................................................................................... 43
12.5. CALCULATION OF THE SHARE ....................................................................................................................... 44
13. QC MENU........................................................................................................................................... 45
13.1. START CONTROL MEASUREMENTS ................................................................................................................ 45
13.2. OVERVIEW OF CONTROL MEASUREMENTS ...................................................................................................... 46
13.3. CONTROL MEASUREMENT DATA................................................................................................................... 46
13.4. SELECT AND DELETE CONTROL RESULT ........................................................................................................... 47
13.5. PRINT FROM ............................................................................................................................................ 47
13.6. CHANGE RANGE ....................................................................................................................................... 47
13.7. CATALOGUE MENU ................................................................................................................................... 47
13.8. SAVE TO.................................................................................................................................................. 47

4 Coag 4D Plus User Manual v 1.0

14. MEASUREMENT ................................................................................................................................. 48
14.1. SAMPLE IDENTIFICATION ............................................................................................................................ 48
14.2. STARTING THE MEASUREMENT .................................................................................................................... 48
14.3. ORDER TEST REQUESTS FOR SAMPLE TUBES .................................................................................................... 48
15. RESULTS MENU .................................................................................................................................. 49
15.1. PREPARING THE MEASUREMENT .................................................................................................................. 49
15.2. THE MEASUREMENT PROCESS...................................................................................................................... 49
15.3. INDICATION OF MEASUREMENT PHASES ......................................................................................................... 49
15.4. RESULTS MANAGEMENT ............................................................................................................................. 50
15.5. SAVE RESULTS .......................................................................................................................................... 50
16. SAVED RESULTS MENU ...................................................................................................................... 51
17. SYSTEM MENU................................................................................................................................... 52
18. MAINTENANCE .................................................................................................................................. 53
18.1. STEPS BEFORE CLEANING: ........................................................................................................................... 53
18.2. CLEANING OF MEASURING CELLS .................................................................................................................. 53
18.3. CLEANING INCUBATION SITES AND REAGENT HOLDERS ...................................................................................... 54
18.4. CLEANING SURFACES ................................................................................................................................. 54
19. MESSAGES AND ERROR MESSAGES ................................................................................................... 55
19.1. MESSAGES IN ALPHABETICAL ORDER ............................................................................................................. 55
20. WASTE MANAGEMENT ...................................................................................................................... 56
21. APPENDIX "A" - ORDERING AND SERVICE INFORMATION .................................................................. 57
21.1. HOW TO ORDER PARTS .............................................................................................................................. 57
21.2. INFORMATION ABOUT THE MANUFACTURER ................................................................................................... 57
21.3. GUARANTEE ............................................................................................................................................ 57
22. APPENDIX 'B' - ERROR MESSAGES NEXT TO SIGNALS AND RESULTS................................................... 58

Coag 4D Plus User Manual v 1.0 5

 1. Introduces and

Thank you for choosing the Coag 4D Plus coagulometer from Diagon Ltd.

The Coag 4D Plus coagulometer is a 4-channel semi-automated in vitro diagnostic device that tests
human plasma samples rapidly and with outstanding accuracy. It is suitable for coagulation time
detection, chromogenic and immunological assays. Measurements can be performed from centrifuged
plasma samples, anticoagulated with Na-citrate, prepared according to specifications of standard
sampling. The built-in thermal printer is suitable for printing the measured results.

To fully understand and use the coagulometer correctly, please read the enclosed user manual.

1.1. Contact address

Diagon Ltd.

1047 Budapest, Baross utca 48-52. 1325 Újpest, Pf. 41.

tel.: (+36 1) 369 6500 e-mail: [email protected]
fax: (+36 1) 369 6301 www.diagon.com
Hungary

Ordering supplies, replacement parts and consumables:

To order stock, replacement parts and consumables, please contact us at [email protected].

Service and maintenance:

In the event of a malfunction or periodic maintenance, please contact us at [email protected].

Validity of the instructions for use:

All information in this manual refers to the Coag 4D Plus coagulometer and accessories manufactured by
Diagon Ltd. The software version number is 1.0.

All brand names, product names and trademarks belong to the owner.

6 Coag 4D Plus User Manual v 1.0

 1.2. Legal declaration

All products, graphics, displays, screens, etc. shown in print are for informational and illustrative
purposes and should not be used for clinical investigation. The data on the findings and screens are not
based on actual patients and test results.

The information has been prepared so that it may be used by personnel trained by Diagon Ltd, by other
persons knowledgeable or skilled in the operation and services of the product described herein, or under
the direct supervision or with the cooperation of Diagon Ltd technical sales or service representatives.

In no event shall Diagon Ltd or its affiliates be liable for any damage or loss caused by or in connection
with the use of the information contained herein by persons not fully trained by Diagon Ltd. This
limitation does not apply to persons or persons who are familiar with the operation and services of the
product contained herein or who work under the direct supervision of or in cooperation with Diagon Ltd
technical sales or service representatives.

It does not constitute a relationship of trust if any person using the information responds to Diagon Ltd
verbally, in writing or electronically (e.g., provides feedback, asks questions, makes suggestions, offers
ideas, etc.). Any such response or any information submitted in connection therewith shall be deemed
to be non-confidential and Diagon Ltd shall be free to reproduce, disclose or otherwise use such
information for any purpose, including, but not limited to, research, development, manufacture, service,
use or sale of products. The person who submits the information to Diagon is fully responsible for its
content, including its truthfulness, accuracy, and that it does not infringe the proprietary rights of any
other person.

Diagon Ltd does not engage in the provision of medical advice or services.

The information in this manual can be updated in paper or electronic form. Always refer to the most
recent document for the most up-to-date information.

Due to successive updates of the manual, the initial table of contents or page numbering may change.

No part of this material may be reproduced, stored, retrieved or transmitted in any form or by any means
without the prior written permission of Diagon Ltd.

1.3. Limited guarantee

The distributor provides a guarantee in accordance with the distributor's own laws.

Coag 4D Plus User Manual v 1.0 7

 2. Package contents, accessories

NUMBER OF
NAME PIECES PER
PACKAGE
COAG 4D PLUS COAGULOMETER 1 pc
POWER SUPPLY (ATS050T-A091) 1 pc
POWER CORD 1 pc
USB TO SERIAL PORT CONVERTER 1 pc
MAGNETIC ROD (2pcs) 1 pc
USER MANUAL 1 pc
REAGENT VIAL ADAPTER (for 22mm vial) 2 pieces
THERMAL PAPER 1 pc
PEN FOR TOUCH SCREEN 1 pc
CUVETTE (1X500 PIECES) 1 pc
DUST COVER 1 pc
Table 1 - Package contents and list of accessories

Ordering details for accessories, consumables, coagulation reagents, calibrators and controls that can be
ordered from the manufacturer are given in APPENDIX A.

8 Coag 4D Plus User Manual v 1.0

 3. Symbols used on Coag 4D Plus, accessories and packaging
3.1. Data table markings

Computer interface markings

Production number

Catalogue number

In Vitro Diagnostic Device

CE conformity marking

Read the user instructions

Warning in the user manual

Manufacturer name and address

Not to be disposed of in landfills, to be

treated as special waste

Coag 4D Plus User Manual v 1.0 9

 3.2. Markings on the cover of the appliance

Biological hazard

3.3. Markings on accessories

Single-use device

3.4. Indications for outer packaging

Fragile

Protect from water

Permitted storage, transport situation

Permissible storage, transport temperature range

Permissible storage, transport humidity range

3.5. Computer interface signals

LAN output (1pc) USB connector (4 pcs)

10 Coag 4D Plus User Manual v 1.0

 4. Safety requirements
Before using the appliance, please read the enclosed instructions carefully. Read the instructions before
installing the Coag 4D Plus and follow them during installation and use. Keep the instruction manual
and keep it close to the unit!

4.1. Markings related to safety regulations


A general warning sign. It may warn of information of particular importance in
the instructions for use, the possibility of an event leading to damage to the
system or an incorrect measurement result

General source of danger - the symbol is followed by a description of the source

! of danger and what you need to know about it.

Serious or life-threatening source of danger - the symbol is followed by a

description of the source of danger and what to know about it.

Risk of infection - the symbol is followed by a description of the source of the

hazard and information about it.

A message identifying the source of a hazard and providing specific

information for the prevention or elimination of the hazard.

4.2. Normal conditions of use

The Coag 4D Plus coagulometer is designed for in vitro diagnostic use only.
The primary test sample is a centrifuged plasma sample prepared from
Na-citrate anticoagulated human whole blood. Any other use is not considered as intended. The risk of
erroneous results and/or damage to the instrument is substantially reduced when the permitted reagents,
and cuvettes are used. These are listed in Appendix A of this user manual or at www.diagon.com. Proper
conditions of use include compliance with the cleaning and maintenance procedures described in this
user manual

Coag 4D Plus User Manual v 1.0 11

  The Coag 4D Plus coagulometer is an in vitro diagnostic device for professional
use (by a healthcare professional) according to Directive 98/79/EEC.

4.3. General information for use

■ The unpacking, setting up and installation of the device is the responsibility of the Diagon
representative.
■ Operators should not disturb the outer casing of the appliance or touch the units, parts and circuits
inside the appliance.
■ If the appliance emits any unusual smell or smoke, or if you notice any malfunction, immediately
turn off the main switch, unplug the power cord and contact your local service centre immediately.
■ Be careful not to pour samples, reagents or other liquids inside the instrument, as foreign objects
or liquids may cause a short circuit or fire. If this should occur and the instrument fails,
immediately switch off the instrument using the main switch, disconnect the mains power cord
and contact your local service centre.

4.4. Installation of the Coag 4D Plus coagulometer

■ The device is designed for indoor use only. Do not use outside buildings or in uncovered areas.
Protect from rain, dust and direct sunlight.
■ The appliance must be positioned so as to ensure easy access to the main switch and the power
cord plugged into the mains socket or uninterruptible power supply.
■ The appliance must be installed so that it is not exposed to rain, dust, harmful influences, radiant
heat and high humidity.
■ The appliance should only be placed on a level and vibration-free surface with adequate load-
bearing capacity.
■ The appliance should be installed in a well-ventilated area.
■ Avoid placing devices that emit electromagnetic radiation or cause electrical interference in the
immediate vicinity of the Coag 4D Plus. Do not use the device near electrical wiring.
■ Do not install the appliance near chemical storage units, gas containers or other sources of gas
(e.g. oxygen, hydrogen, anaesthetic/suppressant gases) or in an environment where there is a
risk of contact with flammable gases.
■ Only standard equipment recommended by the manufacturer may be connected to the Coag 4D
Plus coagulometer.
■ Only use the standard and intact connection cable recommended by the manufacturer for the
connection between the device and external IT devices.

12 Coag 4D Plus User Manual v 1.0

 4.5. Usage information about the electricity network

■ The device can only be used with the network specified in the data
ATS050T-A091 type adapter and to an electrical mains supply with the specified parameters.
Please note that the appliance must be earthed, otherwise there is a risk of fire and electric shock.
■ Do not damage the power cord, place heavy objects on it or use excessive force when
unplugging it, otherwise there is a risk of fire or electric shock from a short circuit or broken
cord. If the power cord is damaged, contact your local service centre.
■ The appliance should only be connected to a suitable mains socket outlet that is earthed. Use
only and exclusively with a power cord that complies with the local standard supplied with the
appliance.
■ If you intend to connect any peripheral device to the Coag 4D Plus, please switch off the power
using the power button on the back of the device, otherwise there is a risk of electric shock or
device malfunction.

4.6. Accident risks and accident prevention

■ Strictly observe local safety and health regulations when operating the device!
■ The barcode readers that can be connected to the Coag 4D Plus emit a low-energy laser beam.
The laser light can cause pain or even permanent damage if it enters the eye directly. Avoid
direct laser light entering the eye.

4.7. Stop the working in emergency

If an emergency stop is required at any time during operation, turn off the switch on the back of the
appliance. In this case the measurement will be lost and must be repeated.

 Warning: the data of the currently running measurement will be lost. Coag 4D Plus
stores the necessary information in the backup folder.

If you have switched off the appliance during operation due to an emergency, you must eliminate the
cause of the fault before restarting it.

Coag 4D Plus User Manual v 1.0 13

 4.8. Precautionary measures

■ The entire surface and components of the appliance must be considered potentially infectious.
■ Blood samples are classified as biohazardous material, so always wear protective gloves when
handling samples.
■ Make sure that the reagents do not come into contact with mucous membranes or skin.
■ Controls and calibrators should also be considered potentially infectious. When using them, the
required protective equipment must be used.
■ Never touch liquids or solid waste generated by the operation of the appliance, always wear
gloves and other protective equipment as required. If you do come into contact with potentially
infectious substances or surfaces, wipe the affected skin with a dry cloth, wash with plenty of
water and follow the disinfection procedures prescribed by the laboratory.
■ If infectious fluid or solid waste gets into an open wound or on mucous membranes, flush
thoroughly with plenty of water and seek medical attention immediately.
■ To prevent contamination and infection, follow the rules when removing liquid or solid waste
from the appliance.
■ Eating, drinking or smoking near the appliance is strictly prohibited!

4.9. Safe handling of reagents

!
■ In all cases, follow the instructions for use in the reagent box and the instructions on the
reagent labels.
■ Always store reagents at the temperatures specified in the instructions for use.
■ If no tests are to be performed for a long period of time, the reagents should be stored in a
refrigerator with a closed lid to ensure storage stability of the reagents. Improper storage may
adversely affect the results of the measurements.
■ Take care not to contaminate the reagent with dust or infectious substances.
■ Reagents should never be used after their expiry date. Expired reagents and the resulting reagent
waste should always be disposed of in accordance with the hazardous waste management
regulations.
■ Avoid direct contact with reagents, as they can cause irritation of the skin and mucous
membranes.
■ If a reagent gets on your skin, immediately wipe off with a dry cloth and rinse the affected
area with plenty of water.
■ If a reagent gets in your eyes, rinse immediately with plenty of running water and seek
medical advice.
■ If you swallow the reagent, vomit by drinking large amounts of warm, salt water and seek
medical attention.
■ Always wear protective gloves and local protective equipment when handling samples and
reagents. Wash hands with disinfectant after completing measurements to avoid the risk of
infection.
■ For more information on the reagents, please refer to the user guide supplied with the reagents
or visit www.diagon.com. Please note that the range of products is subject to change, so please
contact the manufacturer directly or visit the above website for the current range.

14 Coag 4D Plus User Manual v 1.0

 5. Technical description
The Coag 4D Plus is a 4-channel optical coagulometer. It is suitable for the detection of coagulation,
chromogenic1 and immunological2 assays from Na-citrate anticoagulated and properly prepared plasma
samples. The device is suitable for a wide range of coagulometric, chromogenic and immunological
tests:

■ Prothrombin time (PT)

■ Activated Partial Thromboplastin Time (APTI/APTT)
■ Trombin Time (TT)
■ Fibrinogen (Fib)
■ Factor tests (II, V, VII, X, VIII, IX, XI, XII)
■ Antithrombin III,
■ Protein C,
■ Protein S,
■ D-Dimer
■ Lupus Anticoagulant (LA)
■ other tests specified by the user

The results should always be evaluated in the light of the clinical

background and in conjunction with the results of other studies!

1
2 optical measuring channels designed for this purpose
2
2 optical measuring channels designed for this purpose

Coag 4D Plus User Manual v 1.0 15

 5.1. Measurement principle

The principles of the measurements that can be performed on the Coag 4D Plus coagulometer are as
follows:

5.1.1. Coagulometric measurements

The procedure for coagulometric measurements is as follows: a defined volume and temperature of
reagent is added to a defined volume of plasma incubated for a defined time. The addition of the reagent
starts the coagulation process. When the clot is formed, certain optical characteristics of the sample are
altered.

The coagulation process can be detected by several methods. Among these, the Coag 4D Plus
coagulometer uses the nephelometric method, i.e. it follows the variation of scattered light at a given
wavelength (640nm). During the coagulation process, the intensity of the scattered light increases and
a sigmoidal curve is obtained. At the end of the measurement, by finding the coagulation point of the
coagulation curve, the coagulation time (in seconds) associated with the curve is obtained.

Prothrombin time (PT) CV≤2%

Activated Partial Thromboplastin Time (APTI) CV≤2%

Trombin time (TT) CV≤5%

Fibrinogen (Fib) CV≤5%

Factor tests (II, V, VII, X, VIII, IX, XI, XII) CV≤5%

Table 2 - Expected performance characteristics for coagulometric measurements

5.1.2. Chromogenicity measurements

The procedure for chromogenic measurements is to add a known amount of a substrate (chromogen)
that induces the formation of a colour reaction product to a given amount of plasma incubated for a
specified time. When the reagent is added, the colour reaction between the test coagulation enzyme and
the substrate in the sample is initiated. This colour reaction is detected by the Coag 4D Plus
coagulometer at 405 nm by following the change in transmitted light (photometry). At the end of the
measurement, the change in absorbance per unit time (OD/min) is obtained from the optical curve. The
intensity of the colour change is concentration dependent and therefore requires calibration.

Antithrombin III CV≤5%

Table 3 - Expected performance characteristics for chromogenicity measurements

5.1.3. Immunological measurements (Latex agglutination)

The procedure for immunoassays: a known amount of plasma incubated for a defined period of time is
added to a known amount of plasma containing a known amount of latex microspheres coated with
antibodies. The addition of the reagent to the sample triggers agglutination of the coagulation enzyme
or product being tested and the antibody raised against it. The Coag 4D Plus coagulometer detects the
agglutination process by following the change in transmitted light at a given wavelength (570 nm)
(turbidimetry). The optical curve at the end of the measurement gives the change in absorbance (ΔOD)
during the measurement process. The intensity of the change in turbidity due to agglutination is
concentration dependent and therefore requires calibration.

D-Dimer CV≤10%

16 Coag 4D Plus User Manual v 1.0

 Table 4 - Expected performance characteristics of immunological measurements

5.2. Data evaluation and control processes

During the measurement, the system analyses the measurement curve. The complete curve is analysed
at the end of the measurement. It is important that any deviation of the measurement curve is detected
by the system before the results are displayed and that error messages are issued if this is the case.
The following cases occur:
- no disqualification, a valid result is displayed,
- one or more errors occur, the result is displayed with error messages,
- will not display results for a reason, but error messages and error messages will.
Explanations of the various error messages and error messages are given in Appendix B.

5.3. Appropriate operating conditions

Operating temperature range Between 15 °C and 30 °C

Relative humidity Between 20 and 85%

Maximum operating height 2000 m
Horizontal table surface with minimum dimensions of 40 x 50
Location
cm

5.4. Quality control processes

The safe operation of the Coag 4D Plus coagulometer is ensured by internal and external quality control
functions.

5.4.1. Electronic self-checking for the following functions

■ Control electronics: computer, memory, touch screen
■ Optical system: light sources, detectors
■ Temperature control: measuring block, reagent holder/cuvette incubator

The appliance must always be operated only by a qualified person

trained in the safe operation of the appliance in accordance with
Directive 98/79/EEC.

WARNING!

An instrument that is not properly maintained/maintained may give an abnormal measurement error,
which may endanger human health.

Make sure that the measuring instrument is used under the conditions specified in the instructions. If
the measuring instrument is used in conditions other than those under which it is intended to be used,
the measuring instrument may not function properly and the measurement results may be unreliable.
This may damage the analyser components and cause personal injury.

Coag 4D Plus User Manual v 1.0 17

 5.5. Technical description

Measurement methods Photometry 405 nm

Turbidimetry 570 nm
Nephelometry 640 nm

Measurement speed max 60 PT / hour depending on the user

Sample treatment manual pipette
Sample identification Barcode scanning or manual data entry
Reagent intake Barcode scanning or manual data entry
Memory Storage of more than 1.000.000 measurement results and their curves,
by identification number, date and time of measurement
Interface 4 USB ports, network port, 1 Ethernet port
Interface 7" colour touch screen
Network adapter Input: 100-240V, 50-60Hz, 1.2A
Type: ATS050T-A091 Output: 9 V DC, 5 A
Coag 4D Plus input feed 9 V DC, 5 A
Dimensions width: 210 mm, depth: 362 mm, height: 83 mm
Mass 4,2 kg
Table 5 - Technical information

5.6. Samples

Sample type 3,2 % Na-citrate anticoagulated plasma in primary sampling tube and
secondary sample container

Sample volume 5-200 µl

5.7. Electromagnetic compatibility (EMC)

Product name Coag 4D Plus coagulometer

Certificate number. EMC 80210048

Investigations EN 61326-1:2013
EN 61326-2-6:2013
EN IEC 61000-3-2:2019
EN 61000-3-3:2013+A1:2019

The Coag 4D Plus coagulometer meets the electromagnetic compatibility requirements of EN 61326-1
and EN 61326-2-6.

This instrument is designed for industrial (laboratory) use and has been tested according to EN 55011
Class A equipment. In a domestic environment this equipment may cause radio interference and must
be protected against such interference.

Do not use in a home environment! Do not use this instrument near strong radiation sources, otherwise
the normal operation of the instrument may be disturbed.

18 Coag 4D Plus User Manual v 1.0

 5.8. Electronic device security (2014/35/EU Annex I)

Product name: Coag 4D Plus coagulometer

Certificate number PC-2021-021

Investigations MSZ EN 61010-1:2011+A1:2020 (IEC 61010-1:2010+AMD1:2016)
MSZ EN 61010-2-101:2017 (IEC 61010-2-101:2015)

5.9. Storage and transport conditions

Temperature range: -20°C to 50°C

Relative humidity: Between 20% and 85%

Coag 4D Plus User Manual v 1.0 19

 6. PARTS OF THE COAG 4D PLUS COAGULOMETER

Thermal printer

Display (touch screen)

Reagent holder (2 places)

Cell incubator (2x10 places)

Measuring sites (4 coagulation, of which

2 immunological, 2 turbidimetric)

Figure 1 - Main parts of Coag 4D Plus

Used cuvette from the operation of the Coag 4D Plus is considered

hazardous biological waste and must be discarded and disposed of in
accordance with local regulations for waste management and disposal.

6.1. Power supply connection

The mains adaptor socket on the back of the unit is used to connect the ATS050T-A091 9 V DC, 5 A,
adaptor, which can be powered from 100-240V, 50-60Hz, 1.2A. The main electrical switch is located
on the rear of the unit, next to the mains adapter socket.

Adapter connector

4 USB and
1 Ethernet
Main switch

Datastable

Figure 2 - Back of the Coag 4D Plus


The mains adapter must be connected only to a power outlet with a power cord that
complies with local standards and is properly grounded.

20 Coag 4D Plus User Manual v 1.0

 6.2. USB and Ethernet connection

The back of the device has 4 USB 2 and one Ethernet socket for connecting peripherals. These allow
network communication, USB connectivity to clinical laboratory networks and other information
technology (IT) functions to maximise the performance of the Coag 4D Plus. An external computer can
be connected to the instrument via USB or network LAN connection.

6.3. Reagent space

The 2 reagent holders are placed under each other in the middle of the incubator. It contains a magnetic
stirrer tempered at 37 degrees C. It is used for storing reagent bottles with a diameter of 30 mm or
smaller with a restrictor for measuring at 37 degrees C.

6.4. Cellular incubator

There are 20 slots for incubating the cuvettes, twice in groups of 10 above the weighing stations,
allowing easy tracking of the incubation steps according to the workflow.

6.5. Measuring sites

The measuring site consists of 4 nephelometric measuring sites (channels) on the front edge of the
device, of which 2 measuring sites on the right are suitable for turbidimetric measurements and 2
measuring sites on the left are suitable for photometric immunological measurements. The measuring
sites are integrated in a measuring block with electronic temperature control. The optical measuring
system is composed of light emitting diode (LED) light sources and photodiode sensors with a
sufficiently narrow wavelength range per channel. The channels detect sample and reagent introduction,
as well as cuvette insertion and removal, thus ensuring trouble-free operation of this part of the
instrument. The software automatically records the response curves of the measurements run on the
channels.

The measurement wavelengths:

■ Photometry 405 nm (M4-M3)
■ Turbidimetry 570 nm (M2-M1 )

■ Nephelometry 640 nm (M4-M1)

M1 M2 M3 M4
Figure 3 - Measurement sites
6.6. Used cuvette management

Throw used cuvettes in the laundry bag provided with the cuvettes. Once the bag is sealed, it can be
disposed of hygienically in accordance with waste management and disposal rules.

 Used cuvettes generated during the operation of the Coag 4D Plus must be treated
as hazardous waste.

Coag 4D Plus User Manual v 1.0 21

 6.7. Location of warning and information markings on the device

During use, the instrument may come into contact with sample, reagent, calibrator and control and
therefore the surfaces of the instrument are considered biohazardous.

Figure 4 - Biological hazard sign

7. INSTALLATION OF COAG 4D PLUS

 Before installing the Coag 4D Plus coagulometer, please read chapter 7 -

Installing the Coag 4D Plus

7.1. Operating conditions

!
■ For proper positioning of the device, an area at least 50 cm long and 40 cm wide is required.
■ Make sure that the location you choose for the appliance is protected from dust, liquids, solvents,
gas and acid vapour, and shock.
■ Adequate lighting is required for operation, but direct sunlight should be avoided.
■ The ambient temperature range is minimum +15°C and maximum +30°C. Avoid significant
temperature, humidity and voltage fluctuations (see chapter 5.4 Technical specifications). Air
conditioning is recommended for optimum performance and long life of the appliance.
■ Leave at least 10 cm of free space behind the appliance for proper operation and access to
sockets, switches and main switch.

 The appliance must be positioned so that the main switch is always accessible.
In the event of an emergency, the appliance must be disconnected from the
mains immediately.

22 Coag 4D Plus User Manual v 1.0

 7.2. Important operational information


■ The appliance should only be connected to an electrical outlet that is properly grounded.
■ Always use the standard and intact connection cable recommended by the manufacturer for the
connection between the device and the external IT.
■ Only standard equipment recommended by the manufacturer may be connected to the
coagulometer.
■ The electrical cable must comply with national standards.
■ It is recommended to use only the fuses specified by the manufacturer. See the data plate on the
back of the appliance for information.
■ Do not throw away or destroy the packaging, keep it for possible future transport. Store away
from heat and moisture. If you do decide to dispose of the packaging, follow local waste disposal
regulations.

7.3. Moving, unpacking and placing the Coag 4D Plus

When you unpack your device, make sure that it has not been damaged in transit and that all accessories
are intact (see chapter 2. Contents of the package, accessories).

 Follow the instructions in this chapter before connecting the appliance to the
mains.

If you notice any damage to the device or if the parts and accessories supplied do not match the list of
accessories (see chapter 2. Package contents, accessories), contact the distributor or the manufacturer.

Make sure that the device is not damaged during unpacking. Do not operate the Coag 4D Plus with
damaged parts. Damaged parts should only be replaced by a qualified service technician before putting
into service.

7.4. Printer connection (optional)

In addition to the Coag 4D Plus coagulometer's internal thermal printer, you can optionally connect a
printer via the USB ports on the back of the interface panel and print test results. The printer is supplied
with a USB cable for using the printer. Install the printer according to the instructions provided with the
printer. The recommended printers are Windows compatible printers with a USB port.

7.5. Online connection

To get the most out of the Coag 4D Plus, the instrument should be connected to a clinical laboratory
network via the mains or USB connector on the back panel. For online fitting, please ask the local
laboratory network maintenance technician to work with the technician sent by the Coag 4D Plus
manufacturer or distributor.

 Only use the standard and intact connection cable recommended by the
manufacturer to connect the Coag 4D Plus to external information technology
(IT) devices.

Coag 4D Plus User Manual v 1.0 23

 7.6. Protecting your Coag 4D Plus computer security

The Coag 4D Plus is protected and controlled by the operating system and installed software and
protection software to ensure safe operation.


Do not remove or inactivate the software.
Do not download or install any other software on the Coag 4D Plus.
The manufacturer is not responsible for damage caused by other programs.
Ask your service provider to check the software during preventive
maintenance.

24 Coag 4D Plus User Manual v 1.0

 8. OPERATING COAG 4D PLUS

 Before using the coagulometer, read Chapter 8 - Operating the Coag 4D Plus
to prevent damage, injury or misuse.

8.1. Starting up the system

Before turning on the printer for the first time, remove the blanket, make sure that the thermal paper is
correctly inserted in the printer and that the printer is connected to the correct ATS050T-A091 power
adapter.

Once the device is switched on and the automatic initialisation is complete, the system must be
configured. This consists of the following steps:

■ Setting the system time

■ Setting the system language
■ Local settings
■ Set permissions and passwords

8.2. Device interface (interface)

The touch screen is used for visual display of the software that operates the instrument, for communication
with the user and for manual control of the instrument, such as data input, setting of test parameters, ranges
of values, display of measurement results, validation of software messages. The touchscreen allows the
user to use the displayed optical elements as push buttons, providing a visually supported, clear and easy
to use interface to the instrument control software.
The visible surface of the colour LCD touch screen is 155x85 mm.


1.1.1. Never use an object that could cause irreparable damage to the screen surface
(e.g. a pen or a nail). Please, use your fingertip or a special pen designed for
this purpose.

Coag 4D Plus User Manual v 1.0 25

 8.3. Switching on the Coag 4D Plus coagulometer

Turn the switch on the back of the device to

the ON position to power up the device and the
operating system, and the software will start.

Coag 4D Plus starts the initialisation process

each time the system is started. The self-
testing of the internal parts and peripherals of
the device starts automatically.

Figure 5 - Initialisation

Once the initialisation process is complete, the Coag 4D Plus will warm up and reach operating
temperature.

 DO NOT start the device until it has been properly installed and set up by an
authorised support or service technician.

Once the start-up process (initialisation and

warm-up) is complete, Coag 4D Plus will
display the Main Menu. The current
temperature of the measuring block and the
incubator are displayed in the upper right
corner of the screen. Until the temperature
reaches the correct temperature of 37±0.5ºC,
the temperature displayed is red.

Figure 6 - Warm-up process

When the temperature is in the 37±0.5ºC

range the temperature displayed is green. Then
the temperature of the incubator and the
measuring block is correct.

Figure 7 - The temperature is right

26 Coag 4D Plus User Manual v 1.0

 8.4. Structure of the main menu

Information line

Their main menu

Control line

Figure 8 - Structure of the main menu

■ The information bar at the top of the main screen is the same for all menu items. The information
bar contains the date and time, the menu name and the measuring block and incubator
temperature.
■ The Main Menu interface displays the control buttons for the main menus you can select. The
main menus are Measurement, Results, Catalogue, QC, Test Setup and Calibration. The
corresponding menu button is used to enter the menu.
■ The control bar is located at the bottom of the screen. It displays the software version, the menu
button to log in as a specific user, the service button and the exit button.

8.5. Functions of the Main Menu

- In the Measurement menu, you can select the sample for the test and
perform the measurement. (see chapter 17. Measurement menu)

- The Results menu is for retrieving the accepted measurement results.

(see Chapter 18. Results)

- The Catalogue menu is for retrieving and checking the reagents,

calibrators and controls you have entered. (see ... Catalogue chapter)

- The QC menu is used to perform quality control processes (see chapter

14. QC menu)

You can set the test parameters in the Test Setup menu. (see chapter
12. Test Setup menu)

- The Calibration menu can be used to display calibration data and for
manual data entry (see chapter 13. Calibration menu)

Coag 4D Plus User Manual v 1.0 27

 8.6. Functions of the control line

- Switch off the Coag 4D Plus coagulometer

(see chapter 8.7 Switching off)

- Identify users
(see chapter 8.8 Users)

- Logout users
(see chapter 8.8 Users)

- It allows the user to make a note

- Opens the maintenance function screen

(see chapter 8.9 System)

8.7. Switch off

Before turning off the power switch, the

program must be stopped by pressing the

Power off button .

To avoid accidental shutdowns, the device will
ask for confirmation.
After pressing Yes, the Coag 4D Plus program
will stop.

Figure 9 - Switching off

Then, the appliance can be switched off using the rocker switch on the back of the appliance. After the
instrument is switched off and the power switch is turned off, the incubator and the reagent holder are
also no longer tempered at 37 °C.

28 Coag 4D Plus User Manual v 1.0

 8.8. Specifying a user

Under this menu item, you can enter your user

name and password to log in. The
administrator can define user names and
passwords for different privilege levels. The
authorised user can also change passwords
here.

Figure 10 - Entering a user

To log in, you need an ID and a password.

Enter the ID and password and press OK.

Figure 11 - Login and password

The administrator has the highest user rights.

Administrator, Service and Labor Manager
level privileges are required to define a new
user and to perform non-routine work. When
defining a new user, the user ID, full name and
secret password are required. In the drop-
down window, the associated privilege level
can be selected. Selectable privilege levels are
Service, Labor manager and Assistant.

Figure 12 - New user

Coag 4D Plus User Manual v 1.0 29

If you change your password, you must enter
the old password and then the new password.
The user must then log in with the new
password.

Figure 13 - Change password

The Allow / Deny users function allows the

administrator to define the users who can
access the Coag 4D Plus
.

Manage Users is located in the System menu.

Figure 14 - Allowing and blocking a user

8.9. System

If you are a lab manager or more, you can

choose which task you want to perform by
clicking on the System button in the pop-up
window. For a detailed description of the
System menu, see the Service description.

Figure 15 - System menu

30 Coag 4D Plus User Manual v 1.0

 9. Reagent holders and reagents
9.1. Reagent holder

Two reagent holders are provided for reagents and dilution buffers. The operating temperature of the
reagent holder is 37 +/- 0,5 °C. The current temperature can be read on the right upper part of the screen.
If the temperature is within the acceptable temperature range 37 +/- 0,5 °C, the temperature is displayed
as a green number. If the temperature does not reach or exceeds the permissible range (e.g.: immediately
after switching on until the temperature is set), the temperature is displayed in red. The reagent holder
can accommodate up to 2 reagent bottles (diameter: 30 mm). The small reagent bottle (diameter: 22 mm
and 16 mm) also can be used with the appropriate reducers (in the appropriate positions 30/22; 22/16).

There is reagents, starting reagents and diluents stored at room temperature next to the instrument. (The
temperature is not displayed on the main screen).

9.2. Placement of reagents

The reagent container should be filled with solutions for which it is necessary to have a temperature of
37 °C at the time of measurement. Examples are PT and CaCl2.

To check and load reagents in the catalogue, tap the catalogue menu button in the main menu. The
Catalogue menu then displays a table of reagents, controls, calibrators and other reagents.

In this table, the reagent name (Name), batch number (LOT), reference number (RefNo), expiry date
(Expiry), product group (Type).

9.3. Adding the reagents to the catalogue

Adding of reagents can be started by scanning the so-called vial code (barcode) on the reagent bottle. In
the main menu, use the manual barcode reader by holding the manual barcode reader in front of the
reagent vial. After a successful scan, the barcode reader will beep.
If the reagent is not in the catalogue, the catalogue entry window will pop up.
The catalogue entry window allows you to enter the reagent name Lot number, catalogue number,
.

volume and expiry date.

Figure 16 – Adding reagent

Coag 4D Plus User Manual v 1.0 31

Furthermore, after pressing the Data Sheet
button, you can scan the barcodes on the
accompanying paper with the barcode reader,
which contain the reagent calibration and other
data.

Figure 17 – The lines of the data sheet

The barcodes for the device on the data sheet

must be scanned from top to bottom. After
each bar code has been scanned, the bar code
reader shall beep to acknowledge that the bar
code has been recognised and scanned, and the
sequence of characters corresponding to the
bar code content shall be displayed in the data
entry line. If the scan is not successful, the
screen will inform the user. In this case, this
step must be repeated.

Figure 18 - Scanning the data sheet

When the last barcode has been scanned, the

reagent is catalogued and the Save button
saves the reagent in the catalogue.

Figure 19 - Catalogue entry

After saving the reagent has been added to the

catalogue. The Save button will disappear.

Figure 20 - Reassurance message

32 Coag 4D Plus User Manual v 1.0

If the currently selected reagent is correct,
press OK.

Figure 21 - The selected reagent

You can then start the measurement in the

measurement menu .

Figure 22 - Measurement window

If the scanned reagent can be found in the

catalogue after scanning the vial code, you can
immediately confirm that the reagent is
suitable for the desired measurement in the
Select reagent window of the measurement
menu.

Figure 23 - The selected reagent

After pressing OK, the measurement menu appears (see Figure 22) and you can start the measurement.
Scanning of the start reagents (CaCl2), controls and calibrators can be done in the main menu or in the
measurement menu, as described above.
If a test needs to be calibrated, a window will prompt you to scan the reagents when you apply a new
reagent in the Measurement menu - Calibration Measurements interface. After successful calibration,
the system returns to the screen with the data of the calibration performed. Press the "OK" button to
accept the calibration data.
After a successful scan, the reagent is recorded in the "Catalogue" and appears in the list of registered
reagents.

Reagents can be loaded without using the external barcode reader, in which case the necessary data is
entered manually in the dialog windows.

Coag 4D Plus User Manual v 1.0 33

 10. Catalogue menu
After a successful scan, the new LOT number
of reagents, controls, dilution buffers,
calibrator will be registered in the Catalogue
menu.
The catalogue is accessible from the Main
Menu screen by tapping the Catalogue button.
The Catalogue menu allows the user to view
information on reagents, dilution buffers,
calibrators and control samples already
recorded in the system.

Figure 24 - Catalogue menu

The catalogue table shows the product name ("Name"), serial number ("LOT"), article number
("Reference number"), expiry date ("Expiry"), product groups ("Type").

10.1. Filtering for different product groups

To filter information on different product groups, use the buttons on the right of the Catalogue screen.

Pressing the Reagent button will list only

reagents in the table, the Controls button will
display information on controls, the
Calibrators button will display information
on calibrators, the Other button will display a
list of sample dilution buffers, the Expired
button will display information on expired
materials, and the All button will display all
products in the table.

Figure 25 -Catalogue filter

34 Coag 4D Plus User Manual v 1.0

 10.2. Other operations in the Catalogue menu

In addition to viewing the product information, you can also delete products from the list in the
Catalogue menu, add new products or copy the permanent parameters (e.g. name, article number) to a
sample of a previous product when manually uploading. In this case, the missing (variable) parameters
must be entered. You can access the Main Menu by pressing the Back button.

 When entering data manually, make sure that the names match the names you
entered in the Test settings menu.

10.3. Delete

The details of the products you have added

will be available in the Catalogue until you
remove them by clicking the Delete button.

To delete, select the rows of reagents, dilution

buffers, washes, calibrator and control
samples to be removed, then press the Delete
button.

Figure 26 - Deleting from the catalogue

The program will ask you to confirm the "Are you sure you want to delete this line? " question.
To perform the operation, press the "YES" button.

10.4. Add a new product

To add a new product, tap the Add button in the Catalogue menu. Pressing the button will display the
Add Catalogue Item screen. First select the type of new product using the Reagents, Controls or
Other buttons.

You can enter data manually without using

the barcode scanner. To enter the data
manually or to make changes to the saved
data, use the Add Catalogue Item screen.

Figure 27 - Adding a catalogue item

Coag 4D Plus User Manual v 1.0 35

 11. Test settings menu

The Coag 4D devices are supplied and installed with the test
parameters specified by Diagon Ltd.
Diagon Ltd. is not responsible for the results obtained with the tests
installed by the user.

Tests can be defined in the "Test settings" menu. The user can decide whether to use pre-defined tests
or self-defined tests. To open the menu, tap on the "Test settings" button. To define a new test, the user
must have a password with the privilege level "Service", "Administrator" or "Lab Manager".

To define a new test, first press the "Add"

button, then enter the short or full name of the
test ("Short name" and "Name"). Select the
test type, i.e. decide whether you want to use
it as the main test or as an additional test.

Figure 28 - Add test general

11.1. Analysis

Tap on the "Analysis" table. The program allows you to choose from the options offered by the pop-
up windows and enter data in the white data entry fields.

Figure 29 - Analysis

36 Coag 4D Plus User Manual v 1.0

 Measurement
mode
■ Coagulation
■ Kinetic
■ Based on difference

Wavelength
■ 640 nm
■ 570 nm
■ 405 nm

Algorithm
■ PI
■ APTI
■ FIB
■ TI
■ Factor
■ Immunology
■ Chromogenic
■ Other

Min Time The test time in seconds at which the analysis starts.

Max Time The test time in seconds that the Analysis lasts.

Lag Time The duration of the measurement phase that is not included in the Analysis.

Duplicate from By ticking the box, you activate the double measurement from each sample.

Max deviation The Max deviation shows how much difference is allowed between the two measured
values.

11.2. Reaction

Tap on the "Reaction" table. When activated, the program will allow you to choose from the options
offered by the pop-up windows and enter data
into the white data entry fields.

Figure 30 - Reaction

Sample

■ Incubation - value in seconds

■ Rate - sample dilution rate
■ Name of diluent - name of the diluent

Reagent number - The number of rows corresponds to the number of reagents given.
Reag 1
■ Name - Name of the reagent
■ Incubation - Incubation time in seconds

Coag 4D Plus User Manual v 1.0 37

 11.3. Calibration

Touch the "Calibration" table. When activated, the program will allow you to choose from the
options offered by the pop-up windows and enter data into the white data entry fields.

Figure 31 - Calibration

Unit of - Dimension requiring calibration, by number.

measurement, no. The same number of rows as the specified number is displayed.

Unit of
measurement
■ %
■ mg/dl
■ g/l
■ μg/ml
■ μg/l
■ OD/min
■ ugFEU/ml
■ IU/ml

Identifier - Calibrator reference number

Name - Calibrator name

Mode
■ Linear regression
■ Per point
■ Polynomial
■ Other
Driving function
■ Lin-Lin
■ Lin-Inv
■ Log-log
■ Other

Rates - The dilution ratio of the different calibration points

(e.g. none (no dilution), 1/2, 1/3, etc.)

Average - The average normal clotting time of the test, which is the default value calculated
by the instrument (e.g. INR). The value and the calculation function can be
activated by ticking the box.
ISI - The value and the counting function can be activated by ticking the box.

Extrapolation - Results outside the calibration range can be extrapolated

Extrapolation range - Determining the extrapolation range

38 Coag 4D Plus User Manual v 1.0

 11.4. Control

Touch the "Control" table. When activated,

the program will allow you to choose from the
options offered by the pop-up windows and
enter data into the white data entry fields.

Figure 32 - Control

Level no. - Number of control levels to be used. The number of rows displayed is equal
to the number of control levels specified.

Name - Control name.

Time period [hours] - Control measurement at specified time intervals (hours)

Test period - Control measurement per number of tests given

All new vial - When the user starts using a new reagent bottle, a control measurement is
taken. The function is activated by ticking the box.

Extrapolation - Results outside the calibration range can be extrapolated.

Extrapolation range - Determining the extrapolation range

11.5. Output from

Touch the "Output" table. When activated, the program will allow you to choose from the options
offered by the pop-up windows and enter data into the white data entry fields.

Figure 33 - Output

Unit of - The number of types of unit of measurement, given by numeric digit. The number
measurement, no. of rows corresponding to the specified number is displayed.

Unit of
measurement:1
■ s
■ OD/min
■ %

Coag 4D Plus User Manual v 1.0 39

 ■ INR
■ mg/dl
■ g/l
■ μg/ml
■ μg/l
■ ugFEU/ml
■ DOD
■ Rate
■ IU/ml
Screen, print, - These options should be given where the units should appear. By ticking the box, you
online can choose how the results are displayed.

Code - Online code of the result in the laboratory information system

Unit of - The options correspond to those in Unit of Measurement 1

measurement: 2

Order code - Code number of the lab request from the laboratory host
number
Barriers - In the pop-up window, after selecting the unit of measurement, the user can define a
range by specifying the lower and upper limits; if the result falls outside this range,
the user can specify the format of the results.

40 Coag 4D Plus User Manual v 1.0

 11.6. Repeat

Touch the "Repeat" tab. When activated, the

program will allow you to choose from the
options offered by the pop-up windows and
enter data into the white data entry fields.

Figure 34 - Repeat

Repeat in case of error - A repeat measurement with an error signal is required.

■ Re-dilution - From the pop-up window, after selecting the unit of measurement, the user can specify
a range based on the lower and upper limits. If the result falls outside this range, the test is
repeated with the same sample after dilution based on other parameters.

- After defining a new test, you can activate the test by ticking the box next to Enabled

- After making changes, the new test parameters are saved by pressing the "Save"
button.

■ Re-dilution - For the Ddimer test, the reaction curve is re-diluted based on the Slope Check function if
slope the slope exceeds the specified limit. The values for the time limit, dilution rate and slope
of the curve are factory set but can be modified. If the slope exceeds the current value, the
measurement is stopped and a new measurement must be started.

11.7. View and modify the parameters of defined tests

First select the test from the "Test settings" menu on the left. The parameters of the selected test will
then appear on the screen. Some specific test parameters can be modified by a user with the appropriate
authorisation. To modify the test, clear the protected status in the "Enabled" window and then make
the desired change. Finally, save the changes by pressing the "Save" button.

11.8. Delete defined test

First select the test from the "Test settings" menu on the left. Then press the "Delete" button. Press the
"OK" button to complete the process.

11.9. Print the parameters of the defined tests

First select the test from the "Test settings" menu on the left. Then press the "Print" button.

Coag 4D Plus User Manual v 1.0 41

 12. Calibration menu
In the calibration menu you can view the
calibrations and their details for the different
tests.
In the main menu, press the "Calibration"
button to enter the "Calibration" menu. On
the left side of the screen, select the test for
which you want to see the calibration data. The
name of the selected test is displayed on a blue
background. Then select the reagent serial
number and press the " " button.

Figure 35 - Calibration menu

The screen displays the calibration curve with the corresponding data.
12.1. Master calibration
The master calibration data specified by the manufacturer are included on the data sheet in the reagent
package (accompanying paper). The data sheet contains both numerical and bar-coded data specific to
the Coag 4D Plus instrument. To scan the master curve, use the external barcode reader as described in
section 9.3 Scanning the reagents. After scanning, the program returns to the "Calibration" menu
where the calibration data can be viewed.

12.2. Manual calibration

Some tests must be calibrated manually as
specified in the reagent data sheet. Calibration
is started by pressing the Calibration
Measurements button in the Measurement
menu.

Figure 36 - Starting a calibration measurement

Then select the reagents and the calibrator for

the calibration. Then press the OK button.

Figure 37 - Reagent and calibrator selection

42 Coag 4D Plus User Manual v 1.0

Then the calibration measurement surface
should be used to select the concentrations .

Figure 38 - Selection of concentration

Perform the measurement on all concentrations and approve the result after successful calibration. The
calibration result is then entered in the calibration menu, where the calibration curve and the
corresponding data series are displayed. You can then take sample or control measurements.
To view the calibration data, press the " " button. If you accept the calibration, save the data by
pressing the "Save" button. If you decide to read any of the calibration points again, restart the
calibration as described above by tapping the boxes next to the accepted calibration points to uncheck
them. The instrument will only re-measure those points where the checkbox is selected.

For all tests that require calibration, the valid calibration data are listed separately in the test reagent
serial number list. As a result, a reagent may be listed with more than one serial number.
The calibration is valid until the expiry date of the reagent; it can be used at any time if a previously
used batch number of reagent is inserted. The calibration list may contain the same batch number reagent
more than once depending on the number of successful calibrations. In this case, the last calibration is
always the valid one and is used by the instrument for that batch number reagent.
If you want to recalibrate a master or manually calibrated test, a pop-up window appears after the
selection and the program asks for confirmation. Press Yes to proceed.

12.3. Print calibration data

If you want to print a specific calibration with its data, select the appropriate batch number of reagents
and press the "Print" button. Printing is done on thermal paper using the built-in printer.

12.4. Clear calibration data

If you no longer wish to use the calibration

and its data, select the test, select the batch
number of reagents to be deleted and press the
"Delete" button. Tap Yes to complete the task.

Figure 39 -Clearing calibration data

Coag 4D Plus User Manual v 1.0 43

 12.5. Calculation of the share

For tests where the result is given in a ratio format, the average normal clotting time should be given to
calculate the result. In the Calibration menu, after selecting the test, enter the normal value in seconds
(MNPT, MNPTT, MNTT) in the Average field.

These values are also specified by the reagent manufacturer and are included in the data sheet that
accompanies the reagent box. However, it is recommended that each laboratory should establish the
exact values for the local population itself.

44 Coag 4D Plus User Manual v 1.0

 13. QC menu
Press the "QC" button to enter the "Quality
Control" menu. Always prepare reagents and
control materials according to the instructions
for use. If necessary, you should record in the
"Catalogue" as described in chapter 9.2.
external barcode reader for entering a new
batch number reagent.

Figure 40 - QC menu

13.1. Start control measurements

Go to the Measurement menu, select the test

from the list on the left and then select the
Control Measurement button. By pressing the
"OK" button, the program will go to the
"Work List" menu where you can display and
select the type of control, e.g. Dia-CONT I or
Dia-CONT II, by touching the header of the 4
measurement channels.

Figure 41 - Starting QC measurement

During the measurement, you can track the

steps of the process on the worklist. The
different phases are indicated by labels,
different colours and a beep.

For detailed information, see Chapter 15,

Starting a measurement.

Figure 42 - QC measurement

Coag 4D Plus User Manual v 1.0 45

 13.2. Overview of control measurements

When the measurement is completed, the numerical result is displayed in the "Worklist". To display
and analyse the control results, use the "QC" menu. Enter the menu, use the scroll arrow to select the
test from the list, select the control to be displayed. When the result is displayed on the control card
(Levey-Jennings diagram), the X axis will show the number of measurements and the Y axis the unit of
measurement. To select the period to be displayed, use the Today, Daily, Monthly, Yearly and Control
Lot filters on the right of the screen. The requested dates can be set using the calendar above the control
card.

13.3. Control measurement data

To do this, tap the scroll arrow and select the

year, month and day you want to set.

Figure 43 - QC information

Statistics - Evaluation of measurement results

■ Max - Maximum measured value

■ Average - Average measured values
■ Min - Lowest measured value
Time period (hours) - In the Test settings menu, in the Control submenu, the time, in hours,
between the start of automatic control measurements

Test period - In the Test settings menu, in the Control submenu, the number of tests
between the start of automatic control measurements

All new vial - In the Control sub-menu of the Test settings menu: for each new bottle,
measurements are taken automatically after control measurements

Last measurement time - Date of last control measurement

Test score - Total number of measurements for a given test

Selected point - Data for a selected point on the control card

■ Upper limit - Upper limit of the control range specified by the manufacturer
■ Lower limit - Lower limit of the control range specified by the manufacturer
■ Value - Measurement result of the selected point
■ Time - Date of measurement of the selected control outcome
■ Control name - Name of the control for the selected measurement result

Control serial number - Serial number of the control used for the selected measurement

Reagent factory - Serial number of the reagent used for the selected measurement
number

46 Coag 4D Plus User Manual v 1.0

 13.4. Select and delete control result

Select the point on the control card that indicates the control result and tap it. If you touch an area rather
than an individual point on the control card, the cursor will automatically jump to the measurement point
closest to the area you touched. The data for the selected point will be displayed in the information field.
If you want to delete the selected point, press the "Delete" button.

The program asks for confirmation; press Yes to complete the task.

Figure 44 - Deleting QC data

13.5. Print from

To print the control results, press the "Print" button.

13.6. Change range

It is possible to modify the range defined by

the manufacturer. By pressing the "Change
range" button, you can enter the new lower
and upper limits (Max. limit and Min. limit) in
the pop-up window. After pressing OK, the
new and original control limits will be
displayed next to the value.

Figure 45 - Change range

13.7. Catalogue menu

To access the catalogue menu, press the "Catalogue" button. Here you can check information about the
controls you have registered, register a new control and delete data.

13.8. Save to

You can save your changes to the "QC menu" by pressing the "Save" button.

Coag 4D Plus User Manual v 1.0 47

 14. Measurement

The handheld barcode reader emits a low-energy laser. A laser beam

directly to the eye can cause damage, especially if it is repeated. Do not
look into the laser of the handheld reader!

14.1. Sample identification

Barcode identification is the easiest method for identifying samples in primary blood collection tubes.
If there is no barcode on the tube, the sample identification code must be entered manually using the
keypad.

14.2. Starting the measurement

The device detects the cuvette and then the insertion of the reagent.

14.3. Order test requests for sample tubes

The Coag 4D Plus has maximum capacity when connected online to the Clinical Laboratory Information
System (LIS). Retrieving test requests from the LIS and sending results back to the LIS simplifies and
speeds up the process of starting measurements and managing results. In offline mode, test requests are
manually assigned to samples identified manually or by barcode.

48 Coag 4D Plus User Manual v 1.0

 15. Results menu
Once the measurements have been taken, the results assigned to the identified samples can be viewed in
the worklist. To view the worklist, press the "Results" button. The first column on the screen will show
the time of the measurement, followed by the sample identification code, the test name, the status, the
measurement indication and the results in the required units. The worklist shows tests that have been
defined and approved in the "Test settings" menu.
Under the short names of the tests, the unit of measurement specified when the test was defined is
displayed.

Figure 46 - The Results menu

15.1. Preparing the measurement

Dissolve the reagents required for the measurement in the required quantities or, if they are liquid,
prepare them together with the starting reagents and diluents.
Place cuvettes on the incubation sites and wait at least one minute before taking measurements. During
this time, the cuvettes placed in the incubator will warm up to 37 °C.

15.2. The measurement process

Go to the Measurement menu and select the test type to be measured and the purpose of the
measurement. Place the cuvettes on the measuring site. Enter the sample ID or scan it with the manual
barcode reader. After identifying the samples and assigning the required tests, aspirate the sample from
the plasma section of the sample tube using a pipette of the appropriate volume. Care must be taken to
ensure bubble-free aspiration. Pipette the aspirated sample into the cuvette. The incubation will start and
the display will start to increment the appropriate incubation time. After the incubation time has elapsed,
the instrument will indicate to pipette the reagent. After pipetting in the reagent, the reaction is started
and the instrument records the measurement curve, which is evaluated by the software and, after
successful evaluation, the primary result is displayed.

The sample preparation (dilution) procedure, number of reagents, incubation time may vary depending
on the different test needs.

15.3. Indication of measurement phases

The different stages of the measurement can be followed on the display, as they are indicated by different
colours. The tests assigned to each sample are not started until the incubation time of the sample has
elapsed.

Coag 4D Plus User Manual v 1.0 49

 15.4. Results management

When the Coag 4D Plus is online, the result displayed on the worklist is immediately sent to the
Laboratory Information System (LIS) via the communication link.

Sending results from the device to LIS does not require any user intervention. For online systems,
samples can be selected for re-measurement during validation in the LIS or in the tool worklist.

Double-click on the result cell to display a

pop-up window. Here you can view the
measurement curve of the sample.

Figure 47 - The measurement curve

15.5. Save results

If the results obtained according to the worklist are automatically saved and transferred to the Saved
results database.

50 Coag 4D Plus User Manual v 1.0

 16. Saved results menu
To view the results of previous measurements,
press the "Saved Results" button on the main
screen. The Coag 4D Plus coagulometer can
store tens of thousands of results.

The results are displayed in chronological

order in the results list.

Figure 48 - Stored results menu

To find the results, use the "Filter" button.

From the drop-down screen you can select the
sample and specific date.

Figure 49 - Filter

If the result is not sent due to a communication error, the results can be resent from the stored results
menu. Select the result to be sent and press the Send button. The user will be notified by a beep when
the result has been sent. The message "Selected rows have been sent to the lab machine" will also
appear on the screen.

To view the reaction curve for a selected

result, press the Measurement curve button.
The window can be closed by pressing the
"Close" button.

You can return to the previous menu by

pressing the "Back" button.

Figure 50 - Measurement curve

Coag 4D Plus User Manual v 1.0 51

 17. System menu
This menu provides exclusive access to
parameters related to device setup and service.

Figure 51 - System menu

 This function is only available for the service

52 Coag 4D Plus User Manual v 1.0

 18. Maintenance
Reliable operation and measurement results require use and cleaning according to the manufacturer's
recommendations. Failure to follow these recommendations may lead to erroneous results and
malfunction of the instrument, including loss of warranty.

Cleaning / disinfecting solutions recommended for use:

■ 10% sodium hypochlorite solution (9 parts tap water, 1 part sodium hypochlorite)
or
■ 70% ethanol or isopropyl alcohol
■ Terraline Protect 2v% dilution

 Clean and disinfect the appliance according to the instructions. Wear protective gloves
when carrying out the disinfection/cleaning procedure. Take care not to get solution
in your eyes.

18.1. Steps before cleaning:

■ Switch off the device and unplug the power cord.

■ If liquid or blood gets on the lid of the device, first wipe it off with a dry soft cloth or paper
towel, following the instructions for hygiene and waste disposal; then carry out the
cleaning/disinfecting procedure.
■ To carry out disinfection: wipe the outer cover. Use a soft cloth moistened with a
cleaning/disinfectant solution. Then allow the cleaning/disinfectant solution to dry up.
■ Make sure that the wiper is only wet; do not get liquid inside the instrument or along the joints
in the measuring cells. Washing solution in the measuring cell may cause malfunctioning of the
instrument.

18.2. Cleaning of measuring cells

■ 4 cotton swabs, 1-1 per measuring point, one end wet and the other dry
■ isopropyl alcohol

■ Moisten a cotton swab with isopropyl alcohol. Using the moistened cotton swab, wipe the inside
of each measuring point clean.
■ Take a dry cotton swab and wipe the inside of all four cells dry. When wiping, make sure that
no pieces of cotton wool remain in the weighing chamber.
■ Take a dry cotton swab and wipe the inside of each measuring cell dry.

 When wiping, make sure that any pieces of cotton wool do not remain in the measuring
cells.

Coag 4D Plus User Manual v 1.0 53

 18.3. Cleaning incubation sites and reagent holders

■ cleaning cloth
■ surface disinfectant solution

■ Lift out the reducers.

■ Stubborn stains can be removed with a surface disinfectant
Put the restraints back on.

18.4. Cleaning surfaces

■ cleaning cloth
■ surface disinfectant solution

■ Wet the cloth with the surface disinfectant solution.

■ Use the cloth to wipe clean the cover of the appliance.

 Make sure that the display does not come into contact with the surface disinfectant.

If liquid is spilled into the measuring cell or incubator chamber, soak it up

immediately with a paper towel or cotton swab wrapped around a stick.

54 Coag 4D Plus User Manual v 1.0

19. Messages and error messages


When using the Coag 4D Plus coagulometer, messages are displayed on the screen.
The messages may provide information about measurements, warnings about
operation or error messages.

19.1. Messages in alphabetical order

Coag 4D Plus User Manual v 1.0 55

 20.Waste management

The liquid generated during operation of the Coag 4D Plus analyser must be treated as hazardous
waste. It must be disposed of and disposed of in accordance with local regulations for waste
management and disposal.

The used measuring cuvettes generated during the operation of the Coag 4D Plus coagulometer
are classified as hazardous biological waste. They must be disposed of and disposed of in
accordance with local regulations for waste management and disposal.

The blood samples and sampling tubes used in the operation of the Coag 4D Plus coagulometer
are classified as hazardous biological waste. They must be discarded and disposed of in accordance
with local regulations for waste management and disposal.

Used washing liquids, used disinfectants and used measuring cuvettes generated during the
operation of the Coag 4D Plus coagulometer are considered hazardous biological waste. They
must be disposed of and disposed of in accordance with local regulations for waste management
and disposal.

The scrapping, removal from service and transport for disposal of the equipment must be carried
out in accordance with local rules on waste treatment and disposal.

56 Coag 4D Plus User Manual v 1.0

 21. APPENDIX "A" - ORDERING AND SERVICE INFORMATION

For each request to the service department, please provide the serial number and the type of appliance.
This information is printed on the back of the appliance.

Figure 52 - Data table

Item number Name

g-Coag4D Coag 4D Plus coagulometer

21.1. How to order parts

Item number Name Quantity

gt-Ireag30/22 Adapter for 30/22 reagent bottle 2 pieces
gt-Ireag22/18 Adapter for the 22/18 reagent bottle 2 pieces
gt-Ireag22/16 Adapter for the 22/16 reagent bottle 2 pieces
gt-MS Magnetic stirrer 10 pieces
CEA651A Printing paper 1 pc

21.2. Information about the manufacturer

Name Address Website Contact

Manufacturer Diagon Ltd. H-1047 Phone +36-1-369-6500/144
Budapest,
www.diagon.com Fax +36-1-369-6301
Baross u. 48- 52.
Hungary e-mail [email protected]
Distributor Diagon Ltd. H-1047 Phone +36-1-369-6500/144
Budapest, Fax +36-1-369-6301
www.diagon.com
Baross u. 48- 52.
e-mail [email protected]
Hungary
Service Diagon Ltd. H-1047 Phone +36-1-369-6500/122
Budapest, Fax +36-1-369-6301
www.diagon.com
Baross u. 48- 52. e-mail [email protected]
Hungary

21.3. Guarantee

The distributor provides a guarantee to the extent required by the legislation in force in the country
concerned.

Coag 4D Plus User Manual v 1.0 57

 22. APPENDIX 'B' - Error messages next to signals and results

Indications next to the results:

■ R - Repeated measurement, the sample was weighed again.

■ D - Rediluted. The measurement was repeated with a different dilution.
■ T - Transmitted. The result has been sent to the host computer.
■ Q - The quality control period for the reagents used has expired.
■ 1/n - Dilution rate used during automatic calibration
■ W - Poor coagulation
■ X - Extrapolated result
■ S - Measurement interrupted due to Slope error

Error messages:

■ CALIBRATION IS - Calibration data for the reagents used for the measurement are
MISSING missing.
■ MEASUREMENT - False results for immune and chromogenic tests.
FAULT
■ <0.22 - For D-Dimer tests the result is <0.22 µg FEU/ml.
■ >5,0 - For D-Dimer tests the result is >5 µg FEU/ml.
■ >MAX IDÖ - The maximum time was reached during the measurement. The
current maximum time is displayed.
■ MAX ERROR - For replicate measurements, the difference between the results
exceeds the specified limits.
■ CUBING - The as over-incubator.
■ DISCOVERY - During the measurement, a stop (CANCEL) occurred.
■ TÖRÖLVE - The measurement was cancelled.
■ SAMPLE_IDENTIFIE - The Sample ID does not correspond to the sampling location.
R_SPACE
■ MULTIPLE - Sampling has stopped.
HEADLINES
■ > - The result is outside the limits.

Device status:

■ INICIALIZATION - all parts have been initialised

■ SECTION - all operations are complete
■ MEASURE - measurement in progress
■ LOGO - shutdown process
■ VISIT - units are warming up

Error message when

evaluating
- the measurement has stopped and a new measurement will
■ DDI SLOPE LIMIT start.
■ DISCONTINUITY - there is an extreme peak or jump in the measurement curve
■ POSTCHECK-DMIN - large variation in the initial part of the measurement curve
■ NO LAST PLATE - no plateau phase on the measurement curve after the end of the
reaction

58 Coag 4D Plus User Manual v 1.0