CA52 Operation Manual

Coagulation Analyzer
Model: CA52
Operation Manual
For In Vitro Diagnostic Use
About this Manual
Version No.: B/0
Release Date: Nov 20, 2018
© 2004-2018 Genrui Biotech Inc. All rights reserved.
Item No.: P01.91.300085-10
81000002
Statement
This manual will help you understand the operation and maintenance
of the product better. It is reminded that the product shall be used
strictly complying with this manual. User’s operation failing to comply
with this manual may result in malfunction or accident for which Genrui
Biotech Inc. (hereinafter called Genrui) cannot be held liable.
Genrui owns the copyrights of this manual. Without prior written

consent of Genrui, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to

confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him,
expressly or implicitly, any right or license to use any of the intellectual
properties of Genrui.
Genrui reserves the right to modify and update this manual without
I
prior notice.
Genrui reserves the final explanation right to this manual.
Warning
This system can only be operated by test professionals, doctors, lab
workers or personnel for system maintenance and troubleshooting,
who have been trained by Genrui.
It is important for the hospital or organization that employs this

equipment to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown or injury of human health.
Make sure to use the instrument under the provisions of this Operation
Manual. Otherwise, the instrument may not work normally, the test
result is unreliable and it may damage the instrument parts and
endanger people’s safety.
II
Customer Service Department
Manufacturer: Genrui Biotech Inc.
4-10F, Building 3, Geya Technology Park, Guangming

Address:
District, 518106, Shenzhen, China
Website: www.genrui-bio.com
E-mail
service@genrui-bio.com
Address:
Tel: +86 755 26835560
Fax: +86 755 26678789
III
Table of Contents
Chapter 1 Instrument Introduction ................................................... 1
1.1 Overview ..................................................................................... 1
1.2 Technical Parameters .................................................................. 1
1.3 Structure Description ................................................................... 3
1.3.1 Diagram of Main Components.............................................. 3
1.3.2 Diagram of Operating Panel ................................................. 3
1.3.3 Back View of the Instrument................................................. 4
1.3.4 Menu Interface ..................................................................... 4
1.4 Symbols, Screen Printing, Labels and Figures ........................... 5
1.4.1 Symbol.................................................................................. 5
1.4.2 Screen Printing and Labels .................................................. 6
1.4.3 Figures.................................................................................. 7
1.5 Warranty and Service .................................................................. 7
1.6 Training........................................................................................ 8
1.7 Summary of the Operation Manual ............................................. 9
Chapter 2 Safety and Precautions .................................................. 10
2.1 Safety ........................................................................................ 10
2.2 Precautions ............................................................................... 11
Chapter 3 Instrument Installation.................................................... 14
3.1 Working Conditions ................................................................... 14
3.2 Instrument Installation ............................................................... 15
3.2.1 Installation Operators ......................................................... 15
3.2.2 Damage Check ................................................................... 15
3.2.3 Packing List ........................................................................ 16
IV
3.2.4 Installation .......................................................................... 16
Chapter 4 Measurement Flowchart ................................................. 18
Chapter 5 Routine Operations ......................................................... 20

5.1 Sample Preparation .................................................................. 20
5.2 Sample Measurement ............................................................... 22
5.3 Basic Operating Procedures for Daily Use ............................... 27
5.4 Result Report ............................................................................ 31
5.4.1 Result Review .................................................................... 31
5.4.2 QC Review ......................................................................... 32
5.4.3 Deleting Results ................................................................. 34
Chapter 6 Software Operation ......................................................... 35

6.1 Editing Test Items ...................................................................... 35
6.2 System Setup ............................................................................ 40
6.3 System Maintenance ................................................................. 42
Chapter 7 Daily Use and Maintenance............................................ 47
7.1 Daily Maintenance and Care ..................................................... 47
7.2 Common Faults and Troubleshooting ....................................... 48
7.3 List of Replacement Components ............................................. 50
7.4 Explanation about Elimination or Reduction of Instrument
Downtime ........................................................................................ 50
Chapter 8 Consumables and Ordering Information ...................... 52
Chapter 9 Transportation and Storage ........................................... 53

9.1 Transportation ........................................................................... 53
9.2 Storage ...................................................................................... 53
9.3 Product’s Outer Packaging Illustration ...................................... 53
V
Appendix ........................................................................................... 55
A 1 Replacement of Printing Paper ................................................. 55
A 2 COM Communication Protocol ................................................. 56
A 3 Reagent Replacement .............................................................. 60
A 4 Hazardous Substances ............................................................. 61
VI
CA52 Operation Manual Chapter 1 Instrument Introduction
Chapter 1 Instrument Introduction

1.1 Overview
This Coagulation Analyzer is a type of dual-channel instrument. Its

measurement principle is optical colorimetry. After mixing the
reagents with plasma, fibrinogen converts into fibrin and coagulates,
thus the optical density of the test sample changes and the analyzer
can detect the coagulation end-point.
Product structure and composition: It mainly consists of

microprocessors, a detection system, LCD screen, printer and
pipette.
Scope of application: This instrument is mainly applicable to

determine prothrombin time (PT), activated partial thromboplastin
time (APTT), thrombin time (TT), fibrinogen (FIB) and other blood
coagulation factors in clinical coagulation tests.
1.2 Technical Parameters
Sample preheating positions: 12
Reagent preheating positions: 5
Timer: 2
Testing channels: 2
Total stored items: 2000
Wavelength: 470nm
1
Temperature of testing positions: 37.0℃±1.0℃
Temperature of preheating positions: 37.0℃±1.0℃
Reagent volume: At least 20μL
Sample volume: 20-40μL
Repeatability: When testing normal QC plasma, the CVs (coefficient

of variance) of prothrombin time (PT), activated partial
thromboplastin time (APTT) and fibrinogen (FIB) are ≤ 5%; that of
thrombin time (TT) is ≤ 8%
Deviation between channels: ≤ 5%
Accuracy: For FIB measurement, the relative bias (B) within ±8.0%.
Linearity: The linear regression coefficient (r) ≥ 0.980
Calculation: Able to calculate with measuring units of S, %, PTR, INR

and g/L
Power supply: 100-240V~; 50/60Hz Power rating: ≤80VA
Built-in printer: 24-digit thermal printer (57mm wide)
Dimension: 371mm (L) × 338mm (W) × 144mm (H)
Working environment: Temperature 10℃-30℃
Relative humidity ≤ 70%
Weight: 4.5kg
Expected service life: Eight years
2
1.3 Structure Description

1.3.1 Diagram of Main Components
Thermal printer
LCD
screen
Operating Reagent
panel preheating
position
Testing channel 1 and 2

Sample preheating position Power indicator
light, used to
1.3.2 Diagram of Operating Panel
indicate the work
Number keys,
status of the
used to input
power supply
numbers and
Menu key, used
letters
to return to the
Temperature
previous menu
indicator light,
Paper feed key, can
which lights up
be used to manually
when reaching the
feed paper under
set temperature
offline status
Confirm key, used to Cursor Keys used to enable Activate key of the
confirm an operation keys software timer 1 and 2 optical detection channel
3
1.3.3 Back View of the Instrument

Online pipette jack RS-232 computer port
Pipette holder
Power switch
Dustproof net of
Rear marker Grounding rod Three-core power socket
the housing fan
1.3.4 Menu Interface
As illustrated in the figure above, the main interface displayed after

instrument startup has six submenus, which can be selected with the
number keys on the keyboard by operators.
During routine work, operators mainly use item 1, 2 and 3. Item 1 is

used to test samples, item 2 and 3 can help users print reports.
4
1.4 Symbols, Screen Printing, Labels and Figures

1.4.1 Symbol
The following symbols listed in the table below are applicable to this
manual.
Symbol Meaning
Caution!
1. The analyzer may be damaged or the test results

may be affected.
2. Please refer to this manual.
Biohazard, do not touch directly.
The background color of this symbol is yellow, the

symbol itself and the outline is black.
May cause electric shock.
High temperature of the print head and its

surrounding area, contact may lead to scald. When
replacing the print paper, stop printing first, then
wait at least 20 minutes to replace it.
5
Symbol Meaning
Personal injury, the components, such as the fan,

may cause personal injuries. Be careful when using
them.
The operation interfaces included in this manual

may not be consistent with various software
versions or instrument models. Please operate
based on the actual interfaces on your analyzer.
1.4.2 Screen Printing and Labels
The following stencils and labels listed in the table below are
applicable to this manual.
Label Meaning
Product serial number
Equipotential terminal, connected with the ground

cable
Production date
In vitro diagnostic devices, only for in vitro auxiliary

diagnosis
6
～ Alternating current
Power ON
Power OFF
Connecting to the pipette compatible with the

PIPETTE
instrument
POWER Main power supply
Communication port, which can exchange data with

COM this kind of analyzing system in the testing
RS-232 department or other instrument systems and
equipments
1.4.3 Figures
All the figures in this manual are only used for illustration or examples,
not for other purposes. Specific operations should be based on the
actual instrument. Modification may be made without prior notice.
1.5 Warranty and Service
Genrui warrants that this product will be free from defects in materials
and workmanship that occur within the warranty period. This
warranty shall not apply to damages caused by the following
situations:
1) Operation environment does not meet the specified requirements;
7
2) Not use the specified power supply or power supply is abnormal;
3) Man-made damage;
4) Non Genrui authorized personnel making the repair;
5) Other irresistible natural factors, such as earthquakes, fires, war,

etc.
6) Damage caused by accidents.
7) Replacement or removal of serial number label and manufacture

label.
If a product covered by this warranty is determined to be defective

because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Genrui will, at
its discretion, repair or replace the defective part(s) free of charge.
Genrui will not provide a substitute product for use when the
defective product is being repaired.
1.6 Training
In order to help users properly use the coagulation analyzer and give
full play to its performance, Genrui holds periodical free training for
users throughout the world, please visit Genrui website or contact the
local offices to get the training schedule.
Only personnel trained by Genrui or its authorized distributors can

operate this instrument, otherwise it may damage the protection
provided by the instrument.
Please carefully read this manual and the related reagents
8
instructions, if not operating in accordance with the provisions of this

instrument manual, it may damage the provided protection or greatly
affect the test results.
1.7 Summary of the Operation Manual
This manual mainly intends to help users learn about the safety,
structure, installation, analysis principles, operating procedures,
maintenance and service, problems and troubleshooting, etc. of the
coagulation analyzer. Please follow this manual to operate the
instrument.
9
CA52 Operation Manual Chapter 2 Safety and Precautions
Chapter 2 Safety and Precautions
The following are the warning symbols related to the analyzer, if

ignore these symbols, the users may run the risk of death or serious
injury. The following warning symbols are not sorted by their
importance. All the symbols have the equivalent importance.
2.1 Safety
Electric shock
1) When the power supply is turned on,
unauthorized service technicians are prohibited to
open the analyzer’s panel.
2) Avoid spilling any liquid onto the workbench, if
liquids penetrate into the analyzer, please turn off
the power immediately and contact Genrui promptly.
Biohazard
1) All the test samples and quality controls should
be regarded as infectious. Please wear gloves when
contacting them.
2) Components contacting with test samples, such
as pipette tips and measuring cups, should be
regarded as infectious. Please wear gloves when
contacting them.
3) All the wastes are potentially infectious and
should be regarded as medical wastes and
disposed of according to the current regulatory
requirements.
4) When the service life of the instrument ends, it
10
should be disposed of according to local

requirements for environmental protection and
cannot be disposed of and discarded as common
wastes.
2.2 Precautions
Scope of Application
1) This instrument is applicable to determine the
prothrombin time (PT), activated partial
thromboplastin time (APTT), thrombin time (TT) and
fibrinogen (FIB) in clinical coagulation tests.
2) When making a clinical judgment based on the
test results, please consider the patient’s clinical
examination results, other test results or clinical
symptoms as well.
Operators
This analyzer can only be used by personnel who
have been trained and authorized by Genrui or its
distributors. Otherwise, it may damage the provided
protection or greatly affect the test results.
Actions in Case of Breakdown
If the instrument has a hazardous breakdown, such
as fire, strange smell, smoke or other dangerous
situations, someone should directly cut off its
electricity or the main power supply, and then
contact Genrui.
11
Application Environment
Please correctly install the instrument according to
the environmental conditions specified in this
manual. Otherwise, the test results obtained may be
inaccurate and the analyzer may be damaged.
Electromagnetic Interference
1) The analyzer is susceptible to electromagnetic
interference during running, which may affect the
test results and lead to incorrect operations. During
its running, please do not use devices that generate
electromagnetic waves, such as electric drills,
mobile phones, intercoms, etc.
2) The analyzer can emit electromagnetic waves
during running. Please do not install or use
electromagnetic-sensitive equipment near the
analyzer.
Poor Grounding
1) The power supply must be correctly grounded;
otherwise, there is a risk of electric shock.
2) The grounding impedance must be lower than 0.1
Ω; poor grounding can cause unstable test results
and electricity leakage of the shell, and thus there is
the risk of electric shock.
Device Connection
1) For a device not permanently connected, please
do not place it at a location that is hard to
disconnect.
2) For all the external switches or breakers and
12
external over-current protection devices, it is

recommended to place them near the analyzer.
3) Devices connecting with the input and output
ports of this analyzer (COM RS-232 or USB port)
should conform to the requirements of National
Standards GB4793 and GB4943 of China as well as
IEC60950.
Combustion
Do not use inflammable hazardous materials such
as alcohol and ether near the analyzer.
13
CA52 Operation Manual Chapter 3 Instrument Installation
Chapter 3 Instrument Installation
3.1 Working Conditions
The Coagulation Analyzer is a precise electronic instrument, to

ensure its normal functioning and accurate results, the following
environmental conditions must be complied with.
Content Requirements
Flat workbench with tilt < 1/200 and sufficient

intensity, which can bear the weight of 50kg.
Dust-free, without corrosive and inflammable

Location
gases, free from heat or wind sources and
mechanical vibration.
Avoid direct sunlight and with good ventilation.
Enough space to place the analyzer with the area

2
Space of more than 0.40m (length ≥ 80cm, width ≥
50cm)
Ambient
10℃-30℃
temperature
Relative
≤70％
humidity
Atmospheric
70kPa-106kPa
pressure
14
Able to exchange air with external environment,

Ventilation smooth air flow, no direct wind blowing to the
analyzer.
100-240V~, 50/60Hz, correct grounding and

Power supply
grounding impedance < 0.1Ω.
Do not close to the electric-brush engine or

electric devices which are frequently switched
on/off.
Electromagnetic
waves Do not place the analyzer in the same room with
high-power and strong-interference devices such
as centrifuge, refrigerator, incubator, or do not
share a power socket with these devices.
3.2 Instrument Installation

3.2.1 Installation Operators
This coagulation analyzer can only be installed by Genrui or its

authorized distributors, users are required to provide the
corresponding environment and space. When you receive this
analyzer, please notify Genrui or your local distributor immediately.
3.2.2 Damage Check
All the analyzer packages have been strictly examined by Genrui

before transportation. When you receive the instrument, please
check carefully to verify whether there are the following damages
before opening the packaging box:
1) Inversion or deformity of the outer package;
15
2) Obvious moistened marks on the outer package;
3) Obvious crash marks on the outer package;
4) Indication of the outer package been opened.
Once you find any of the above issues, please do not open the
package and do not power on the instrument. Otherwise, it may lead
to electric shock. Please notify the local distributor immediately.
If the outer package is intact, please open the packaging box and
check the items in the box at the presence of the distributor or Genrui
personnel:
1) Verify if all the components are equipped according to the packing

list;
2) Carefully check the appearance of all the components to verify

whether there is breakage, crash or deformity.
3.2.3 Packing List
Please check the Packing List in the instrument packaging box.
3.2.4 Installation
1) Open the dedicated packaging box of the analyzer and carefully

verify if the instrument and accessories in the box are consistent with
the packing list. If there is any loss or damage, please contact the
supplier at once.
2) If the articles in the box are correct, take out the instrument
carefully and put it on a stable, flat and well-ventilated workbench. Do
16
not place it at a location that is hard to disconnect, e.g. near the wall.
3) Take out the power cable, plug one end into the power jack at the
rear panel of the instrument and insert the other end into the
grounded three-wire socket. For a device not permanently connected,
please do not place it at a location that is hard to disconnect. The
grounding resistance should be lower than 0.1Ω.
4) If different devices need to cooperate together for achieving some

functions, an identical reference potential is required, then it is
necessary to connect all the isoelectric terminals. Isoelectric
connections can inhibit potential difference, thereby eliminating
electromagnetic interference. If it is necessary to make an isoelectric
connection, take out the attached isoelectric grounding wire and
insert it into the isoelectric port for connection with the isoelectric
earth wire.
5) Take out the attached online pipette and insert its plug into the
“ONLINE PIPETTE” jack at the rear panel of the analyzer housing.
6) Turn on the power switch at the rear panel of the instrument.
7) Preheat for at least 15 minutes after the instrument is powered on.
8) Wait until the TEMP indicator lights up and operate according to

the prompt message displayed on the instrument screen as well as
the descriptions in Chapter 4-7 of this manual and the reagent
instructions.
9) The fuse used in this instrument is indicated as “F3AL250V”, which

has 3A rating for current and an AC 250V rating for voltage.
17
CA52 Operation Manual Chapter 4 Measurement Flowchart
Chapter 4 Measurement Flowchart

Turn on the power switch
Start up and preheat until the TEMP indicator lights up
Press “1” to open the “Measure” interface
Press “1” to open the sample Press “2” to open the QC

measurement window measurement window
Press “1” and “6” to enter the

measurement IDs for CH1 and CH2
Press “1” and “6” to set
the QCs and test items
for CH1 and CH2
Press “2” and “7” to enter the
measurement items for CH1 and CH2
Put the sample or reagent into the preheating positions

and meanwhile press the “TIMER X” key to start timing
18
CA52 Operation Manual Chapter 4 Measurement Flowchart
After preheating, place the samples into the testing channels
Press the “OPTIC X” key; the screen displays “Add Reagent To CHX”
Add the reagent along the wall of the corresponding colorimetric

cell, please note that no air bubbles should be generated
The instrument automatically starts testing
After testing, the results are displayed on the screen
Prepare the
Yes
Continue to test next sample
No and reagent
Press the “MENU” key to return to the main menu
19
CA52 Operation Manual Chapter 5 Routine Operations
Chapter 5 Routine Operations

5.1 Sample Preparation
There are two methods for sample collection, as illustrated in the

following flowchart:
Prepare the anticoagulant
Draw venous blood

Directly draw venous blood
with an anticoagulant tube
Shake well at once with the

anticoagulant as per the ratio of 9:1
Centrifuge 10 minutes at 3500r/min and get the supernatant

(plasma)
Test the sample
1) The freshly-prepared 0.109mol/L sodium citrate is used as

anticoagulant and the mixing proportion of the blood sample and
anticoagulant is 9:1.
2) During venous drawing, the tourniquet should not be overly

tightened and cannot be used for more than five minutes; otherwise,
coagulation and fibrinolytic factors will be activated. Do not collect
blood samples at the venous-infusion site or its proximal area. The
puncture should be successful at the first trial; extravasated blood, air
bubbles, and pollution of tissue fluid should be avoided. The collection
20
volume must be accurate; if the value is less than 90% of the specified
volume, the sample cannot be used. If you use anticoagulant tubes
(vacuum collection tubes), make the judgment above based on the
sample in the second or third tube.
3) The blood sample should be well mixed with the anticoagulant

immediately after collection and be centrifuged as soon as possible.
4) The centrifugation should be performed at 3500rpm for 10 minutes

and the sample should be tested within 60 minutes after collection. If
the sample is allowed to sit for a prolonged time, the result may be
inaccurate.
5) The test tube containing plasma should be plugged and sealed

promptly to avoid a pH increase.
6) All the parts contacting the sample (syringes, cuvettes, measuring

cups, etc.) must be made from plastics or siliconized glass. It is not
suitable to use common glass tubes to avoid the activation of
coagulation factors. They should also be free from detergents or
cleaning solutions.
7) The following factors can affect the test results:
(1) Sodium oxalate, EDTA and heparin cannot be used as

anticoagulants;
(2) Fibrinolytic drugs may extend the clotting time;
(3) Improper sample collection and treatment can change the clotting
time;
(4) Measuring cups and pipette tips are disposable articles and cannot
be reused.
8) All the contacts associated with analyzer operation have potentially

biological risks. Please wear protective gloves during operation to
prevent infection.
21
5.2 Sample Measurement
10-20 minutes after turning on the power switch, the temperature

indicator lights up, which means that the testing channel of this
analyzer has reached the constant temperature of 37±1.0℃ and you
can start the sample measurement.
Press “1” on the main menu to open a window for selecting to

measure a sample or QC, as illustrated below:
1) Press “1” to open the sample measurement window, as illustrated

below:
Press “1” and “6”, after the cursor appears in the “ID” fields for CH1
and CH2, enter the measurement ID of the corresponding channel
and press the “ENTER” key to confirm or the “MENU” key to cancel.
Note: After completing an assay in any channel, the patient number
will be automatically increased “1”; if the next sample is from the
same patient, please change the patient number to the original value.
22
Press “2” and “7, after the cursor appears on the measurement items
of CH1 and CH2, set the item number for the corresponding channel.
You can search the desired items by pressing the upward and
downward keys, then press “ENTER” to confirm or “MENU” to cancel.
2) Press “2” to open the QC measurement window, as illustrated

below:
Quality controls are used to examine and control the instrument

precision during assay, monitor the changes of stability, improve the
result consistency for inter- and intra- batch samples during routine
assay, and thus finally ensure the reliability of test results for every
patient sample.
Preparations before measurement:
Selection of QCs:
(1) Blood-coagulation QC plasma powder produced by a specialized

manufacturer; (2) Fresh anticoagulant plasma from healthy donors;
(3) anticoagulant plasma from animals;
Preparation of QCs:
Dilute the QC plasma powder according to its instruction, place the

plasma for 20 minutes and make it stable before use.
23
3) When preheating samples or reagents, press the “TIMER X” key to

start up the software timer of the corresponding channel. Then, the
preheating time will display on the screen, thereby helping you
complete the preheating process correctly. The instrument will
automatically alarm when the set time is reached.
4) After preheating, place the samples into the corresponding assay

channel and aspirate an appropriate volume of the preheated
reagent with the online pipette. By pressing “OPTIC X”, the screen
displays “Add Reagent To CHX”; at this time, you should immediately
add the reagent along the wall of the corresponding colorimetric cell
(Figure 1); please note that the pipette should be pressed down
thoroughly. The instrument sounds once and the check box of this
channel is displayed with an inverse color to prohibit any operation to
the channel. After removing the pipette, the instrument will
automatically start up the measurement. After testing, the instrument
will sound and the assay results will display on the line just below the
ID of the corresponding channel.
Colorimetric cell
Lean on the tilt wall
Figure 1: Pipetting diagram
24
5) If there are other samples to be tested, set a new item and ID as

per Step 1. Dispose of the tested colorimetric cells and put the next
preheated sample into the corresponding channel for performing the
next assay.
6) After measurement, press the “MENU” key to return to the main

menu. Then, open the “Result” window and perform an appropriate
operation to print the result report of the tested sample.
Notes:
1. If the channel ID is larger than 1999, the ID for the next assay will
be automatically changed to 0.
2. You should be careful when using the pipette to add the samples,
making sure they are free from air bubbles. The correct operations
for pipetting plasma and reagents are illustrated as follows:
① Place the pipette on the bottom of the colorimetric cell (Figure 2).
② Press the pipette to its first stay location. At this time, the status is
illustrated in Figure 3 and some plasma remains in the pipetting tip.
③ Elevate the pipette to the location as illustrated in Figure 4 and

then press it thoroughly to add the remained plasma. Please note
that the pipette should be above the liquid level when all the plasma
is added (Figure 5). If it is below the liquid level or contacts the liquid
surface, air bubbles will be generated and thus the assay results will
be inaccurate.
25
Figure 2 Figure 3 Figure 4 Figure 5
Pipetting reagents: Hold the pipette close to the wall of the

colorimetric cell and add the reagent (Figure 6). Please note that the
pipette should be pressed down thoroughly and the reagent should
be released with a certain speed to facilitate sufficient mixing of the
reagent and plasma. After pipetting, the pipetting tip should be above
the liquid level and cannot touch the surface (Figure 7).
Figure 6 Figure 7
26
5.3 Basic Operating Procedures for Daily Use
1) Startup: After turning on the power switch, the system performs a

self-inspection and meanwhile the thermostat heats up the testing
channel. 10-20 minutes later, the TEMP (temperature) indicator lights
up and you can carry out the normal measurement.
2) Shutdown: After the completion of measurement, press the

“MENU” key to return to the main menu and then shut it down. Never
turn the analyzer off suddenly during testing or printing.
3) Examples of basic operating procedures for routine assays: In

order to allow you be rapidly familiar with the analyzer, the operating
examples of routine assays are listed as follows.
Note: The reagents in the following examples are from Sunbio, Inc. If
you use a different reagent, please refer to the corresponding
reagent instructions.
I. PT assay (Sunbio reagent)
(1) Preheat the PT reagent (get an appropriate volume according to

the assay) at 37℃ for 10 minutes;
(2) Add 20μL plasma and preheat them for 2 minutes (the sample
should be placed at the cup bottom and there should be no air
bubbles);
(3) Put the preheated samples into the testing channel and aspirate
40μL of the PT reagent with the online pipette;
(4) After pressing the “OPTIC X” key, the screen displays “Add
27
Reagent To CHX” and then you should add the PT reagent (the
pipette should be pressed down thoroughly and a sound should be
heard), then the instrument starts measurement;
(5) Approximately 80 seconds later, the screen displays “XX .XX S”;
(6) Repeat steps 2-5 for continuous measurement. Press the

“MENU” key to return to the main menu.
II. APTT assay
(1) Get an appropriate amount of the APTT reagent (according to the

required quantity of the assay). No need to preheat this reagent. But
preheat the CaCl2 solution at 37℃ for 10 minutes;
(2) Add 20μL plasma and then 20μL of the APTT reagent. Mix and
preheat them at 37℃ for 3 minutes;
(3) Place the preheated mixture into the testing channel and aspirate
20μL of the 0.025mol/L CaCl2 solution (preheated) with the online
pipette;
Reagent To CHX” and then you should add CaCl2 solution (a sound
should be heard), then the instrument starts measurement.
(5) Approximately 100 seconds later, the screen displays “XX .XXS”;
(6) Repeat steps 2-5 for continuous assay and press the “MENU” key
to return to the main menu.
28
III. TT assay
(1) Get an appropriate amount of the TT reagent (according to the

required quantity of the assay). No need to preheat this reagent;
(2) Add 30μL plasma and preheat them for 2 minutes (the sample
should be placed at the cup bottom and there should be no air
bubbles);
(3) Place the preheated colorimetric cell into the testing channel and
aspirate 30μL of the TT reagent with the online pipette;
Reagent To CHX” and then you should add the TT reagent (a sound
should be heard), then the instrument starts measurement.
(5) Approximately 60 seconds later, the screen displays “XX.XX S”;
IV. FIB assay
(1) Get 40μL of the diluted test plasma and put it into a colorimetric
cell, and then preheat for 3 minutes;
(2) Aspirate 20μL of the FIB reagent with the online pipette. No need
to preheat this reagent;
Reagent To CHX” and then you should add the FIB reagent (a sound
should be heard); then the instrument starts measurement.
29
(4) Approximately 60 seconds later, the screen displays “XX .XX S”;
V. Commonly-used test samples for blood coagulation assays

and the reagent consumption
Test Sample Preheating Reagent Preheating Reagent

No.
item (μL) time (min) 1 (μL) time (min) 2 (μL)
1 PT 20 2 40
(CaCl2)
2 APTT 20 0 20 3
20
3 TT 30 2 30
4 FIB 40 3 20
Note:
1. The operating procedures are only used for

reference. The use methods of the reagents from
different manufacturers may vary slightly. Please
operate according to the corresponding reagent
instructions.
2. Do not touch the transparent side of the

colorimetric cell during testing; otherwise the results
may be inaccurate.
3. Colorimetric cells and pipette tips are disposable

articles and cannot be reused.
30
5.4 Result Report

5.4.1 Result Review
After testing, you can open the “Result” menu to view and print the
result report.
You can open the “Result” submenu from the main menu. The screen
displays as follows:
1) “Total” means the total measurements of this ID, of which the

maximal value is 50.
2) “NO.” means any QC No. within the “Total” above, which can be
increased or decreased “1” by pressing the left or right arrow key
once.
3) Press “0” to directly search the desired ID.
4) Search the ID number according to the measurement time by

pressing the up or down arrow key. The ID displayed on the search
window is the last test number.
5) Press “1” to enter the print content selection interface. Press “1” to
print only the currently displayed results for the queried ID; press “2”
to print all the results stored under this ID.
31
5.4.2 QC Review
After testing, you can open the “QC” menu to view and print the QC
report.
You can open the “QC” submenu from the main menu. The screen
displays as follows:
Then, press the number keys “1”, ”2”, ”3”, ”4” or ”5” to open the
corresponding QC review menu. The screen displays as follows:
1) “Total” means the total QC measurements of this QC, of which the

maximal value is 50.
2) “NO.” means any QC No. within the “Total” above, which can be
increased or decreased “1” by pressing the left or right arrow key
once.
3) Press “1” to print the displayed data of the searched ID.
32
4) Press “2” to delete the displayed data of the searched ID.
5) After obtaining more than five groups of results for the same QC
under the same test item, you can view the statistical results on the
QC review interface; at most 50 groups of results for the same QC
under the same test item can be saved to prepare the QC report.
Moreover, AV, SD and CV values will be automatically calculated, as
illustrated below:
The statistical data can also be displayed and printed in graphic

format, as illustrated below:
33
5.4.3 Deleting Results
This function can help you delete the wrong results. Please note that
the results for the entire ID will be deleted and thus this function
should be used with caution. Press “6” to open the system
maintenance window and then press “1” to open the result deletion
interface. The screen is displayed as follows:
Find the ID needing to be deleted and press “1” to delete its results.
34
CA52 Operation Manual Chapter 6 Software Operation
Chapter 6 Software Operation
In addition to the three menus frequently used in routine

measurement, this instrument also has three menus and their
functions are as follows: The “Edit Test” menu is used to revise the
contents of a test item; the “Setup” menu is used to set up the system
parameters; and the “Maintain” menu is used to perform the setup for
system maintenance. The details are described below.
6.1 Editing Test Items
This section mainly describes how to set up the measurement

parameters of a reagent when using it for the first time. It is
recommended that the parameters should be set again according to
the reagent instructions when exchanging the reagent every time, in
order to obtain correct results. Press “4” on the main menu to open
the “Edit Test” window, as illustrated below:
1) Press “1” to switch among different test items.
2) Press “2” to switch among different measurement methods.
“B”: Coagulation + Absorbance (used if FIB should be calculated with

PT)
35
“C”: Coagulation
3) Press “3” to set up the reaction time, which means the required
time for measuring this item and is generally twice of the median of
its normal values. The maximal value is 319.
4) Press “4” to set up the notification time of preheating. When the set
preheating time reaches, the instrument will sound. The maximal
value is 399.
Press the down arrow key to switch to the next page of the “Edit Test”
window, as illustrated below:
5) Press “1” to enter the upper limit of the normal reference values.
The value is determined according to the reagent instruction.
6) Press “2” to enter the lower limit of the normal reference values.
The value is determined according to the reagent instruction.
7) Press “3” to choose the desired result report; press the left or right
arrow key to move the cursor leftward or rightward; press “3” to
switch among different display options.
S – Expressing with second;
R – Abbreviation of PTR, representing the ratio of prothrombin
36
time;
I – Abbreviation of INR, representing the international

normalized ratio;
% - Expressing with percentage;
E – Displaying the absorbance value
8) Press “4” to switch among different measurement units of this item.
Press the up arrow key to return to the previous menu page and the
down arrow key to enter the next menu page, as illustrated below:
9) Enter the normal reference values of this item (see the reagent
instruction) in the “Reference” field.
10) Enter the international sensitivity index of this item (see the
reagent instruction) in the “ISI” field.
11) If “%” is selected for the result display, the percentage curve
occurs, of which the measurement mode can be selected. There are
two modes, default and custom.
Default mode: Results in percent are calculated according to the

default formula of the instrument, the mode selection interface is
37
shown as follows:
Custom mode: Results in percent are calculated according to the

percentage curve set by users, the mode selection interface is shown
as follows:
Press “1” or “2” to switch between the default mode and custom
mode. Select the custom mode and press “ENTER” to modify the
percentage curve, which is shown below, press numeric key “1”, “2”,
“3”, “4” or “5” to display the cursor position, press “ENTER” to confirm
the modification and press the arrow keys to move the cursor.
38
12) After selecting the FIB item, the concentration curve can be
revised, press numeric key “1”, “2”, “3”, “4” or “5” to display the cursor
position, press “ENTER” to confirm the modification and press the
arrow keys to move the cursor. The screen displays as follows:
13) Select the PT item and choose the measurement method as “B”
to revise the derivation curve, press numeric key “1”, “2”, “3”, “4” or
“5” to display the cursor position, press “ENTER” to confirm the
modification and press the arrow keys to move the cursor. The
screen displays as follows:
39
6.2 System Setup
There are five submenus on the system setup menu, as illustrated

below:
1) Clock setup, as illustrated below:
Press the corresponding key of “0”-“9” to change the value for cursor
location and press the arrow keys to move the cursor, then press
“ENTER” to save and exit or press the “MENU” key to return without
changing the currently displayed time and date.
2) Setup of serial port, as illustrated below:
40
Press “1” to change the baud rate; press “2” to set up the check digit
and press “3” to set up the COM status.
3) Print setup, as illustrated below:
Press “1” to automatically print after measurement; press “2” to not

automatically print.
4) Fan setup, as illustrated below:
Press “1” or “2” to select to turn on/off the fan. This function is mainly
used to adjust the temperature inside the instrument when the
41
ambient temperature changes greatly. When the ambient

temperature is lower than 15℃, the fan may be turned off to promote
the rapid elevation of instrument temperature; when the ambient
temperature is higher than 30℃, the fan should be turned on to
facilitate the heat dissipation.
5) Contrast setup, as illustrated below:
Press the left or right arrow key to adjust the LCD contrast.
6.3 System Maintenance
This menu mainly includes six submenus, as illustrated below:
1) Deleting results. Please refer to the result deletion operation in the

“Result” menu for details.
2) QC setup, as illustrated below:
42
Press “1” to choose the desired QC number; press “2” to select a test
item of this QC; press “3” to enter the target value of the reagent used
in this QC measurement. The standard deviation means the
allowable standard deviation of this item; these two items provide the
central value and standard deviation for the statistical graphic.
The range of normal values is variable in different regions and

different population and there are also differences among
instruments, therefore, the value range provided by a different area
can only be used for reference. Please determine the range of
normal values applicable to the population in your region!
3) Temperature correction, as illustrated below:
Press “1” to enter the desired temperature. If the set detection

temperature is different from the actual temperature, adjust the
pre-set value with up and down arrow keys to correct the
temperature.
43
4) Sensitivity, as illustrated below:
Use the left and right arrow keys to adjust the pipette sensitivity.
5) ADC, as illustrated below:
This function can display the internal AD converting parameters,

which is used by service technicians during reparation.
6) Add result, as illustrated below:
Press “0” to select the desired ID that needs to add results, press “1”
44
to select the item that needs to add results, press “2” to enter the
specific value of the result added, press “3” to enter the specific
adding time, and use the up and down arrow keys to switch between
different IDs.
7) Language switch, as illustrated below:
Press and hold any key on the keyboard during startup, and enter the
password “1234” to open the system maintenance window. Press “1”
to open the language interface and switch between Chinese and
English.
8) System reset, as illustrated below:
Press and hold any key on the keyboard during startup, and enter the
password “1234” to open the system maintenance window. Press “2”
to open the system reset interface.
45
Note: All the stored data will be lost after system reset and the
system parameters will restore the factory settings. Please use this
function with caution.
9) Slope adjustment, as illustrated below:
For different reagents, the measurement results may be adjusted as

needed. Press “1” to switch to the corresponding test item, press “2”
to enter the appropriate slope and press “3” to enter the specific
intercept. You should use this interface to make adjustments when
exchanging for reagents from a different manufacturer. Please refer
to Appendix 3 for detailed procedures.
46
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
Chapter 7 Daily Use and Maintenance

7.1 Daily Maintenance and Care
Reagents are an important factor for the normal functioning of the

instrument as well as the reliability and validity of test results.
Meanwhile, this also depends on proper instrument maintenance and
care. The daily maintenance and care procedures are described
below.
1) Daily maintenance
(1) Turn off the power switch after use every day.
(2) Check the testing channels and all the preheating positions daily
to verify if they are clean and dust-free. Wipe them with soft lens
paper or alcohol-dipped cotton swabs if necessary.
(3) During measurement, if a testing channel is not used, an empty

colorimetric cell should be put in it to protect the light source.
2) Washing and disinfection of the instrument surface
Washing: Dip a piece of wet towel with cleaning solution to wipe the
analyzer tabletop, until all the stains are removed. It is recommended
to perform this operation once a day.
Disinfection: Dip a piece of wet cloth with 75% alcohol or

pasteurization solution to wipe and disinfect the analyzer surface. It is
recommended to perform this operation once a week.
Note: Make sure to turn off the power switch and pull out the plug
47
before cleaning the analyzer housing. Please use clean water,

neutral cleansers or corrosion-free detergents for washing; do not
use organic solvents or hot water to avoid instrument damage due to
deformity.
3) Preventive maintenance and inspection for safety purpose
Check if the power cable is connected and well grounded before

startup;
Check if the isoelectric grounding rod is well connected before

startup;
Perform the instrument maintenance and care strictly according to

the description in this section.
7.2 Common Faults and Troubleshooting

Fault
Possible causes Troubleshooting
Description
1. The power switch
Turn on the power switch
is off
2. The power supply
Reinsert the power plug
is unavailable
No display on
3. The display signal
the screen Reinsert the display cable
cable is loose
Contact a service
4. The LCD screen is
engineer to exchange the
broken
LCD screen
The printer 1. The printing paper Exchange for new printing
does not print is unavailable paper
48
Check whether the paper

below the roller of printing
head is wrinkled or not
2. The printing paper
vertical with the roller. If
is not correctly
yes, lift the depression bar
installed
of the printing head and
make the paper flat and
vertical.
Check if the thermal side
The printing 1. The thermal side
of the printing paper is
paper can of the printing paper
toward the printing head
move out of is not toward the
(i.e. downward),
the printer, but printing head
otherwise, correct it
there are no
2. It is not the thermal Reinstall the proper
words on it
printing paper thermal printing paper
1. Reagent Exchange for effective
ineffective reagents
2. The specified
Change to use the proper
The anticoagulant plasma
anticoagulant
measurement is not used
result is 3. The reagents and
abnormal samples are not
Preheat according to the
preheated strictly
operating procedures
according to the
operating procedures
49
4. There is
interference
Reconnect the ground
generated due to bad
cable
connection of the
ground cable
If the instrument fault is still present or there are other faults, please
contact Genrui or the local distributor.
7.3 List of Replacement Components
List of parts and consumables that can be replaced by users
Consumables: Printing paper, see Appendix 1
Parts: None
List of parts that should be replaced by authorized service engineers
Fuse, with specifications of F3A250V
Power supply and the switch
PCB hardware system
7.4 Explanation about Elimination or Reduction of

Instrument Downtime
We provide the responsible personnel with specific explanations to

eliminate or reduce instrument downtime, and the risks in product
shipment or disposal. These explanations should include the
requirements about minimizing biological harm:
50
1) Serum, reagents, and all the other liquids should be regarded as

infectious. If a small amount of these materials spills on the
instrument surface, please wipe it off using a cotton ball dipped with
75% alcohol; otherwise, touching the instrument surface may cause
biological risks such as infection. If a large amount of liquid splashes
and penetrates into the analyzer, please stop using the instrument
and pull out the power plug, and then contact Genrui or local
representative;
2) If the instrument needs to be moved, relocated, presented, lent or

repaired, thoroughly disinfect its surface to minimize the biological
harm. If the instrument is crushed or dropped, whether there is
obvious damage on its surface or inside, stop using it and contact
Genrui or local representative;
3) If there is an instrument breakdown after the warranty period, ask

Genrui’s service engineer, reparation engineer in the device
department of the hospital or other qualified engineers to repair it;
otherwise, there is the risk of electric shock. It’s best to contact
Genrui before reparation;
4) When the expected service life of this instrument ends (about eight
years), it is recommended to stop using it or resume using after
overall troubleshooting, maintenance and care by Genrui;
5) This analyzer can only be used by personnel who are trained and
authorized by Genrui; otherwise, the protection provided by the
instrument may be impaired or the test results may be significantly
affected.
51
CA52 Operation Manual Chapter 8 Consumables and Ordering Information
Chapter 8 Consumables and Ordering
Information
The consumables commonly used for this analyzer include:
No. Name Specification Material Number
1 Printing paper φ57*35mm 00431-A-05-0005----
2 Pipetting tip 10-50μL 00427-A-05-0001----
3 Colorimetric cell Large size 00434-A-05-0008----
4 Reagent cup C900 00437-A-05-0011----
Vacuum
5 anticoagulant 109mmol/L 00436-A-05-0010----
tube
6 PT reagent 10*2.5mL 00527-A-05-0018----
7 TT reagent 10*2.0mL 00526-A-05-0017----
8 APTT reagent 10*2.0mL 00528-A-05-0019----
9 FIB reagent 10*2.5mL 00528-A-05-0020----
The analyzer and consumables are available by contacting Genrui or

your local distributor.
52
CA52 Operation Manual Chapter 9 Transportation and Storage
Chapter 9 Transportation and Storage

9.1 Transportation
This analyzer can be delivered by general transportation; however,

fierce impact, vibration, or exposure in rain and snow should be
avoided during shipment. The transportation requirements are
determined according to the ordering contract.
9.2 Storage
The packaged analyzer should be stored in a well-ventilated room

that has the environmental temperature of -10℃~+55℃ and relative
humidity of 93% and is free from corrosive gases.
9.3 Product’s Outer Packaging Illustration
——“Fragile”: Carefully carry and place.
——“Up”: Upward to place and transport the product.
—— “Rain proof”: Protect the package from the rain.
——“Layer limit”: Maximum pile up layers of the same
53
CA52 Operation Manual Chapter 9 Transportation and Storage
package.
——“Humidity limit”: Humidity limit for transportation and

storage environment.
——“Temperature limit”: Temperature limit for

transportation and storage environment.
Note: The illustrations are for reference only, subject to pictures on

the outer package.
54
CA52 Operation Manual Appendix
Appendix
A 1 Replacement of Printing Paper
1) Open the printer cover and remove the roller (be careful to take it
out horizontally), and then take out the residual printing paper.
2) Put the paper roll into the paper slot. Note that there are
differences between the sides of the thermal printing paper. Make
sure that the thermal side is downward. Place the printing paper
below the roller, as illustrated in the figure below. Ensure that the
movement direction of the printing paper is vertical with the roller
orientation, thereby avoiding inability of normal printing due to paper
jam.
Printer cover Paper outlet
Paper slot Paper roll
Non-thermal
Paper roller
side upward
Diagram for replacement of printing paper
3) Install the roller: First align the terminal with the gears and then
press the roller down into place.
4) Press the “FEED” key. Then, a segment of the printing paper

moves out of the printer (passing the printer cover). Observe whether
55
the paper moves smoothly and is vertical with the printer roller;
otherwise, adjust it as needed.
5) Pull out the printing paper from the paper outlet at the printer cover
and close the cover.
Note: The “FEED” key is available on the main interface and all the
screens waiting for keyboard entering. This function is disabled on all
the other interfaces to protect the printer.
A 2 COM Communication Protocol
Hardware conditions: Connect the RS-232C ports of the two

instruments needing to be communicated by RS-232C cable, or
connect the instrument with the COM port of the computer. Open the
COM interface and select to display in character format. This
instrument provides the following options about COM status:
Baud rates: 115200, 57600, 38400, 19200, 9600, 4800
Parity check: Odd, Even, None
Working status: Sending, simplex
Format of sending a frame:
Character number Field Content
1 Frame head 0x02
2 Version number 1(ASCII)
56
2 Instrument type 4(ASCII)
2 Instrument No. 6(ASCII)
15 Time 0-9(ASCII)
7 Patient No. 0-2000(ASCII)
6 Item No. 0--Z(ASCII)
5 Result 0--Z(ASCII)
6 Unit 0--Z(ASCII)
6 Lower limit 0--Z(ASCII)
6 Upper limit 0--Z(ASCII)
7 PTR 0--Z(ASCII)
7 INR 0--Z(ASCII)
7 PTA 0--Z(ASCII)
6 Item No. 0--Z(ASCII)
5 Result 0--Z(ASCII)
57
6 Unit 0--Z(ASCII)
6 Lower limit 0--Z(ASCII)
6 Upper limit 0--Z(ASCII)
1 Frame tail 0x03
The data results sent are as follows:
1 4 6 11 12 15 10 14 000162 FIB-C 296.9mg/dL 200.0 400.0
1 4 6 11 12 15 15 19 QC1 PT 000.0S 011.0 017.0
1 4 6 11 12 15 09 31 000153 PT 000.0S 011.0 017.0

01.05R 01.07I 087.4% FIB-C 000.0mg/dL 200.0 400.0
Frame head: (select in the COM setup interface to display in

character format)
Version number: 1
Instrument type: 4
Instrument No.: 6
Time: 11 12 15 10 14 (December 15th, 2011 10:14)
Patient No.: 000162 (the measurement ID is 000162 and QC1 means

it is a QC measurement)
Item No.: FIB-C (the measurement item is FIB-C)
58
Result: 296.6 (display the stored measurement result)
Unit: mg/dL (the measuring unit for the result)
Lower limit: 200.0
Upper limit: 400.0 (the normal reference range is set as 200~400)
PTR: 01.05R (this result can be exported when selecting “R” in the
“Edit Test” window)
INR: 01.07I (this result can be exported when selecting “I” in the “Edit
Test” window)
PTA: 087.4% (this result can be exported when selecting “%” in the
“Edit Test” window)
Item No.: FIB-C (The FIB calculation results can be exported when
selecting the measurement method of “B” in the “Edit Test” window)
Result: 000.0 (the calculated result)
Unit: mg/dL (the measuring unit of the calculated item result)
Lower limit: 200.0
Upper limit: 400.0 (the normal reference range is calculated as

200-400)
Frame end:
59
A 3 Reagent Replacement
1) If the reagents are not of the same brand as the attached reagents
of this analyzer or you need to change the reagent manufacturer, you
must press and hold any key on the keyboard during startup and
enter the password “1234” to open the system maintenance interface,
and then press “3” to open the slope adjustment window.
2) Press “1” to choose the test items of the corresponding reagent;

press “2” to change the slope to “1.00”, and press “3” to change the
intercept to “0.00”.
3) Open the measurement interface to perform a normal

measurement. Measure with QC plasma and the reagent needs to be
replaced, measure 3 times for each channel and then calculate the
overall average (AV).
4) Calculate the slope factor “K” as per the formula: K = Target value
of the QC plasma / AV. Restart the analyzer and open the slope
adjustment window, then enter the calculated slope factor “K” to the
slope field of the corresponding item and exit the slope adjustment
interface.
5) After changing, perform 3 times of measurements for each

channel to verify if the test requirements can be met.
60
A 4 Hazardous Substances
Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE
Host shell ○ ○ ○ ○ ○ ○
Host PCBA ×(1) ○ ○ ○ ○ ○
Host sheet metal

○ ○ ○ ○ ○ ○
parts
Host machining
Host ○ ○ ○ ○ ○ ○
part
Host plastic
○ ○ ○ ○ ○ ○
pieces
Host metal
○ ○ ○ ○ ○ ○
pieces
Host connection
○ ○ ○ ○ ○ ○
cable
Labels ○ ○ ○ ○ ○ ○
Closure
Accessories ○ ○ ○ ○ ○ ○
assembly
Maintenance
○ ○ ○ ○ ○ ○
tools
Packaging
Package ○ ○ ○ ○ ○ ○
materials
61
○: means the content of the hazardous substance in all homogeneous

materials of the part is in the limited requirement according to the standard of
SJ/T 11363-2006.
×: means the content of the hazardous substance in at least one of the
homogeneous materials of the part is beyond the limited requirement
according to the standard of SJ/T 11363-2006.
(1): some parts of the circuit board used lead solder during processing.
Notice: the product marked with “×” is because there has no other technologies
or parts to be replaced at present stage, under normal use conditions, leak and
mutation will not occur in 5 years, and it will not cause environment pollution or
harm to people and property.
62
Add:4-10F, Building 3, Geya Technology Park, Guangming District,
518106, Shenzhen, China
Web:www.genrui-bio.com
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Coagulation Analyzer

Release Date: Nov 20, 2018

© 2004-2018 Genrui Biotech Inc. All rights reserved.

Item No.: P01.91.300085-10

Genrui owns the copyrights of this manual. Without prior written

Materials protected by the copyright law, including but not limited to

Genrui reserves the final explanation right to this manual.

It is important for the hospital or organization that employs this

Manufacturer: Genrui Biotech Inc.

4-10F, Building 3, Geya Technology Park, Guangming

Tel: +86 755 26835560

Fax: +86 755 26678789

Chapter 4 Measurement Flowchart ................................................. 18

Chapter 5 Routine Operations ......................................................... 20

Chapter 6 Software Operation ......................................................... 35

Chapter 9 Transportation and Storage ........................................... 53

Chapter 1 Instrument Introduction

This Coagulation Analyzer is a type of dual-channel instrument. Its

Product structure and composition: It mainly consists of

Scope of application: This instrument is mainly applicable to

1.2 Technical Parameters

Sample preheating positions: 12

Reagent preheating positions: 5

Total stored items: 2000

Temperature of testing positions: 37.0℃±1.0℃

Temperature of preheating positions: 37.0℃±1.0℃

Reagent volume: At least 20μL

Sample volume: 20-40μL

Repeatability: When testing normal QC plasma, the CVs (coefficient

Deviation between channels: ≤ 5%

Linearity: The linear regression coefficient (r) ≥ 0.980

Calculation: Able to calculate with measuring units of S, %, PTR, INR

Power supply: 100-240V~; 50/60Hz Power rating: ≤80VA

Built-in printer: 24-digit thermal printer (57mm wide)

Dimension: 371mm (L) × 338mm (W) × 144mm (H)

Working environment: Temperature 10℃-30℃

Relative humidity ≤ 70%

Expected service life: Eight years

1.3 Structure Description

Testing channel 1 and 2

1.3.3 Back View of the Instrument

1.3.4 Menu Interface

As illustrated in the figure above, the main interface displayed after

During routine work, operators mainly use item 1, 2 and 3. Item 1 is

1.4 Symbols, Screen Printing, Labels and Figures

1. The analyzer may be damaged or the test results

2. Please refer to this manual.

Biohazard, do not touch directly.

The background color of this symbol is yellow, the

May cause electric shock.

High temperature of the print head and its

Personal injury, the components, such as the fan,

The operation interfaces included in this manual

1.4.2 Screen Printing and Labels

Product serial number

Equipotential terminal, connected with the ground

In vitro diagnostic devices, only for in vitro auxiliary

Connecting to the pipette compatible with the

POWER Main power supply

Communication port, which can exchange data with

1.5 Warranty and Service

1) Operation environment does not meet the specified requirements;

2) Not use the specified power supply or power supply is abnormal;

4) Non Genrui authorized personnel making the repair;