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Model: CA52
Operation Manual
For In Vitro Diagnostic Use
About this Manual
Version No.: B/0
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.
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.
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.
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
Website: www.genrui-bio.com
E-mail
service@genrui-bio.com
Address:
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
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
Timer: 2
Testing channels: 2
Wavelength: 470nm
1
CA52 Operation Manual Chapter 1 Instrument Introduction
Accuracy: For FIB measurement, the relative bias (B) within ±8.0%.
Weight: 4.5kg
2
CA52 Operation Manual Chapter 1 Instrument Introduction
Thermal printer
LCD
screen
Operating Reagent
panel preheating
position
3
CA52 Operation Manual Chapter 1 Instrument Introduction
Pipette holder
Power switch
Dustproof net of
Rear marker Grounding rod Three-core power socket
the housing fan
4
CA52 Operation Manual Chapter 1 Instrument Introduction
The following symbols listed in the table below are applicable to this
manual.
Symbol Meaning
Caution!
5
CA52 Operation Manual Chapter 1 Instrument Introduction
Symbol Meaning
The following stencils and labels listed in the table below are
applicable to this manual.
Label Meaning
Production date
6
CA52 Operation Manual Chapter 1 Instrument Introduction
~ Alternating current
Power ON
Power OFF
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.
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:
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CA52 Operation Manual Chapter 1 Instrument Introduction
3) Man-made damage;
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.
8
CA52 Operation Manual Chapter 1 Instrument Introduction
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
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
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CA52 Operation Manual Chapter 2 Safety and Precautions
11
CA52 Operation Manual Chapter 2 Safety and Precautions
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
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CA52 Operation Manual Chapter 2 Safety and Precautions
Combustion
Do not use inflammable hazardous materials such
as alcohol and ether near the analyzer.
13
CA52 Operation Manual Chapter 3 Instrument Installation
Content Requirements
Ambient
10℃-30℃
temperature
Relative
≤70%
humidity
Atmospheric
70kPa-106kPa
pressure
14
CA52 Operation Manual Chapter 3 Instrument Installation
15
CA52 Operation Manual Chapter 3 Instrument Installation
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:
3.2.4 Installation
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
CA52 Operation Manual Chapter 3 Instrument Installation
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.
5) Take out the attached online pipette and insert its plug into the
“ONLINE PIPETTE” jack at the rear panel of the analyzer housing.
17
CA52 Operation Manual Chapter 4 Measurement Flowchart
18
CA52 Operation Manual Chapter 4 Measurement Flowchart
Press the “OPTIC X” key; the screen displays “Add Reagent To CHX”
Prepare the
Yes
Continue to test next sample
No and reagent
19
CA52 Operation Manual Chapter 5 Routine Operations
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CA52 Operation Manual Chapter 5 Routine Operations
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) Improper sample collection and treatment can change the clotting
time;
(4) Measuring cups and pipette tips are disposable articles and cannot
be reused.
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CA52 Operation Manual Chapter 5 Routine Operations
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.
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CA52 Operation Manual Chapter 5 Routine Operations
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.
Selection of QCs:
Preparation of QCs:
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CA52 Operation Manual Chapter 5 Routine Operations
Colorimetric cell
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CA52 Operation Manual Chapter 5 Routine Operations
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.
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CA52 Operation Manual Chapter 5 Routine Operations
Figure 6 Figure 7
26
CA52 Operation Manual Chapter 5 Routine Operations
Note: The reagents in the following examples are from Sunbio, Inc. If
you use a different reagent, please refer to the corresponding
reagent instructions.
(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
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CA52 Operation Manual Chapter 5 Routine Operations
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”;
(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;
(4) After pressing the “OPTIC X” key, the screen displays “Add
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.
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CA52 Operation Manual Chapter 5 Routine Operations
III. TT assay
(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;
(4) After pressing the “OPTIC X” key, the screen displays “Add
Reagent To CHX” and then you should add the TT reagent (a sound
should be heard), then the instrument starts measurement.
(6) Repeat steps 2-5 for continuous assay and press the “MENU” key
to return to the main menu.
(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;
(3) After pressing the “OPTIC X” key, the screen displays “Add
Reagent To CHX” and then you should add the FIB reagent (a sound
should be heard); then the instrument starts measurement.
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CA52 Operation Manual Chapter 5 Routine Operations
(4) Approximately 60 seconds later, the screen displays “XX .XX S”;
(5) Repeat steps 1-4 for continuous assay and press the “MENU” key
to return to the main menu.
1 PT 20 2 40
(CaCl2)
2 APTT 20 0 20 3
20
3 TT 30 2 30
4 FIB 40 3 20
Note:
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CA52 Operation Manual Chapter 5 Routine Operations
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:
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.
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.
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CA52 Operation Manual Chapter 5 Routine Operations
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:
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.
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CA52 Operation Manual Chapter 5 Routine Operations
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:
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CA52 Operation Manual Chapter 5 Routine Operations
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.
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CA52 Operation Manual Chapter 6 Software Operation
35
CA52 Operation Manual Chapter 6 Software Operation
“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.
36
CA52 Operation Manual Chapter 6 Software Operation
time;
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.
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CA52 Operation Manual Chapter 6 Software Operation
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.
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CA52 Operation Manual Chapter 6 Software Operation
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:
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CA52 Operation Manual Chapter 6 Software Operation
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.
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CA52 Operation Manual Chapter 6 Software Operation
Press “1” to change the baud rate; press “2” to set up the check digit
and press “3” to set up the COM status.
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
CA52 Operation Manual Chapter 6 Software Operation
Press the left or right arrow key to adjust the LCD contrast.
42
CA52 Operation Manual Chapter 6 Software Operation
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.
43
CA52 Operation Manual Chapter 6 Software Operation
Use the left and right arrow keys to adjust the pipette sensitivity.
Press “0” to select the desired ID that needs to add results, press “1”
44
CA52 Operation Manual Chapter 6 Software Operation
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.
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.
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
CA52 Operation Manual Chapter 6 Software Operation
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.
46
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
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.
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.
Note: Make sure to turn off the power switch and pull out the plug
47
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
48
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
49
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
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.
Parts: None
50
CA52 Operation Manual Chapter 7 Daily Use and Maintenance
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
Information
The consumables commonly used for this analyzer include:
Vacuum
5 anticoagulant 109mmol/L 00436-A-05-0010----
tube
52
CA52 Operation Manual Chapter 9 Transportation and Storage
9.2 Storage
53
CA52 Operation Manual Chapter 9 Transportation and Storage
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.
Non-thermal
Paper roller
side upward
3) Install the roller: First align the terminal with the gears and then
press the roller down into place.
55
CA52 Operation Manual Appendix
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.
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CA52 Operation Manual Appendix
15 Time 0-9(ASCII)
5 Result 0--Z(ASCII)
6 Unit 0--Z(ASCII)
7 PTR 0--Z(ASCII)
7 INR 0--Z(ASCII)
7 PTA 0--Z(ASCII)
5 Result 0--Z(ASCII)
57
CA52 Operation Manual Appendix
6 Unit 0--Z(ASCII)
Version number: 1
Instrument type: 4
Instrument No.: 6
58
CA52 Operation Manual Appendix
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)
Frame end:
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CA52 Operation Manual Appendix
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.
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.
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CA52 Operation Manual Appendix
A 4 Hazardous Substances
Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE
Host shell ○ ○ ○ ○ ○ ○
Host machining
Host ○ ○ ○ ○ ○ ○
part
Host plastic
○ ○ ○ ○ ○ ○
pieces
Host metal
○ ○ ○ ○ ○ ○
pieces
Host connection
○ ○ ○ ○ ○ ○
cable
Labels ○ ○ ○ ○ ○ ○
Closure
Accessories ○ ○ ○ ○ ○ ○
assembly
Maintenance
○ ○ ○ ○ ○ ○
tools
Packaging
Package ○ ○ ○ ○ ○ ○
materials
61
CA52 Operation Manual Appendix
62
Add:4-10F, Building 3, Geya Technology Park, Guangming District,
518106, Shenzhen, China
Web:www.genrui-bio.com
P0 1 . 9 1 . 3 0 0 0 8 5- 1 0