H9 HbA1c Analyzer

Installation Guide

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1. Installation Preparation

2. Parameters Settings Of User Interface

3. Calibration,QC & Sample Testing

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1.1Installation Preparation
Before installation start, Please carefully check the user manual for details
of installation requirements and comply them.

1)Environment
Working Temperature: 10℃ ～ 35 ℃
Humidity:≦ 80%(No Dewing)
Air Pressure: 75 kPa ～ 106 kPa

2)Space
The installation space should be:
Distance of left/right side from the wall ≥ 50 cm
Distance of rear side from the wall ≥ 50 cm

•Power Supply
Voltage ： A.C.100 ～ 240V ；
Frequency ： 50/60 Hz ；
Input Power ： 120VA

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1.2 Open Package
Please follow the user manual to check the package carefully for damage before
opening, and then open the package according to the steps on the manual.

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 1.3 Loosen screws on 2D Arm
Open the left door, and loosen the fixing screw of 2D arm

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To confirm if the 2D arm can be moved normally by your hands after having
removed the fixation of 2D arm

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1.4 Connect the reagents

Reagent A/B/C/L

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1.5 Install column and filter

Unsrew the knob of filter, and put the Filter in. Then tight the knob.

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Liquid Derection

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1.6 Thermal Paper Installation

Pull the holder on top right corner of printer, and open printer door.
Load thermal paper according to the direction in Picture , and leave a segment of paper
outside the exit.

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1.7 Power Adapter Connection

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 2.1 System Start-up

System will do Self testing after switching on, after Self Testing, Press “No” to avoid
System Cleaning.
After that, it will jump to Menu Interface.

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2.2 Reset&Parameters Selections
Press “Service”, click 'Reset' to reset the column, filter,and select the
tests of reagents( as shown on the label of reagents kits). Then click
'Reset A', 'Reset B', 'Reset C', 'Reset L' in sequence.

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About the reset of column, you shall input the serial number
of column(as shown on the label of column papery package)
to reset column.

To set the temperature according to the temp labeled on the

plastic packge of column. adjust by pressing “+” or “-”

The SE column version: A2

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 Reagents:
So, press 'System Settings', enter password'661166',set
the correct version of column and reagent,even for
the stepping value of high pressure pump.

H9 SE
reagent
,
version
:A0

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2.3 Hardware Test
Press “Service” , check all the parameters,

Then press “System Maintenance”, enter password “661166”. Enter Hardware Test
interface.

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1) Valve Test
In a quiet environment, press the switch button solenoid valves 1-9, pay attention to whether
hear the sound of solenoid valve opening and closing; If not , it may be solenoid failing to work.
Check the connecting lines, or whether solenoid is broken.

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2) Pump Test

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3) Motor Test

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2.4 Priming &Bubble
Elimination&Column Activation
For the first time installation, firstly do “HP Pump Cleaning” 2 times.

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Then press “Liquid Line Priming”.If there is any bubble inside the tub
es of reagent,do “Bubble Elimination” .
Remove the brown connector above right high pressure pump head,one
side of the drain tube(including in the accessories) should be connected to
right pump head,the other side should be inside an empty bottle.

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After having done the “Bubble
Elimination”, please screw the
previous brown connector tightly
above the right high pressure pump
head(Primary pump head).

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Get one fresh venous whole blood,mix it well and unplug the cap of sample tube to
put it onto the ST station(Emergent Aspiration).Then click'Column Activation' in
the 'System Maintenance' interface to activate the performance of column.

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3.1 Check ADC&Factor of Dual Wavelenth

Colorimetric Module(Test Module) change to “415+500nm” ， 415ADC should

be in the range of 24000-26000, 500ADC should be in the range of 16000-
18000,firstly to set Gain415nm 250 ， Gain 500nm is from 1~250.The bigger
the gain, the smaller the ADC ， the smaller the gain, the larger the ADCdo the
fine adjustment for the adjustable resistance (VR1) on the degassing control
board ， ADC will be smaller by clockwise adjusting , and ADC will be larger by
anti-clockwise adjusting...
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In "Operation Parameters" interface , The
Factor will be used to calculate final ADC value
and absorbance, it should be in the range of
0.6-1.5 ， suggest to only set as 1.0000,no
necessary to execute the “Start” for new
column module.
3.2 Run Blood Sample
Firstly, ensure the button of
'Autosampler Circulation Function'
is ' Turn-on' status.
Secondly,get one fresh whole blood
and mix it well, then run this one
blood sample 10 times repeatedly to
test the reproducibility, to see
whether stability of the results. Put
the blood on the rack, Press “Start”.

If Ok, go to Calibration.

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 3.3 Calibration&QC
Prepare Calibrator and Quality Control Material 　

a)Prepare 1 piece low level calibrator, 1 piece

high level calibrator, add 100 µl deionized
water respectively, redissolve them and then
keep them steady for 30 minutes.

b)Load them to centrifugal tube （ 1.5 mL ） and aspirate

10µl to each centrifugal tube and label on them C1 for low level calibrator, C2
for high level calibrator .
The sealed re-dissolving materials should be
stored at -20 ℃.(-70 ℃ is best if you have the facility)
When use
c) When using, take out high/low level calibrator,
recover to room temperature, add 1500 uL
Hemolysin L reagent to dilute and mix it well.

So do the same steps for QC material, micro tube

labeled as QC1 for low level, QC2 for high level.

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Input the information of Calibrator manually,

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Prepare QC material, input QC information manually, just like calibrator.

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Respectively coming into calibration and QC interface,input the information
of calibrator and controls manually, then prepare to put diluted calibrator and
diluted controls respectively into sample rack,in the way as shown below:

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Then the next,coming into the ‘Test’ Interface,select the Auto Calibration and Auto
QC button,then start,the system will automatically execute calibration&QC and
testing samples together.If in the process of testing,the retention time(RT) is not
appropriate from 50 to 60s(Close to 55s the best for variant 2 mode),the user can click
‘Test’ button twice and will emerge the temperature adjusting button,meanwhile,the
RT could be adjusted by increasing or decreasing the temperature.As shown below:
 After QC test, the system jump to QC curve interface. Press “High/Low Level” to
view QC curves. If the QC result is within ± 2SD, it means good condition of the
analyzer.

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3.4 Assaying Samples
After QC, start to test sample blood. See the steps in user manual.

For normal tests,directly put samples into rack as the previous

way that’s before upgrading to test. Suppose to do daily QC.For
daily QC,put No.1 and No.2 position as the QC1 and QC2,select
the Auto QC button and following the normal samples on the
rack.

Remember to put an empty rack after the normal samp

le rack to stop the test.
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