SHENZHEN LIFOTRONIC TECHNOLOGY Co.

, Ltd

H9 HbA1c Analyzer
Installation Guide
CONTENTS

1 Preparation for installation

2 Installation requirement condition

3 Installation steps
01
Preparation for installation
 Preparation for installation

1. Tools:
Common Repair Kit
10-100uL pipette
100-1000uL pipette

2. Accessories:
200uL tips
Several 0.5-100ul tips
1000uL tips
Several EP tube
A set of calibrators, quality controls, reagents, and columns.
Marking pen
Disposable rubber gloves
Distilled water/Deionized water
 Preparation for installation

Confirm reagent
     1. The reagents include normal temperature reagents (A eluent, B eluent, C eluent and
hemolytic agent) and refrigerated reagents (calibrator, quality control). The reagents are in the
same lot number;
     2. Whether refrigerated reagents are placed in the refrigerator at 2-8 ℃;
     3. Whether the reagent packaging outer box is damaged and whether the reagent has
leaked;
 Preparation for installation

1. Inspection before unboxing

Before removing the package for installation, please check whether the packing box is intact.

2. Unpacking steps
(1) Stand the packing box upright and make sure that the arrow on the packing box is facing up;
(2) Use a tool to open the packing tape on the packing box, and take out the packing list to
check whether the items are complete; if it is missing, please immediately inform the user
service department
(3) Take out the upper fixed foam cover, embrace the instrument with both hands, pull it out of
the box, and place it on the table.
 Installation requirement

02
condition
 Installation requirement condition

1.1 Space requirement

Ensure the required space for repair and maintenance. Considering the radiating of the
instrument and the liquid pipe behind the analyzer shall not squeezed, the installation of the
analyzer should meet the following requirements:
·The distance from the wall to left and right side doors of the analyzer should more than
50cm;
·The distance from the wall to back door of the analyzer should more than 50cm;
·Make sure there is enough space on the work surface for the analyzer and reagent bucket.
 Installation requirement condition

1.2 Power requirements

·The analyzer must be used in a well grounded condition. Before turning on the analyzer, make
sure that the input voltage meets the requirements of the instrument.

·The use of patch panels may introduce additional electrical interference and cause erroneous
analysis results. Please choose a place near the power outlet
Analyzer to avoid the use of patch panels.
• Voltage: A.C.100 ～ 240V
• Input power: 150VA
• Frequency: 50 / 60Hz
 Installation requirement condition

1.3 Environmental requirements

(1) Working temperature: 10 ℃ ～ 35 ℃

(2) Working humidity: ≦ 80%
(3) Atmospheric pressure: 75 kPa ～ 106 kPa
(4) The environment should be as clean as possible without dust, mechanical vibration, large
noise sources and power supply interference.
(5) It is recommended to evaluate the electromagnetic environment of the laboratory before
operating the equipment.
(6) Do not place the device near sources of strong electromagnetic interference, so as not to
affect the normal operation of the device.
(7) Keep away from brush-type motors, flashing fluorescent lights, and electrical contact devices
that are frequently switched.
(8) Choose a well-ventilated location to avoid direct pipeline or direct heat sources and fans.
(9) Avoid direct sunlight or place in front of heat and wind sources.
03
Product installation
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3.1 The 2D arm is fixed on the metal plate by two black screws. These two screws are to
prevent collision of the 2D arm during transportation.

Open the left door, take them out.

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3.2 Connect the reagents

(1) Remove the A B C eluent from the reagent bag, tight every joint on the cap ,and attention to
connect correspondingly.
(2) Connect L eluent and waste liquid bucket. Connect L eluent in red and waste liquid bucket in
black. Tighten the joint.
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Note:
1. Unopened kits are stored under specified storage conditions (protected from light, sealed at 10-30
° C), and the validity period is 18 months; reagents that have been opened should be stored under
specified storage conditions, and the validity period is 3 months. Use before the expiration date of
the kit identification. Do not mix reagents from different reagent bottles.
2. Reagent packaging is divided into normal temperature packaging and cold chain packaging, one
box for normal temperature reagents, and the another box for calibration quality control. Please
confirm whether the reagents are complete when installing.
3. If the reagent at room temperature is frozen, it must be returned to room temperature and mixed
for 10 minutes before use. The reagent is required to arrive at the department 24 hours in advance.
 Product installation

3.3 Installation of filters

Open the knob of the filter, place the smaller end of the filter down into the holder, and tighten the
knob firmly to prevent leakage (note the direction of the filter).

Replace when pressure reaches 10M.

Filter
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3.4 Column Installation

Open the heating module
Installed the column (note the direction of the column).
Tighten the hand-tight handle to prevent leakage.

Reset
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3.5 Instrument start up

After powering on, select "No" to skip the instrument's automatic cleaning process. If you click “Yes”
or there is no selection within 30 seconds, the instrument will perform automatic cleaning (Note: click
“No” for the first installation and “Yes” for normal use).

As shown below:
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3.6 Menu interface

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3.7 Service interface

1. This interface can reset the

column, filter, reagent and adjust
the temperature of the column.
2. Click System Settings to perform
hardware test, liquid test, and check
whether the parameter settings are
correct.

System Settings password:

661166
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3.8 Hardware detection:

Check whether each pump is

operating normally, and whether
there is a crisp "click" sound during
switching the valve
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3.9 Performing the Liquid Line Priming

1. Operation path: service → system
maintenance → Liquid Line Priming.
2. After completion, turn on the high-
pressure pump and check the pressure
value and ADC value.
(For specific pressure values, refer to the
reference values on the packaging bag).

Note:
The 415nm ADC value: 24000-26000,
500nm ADC value:16000-18000 (check it in
the hardware parameter interface).
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Note:
1. If the pressure value is low, check
for leaks first, and check the joint
whether it is tightened and if
necessary perform the "Bubble
Elimination" procedure.
2. Make sure there are no bubbles in
the cuvette to confirm whether the
ADC is normal.
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3.10 Performing Column Activation
1. Use the EDTA K2 anticoagulation vacuum tube to collect venous blood samples, put them in the
ST position and close the door.
2. Enter the service → system maintenance interface, click the <Column Activation> button as shown
below, and click "Yes".
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3.11 Empty test:
Place two empty EDTA tubes in the first two positions of the sample rack, and perform “Empty test” to
prevent interference from reagent peaks.

Judgement standard:
1. The two measured figures can overlap.
2. No baseline drift
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3.12.1 Repeatability test:
1. Mix the whole blood sample, place the blood sample in the
test tube rack, and click "Start" on the test interface to start the
test;
2. Cyclic test 20 sets of data and calculate CV value, requiring
CV ≦ 3%.

Explanation:
1. Samples taken from the refrigerator need to stand at room
temperature for 30 minutes.
Test after mixing
2. Select the anticoagulated fresh blood sample of the day
(median and high recommended), if yes
Refrigerated aging blood samples should not exceed 48 hours;
3. If the Auto Sampler Circulation function is turned on, put an
empty sample rack after the test. The instrument will stop after
the final sample.
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3.12.2 Check chromatogram after repeatability
test:
1. Check the peak state:
(1) The peak is sharp;
(2) The elution is thorough;
(3) It shows a normal distribution state;
(4) no base line drift.
2. Check time: check the retention time, whether
the peaks fit.
3. Inspection area: check the total area, whether it Hba1c
is between 5-20.
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3.13.1 Preparation for calibration
1. Take out the calibrator from the 2-8 ℃ storage environment,
prepare an appropriate amount of distilled water or deionized
water, restore the temperature to room temperature, click
[Calibration], enter the calibration interface, enter the
corresponding lot number and concentration, and ensure that you
click "Save" without error;
2. Tap the bottle cap to ensure that all the lyophilized samples are
scattered on the bottom of the bottle. Unscrew the cap carefully,
accurately measure 100ul of distilled water or deionized water,
slowly inject it into the bottle, close the cap, and carefully flip the
brown bottle. Secondly, leave it in the dark for about 30 minutes
to allow it to fully
redissolve;
3. Take 1500uL of hemolytic agent into the EP tube and mark it
clearly;
4. Add 10uL of reconstituted calibrator, cover and mixed gently,
place in the sample rack, cut off the cap of the EP tube;
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3.13.2 Preparation for QC
1. Take out the QC from the 2-8 ℃ storage environment,
prepare an appropriate amount of distilled water or deionized
water, restore the temperature to room temperature, click [QC],
enter the QC interface, enter the corresponding lot number,
target value, SD and expiration dates, and ensure that you click
"Save" without error;
2. Tap the bottle cap to ensure that all the lyophilized samples
are scattered on the bottom of the bottle. Unscrew the cap
carefully, accurately measure 100ul of distilled water or
deionized water, slowly inject it into the bottle, close the cap,
and carefully flip the brown bottle Secondly, leave it in the dark
for about 30 minutes to allow it to fully dissolve;
3. Take 1500uL of hemolytic agent into the EP tube and mark it
clearly;
4. Add 10uL of reconstituted QC samples, cover and mixed
gently, place in the tube rack, cut off the cap of the EP tube;
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3.13.3 Calibration interface operation
       Place three whole blood samples in positions 1, 2, and 4 of
the sample rack, low-value EP tubes in position 3 of the sample
rack, and high-value EP tubes in position 5 of the sample rack.
Test on the analyzer. The instrument automatically test twice to
get the new slope intercept. Click “Save” to analyze the
interface operation.

Note:
The instrument will prompt calibration failure if:
1. No blood samples were placed at positions 1, 2, or 4.
2. No calibrator is placed at positions 3 or 5.
3. Put the high value calibrator on the 3rd position or the low
value calibrator on the 5th position;
4. The difference between the two test values of the low
value calibrator or high value calibrator is greater than 0.5%.
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3.13.4 QC interface operation
       Place three whole blood samples in positions 1, 2, and 4 of
the test tube rack, low-value EP tubes in position 3 of the
sample rack, and high-value EP tubes in position 5 of the
sample rack. Test on the analyzer.

Note:
The instrument will prompt QC failure if:
1. No blood samples were placed at positions 1, 2, or 4.
2. No QC samples is placed at positions 3 or 5.
3. Put the high value QC on the 3rd position or the low value
QC on the 5th position;
4. The difference between the two test values of the low
value QC or high value calibrator is greater than 0.5%.
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3.14 Perform calibration and quality control on the test interface:
        In the analysis interface, you can do automatic calibration and automatic quality control. Click on
automatic calibration and automatic quality control. The instrument will prompt the placement position
on the top. The first to fifth positions are the whole blood samples, C1, C2, QC1, QC2. Click to start
the analysis. , The instrument starts the test; you can also test calibration and quality control
separately, and there will be a prompt on the placement.
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3.15 Sample test:
Mixed the whole blood sample, place the blood sample in the
sample rack, and click the analysis interface "Start "to start
the test;

1. Samples taken from the refrigerator need to stand at room

temperature for 30 minutes. Test after mixing
2. Select the anticoagulated fresh blood sample of the day, if
yes Refrigerated aging blood samples should not exceed 48
hours;
3. If the automatic loop sampling function is turned on, put an
empty sample rack after the test. The instrument stops
automatically.
4. If testing diluted blood, a whole blood sample must be
placed before diluted blood, EP tube hat needs to be cut off
THANK YOU ！