H8 HbA1c Mode

2021-9-2
CONTENTS

3
1
PART 01
 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

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 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;

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 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 or the agent
of your area
(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.

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PART 02
 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.

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 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 power strip 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
• Grounding: < 5V

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 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.

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PART 03
2D Arm

Probe

H.P Pump Driver

Swab

Rack Module

Tank Filter

Diluted Tank

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 Evacuation Valve
integrated with High
Pressure Pump and
inhibited fluctuation of flow
tubing

Filter

Column Module

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 6 Way Valve
Preposed Filter

Degasser

Test Module

Main Pump

Flow Cell
Second Pump

Pressurizer

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 3.1 Open the right door, and cut off the yellow tie line of 2D arm

Remove the clip Ribbon

Clip

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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.

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 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 400T or column pressure reached 10mPa.

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.

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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 Setting Interface
Select “system”-> “Settings”,
Target Temperature (Column Temperature) is suggested to set to 35℃ for a new column.
Reset Count : Filter、ReagentA/B/C/L, Input the Series No. to reset column counter and Reagent account.

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 3.7 Pump Valve Test Interface

In a quiet environment, press the

switch button Solenoid Valves 1-11,
pay attention to whether hear the
sound of Solenoid Valve opening
and closing;
If not , the Solenoid Valve may be
failed to work.
Check the connecting lines, or
whether Solenoid Valve is broken.

Service Account: lifo

Service password: 661166

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 3.8 Prime Liquid Line
After Pump Valve Test please perform Priming. Enter “Maintenance” interface, then select “Prime Liquid
Line”; Machine will told you to loosen the evacuation valve, after the operation, tightened the evacuation
valve back.

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 3.9 Bubble Elimination
1. Check pressure, 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. Also we need to loosen evacuation valve.
2. Make sure there are no bubbles in the cuvette to confirm whether the ADC is normal.

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 Start the high-pressure pump and check the ADC after the pressure rises and stabilizes.
ADC 415nm range: 12000~13000
ADC 500nm range:8000~10000

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 Adjust ADC and check other parameters
If ADC are out of range, enter other settings interface, adjust DAC_LED/Gain415/Gain500 and check the
ADC value.
Test Mode Variant, Reagent version A1,and AutoNumber Edit Mode.
Primer counts means the extra
aspiration times of first sample for
every batch test.
Usually it should be at least 1 to
eliminate the uncertainty or
fluctuation of first sample result in
HPLC.
1st Temp and 2nd Temp can be set
to both 0.

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 3.10 Check the Elution Sequence
Select Parameters Setting, password is “130325”,check the ABC value in Variant area,
they should be A:46 ,B:24,C:20,otherwise you need to change them by yourself.
Variant Mode Elution Sequence
A: 46 S
B: 24 S
C: 20 S
A: 50 S

HbA1c RT Identified Window:

45.0 ~65.0 S

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 3.11 Performing Column Activation
1. Put a whole blood sample and diluted blood sample(100ul WB : 1500ul DB) in sample rack, the diluted
blood must prepare in EP tube and put inside sample rack with sample adapter;
2. Go to test interface, click start to start the test.

Whole blood W
Diluted blood D

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 3.12 Empty Test
If ADC and Pressure are ok, put an empty rack into machine, then select “Empty Test”.
Red and blue graphs should be close.
If replace a new column or modify the flow rate or change column temperature,
suggest perform “Empty Test” again.

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 3.13 Repeatability test:
1. Mix the whole blood sample, place the blood sample in the test tube rack first position, and click
"Repeatabililty" bottom to set test times, suggest to test 20 times.on the test interface to start the test;
2. Cyclic test 20 sets of data and calculate CV value, requiring CV ≦ 3%.

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 Interpretation for Specimens:
1. Specimens taken from the refrigerator need to stay in room temperature for 30 minutes.Mix well and test.
2. It is better to use fresh blood of the same day (low,median and high levels recommended), refrigerated blood samples should not
exceed 7 days in 2~8℃;

Check chromatogram after repeatability test:

1. Check the Peak: Sharp, elution is thorough, normal distribution,identified correctly,and base line is not drifting.
2. Check Retention Time of HbA1c(RT): Check the peak time whether it is acceptable.
3. Total Area: Check the total area whether it is within normal range.

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RT Suggestion:
Best range is 50.0-55.0S,

If out of range, suggest adjust

column temperature.

If increase 1℃,RT will decrease

RT
1S; -℃
+℃
If decrease 1℃,RT will increase
1S; Base Line

Increase Flow rate, RT will decrease;

Decrease Flow rate, RT will increase;

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 A0
Standard graph

P3

HbA1c
b
a F
LA1c Variant

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 P3 Peak Resolution
The P3 peak may split due to improved resolution.
When this occurs, an "Unknown" peak will present between HbA1c and HbA0.
The presence of this "Unknown" peak has no effect on the HbA1c quantitation.

Usually if a sample gets stale, P3 will increase immediately.

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 3.14 Preparation for calibration and QC operation
1. Take out the calibrator and QC 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 dissolve;
3. Take 1500uL of hemolytic agent into the EP tube and mark it clearly;
4. Add 10uL of reconstituted calibrator, cover and mixe gently, place in the tube rack, cut off the cap of the EP
tube;

Preparation of quality control products is the same

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 3.15. Auto Calibration and QC
Enter the serial number of the calibrator and control.

Target valve calculation: (Low valve + High valve)/2

SD calculation: (High valve - Low valve) /4

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 3.16. Auto Calibration and QC
Cut the cap of EP tube, place the W.B and D.B with dilution rack on the sample rack, from 1 - 5 positions, W.B,
C1,C2, QC1,QC2. Meanwhile go back to system interface click the Cal and QC bottom, jump to the test interfac,
Click “START” bottom.
Color of diluted sample gets deeper, total area will get higher.
If you want to dilute a whole blood, compare the color of QC, otherwise you need to change the diluted
ratio.

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 3.17.1 Individually Calibration
Put a normal whole blood sample on position 1,3. Put C1(low level) and C2(high level) on position 2, 4
on the rack. Press “Start”.
After calibration, system will get factor and offset automatically.
K range: 0.7-1.4 B range: -2 - + 3

C2
C1

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 3.17.2 Individually QC
Put a normal whole blood sample on position 1, 3. Put QC1(low level) and QC2(high level) on
position 2, 4 on the rack. Press “Start”.
After QC test, press “QC Chart” 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.

QC2
QC1

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 3.18 Sample test:
Mixed the whole blood sample, place the blood
sample in the test tube rack, and click the
analysis interface "Start " bottom 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
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 THANKS
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
4th Floor, Building 15, 1008 Songbai Road, Nanshan District, Shenzhen 518055, P.R.China
Tel: 0755-29060026 Fax: 0755-29060036 Web: en..lifotronic.com