GH900-Plus HPLC HbA1c Analyzer

Installation
Introduction
CONTENTS
1 Product Principle

2 Reagents

3
1 Installation Requirements
3
1
4 Preparation for Installation

5
1 Product Installation

16 Product Maintenance
PART 01

Product Principle
Product Principle

Column Test Module

Sample

6-Way
Stronger affinity protein
Valve
HP Pump Weaker affinity protein

Sampling
Valve Ready to transfer mixture from
mixing cup to elution loop.
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump
Sampling
Valve Inject mixture into column.

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Stronger affinity protein
Valve
HP Pump Weaker affinity protein

Valve Seperation
Elution of mixture inside column.
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Stronger affinity protein
Valve
HP Pump Weaker affinity protein

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Stronger affinity protein
Valve
HP Pump Weaker affinity protein

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump

Valve

Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump

Detector
Valve All the hemoglobin opacity will
be detected inside the test
Eluent module.

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Product Principle

Column Test Module

Sample

6-Way
Valve Output

HP Pump Absorbance

Valve

Eluent Time

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Product Principle

Column Test Module

Sample

6-Way
Valve Output

HP Pump Absorbance

Valve
Time
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
Absorbance
HP Pump

Valve
Time
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve Output

Absorbance
HP Pump

Valve
Time
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump Absorbance

Valve
Time
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
HP Pump Absorbance

Valve
Time
Eluent

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Product Principle

Column Test Module

Sample

6-Way
Valve
Absorbance
HP Pump

Valve
Time
Eluent

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 Product Principle

Column Test Module

Sample

6-Way Micro
Valve Computer

HP Pump

Valve

Time
AB

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PART 02

Reagents
Reagents
2.1 Eluent A and B
Sequential elution, Different eluents have
Application different cationic properties.

Storage Temp. 10°C – 30°C

Shelf Life 18 Months

Validity Period (after

3 Months
opening)

Comes in Normal Temperature Pack

• Do not expose to direct sunlight

• Do not use if frozen
• Lot number for each should be same
• Do not mix with leftovers
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Reagents
2.2 Hemolytic Agent L
Application Lysing RBC, Dilution, System Cleaning

Storage Temp. 10°C – 30°C

Shelf Life 18 Months

Validity Period (after

3 Months
opening)

Comes in Normal Temperature Pack

• Do not expose to direct sunlight

• Do not use if frozen
• Lot number should be same with Eluent A and B
• Do not mix with leftovers
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Reagents
2.3 Column
Application Elution

Storage Temp. 2°C – 8°C

Shelf Life 12 Months

Validity Period (after

12 Months
dissolved)

Comes in Cold Chain Pack

• Should be compatible with the reagents

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Reagents
2.4 Calibrators & Quality Controls
Application Calibration & Quality Control

Storage Temp. 2°C – 8°C

Shelf Life 12 Months

Validity Period (after

2 Weeks @ -20°C
dissolved)

Comes in Cold Chain Pack

• Should be compatible with the reagents

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PART 03

Installation Requirements
Installation Requirements
3.1 Space requirement
Ensure the required space for repair and maintenance. Considering the EMI of the instrument and liquid
pipes behind the analyzer, the installation of the analyzer should meet the following requirements:
·The distance from the wall to the left and right side of the analyzer should be more than 50cm;
·The distance from the wall to the back of the analyzer should be more than 50cm;
·Make sure there is enough space on the work surface for the analyzer and reagent bucket.

GH900-Plus

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Installation Requirements
3.2 Power requirements
·The analyzer must be used with a good electrical grounding. Before
turning on the analyzer, make sure that the input voltage meets the
requirements of the instrument. Use UPS if necessary.

·The use of power strips or extension cords may introduce additional

electrical interference and cause erroneous analysis results. Please choose
a place near the main power wall outlet.

• Voltage: 100 ～ 240VAC

• Input power: 150VA
• Frequency: 50 / 60Hz
• Grounding
• Earth and Neutral : 0V< Voltage < 5VAC
• Live and Neutral : 100V ~ 240VAC
• Live and Earth : 100V ~ 240VAC

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Installation Requirements
3.3 Environmental requirements

(1) Working temperature: 10 ℃ ～ 30 ℃

(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 (refrigerator etc.).
(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 04

Preparation for Installation

Preparation for installation
Tools:
Common Repair Kit
10-100uL pipettor
100-1000uL pipettor

Accessories:
Pipettor tips
Several EP tubes
Marking pen
Disposable rubber gloves

Other:
Distilled or Deionized water
Blood sample (EDTA K2 Tube, fresh preferred)

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Preparation for installation
Unpacking the reagents
     1. Normal temperature
reagents (A eluent, B eluent and
hemolytic agent L) and
refrigerated reagents (calibrator,
quality control and column) are
in separate packs. Check lot
numbers before proceeding.
     2. Check whether refrigerated
reagents are placed in the
refrigerator at 2-8 ℃;
     3. Check whether the reagent
packaging outer box is damaged
and whether the reagent has
leaked;

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Preparation for installation
Unpacking the device
(1) Before removing the package for installation, please check whether the
packing box is intact.
(2) Check the tilt indicator label on box.

Unpacking steps
(1) Keep 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 foam cover, hold the instrument with both hands,
pull it out of the box, and place it on the table.

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PART 05

Product Installation
Product installation
Printer

Eluent holder

Sample
Column & Filter
compartment
compartment

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Product installation
Evacuation
Valve

Filter

Column
Module

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Product installation

2D Arm

Probe

Waste Filter
Dilution Tank

Rack Module Waste/Vacuum Pump

Valve for Waste or

Vacuum Selection
Rack Sensor

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 Product installation
6 Way Valve Board

Main Board
Degasser

Valve 9,6,8
6 Way Valve
1mL Plunger Pump
Preposed Filter
High Pressure
Sensor
High Pressure Pump
Flow Cell

Gradient Valve
Test Module

Backpressure Tubing
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Product installation
5.1 Remove the fixtures

To prevent the 2D arm movement while

in transport, the arm is fixed with a tie.

Open the right door, and cut off the tie

of 2D arm. Try to move the arm to make
sure it can.

Note: If you plan to move the device to

another place, please tie the 2D arm.

Tie

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Product installation
5.2.1 Connect the reagents
(1) Loosen two screws from left side of machine, then install the eluent holder frame.
(2) Connect eluent A/B caps to corresponding eluents and make sure the tube is at the bottom of the eluent
bag.

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Product installation
5.2.2 Connect the reagents
(3) Connect L agent to red connector and
waste liquid bucket to black connector.
Tighten the connectors.
(4) Connect the red cap to hemolytic agent L
Bottle and connect the black cap to waste
bucket.

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Product installation
5.3 Installation of filter
Turn the knob of the filter counterclockwise, remove the preinstalled placeholder filter. Place the smaller end
of the new filter down into the holder, and tighten the knob firmly to prevent leakage (note the direction of
the filter).
Replace after 400 tests or if column pressure is above 10MPa.

Knob

Filter

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Product installation
5.4 Column Installation
(1) Open the heating module cover. Remove column from it’s packaging. Remove the screws on column ends.
(2) Connect the tube screws by plugging them and rotating them clockwise, mind the direction of the
column. Arrow sign on the column should point to the same direction with the arrow label on the
compartment.
(3) Make sure tube screws are tightened Tube
to prevent
Screws leakage.
(4) Place the column to the slot.
(5) Close the cover.

Screws

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

Account: lifo
Password: 661166

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Product installation
5.6.1 Replacing column
Go to “System”-> “Maintenance”-> “Change column”
Enter S.N. then select “Yes” to continue.
Note: S.N. is written on the column box

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Product installation
5.6.2 Replacing column
Enter Column Temperature (written on the column packaging). Select “Yes” to continue.
On the next popup when asked to replace column, select “Skip” to skip column activation for now (installation
purposes).

Note: When column replacement is desired, follow the instructions to replace and activate column.

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Product installation
5.6.3 Adjusting column temperature
To adjust column
temperature if needed,
select “Screen
Brightness / Column
Temp” and enter
desired column
temperature.

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Product installation
5.7 Resetting reagent & filter counters
To reset reagent counters after reagent replacement, Go to “System”-> “Maintenance”
Select “Change Reagent” to replace reagents. The software will guide you through the steps.
Select “Change Filter” to replace reagents.
If single reagent replacement is needed, Go to test tab and select the desired reagent to be replaced.

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Product installation
5.8 Testing Hardware

Go to “System”-> “Service”-
>”Pump Valve Test
Service Account: lifo
Service password: 661166
In a quiet environment, turn
the Solenoid Valves 1-11 ON,
pay attention to the sound of
Solenoid Valve opening, then
turn them off and listen to
them closing;
If there is no sound, the
Solenoid Valve may be faulty.
Check the connectors or
whether if the Solenoid
Valve is broken.
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Product installation
5.9 Priming Liquid Line
Enter “Maintenance”
interface, then select
“Prime Liquid Line”;

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Product installation
5.10 Checking pressure and ADC values
Start the high-pressure pump and check the pressure, wait for pressure to stabilize, then check ADC
values.
If the pressure is not in range, please do a bubble elimination procedure.
ADC 415nm range: 24000~28000
ADC 500nm range: 16000~20000
Pressure range: Column P.±1 MPa

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Product installation
5.11 Adjusting ADC
If ADC values are out of
range, go to “Other Settings”
in the Service menu, adjust
Gain415
Gain500
DAC_LED
values and check the
corresponding
ADC415
ADC500
values.
Increasing DAC_LED value will
increase both ADC values. ADC 415nm range: 24000~28000
Increasing Gain values will ADC 500nm range: 16000~20000
decrease corresponding ADC
value.
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Product installation
5.12 Bubble Elimination
It is necessary to remove bubbles from the liquid line, bubbles may exist after reagent replacement or
during installation.
Perform the "Bubble Elimination" procedure. The system will instruct you to open the evacuation valve. Turn
the valve 45 degrees counterclockwise, wait for the operation to finish, then close the valve.

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Product installation
5.13.1 Checking other parameters
Make sure Test Mode is 130S
PPS value means the speed of
the HP Pump, flow rate can be
adjusted by increasing or
decreasing this value. Might
be helpful to solve issues with
the retention.

Primer counts means the extra

aspiration times of the first
sample for every batch test.
Usually it should be at least 1 to
eliminate accuracy issues or
fluctuation of first sample.

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Product installation
5.13.2 Checking other parameters
Check reagent volume settings
A: 800
B: 400
L: 2500 400
N: 400

Aspiration volume can be

changed. Might be helpful to
solve total area issues.

Reference range

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Product installation
5.14 Checking the Elution Sequence
Select “Parameters Setting”, the password is “130325”, check the A,B,C values in Variant area,
should be A: 46, B: 24, C: 20, otherwise these values needs to be readjusted.
Variant Mode Elution Sequence
A: 46 S
B: 24 S
C: 20 S
A: 50 S

HbA1c Identification Window:

45.0 ~65.0 S

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 Product installation
5.15.1 Performing Column Activation
Place a whole blood sample and
diluted blood sample to the sample
rack. Dilution ratio is: Whole blood W
(100μL WB : 750 μL L) Diluted blood D
Diluted blood must be prepared with
an EP tube and put into the sample
rack with sample adapter;
1. Go to “Test” tab.
2. Place the sample rack.
3. Close the door.
4. Input sample ID.
5. Choose sample type.
6. Start the test.
Note: This procedure should be done
after each column replacement

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 Product installation
5.15.2 Checking the RT of HbA1c
Check the “time” of A1c in result
interface

The best RT of A1c is 50-55S, adjust the

column temperature in “system”-
>”settings”-> “screen brightness and
column temperature”.

Need to check the RT of the A1c and

415&500 ADC before you doing empty
test!!!!!

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Product installation
5.16 Empty Test
Select “Empty Test”
Red and blue graphs should be overlapping each other. There should be no baseline drift.
This procedure should be done each time after column replacement, modification to the
flow rate or column temperature.

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Product installation
5.16 Empty Test

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Product installation
5.17 Repeatability test:
1. Mix the whole blood sample, place the blood sample to the first position in the sample rack, and go to
“System->Service->Performance Setting”, toggle “Repeatability” checkbox on. Cyclic test 20 sets of data
and then calculate the CV, should be ≦ 3%. Note that sample volume must be enough for all the tests.

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 Product installation
5.18 Checking chromatogram Range: 45 ~ 65 S Range: 50K ~ 300K
Recommended: 50 ~ 55 S Recommended: 80K ~ 140K
Check chromatogram after
repeatability test:
1. Check HbA1c Peak: Sharpness,
thorough elution, distribution,
correct retention.
2. Total Area: Check the total
area whether it is within
normal range.
3. Check Retention Time of
HbA1c: Check the peak time
whether it is acceptable.
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 Product installation
If RT is out of range, it is suggested
to adjust column temperature.
Column Temp ↑ = RT ↓
Column Temp ↓ = RT ↑
Flow Rate ↑ = RT ↓
Flow Rate ↓ = RT ↑
+℃ RT -℃
4. Check Baseline Drift
The end of the chromatogram line
Base Line
should be on the same level as the
start. There should be no sharp
falling edge near to ending.

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 Product installation
5. Check for Variants
If another peak exists after the HbA0 peak, this might suggest that there is a variant hemoglobin in patient’s
sample. This won’t be included in total area calculation, and it won’t affect HbA1c result usually.

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 Product installation
6. Interpretation for remarks
Interpretation of HbA1c Result with Asterisk and Red Color:
e0 ： Abnormal peak time of A0;
e1 ： Total area < 50000 ；
e2 ： Total area > 300000 ；
e3 ： HbA1c > 15% ；
e4 ： HbA1c < 4% ；
e5 ： Variant existence;
e6 ： ADC415 reach maximum limit;
e7 ： A0 concentration less than 80% ；
e8 ： HbA1c retention time is out of range.

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Product installation

A0
Standard graph

P3

HbA1c
b
a F
LA1c Variant

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 Product installation
P3 Peak
The P3 peak may be the result of degenerated
hemoglobin.
When this occurs, an "Unknown" peak will be
present between HbA1c and HbA0.
The presence of this "Unknown" peak has no
considerate effect on the HbA1c quantitation.
Usually if a sample gets stale, P3 will increase.

Sample Preparation Guide:

Specimens taken from the refrigerator have to stay in room temperature for 30 minutes. Mix before testing. It
is better to use fresh blood of the same day. Refrigerated blood samples should not exceed 7 days in 2~8℃;
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Product installation
5.19.1 Calibration setup
Calibration information can be
checked from this tab.

Go to “Calibration” tab, enter Lot

Number and calibrator value to
D.B. Cal. section.

Manual calibration can be set from

Manual section.
Allowed ranges:
K: 0.7~1.4
B: -3 ~ +3
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Product installation
5.19.2 QC Setup
Go to “QC” tab, enter Lot Number,
calculate Target and Deviation
values with formulas below, enter
them.

Target Value calculation:

(High value + Low value) / 2
SD calculation:
(High value - Low value) / 4

Up to date QC results can be

checked from this page.

Acceptable range:
-2SD ~ +2SD

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Product installation
5.19.3 Preparing Calibrators and QCs
1. Take out the calibrators and QCs from the 2-8 ℃ storage environment, prepare an appropriate amount of
distilled water or deionized water, wait for the temperature of bottles to reach room temperature.
2. For each item, tap the bottle cap to ensure that all the lyophilized samples are scattered at the bottom of
the bottle. Unscrew the cap carefully, aspirate 100ul of distilled water or deionized water, inject it slowly into
the bottle, close the cap, and flip the bottle carefully. Leave it in the dark for about 5 minutes, then flip it
again, wait for another 5 minutes for full dissolution;
3. Aspirate 1500uL of hemolytic agent and inject it into the EP tube and mark it corresponding to the item to
be used.
4. Add 20uL of reconstituted item, close the cap and mix gently. The item is ready for use.

Suggestion: You should divide the remaining items to EP tubes as 20uL, mark them, and keep them in -20 ℃
for future use up to 2 weeks.

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Product installation
5.19.4 Auto Calibration and QC
Cut caps of EP tubes, place them
with adapter on the sample rack
with the order of:
| 1. C1 | 2. C2 | 3. QC1 | 4. QC2 |
Go to “Test” tab and toggle
Calibration and QC checkboxes
on.
If you just need to do calibration
or QC individually, you can toggle
corresponding checkbox only,
and load the tubes
corresponding to the user
interface.

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Product installation
5.19.5 Checking Cal Results
Calibration information can be
checked from this tab.

Current calibration factor and

offset values can be seen here.

Previous calibration results can be

seen here.

Factor and offset limits

K: 0.7~1.4
B: -3 ~ +3

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Product installation
5.19.6 Checking QC results
The analyzer will show daily record
of QC results by chosen level and
date here.

Details of a chosen point on the

graph can be viewed here.

LJ Curve graph. X axis corresponds

to date of the month. Y Axis
corresponds to deviance.

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Product installation
5.20 Sample test:
Mix the whole blood sample, place the blood
sample in the test tube rack, close the door and
select "Start " to start the test;

1. Samples taken from the refrigerator need

to wait at room temperature for 30
minutes. Mix before testing.
2. First test of the day should always be a
whole blood sample, and this result can be
discarded.
3. Refrigerated aging blood samples should
not exceed 48 hours.
4. If diluted blood is chosen, a whole blood
sample must be placed before diluted
blood. EP tube caps need to be cut for all
Dilution ratio for DB Samples
samples. 20uL WB : 1500uL Hemolytic Agent L
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PART 06

Product Maintenance
Product Maintenance
6.1 Daily Maintenance
Check the liquid level of each bottle of reagent and waste bottle,
replace reagents and discard the waste liquid if necessary.

Check the remaining number of chromatographic columns,

filters and replace them if necessary.

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Product Maintenance
6.2 Weekly Maintenance

Wear protective gloves.

Use a disposable towel or fabric

to clean the sample rack, surface
and the screen.

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Product Maintenance
6.3 Monthly Maintenance
Use a Q-Tip and a clean gauze with
%0.5 sodium hypochlorite solution to
clean the dilution cup and the probe,
then clean it again with distilled water.
After cleaning, execute “diluting tank
cleaning” procedure on software.

Note: Wear protective gloves and

glasses. Device must be powered off.

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Product Maintenance
6.4.1 Quarterly Maintenance
Cleaning & Replacing the pre-posed filter
Open SV1 on the system maintenance
interface, start the high-pressure pump,
and listen to the noise of the high-
pressure pump. In case of abnormal
noise, cleaning or replacing filter is
necessary.

Steps:
1. Remove the left door of the device.
2. Remove the top joint on the left side of
the auxiliary pump.
3. Use a wrench to remove the nut. The
filter is located on the bottom side of the
nut.

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Product Maintenance
6.4.2 Quarterly Maintenance
Replacing the pre-posed filter

Steps:
4. Check the filter. If it is not too dirty, wipe with
towel and rinse with deionized water;
5. If replacement is necessary, remove the filter
and install a new one.
6. Power on the device and start the high-
pressure pump for a minute, check whether is
the pressure stable and whether is there a
leakage.

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Product Maintenance
6.5.1 Quarterly Maintenance
Cleaning the 6-way valve
Steps:
1. Turn off the machine, cut off the power. Open the left door.
2. Unscrew the 5 hexagonal socket screws that fix the valve-
head of the six-way valve. (Note: if necessary, unscrew the four
M4*8 combination screws that fix the six-way valve. But do not
loosen the 6 stainless-steel joints on the steel stator);
3 Remove the stainless-steel stator and take out the black rotor;
4 Rinse the black rotor with a syringe (preferably 75% alcohol),
and then wipe it dry with a dust-free cloth (if you use tissue, dry
it gently);
5 The stainless-steel stator should be wiped with a dust-free
cloth and 75% alcohol, and finally wiped with a dry dust-free
cloth (if you use tissue, wipe it gently);
6 Install the rotor, and tighten the 5 hexagon socket screws of
the stainless-steel stator in a star-shaped sequence (1-2-3-4-5)

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Product Maintenance
6.5.2 Quarterly Maintenance
Cleaning the 6-way valve
Confirmation:
1 Confirm that the six-way valve is installed in place and the wires and
connectors are correct.
2 Turn on the machine and confirm that the two mode of six-way valve A and
B are switched normally. Confirm the pressure is normal. Confirm the
chromatogram is normal and the quality control is normal.

Recommended Frequency: Every 3 months or 6000 tests.

Operator time: Approximately 20 minutes.
Precautions: Wear proper protective gloves.

Materials Required
Common Kit: Including hexagon socket, screwdrivers, medical gloves,
syringes, etc.
75% alcohol
Non-dust Cloth
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Product Maintenance
6.6 Half-yearly Maintenance
Replacing the post filter
Open the right door and perform the operation on the outer wall of the probe washing. Check whether the
liquid flow is smooth when the waste liquid pump is pumping. If there is blockage, the post-filter needs to be
replaced.

1. Open the right door of the system.

2. Use a cross screwdriver to remove the waste liquid filter and mark the direction of the liquid path.
3. Use a cross screwdriver to open the waste liquid filter, remove the diaphragm inside and place it under
running water to rinse.
4. After washing, install back to the original position and twist the filter.
5. Install the waste liquid filter back to the original position according to the direction marked previously.
6. Connect pipes and joints.
7. Start the machine and enter the hardware test interface, and switch on the waste pump.
8. Observe whether there is liquid leakage and whether the liquid discharge of the waste liquid pump is
smooth

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Product Maintenance
6.7 Half-yearly Maintenance
Lubricating the 2D-Arm
Steps:
Do the cleaning of the 2D arm and move the 2D arm to see if it can move fluently.
Add oil to lubricate the 2D arm if needed.

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Product Maintenance
6.8 Yearly Maintenance
Replacing HP Pump diaphragm
Execute the high pressure pump cleaning procedure first. Check the pipeline connected to A, B and C eluent,
if there is no liquid in the pipeline, it indicates that the diaphragm has been damaged and needs to be
replaced.

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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