GH-900 HbA1c Analyzer

Service Manual

IVD

Shenzhen Lifotronic Technology Co., Ltd.

Intellectual Property

Shenzhen Lifotronic Technology Co., Ltd. (hereinafter “Lifotronic”) has the copyright
of this manual not publicly published the right to treat it as confidential materials. This
manual is merely a reference for the operation, maintenance and service of Lifotronic’s
products. This manual and all intellectual properties (including copyright) pertaining to
it shall reside with Lifotronic. Without the prior written permission of Lifotronic, no
person shall use, disclose or allow others to obtain this manual by any means in whole or
in part, and no one shall photograph, copy, duplicate or translate (without limitation to
the foregoing) this manual in whole or in part.

Lifotronic has the right of final interpretation of this Manual.

Lifotronic reserves the right to update product technology without prior notice;

Lifotronic reserves the right to modify product specifications without prior notice.

Lifotronic reserves the right to modify the manual without prior notice.

Statement

Lifotronic makes no guarantee for this document whatsoever, including (but not limited
to) implied merchantability and suitability for a particular purpose.

Lifotronic shall be responsible for the safety, reliability and performance of its product
only when:

 The assembling, expansion, readjustment, improvement and repair are carried out
by Lifotronic authorized personnel;
 The machine is used according to operation instructions;
 Electrical devices are in compliance with national standards.

Lifotronic shall not be responsible for the safety, reliability and performance of its
product if:

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 The product has reached its lifetime limit;
 Parts have been disassembled, stretched or readjusted;
The machine is not used properly according to User Manual.

Warranty

Repair Service

Scope of free service:

Product is entitled to free service if it is within Lifotronic warranty provisions.

Scope of fee-based service:

(1) Lifotronic will provide fee-based service if the product is not within the range of
Lifotronic’s warranty provisions;
(2) Within warranty period, fee-based service will be provided if the product defect is
caused by:
 Misuse;
 Man-made damage
 Replacement with parts not approved by Lifotronic;
 Repair of the machine by personnel not authorized by Lifotronic;
 Grid voltage beyond equipment specifications;
 Uncontrollable natural disasters.

Lifotronic shall not be responsible for direct, indirect or consequential damage or delay
caused by the foregoing (including but not limited).

II
Return of Product

(1) Obtain Return Material Authorization. Contact Lifotronic’s Customer Service Dept.
and provide the S/N of Lifotronic product. The S/N is marked on the package. Return of
product will not be accepted if the S/N is not clearly legible. Please note the type, S/N of
product and reason of return.

(2) Freight expense: Freight (including customs fees) of products returned to Lifotronic
for service shall be borne by the customer.

Contact

Manufacturer：Shenzhen Lifotronic Technology Co., Ltd.

Register Address: 4th Floor, Building 15, 1008 Songbai Road, Nanshan District,
Shenzhen, China
Manufacturing Address: 4th Floor, Building 15, 1008 Songbai Road, Nanshan District,
Shenzhen, China
Postcode：518055
Tel：86-755-29060026
Fax：86-755-29060036
Service Line：86-755-29060197
Web：en.lifotronic.com

III
● The system is operated and used by Lifotronic or designated agents trained
professionals, doctor or lab assistant;
● If hospitals or institutions can not achieve a satisfactory repair / maintenance plan, it
may cause abnormal instrument failure, and may endanger human health.
● Ensure to run the instrument under the conditions that are written in this manual. If
not, it may fail to run, result in inaccurate results, or even damage the components
and injure humans.

This manual is for and only for:

1. Daily operations personnel

2. System maintenance and troubleshooting personnel
3. Personnel that learn to use the system

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 Content

Contact ........................................................................................................................................... III

Chapter-1 Instrument Introduction ........................................................................................................... 6

1.1 Overall Framework .................................................................................................................. 6

1.2 Methodology .............................................................................................................................. 7

1.3 Test Parameters ........................................................................................................................ 8

Chapter 2 Hardware.................................................................................................................................. 9

2.1 Mainboard ................................................................................................................................. 9

2.2 Sample Loader ........................................................................................................................ 14

2.3 Thermal Printer ...................................................................................................................... 15

2.4 2D Arm .................................................................................................................................... 15

2.5 Optoelectronic Measurement Module .................................................................................. 16

2.6 Column Warming Module ..................................................................................................... 18

2.7 Solenoid Valve ......................................................................................................................... 18

2.8 Plunger Pumb ......................................................................................................................... 19

2.9 Mixing Cup Warming Module .............................................................................................. 20

2.10 System Parameters Settings ................................................................................................. 20

2.11 Hardware Test ...................................................................................................................... 21

Chapter 3 Abnormal Test Chromatograms ............................................................................................. 23

3.1 Normal Test Chromatogram ................................................................................................. 23

3.2 Test Chromatogram with Column Blocked or Defected ..................................................... 23

3.3 Test Chromatogram with Bubbles ........................................................................................ 24

3.4 Test Chromatogram of Sample without Enough Dilution .................................................. 24

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 3.5 Test Chromatogram of Sample with Over Dilution ............................................................ 25

3.6 Test Chromatogram without Sample Aspirated .................................................................. 25

3.7 Test Chromatogram with ADC Value over 20000 ............................................................... 26

3.8 Test Chromatogram of Eluent A Polluted by Eluent B or C .............................................. 26

3.9 Test Chromatogram of Eluent B Polluted by Eluent A....................................................... 27

3.10 Test Chromatogram of Eluent B Polluted by Eluent C ..................................................... 27

3.11 Test Chromatogram of Eluent C Polluted by Eluent A or B ............................................ 28

Chapter 4 System Liquid Line Chart ...................................................................................................... 29

4.1 Hemolysin Liquid Route ........................................................................................................ 29

4.2 Sample Probe Wiper Liquid Route ....................................................................................... 30

4.3 Sample Pass through Column Liquid Route ........................................................................ 30

4.4 Eluent A Liquid Route ........................................................................................................... 31

4.5 Eluent B Liquid Route ........................................................................................................... 32

4.6 Eluent C Liquid Route ........................................................................................................... 33

4.7 Liquid Line Wash Route ........................................................................................................ 34

4.8 Liquid Line Counter Wash Route ......................................................................................... 35

4.8 Mixing Cup Liquid Line Wash Route................................................................................... 36

Chapter 5 Fault Table ............................................................................................................................. 38

Chapter 6 Trouble Shooting ................................................................................................................... 39

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 Chapter-1 Instrument Introduction

1.1 Overall Framework

GH-900 HbA1c Analyzer is consisted of the parts listed below, see in Picture 1
1) Liquid Line: Liquid line switch part, sample aspirating part, rinsing part,
disposing part, reagent tube
2) Hardware: Control panel, analog board, power module, display module, print
module, wire harness
3) Software: System software, data processing algorithm, liquid line sequential
algorithm, printer driver, clock & memory, HCI, temperature control
algorithm
4) Mechanical Part: Industrial design, shell, holder, sample arm, injection
transmission components, waste transmission components, cuvette, column,
mixing cup

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 Picture 1 Overall Framework

1.2 Methodology
HbA1c Analyzer adopts Lower Pressure Liquid Chromatography (LPLC)
methodology, to separate HbA1c based on the differences of electric charge quantity
between different hemoglobin. HbA1c will be eluted first at certain low concentration
eluting condition. And then measure the absorbance points to form chromatogram, get
the precise HbA1c testing result.

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 Picture 2 HbA1c Test Curve

1.3 Test Parameters

● GH-900 Analyzer is a diagnosis device that is used for disease screening. When diagnosing disease,
clinicians should take clinical examination results or other test result into consideration.

GH-900 Analyzer adopts Low Pressure Liquid Chromatography (LPLC) to measuring the
content of HbA1c in human blood.
The GH-900 Analyzer could display as much as 5 types of blood parameters and 1 type of
chromatogram result.

Item Unit Reference Standard

HbA1a+HbA1b Area% NGSP

HbA1c Area% NGSP
HbA0 Area% NGSP
HbA1c mmol/mol IFCC
Average Blood Glucose (eAG) mmol/l ADAG
Chromatogram — —

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 Chapter 2 Hardware

2.1 Mainboard
The hardware of HbA1c Analyzer shows in Picture 2 and includes 5 main parts:
Power module, control module, temperature control module, cuvette testing module,
input/output module.
1) Power module provides different voltage for the system to keep it working
normally;
2) Adopting MCU single chip, control module is the core part of the whole
system, which conducts data collection, chromatogram display and liquid line
control etc.
3) Temperature control module is used to provide an appropriate environment for
mixing cup and column. That will make system more stable and results more
precise.
4) Cuvette testing module is intended to test the contents of eluted components.
5) Input/output module is the main route of human-computer communication that
has functions like QC, calibration, sample testing, system setting, maintenance
etc.

Picture 2 Hardware Diagram

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 24V Control
Sample_Tray Panel Power

X arm Optocoupler

Step Motor-X

Z arm Optocoupler

Step Motor-Z

Inject Pump Optocoupler

Inject Pump

Peristaltic Pump Out

Peristaltic Pump In

SV1

SV2

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 Peltier
Heater
Fan

Printer
SV 3-9

Data Collect

LED

Scan Com PC LCD Display RFID Air Temp PET Temp Heater Temp

Picture 2.1 Main board Layout

In general, it’s not necessary to test the electronic components on the
motherboard, just properly connect the cables secure and intact without fracture. If
there is no obvious burn marks on the board, it is not easy to determine the location of
damage, just replace the whole board.

Port Name Functions

J17 SAMPLE TRAY Sample Tray Port

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J24 +24V,GND 24VControl Panel Power Port

J15 MZ_2 X arm Optocoupler Port

J16 MTOR_X X arm Motor Port

J13 MZ_1 Z arm Optocoupler Port

J14 MTOR_Z Z arm Motor Port

J11 MZ_4 Inject Pump Optocoupler Port

J12 INJECT_PUMP Inject Pump Port

J10 PUMP_OUT Peristaltic Pump Out Port

J9 PUMP_IN Peristaltic Pump In Port

J34 PET Peltier Port

J33 HEATER Mixing Cup Heater Port

J8 SV1 Solenoid Valve 1 Port

J32 FAN Cooling Fan Port

J7 SV2 Solenoid Valve 2 Port

J31 PRINTER Printer Port

J6 SV3 Solenoid Valve 3 Port

J5 SV4 Solenoid Valve 4 Port

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J4 SV5 Solenoid Valve 5 Port

J25 DATA_COLLECT Data Collection Port

J3 SV6 Solenoid Valve 6 Port

J2 SV7 Solenoid Valve 7 Port

J26 LED LED Emitter Port

J1 SV8 Solenoid Valve 8 Port

J18 SV9 Solenoid Valve 9 Port

J20 LCD LCD Screen Port

J19 COM_PC Serial Connection Port

J22 RFID_Uart RFID Card Reader Port

J27 AIR_DETECT Room Temp Sensor Port

J28 PET_DETECT Peltier Temp Sensor Port

J29 HEATER_TEMP Mixing Cup Heater Temp

Sensor Port

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 2.2 Sample Loader

Follow the user manual instruction to dissemble the sample loader as seen in Picture
Sample Loader
Connection Cable

Base Board
Optocoupler Test

Sample Tray
Driving Disk
Groove

Picture 2.2 Sample Loader Layout

Protruding Point

Sample Tray Optocoupler

Test Point

Picture 2.3 Sample Tray Layout

1) There are two protruding points stuck with two grooves on the driving disk, to rotate
sample tray.

2) Sample Loader Positioning: There are is gap on the back of sample tray working as
sample tray optocoupler test point, it will generate a signal once the optocoupler
meets the gap. The system uses the test point as the default position and orientates
the sample loader position by this process.

3) Please check sampling needle and sample tray position every time you installed the
sample loader (whether it’s an installation or a service). if there is deviation, please
go the service menu to adjust positioning.

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2.3 Thermal Printer

Open the printer door gently and slowly press it down.

Printer Door Trigger Printer Screws

Indicator Light
and Print Button
Please keep the paper’s heat-sensitive side up when changing the thermal paper, and use the
printer door to stuck the paper.

How to Change Thermal Printer:

1) Remove the front cover, disconnect the

thermal printer cable with the
mainboard.

2) Use a cross screwdriver to take off the 2

printer screws.

3) Hold and pull out the thermal printer.

4) Put on the new printer;

5) User a cross screwdriver to fix the

printer screws;

6) And then connect the printer cable to the mainboard.

Printer Screws

2.4 2D Arm

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2D Arm is to move the sample probe vertically and horizontally.

Sample Probe
Motion Slider

X-axis

Y-axis
Sample Probe

Driving Belt
Sample Probe
Wiper

As shown in the right picture, X-axis drive

Z-axis on two rails back and forth, therefore the
two rails should be kept horizontally parallel,
and must be applied lubricant.

Rails and Slider

2.5 Optoelectronic Measurement Module

Components of Optoelectronic measurement module.

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 Nylon Screw to Fix
Colorimetric Cell
Filter Lens

Optical Sensor

Data Collection Chip

Main Module

Colorimetric Cell

Disassemble Assemble

Thick Metal Inlet

Tube and Thin
Outlet Tube

Long Tube to
Connect Column

Short Tube to
Screw Position
Connect Waste Line

When LED value rise 1, the light is getting stronger, ADC value will rise (700-800).

Thus, the optical sensor aging will lead to ADC value shrink.

ADC value within 17,000-19,000 means the colorimetric cell is filled with bubble-free eluent and
has no significant changes.

If ADC value is out of 17,000-19,000, or vary greatly to reach 20,000 or 0, it means the
instrument has faults to be fix. (Please refer to the Fault Information Section)

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2.6 Column Warming Module

This module is to stabilize the column temperate at 25 ℃, please see below picture.

Cooling Fan

Heatsink
Column

Peltier Heater

Temperature
Sensor

Warming Cover

Peltier heater, heatsink and cooling fan compose the warming module, and temperature sensor will
monitor real time temperature through the warming cover.

Temperature too high or too low will affect the ion change and then test results.

2.7 Solenoid Valve

There are 8 3-way solenoid valves in the analyzer. Each solenoid valve has two exits and one
entry, but only one exit can work with the entry to be a route at one time. For example, the entry
and the exit marked with ON work as a route once there is no electrical current. The entry and the
exit marked with OFF work as a route once there is electrical current.

It’s easy to test the solenoid valve at service menu, input the service password and then choose
“Service Test” menu to check the solenoid valve one by one. If there is “Di” sound, it means the
solenoid valve connection is good. If there is no sound, it means the solenoid valve is broken or
connection wrong.

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 ON Exit, will close once
there is electrical current

OFF
Exit

Entry

2.8 Plunger Pumb

Plunger pumb is to precisely aspirate sample and hemolysin. And it’s connected to No.2 Solenoid
Valve. It’s necessary to check whether the aspirate volume is correct.

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2.9 Mixing Cup Warming Module

Once the analyzer is powered on, the film heater will start, the heat will transfer through the
aluminum block to the mixing cup. (Temperature sensor will monitor the real time temperature
and keep it at 51℃. Blood sample and hemolysin should react at this temperature to destroy the
Erythrocyte membrane completely to release all the hemoglobin.

Mixing Cup
Aluminum Block
Film Heater

Temperature Sensor

2.10 System Parameters Settings

Aspiration Volume: Default is 10ul.

Chromatography Column: Set the duration of mixed liquid pass through the chromatography
column, default is 2000ms.

Speed: Set “High” and “Low” speed to generate a speed difference for
certain pressure between 2 pumps.(Difference should be 60, e.g
when High speed is 50, Low speed should be 110)

“Superhigh” is the speed for counter wash.

2D Arm

X Axis Route: To adjust Sample Probe horizontally for accurate aspiration,

distance is in mm

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Z Axis Routes: To adjust Sample Probe vertically to reach lowest 2mm to the
sample tube bottom for aspiration, distance is in mm

Sample Loader: Adjust the sample loader position to suit sample probe exactly in the
middle.

2.11 Hardware Test

It’s very useful to diagnose the parts one by one to detect the system issues.

Solenoid Valve: There are 9 solenoid valves, press “on” and “off” to test them by sound.

Inlet Pump: Press “FWD” and “REV” to check whether it’s working properly.

Outlet Pump: Press “FWD” and “REV” to check whether it’s working properly.

Plunger Pump: Press “In” and “Out” to check whether it’s working properly.

X Axis Motor: Press “In” and “Out” to check whether it’s working properly.

Z Axis Motor: Press “Up” and “Down” to check whether it’s working properly.

Bar Code:

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HIS Test, RFID Test, Print Test, Sampler Loader Positioning

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 Chapter 3 Abnormal Test Chromatograms

3.1 Normal Test Chromatogram

3.2 Test Chromatogram with Column Blocked or Defected

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3.3 Test Chromatogram with Bubbles

3.4 Test Chromatogram of Sample without Enough Dilution

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3.5 Test Chromatogram of Sample with Over Dilution

3.6 Test Chromatogram without Sample Aspirated

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3.7 Test Chromatogram with ADC Value over 20000

3.8 Test Chromatogram of Eluent A Polluted by Eluent B or C

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3.9 Test Chromatogram of Eluent B Polluted by Eluent A

3.10 Test Chromatogram of Eluent B Polluted by Eluent C

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3.11 Test Chromatogram of Eluent C Polluted by Eluent A or

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 Chapter 4 System Liquid Line Chart

4.1 Hemolysin Liquid Route

Hemolysin Liquid Route: Diaphragm pump generate power to aspirate hemolysin from

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SV2SV1Sample Mixing Cup.

4.2 Sample Probe Wiper Liquid Route

Sample Probe Wiper Liquid Route: Diaphragm pump generate power to wash and wipe
sample probe with hemolysin before and after aspirate sample.

4.3 Sample Pass through Column Liquid Route

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 Sample mixed with hemolysin and heated to 51Ԩ, inlet pump and outlet pump will aspirate
proper sample volume to pass through column.

Once sample pass through column, glycated hemoglobin will be adsorbed to resin in the column
for next washing step.

4.4 Eluent A Liquid Route

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 Eluent A is adsorbed into column by 2 peristaltic pumps, and to elute HbA1a and HbA1b which
have the weakest absorption to resin. The change of absorbance will form the first crest of
diagram through colorimetric cell.

4.5 Eluent B Liquid Route

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 Eluent B is adsorbed into column by 2 peristaltic pumps, and to elute HbA1c which has the 2nd
level absorption to resin. The change of absorbance will form the 2nd crest of diagram through
colorimetric cell.

4.6 Eluent C Liquid Route

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 Eluent C is adsorbed into column by 2 peristaltic pumps, and to elute HbA10 which have the
strongest absorption to resin. The change of absorbance will form the 3rd crest of diagram through
colorimetric cell (It’s too high to display on the screen completely).

4.7 Liquid Line Wash Route

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 There will be liquid line wash every time when the operator power on/off the instrument.

And there will be liquid line wash before/after the sample test.

Procedure:

1. The instrument will absorb eluent C to elute column completely.

2. And then absorb eluent B to wash the column.

3. At last absorb eluent A to wash the column and balance the resin.

4.8 Liquid Line Counter Wash Route

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 Eluent A is absorbed into column by 2 peristaltic pump’s reverse motion to counter-wash the
liquid line. It’s main for clean the colorimetric cell, pretreatment and chromatography column.

4.8 Mixing Cup Liquid Line Wash Route

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 Eluent A is absorbed into column by 2 peristaltic pump’s reverse motion to wash the mixing
cup, and then diaphragm pump will absorb the waste liquid into the waste liquid bottle.

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 Chapter 5 Fault Table

The operator can use below Faults Table to diagnose possible reasons for specific fault
and take proper action to solve the issue.

Faults Possible Reason Actions

1. Power cord failure. 1. Check power cord

The instrument 2. Power adaptor failure. connection.
doesn’t work while 3. No electricity. 2. Check whether indication
power switch is on. light of power adaptor is
on.
3. Check whether there is
electricity from power bar。
1. Pump tube broken. 1. Change pump tubes.
Liquid Leaking 2. Luer connector broken. 2. Change luer connector.
3. Luer connection loosen. 3. Lock luer connection.
4. Pretreatment column 4. Change pretreatment
blocked. column.
5. Pretreatment column and 5. Lock pretreatment and
chromatography column chromatography column
connection loosen. connection.
1. Thermal paper run out; 1. Change new paper roll.
Printer Failure 2. Paper Jamed. 2. Remove jammed paper.
3. Electrical problem. 3. Enter “Hardware Test”
Menu to do “Print Test”, if
the test failed again, then
have to replace the
mainboard or printer.
1. Motor or Optocoupler 1. Reconnect the motor and
Sample Loader signal cable connection optocoupler signal cable.
didn’t move or failed. 2. Change the optocoupler.
move to wrong 2. Optocoupler broken。 3. Change the motor.
position. 3. Motor broken。

1. Touch screen installed to 1. Loosen the screen fixed

Touch screen input tight. screws a little bit
failure 2. Touch screen broken. 2. Change the screen.

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 1. Bad connection of motor 1. Reconnect the signal cable.
Peristaltic pump signal cable. 2. Change the motor.
doesn’t move 2. Motor broken. 3. Change the mainboard.
3. Mainboard broken.
1. Defective card. 1. Change new RFID card.
Can’t swipe card 2. RFID cable bad 2. Reconnect RFID cable.
or reading error connection. 3. Change RFID card reader.
3. RFID card reader broken. 4. Change mainboard.
4. Mainboard broken.
1. There are bubbles, bulk 1. Shake the blood sample
or flocculent tissue in tube several times and then
sample. test again.
Abnormal test
2. Software problem. 2. Contact your distributor for
chromatogram and 3. Pretreatment or software update.
result chromatography column 3. Change the pretreatment or
defective or blocked. chromatography column.
4. Inlet pump blocked. 4. Change inlet pump.
1. 2D arm’s X Axis screw 1. Tighten the screw.
Sample probe loosen. 2. Adjust X & Y Axis.
arrive wrong 2. 2D arm’s X Axis motion 3. Change optical sensor.
position for slider move with friction
aspiration, or 2D and noise.
arm error message 3. Optical sensor broken.

1. There are bubbles in 1. Eliminate bubble in liquid

liquid line. line..
2. Optoelectronic 2. Change optoelectronic
ADC value out of
measurement module measurement module.
normal range, broken. 3. Change mainboard.
fluctuating widely 3. Mainboard broken. 4. Change RFID car module.
4. RFID module broken.

Chapter 6 Trouble Shooting

As the service engineer, you need to be familiar with the principle, structure, operation
procedure, liquid line and action sequence etc. Thus you could help you to find failure point
precisely and solve it quickly.

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