H8 HbA1c Analyzer(HPLC)

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).

2
 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

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 ●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

Chapter 1 Installation of Instrument

1.1Preparation

1.2 Requirement of Installation

1.3 Packing inspection and unpacking

1.4 Removal and Installation

1.5 Link of Reagents

1.6 Power on the Instrument

Chapter 2 Introduction of Instrument

2.1 Overall Framework

2.2 Methodology

2.3 Mechanical Composition

Chapter 3 Liquid Diagram

3.1 Diagram

3.2 Eluent A,B,C Liquid Route

3.3 Hemolytic Agent Liquid Route

5
3.4 High Pressure Pump Cleaning Route

3.5 Sample Probe Inside Cleaning Route

3.6 Sample Probe Outside Cleaning Route

3.7 Sample Needle Sampling and Proofing

3.8 Sucking Up The Diluted Sample Already

Chapter4 Hardware Structure&Configuration

4.1 PCB Configuration Figure

4.2 Control Board

4.2.1 Overview

4.3 Interface Board

4.4 LED Light Panel

4.5 Photoelectric Switchboard

4.6 High Pressure Pump

4.7 Colorimetric cuvette assembly( Test Module)

4.8 Two dimensional arm assembly

4.9 Constant Temperature Module

4.10 Online Degassing Machine(Degasser)

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Chapter 5 Machinery& Maintenance

5.1 Guideline for maintenance of Glycosylated Hemoglobin

Analyzer

5.2 The Replacement of Diaphragm

5.3 The Replacement of Pre-filter

5.4 The Replacement of 2-D Arm Assembly

5.5 The Replacement of Puncture Probe

5.6 The Replacement of Swab Assembly

Chapter 6 Upgrade Software

6.1 Tool

6.2 Range of application

6.3 Procedures of Upgrading

Chapter 7 Common faults and Solutions

7.1 Introduction

7.2 Messages of Malfunction

7.3 Analyzing&Processing of Malfunction

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Chapter 1 Installation of Instrument
1.1 Preparation

1.1.1Destination
According to this section, the steps are introduced and can be successfully installed on
the client side.

1.1.2 Tool
■ Blade or pliers
■ Pipette (10-100ul and 100-1000ul range)
■ Cross-head Screwdrivers

1.1.3 Supplementary material

■ 0.5-100ul suction head several.
■ 1000uL suction head several
■ EP Tube several
■ A set of QC and Calibration Material
■ Marking pen
■ Disposable rubber gloves.
1.2 Requirement of Installation

1.2.1 Requirement of Space

To ensure the necessary space for maintenance, considering the heat dissipation of the
instrument, the liquid channel in the back of the analyzer is not pressed to affect the
normal flow of the reagent, and the analyzer installation needs to be satisfied:
●The reserved space of left, right door and wall of the analyzer is greater than
50 cm;
● The retention space of the rear side door and wall of the analyzer is greater
than 50 cm;
●At least 60cm of space above the analyzer;
●The surface of the instrument should be at least 60kg.
● Do not place the analyzer in a position where it’s difficult to operate the
device.

1.2.2 Requirement of Power

Warning:
● The analyzer must be used in good grounding conditions.
● Please make sure that the input voltage meets the requirements before
opening the system.
● Confirm that the analyzer switch is in the "OFF" state before connecting the
power cord.

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Caution:
● Additional electrical interference may be introduced with the use of the
switchboard, resulting in erroneous analysis results. Please select a place close to the
power outlet to install the system and avoid using the cutting board.
● Please use a random power cord.Use of other power lines may damage the system
or lead to incorrect analysis.

Voltage Frequency Input-Power

100V-240V 50Hz/60 Hz 120VA

1.2.3 Requirement of working environment

Notice:
● Please be sure to store and use the instrument under specified environmental
conditions.
● If room temperature exceeds the normal working temperature range of the
analyzer, the results obtained will not be reliable.

Working conditions Storage environment conditions

Environment Temperature 10℃～30℃ 0℃～55℃
Relative Humidity 20%～80% 10%～90%
Atmospheric Pressure 70KPa～106KPa 50KPa～106KPa

 The environment should be clean, no mechanical vibration, no pollution, no noise source and
the power interference.

 Evaluating the electromagnetic environment in the laboratory is suggested before operating

the instrument.

 Keep away from strong electromagnetic interference sources, so as not to affect the normal
operation of the equipment.

 Do not get close to brush type motor, flashing fluorescent lamp and frequent switch of
electrical contact equipment.

 Avoid direct exposure to strong light or before the source of heat and wind.

 Choose a well-ventilated position.

 Don't put the instrument on the slope.

 Good grounding environment.

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 Indoor use.

1.3 Packing inspection and unpacking

1.3.1 Inspection before unpacking
Before removing the packaging for the complete machine installation, please
check whether the packing case is in good condition.

1.3.2 Unpacking of main box

1. The appearance of the main box is as shown in the figure. When unpacking the case,
the packing belt should be cut first.

2. After removing the packing belt, remove the top cover of the wood, you can see the
attached package in the box, and take out the attached package, as shown in the
figure.

3. Remove the packaging bag from the main machine, then 2 people lift the bottom of
the machine to the left and right side, and carry it to the workbench.

Caution:

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In the process of moving the machine, Minimize inclination and avoid the big impact.

1.3.3 Checking packing list

classification SN Name Number

Device 1 Glycosylated Hemoglobin Analyzer 1
2 Sample Rack 2
3 Brackets Of Dilution 10
4 10L Waste Bottle 1
5 Reagent filter assembly 3
6 L liquid reagent tube assembly. 1
Standard 7 Liquid level detection component. 1
configuration 8 Power Cord 1
9 Power Adapter 1
10 Scanner 1
11 Open end wrench 2
12 Printing Paper 1
13 Mannual Guide 1
14 certificate of quality 1
15 Warranty card 1
16 Product specification 1

1.4 Removal and Installation

1.4.1 Remove the 2-d arm fixation

In the process of transportation, in order to avoid the damage of the 2-d arm, the
instrument is fixed on the sheet metal by the zapping band before leaving the factory,
and the fixation belt must be removed before use. The specific steps are as follows:
1.Sketch after opening the right door of the instrument

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2.Cut the 2-d arm with the cutting pliers and clean the cut belt

1.4.2 Installation of Chromatographic Column

1. Remove the column from the standard set of special reagent.
2.Install the column in the direction of liquid flow in the following figure, open the
thermostatic component of the column, and install the column (pay attention to the
direction of column). Tighten the tight joint to prevent leakage.

Flow Direction

Caution:
• Have to follow the direction of the arrow indicated on the label to install the
column, not reverse assembly.。
• Do not oscillate or shake the column.
• When the pressure is increased at the time of testing (about 4.0MPa higher
than the initial pressure), a new line filter should be replaced immediately.If
the pressure is not reduced, a new column should be replaced.
• More than 2 days no testing, it is suggested that install the Column in the
opposite direction, to perform the activation process, and seal it with plug then
stored in the refrigerator2 ~ 8 ℃, prevent dry chromatography column from
losing efficacy;
• Please amend the chromatography column and filter at ordinary times stored in
2 ~ 8 ℃ refrigerator, just turn off the instrument when there’s no testing.

1.4.3 Installation of Filter

1. Turn on the knob of the filter and place the smaller end of the filter into the fixed
seat and tighten the knob.

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1.4.4 Installation of Printing Paper
1） Turn on the wrench in the upper right corner of the thermal printer and open
the printer door.
2）In the direction shown in the following figure, the printer paper is put into the
paper cavity, and the paper head is outside the outlet of the paper.
3） Close the door of Printer.
4） Check the position of the printing paper and make sure the printing paper is
aligned with the paper.(the printing paper is 57mm wide and 5CM in diameter)

1.4.5 Installation of power adapter and scanner

1: The three core power cord out of the accessory kit power adapter, power cord end
in a power switch, the power adapter at the other end inserted into the power socket,
insert the output terminal of the power adapter analyzer on the back of the power
input socket.
2: The baud rate setting in the scanner and machine must be consistent, otherwise
unable to identify the barcode, It’s necessary to be transferred to the 19,200 . A scan of
the 19,200 bar code will be successful just once.

1.5 Link of Reagents

1.5.1 The eluent A,B,C should be placed on reagent storehouse,then take

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out the reagent filter components respectively from the attachment and

insert into A,B,C three kinds of eluent, and tighten the cap.The last,

Screw the hard-pipe threaded joint of the instrument on the cap.

1.5.2 From the attachment, the L liquid reagent tube assembly is removed,

and one end is connected to the L liquid joint on the back of the

instrument, and the other end is inserted into the L tank.

1.5.3 The waste liquid sensor component is removed from the attachment

and one end is connected to the waste liquid junction on the back of the

instrument, and the other end is inserted into the waste bottle.

1.6 Power on the Instrument

1.6.1 Checking before Powering-on
1) check and ensure that the instrument correctly connects the manufacturer's standard

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 power adapter and power cord;
2) check and ensure that the instrument has properly installed the column and filter;
3) check and ensure that the 2-d arm fixed screw is completely removed;
4) check and ensure that ABC elution fluid, hemolytic agent and waste liquid junction
pipe are not folded, and the connection is positive.

1.6.2 First Power-on

The power switch in the back side of the analyzer is placed "ON", and the instrument
will enter the cleaning process automatically. After the cleaning program is completed,
enter the login screen and click "login" directly:

1.6.3 Checking after Switch-on

1: check that the test mode is set correctly.
2. Confirm the pump valve and the motor works normally.

Chapter 2 Introduction of Instrument

2.1OVERALL FRAMEWORK

H8 HbA1c Analyzer is composed of the following parts listed below.

Thermal LCD
Printer Screen

High Pressure
2D Arm Module
Pump

Negative
Sampling System
Pressure pump

System
LED Lamp
Test Module Panel
Waste Pump Control Board (Colorimetric
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Pool)
Photoelectric
100ul Plunger Pump Switchboard
 SN Name Functional Specification
1 Control Board Core Board+MCU+Pump&Valve Motor Drive+Optocoupler
Detection +Temperature Pressure Monitoring；
2 Pinboard Main control board all signal transfer, centralize the line;
3 Interface Board The whole machine external USB, Ethernet, power supply;
4 LED lamp Provide a light source of 415nm+500nm of testing module;
panel
5 Photoelectric Electrical signal converted by Light signal of
Switchboard
415nm+500nm of testing module;

6 Indicator Red light: the whole machine is in trouble;

Light Board
Green light: the whole machine is in normal operation state;
Yellow light: the whole machine is in standby mode;

2.2 METHODOLOGY

HbA1c Analyzer adopts Ion-exchange Liquid Chromatography

methodology, that is exactly HPLC. To separate HbA1c based on the

difference of electric charge quantity between different hemoglobin.

Different hemoglobin will be eluted at certain low concentration

eluting condition. And then measure the absorbance points to form

the chromatogram, get the precise testing result including HbA1c%.

2.3 Mechanical Composition

①----Reagent Storehouse ②----Thermal Printer
③----Touch Screen ④----Service Cabin（Column、Filter、Evacuation Valve）
⑤----Sampling House ⑥----Status Indicator Light

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 ①----High Pressure Pump Components ②----Colorimetric Pool Module ③----Pressurizer
④----Online Deairing Machine

①----2D Arm Module ②----Sampling Rack Components

③----System Control Board PCBA

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①----Power On/Off ②----Power Input
③----USB Connector ④----Ethernet
⑤----Hemolytic Agent Joint ⑥----Waste Liquid Joint
⑦----Waste Liquid Sensor

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 Chapter 3 Liquid Line of Instrument
3.1 Diagram

3.2 Eluent A,B,C Liquid Route

Eluent A,B,C Bottle Degasser(Air Exhausting Device) SV1,SV2,SV3

High Pressure Pump 3 Way Valve 6 Way Valve Filter Column

Test Module(Detector/Colorimetric Pool) Pressurizer Diluting Cup

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Filter SV11 P1(Waste Liquid Diaphragm Pump) Waste Bottle

3.3 Hemolytic Agent Liquid Route

Hemolytic Agent Bottle SV9 5ML Plunger Pump （ Power ） SV6

Diluting Cup（Rinse） Filter SV11 P1(Waste Diaphragm Pump)

Waste Bottle

Before each test, the instrument will automatically use Hemolytic

Agent to clean the diluting cup to avoid contamination.

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 3.4 High Pressure Pump Cleaning Route

Hemolytic Agent SV9 5ML Plunger Pump （ Power ） SV5 HP

Pump Diluting Cup Filter SV11 P1(Waste Diaphragm Pump)

Waste Bottle

To ensure the moist and lubricating status, the two backshafts of

High Pressure Pump have to been steeped with Hemolytic Agent.

The backshafts would be maintained by replacement and rinse with

Hemolytic Agent. If there is no liquid in the liquid lines connected to

front and back end of high pressure pump, there should be leakage

happened to

pump.

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 3.5 Sample Probe Inside Cleaning Route

Hemolytic Agent SV9 5ML Plunger Pump（power） SV8

6 Way Valve Sample Probe Diluting Cup Filter

SV11 P1(Waste Diaphragm Pump) Waste Bottle

The cleaning of the inner wall of the sampling needle is to insert the

sampling needle into the dilution pool and then use the 5ML plunger

pump to inject the hemolytic agent into the sampling needle, to clean

the sampling needle, and the waste liquid is pumped away by the

diaphragm pump.

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3.6 Sample Probe Outside Cleaning Route

Hemolytic Agent SV9 5ml Plunger Pump （ Power ） SV10

Swab Waste Liquid Filter （ Post-filter ） SV11 P1(Waste

Diaphragm Pump) Waste Bottle

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3.7 Sample Needle Sampling and Proofing

Sample Needle 100uL Plunger Pump Aspirating Sample

The Sample Needle will aspirate 5uL sample from the venous whole

blood with the power generated by 100uL plunger pump and dispense it

to diluting cup for dilution.

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3.8 Sucking Up The Diluted Sample Already

A.The Flow Direction of sucking up the diluted 750uL Sample:

Diluting Cup(750uL) Sample Probe 6 Way Valve SV8

5mL Plunger Pump

26
 6 Way Valve Position A Mode: 6 Way Valve Position B Mode:
Use 5mL Plunger Pump to aspirate Use High Pressure Pump to dispense
750uL Diluted Sample to 6 Way Valve. 5 uL Diluted Sample into
Chromatography Column for test.

Meanwhile,to use 5mL Plunger Pump to dispense Hemolytic Agent to

clean liquid line connected to sample probe.

B. The Flow Direction of eluting sample:

Eluent ABC High Pressure Pump 6 Way Valve Filter Column

Colorimetric Module Pressurizer Diluting Cup Waste Filter

SV11 P1(Waste Diaphragm Pump) Waste Bottle

Attention: There are three kinds of Eluent A, Eluent B, Eluent C. Different

concentrations from low to high, CA<CB<CC. Entering into the

chromatography Column in sequence, to elute the various components

of Hemoglobin successively. HbA1a(Fructose/Levulose)

HbA1b(Lactose/Lactin) HbF(Fetal Hemoglobin) LA1c(Unstable GHb)

HbA1c(Stable GHb) HbA10(Non GHb)

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Supplement: Two kinds of functions of Hemolytic
Agent(Reagent L); one for cleaning diluting cup and
diluting sample with the same flow direction of liquid
route, the other one for cleaning the sample probe and
High Pressure Pump.

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 Chapter 4 Hardware Structure&Configuration
4.1 PCB Configuration Figure

Main Control Board

Interface Board
Pin Board

4.2 Control Board

4.2.1 Overview
Main control board is consist of both analog and digital, analog part mainly
responsible for the sensor signal extraction, amplification, conditioning, AD sampling,
and other functions, and the digital part mainly provides motor, pump, valve drive
signal, the whole machine external interface, platform based on embedded software ,
2 of 80 pin sockets used to connect to the core board.

4.2.2 Function

(1) It is driven by stepper motor.

(2)The valve, pump drive.
(3)Control temperature control
(4)Pressure detection
(5)External interface: USB, Ethernet.
(6)Power conversion
(7)It is driven by a six-way valve.
(8)Printer driver
(9)It is driven by a color module.

4.2.3 Block Diagram

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4.2.4 Sockets List
S PIN Function Description
N Numb
er
CN1 80 Used to connect Core Board CN1；
CN2 80 Used to connect Core Board CN2；
J105 3 Powering the printer；1：+5VDC；2：Hollow；3：GND；
J3 2 Used to upgrade the core board system program;The jumper cap can be used
after short connection;
SD1 13 MicroSD card rabbet；
J102 10 2 way USB signal sockets；
J106 2 Powering 6 way valve；1：+24VDC；2：GND；
J107 18 Ethernet interface socket；
J108 40 Be used to connect TFT；Note: 10-i02d000-00007 main control board PCBA
is 30pin;
J109 5 Be used to connect screen；
J111 32 Optocoupler Signal；
J112 32 Control signal of Optocoupler and 6 way valve
J113 32 Analog signal of Pressure、Temp-sensor、Double color LED light、A/D；
J114 32 Control Signal of Valve,Pump,Indicator,Printer,fan；
J115 32 Various Motor；
X,Z-axis-Motor,5mL-Plunger-Pump,100uL-Plunger-Pump-Motor,Auto-sampl
er；
J116 2 Peltier；
J117 4 Powering Main Control；1、2：GND；3、4：+24VDC；

List 5- 2 Main-control Function

4.2.5 Connection pin definition and distribution

J102 Socket Definition：
1 1 way USB_DN1；
3 1 way USB_DP1；
2 1 way USB Power Supply Pin：+5VDC；
5 1 way USB Supply Ground Pin；

6 2 way USB_DN1；
8 2 way USB_DP1；
7 2 way USB Power Supply Pin：+5VDC；

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 4 2 way USB Supply Ground Pin；

9、10 Empty pin；

J111 插座定义：
1 X-motor Origin-optocoupler signal output；
2 X-motor Origin-optocoupler Power Supply
Pin ：1V~2V；
3、4、7、8、11、12、 GND；
15、16、19、20、23、
24、27、28
5 The high-pressure pump blocks the optical
coupler signal output pin.；
6 The high-pressure pump blocks the optical
coupler Power Supply pin.：+5V；
9 5ML Plunger Pump Reset Optocoupler signal
output pin；
10 5ML Plunger Pump Reset Optocoupler Power
supply pin：1V~2V；
13 100uL Plunger Pump Reset Optocoupler
signal output pin；
14 100uL Plunger Pump Reset Optocoupler
Power supply pin：1V~2V；
17 Z-motor Origin-optocoupler signal output
pin；
18 Z-motor Origin-optocoupler Power Supply
Pin：1V~2V；
21 Tube-detection-optocoupler signal output
pin；
22 Tube-detection-optocoupler Power Supply
Pin +5V；
25 Storehouse door switchdetection-optocoupler
signal output pin；
26 Storehouse-door-switch-detection-optocouple
r Power Supply Pin+5V；
29 Auto-sample Front-optocoupler signal output
pin ；
30 Auto-sample Front-optocoupler Power
Supply Pin+5V；
31 The loudspeaker signal；
32 The loudspeaker signal；

J112 Sockets Definition：

31
 1 Auto-sampler post-optocoupler signal output
pin；
2、3、7、11、15、19、 GND；
23、27、31、24
4 Auto-sampler post-optocoupler Power Supply
Pin：+5V；
5、6、8、10、12、14、 Empty pin；
16、18、20、17
9 Motion control module PUL-；
13 Motion control modulePUL+（+5V）；
21 Control Signal Input Pin of 6 Way Valve；
25 Six - way valve A position feedback pin；
29 Six - way valve A position feedback pin；
28 Six-way valve COMM signal pin；
26 Float sensor signal pin.；
30 X axis code teeth optocoupler power supply
pin：1V~2V；
32 X axis code teeth optocoupler signal Input
Pin；

J113 Sockets Definition：

1 With 415nm photoelectric conversion board MAX5402
communication SPI_ chip selection.
3 With 500nm photoelectric conversion board MAX5402
communication SPI_ chip selection
5 Communication SPI_ clock with 415nm and 500nm
photoelectric conversion board MAX5402
9 Communication SPI_ data with 415nm and 500nm
photoelectric conversion board MAX5402
10 Power supply of 415nm and 500nm photoelectric
switchboard.：+3.3V；
12 LED lamp panel power supply negative
13 LED lamp panel power supply positive
14 Communication I2C_ data with 415nm photoelectric
conversion board
16 Communication I2C_ clock with 415nm photoelectric
conversion board
18 AGND；
17 The pressure sensor powering positive：+5V；
19 The pressure sensor powering negative
21 The pressure sensor input signal positive
23 The pressure sensor input signal negative
25 The pressure sensor blocks the site of Internet Linking

32
 27 Chromatographic column temperature sensor contact 1
29 Chromatographic column temperature sensor contact 2
24 Ambient temperature sensor contact 1
28 Ambient temperature sensor contact 2
31 Communication I2C_ data with 500nm photoelectric
conversion board
32 Communication I2C_ clock with 500nm photoelectric
conversion board.
2、4、6、8、20、22、 Empty pin
26、30、7、15

J114 Socket Definition：

1 SV1 control signal
2、4、6、8 +24VDC
3 SV2 control signal
5 SV3 control signal
7 SV4 control signal
9 SV5 control signal
11 SV6 control signal
13 SV7 control signal
15 SV8 control signal
17 SV9 control signal
19 SV10 control signal
21 SV11 control signal
23 SV12 control signal
10 Waste Pump control signal 1
12 Waste Pump control signal 2
14 Vacuum Pump control signal 1
16 Vacuum Pump control signal 2
18 Indicator light panel green control signal
20 Indicator light panel yellow light control
signal
22 Indicator light board red light control signal.
25、27 Indicator light board +5V power supply
26 12VDC；
24 Printer communication RX
29 Printer communication TX
31 Printer communication BUSY
28 Fan power supply +
30 Feedback of Fan State
32 Fan power supply -

J115 Socket Definition：

33
 2 Auto-sampler Motor A1
4 Auto-sampler Motor A2
6 Auto-sampler Motor B1
8 Auto-sampler Motor B2

11 100uL Plunger Pump A1

13 100uL Plunger PumpA2
15 100uL Plunger PumpB1
17 100uL Plunger PumpB2

19 5mL Plunger PumpB2

21 5mL Plunger PumpB1
23 5mL Plunger PumpA2
25 5mL Plunger PumpA1

12 X-axis Motor A1
14 X-axis Motor A2
16 X-axis Motor B1
18 X-axis Motor B2

26 Z-axis Motor S1A

28 Z-axis Motor S1B
30 Z-axis Motor S2A
32 Z-axis Motor S2B

9、10、20 GND
1、3、5、7、22、24、 Empty pin
27、29、31

4.2.6 Real Figure

4.3 Interface Board

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4.3.1 Function

The instrument external USB, Ethernet, power interface.

4.3.2 Sockets List

J301 Main control board power sockets；1、2：GND；3、
4：+24V；
J302 The boat switch is connected to the socket；
J303 Adaptor connection socket；
J304、J306 Ethernet socket；
J305 2 way USB signal socket；
J307 Motion control module power socket；1：GND；2：
+24V；

Interface Functional Diagram

4.3.3 Connection pin definition and distribution

J305 socket definition：
1 1way USB_DN1；
3 1way USB_DP1；
2 1way USB power supply positive pin：+5VDC；
5 1way USB power supply ground pin；
6 2 way USB_DN1；
8 2 way USB_DP1；
7 2way USB power supply positive pin：+5VDC；
4 2 way USB power supply ground pin；
9、10 Empty pin；

4.3.4 Real Picture

4.4 LED Light Panel

4.4.1 Overview

35
The main function of LED lamp board is to carry dual wavelength LED light.

4.4.2 Function
Providing a light source of 415nm+500nm.

4.4.3 Diagram

4.4.4 Socket
J9 LED power supply 1：negative；2：positive；

4.4.5 Real Picture

4.5 Photoelectric Switchboard

4.5.1 Overview
The main function of the photoelectric switchboard is to convert the optical signal into
electrical signal, and the data is sent to the main control board through the IIC bus
after the ADC collection is amplified and adjusted.
4.5.2 Function
(1) Photoelectric conversion
(2) Magnification setting
(3) The ADC conversion

36
4.5.3 Real Picture

4.6 High Pressure Pump

4.6.1 Function
The high pressure pump is a double piston tandem high pressure pump which is
necessary for conveying analysis.Have been working on the analysis of the process
usually, based on the cycle of the analysis , through the solenoid valve
switch ,transmitting three kinds of eluent of different salt concentration, gradient
(concentration gradient), the components of hemoglobin will be separated by making
use of analyzer.
4.6.2 Real Picture

4.6.3 Adjustment
Confirmed in high-pressure pump (PPS) in 1024, under the premise of the 8 MPa
tooling PEEK tubes, to connect a small tube in the side of column-liquid-out. Then in
the maintenance of interface, open the SV1 and the high-pressure pump, weighing
liquid within 5 minutes and 3 times in a row, remarked to X1, X2, X3, calculate the
mean X = (X1 + X2 + X3) / 3;Then, Y = 7.5*1024/X, and finally the high pressure

37
pump (PPS) is set as Y.
4.7 Colorimetric cuvette assembly( Test Module)

4.7.1 Function
The changes in the absorbance of hemoglobin in the samples after elution separation
of the chromatographic column will be measured.The light source adopts blue LED ,
the detector adopts 415nm/500nm dual wavelength, which improves the
anti-interference ability of the system.
4.7.2 Picture

4.7.3 Adjustment
Connecting the 8 MPa tooling PEEK tube ,coming into the senior maintenance - >
pump valve test, open the SV1, start the high pressure pump, under the premise of
stable pressure , switch to the Interface of Other Settings, set the value of DAC - LED
to 4000, by adjusting the gain of 415 (on a scale of 0-255 range adjustment), make
ADC415 values between 12000-13000, by adjusting the gain of 500 (on a scale of
0-255 range adjustment), make ADC500 values between 4000-5000;
Note: Under the premise of no bubble in the colorimetric cuvette ,to adjust the
gain .The larger the gain value, the smaller the ADC value. Conversely, the smaller
the gain, the larger the ADC value.
4.8 Two dimensional arm assembly

4.8.1 Function
The two - dimensional arm component mainly realizes the pretreatment of the sample,
including the procedure of puncture sampling and sample dilution.The 2-d arm can
automatically identify the sample type placed on the sample rack, and then the whole
blood sample is automatically diluted and then sent to the sample valve. For the
dilution sample, the sample is sent directly into the sample valve.
4.8.2 Picture

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4.8.3 Adjustment

(1) Dilution Cup

Place the positioning fixture into the dilution cup, clicking “next”, at the time the

button of the dilution cup changed from to , by + +, +, -, -- button to

adjust the position of the X axis. Finally ensure the needlepoint above the fixture
holes, to click “save”, the X axis reset and go again to saving location for the user to
confirm; Remove the positioning fixture.
(2) Top Of The Cup
Click next, and the sampling needle Y down to the top of the cup, through + +, +, --, -
button to adjust the Y axis until making the needle tip aligned with the end face of
cleaning cup. To click the “save” button again and confirm the location is accurate.
(3) The Swab
Click “next”, start debugging swab position, by + +, +, --, - button to adjust the Y axis
until the tip aligned with swab bottom, judgment standard is to touch swab underside
with fingers, if the needle tip can be touched, the location setting is accurate, to click
“save” and confirm again.
(4) The Sample 10
Click “next”, then the Y-axis goes to zero, the X-axis moves to the test tube rack 10#,
and observing that test tube detects the optical coupling in the middle position of 10#,
then click “save”, and reconfirm.
(5) Diluted Blood
In 10 # position of sample rack, put into the dilution pipe rack and EP tube, click
“next”, by + +, +, -- , - button to adjust the Y axis until the needle is away from the

39
bottom of the EP tube 1 mm, by pulling EP up (a little well, not completely resisted by
the needle), to judge the position has been adjusted in the right place, click “save” and
confirm once again. If it is confirmed well, please be sure to take dilution pipe rack
and EP!
(7) Whole Blood
Under the premise of taking out the dilution pipe rack and EP in the 10 # position ,
click “next”, by + +, +, --, - button to adjust Y go to the travel limit with 0.5 mm left,
with a 0.5 mm feeler to confirm, click “save” and confirm again.
4.9 Constant Temperature Module

4.9.1 Function
In order not to make room-temperature changing affect the analysis, usually, the
column should be kept at a certain temperature with the oven.
4.9.2 Picture

4.10 Online Degassing Machine(Degasser)

4.10.1 Function
This device could eliminate the bubbles existed in the elution liquid that’s transmitted
by pump. In order to maintain the vacuum pressure of the degassing vessel, the
vacuum pump will work intermittently.
4.10.2 Picture

40
4.10.3 Adjustment
Negative pressure will not affect the degassing effect of vacuum, and the engine won't
be at fault, negative pressure is set to 65%, less than 65% negative pressure pump
work on 5 seconds, if more than 65% negative pressure pump does not work.
4.11 Sampling Frame Assembly

4.11.1 Function
The sampling frame assembly is used to transfer and place the test tube rack ,to
realize automatic loading of the sample.
4.11.2 Picture

4.11.3 Adjustment

(1) The parameter of entering sample rack

Click "other Settings"; In the sample warehouse, push into the test rack, and see if the
test rack is fully in place, if not fully in place, and adjust the parameters. If it is in
place, it will make a clear impact sound and adjust the small parameters.
(2) The parameter of returning sample rack

The parameter of returning sample defaults to 1500, in the upper right corner of the

screen, click .Then test tube rack would retreat from the sample storehouse. On

41
the premise of Without skidding, test tube rack can completely back, until breaking
away from origin opto-coupler of the test tube rack. If the test tube rack cannot be
separated from the origin opto-coupler, it will need to be adjusted about the tightness
of the installation of the sample motor.

Chapter 5 Machinery& Maintenance

5.1 Guideline for maintenance of Glycosylated Hemoglobin
Analyzer

Safety Precautions

Electronic Precautions

Environment Protection

Biological Warning

Tools and Supplies

Analyzer Performance Verification

Maintenance engineers can use standard tools to repair the analyzer.The

maintenance steps (including the required tools) see 6.2-6.6. If there is a

verification step after the repair steps, the maintenance engineer must

strictly follow the verification steps.

5.2 The Replacement of Diaphragm

5.2.1 Purpose: Due to the abrasion of the diaphragm in the pump in the
working process of analyzer, the diaphragm should be replaced during

maintenance every half year.

5.2.2 Tools/ Supplied needed

42
Cross screwdriver
Open end wrench
Hexagonal screwdriver in no.5.
5.2.3 Removal
(1) Power off and unplug the main power cord;
(2) Open the left door;
(3) Open the top cover.
(4) No.5 internal hexagonal screw M4*20 (4 pieces) of the main pump head and the
auxiliary pump head are unscrewed by the hexagonal screwdriver, as shown in the
figure below:

(5) Remove the fixed base cleaning block from the straight line bearing seat, as shown
in the figure below:

(6) Unscrew the plunger rod connector with an open spanner.

43
(7) Remove the diaphragm (note: the direction of diaphragm )

Installation
The installation step is the reverse operation of the disassembly step.

Verification
a.Check the assembly of all parts and put them in place;
b. Check whether the connection of gas and liquid pipe is correct;
c. Start-up verification.

5.3 The Replacement of Pre-filter

5.3.1 Purpose
The prefilter is blocked in the working process and needs to be replaced during
maintenance every half year.

5.3.2 Tools/ Supplied needed

Cross screw batch
Open end wrench
Paper clip (or art knife)

5.3.3 Removal
(1) Open the left door;
(2) Unscrew the grip joint on the filter holder of the pump side head.
(3) Unscrew the filter installation seat with the open spanner, as shown below.

44
(4) Remove the filter mounting block.

Prefilter

(5) Use a paper clip or an art cutter to take out the pre-filter.

Installation
The installation step is the reverse operation of the disassembly step.

Verification
a.Check the assembly of all parts and put them in place;
b. Check whether the connection of gas and liquid pipe is correct;
c. Start-up verification.

5.4 The Replacement of 2-D Arm Assembly

45
5.4.1 Purpose
The malfunction of two - dimensional arm in the working process , it’s necessary to
be replaced when maintenance.

5.4.2 Tools/Supplies Needed

Cross screwdriver

5.4.3 Removal
(1) Remove cover and right door.
(2)Unscrew the 2 countersunk head screws of the fixed towing chain on the right
vertical board, as shown in the figure below.

(3)Unscrew 6 composite screws from the right panel, and remove the 2-d arm
components to tidy up the pipeline, as shown in the picture below:

Installation
The installation step is the reverse operation of the disassembly step.

Verification
a.Check the assembly of all parts and put them in place;
b. Check whether the connection of gas and liquid pipe is correct;
c. Start-up verification.

46
5.5 The Replacement of Puncture Probe
5.5.1 Purpose
The malfunction of puncture probe in the working process, it needs to be replaced
when maintenance.

5.5.2 Tools/Supplies Needed

Cross-screwdriver

5.5.3 Disassembly and Removal Procedures

(1)Remove cover and right door.
(2) Cut the ribbon and remove the puncture needle, as shown in the figure below

(3) Cut off the ribbon, take out the needle from the silicone tube.

Installation
The installation step is the reverse operation of the disassembly step.

Verification
a.Check the assembly of all parts and put them in place;

47
b. Check whether the connection of gas and liquid pipe is correct;
c. Start-up verification.

5.6 The Replacement of Swab Assembly

5.6.1 Purpose
The Malfunction of swab in the working process , it needs to be replaced when
maintenance.

5.6.2 Tools/Supplies Needed

Cross-screwdriver

5.6.3 Disassembly and Removal Procedures

(1) Remove cover and right door.
(2)Unplug the pipeline (note: the coarse is the liquid-out end, and the fine is the inlet
end).

(3) Pull out the locking plate and take down the swab assembly.

48
Reassembly And Installation
The installation step is the reverse operation of the disassembly step.

Verification
a.Check the assembly of all parts and put them in place;
b. Check whether the connection of gas and liquid pipe is correct;
c. Start-up verification.

Chapter 6 Upgrade Software

6.1 Tool
a. The computer
b. Usb flash disk (SD card reader)
c. MicroSD card (including card set)

6.2 Range of application

Applicable to all I02D series sold instruments.

6.3 Procedures of Upgrading

6.3.1 Method and steps of upgrading MPU

a.copy the upgrade file (G-08-I02D000-00002 I02DMPU operating system download

program) to the microSD card (do not delete the other files on the microSD card, and
use I02D special microSD card). As is shown in the figure below:

49
b. Power off, to remove the cover of the instrument, and to short out the J3 socket of
the main control board, and insert the micro SD card into the card slot of the board
card SD1. As shown in the picture below.

c.starting up, waiting for about the 80S, the yellow light of the core board starts
flashing, indicating that the download is successful.

50
d. waiting for 5seconds , turn off power. Operation completed.
6.3.2 Method and steps of upgrading QT
a. Make sure that the main control board J3 is disconnected (make sure the SD card is
not inserted in the SD1 slot).As shown.
Note: it is suggested to copy the QT program (G-08-I02D000-00005 I02D application
software download program) and the lower computer (G-08-I02D000-00004
I02DMCU motion control unit download program) to the U disk at the same time.

b. Insert the USB port with the QT program (g-08-i02d000-00005 I02D application
software download program) into the USB port of the switch board, and confirm that
the instrument is turned off.
Copy the update. Sh /I02D_QT/ script.tar.gz to the H8 directory in the U disk, as
shown in the figure below.

51
c. Insert the USB flash disk into the USB port on the back of the instrument, and then
turn it on, and the screen will appear on the screen.

d. click on the screen to show the interface shown below (the image is dark and the
word "successful" is displayed), which means that it is finished and the USB flash
drive is taken out.

e.Restart the device.If the above upgrade is successful, the application (QT) interface
52
appears, as shown in the figure below.

6.3.3 Method and steps of upgrading lower computer

a.. The target document (G-08-I02D000-00004 I02DMCU motion control unit
download program) is named after the "H8" folder, including the following contents,
and the USB interface on the back of the instrument is inserted after the machine is
turned on.

b.Click "system" -> "advanced maintenance", enter the account and password to enter
the advanced maintenance interface.
Account：lifo
Password：661166

53
C. Click "other Settings" on the left sidebar.

d.Click the "lower computer" in the software upgrade to update the data and
disappear after the update. (the update time is about 1min, and the LED lights in the
MCU chip will be flashing as normal after the update.)

54
e.Restart the device to see if the "information" interface is corresponding to the new
version of software.

Chapter 7 Common faults and Solutions

7.1 Introduction

It introduces the phenomenon and the attentions in the process of malfunction.

7.2 Messages of Malfunction

55
 List 7- 1Error Codes and Error Messages

Classification Error Codes Reason

0X0001 Unknown command
0X0002 Instruction parameter error
0X0003 The instruction process is executing.
0X0005 Insufficient Storage Space
0X0006 The X-axis is disturbed by the Z axis
0X0007 The command queue has been cleared
0X0008 The z-axis hits the interference when the sample
frame is removed
0X0009 The door is disturbed when the rack is removed
0X0102 Try to operate the incoming sample motor
0X0103 The sample motor code plate is lost
Sampling 0X0104 The target position of the incoming motor is beyond
motor error the maximum limit
0X0105 Error of incoming motor reset sensor
0X0106 Sampling motor’s waiting motion to run out of time
0X0107 The sampling motor controller is not initialized
0X0202 Attempt to operate the running high pressure pump
motor
High-pressure 0X0203 High - pressure pump motor code plate lost step
pump motor 0X0204 The target position of the high pressure pump motor
error exceeds the maximum limit
0X0205 The high pressure pump motor reset sensor error
0X0206 The timeout of high-pressure pump motor waiting
movement
0X0207 The high-pressure pump motor controller is not
initialized
0X0302 Attempt to operate the running 5ml plunger pump
motor
0X0303 5ml plunger pump motor code plate lost step
5ml plunger 0X0304 The target position of 5ml plunger pump motor
pump motor exceeds the maximum limit
error 0X0305 5ml plunger pump motor reset sensor error
0X0306 The timeout of 5ml plunger pump motor waiting
movement
0X0307 5ml plunger pump motor controller is not initialized
0X0402 Attempt to operate the running 100 μ l plunger
pump motor
100ul plunger 0X0403 100μl plunger pump motor code plate lost step

56
pump motor 0X0404 The target position of 100 μ l plunger pump motor
error exceeds the maximum limit
0X0405 100μl plunger pump motor reset sensor error
0X0406 The timeout of 5ml plunger pump motor waiting
movement
0X0407 100 μ l plunger pump motor controller is not
initialized
0X0502 Attempt to operate the running Z-axis motor
0X0503 Z-axis motor code plate lost step
X-axis motor 0X0504 The target position of Z-axis motor exceeds the
error maximum limit
0X0505 Z-axis motor reset sensor error
0X0506 The timeout of Z-axis motor waiting movement
0X0507 Z-axis motor controller is not initialized
0X0602 Attempt to operate the running Z-axis motor
0X0603 Z-axis motor code plate lost step
0X0604 The target position of Z-axis motor exceeds the
Z-axis motor maximum limit
error 0X0605 Z-axis motor reset sensor error
0X0606 The timeout of Z-axis motor waiting movement
0X0607 Z-axis motor controller is not initialized

57
7.3 Analyzing&Processing of Malfunction

7.3.1 Phenomenon &Troubleshooting

Introduce common fault phenomena and processing steps (according to hardware card,
optics, mechanical components).A detailed and effective solution to a common failure
of a machine that does not alarm but does have problems, such as poor repeatability,
poor classification of WBC, high PLT background, unstable HGB values, etc.If
possible, increase histogram of some clinical reference cases.

7.3.2 Error Message&Handling

About optical systems

List 7- 2 ADC Related troubleshooting
Trouble Reason Handling Procedure
ADC value 0 1. Poor contact of 1. Reset the signal line.
sampling board or 2. Replace the acquisition board.
LED signal lines. 3. Replace LED board.
2. Failure of
acquisition board.
3.The LED board
failure

ADC value 16383 1. The channel gain 1. Increase the gain value.
value is too small. 2. Reduce the LED value.
2.LED value setting is 3. Replace the data acquisition board.
too high. 4. Performing to prime A liquid.
3. Failure of When necessary, the colorimetric
acquisition board. pool was taken out in the process of
4.There are bubbles in priming, and A few strokes were used
the color pool. to help the bubbles to escape rapidly.

ADC415unstable Having bubbles in the Open SV1, open the high pressure

58
between12000 and colorimetric cuvette pump and observe whether the ADC
13000 value is stable.When necessary, take
out the colorimetric cuvette in the
process,Use fingers flip the liquid
tube lightly to help the bubbles
escape quickly.

About External Connections

List 7- 3 Troubleshooting

Trouble Message Possible Reason Handling Procedure

Communication 1. Loose 1. Check whether the connection

Trouble communication cable. between the analyzer and the receiver
2. The network IP is normal.
address does not 2. The computer terminal and the
match. analyzer IP address are consistent.
3.The analyzer 3.Open the analyzer interface LIS
interface LIS transfer switch.
transmission switch is
not opened.

Barcode scanning 1.The barcode 1.Check whether the barcode

gun communication scanning gun is not scanning gun is properly connected.
failure connected. 2.Check if the connection is properly
2.Loose connection connected.

Invalid Barcode 1. The barcode model Please contact with customer

does not match. service department of Lifotronic
2.Scan to invalid
barcode data.

59
About Reagents &Testing

List 7- 4Troubleshooting

Trouble Message Possible Reason Handling Procedure

No Hemolytic Agent 1. The connection tube of 1. Check whether the
the hemolytic agent is not hemolytic connection tube
inserted below the liquid. is well connected.
2.The hemolytic agent 2.Replace the new
ran out. hemolytic agent.

No Eluent A 1. A liquid runs out 1. Replace the A solution.

2.Not timely reset A 2. Reset A liquid count.
liquid count.

No Eluent B 1. The liquid run out B 1. Replace the B solution.

2.Did not reset B liquid 2. Reset B liquid count.
count in time.

No Eluent C 1. The liquid run out of C 1. Replace the C solution.

2. Did not reset the C 2. Reset C liquid count.
liquid count in time.

Existing bubbles in the line A or B or C eluent is used Check the connection tube
connected reagents or the connection tube is and reagent dosage, then
not inserted below the perform to prime A\B\C
liquid. solution to remove the
bubbles.
Abnormal Graphs 1. Liquid road blocked. 1. Clean the system after
2. Column column or replacing the filter.
filter failure. 2. Replace the column or
3. Failure of reagent. filter.
4. Sample analysis was 3. Reagents.
conducted when the 4. After the temperature of
temperature of the the column is stable,
column was not stable. sample analysis is
Bubbles occur. conducted.
5.Bubble removal

Results ranged from 3% to 1. Small sample size. 1. Increase the sample

60
 18% The whole blood sample is size.
not enough. 2. Replace the whole
3. Column column or filter blood sample or adopt the
failure. diluted blood model.
4. Failure of reagent. 3. Replace the column or
The system didn't build up filter.
the pressure. 4. Reagent.
5.Bubble removal

Error Code e1 1. The sample size is too little 1.Mix it well and repeat
or not absorbed. the test. If the retest value
2.No samples were placed in is still abnormal, it is
the sample. recommended to test with
the method of diluting
blood.
2.Reposition the sample
and retest it.

Error Code e2 1. Excessive absorption. 1. Mix it well and repeat

2.There are bubbles. the test. If the retest value
is still abnormal, it is
recommended to test with
the method of diluting
blood.
2.After the bubble action
was performed, retesting
the sample.

61