HANSA MEDICAL GERMANY GmbH

High Fact

Portable Automatic Multi-function

Analyzer

Service Manual

Version: A 1.1
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Contents

CONTENTS ............................................................................................................................... I

INSTRUCTION ........................................................................................................................ 1

INTELLECTUAL PROPERTY .............................................................................. 错误!未定义书签。

DECLARATION ................................................................................................ 错误!未定义书签。

WARRANTY AND MAINTENANCE SERVICES .................................................... 错误!未定义书签。

AFTER-SALES SERVICE .................................................................................................................. 1

FOREWORD ............................................................................................................................ 2

READER ......................................................................................................... 错误!未定义书签。

CONTENTS ..................................................................................................................................... 2

SAFETY SYMBOLS AND LABELS ..................................................................................................... 2

SAFETY PRECAUTIONS .................................................................................................................. 3

FIRE AND EXPLOSION PROTECTION ................................................................................................ 4

ELECTROMAGNETIC INTERFERENCE PREVENTION ........................................................................ 4

PROTECTION AGAINST BIOLOGICAL RISKS .................................................................................... 5

WASTE DISPOSAL .......................................................................................................................... 5

1 ANALYZER OVERVIEW ............................................................................................... 6

1.1 SYSTEM CONSTRUCTION................................................................................................... 6

1.2 FUNCTION OVERVIEW ....................................................................................................... 8

2 DEVICE PERFORMANCE AND TEST PROCESS ....................................................... 9

2.1 PRODUCT SPECIFICATIONS AND TECHNICAL INDEX .......................................................... 9

2.2 WORKING PRINCIPLE ..................................................................................................... 10

2.2.1 Light transmission system ..................................................................................... 10

2.2.2 Fluorescence system .............................................................................................. 10

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2.2.3 Light reflecting system .......................................................................................... 10

2.3 LINEARITYWITHIN OPTICAL MEASURING RANGE .......................................................... 10

2.4 STORAGE, TRANSPORTATION AND WORKING ENVIRONMENT ........................................... 10

2.5 TEST AND QUALITY CONTROL PROCESS .......................................................................... 11

3 INSTALLATION ............................................................................................................ 13

3.1 INSTALLATION ENVIRONMENT REQUIREMENTS ............................................................... 13

3.2 INSTALLATION REQUIREMENTS ....................................................................................... 14

3.2.1 Installation space .................................................................................................. 14

3.2.2 Power supply ......................................................................................................... 14

3.3 INSTALLATION PROCESS ................................................................................................. 15

3.4 STARTUP TEST ................................................................................................................ 15

3.5 SHUTDOWN .................................................................................................................... 16

3.6 COMMUNICATION SETTINGS ........................................................................................... 17

3.6.1 Wi-Fi settings ........................................................................................................ 17

3.6.2 LAN settings .......................................................................................................... 18

4 MODULE INTRODUCTION ........................................................................................ 20

4.1 OUTER SHELL MODULES ................................................................................................ 20

4.1.1 Composition of outer shell .................................................................................... 20

4.1.2 Disassembly and assembly of outer shell .............................................................. 21

4.1.3 Disassembly of middle shell .................................................................................. 22

4.1.4 Disassembly of upper shell .................................................................................... 23

4.2 HOST PART...................................................................................................................... 24

4.2.1 Function Introduction ........................................................................................... 24

4.2.2 Disassembly and assembly device process ............................................................ 26

4.3 PCB COMPONENT ........................................................................................................... 27

4.3.1 Function Introduction ........................................................................................... 27

4.3.2 PCB structure disassembly and assembly ............................................................. 27

4.4 VERTICAL MOTION COMPONENTS ................................................................................... 28

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4.4.1 Composition and structure .................................................................................... 28

4.4.2 Maintenance of vertical movement component ..................................................... 29

5.4.3 Replace the hole-broken rod of the vertical movement component ............................... 33

4.5 BARCODE SCANNING COMPONENT ................................................................................. 38

4.5.1 Function introduction ............................................................................................ 38

4.5.2 Composition and structure .................................................................................... 38

4.5.3 Maintenance of Scanner Module........................................................................... 39

4.6 DETECTION UNIT ........................................................................................................... 40

4.6.1 Function introduction ............................................................................................ 40

4.6.2 Component / Part replacement.............................................................................. 42

4.7 HORIZONTAL MOVEMENT COMPONENTS ......................................................................... 44

4.7.1 Function introduction ............................................................................................ 44

4.7.2 Composition and structure .................................................................................... 44

4.7.3 Disassembly and assembly of the incubation module ........................................... 45

4.7.4 Disassembly of movement module and assembly of incubation module ............... 46

4.8 BOTTOM SHELL AND EXTERNAL INTERFACE COMPONENTS ............................................. 47

4.8.1 Function introduction ............................................................................................ 47

4.8.2 Composition and structure .................................................................................... 47

4.8.3 Disassembly and assembly of bottom shell and external interface board ............. 47

4.9 OPTICAL COMPONENTS ................................................................................................... 48

4.9.1 Composition and structure .................................................................................... 48

4.9.2 Layout of optical components ............................................................................... 50

4.9.3 Replace the halogen light ...................................................................................... 51

4.9.4 Potential parameter adjustment ............................................................................ 55

5 INSTRUMENT HARDWARE CIRCUIT ...................................................................... 58

5.1 OVERVIEW...................................................................................................................... 58

5.2 SAFETY PRECAUTIONS ................................................................................................... 58

5.3 CIRCUIT BOARD LIST ...................................................................................................... 58

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5.4 POSITION OF CIRCUIT BOARD .......................................................................................... 60

5.5 DISASSEMBLY OF CIRCUIT BOARD .................................................................................. 61

5.6 ELECTRICAL DIAGRAM ................................................................................................... 61

5.7 CIRCUIT BOARD FUNCTION ............................................................................................. 68

5.7.1 Control structure of complete machine ................................................................. 68

5.7.2 Main control board core board function ............................................................... 70

5.7.3 Motor-driven board function ................................................................................. 70

5.7.4 AD board function ................................................................................................. 71

5.7.5 HbA1c receiving board function............................................................................ 71

5.7.6 Fluorescence light source receiving board function .............................................. 72

5.7.7 Colorimetric receiving board function .................................................................. 72

5.7.8 Temperature sensor board function ....................................................................... 72

5.7.9 Hall sensor board function .................................................................................... 72

5.7.10 Micro switch board function ................................................................................. 72

5.7.11 Connection board .................................................................................................. 72

5.8 POWER SUPPLY MODULE ................................................................................................. 73

5.8.1 Basic performance index description .................................................................... 73

5.8.2 Electrical insulation diagram................................................................................ 75

5.9 BOARD INDICATOR LIGHT DESCRIPTION .......................................................................... 76

6 TROUBLESHOOTING ................................................................................................. 80

7 MAINTENANCE ......................................................................................................... 104

7.1 ROUTINE MAINTENANCE .............................................................................................. 104

7.2 PERIODIC INSPECTION .................................................................................................. 105

8 PROGRAM UPGRADE ............................................................................................... 107

8.1 MASTER CONTROL BOARD PROGRAM UPGRADE .......................................................... 107

8.2 AD BOARD PROGRAM UPGRADE ................................................................................. 109

8.3 UI INTERFACE UPGRADE ............................................................................................... 110

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8.4 CONFIRM THE PROGRAM VERTION ................................................................................ 111

9 AFTER-SALES SERVICE RECORD FORM ............................................................. 113

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Instruction
Please carefully read and understand the contents of the service manual to maintain the system
properly.
Keep this service manual properly after reading it, and keep it in a convenient place for easy reference
at any time.

Product name: Portable Automatic Multi-function Analyzer

Specification and model:High Fact
The Portable Automatic Multi-function Analyzer consists of an Analyzer and accessories. The main
components of the Analyzer include the measuring unit, control unit, scanning unit, display and printing
unit.
Applicable Scope: The Analyzer is intended to be used with compatible reagent kits in medical
institutions and clinical department’s laboratories. It is suitable for the test of the biochemical, coagulation,
and other physiological indicators in whole blood, serum, plasma, urine, and other samples.

Date of preparation or revision of service manual:

Version No.

After-sales Service

Service address:
Postal code:
Service hotline:

Warning:

If the hospitals or institutions responsible for using the Analyzers cannot

implement a set of satisfactory maintenance plans, it may cause the malfunction of the
abnormal Analyzer, and endanger personal health.

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Foreword

Contents
This manual is the service manual for High Fact Portable Automatic Multi-function Analyzers. This
service manual introduces the principle, installation, basic theory, maintenance and repair methods,
troubleshooting, and other contents of High Fact Portable Automatic Multi-function Analyzers. Please
follow the instructions in this service manual for repair.
The "tester" mentioned in the text refers to "High Fact Portable Automatic Multi-function Analyzers"

Safety symbols and labels

Safety symbols and labels may remind the operator to pay more attention to potential hazards in use.
Those symbols shall be used together with the characters.

Symbols Meaning

Biological hazard

Warning:
Crushing of hands

Serial number

Manufacturer

In Vitro Diagnostic Medical Devices

Warning, especially reminds the users that they need to pay attention to the
important warning information in the instructions for use.

Upward: Indicates that the correct position for transporting the package is
upright.

Fragile items: Indicates that there are fragile items in the transport package,
which shall be handled with care when it is moved.

Double insulation or reinforced insulation

Sun-proof sign: the transportation package cannot be directly exposed to the

sun.

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Symbols Meaning

Stacking layer limit mark: The stacking layer of packages cannot exceed six
layers.

Rainproof sign: the package is rainproof.

Consult instructions for use

Serial interface.

USB interface.

Network port RJ45 interface

RS485 interface.

Stand-by

Power input from supply mains

Test channel 1

Test channel 2

Authorized representative in the European Community

Conformity to the European directive 98/79/EC on In vitro diagnostic medical

devices CE marking
Symbol for the marking of electrical and electronics devices according to
Directive 2012/19/EC. The device, accessories and packaging have to be
disposed correctly at the end of the usage, please follow Local Ordinance or
Regulatory for disposal.

Safety Precautions
For safety and effectiveness considerations, please read the following safety precautions carefully.
Any operation against the following safety precautions may cause system damage and personal injury.

Warning:

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 Please observe this Manual for operation. Otherwise, the protective measures
provided by this Analyzer may become ineffective.
 Do not place and operate the Analyzer in a position where power disconnection
is difficult to carry out.If the solution spills into the Analyzer, it may cause the Analyzer
to malfunction and cause electric shock. Please do not place objects on the Analyzer. In
case of spillage, please disconnect the power supply immediately.
 Do not plug or unplug the power supply with wet hands.
 Before opening the Analyzer for any adjustments, changes, repairs, or
maintenance, it shall be disconnected from all power sources.
 Do not touch the moving parts of the system when the Analyzer is working.
These movement parts include puncture rod, reagent cartridge holder, suction nozzle,
and filter-wheel. When the Analyzer is working, do not put your fingers or hands into
the open parts.
 When the Analyzer is working, please do not look directly at the light beams
emitted by the halogen light source since these light beams may cause damage to your
eyes.
 Before replacing the halogen light source, please turn off the light source and
wait at least 15 minutes for it to cool down. Do not touch the light source before it cools
to avoid skin burn.

Fire and explosion protection

Warning:

 Alcohol is flammable and must be used with great care.

Electromagnetic Interference Prevention

Caution:

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Electromagnetic interference may affect the regular operation of the device. It is forbidden to
install the device in an environment with strong electromagnetic field interference. It is forbidden
to use radio frequency transmitting equipment and CRT display equipment in the equipment
installation area.
It is forbidden to use other medical devices that may cause electromagnetic interference
around the Analyzer. Otherwise, it may interfere with the regular operation of the device.
It is forbidden to use this equipment near strong radiation sources (unshielded radio
frequency sources). Otherwise, it may interfere with the regular operation of the Analyzer.
Before the use of the Analyzer, please evaluate the electromagnetic environment in which it
is used.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take protective
measures.To ensure the normal operation of the Analyzer, the user is responsible for ensuring the
electromagnetic compatibility environment of such equipment.

Protection against Biological Risks

To effectively protect against biological risks, please observe the following precautions.

Biological hazard:

 Improper use of samples may result in infection. Avoid direct contact with samples.
Please wear protective gloves and lab coats when operating the system, and wear
protective glasses if necessary.
 If the skin accidentally contacts with samples or mixtures, please take immediate
actions in comply with the standard operation procedure, and consult a doctor.

Waste Disposal
To prevent environmental pollution and personal injury caused by discarded articles, please observe
the following precautions when such discarded materials are processed:
 After being used, the disposal of the samples, reagents, and the whole machine
shall be governed by the regulation for pollution or the relevant laws and regulations.
Please abide by the relevant local standards.

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1 Analyzer overview

1.1 System construction

The full name of this product is High Fact Portable Automatic Multi-function Analyzer, which is
intended to be used with compatible reagent kits in laboratories of medical institutions and clinical
departments. It is suitable for testing the biochemical, coagulation, and other physiological indicators in
whole blood, serum, plasma, urine, and other samples.
The sketch of the appearance of the the analyzer is as follows.

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Figure 2- 1 Appearance Illustration

Table 2- 1 Structure specification
No. Name Function
A printer is inside the compartment, which can print out
1 Printer lid
the test results
2 Touch screen Input instructions, display test results
3 Cartridge holder Hold the reagent cartridges
4 Channel lid Covers the reagent cartridge compartment
Protect the light source. The lid can be removed when
5 Light source lid
changing the light source
6 Stand-by button Activate the display screen/Enter the sleeping mode
7 Type B USB port For function extension
A standard interface for serial communication, connect to
8 RS232 port
devices such as PC
9 RJ45(Ethernet port) Connect to LAN
Back-up or transfer data from the analyzer; Upgrade
10 Double USB port the software; Connect to U disk or devices supporting
USB communication
11 Power port Connect to power source
12 Concave Space for placing hands when moving the analyzer

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1.2 Function overview

During the standard test of the reagent cartridge, the main workflow of the Analyzer is shown as
follows:
1. Initialize all mechanical units;

2. The reagent cartridge holder moves to the inner optical coupler position, and the hole-broken rod
and suction nozzle move to the initial upper position;

3. The hole-broken processing shall be done to the reagent loading compartment and take out the TIP
with suction nozzle;

4. The reagents/samples to be removed run horizontally below the TIP , and the first round of
reagents/samples to be removed for TIP are the test compartment of the reagent cartridge;

5. Conduct the first cycle of constant temperature incubation on the reagent cartridge holder of the
reagent cartridge;

6. The reagents/samples to be removed run horizontally below the TIP, and the second round of
reagents/samples to be removed for TIP are the test compartment of the reagent cartridge;

7. Conduct the second cycle of constant temperature incubation on the reagent cartridge holder of the
reagent cartridge;

8. The reagent cartridge will collect the absorbance data during each cycle of incubation;
9. Remove the TIP, exit the reagent cartridge, and the test is completed.

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2 Device Performance and Test

Process

2.1 Product specifications and Technical Index

Item Specification

Language English/Simplified Chinese

Display 9.7-inch touch screen, 1024*768 pixels

Communication
USB (x2), LAN (x1), RS232 (x1)
interface

WIFI Implement IEEE 802.11b/g/n standard

Rating 100 - 240V AC, 50/60 Hz, 130 VA

Size 445.0mm×293.0mm×308.6mm
Net weight < 15kg;
Printer Built-in thermal printer
Measuring system Light transmission system, fluorescence system, light reflection system
Wavelength of light
340nm,405nm,455nm,505nm,546nm,578nm,630nm,635nm,660nm,700nm, etc.
sources
Internal working
37℃±0.5℃
temperature
Data storage 80000 sample test results, 10000 QC test results
Noise ≤65 dBA
Service life The service life of the analyzer is determined by the service life of the main
components. During the period of use, the user should maintain the analyzer complying
with the requirements of this user manual. After maintenance, normal operation can be
performed when its safety and effectiveness are verified.
Date of manufacture See label for date of manufacture
Software release
V01
version

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2.2 Working Principle

2.2.1 Light transmission system

When passing through the detection area of the reagent cartridge, the light beam is absorbed by the
analytes, which reduces the light intensity. The content of the detected substance can be quantitatively
obtained by analyzing the amount of absorbed light.

2.2.2 Fluorescence system

When passing through the detection area of the reagent cartridge, the light beam excites the
fluorescent substances in the tested solution. The content of the detected substance can be quantitatively
obtained by analyzing the amount of generated fluorescence.

2.2.3 Light reflecting system

When passing through the detection area of the reagent cartridge, the light beam is absorbed by the
analytes in the detection area, while the remaining light is reflected. The content of the detected substance
can be quantitatively obtained by analyzing the reflected light and calculating.

2.3 LinearityWithin Optical Measuring Range

The linearity within optical measurement range meets the requirement below:

Measuring system Linearity correlation coefficient

Light transmission system The maximum light absorbency ≥2.0, R≥0.995

Fluorescence system Fluorescent intensity within 500~ 2300, R≥0.99

Light reflecting system Reflectivity within 5.5 % ~ 80.0 %, R≥0.99

2.4 Storage, transportation and working environment

Transport and storage conditions

 Environmental temperature: -20℃～55℃.

 Environmental humidity: 85% or less.

Working conditions
The Analyzer shall be installed in the following working environment:

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 It is preferred to install the analyzer under an environment free from dust, mechanical vibration,
pollution, large noise sources and EMI;
 The analyzer is for indoor use only. Keep dry and keep away from sunlight. Please choose a well -
ventilated position to place the analyzer.
 Environment temperature: 15℃ ～30℃.

 Relative humidity: 25%～85%

Power requirement
 Power supply: The Analyzer is a functional grounding type and must be used because the power
outlet is well-grounded. Before starting the Analyzer, be sure to confirm that the input voltage meets
the requirements of the Analyzer.

Rated Voltage Rated Current Frequency

100 - 240V AC
Power Input (Voltage fluctuation:±10%) 130 VA 50 Hz

Attention

Please use the power supply cord provided with the machine; the replacement
must meet the parameter requirements for "Analyzer Input" in "1.2 Product
Specifications and Technical Indicators, and the use of other power supply cord
may lead to machine damage or incorrect analysis results.

2.5 Test and quality control process

1.Power on, click "Detect" in the 2. Open the inner packaging box of the
homepage menu, click "Add Detect" to reagent, place the reagent card into the 3. After the test, print the results, discard
enter the detect application interface, reagent cartridge holder, put the TIP header, the kit, and the test is end.
enter basic information related to the add the sample to be detected and click "Start
sample, and open the bin gate. Detection" to start the detection.

Figure 3- 1 Test flowchart

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1. Power on, click "Quality Control" in the 2. Open the inner packaging box of the reagent,
homepage menu, click "Add Quality place the reagent cartridge into the reagent cartridge 3. After the quality control, print the results,
Control" to enter the Quality Control holder, put the TIP header, add the control solution to discard control material kit, and the quality
application interface, enter basic information be tested and click "Start Quality Control" to start the control is end.
related to the quality control item, and open quality control.
the bin gate.

Figure 3- 2 Test flowchart

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3 Installation

3.1 Installation environment requirements

Please confirm that the installation environment of the Analyzer meets the following requirements:
 For indoor installation only;
 The bench surface (or ground surface) shall be flat (the inclination is less than 1/200);
 The bench surface (or ground surface) can bear the weight of the Analyzer at least (the weight of a
single Analyzer is approx.15Kg);
 Well ventilation;
 The environment shall be as dust-free as possible;
 Avoid exposing to direct sunlight
 Avoid being placed near the heat and wind sources;
 No corrosive and flammable gas;
 There are no vibrations on the bench surface (or ground surface);
 No big noise source and power interference;
 Keep away from the brush-type engines and the electrical contact equipment that is frequently
switched on /off;
 Keep away from the equipment that emits electromagnetic waves, such as mobile phones, radio
transceivers, and so on.;
 The environmental temperature is 15℃～30℃; the environmental humidity is 25%RH～85%RH;
If the room temperature cannot meet the requirements, an air conditioner needs to be installed.

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3.2 Installation requirements

3.2.1 Installation space

The following shows the installation space by taking a test scenario of a single Analyzer as an
example:

Wall
body ≥200

≥500 ≥500 Barr

Barr
ier Detector ier

Desktop

Figure 4- 1 Schematic diagram of Analyzer layout (unit: mm)

3.2.2 Power supply

Power supply: 100V to 240V~ (±10% fluctuation allowed), 50/60Hz (±3Hz fluctuation permitted);
three-core power cord with a good grounding; the system needs a well-grounded power socket to provide
the required power;
Grounding inspection method:
1. Adjust the multimeter to the AC voltage gear, and the measuring range shall be greater than 300V;
2. In the three-core socket shown in the following figure, insert two black and red meter pens
respectively into A and B sockets. At this time, the reading of the multimeter shall be the voltage value of
the nominal power supply (for example, it is 220V in mainland China);

Figure 4-3 Schematic diagram of three-core socket

3. Insert the black meter pen into the O socket and the red meter pen into the A and B sockets,
respectively. Under the condition of standard grounding, the multimeter’s reading shall be displayed as 0V
and the nominal power supply and voltage measured in Step 2 respectively. Otherwise, it is believed that

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the user terminal is not grounded correctly, and it is recommended that the user rectify it.

Warning:

 The power supply must be grounded correctly, and incorrect grounding may
cause electric shock and damage the system.
 Please confirm that the output voltage of the power socket has met the system
requirements and a proper fuse has been installed.

3.3 Installation process

1. Place the Analyzer on the workbench;
2. Installation of power supply cord:
Insert the specified power supply cord into the power cord socket at the back of the Analyzer to
complete the installation of the Analyzer's power supply cord;
3. Installation of printing paper:
The specific installation steps are as follows:
1) Open the top lid of the printer;
2) Pull the door handle outward to open the upper cover of the printer.
3) Take out the printing paper and put it into the paper slot. Note that the thermal side of the
printing paper is facing up.
4) Pull a little of the printing paper out of the paper outlet between the printer's upper lid and back
lid, and then close the top lid of the printer.

3.4 Startup Test

The display screen of the Analyzer may light up by slightly touching the soft key on the back of the
Analyzer after the Analyzer is correctly installed. After the Analyzer is initialized and enters the main

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interface, if there are no warning prompts popped up , the Analyzer passes the startup test;

Note:

Before power on, check whether each signal cables are well connected and whether
the power supply cord is tightly connected.

3.5 Shutdown
Please follow these steps to perform the shutdown operation.
Click the power button on the screen to select shutdown or press the soft key on the back of the
Analyzer to turn off the display and unplug the power cord.

Attention

Before shutting down, make sure that there are no reagent cartridges left on the
reagent cartridge holders.

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3.6 Communication settings

3.6.1 Wi-Fi settings

Touch【 Communication settings 】 via the menu page
【Wi-Fi Setting】to enter the menu page【 Wi-Fi Setting】, as
shown in the left figure; please refer to the following
description to set the content of the text box.
【Mode Setting】: Touch the『AP/STA』on the right side
to complete the mode check
【Protocol Type】: Touch the『 TCP/UDP』on the right
side to complete the type check.
【Protocol Port】: View the default protocol port and click
the『 』text box on the right side to enter a new protocol
port.
【Server Address】: View the default server address, and
click the『 』text box on the right side to enter a new
server address.
【Reset】: The ex-factory settings will be restored after
『Reset』 is clicked.
【Save】: The above settings will take effect only when
you touch『Save』.
【AP Setting】: Enter the【AP Setting】menu after [AP
Setting] is clicked.
【STA Setting】: Enter the【STA Setting】 menu after
『STA Setting』 is clicked.
【AP Setting Menu】 as shown in the left figure.
【Name】: Touch the『 』textbox on the right side to
edit the network name on the pop-up page.
【Password】: Touch the『 』textbox on the right side
to modify the network password on the pop-up page.
【IP Address】: View the default IP address, and click the
『 』text box on the right side to enter a new server
address.
【Save】: Click『Save』for the above setting.
After touching『 』, it will return to【Wi-Fi Setting】
menu.

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【STA Setting】 as shown in the left figure.

【SSID】: Touch the『Search』 on the right side and pop
up the 【Network Name Selection】 to select the network on
the pop-up page.
【Password】: Touch the『 』 text box on the right
side to enter the password of the selected network on the
pop-up keyboard.
The IP address, subnet mask, and gateway address can be
viewed in the interface.
Touch『Save』, the above settings are valid.
After touching『 』, it will return to【Wi-Fi Setting】
menu.
【Network List Interface】 menu is shown on the left.
The interface lists all the available networks.
After touching 『○』 in the selection column to select an
available network.
【Confirm】: Touch the『Confirm』 to confirm the seleted
network and return to【STA Setting Menu】.
【Refresh】: Touch the『Refresh』to search for the
available networks again.
Touch the 『Previous Page』 to go to the previous page of
the network list.
Touch『Next Page』 to go to the next page of the network
list.
Touch『 』to return to【Wi-Fi Setting】menu.

3.6.2 LAN settings

Touch【Communication settings】via the menu page
【LAN Setting】to enter the menu page【 LAN Setting】, as
shown in the left figure; Please refer to the following
description to set the content of the text box.
【IP Address】: Touch the『 』text box on the right
side and enter the IP address on the pop-up keyboard.
【Subnet Mask】: Touch the『 』text box on the
right side and enter the subnet mask on the pop-up keyboard.
【Default Gateway】: Touch the『 』text box on the
right side and enter the default gateway on the pop-up
keyboard.
【DNS】: Touch the『 』text box on the right side
and enter the domain name on the pop-up keyboard.
【Server IP】: View the default server IP and touch the

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『 』text box on the right side and enter a new server IP.
【Port】: View the default port, and touch the『 』
text box on the right side to enter a new port.
Touch『Save』, the above network settings are valid.
Touch『 』 to return to the upper menu.
Note: The LAN IP address is valid only after restart.

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4 Module Introduction

4.1 Outer shell Modules

In the routine maintenance of the Analyzer, the maintenance and replacement of most of the parts
shall be carried out after the outer shell is partially removed. Therefore, first, introduce the composition and
assembly/disassembly of the outer shell.

4.1.1 Composition of outer shell

The outer shell is the constituent part of the Analyzer’s appearance, which plays the protective and
dust-prevents role in the internal components of the whole Analyzer.
The outer shell components include upper shell, middle shell, bottom shell, channel lid, halogen light
lid, printer back lid, and bottom lid. There are holes reserved at the bottom and used to pick up the TIP that
falls off due to abnormalities; fasten the shells with screws. The composition diagram of the outer shell is
shown in the figure below.

Printer back cover

Upper shell

Middle shell

Channel lid

Halogen light
cover

Bottom lid
Bottom shell

Figure 5- 1 Component layout for outer shell

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4.1.2 Disassembly and assembly of outer shell

If you need to repair the internal parts or outer shell of the Analyzer, please turn off the power switch
of the Analyzer, and then perform the operations in the order shown in the following figure.

Attention

When disassembling the outer shell, turn off the power switch of the Analyzer and
disconnect the power cord.

Tighten the screws

Remove the middle shell

Unplug wiring

Lift off the middle shell

Figure 5- 2 Disassembly and assembly flowchart of Analyzer outer shell

First, unscrew eight screws connected to the middle shell near the edge of the bottom shell, then
disassemble the middle shell, lift the middle shell by 3/2 with your hands; hold the middle shell with one
hand and reach in it to pull out the adapter cable with other hands, and you can see the internal structure of
the whole machine.

Middle shell component

Host part

Figure 5- 3 Schematic diagram of disassemble outer shell

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4.1.3 Disassembly of middle shell

The middle shell portion consists of channel lids, a halogen light back lid, and an upper shell
component; when the middle shell is disassembled, the upper shell component must be firstly disassembled;
and the disassembly and assembly structure schematic diagram of the middle shell is shown as follows:

Upper shell component

Halogen light back lid

Middle shell component

Channel lid

Figure 5- 4 Disassembly and assembly structure schematic diagram of middle shell

At first, unscrew the internal screws and pull out the connector to separate the middle shell from the
upper shell. Please note that the cable ties must also be loosened. Otherwise, they cannot be completely
separated;
Then, disassemble/assemble the channel lids of the middle-shell reagent cartridge and the back lid of
the halogen light, unscrew four fixing screws at the bottom of the channel lids to remove the channel lids;
unscrew two fixing screws on the lid of halogen light, and then remove the back lid by lifting the back lid;
The disassembly and assembly process of the middle shell is shown in the following figure:

Disassemble the upper shell

Disassemble the bin gate

Disassemble the back cover

Figure 5- 5 Disassembly and assembly flowchart of Analyzer middle shell

At the installation time, it is ok to operate according to the above procedures in a reverse direction. At
installing the channel lid, it is necessary to adjust the gap evenly between the channel lid and the middle
shell.

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4.1.4 Disassembly of upper shell

The upper shell part is composed of printer lid, printer, connection board, upper shell, and its
structural diagram is shown in the figure below

Printer lid

Printer

Upper shell

Connection board

Figure 5- 6 Disassembly and assembly structure schematic diagram of upper shell

When disassembling the printer, the printer lid must be removed before disassembling the printer, and
the disassembly process of the printer is shown in the following figure:

Remove the printer cover

Unscrew the screws

Remove the printer

Figure 5- 7 Printer disassembly and assembly flow chart

The specific disassembly steps are as follows:
1. Remove the printer lid first
2. Loosen the printer retaining screws
3. Remove the printer
4. During installation, reverse the previous steps

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4.2 Host part

4.2.1 Function Introduction

The host portion mainly includes PCB control part, code scanning component, vertical movement
component, pump component, light transmission system, fluorescence system and light reflection system,
light source component, horizontal movement component, bottom shell, and external interface component;
The parts formed by PCB components can achieve such functions as the control over the movement of
various mechanical parts of the Analyzer, the suction and movement of samples as well as mixture, data
reading, data transmission, and temperature control.
The part of a code scanning component mainly realizes such basic functions as reading the QR code
on the reagent cartridge and assisting in removing the TIP;
The part of vertical movement component mainly realizes such basic functions as sealing and
breaking the hole of the reagent cartridge, suction and discharging of sample solution, and detaching the
TIP;
The part of piston pump component mainly assists the function that the TIP header sucks discharges
the sample solution;
The light transmission system mainly achieves data acquisition of reaction liquid;
The fluorescence system and the light reflection system, which mainly realize the data acquisition
function of reaction liquid;
The part of light source component mainly provides different wavelengths of light energy for the light
transmission system test component;
The part of horizontal movement component mainly realizes such basic functions as horizontal
forward and backward movement and opening the channel lid;
The bottom shell and external interface components mainly provide the whole machine with such
functions as positioning, data transmission, and power input;

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Plunger pump component

Scan code
component

Vertical motion
components

Fluorescence
system and
PCB reflecting system
component

Horizontal
movement
components
Transmission system
Light source components
Bottom shell and
external interface
components

Figure 5- 8 Structural schematic diagram of host part

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4.2.2 Disassembly and assembly device process

The Disassembly and assembly device process is shown in the following figure:

PCB component

Vertical motion components

Scan code component

Plunger pump
component

Transmission system

Light source components

Fluorescence system and light reflecting system

Horizontal movement components

Bottom shell and external interface components

Figure 5- 9 Device disassembly and assembly flow chart

Note: Necessary to unplug the corresponding connecting wire terminals when these components
are disassembled during installation, reverse the previous steps.

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4.3 PCB component

4.3.1 Function Introduction

The PCB component is composed of a fan, a master control board, a driver board, an analog board, a
power supply, and a bracketcartridge holder, and the specific structure is shown in the following figure.
The fan is mainly to provide heat dissipation to the complete device; The built-in power module
mainly provides a stable 24V voltage to the master control board;
The master control board is the core part of the complete device;
The analog board realizes data acquisition;
The drive board is responsible for sending motion commands to the motor;

Power supply Driver board

Holder

Fan Main control board

AD board

Figure 5- 10 Structural schematic diagram of PCB component

4.3.2 PCB structure disassembly and assembly

Based on the assembly/disassembly process of PCB, seach component is installed independently, so
there are no sequences for its disassembly and assembly.

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4.4 Vertical motion components

The main functions of the vertical component are to suck/discharge the solution, break the hole and
detach the TIP and, by means of the screw rod motor, cooperate with the horizontal component in
completing the puncture of the protective film of the reagent cartridge by driving the hole-broken rod to
move up and down; then, drive the suction nozzle to cooperate with the horizontal component movement
in getting the TIP. After completing a series of actions, including the movement and even mixture of
solution in the reagent compartment, the uncapping clip will remove the TIP from the suction nozzle,
cooperate with the horizontal component to make the TIP return to the reagent cartridge, and bring the
horizontal component out of the machine.

4.4.1 Composition and structure

The vertical movement component is mainly composed of uncapping clip module, vertical
movement module, guide rail, spring, optocoupler, sheet metal fixing bracket, and fixing plate, as
shown in the following figure.

Fixing plate
Optocoupler
Vertical movement
Guide rail module

Sheet metal fixing brack

et
Uncapping clip
module

Spring

Figure 5- 11 Vertical motion components schematic diagram

Vertical movement module: provides the power to move up and down to drive the hole-broken rod
and the suction nozzle to move up and down and complete a series of actions on the reagent cartridge;
The uncapping clip module: Cooperate with the code scanning component to complete the
detaching of the TIP from the suction nozzle;
Spring: Provide power to reset the uncapping clip;
Guide rail: the guarantee for the detaching to complete the linear movement;

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Sheet metal fixing bracket: Fixed free uncapping clip;

Fixing plate: Provide positioning reference for the entire assembly.

4.4.2 Maintenance of vertical movement component

5.4.2.1 Disassembly and assembly of the vertical motion component

The disassembly and assembly process of the vertical motion components is shown in the following
figure:

Sheet metal fixing bracket

Uncapping clip module

Spring

Guide rail

Vertical movement module

Figure 5- 12 Disassembly and assembly flow chart of vertical motion component

1. Unscrew the screws on the sheet metal fixing bracket from left to right, and then remove the
holder. ；
2. Remove the uncapping clip and spring.
3. Unscrew the jackscrew with a hexagonal screwdriver to remove the guide rail;
4. Remove the fixing screws of the vertical motion module to complete the disassembly of the
components to be rectified.

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Figure 5- 13 Disassembly and assembly schematic diagram of vertical motion components

5.4.2.2 Installation of vertical motion component

The assembly diagram of the vertical motion component is shown as follows:

Figure 5- 14 Assembly schematic diagram of vertical motion components

The assembly process of the vertical motion components is as follows:

1. The vertical movement module is installed on the fixing plate to be aligned with the positioning
pins;
2. Fix it with four M3X6 three-combination screws.
3. Same as above, fix another vertical motion module with four M3X8 three-combination
screws.

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4. Insert the guide rail into the 4mm diameter hole at the back of the fixing plate, and then fix it with
M3X5 fastening screws from the bottom of the fixing plate.
5. Install the spring and uncapping clip, cover the sheet metal for fixation, and fix it with four m3x6
three combination screws;

5.4.2.3 Installation of vertical motion component (vertical motion module)

The schematic diagram for disassembling the suction nozzle (the maintenance of the vertical
movement module) of the vertical movement component and the hole-broken rod is shown as follows:

Sheet metal fixing

bracket

Hole-broken rod
Suction nozzle
Screw rod mounting plate;

Figure 5- 15 Disassembly and assembly schematic diagram for suction nozzle and
hole-broken rod i

Disassembly and assembly process for suction nozzle and hole-broken rod is as follows:
1. Remove the 2 M3x8 triple combination screws that fix the screw rod fixing plate;
2. Remove the screw rod fixing plate;
3. Unscrew two M3x8 three-combination screws used to fix the hole-broken rod, remove the
hole-broken rod, and install it in a reverse direction if necessary to replace.
4. First, unscrew the pipe connector connected to the suction nozzle, and take it out to separate.
5. Unscrew M3x8 three-combination screws fixed on both sides of the suction nozzle to take out the
suction nozzle and install it in a reverse direction if necessary to replace.

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The schematic diagram for disassembling the uncapping clip (the maintenance of the vertical
movement module) of the vertical movement component is shown as follows:

Figure 5- 16 Disassembly and assembly schematic diagram of uncapping clip

The disassembly process of the vertical movement component（the maintenance of uncapping clip
module) is as follows:
1. Unscrew four M3x8 three-combination screws used to fix the sheet metal fixing bracket, and
remove the sheet metal fixing bracket.
2. Take out the uncapping clip and replace it.

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5.4.3 Replace the hole-broken rod of the vertical movement component

Unscrew the four fixing screws of the vertical component.

Unplug two connectors

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Put the cable inside and fix it to the

position for the ties or cut the ties.

Pull out the vertical

component to tilt it at an
angle of about 45°

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Remove the screw used to fix the

hole-broken rod

Remove the hole-broken rod and

install a new hole-broken rod

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Install a new hole-broken rod and tighten the fixing screw

After the hole-broken rod is installed, install the component back to the original position

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Note that the positioning pins on both sides of the component should be in a good position

Position of right positioning pin

Position of left positioning pin

Note that after the vertical components return to their positions, reconnect the micro switch connector by
pressing the left and right sides, and tie the cable ties

Connect the connectors and tie the cable ties

At this point, the replacement of the hole-broken rod is complete

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4.5 Barcode scanning component

4.5.1 Function introduction

The function of the barcode scanning component is to drive the barcode scanner to slide left and right
to read the QR code data attached to the reagent cartridge; push the uncapping clip forward to make the
uncapping clip remove the TIP from the suction nozzle.

Synchronous pulley
Synchronous
belt
Stepping motor Photoelectric
switch

FPC line

Positioning plate

Guide rail
Scanner
Slider

Figure 5- 17 Structural schematic diagram of scan code component

4.5.2 Composition and structure

The code scanning components mainly include stepping motors, synchronous belts, synchronous
pulley, FPC lines, guide rails, sliders, code scanners, optocoupleres, and positioning plates as shown in
Figure 25:
Stepping motor: used to provide the power to drive and drive the sliding rail to slide left and right by
means of a synchronous belt and synchronous pulley;
Synchronous belt: a bridge for power transmission;
Synchronous pulley: rotates under the drive of a motor to drive the synchronous pulley to move;
Guide rail: play a guiding role in providing the guarantee for the horizontal left right movement;
Slider: fixed freely on the guide rail to move left and right under the drive of the synchronous belt;
Code scanner: iInstalled on the slider, it moves left and right under the drive of the slide rail;
FPC line: data transmission and provide power supply for the scanner;
Optocoupler: provide positioning reference for scanning barcode motor movement

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4.5.3 Maintenance of Scanner Module

Motor Module

Guide rail

Snap ring

Scanner module Synchronous belt pressing plate

Figure 5- 18 Disassembly and assembly schematic diagram of scanner component

1) The assembly and disassembly procedures of the barcode scanner module are as follows:
1. Fix the code scanner module on the slider with two M2x4 countersunk screws;
2. Make the slider pass through two guide rails to fix it freely on the guide rails;
3. Fix both ends of the guide rail on the round orifice plate, first fixing it with a snap ring and then
setting it with fastening screws;
4. Pass the synchronous belt through the upper end of the slider;
5. Press the synchronous belt onto the slider with a synchronous belt board, and then tighten it with
M3x6 countersunk head screws;
6. Pass the motor module through the synchronous belt, and then tighten it with M3x8 three
combination screws.
7. Pull the slider by hand to slide smoothly left and right to complete the installation.

2) The disassembly procedures are opposite to the assembly procedures, and the precautions are as
follows:
1. Necessary to adjust the tensile force of the synchronous belt when the motor components are
installed.
2. When two ends of the guide rail are installed, adjust the round orifice plate properly (unscrew the
fixing screws of the round orifice plate). Otherwise, the holes will not be aligned correctly;
3. Necessary to pay attention to the direction of the FPC line when the barcode scanner module is
installed.
4. Necessary to pay attention to the direction of motor outlet.

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4.6 Detection Unit

4.6.1 Function introduction

The detection unit is the core component of the Analyzer, which is mainly responsible for reading the
solution out of the reagent compartment, reading and calculating the value of different colored solutions
after the reaction; And coordination with the AD board and the main control board to recorde and save the
read values. The detection methods include transmission, reflection, and fluorescence. With the
coordination of horizontal components, different test methods can be selected for other solutions;

The installation location of the detection unit in the whole machine is shown in the following figure.

Detecting Unit Detecting Unit

Figure 5- 19 The position of the detection unit in the complete device

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The detection unit is mainly composed of the following components: reflection system and
fluorescence system, transmission system, light source component, Y-shaped optical fiber, and optical
positioning base.
The following figure shows the structural layout of the detection unit.

Fluorescence system and reflecting system

Transmission
system

Y-shaped Optical
Light source
optical fiber positioning base
components

Figure 5- 20 Structural layout of detection unit

Fluorescence system and reflection system: mainly provide the reflection test method and the
fluorescence test method, and shall be fixed on the optical positioning base with positioning pins and
screws;
Transmission system: it is the main detection unit of the Analyzer and fixed to the positioning base
with positioning pins and screws;
Light source component: it is illuminated by a halogen light, passes through the internal filter of the
filter-wheel (there are eight filters of different wavebands installed in the filter-wheel); the filter-wheel can
be rotated under the drive of the stepping motor; the light spots of different wavebands can be transmitted
to the test component of transmission system via the Y-shaped optical fiber; in the horizontal component
matching belt, the reagent cartridge chamber; can be tested through the test component of the transmission
system; there is the absorbance of different solutions in each compartment;
Y-shaped optical fiber: a transmission line that divides the optical path into two.

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4.6.2 Component / Part replacement

5.6.2.1 Installation of detection unit

Installation of Transmission system
1. First, connect the Y-shaped optical fiber to the transmission system test component. Then, put
the transmission system detection component on the optical positioning base, align the positioning
pin with installing it in place, and fix it with M3x8 three-combination screws, as shown in the
following figure.
2. Be careful not to twist the Y-shaped optical fiber during the installation of the transmission
system detection component.

Figure 5- 21 Installation schematic diagram of transmission system detection components

Installation for fluorescence system and reflecting system

1、 Install the reflective and fluorescent components on the positioning substrate, align the
positioning pins, and fix them with two M3x8 three-combination screws;
2、 Be careful that the components do not knock against or press the optical fiber in the
installation process.

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Figure 5-22 Installation schematic diagram of reflection and fluorescence components

Light source components installation：

1、 Put the halogen light on the connecting base, align it with the positioning pin and then fix it
with a thumbscrew;
2、 In the installation process, the halogen light must be in place, and the flange surface of the
halogen light is fit wellshould be fitted to the surface of the fixing base;

Holder

Figure 5- 23 Schematic diagram of halogen light installation

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4.7 Horizontal movement components

4.7.1 Function introduction

Driven by the screw rod motor, the horizontal movement component can drive the reagent cartridge to
move back and forth inside the Analyzer for precise positioning, and assist the vertical motion assembly in
puncturing the protective film, and to obtain and remove the TIP from the suction nozzle; the auxiliary
detection unit can accurately read the solution data on reagent cartridge from each chamber; the constant
temperature incubation system and the temperature test system are also provided;

4.7.2 Composition and structure

The horizontal movement component includes a main positioning plate, a screw rod motor, a motor
fixing plate, a guide rail, and a screw fixing plate.

Incubation
Screw rod motor components

Motor mounting Screw rod

plate mounting plate;

Main positioning Guide rail

plate

Figure 5- 24 Schematic diagram of the horizontal movement component layout

The horizontal movement component can be divided into two parts: Movement module an incubation
module

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4.7.3 Disassembly and assembly of the incubation module

Incubation components include reagent cartridge holders, sliders, sliding nuts, linear bearings,
drag chains, drag chain connection holders, silicone heaters, silicone heater pressing
plates,optocoupler interuptor, temperature sensors, wires and screws.

Reagent cartridge holder

Silicone heater pressing plates
Drag chain Sliding nuts

Drag chain holders

Temperature
Sensor

Linear bearing
Slider
Silicone heater

Figure 5- 25 Structure schematic diagram of incubation module

1、 The sliding nut and linear bearings are installed on the slider, and the reagent cartridge holder is
assembled with the slider;
2、 The silicone heaters are attached to both sides of the reagent cartridge holder and then fixed with
the silicone heater pressing board;
3、 The temperature sensor is fixed at the bottom of the reagent cartridge, and the connecting wire
passes through the slider;
4、 The drag chain fixing bracket is fixed to the slider and then connected to the drag chain;
5、 The connecting wire of the silicone heater and the connecting wire of the temperature sensor
shall pass through the drag chain;

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4.7.4 Disassembly of movement module and assembly of incubation

module
The movement module comprises a screw rod motor, a motor fixing plate, a screw rod fixing
plate, the main positioning plate, a guide rail, and screws.

Figure 5- 26 Schematic diagram of the horizontal module structure

1、 The screw rod motor is fixed to the motor fixing plate;

2、 The incubation module is assembled on the screw motor through the slider nut;
3、 Make the guide rail pass through the linear bearing till it is inside the hole of the mounted motor
positioning plate;
4、 Install the bearing on the screw rod and then install it on the screw rod positioning plate;
5、 Then install the assembled components on the main positioning plate. First, fix the drag chain
fixing plate and then fasten the screw rod fixing plate and the motor positioning plate;
6、 The incubation components can be removed and replaced in a reverse direction.

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4.8 Bottom shell and external interface components

4.8.1 Function introduction

The bottom shell and external interface components mainly provide such functions as positioning,
data transmission,and power input for the installation of the whole machine;

Power input
interface Base
External port
board

Power switch

Figure 5- 27 Structural schematic diagram of bottom shell and external interface components

4.8.2 Composition and structure

The bottom shell and the external interface components include bottom shell, power input
connector, serial port board, and power switch;

4.8.3 Disassembly and assembly of bottom shell and external interface

board
1. Remove four screws which fix the external port board, then remove and replace the circuit board;
2. It is necessary to unscrew the hexagon nut on the switch before the power switch is removed and
replaced;

Figure 5- 28 Structural schematic diagram of bottom shell components

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4.9 Optical components

4.9.1 Composition and structure

The Analyzer is a typical precision instrument that combines opto-electromechanical arithmetic, in
which the portion of optical detection is one of the core components of the Analyzer. It consists of three
parts: transmission system, fluorescence system, and reflection system, as shown in the following figure.
The transmission system comprises a front beam splitting light source and a transmission test component,
achieving dual-channel test through a Y-shaped optical fiber. The fluorescence system is composed of an
excitation optical path and a receiving optical path. The fluorescence receiving optical path and the
excitation optical path shall be set at 90 degrees to reduce stray light interference. Two red LEDs and two
blue LEDs of the reflection system (only one LED is shown in the schematic diagram) are set at a certain
angle to the central axis, and the PD module is set on the central axis. The fluorescence system and the
reflection system are integrated into one component.

PD

Reagent
Filter wheel cartridge

Lens Y-shaped optical fiber Lens

Reflecting
Halogen light mirror

Reflecting
mirror

Lens

Reagent
cartridge
PD

Figure 5- 29 Installation schematic diagram of transmission system light path

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PD
Lens

Fluorescence
receiving filter
Lens

Reagent cartridge
Fluorescence excitation filter Fluorescence excitation filter

LED LED

Figure 5- 30 Installation schematic diagram of fluorescence system light path

PD

Red LED Blue LED

Reaction
zone

Figure 5- 31 Schematic diagram of reflecting system light path

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4.9.2 Layout of optical components

The layout of the optical components on the instrument is shown in the following figure. The front
splitting light source component is installed on the bottom shell while the transmission detection
component, the fluorescence system, and the reflection system are installed on the optical positioning
substrate, and the front splitting light source component and the transmission detection component are
mutually connected via Y-shaped optical fiber.

Reflecting system Optical positioning base

Fluorescence system

Transmission system
Front split light
source assembly

Y-shaped optical fiber

Figure 5- 32 Layout drawing of optical components

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4.9.3 Replace the halogen light

Step 1: Open the bin gate of the halogen light
1、 Unscrew the two M3x5 fastening screws on the lid of halogen light by a cross
screwdriver. As shown in Figure 1A
2、 Pull open the halogen light lid at the handle position. As shown in Figure 1B

Halogen light lid

M3 x 6 fastening screws

Figure 1A

Handle
position

Figure 1B

Figure 5- 33 Open the halogen light bin gate

Step 2: Take out the dead halogen light
1、 Press the buckle of the halogen light power cord with your thumb, and pull out the
power cord socket. As shown in Figure 2A.
2、 Hold the hand screw with two fingers and unscrew the hand screw outward, as shown
in Figure 2B below.
3、 Do not completely unscrew the thumbscrew, as shown in following Figure 2C. At this
time, pull the halogen light outward to disengage the pin, and then rotate the halogen light
outward to a certain angle. Pull out the halogen light with the thumbscrew remain on the
lamp holder, as shown in the following Figure 2D.

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Buckle

Thumb screw

Figure 2A Figure 2B

Dowel

Figure 2C Figure 2D

Figure 5- 34 Remove the halogen light

Step 3: Install the new halogen light
1、 Take out a new halogen light, as shown in following Figure 3A, and be careful not to
touch the contaminated lamp beads with your hands.
2、 Align the pinhole of the halogen light with the pin, rotate the hook and place it under
the thumbscrew, as shown in Figure 3B
3、 Press and hold the lamp bead holder of the halogen light with your hand, as shown in
following figure 3C. If the mounting base of the halogen light can be completely fit, it
indicates that the alignment is in place.
4、 After being aligned, turn thumb screws with another finger inside and outside to
compress the halogen light, as shown in Figure 3D.

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New halogen light

Figure 3A Figure 3B

Figure 3C Figure 3D

Figure 5- 35 Install the halogen light

Step 4: Install the halogen light lid
1、 Put the halogen light power cord and the connector buckle into the Analyzer to avoid
pressing the wires when the halogen lamp lid is closed, as shown in the following Figure
4A.
2、 Insert the lid into two mounting holes, and then close the lid, as shown in following
figure 4B.
3、 Tighten two M3 x5 fastening screws with a cross screwdriver. Doing so, the
replacement of the halogen light is complete, as shown in Figure 4C.

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Figure 4A Figure 4B

Figure 4C

Figure 5- 36 Install the halogen light bin gate

Step 5: Power-on self-test
Plugin the power supply and slightly tap/touch the switch. The Analyzer will enter the
startup self-test interface. No halogen light attenuation failures are reported after the
self-test is over.
The above is to complete the replacement of the halogen light. After the halogen light is
replaced, it is necessary to adjust the optical potential parameter again, and the adjustment
method is detailed in the next section.

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4.9.4 Potential parameter adjustment

4.9.4.1 Potential parameter debugging requirements

Table 5- 1 Potential parameter debugging requirements table
AD value range
Light path 31# chamber (550ul)
Air Purified Water Standard object
340
9000~13500
405
505
546
Purified Water 54000~56000 49000~51000
578
/
630
660
700

5.8.4.2 340/405 potential parameter adjustment

After the halogen light is replaced, it is necessary to conduct optical debugging again. The
replacement process is shown as follows.
1） Prepare an empty reagent cartridge. The diagrams of each chamber of the empty reagent cartridge
are as follows:

Sample
chamber
Diluent TIP
31# 32# 33# 34# Insert the kit in the direction of Diluent
chamber header
chamber chamber chamber chamber the meter chamber

Figure 5- 37 Schematic diagram of each chamber of reagent cartridge

2） In the maintenance mode interface of the Analyzer, click 【Optical Path Debug】-【Channel 1】
-【340】 to enter the Optical Path Debug interface, and click “Open / Close Lid” to open Channel
1;
3） Click "Auto Test" in the Debug interface column, and then click two "Test" buttons behind "Air"
and "Purified Water" successively for test after the test is over, check whether AD value after the
test meets the requirements of Table 5-1. If the AD value meets the requirements, click "All
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Settings" to save all the PD debugging values; if the AD value does not meet the requirements,
change the PD value of the corresponding item until the AD value meets the requirements of
Table 5-1, and then click the "Setting" button of the related item to save the PD value;, and record
the above PD and AD values in the record sheet;
4） In the same way, debug, calibrate and record optical path 340 of channel two according to the
above operations.
5） Debug optical path 405 according to the above-mention procedures.
6） The debugging parameters need to be recorded in the column "Optical Debugging Parameter" of
the "Debugging Parameter Record Form," and refer to the attachment for more information on the
Form;

Figure 5- 38 Interface diagram of optical path 340 debugging interface

5.8.4.3 505/546/578/630/660/700 potential parameter adjustment

After the halogen light is replaced, it is necessary to conduct optical debugging again. The
replacement process is shown as follows.
1） In the maintenance mode interface of the Analyzer, click 【Optical Path Debug】-【Channel 1】
-【505】 to enter the Optical Path Debug interface, and click “Open / Close bin gate” to open
Channel 1;
2） Add 550uL purified water to t31# compartment of an empty reagent cartridge with a pipette (with
a pipette head), and put the reagent cartridge into Channel 1 of the Analyzer;
3） Click "Auto Test" in the Debug interface column, and then click two "Test" buttons behind "Air"
and "Pure Water" successively for test after the test is over,; check whether AD value after the test
meets the requirements of Table 5-1. If the AD value meets the requirements, click "All Settings"
to save all the PD debugging values; if the AD value does not meet the requirements, change the
PD value of the corresponding item until the AD value meets the requirements of Table 5-1, and

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then click the "Setting" button of the related item to save the PD value;, and record the above PD
and AD values in the record sheet;
4） In the same way, debug, calibrate and record optical path 505 of channel two according to the
above operations.
5） Debug optical path 546/578/630/660/700 according to the above-mention procedures.
6） The debugging parameters need to be recorded in the column "Optical Debugging Parameter" of
the "Debugging Parameter Record Form," and refer to the attachment for more information on the
Form;

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5 Instrument Hardware Circuit

5.1 Overview
This chapter describes the functions of the circuit boards of the Portable Automatic Multi-function
Analyzer

5.2 Safety Precautions

When the Analyzer is working, do not touch the hardware board with your hands or other objects.
If it is necessary to disassemble the circuit board from the Analyzer or plug/unplug the connector on
the board, you must turn off the power switch to operate. When removing the circuit board, please wear
anti-static gloves or take other anti-static measures.

5.3 Circuit board list

The hardware boards of the High Fact portable full-automatic multi-function Analyzer are listed in
the following table 6-1, and the functions of each board are briefly summarized.
Table 6- 1 Hardware circuit board table

Board PCBA（PCB） Function No.

Main control board

Achieve such communication functions as WIFI and relay board for
20200125 #1
Ethernet port, PC serial port, and USB port.
（32900083）
Core board The core board mainly includes MCU, FPGA and Nandflash, as well as the
20200127 core board for control and communication of each module. #2
（32900084）

AD board Realize the functions, including analog signal acquisition, AD conversion

20200128 and processing, and temperature monitoring of fans and silicone #3
（32900085） heatersilicone heaters.

Motor-driven board
Responsible for controlling the power supply to the motor, the operation of
20200129 #4
the motor, and start and stop the motors at the optocoupler positions.
（32900086）

HbA1c receiving
Realize the photoelectric conversion and data acquisition of the reflective
board #5
LED lamp, and transmit them to the AD board
20200130

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（32900087）

Colorimetric
receiving board Realize the photoelectric conversion and data acquisition of each
#6
20200131 wavelength of transmission, and transmit them to the AD board
（32900088）
Fluorescence
receiving board Realize the photoelectric conversion and data acquisition of the
#7
20200132 fluorescence, and transmit them to the AD board
（32900089）
Hall sensor board
20200133 The test of the Lid On / Off can be achieved via the hall sensor. #8
（32900090）
Temperature sensor
board
Realize the real-time collection of temperature. #9
20200134
（32900091）
External port board
20200136 Realize the functions of PC serial port, Ethernet port, USB port interface. #10
（32900093）
Microswitch board
20200137 Realize the test of TIP. #11
（32900094）
Indicator light board
Realize the status indication function of three colors of red, green and
20200139 #12
yellow.
（32900095）
Connection
boardConnetion
Realize the relay function of printer, speaker, indicator light, LCD screen,
board #13
and Hall sensor.
20200138
（32900096）
Fluorescence light
source board
Realize the power supply of fluorescent light source. #14
20200069
（32900052）

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5.4 Position of circuit board

The position of the circuit board in the complete device is shown in Figure 6-1 and Figure 6-2.

Figure 6- 1 Circuit board position schematic diagram 1

Figure 6- 2 Position schematic diagram 2

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5.5 Disassembly of circuit board

When a circuit board is to be removed, unplug the connector on the circuit board (refer to the
connecting wire diagram) and then remove the fixing screws.

5.6 Electrical diagram

Basic block diagram of hardware

Color LCD
彩色LCD屏
screen Thermal 状态
Status Data storage Ambient
电容触摸输入
热敏打印机 LED 数据存储 环境温度检测
capacitive printer LED temperature
touch input detecting

UART
UART串口
serial port
4G模块 Open and close
开关仓门检测
N720 lid detection
主控板
Main control
UART串口
蓝牙模块 board Detection of TIP
TIP头检测
I482E-S
UART
WIFI模块
WIFI module UART串口
serial port Voice
语音功能function
HF-LPB120
HF-LPB120 核心板
Core board
UART MCU+FPGA
UART串口 电机驱动控制及
Motor drive control
Network port RJ45 serial port
网口RJ45 STM32F767IGT6+EP4CE10F17C8N
LAN8720A andoptocoupler
位置光耦检测
LAN8720A detection
QR code
二维码扫描头 USB
USB口port
scanning head

PCPC串口
serial port 485485接口
interface

Silicone
加热片
heaterSilicone Halogen
卤素灯供电 light
heater power supply
风扇
Fan 模拟板
AD board 荧光光源及反射光
Fluorescent light
MCU：STM32F401RCT6 源供电
source and
Incubation reflective light
孵育温度检测 AD data
AD数据采集
source power
temperature collection
detection supply
Figure 6-3 Basic block diagram of system hardware

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USB
USB
VCC_5V WIFI module
WIFI模块
DC-DC circuit
DC-DC电路 VCC_5V VDD_3V3
VCC_5V VDD_3V3
VCC_5V
LDO power
线性稳压电源
supply
VDD_3V3
VDD_3V3
Network
网口
VIN_24V
VIN_24V Soft power-on DC-DC circuit interface
缓上电电路
circuit DC-DC电路 Printer VDD_3V3
VDD_12V 打印机VCC_5V VDD_3V3
VDD_24V
VDD_24V VDD_12V VCC_5V
Scanner
扫描仪
VDD_3V3
VDD_3V3
LDO power
线性稳压电源
supply MCU
VDD_3V8
VDD_3V8 MCU
VDD_3V3
AD board VDD_3V3
模拟板供电
power supply Liquid Crystal
VDD_24V 液晶显示屏 SD interface
VDD_24V Display (LCD) SD接口
VCC_12V
VCC_12V
VDD_3V3
VDD_3V3

Voice
语音模块 module
Motor-driven VDD_3V3
电机驱动供电 VDD_3V3
power supply
VDD_24V
VDD_24V

Figure 6-4 Block diagram of main control board power module

VDD_24V DC-DC
DC-DC
Circuit
LDO LDO
Circuit VDD_5V
LDO
LDO
Circuit

电路 +6.5V 电路 电路
+3.3V

VDD_24V DC-DC
DC-DC
Circuit VDD_12V
Silicone heater MCU

加热片 MCU
电路
Figure 6- 5 Block diagram of power module of AD board

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Hardware connection diagram：

USB2 J2 J200 USB1
External port
外接口板
board
卤素灯
Halogen 风扇
Fan 加热片2
Silicone 加热片1
Silicone
light heater 2 heater 1
J1 J3 轻触开关
Tact switch

Switching
J11 J23 J12 J19 J30 J21 J25 J24 开关电源
power supply

温度传感器板2
Temperature sensor board J24
2 J1 J4
温度传感器板1
Temperature sensor board J22
1
J2 J11 Main control
模拟板
AD board
主控板
board
比色接收板2
Colorimetric receiving J4
board 2
比色接收板1
Colorimetric receiving J3 J8
board 1
J8 J7 J6 J5 J15 J16 J17 J18 J9 J13 J15 J16
扫描头
Scanning
head
微动开关板1
Micro switch
board 1
微动开关板2
Micro switch
J13 J13
J2 J1 J2 J1 board 2
垂直电机1 分光轮电机
Spectro-wheel
Fluorescence
荧光光 Fluorescenc
荧光光 打印机
Printer
J J
Vertical motor 1
J J motor
light source e light
3 2 垂直光耦1
Vertical 分光轮光耦
Spectro-wheel
糖化接收板1
HbA1c receiving 糖化接收板2
HbA1c receiving 源板1
board 1 源板2
source J6 J5 optocoupler 1
3 2 optocoupler
board 1 board 2 board 2 水平电机2
Horizontal motor 2
扫码电机
Barcode scanning
电 电

Motor-driven board 1
Connection J4 J J J J J

Motor-driven board 2
motor
J2 转接板board
机 54 6 水平光耦2外
Horizontal
optocoupler 2 outer 机 5 6 扫码光耦
Barcode scanning
Fluorescence
荧光接 荧光接
Fluorescen J3 水平光耦2内
optocoupler
receiving ce
J1 J7
驱 Horizontal
optocoupler 2 inner 驱 柱塞泵电机2
收板2 收板1 Plunger pump
board 2 receiving
board 1
动 J J 垂直电机2
Vertical motor 2 动 J J motor 2
柱塞泵光耦2
Plunger pump
板 9 8 垂直光耦2
Vertical 板 9 8 optocoupler 2
温

Temperature sensor board

Indicator
Indicator
霍尔传感器板2
霍尔传感器板1

2
Holl sensor board 1 optocoupler 2
Holl sensor board 2

喇叭
Horn
度 水平电机1
Horizontal motor 1 柱塞泵电机1

指示灯板2

指示灯板1
Plunger pump
传 J J J 水平光耦1外
Horizontal J J
motor 1
柱塞泵光耦1

light board 1
Plunger pump

light board 2
Liquid Crystal Display
液晶显示屏 感 optocoupler 1 outer

3
(LCD) 11 10 12 水平光耦1内
Horizontal 11 12 optocoupler 1
器 optocoupler 1 inner
板
3

Figure 6- 6 Hardware connection diagram

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Table 6- 2 List of hardware circuit board plug-in bit numbers and wires

Designator of
Designator of
the connector
Wire Name Wire No. the connector
for the other
for one end
end

Connection line of Main control board to AD

J11 (Main
board ~with JST terminal PHR-10 33100113 J2 (AD board)
control board)
Line length 100mm
Built-in connecting wire ~ with JST terminal Built-in
J24 (Main
VHR-6N and VHR-2N 33100115 switching
control board)
Line length 140mm power supply
Wire line 1 of main control board to
J13
motor-driven board~with JST terminal FC2* J16 (Main
33100116 (Motor-driven
9P control board)
board 2)
Wire length 150mm
Connection wire 2 of main control board to
J13
motor-driven board~with JST terminal FC2*
33100117 J15 (AD board) (Motor-driven
9P
board 1)
Wire length 200mm
Connection line 1 of main control board to
J30 (Main J1 (External
serial port board ~with JST terminal PHR-12 33100120
control board) port board)
Shielded wire length 260mm
Connection wire 2 of main control board to
J21 (Main J3 (External
serial port board ~with JST terminal PHR-12 33100121
control board) port board)
Wire length 260mm
Connection wire of main control board to
connection board~ with 2*17P FC pitch: 2.0 J13 (Main J6 (Connection
33100123
34PIN gray flat cable control board) board)
Wire length 300
Micro switch
Micro switch light connection wire~with JST
J9 (Main control board 1
terminal PHR-8 and PHR-4 33100124
board) Micro switch
Wire length 430mm
board 2

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Designator of
Designator of
the connector
Wire Name Wire No. the connector
for the other
for one end
end

Connection wire of main control board to AD

board ~with JST terminal VHR-2N J4 (Main control
33100134 J1 (AD board)
SVH-41T-P1. 1 board)
Length 80mm
80 fans + wire materials ~ fan model:
AD08024MB257304 with JST terminal
33100136 J23 (AD board) /
(XHR) 2P
With wire length 100mm
FPC flat cable ~ HY180113-14A, 350*6.6mm J10 (Main
33100143 /
12pin, 0.3mm thick on the same surface control board)
Colorimetric PD connecting wire – left ~ with Colorimetric
JST terminal PHR-3/ PHR-4 33100106 J3 (AD board) receiving board
Shielded wire length 200mm 1
Colorimetric PD connecting wire – right ~ Colorimetric
with JST terminal PHR-3/ PHR-4 33100111 J4 (AD board) receiving board
Shielded wire length 410mm 2
Connecting wire of ambient temperature Temperature
J3 (Connection
sensor ~ with JST terminal GHR-05V-S 33100118 sensor small
board)
Wire length 460mm board
Printer connection wire~with JST terminal
J5 (Connection
XHP-5 and XHP-3, XHP-2 33100122 Printer
board)
Wire length 120mm
Screen connecting wire ~ with JST terminal
J2 (Connection Liquid Crystal
PHR-8 33100126
board) Display (LCD)
Wire length 340mm
Hall switch connection wire~with JST
J7 (Connection Holl sensor
terminal PHR-6 and PHR-4 33100130
board) small board
Wire length 600mm
Horn~UGS5008-01WC260-02 Outlet length
J4 (Connection
260mm with JST (PHR) 2P connecting 32300059 Horn
board)
terminals

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Designator of
Designator of
the connector
Wire Name Wire No. the connector
for the other
for one end
end

Horizontal optocoupler wire -left front ~ with J12

JST terminal PHR-4 32400088 (Motor-driven /
Wire length 580mm board 1)
Horizontal optocoupler wire -right front ~
J6 (Motor-driven
with JST terminal PHR-4 32400090 /
board 1)
Wire length 310mm
Horizontal optocoupler wire - rear left ~ with J10
JST terminal PHR-4 32400093 (Motor-driven /
Wire length 380mm board 1)
Horizontal optocoupler wire - rear right ~
J4 (Motor-driven
with JST terminal PHR-4 32400094 /
board 1)
Wire length 170mm
The connecting wire of silicone heater
Temperature
temperature sensor - left ~ with JST terminal
33100127 J22 (AD board) sensor small
GHR-05V-S
board
Wire length 600mm
The connecting wire of the Silicone heater
Temperature
temperature sensor - right ~ with JST terminal
33100128 J24 (AD board) sensor small
GHR-05V-S
board
Wire length 650mm
Horizontal screw rod motor – J11
left~17E2105W4-245.8SSSN-001 30600074 (Motor-driven /
Wire length 280mm board 1)
Horizontal screw rod motor – right
J5 (Motor-driven
~17E2105W4-245.8SSSN-003 30600075 /
board 1)
Wire length 240mm
Vertical optocoupler wire– right ~ with JST
J2 (Motor-driven
terminal PHR-4 32400086 /
board 1)
Wire length 180mm

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Designator of
Designator of
the connector
Wire Name Wire No. the connector
for the other
for one end
end

Vertical optocoupler wire–left ~ with JST

J8 (Motor-driven
terminal PHR-4 32400089 /
board 1)
Wire length 320mm
Vertical screw rod motor –left ~
J9 (Motor-driven
17E2105Q4-87.8SSSN-001 30600072 /
board 1)
Wire length 290mm
Vertical screw rod motor –right ~
J3 (Motor-driven
17E2105Q4-87.8SSSN-003 30600073 /
board 1)
Wire length 160mm
Fluorescence PD connecting wire – left ~ Fluorescence
with JST terminal PHR-3 33100102 J5 (AD board) receiving board
Shielded wire length 150mm 1
HbA1c PD connecting wire – left ~ with JST HbA1c
terminal PHR-3 33100103 J7 (AD board) receiving board
Shielded wire length 100mm -left J2
HbA1c light source connecting wire – left ~ HbA1c
with JST terminal PHR-8 33100104 J17 (AD board) receiving board
Wire length 100mm -left J1
Fluorescence light path connecting wire – left Fluorescence
~ with JST terminal PHR-4 and PHR-2 33100105 J15 (AD board) light source
Wire length 180mm board
HbA1c PD connecting wire – right ~ with HbA1c
JST terminal PHR-3 33100107 J8 (AD board) receiving board
Shielded wire length 260mm right J2
HbA1c light source connecting wire – right ~ HbA1c
with JST terminal PHR-8 33100108 J18 (AD board) receiving board
Wire length 260mm right J1
Fluorescence PD connecting wire – right ~ Fluorescence
with JST terminal PHR-3 33100109 J6 (AD board) receiving board
Shielded wire length 260mm 2

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Designator of
Designator of
the connector
Wire Name Wire No. the connector
for the other
for one end
end

Fluorescence light path connecting wire – Fluorescence

right ~ with JST terminal PHR-4 and PHR-2 33100110 J16 (AD board) light source
Wire length 280mm board
Barcode scanning
J5 (Motor-driven
motor~17H2030-50-4AT-001 30600076 /
board 2)
Wire length 430mm
Barcode scanning optocoupler wire–left ~
J6 (Motor-driven
JST terminal PHR-4 32400091 /
board 2)
Wire length 340mm
Optocoupler wire of filter-wheel ~ with JST
J2 (Motor-driven
terminal PHR-4 32400092 /
board 2)
Wire length 500mm
Filter-wheel motor~14H2028-50-4AT-001 J3 (Motor-driven
30600077 /
Wire length 480mm board 2)
Halogen light-diameter 35.0* length 34.5mm 30700019 J11 (AD board) /

5.7 Circuit board function

5.7.1 Control structure of complete machine

The entire hardware system of the portable full-automatic multi-function Analyzer comprises

three units: the main control unit, an analog unit, and a motor-driven unit. Among them, The main

control unit is composed of main control board power module, master control MCU module, LCD

module, indication module, printer module, barcode scanning module, storage module, interface

module, WiFi module, lid state test module, TIP detetion module, ambient temperature test module

and voice control module; The analog unit is composed of AD board power module, analog MCU

module, LED driving module, photoelectric conversion module and temperature control module, in

which the power module provides various working power sources for the entire system; the master

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MCU unit processes the human-computer interaction information, processes various kinds of

businesses, controls the work of the entire system and sends the commands to the analog MCU; the

analog MCU unit is responsible for receiving the commands from the master MCU and performs

the constant temperature incubation function to make the reactant constant at 37℃±0.5℃; controls

the light source current, acquires analog data and uploads them to the master control MCU; the

LCD module provides the human-computer interaction interface and displays the test results; the

indicator module provides such functions as test indicator and alarm indicator; the printing module

prints the test results; the kit in-position test module recognizes the status of gate switch; the TIP

test module recognizes the status of TIP; the barcode scanner module recognizes the barcode and

the sample barcode on the kit and records the barcode information; the storage module saves the

test data for subsequent query; the interface module includes dual USB ports, Ethernet ports, serial

ports ; USB2.0 is used for software upgrades of the Analyzer and data import and export; RS232

and Ethernet ports are used to interconnect with LIS/HIS and upload test data; since WiFi module

use the data transparent transmission mode, the software is simple and easy to use; the ambient

temperature test module is responsible for testing the surrounding ambient temperature, the system

displays the ambient temperature abnormal if the ambient temperature is higher than 30℃; the LED

drive module provides light source excitation for the entire system, which needs to keep the light

source constant; the photoelectric conversion module converts the light intensity signal into

electrical signal, amplifies and digitizes it, which is the core of the entire system; the temperature

control module includes three parts including heating, fan and temperature test; with the adoption

of PID algorithm, it can make the temperature to slightly fluctuates between the preset range by

adjusting PID parameters, so as to ensure that the temperature of the reactant is constant at 37°C ±

0.5°C without being affected by the external temperature; the motor-driven unit will performs the

functions such as delivering the kit, breaking the holes, uncapping, mixing, rotating light filtering

wheel and moving scanning head; the position photocopier monitors the operating position of each

motor, feeds them back to the master control for position adjustment.

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5.7.2 Main control board core board function

The main functions implemented by the main control board and the core board are:
Communicate through the external port board and the outer PC, transmit the data and
control the commands, communicate with the AD board and send the data, provide
peripheral ports such as WIFI, network port, and USB port; printer serial communication
control, scanning head communication and control, voice module function, a storage
module and LCD communication.

5.7.3 Motor-driven board function

The system provides 8-way stepping motor drivers: 2-way horizontal motors which control reagent
injection independently so as to improve the transmission accuracy and save space, and adopt the
mode of screw rod drive; two-way vertical hole-broken motors are mainly responsible for breaking
the holes and feeding samples; the sample-feeding system adopts the sample-feeding method of the
NPI013-ACR project, which connects the plunger pump and the TIP uncap rod and the TIP through
the pipeline; two-way plunger pump motors with a range of 1mm; The barcode scanning control
motor and TIP head drive motor are shared units. In terms of design, when the scanning head moves
directly above the QR code, the movable baffle of the retracting TIP head is just held up to achieve
the purpose of retracting the TIP head.
one-way sfilter-wheel uses the design that the filter-wheel is driven directly through the rotation
of motor and the initial value is fixed by the optocoupler baffle.

The motor-driven chip selected as TMC5041 is an integrated motion controller with an SPI

interface and has a controller/driver with two 2-phase bipolar stepping motors. The system is divided

into two motor-driven boards, and there are totally eight TMC5041 motor-driven chips, each of which

drives eight motors. Each motor is located in the first channel of TMC5041, so each motor has a

feedback message for stop status. The FPGA control mode for each TMC5041 is the same. For each

TMC5041, FPGA needs to be completed:

1. Perform the power-on initialization configuration for eight motor-driven chips, and complete

the initialization configuration for such parameters as mode, current, speed, and acceleration;

2. When MCU sends a certain motor's startup and running parameters to FPGA, FPGA needs to

initiate a running operation. First, it needs reading back the current position of the motor and adding

/subtracting the data of its current position to be operated; such data shall be sent to the corresponding

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register of the chip to complete the operation of fixed steps;

3. When the optical coupler limit is used and the motor reaches the optical coupler's position, the

motor is required to stop immediately. When the MCU wants to obtain the status information on the

optical coupler, the FPGA needs to read the status register inside the chip and feed the information on

the optical coupler back to the MCU;

4. Each chip needs to send the feedback information on the stop state of the channel one motor to

FPGA, and MCU obtains this information by reading the register.

5. It is necessary to support the calibration function of motor running stroke, mainly for

horizontal motors; FPGA may achieve the stroke calibration of each motor. The upper computer

controls the motor to run to the two positions of the stroke, and the FPGA reads the absolute position

of each position separately. After calculation, the actual number of steps of the motor is obtained, and

the stroke calibration of the system can be carried out through this parameter.

The configuration of each driver chip is realized through a state machine, which is divided into
an initialization state machine and a standard working state machine. The two state machines are
executed serially. After the FPGA is powered on and initialized, conduct the initialization state
machine and enter the standard working state machine.

5.7.4 AD board function

The AD board achieves such functions as signal conditioning and AD acquisition of the
photoelectric signal from the front-end receiving board. After the front-end receiving board transmits
or reflects the reaction cup, the monochromatic light signals of different wavelengths can be
converted into voltage signals. After being filtered and amplified by the AD board, those photoelectric
colorimetric signals, reflection signals, and fluorescent signals will enter the input terminal of the AD
converter. At the same time, the AD board receives the control signal of a main control board and
sends the AD value that can reflect the intensity of light to the main control board. In addition, the AD
board is also responsible for providing power supply to the front-end receiving board, conducting the
real-time temperature test for both channels, providing power supply to two silicone heaters, the
halogen light, and the fans, and performing the control function.

5.7.5 HbA1c receiving board function

The HbA1c receiving board realizes the power supply to the HbA1c LED lamp. The PD receives

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 HANSA MEDICAL GERMANY GmbH

the photoelectric signal, converts the current signal into a voltage signal, and then sends the converted
voltage signal to the AD board for processing.

5.7.6 Fluorescence light source receiving board function

The fluorescent light source board realizes the functions of supplying power to the fluorescent
LED lamp and lighting the LED light; the fluorescent receiving board realizes the conversion of the
photocurrent signal into a voltage signal through the PD and sends the converted voltage signal to the
AD board for processing.

5.7.7 Colorimetric receiving board function

The colorimetric receiving board can receive the photoelectric signal, convert the current signal
into a voltage signal, and then send the converted voltage signal to the AD board for processing. There
are totally three magnifications and seven different wavelengths of light.

5.7.8 Temperature sensor board function

The temperature sensor board can realize the real-time collection function of temperature. The
circuit board can be connected to the MCU through I2C interface, thus transmitting the temperature to
the MCU in real-time.

5.7.9 Hall sensor board function

The Hall sensor board realizes the test of Lid ON/OFF by means of the Hall sensor, and the
changes in electrical level will be transmitted to MCU via IO port.

5.7.10 Micro switch board function

The micro switch board tests whether the TIP is present via the micro-switch, and the changes in
electrical level will be transmitted to the MCU via the IO port.

5.7.11 Connection board

The connection board mainly achieves the signals' relay and is also designed for standard and
beautiful wiring.

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 HANSA MEDICAL GERMANY GmbH

5.8 Power supply module

The power module of the portable full-automatic multi-function Analyzer is the selected Mean
Well’s RPS-200-24-C medical switching power supply, whose input voltage range ranges from 80 to
264VAC and frequency range from 47 to 63Hz, and which has overload, overvoltage, and
over-temperature protection functions. The output voltage is 24VDC to the main control board, the
AD board and the motor-driven boards.

5.8.1 Basic performance index description

6.8.1.1 Input
AC input voltage: 80V~264VAC
AC voltage frequency: 47~63Hz
AC current: 2A/115VAC 1A/230VAC

6.8.1.2 Output voltage-board power supply

The output voltage of the switch power supply is 24VDC; the maximum output current is 5.9A
under the natural air cooling condition, the maximum input current is 8.4A in case of fan cooling, and
the voltage adjustment range: 22.8V to 25.2V.

6.8.1.3 VCC_12V Output-LCD screen voltage

Output voltage range: 11.4~12.6VV
Maximum output current: 300mA

6.8.1.4 +5V output-printer, core board power supply

Maximum output current: 3A
Output voltage range: 4.75～5.25V

6.8.1.6 +3.3V output-main control board

Maximum output current: 3A
Output voltage range: 3.24～3.36V

6.8.1.7 VDD_12V output-power supply for AD board silicone heater

Maximum output current: 3A

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 HANSA MEDICAL GERMANY GmbH

Output voltage range: 11.4～12.6V

6.8.1.8 + LAMP output - power supply for AD board halogen light

Maximum output current: 2.5A
Output voltage range: 11.9～12.1V

6.8.1.9 +6.5V output - power supply for AD board fluorescent and HbA1c
LED light
Maximum output current: 3A
Output voltage range: 6.18～6.83V

6.8.1.10 VDD_5V output- power supply for the analog circuit of the AD board
Output rated current: 800m A
Output voltage range: 4.75～5.25V

6.8.1.11 VDD_3.3V output- power supply for the MCU of the AD board
Maximum output current: 800mA,
Output voltage range: 3.24～3.36V

6.8.1.12 VDD_3.3V output- power supply for the driver chip of the
motor-driven board
Maximum output current: 3A,
Output voltage range: 3.24～3.36V

6.8.1.13 +3.3V output-printer, core board power supply

Maximum output current: 3A,
Output voltage range: 3.24～3.36V

6.8.1.14 +2.5V output-printer, core board power supply

Maximum output current: 300mA,
Output voltage range: 2.45～2.55V

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 HANSA MEDICAL GERMANY GmbH

6.8.1.15 +1.2V output-printer, core board power supply

Maximum output current: 3A,
Output voltage range: 1.176～1.224V

5.8.2 Electrical insulation diagram

Figure 5-7 Electrical insulation diagram

Table 6- 3 Electrical insulation

Reference Creepage Electric
S/ Insulatio Testing
voltage distance clearance Insulation parts
N n Type voltage (V)
(V) (mm) (mm)
Between primary and
A DI/RI AC220 AC2220 3.0 3.0 secondary AC-DC power
modules
Between the power cord N
B DI/RI AC220 AC2220 6.0 3.0
and the outer shell

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 HANSA MEDICAL GERMANY GmbH

5.9 Board indicator light description

Table 6- 4 Board indicator light description
Indicator light board
Indicator light ON Indicator light OFF Indicator light flashes
identification

Main control board (20200141)

+5V power supply works +5V power supply works +5V power supply works
LED9_5V
normally abnormally abnormally
+12V power supply works +12V power supply works +12V power supply works
LED10_+12V
normally abnormally abnormally
WIFI module works WIFI module works WIFI module works
D25
normally abnormally abnormally
Core board (20200127)
+3.3V power supply works +3.3V power supply works +3.3V power supply works
LED3_+3.3V
normally abnormally abnormally
LED2 MCU works abnormally MCU works abnormally MCU works normally

LED1 FPGA works abnormally FPGA works abnormally FPGA works normally

AD board (20200128)
6.5V power supply works 6.5V power supply works 6.5V power supply works
LED3_+6.5V
normally abnormally abnormally
12V power supply works 12V power supply works 12V power supply works
LED7_12V
normally abnormally abnormally
The fan power supply is The fan power supply is The fan power supply is
LED9
normal abnormal abnormal
LED8 Reserve Reserve Reserve
Silicone heater 1 is heated Silicone heater 1 is not Silicone heater 1 is heated
LED4
continuously heated intermittently
Silicone heater 2 is heated Silicone heater 2 is not Silicone heater 2 is heated
LED5
continuously heated intermittently
LED1 MCU works abnormally MCU works abnormally MCU works normally
The indicator light flashes
LED2 / /
during data acquisition
Indicator light board (20200139)
The yellow light is always
The green light is always on The green light flashes The red light is always on
on
System temperature does not
The channel is idle and can be The machine is faulty and
Testing in progress reach the required value,
tested cannot be tested
heating......

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 HANSA MEDICAL GERMANY GmbH

Figure 6- 8 Schematic diagram of the main control board (the position of the indicator light on the circuit board has been marked with a solid blue line)

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 HANSA MEDICAL GERMANY GmbH

Figure 6- 9 Schematic diagram of the core board (the position of the indicator light on the circuit board has been marked with solid
blue lines)

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 HANSA MEDICAL GERMANY GmbH

Figure 6- 10
The schematic diagram of the AD board (the location of the indicator light on the board has been marked with a solid blue line)

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 HANSA MEDICAL GERMANY GmbH

6 Troubleshooting

This chapter has listed the warning messages of the system as well as the corresponding

measures. Please take corresponding measures in time according to the provided measures When a

fault or error occurs, the system will give a warning or error message and automatically deal with

it accordingly.

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1、 Click the “Clear” button on the detailed list
page;
2、 Restart the Analyzer
3、 Check whether the data lines of the main
control board and the AD board are effectively
connected;
4、 Check whether the AD board is powered on
The AD
and runs normally, and observe the LED
board
indicator;
AD board AD board failed to
is communication E11-N transmit or 5、 Export all test data, quality control data, and
abnormal failure receive the system parameters with the customer's consent,
and then replace the core board. After
signal
value. confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; Please complete the data
registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
6、 Replace the main control board；
7、 Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1、 Click the “Clear” button on the detailed list
page;
2、 Please restart the Analyzer;
3、 Export all test data, quality control data, and
system parameters with the customer's consent,
Error in
and then replace the core board. After
AD board AD board reading or
confirming that the fault is resolved, enter the
is EEPROM E12-N writing
system parameters into the Analyzer again and
abnormal failure EEPROM
save them; Please complete the data
data.
registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
4、 Replace the main control board；
5、 Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.
You can follow the procedure below to troubleshoot
step by step:
1、 Click the “Clear” button on the detailed list
page;
2、 Please restart the Analyzer;
Failed to 3、 Replace the main control board；
set PD 4、 Export all test data, quality control data, and
AD board signal system parameters with the customer's consent,
AD board
digital amplificati and then replace the core board. After
is E13-N
potentiometer on digital confirming that the fault is resolved, enter the
abnormal
failure potential system parameters into the Analyzer again and
parameters save them; Please complete the data
. registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
5、 Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1、 Click the “Clear” button on the detailed list
page;
2、 Please restart the Analyzer;
3、 Replace the original temperature sensor board
with the confirmed temperature sensor board;
Communic restart the Analyzer;
ation 4、 Replace the connection board
failed and 5、 Replace the main control board；
Abnormal Failed to obtain
the 6、 Export all test data, quality control data, and
temperatur ambient E21-N
ambient system parameters with the customer's consent,
e temperature
temperatur and then replace the core board. After
e could not confirming that the fault is resolved, enter the
be read. system parameters into the Analyzer again and
save them; please complete the data
registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
7、 Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.
You can follow the procedure below to troubleshoot
step by step:
1、 Pay attention to control the ambient
temperature so that it is within 15-30℃, and
then click the “Clear” button in the detailed list
page;
2、 Connect the well-confirmed temperature
sensor small board to the Analyzer and restart
the Analyzer;
The 3、 Replace the connection board
Abnormal Ambient ambient 4、 Replace the main control board；
temperatur temperature is E22-N temperatur 5、 Export all test data, quality control data, and
e low e is below system parameters with the customer's consent,
15°C. and then replace the core board. After
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the data
registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
6、 Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Pay attention to control the ambient temperature
so that it is within 15-30℃, and then click the
“Clear” button in the detailed list page;
2. Connect the well-confirmed temperature sensor
to the Analyzer and restart the Analyzer;
3. Replace the connection board
The 4. Replace the main control board；
Abnormal ambient 5. Export all test data, quality control data, and
High ambient
temperatur E23-N temperatur system parameters with the customer's consent,
temperature
e e is higher and then replace the core board. After
than 30°C. confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the data
registration before re-debugging only
according to the Debugging Parameter Record
Form to be completed.
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. After the reagent kit for this channel is tested,
click the “Clear” button on the detailed list
page;
2. Restart;
3. Connect the confirmed temperature sensor small
board to the corresponding interface on the AD
boardcircuit board, put the temperature sensor
chip close to the reagent cartridge holder, and
restart the Analyzer. If it is determined that the
Incubation original temperature sensor small board is
temperatur faulty, replace the temperature sensor board;
e <36. 5℃ 4. Check whether the silica gel patch of the
Abnormal Abnormal
or the corresponding channel is close to the reagent
temperatur incubation E24-N
incubation cartridge holder;
e temperature
temperatur 5. Replace the silica gel heating film;
e>37. 6. Export all test data, quality control data, and
5℃。 system parameters with the customer's consent,
and then replace the core board. After
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to complete the data registration before
re-debugging;
7. Replace the main control board；
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Please confirm whether the bin gate can be
closed normally; after the bin gate is closed,
The stray click the “Clear” button on the detailed list
light page;
signal 2. Check whether there is external light source
value of entering;
the 3. Please restart the device;
The stray light
colorimetri 4. Export all test data, quality control data, and
Light path of colorimetric
c optical system parameters with the customer's consent,
abnormalit optical path of E31-C-N and then replace the core board. After
path
y channel is too confirming that the fault is resolved, enter the
exceeds
large system parameters into the Analyzer again and
the
standard save them; please complete the "Debugging
during the Parameter Record Form" as required; it is ok
startup only to complete the data registration before
self-test. re-debugging;
5. Replace the main control board；
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.
You can follow the procedure below to troubleshoot
step by step:
1. Please confirm whether the bin gate can be
closed normally, make sure whether no reagent
cartridges are placed on the reagent cartridge
The stray holders, and click the "Clear" button on the
light
detailed list page;
signal
2. Restart;
value of 3. Check whether there is external light source
the
The stray light entering.
fluorescent
Light path of fluorescence 4. Export all test data, quality control data, and
optical system parameters with the customer's consent,
abnormalit light path of E32-C-N
path and then replace the core board. After
y channel C is too
exceeds confirming that the fault is resolved, enter the
large.
the system parameters into the Analyzer again and
standard save them; please complete the "Debugging
during the Parameter Record Form" as required; it is ok
startup only to complete the data registration before
self-test. re-debugging;
5. Replace the main control board；
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Click the “Clear” button on the detailed list
page;
2. Restart;
3. Observe whether the halogen light can be lit. If
not, please check whether the power supply of
The the halogen light is standard;
service 4. Enter the 546 wavelengths optical debugging
time of interface in the maintenance interface to test the
halogen air signal value strength of the two channels. If
The attenuation light the signal value is less than 30,000, replace the
Light path of channel C exceeds its halogen light according to the halogen light
abnormalit colorimetric E33-C-N service life replacement process;
y light source is or the 5. Export all test data, quality control data, and
too large power system parameters with the customer's consent,
supply of and then replace the core board. After
halogen confirming that the fault is resolved, enter the
light is system parameters into the Analyzer again and
abnormal. save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to complete the data registration before
re-debugging;
6. Replace the main control board；
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Click the “Clear” button on the detailed list
page;
2. Restart;
3. Check whether the bin gate is opened and closed
normally;
The signal 4. Check whether there is external light source
value of entering;
the 5. Check whether the colorimetric light source is
colorimetri
Abnormal ON;
Light path c optical 6. Export all test data, quality control data, and
colorimetric
abnormalit E34-C-N path is system parameters with the customer's consent,
signal of
y abnormal and then replace the core board. After
channel C
in the
confirming that the fault is resolved, enter the
startup
system parameters into the Analyzer again and
self-test
save them; please complete the "Debugging
course. Parameter Record Form" as required; it is ok
only to complete the data registration before
re-debugging;
7. Replace the main control board；
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.
You can follow the procedure below to troubleshoot
step by step:
1. Click the “Clear” button on the detailed list
page;
2. Restart;
3. Check whether the horizontal motor operates
normally;
4. Check whether there is external light source
In the
entering;
startup 5. Check whether the reflective light source light is
self-test on;
Light path Abnormal course, the 6. Export all test data, quality control data, and
abnormalit reflection signal E35-C-N reflection system parameters with the customer's consent,
y of channel C optical and then replace the core board. After
path signal confirming that the fault is resolved, enter the
value is system parameters into the Analyzer again and
abnormal. save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to complete the data registration before
re-debugging;
7. Replace the main control board；
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as needed.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Please confirm whether the lid of the test
channel can be normally closed, ensure that
there are no reagent cartridges on the reagent
cartridge holder, and touch the [Clear] button
In the
on the error list interface;
startup
2. Restart the AnalyzerRestart the Analyzer;
self-test
3. Check whether there is external light source
course, the
entering;
Too much stray stray light
4. Check whether the horizontal motor operates
Light path light in the signal
normally;
abnormalit reflection light E36-C-N value of
5. Export all test data, quality control data, and
y path of test the optical
system parameters with the customer's consent,
channel C reflection
and then replace the core board. After
path has
confirming that the fault is resolved, enter the
exceeded
system parameters into the Analyzer again and
the
save them; please complete the "Debugging
standard.
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Please confirm whether the lid of the test
channel can be normally closed, ensure that
there are no reagent cartridges on the reagent
cartridge holder, and touch the [Clear] button
on the error list interface;
In the 2. Restart the AnalyzerRestart the Analyzer;
startup 3. Check whether there is external light source
Abnormal self-test entering;
Light path
fluorescence course, the 4. Export all test data, quality control data, and
abnormalit E37-C-N
signal in test fluorescen system sparameters with the customer's
y
channel C ce signal consent, and then replace the core board. After
value is confirming that the fault is resolved, enter the
abnormal. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 88 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Use the same batch of the same type of kit and
retest once.
3. Use a different batch of the same type of kit and
retest once.
The signal value
Light path The signal 4. Export all test data, quality control data, and
of channel C is
abnormalit E38-C-N value is system parameters with the customer's consent,
abnormal. This
y unstable. and then replace the core board. After
test is invalid
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the Analyzer;
The
3. Enter the motor self-check function test to
movement
confirm whether it can be restored;
of the
4. Check whether the connecting wire between the
horizontal
motor and the inner optical coupler is effective.
mechanis
Horizontal Please replace the wire materials due to the
m running
Motor motor reason of wire materials
to the
abnormalit malfunction in E41-C-N 5. Replace the corresponding motor drive board;
inner
y test channel C 6. Export all test data, quality control data, and
optical
-Interior system parameters with the customer's consent,
coupler
and then replace the core board. After
position is
confirming that the fault is resolved, enter the
not
system parameters into the Analyzer again and
effectively
save them; please complete the "Debugging
tested.
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
7. Replace the master control board;
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 89 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the AnalyzerRestart the Analyzer;
The
3. Enter the motor self-check function test to
movement
confirm whether it can be restored;
of the
4. Check whether the connecting wire between the
horizontal
motor and the outer optical coupler is effective.
mechanis
Horizontal Please replace the wire materials due to the
m running
Motor motor reason of wire materials
to the
abnormalit malfunction in E42-C-N 5. Replace the corresponding motor drive board;
outer
y test channel C 6. Export all test data, quality control data, and
optical
-exterior system parameters with the customer's consent,
coupler
and then replace the core board. After
position is
confirming that the fault is resolved, enter the
not
system parameters into the Analyzer again and
effectively
save them; please complete the "Debugging
tested.
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
7. Replace the master control board;
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
The
list interface;
movement
2. Restart the AnalyzerRestart the Analyzer;
of the
3. Enter the motor self-check function test to
vertical
confirm whether it can be restored;
mechanis
4. Replace the corresponding motor drive board;
m running
Motor Uncap motor 5. Export all test data, quality control data, and
to the
abnormalit malfunction in E43-C-N system parameters with the customer's consent,
designated
y test channel C and then replace the core board. After
optical
confirming that the fault is resolved, enter the
coupler
system parameters into the Analyzer again and
position is
save them; please complete the "Debugging
not
Parameter Record Form" as required; it is ok
effectively
only to recordthe data before re-debugging;
tested.
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

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 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
The
interfaceTouch the [Clear] button on the error
suction
list interface;
and
2. Restart the AnalyzerRestart the Analyzer;
discharge
3. Enter the motor self-check function test to
mechanis
confirm whether it can be restored.
m
4. Replace the corresponding motor drive board;
movement
Motor Pump motor 5. Export all test data, quality control data, and
running to
abnormalit malfunction in E44-C-N system parameters with the customer's consent,
the
y test channel C and then replace the core board. After
designated
confirming that the fault is resolved, enter the
optical
system parameters into the Analyzer again and
coupler
save them; please complete the "Debugging
position is
Parameter Record Form" as required; it is ok
not
only to recordthe data before re-debugging;
effectively
6. Replace the master control board;
tested.
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
The
list interface;
movement
2. Restart the AnalyzerRestart the Analyzer;
of the code
3. Enter the motor self-check function test to
scanning
confirm whether it can be restored.
mechanis
4. Replace the corresponding motor drive board;
m running
Motor Code scanning 5. Export all test data, quality control data, and
to the
abnormalit module E45-N system parameters with the customer's consent,
designated
y malfunction and then replace the core board. After
optical
confirming that the fault is resolved, enter the
coupler
system parameters into the Analyzer again and
position is
save them; please complete the "Debugging
not
Parameter Record Form" as required; it is ok
effectively
only to recordthe data before re-debugging;
tested.
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 91 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
The interfaceTouch the [Clear] button on the error
movement list interface;
of the 2. Restart the AnalyzerRestart the Analyzer;
spectro-wh 3. Enter the motor self-check function test to
eel confirm whether it can be restored;
mechanis 4. Replace the corresponding motor drive board;
Motor Filter wheel m running 5. Export all test data, quality control data, and
abnormalit motor E46-N to the system parameters with the customer's consent,
y malfunction designated and then replace the core board. After
optical confirming that the fault is resolved, enter the
coupler system parameters into the Analyzer again and
position is save them; please complete the "Debugging
not Parameter Record Form" as required; it is ok
effectively only to recordthe data before re-debugging;
tested. 6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the AnalyzerRestart the Analyzer;
3. Check whether the server can be connected;
4. Whether the current Analyzer's communication
LAN or mode can be connected to the Internet or not.
WIFI 5. Replace the master control board;
communic Network
E52 communic 6. Export all test data, quality control data, and
ation error anomaly
ation is system parameters with the customer's consent,
failed. and then replace the core board. After
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging.
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 92 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the AnalyzerRestart the Analyzer;
3. Check whether the server can be connected;
4. Check whether the configured IP and port are
correct;
Failed to 5. Replace the master control board;
communic
Server error E53 connect to 6. Export all test data, quality control data, and
ation error
the server. system parameters with the customer's consent,
and then replace the core board. After
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the Analyzer ;
The SN
3. Supplementary input;
code of the
4. Export all test data, quality control data, and
Analyzer
system parameters with the customer's consent,
communic Analyzer has is not set,
E54 and then replace the core board. After
ation error no SN code or the SN
confirming that the fault is resolved, enter the
code
system parameters into the Analyzer again and
cannot be
save them; please complete the "Debugging
read.
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 93 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interfaceTouch the [Clear] button on the error
list interface;
2. Restart the Analyzer;
3. Wait till other data processing is completed and
There is perform data transmission again;
data being 4. Export all test data, quality control data, and
The current
communic uploaded system parameters with the customer's consent,
communication E55
ation error or and then replace the core board. After
line is busy
downloade confirming that the fault is resolved, enter the
d. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Confirm that the Analyzer is inserted into the U
disk, and then touch the [Clear] button on the
error list interface;
2. Restart the Analyzer;
3. Check whether the inserted USB flash drive can
read and write data.
Data 4. Export all test data, quality control data, and
communic cannot be system parameters with the customer's consent,
Exportion error E56
ation error exported and then replace the core board. After
to U disk. confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 94 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interface;
2. Check whether the printer indicator light is on;
3. Restart the Analyzer;
4. Export all test data, quality control data, and
Printer system parameters with the customer's consent,
Printer
Printer communic and then replace the core board. After
communication E61
error ation confirming that the fault is resolved, enter the
error
failure. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
5. Replace the master control board;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. The printer confirms that the paper is placed in
the printer, touch the [Clear] button on the
error list interface;
2. Restart the Analyzer;
3. Export all test data, quality control data, and
No print system parameters with the customer's consent,
Printer Printer is out of paper is and then replace the core board. After
E62
error paper detected in confirming that the fault is resolved, enter the
the printer. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
4. Replace the master control board;
5. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 95 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Check whether the lid is stuck, and touch the
[Clear] button on the error list interface;
2. Check whether the lid magnet is normal
3. Restart the Analyzer;
4. Replace the small board of Hall sensor;
It is tested 5. Export all test data, quality control data, and
The lid of test
Lid that the lid system parameters with the customer's consent,
channel C
abnormalit E71-C-N is not and then replace the core board. After
cannot be
y opened confirming that the fault is resolved, enter the
opened normally
normally. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Check whether the lid is stuck, and touch the
[Clear] button on the error list interface;
2. Check whether the lid magnet is normal
3. Restart the Analyzer;
4. Replace the small board of Hall sensor;
It is tested 5. Export all test data, quality control data, and
The lid of test
Lid that the lid system parameters with the customer's consent,
channel C
abnormalit E72-C-N is not and then replace the core board. After
cannot be closed
y closed confirming that the fault is resolved, enter the
normally
normally. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 96 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
Check whether the lid is opened lid during the
Analyzer is testing.
1. Observe whether there is any exit action during
the Analyzer is testing;
2. Restart the Analyzer;
During the 3. Check whether the lid magnet is normal
normal 4. Replace the small board of Hall sensor;
The lid of
Lid test, it is 5. Export all test data, quality control data, and
channel C is
abnormalit E73-C-N detected system parameters with the customer's consent,
opened
y that the and then replace the core board. After
abnormally.
lidis confirming that the fault is resolved, enter the
opened. system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Check whether the reagent cartridge is inserted;
2. Check whether the tip is put on the reagent
cartridge;
3. Restart the Analyzer;
4. Replace the micro switch component;
5. Export all test data, quality control data, and
No Tip is
Tip Fail to detect the system parameters with the customer's consent,
placed on
abnormalit tip in test E81-C-N and then replace the core board. After
the reagent
y channel C confirming that the fault is resolved, enter the
cartridge.
system parameters into the Analyzer again and
save them; please complete the "Debugging
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
6. Replace the master control board;
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 97 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Please confirm that the reagent cartridge has
been correctly inserted into the reagent
cartridge holder, and then touch the [Clear]
button on the error list interface;
2. Use a new reagent cartridge for testing;
3. If it is confirmed that the tipis notfetched,
recalibrate the horizontal and vertical position.
The
If the tipis tetcheded, but the fault is falsely
tiphas not
Tip reported, with the customer's consent, export
Channel C failed been
abnormalit E82-C-N all the test data, quality control data, and
to fetch the tip fetched
y system parameters, and then replace the core
during
board. After confirming that the fault is
testing.
resolved, enter system parameters into the
Analyzer and save them;Please complete the
Debugging Parameter Record Form as
required,only record the data before
re-debugging;
4. Replace the master control board;
5. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. If after the test ,the tip has not been removed
inside the Analyzer, please put an empty
reagent cartridge into the reagent cartridge
holder and enter the maintenance setting
interface to initialize the channel, or restart the
Analyzer;
The tiphas 2. Replace the corresponding motor drive board;
Tip Fail to not been 3. Export all test data, quality control data, and
abnormalit removetip in test E83-C-N detected system parameters with the customer's consent,
y channel C after the and then replace the core board. After
test. confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; Please complete the Debugging
Parameter Record Form as required, only
record the data before re-debugging;
4. Replace the master control board;
5. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 98 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Touch the [Clear] button on the error list
interface;
2. Restart the Analyzer;
3. Check whether the cable of the scanning head is
broken.
Scanning 4. Replace the master control board;
Code
Code scanning head 5. Export all test data, quality control data, and
scanning
communication E91-N cannot be system parameters with the customer's consent,
abnormalit
error sent and and then replace the core board. After
y
received. confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; Please complete the Debugging
Parameter Record Form as required, only
record the data before re-debugging;
6. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Check whether the QRcode is pasted on the
inserted reagent cartridge and whether the
pastedQR code is stained or in an abnormal
position, and put the reagent cartridge into the
reagent cartridge holder again totest;
2. Start the test, open thechannel lid, and observe
whether the scanning head can light up when
scanning the QR code;
Code QR code 3. Please check again after rebooting;
Barcode
scanning data is not 4. Replace the corresponding motor drive board;
scanning failure E92-C-N
abnormalit recognized 5. Replace the master control board;
in test channel C
y . 6. Export all test data, quality control data, and
system parameters with the customer's consent,
and then replace the core board. After
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; Please complete the Debugging
Parameter Record Form as required, only
record the data before re-debugging.
7. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 99 ) of ( 110 )
 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Replace the reagent cartridge that is shipped
It is within 1 year for testing;
recognized 2. Restart the Analyzer;
that the 3. Export all test data, quality control data, and
Code The reagent reagent system parameters with the customer's consent,
scanning cartridge in test cartridge and then replace the core board. After
E93-C-N
abnormalit channel C has has been confirming that the fault is resolved, enter the
y expired out of the system parameters into the Analyzer again and
factory for save them; Please complete the Debugging
more than Parameter Record Form as required, only
1 year. record the data before re-debugging.
4. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Replace a new reagent cartridge that is not used
to test.
2. Restart the Analyzer;
The 3. Export all test data, quality control data, and
Code The reagent reagent system parameters with the customer's consent,
scanning cartridge in test cartridge and then replace the core board. After
E94-C-N
abnormalit channel C has has an confirming that the fault is resolved, enter the
y been used existing system parameters into the Analyzer again and
test record. save them; Please complete the Debugging
Parameter Record Form as required, only
record the data before re-debugging.
4. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 100 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Please check whether the same batch of quality
control solution is used;
2. Please check whether the quality control
solution or reagent cartridge is contaminated or
damaged
3. Touch the [Clear] button on the error list
interface;
The test
4. Please use the correct control solution and
result of
reagent cartridge to perform quality control
QC
again;
QC failure in exceeds
QC failure E101-C-N 5. Restart the Analyzer;
test channel C the
6. Export all test data, quality control data, and
allowable
system parameters with the customer's consent,
range of
and then replace the core board. After
the level.
confirming that the fault is resolved, enter the
system parameters into the Analyzer again and
save them; Please complete the Debugging
Parameter Record Form as required,only
record the data before re-debugging;
7. Replace the master control board;
8. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Please use the correct control solution and
reagent cartridge to perform quality control
again;
When 2. Export all test data, quality control data, and
The test item the switch system parameters with the customer's consent,
cannot be tested of uality and then replace the core board. After
QC failure in test channel C E102-C-N control confirming that the fault is resolved, enter the
due to QC lock is system parameters into the Analyzer again and
failure on,the QC save them; Please complete the Debugging
fails, Parameter Record Form as required,only
record the data before re-debugging;
3. Replace the master control board;
4. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 101 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
1. Retest 2 times;
2. With the consent of the customer, export all the
test and quality control data, and then reformat
the NANDFLASH;
3. Export all test data, quality control data, and
Data system parameters with the customer's consent,
Fail to
storage NANDFLASH and then replace the core board. After
E111-N read or
abnormalit error confirming that the fault is resolved, enter the
write data
y system parameters into the Analyzer again and
save them; Please complete the Debugging
Parameter Record Form as required,only
record the data before re-debugging;
4. Replace the master control board;
5. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.
You can follow the procedure below to troubleshoot
step by step:
1. Retest 2 times;
2. Export all test data, quality control data, and
system parameters with the customer's consent,
and then replace the core board. After
Data
Fail to confirming that the fault is resolved, enter the
storage
EEPROM error E112-Nsss read or system parameters into the Analyzer again and
abnormalit
write data. save them; Please complete the Debugging
y
Parameter Record Form as required,only
record the data before re-debugging;
3. Replace the master control board;sss
4. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Page ( 102 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

Fault
Detailed fault
name in Fault Cause
name in fault After-sales processing method
pop-up Code Analysis
list
window
You can follow the procedure below to troubleshoot
step by step:
8. Please confirm whether the lid of the test
channel can be normally closed, ensure that
there are no reagent cartridges on the reagent
cartridge holder, and touch the [Clear] button
In the
on the error list interface;
startup
9. Restart the AnalyzerRestart the Analyzer;
self-test
10. Check whether there is external light source
course, the
entering;
Too much stray stray light
11. Check whether the horizontal motor operates
light in the signal
communic normally;
reflection light E36-C-N value of
ation error 12. Export all test data, quality control data, and
path of test the optical
system parameters with the customer's consent,
channel C reflection
and then replace the core board. After
path has
confirming that the fault is resolved, enter the
exceeded
system parameters into the Analyzer again and
the
save them; please complete the "Debugging
standard.
Parameter Record Form" as required; it is ok
only to recordthe data before re-debugging;
13. Replace the master control board;
14. Complete the "Maintenance Record Signing
Form" and "Instrument Performance
Confirmation Form" as required.

Remark 1: C represents the ID of test channel; It is used to distinguish different channels

when reporting errors. For test channel 1, C=1; For test channel 2, C=2.

Remark 2: N represents the ID of the instrument, N=0;

Page ( 103 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

7 Maintenance

To ensure that the system has reliable performance, good working conditions, and longevity,

please operate and maintain the system regularly in strict accordance with the requirements of the

Maintenance Manual. It is also essential to understand the maintenance and overhaul knowledge

in this chapter. An in-depth study will enable the Analyzer to achieve the best operating state and

exert the best performance in use.

7.1 Routine maintenance

Proper inspection of the system, the power cord and the probe cable connector is required

before each use.

Cleaning

Warning:

Turn off the analyzer and unplug the power cord before cleaning operation.

Clean the analyzer following the cleaning instruction required by the operator’s institution

whenever necessary.

a) Please put on disposable gloves and other personal protective equipment;

b) Wipe the cartridge holder and the inner side of the lid until they are dry and clean,

using a dry cloth or paper towels;

c) Wipe the exterior shell of the analyzer with soft cloth damped with 75% ethanol
weekly. Please keep the instrument clean.

Note:

Page ( 104 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

1) Do not scrub the screen with water. Clean the screen with a soft, dry
cloth or tissue;
2) Do not immerse the analyzer in liquids;
3) Do not spray alcohol or other liquids on the analyzer directly;
4) Do not allow any liquid to drip into the analyzer.

Disinfection
Disinfect the analyzer following the disinfection instruction required by the operator’s

institution whenever necessary.

Warning:

Turn off the analyzer and unplug the power cord before disinfection.

Operating cautions

1) To ensure the stability and accuracy of the analyzer, please do not place the
analyzer in an environment with high EMI conditions. Ensure that the ambient environment is
well ventilated.
2) Do not move or strike the analyzer when it is running. Do not spill solutions on the
analyzer.
3) Do not insert/pull out the power plug and signal cables when the analyzer is
switched on; Turn off the analyzer and pull out the power supply for long-term storage.
4) The product is precision instrument; please do not disassemble by yourself.

7.2 Periodic inspection

Page ( 105 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

Table 7-1 Periodic inspection

Item Frequency Inspection Purpose

To avoid connecting failure or

Power plug, power
Power Everyday current leakage, which may
outlet, power cord
result in personal injury

Quality Refer to the package

Control Insert of the Test system To avoid inaccurate test results

(QC) corresponding reagent kit

Page ( 106 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

8 Program Upgrade

The Analyzer can provide the program upgrade function. The upgrade is mainly divided into

three modules: the upgrade of master control board, the upgrade of analog board, and the upgrade

of UI interface.

8.1 Master control board Program Upgrade

The steps to upgrade the master control board program are as follows:

1. Put the master control board upgrade folder “Stm32f7_App.bin” under the root directory

of the upgrade U disk;

2. Insert the U disk into the USB port of the Analyzer when the Analyzer is turned off, as

shown in the following figure;

Page ( 107 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

3. Open the Analyzer, and "Mastersoftware upgrading..." will display on the screen after

being opened, as shown in the following figure.

4. Wait till the interface will display "Upgrade Succeed, starting APP", then theAnalyzer

startups which means that the master control board has been upgraded, as shown in the

following figure.

Page ( 108 ) of ( 110 )

 HANSA MEDICAL GERMANY GmbH

8.2 AD Board Program Upgrade

The steps to upgrade the AD board program are as follows:

1. Put the AD board upgrade file "Stm32f4-Ad.bin" under the root directory of the upgrade U

disk;

2. Insert the U disk into the USB interface of the Analyzer to enter the Setting interface of the

Analyzer and then enter the Communication Setting interface, click the 『Upgrade』

button to enter the Upgrade interface, as shown in the following figure;

3. Click the『AD Board Upgradation』button, the text prompt "AD Board Upgrade x/100" will

pop up on the interface, as shown in the following figure.

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 HANSA MEDICAL GERMANY GmbH

4. When the text prompt "AD board upgraded Successfully" appears, it indicates that the AD

board upgrade is completed, as shown in the following figure;

8.3 UI interface upgrade

1. Put the UI interface upgrade folder “DWIN_SET” under the root directory of the upgrade

U disk;

2. Insert the U disk into the USB interface of the Analyzer to enter the Setting interface of the

Analyzer and then enter the Communication Setting interface, click the 『Upgrade』

button to enter the Upgrade interface;

3. Click the 『UI Upgradation』 button, the text prompt "Upgrade xx.bmp" will pop up on the

interface, as shown in the following figure.

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 HANSA MEDICAL GERMANY GmbH

4. When the text prompt " all upgrade successful " appears, it indicates that the UI interface

upgrade is completed, as shown in the following figure;

8.4 Confirm the program vertion

After the program is upgraded, please confirm the Analyzer program version of master

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 HANSA MEDICAL GERMANY GmbH

control board, analog board and UI, then fill carefully in the “Confirmation for Program Upgrade”

in the attachment.

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 HANSA MEDICAL GERMANY GmbH

9 After-sales service record

form

Customer Feedback Form

Dear Customer:
Thank you for your trust and support to our company. To improve continuously the quality
of our company's products and services, perfect our work and provide you with better products
and services, please fill in the following feedback form in your busy schedule. We are eagerly
looking forward to your valuable comments and suggestions on our work, and we would be very
grateful for your opinion. Thank you!
Customer Contact
Name Person

Date Tel:

Project (please mark

Quite
√ below the Satisfaction General Unsatisfactory Remarks
satisfactory
corresponding)
Product quality

After-sales service

What are your requirements and suggestions for products and after-sales services

Signature(stamp)

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 HANSA MEDICAL GERMANY GmbH

Maintenance Record Signing Form

Analyzer No. : Maintenance Staff:

Repair location Repair date

Maintenance
Contact Person
date
Completion
Tel:
Date

Malfunction
phenomenon

Troubleshooting
methods

Remark: 1. If the master control board is replaced, please record the IMEI number
Result of the master control board before and after such replacement;
2. If you replace the core board, please record the data of optical calibration,
mechanical calibration, optical debugging, and temperature calibration before
replacement;
3. If the halogen light is replaced, please record the optical debugging data after the
halogen lamp is replaced;
Name of repaired and replaced
Qty Unit price Total
device
1.
2.
3.
4.
materials
1. Accessories and wires
2.
3.
4.
Total price
Signature of user:

This record is made in duplsicate, one for HANSA MEDICAL GERMANY GmbH and one for the

user.

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 HANSA MEDICAL GERMANY GmbH

Confirmation after program upgrade

Analyzer No. UpgradeOperator: Upgrade date:

Program upgrade information

Master control board

Program type Analog board program  UI interface 
program 
Software version
before upgrade
Software version
after upgrade
Main functions
added or
s
modified after
upgrading
Precautions for
customers after
upgrading

Please follow the steps below to confirm after performing the program upgrade.

S/N Test Item Check Results Remarks

Does the Analyzer report an error when it Error message (if any).
1 Yes No
is started after upgrading? .
Can the Analyzer test normally after
2 Yes No
upgrading?
Can the new function be used
3 Yes No
normally?
Have customers been trained on the Reasons for not training:
4 Yes No
use of the new functions? .

Confirmation conclusion:

Signature of Engineer: Customer signature:

Date: Date:

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 HANSA MEDICAL GERMANY GmbH

Debugging Parameter Record Form

Analyzer No.
Before redebugging After redebugging
Channel 1 Channel 1

Detected Actual Detected Actual

Temperature Temperature
1 1
Temperature Temperature
2 2
Channel 2 Channel 2

Detected Actual Detected Actual

Temperature Temperature Temperature Temperature
Calibration 1 Calibration 1
Temperature Temperature
2 2
Environment temperature Environment temperature

Detected Actual Detected. Actual

Temperature Temperature
1 1
Temperature Temperature
2 2
Light path Items Channel 1 Channel 2 Light path Items Channel 1 Channel 2

Air PD Air PD
Pure
Pure
water
water PD
340 PD 340
Standard Standard
material material
PD PD
Light path Light path
Air PD Air PD
inspection inspection
parameters Pure parameters Pure
water
water PD
405 PD 405
Standard Standard
material material
PD PD
Air PD Air PD
505 Pure 505 Pure
water water PD

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 HANSA MEDICAL GERMANY GmbH

PD

Air PD Air PD
Pure
546 546 Pure
water
water PD
PD
Air PD Air PD
Pure
578 578 Pure
water
water PD
PD
Air PD Air PD
Pure
630 630 Pure
water
water PD
PD
Air PD Air PD
Pure
660 660 Pure
water
water PD
PD
Air PD Air PD
Pure
700 700 Pure
water
water PD
PD
PD PD
Fluorescence Fluorescence
CUR CUR

PD PD
Red Red
Reflection CUR Reflection CUR
Blue Blue
CUR CUR
Horizontal steps Horizontal steps
Mechanical Mechanical
Vertical steps Vertical steps
calibration calibration
HbA1c steps HbA1c steps

Liquid separation-Continuous Liquid separation-Continuous

Channel 1 Channel 2 Channel 1 Channel 2

Plunger
Coefficient value Coefficient value Plunger pump Coefficient value Coefficient value
pump
K1 K1 calibration K1 K1
calibration
K2 K2 K2 K2

K3 K3 K3 K3

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 HANSA MEDICAL GERMANY GmbH

K4 K4 K4 K4

Liquid separation- Single Liquid separation- Single

Channel 1 Channel 2 Channel 1 Channel 2

Coefficient value Coefficient value Coefficient value Coefficient value

K B K B K B K B

Signature of Engineer:

Date:

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