Automatic Chemiluminescence Analyzer

User Manual
Automatic Chemiluminescence
Analyzer User Manual

Read this manual before use and keep it handy

■ Carefully read and understand all instructions and warnings in this

manual.

■ Please keep this manual for future reference.

Revision History

Revision Date Change Description

Initial release 2020-01-16 Initial release

Second release 2021-06-07 Delete the address of facility

1. Add change description

2. Change authorized representative in
Third release 2022-05-07
European Community / Union
3. Change description of content
Product Registration

Product name: Automatic Chemiluminescence Analyzer

Model/Specifications: NP-CL 8

Declaration

Please carefully read and understand these statements:

1. The manual is subject to change without notice.

2. No part of this manual may be copied or reproduced or disclosed to any third
party in any form or by many means without written consent of the Company.
3. In no event will the Company be liable for direct or indirect damages or
damages arising of any use of the product not specified in the manual.
Contents

CHAPTER 1 OVERVIEW 0

1.1 Product Warranties 1

1.2 Use of the Manual 2
1.3 Terminology in the Manual 2
1.3.1 Warnings, Cautions and Notes 2
1.3.2 Pictograms and Meanings of Identifiers 3
1.3.3 Menus, Tabs and Buttons 6
1.3.4 Images about Software Screen 6
1.4 Production Date and Duration 6
1.5 Storage and Shipping Conditions 6
1.6 Disposal 7
1.7 How to Get Help 7
1.8 Vigilance 7

CHAPTER 2 PREVENTIVE MEASURES AND

INSTALLATION INSTRUCTIONS 8

2.1 Safe Use of the System 8

2.1.1 Complying with Warning Labels 9
2.1.2 Preventing Fires and Damages 9
2.1.3 Preventing Electric Shock 10
2.1.4 Avoiding Damages to Other Devices and Facilities 10
2.1.5 Preventing Bodily Injury and Serious Injury 10
2.1.6 Preventing Infection 10
2.1.7 Preventing Water Leaks 11
2.1.8 Computer Operations 11
2.1.9 System Operation Instructions 11
2.1.10 Ensuring Optimal Analysis Performance 11
2.1.11 Implementing Key Inspections During Analysis 11
2.1.12 Handling Reagents, Cleaning Solutions, Calibrators and
Controls 12
2.1.13 Handling Reagents 12
2.1.14 Disposing of Waste Liquid 13
2.1.15 Disposing of Solid Waste 13
2.1.16 EMI and Noise Preventive Measures 13
2.1.17 Parts Replacement and Routine Maintenance 14
2.1.18 Computer Antivirus Protection 14
2.1.19 Cleaning Panel Surface 14
2.2 Installation Instructions 14
2.2.1 Environmental Requirements 15
2.2.2 Power Supply Requirements 15
2.2.3 Electromagnetic Compatibility (EMC) 16
2.2.4 Installation Space Requirements 16
2.2.5 Software Operating Environment 17
2.2.6 Network Security 17

CHAPTER 3 SYSTEM INTRODUCTION

19

3.1 Reaction Principles 19

3.1.1 Sandwich method 20
3.1.2 Competitive method 20
3.1.3 Capture method 21
3.2 Working Principles 21
3.2.1 Instrument Principle 21
3.2.2 Actuator 21
3.2.3 Analysis Procedure 22
3.3 Scope of Application 22
3.4 Hardware System 23

CHAPTER 4 SOFTWARE INTRODUCTION

27

4.1 Software Hierarchy and Function Keys 28

4.1.1 Layout 28
4.1.2 General Menu 35
4.2 Login Interface 35
4.3 Work Interface 36
4.3.1 Test Selection 36
4.3.2 Data Review 37
4.4 Reagent Interface 39
4.4.1 Reagent Status 39
4.4.2 Reagent Information 39
4.4.3 Consumable information 41
4.5 Calibration Interface 41
4.5.1 Calibration Status 41
4.5.2 Calibration Setting 42
4.6 QC Interface 43
4.6.1 QC Status 43
4.6.2 QC Result 44
4.6.3 QC Setting 44
4.7 Utility Interface 45
4.7.1 Assay 45
4.7.2 Maintain 46
4.7.3 System 47

CHAPTER 5 GENERAL OPERATIONS

48

5.1 Working Procedure 49

5.1.1 Sample Working Procedure 49
5.1.2 Calibrator Working Procedure 49
5.1.3 Control Working Procedure 50
5.2 Preparation Before Startup 50
5.3 Startup 51
5.4 Checking and Preparing Reagents 51
5.4.1 Checking Reagent Amount and Reagent Status 51
5.4.2 Loading & Unloading Reagents 52
5.5 Checking Consumable Status 53
5.5.1 Checking Consumable Status 53
5.5.2 Replacing Consumables 54
5.6 Calibration and Control Test 54
5.7 Preparing Samples 55
5.7.1 Sample Tube 55
5.7.2 Barcode 55
5.7.3 Sample Rack 55
5.7.4 Placing Sample Tubes into Sample Racks 55
5.7.5 Preparing for Installation of Sample Rack on the Analyzer 56
5.8 Test Selection 56
5.8.1 Sample Number and Sample ID 56
5.8.2 Test Selection 56
5.8.3 Function Buttons 57
5.9 Starting Analysis 59
5.10 Viewing Sample Result 60
5.10.1 Data Review 60
5.10.2 Function Key 60
5.11 Shutdown Maintenance 61
5.12 Shutdown Procedure 61

CHAPTER 6 CALIBRATION 63

6.1 Calibration Settings 63

6.1.1 Inputting Calibrators 63
6.1.2 Calibrator Position 64
6.2 Implementing Calibration 64
6.2.1 Selecting Calibration Item 64
6.2.2 Placing Calibrators 65
6.2.3 Starting Calibration 65
6.3 Calibration Result 66
CHAPTER 7 CONTROL 67

7.1 QC Settings 68
7.1.1 Adding Controls 69
7.1.2 Setting Target Value and Standard Deviation 69
7.1.3 Control Position 70
7.2 Implementing Control Test 70
7.2.1 Selecting Control Item 70
7.2.2 Placing Controls 71
7.2.3 Starting Control Test 71
7.3 QC Result 71

CHAPTER 8 UTILITY 73

8.1 Assay 74
8.2 Maintenance 75
8.3 System 76

CHAPTER 9 MAINTENANCE
83

9.1 Maintenance Precautions 84

9.1.1 Preventive Maintenance 84
9.1.2 Analyzer Maintenance 84
9.1.3 Safety Instructions to Maintenance and Troubleshooting 85
9.2 Preparation for Maintenance 87
9.2.1 Necessary Items 87
9.3 Maintenance Conditions and Frequency 87
9.3.1 Status of Analyzer During Maintenance 87
9.3.2 Maintenance Interval 88
9.3.3 Maintenance Frequency 88
9.3.4 Regularly Replacing Parts 88
9.3.5 Maintenance of the Spare Parts Inventory 89
9.3.6 Precautions for Continuous Running 89
9.3.7 Precautions for Operations after Long Idle Time 89
9.4 List of Maintenance Items 89
9.4.1 Startup/ Shutdown Maintenance of Flow Path 90
9.4.2 Filling Needle 90
9.4.3 Cooling Fan 91
9.4.4 Dust Filter at Bottom of the Analyzer 91
9.4.5 Fuse and Overheat Protection Device 91

CHAPTER 10 TROUBLESHOOTING 92
10.1 Troubleshooting 93
10.2 Contact Us 99

APPENDICES 100
Chapter 1
Overview
The Automatic Chemiluminescence Analyzer is used together with the matching
reagents, calibrators, controls, and other accessories, to detect the analytes in
samples. It applies to in vitro diagnostics only.
To guarantee the optimal performance and avoid system failures, please always
operate the analyzer in accordance with the listed procedures.

1.1 Product Warranties

Due to space limitations, many more could have been included. However, the
methods documented in this manual can ensure normal use of the product by
users.

a． Warranty coverage

For any failure caused by defects in manufacturing, the Company will provide
repair services free of charge. During the service, some substitutes may be used
or the parts to be repaired may be replaced.

b． Region

Within the countries where the product is sold.

c． Disclaimers

The following is not covered under the warranty even within the warranty period:
◼ Failures resulting in the use of the product not in the applicable environment
as specified in the manual.
◼ Failures resulting in the use of the product not at the specified power supply,
voltage or frequency, and those caused due to power exception.
◼ Failures resulting in circuit corrosion and degradation due to highly corrosive
gases in the air.
◼ Failures resulting in the use of hardware, software or auxiliaries not provided
by the Company.
◼ Failures resulting in the use of the product according to a method not
specified in the manual or incorrect use of the product, and those caused
due to repair by a party other than the Company.
◼ Failures resulting in the maintenance by a party other than the maintenance
company designated by the Company.
◼ Failures resulting in the move or transportation of the installed product with
a method not authorized by the Company.
◼ Failures resulting in unauthorized disassembly or alternation of the product.
◼ Failures resulting in fires, earthquakes, wind damages, floods, lightning
strokes, crimes, violence, terrorist acts, radioactive contaminations, wars,

1
 hazardous substances and other acts of God.
◼ Failures occurred to scrapped analyzers or the analyzers sub-purchased
without the written consent of the Company.

d． Declaration

The manual is subject to change without notice.

1.2 Use of the Manual

◼ Please use the analyzer under the supervision of technical personnel that
have undergone professional training. For clinical examinations, please use
the analyzer under the supervision of physicians or clinical lab technicians.
◼ Use of incorrect reagents and consumables may lead to incorrect test results
and may harm the analyzer or operator.
◼ To guarantee correct use of the analyzer, please thoroughly read and
understand the manual before use.
◼ Keep the manual handy for future reference.

1.3 Terminology in the Manual

1.3.1 Warnings, Cautions and Notes

The following signs and terms are used in this manual. Each term, together with
the corresponding sign indicates a level of severity. To use the analyzer correctly
and safely, please fully understand this section.

This sign indicates a warning. A warning sign requires special attention. Failure to
comply with the indications on the warning sign may cause severe damages,
affect the system functions, or lead to incorrect data of the tested sample.

This sign indicates a caution. A caution sign requires appropriate attention. Failure
to comply with the indications on the caution sign may cause minor damages,
degrade the system functions, hamper the system running or damage the system,
or lead to other damages.

Note
A note includes important messages that should be considered by users when
implementing procedures or understanding concepts.

2
1.3.2 Pictograms and Meanings of Identifiers

Identifiers
An identifier is used to inform users about the functions of an area.

Rear view of the instrument:

3
Right view of the instrument:

Left view of the instrument:

4
Other identifiers
You may find the following identifiers on the analyzer, reagent kit, control or
calibrator and their packages:

Identifier Meaning

Protective conductor terminal

AC

Manufacturer

Date of production

Refer to user manual

Serial number

In vitro diagnostic use only

This side up

Fragile

Keep away from rain

Keep out of sunlight

Stacking limit by number

5
 Catalog number

Authorized representative in the European Community

Do not discard it carelessly, hand it over to appropriate facilities

Unique device identifier

1.3.3 Menus, Tabs and Buttons

All menus, tabs and buttons in the software interface will appear in italics.

1.3.4 Images about Software Screen

Different from other items displayed on the menu page, the images about
software screen in the manual may not be exactly the same as the actual screen in
aspects of location and font size.

1.4 Production Date and Duration

For the production date of the analyzer, please refer to the nameplate at its rear
side. The duration of the analyzer is five years.
The duration of the product is determined based on the aging test and risk
management. During the use of the product, users need to maintain and repair
the product according to the manual. When the product expires, if its basic
security and effectiveness can be maintained after maintenance and repair, its
continued use is allowed.

1.5 Storage and Shipping Conditions

Storage conditions
A packaged analyzer should be stored in a well-ventilated place without corrosive
gases under -20℃ to +55℃ with the relative humidity not exceeding 95%.
Shipping conditions
A packaged analyzer should be shipped as required by the purchase contract.
Strong shock, rain and sun exposure must be avoided during shipping.

6
1.6 Disposal
The analyzer shall be disposed of in accordance with local laws and regulations.

1.7 How to Get Help

Please prepare the following materials when seeking for help:

◼ The SN of the Automatic Chemiluminescence Analyzer (can be found on the
nameplate at the rear side of the analyzer)
◼ Description of the problem
◼ Methods and operations you've taken to try to resolve the problem
◼ Your contact information such as the phone number, fax and email

1.8 Vigilance
If any serious incident has occurred in relation to this product, please contact the
manufacturer and report to the local competent authority.

7
 Chapter 2
Preventive Measures
and Installation
Instructions

Before using the analyzer, an operator must understand how to operate the
analyzer safely.

2.1 Safe Use of the System

To guarantee safe running of the analyzer, please follow all operation procedures
in this manual. Failure to do so may damage the safety features of the system.
Before using the analyzer, please carefully read, understand and comply with the
following safety precautions.
The Company and authorized dealers are not responsible for any losses or
damages caused by failure to operate in accordance with these safety

8
precautions.

2.1.1 Complying with Warning Labels

Pay attention and comply with all the warning labels on the product. Do not cover
or remove these labels. In case that the labels fall off or have blurred fonts,
contact the Company or an authorized dealer to have the relevant labels replaced.

Label Type Description

Neighboring areas of this label may lead to

death or serious injury. Please refer to the
Alarm
manual to make sure correct use of the
product.
The power supply involves high voltage.
High voltage Reliable connection is required. Please refer
danger to the manual to make sure correct use of the
product.
Neighboring areas of this label have potential
biohazard.
Biohazard
Relevant lab safety procedures must be
followed.
Penetration of liquids into neighboring areas
Away from
of this label may damage the instrument.
water
Keep the area away from any liquid.
Contact with any moving mechanical parts in
Mechanical
neighboring areas of this label may be
part
dangerous.

Do not open this area when the analyzer is

Alarm
running.

Alarm No pressing. Keep this area clean.

2.1.2 Preventing Fires and Damages

◼ The product should be correctly installed in an installation environment and

under the installation conditions as specified in this manual.
◼ The product installation should be implemented by personnel authorized by
the Company.
◼ To change the installation of the analyzer, contact the Company or an
authorized dealer.

9
◼ In case of a system failure, disconnect the analyzer from the power supply
network before implementing any repair services.
◼ If liquid is spilled onto the analyzer, immediately disconnect the analyzer
from the power supply network, and then remove the liquid. If liquid is
spilled into the analyzer, report the case to the Company or an authorized
dealer before restarting the analyzer.
◼ To help prevent explosion, do not use any flammable gases near the analyzer.

2.1.3 Preventing Electric Shock

◼ Do not remove any surfaces that are fixed with screws, including the rear
cover, side covers and upper cover.
◼ If any liquid splashes on or seeps into the analyzer, immediately contact the
Company or an authorized dealer. Be careful when handling liquid near the
analyzer. Otherwise, electric shock may occur.
◼ To make sure that all power supplies to the analyzer are disconnected, turn
off the circuit breaker corresponding to the analyzer in the lab.

2.1.4 Avoiding Damages to Other Devices and Facilities

◼ The analyzer should be provided with an independent power supply to avoid

electrical noise from other devices.

2.1.5 Preventing Bodily Injury and Serious Injury

◼ Do not touch any moving parts when the analyzer is running.

◼ Some reagents and substrates used by the analyzer are strong acids or
strong alkalines. Avoid the bare hands or clothes being direct contact with
these reagents and substrates. When taking the reagent or cleaning solution,
wear proper personal protective equipment (protective gloves, goggles,
mask and protective clothing) or comply with other protection requirements
of the lab.
◼ When operating the filling needle or any other sharp parts, wear protective
gloves to avoid bodily injury.

2.1.6 Preventing Infection

◼ When handling the sample and sample rack, carry out maintenance, or
disposing of wastes, be sure to take proper personal protection measures.
◼ All patient samples should be treated as potential source of infection, and
comprehensive protection measures shall be taken in accordance with local
or national and regional laws and regulations.
◼ If the user has his/her skin contact with the source of infection, immediately
flush the contact site with large quantity of water and seek medical help

10
 when necessary.
◼ Any pollutant falls from the system should be immediately removed. The
material used to remove the pollutant should be treated as potential source
of infection.
◼ If any reagent or sample is accidentally swallowed, seek medical help
immediately.

2.1.7 Preventing Water Leaks

◼ To prevent water leaks, make sure that the water supply and drainage hoses
are installed in accordance with local regulations by personnel authorized by
the Company.

2.1.8 Computer Operations

◼ To maintain good working condition of the computer, keep it away from any
liquid.
◼ Staring at the LED display for a long time with the same gesture would
increase body and eye fatigue. Therefore, please take a rest for 10 to 15
minutes after every one hour of continuous working in front of the LED
display. Do not staring at the touchscreen for over 6 hours daily.

2.1.9 System Operation Instructions

◼ Be careful when placing the calibrator, control and sample on the analyzer
for test. Incorrect placement of the calibrator, control or sample will lead to
incorrect analysis results.
◼ After the analysis results are transferred to the host, check the sample No.
and sample ID. Correctly transfer all data.
◼ Operate the analyzer by following procedures specified in the manual.
Incorrect operation may lead to incorrect results or system failures.

2.1.10 Ensuring Optimal Analysis Performance

◼ Hyperlipemia, jaundice, hemolysis and other substances would interfere with

test results. For details about disturbances, refer to the reagent instructions.

2.1.11 Implementing Key Inspections During Analysis

To guarantee the correctness of analysis data, pay special attention to the

following points:
◼ Maintain the analyzer system as required by the manual.
◼ Make sure that the purified water meets relevant quality requirements.
◼ Check for foreign matters in the sample, such as dust and fibrin.

11
◼ Check the volume of each sample and avoid bubbles in the sample.
◼ Calibrate all test items and make sure that the calibration is not expired.
◼ Check the control data.
◼ Check for exception prompts in the analysis results.
◼ Check the obtained analysis results and the test results about the control
sample obtained before and after the analysis results are generated, and
make sure that these results are normal.
◼ Make sure that the power supply, running environment and grounding of the
analyzer comply with requirements to guarantee safe and normal operation.

2.1.12 Handling Reagents, Cleaning Solutions, Calibrators and Controls

◼ Use the reagents, calibrators and controls provided by the Company for
sample analysis. For information about the use of reagents, consult the
reagent manufacturer or your dealer.
◼ Strictly abide by all the safety instructions come with the reagents, calibrators
and controls.
◼ When using reagents on the analyzer, follow this manual and the instructions
provided by the reagent manufacturer.
◼ An inclined reagent bottle may lead to incorrect results or damage the filling
needle.
◼ Follow all applicable warnings or suggestions about carry-over between
analysis and test items. A reagent contaminated by other reagent(s) during
analysis may affect the test results. The actual disturbance varies with
reagent. For details, consult the reagent manufacturer or your dealer. For
information about how to check and analyze disturbances between tests,
consult the Company or an authorized dealer.

2.1.13 Handling Reagents

Reagent that can be used for analysis

◼ The analyzer can be used to analyze serum, plasma and other body fluid
samples.
◼ Use the serum or plasma that does not contain cruor. Cruor in serum may
block the filling needle and have a negative effect on the analysis results.
◼ Chemicals in the sample, such as medicine, anticoagulant and antiseptic may
seriously disrupt the test results.
◼ High viscosity sample may disrupt the test results and affect data reliability.

Notes about sample handling and storage

◼ For information about sample collection and storage, refer to the reagent
instructions. Improper sample storage may change the analyte in the sample.

Preprocessing samples

12
◼ Use only designated blood collection tubes and sample tubes (cups).
◼ Serum and plasma samples should be fully centrifuged to separate the blood
cells and thus reducing the risks of disturbances. Before analysis, make sure
that there is no suspended material (such as fibrin) in the sample.
◼ Make sure that the anticoagulant or the blood collection tube and sample
tube with barriers are compatible with the detection reagent.
◼ When using the blood collection tube with separating agent added, make
sure that the collected serum is sufficient to avoid separating agent
contamination or filling needle blocking.
◼ Make sure that the sample volume is sufficient to guarantee sampling
correctness.
◼ Before analysis, prevent sample evaporation or contamination.
◼ Make sure that there is no bubble in the sample.

2.1.14 Disposing of Waste Liquid

◼ Waste liquid should be disposed of as potential source of infection.

◼ Special treatment may be required before the cleaning of certain waste liquid
and mixture. For applicable methods about disposing of waste liquid, refer to
the local and national rules and rules of other authorities.
◼ Certain substances in the reagent, control, calibrator and cleaning solution
should be managed in accordance with the pollution prevention ordinance
and waste-discharge standards. Dispose of these substances according to the
applicable waste-discharge standards of the hospital and consult relevant
reagent manufacturer or your dealer.
◼ The hospital should be equipped with the waste-discharge system for
disposing of waste liquid, or the waste liquid may be disposed of by a
designated treatment institution.

2.1.15 Disposing of Solid Waste

◼ Solid waste should be disposed of as potential source of infection.

◼ Special treatment may be required before the cleaning of certain solid waste
and mixture. For applicable methods about disposing of solid waste, refer to
the local and national rules and rules of other authorities.
◼ All used cuvettes should be disposed of as infectious waste. These materials
should be properly disposed of according to relevant laws and regulations.

2.1.16 EMI and Noise Preventive Measures

◼ Do not put the analyzer near to a device that has a high electrical noise level.
◼ Do not use a mobile phone, radiophone or transceiver in the same room with
the analyzer.
◼ Do not use any medical device that is prone to EMI near the data processor

13
 or monitor of the analyzer.
◼ The analyzer should be provided with an independent power supply.

2.1.17 Parts Replacement and Routine Maintenance

Before maintenance, make sure that the moving parts are stopped. Otherwise,
mechanical injuries may be caused to the operator.

To guarantee system performance, please replace the parts according to

instructions and maintain and check the system in a regular manner.
◼ After key parts (such as the filling needle) are replaced, calibration may be
required. After parts replacement or major maintenance, it is strongly
recommended to implement control analysis. If any deviation is observed,
recalibrate the system.
◼ Prepare and follow the analyzer maintenance schedule. For the
recommended maintenance schedule, refer to Chapter 9 Maintenance.
Failure to comply with these guidelines cannot guarantee system
performance and safe operation.
◼ Only engineers authorized by the Company can replace the analyzer parts.

2.1.18 Computer Antivirus Protection

The computer hardware should be specially used for the running of the system
software. Without instructions from the Company, the computer hardware cannot
be connected to the network to avoid software virus.

2.1.19 Cleaning Panel Surface

Remove pollutant from the surface of the analyzer in time. The removed
substances should be disposed of as medical waste.

2.2 Installation Instructions

The analyzer must be installed by personnel that have undergone professional
training. Before hardware installation, users should carefully read and understand
the requirements, conditions, and operating procedures specified in the manual.
Users should assist engineers in installation to guarantee normal operation and
lifecycle of the analyzer.

14
 Those have not undergone professional training are not allowed to install,
commission or provide operation training of the analyzer.

2.2.1 Environmental Requirements

The environment in which the analyzer is used must comply with the following
requirements:
◼ Room temperature: 10℃ to 30℃
◼ Relative humidity: ≤ 70%
◼ Atmospheric pressure: 59.4 kPa to 106.0 kPa
◼ If the room temperature and relative humidity are not proper, adjust them.
◼ Do not place the analyzer in an environment with large temperature
fluctuations.
◼ Avoid direct sunlight.
◼ The place should be well ventilated.
◼ Proper grounding must be guaranteed. Do not use the product in places
where possible radio wave interference, dust and sour volatile gas exist.

2.2.2 Power Supply Requirements

The power supply system needs to meet the following requirements:

◼ Voltage: 100V-240V~
◼ Frequency: 50 Hz
◼ Independent grounding terminal should be provided (grounding resistance
of less than 10 Ω or that complies with hospital grounding requirements).
◼ Do not put anything on top of the connected cables, no matter it is
temporary, permanent or intermittent. The cable layout cannot go through
pedestrian roads.
◼ Cables cannot be connected in loop or knotted, or twined together with the
lines of other neighboring electric devices.
◼ Before cable connection, make sure that the power supply is off.
◼ When connecting the system to the power supply, check and make sure that
all switches are off.
◼ The system cannot be connected to the circuit of other interfering electric
devices.
◼ Do not use extended outlet or power strip.
◼ For the power control via a switch on the wall or a time relay, temporary
power outage may damage the analysis template and computer memory.
◼ Do not use extension that has no protective conductor. Otherwise, safe
connection will be disconnected.
◼ When adding or removing parts to the system, disconnect the system with
power supply before disconnecting the power cable of the relevant parts.

15
 If the mains to the analyzer is unstable, or exceptional power outage exists, it is
recommended to use voltage stabilizer, UPS or other backup power devices.
Use the power cable that comes with the product.

2.2.3 Electromagnetic Compatibility (EMC)

To guarantee a proper EMC environment for the analyzer, pay attention to the
following points:
◼ Keep the analyzer away from facilities with high electromagnetic radiation,
such as dental beds, pacers, and welding equipment.
◼ Keep the analyzer away from high-power devices that are started up
frequently, such as refrigerators and centrifuges.
◼ Keep the analyzer away from strong magnetic fields, such as radiology
equipment.
◼ Do not connect too many devices to the power strip for the analyzer.
◼ During a test, do not plug in or out other devices that are connected to the
same power strip as the analyzer.
◼ Make sure that the analyzer power socket is reliably grounded. Do not use
non-standard power cable.

2.2.4 Installation Space Requirements

To meet the requirements for maintenance space of the analyzer, and to make
sure sufficient heat dissipation and avoid squeezing the pipeline of the analyzer,
the installation position of the analyzer should meet the following requirements:
◼ The desktop should be level.
◼ The desktop should be strong enough to bear the weight of the instrument
(load capacity: ≥ 200 kg/m2).
◼ There should be no perceptible vibration.
◼ A gap of over 0.5 m wide should be reserved at the rear side and left and
right sides of the instrument each to ensure proper heat dissipation and
space for operating the power switch.

16
 Figure 2.2.4-1

Length, width, height and weight

◼ Analyzer module: 1200 x 755 x 675 (L x W x H, in mm), approx. 170 kg.

2.2.5 Software Operating Environment

OS: Windows 7 or later

CPU: Intel Core i3 or later
Memory: 4GB or larger
Hard disk: 100GB or larger
Graphics card: discrete graphics card or integrated graphics card
Network card: 100Mbps Ethernet card and above.

2.2.6 Network Security

a. Data interface
TCP/IP transmission, ACCESS data storage.
b. User access control
Identity authentication by user name and password; users are classified into L1,
L2, and L3 users. L1 users have common operator rights, L2 users have lab
administrator rights, and L3 users have reagent administrator rights.
c. Security software
Antivirus software needs to be installed to perform necessary virus protection and
system vulnerability patching.
d. Firewall
Use Windows' built-in firewall, which is enabled by default, and set a security
policy to allow the software to interact with data through the firewall.

17
e. Software environment and security software update
When necessary, engineers can update system software, support software,
application software and security software by using local storage media or
network update methods.

18
 Chapter 3
System
Introduction

The Automatic Chemiluminescence Analyzer and its chemiluminescence

immunoassay reagent constitute a closed system to measure the concentration of
various analytes in clinical serum, plasma and other body fluid samples. This
chapter briefs the working principles and structures of the system.

3.1 Reaction Principles

The analyzer adopts the direct chemiluminescence immunoassay principle to test
the clinical serum, plasma and other body fluid samples. The chemiluminescence

19
reagent used is acridinium ester (AE). Through heterogeneous reaction, the
magnetic separation of magnetic particles can achieve the separation of immune
complex from other substances that are not involved in the reaction.
Based on the immunoreaction mode, the test methods can be classified into
sandwich method, competitive method, and capture method.

3.1.1 Sandwich method

Based on the test object, sandwich method can be classified into double-antibody
sandwich method and double-antigen sandwich method.
The basic principle of double-antibody sandwich method is as follows: the specific
antibody connected to the solid state magnetic particle and the AE-marked specific
antibody combine with two different epitopes on the test antigen, to form the
"antibody-antigen-antibody" immune complex. Magnetic particles are absorbed by
the magnetic field, and the immune complex aggregates directionally. Then, other
substances that are not involved in the reaction can be removed through washing.
After the substrate is added, chemiluminescence reaction occurs to the AE on the
immune complex and the substrate. The chemiluminescence signal can be
measured with the instrument, and the chemiluminescence signal value is directly
proportional to the concentration of the test antigen in the sample.
The basic principle of double-antigen sandwich method is as follows: the specific
antigen connected to the solid state magnetic particle and the AE-marked specific
antibody combine with two different sites on the test antibody, to form the
"antigen-antibody-antigen" immune complex. Magnetic particles are absorbed by
the magnetic field, and the immune complex aggregates directionally. Then, other
substances that are not involved in the reaction can be removed through washing.
After the substrate is added, chemiluminescence reaction occurs to the AE on the
immune complex and the substrate. The chemiluminescence signal can be
measured with the instrument, and the chemiluminescence signal value is directly
proportional to the concentration of the test antibody in the sample.

3.1.2 Competitive method

Based on the test object, competitive method can be classified into double-antigen
competitive method and double-antibody competitive method.
Double-antigen competitive method is used for the test on antigen, and its basic
principle is as follows: the AE-marked antigen and the test antigen in the sample
compete to combine with the antibody connected to the solid state magnetic
particle, to form the "AE-antigen-antibody" and the "sample antigen-antibody"
immune complexes. Magnetic particles are absorbed by the magnetic field, and the
two types of immune complexes aggregate directionally. Then, other substances
that are not involved in the reaction can be removed through washing. After the
substrate is added, chemiluminescence reaction occurs to the AE on the "AE-
antigen-antibody" immune complex and the substrate. The chemiluminescence

20
signal can be measured with the instrument, and the chemiluminescence signal
value is inversely proportional to the concentration of the test antigen in the sample.
Double-antibody competitive method is used for the test on antibody, and its basic
principle is as follows: the AE-marked antibody and the test antibody in the sample
compete to combine with the antigen connected to the solid state magnetic
particle, to form the "AE-antibody-antigen" and the "sample antibody-antigen"
immune complexes. Magnetic particles are absorbed by the magnetic field, and the
two types of immune complexes aggregate directionally. Then, other substances
that are not involved in the reaction can be removed through washing. After the
substrate is added, chemiluminescence reaction occurs to the AE on the "AE-
antibody-antigen" immune complex and the substrate. The chemiluminescence
signal can be measured with the instrument, and the chemiluminescence signal
value is inversely proportional to the concentration of the test antibody in the
sample.

3.1.3 Capture method

Capture method can be classified into capture method and reverse capture method
(indirect method).
For both of them, the basic principle is as follows: the secondary antibody captures
the antibody, and form the "secondary antibody-antibody-antigen" immune
complex with the antigen. The difference is that, for capture method, the secondary
antibody connects to the solid state magnetic particle, and the antigen connects to
the AE; while for indirect method, the antigen connects to the solid state magnetic
particle, and the secondary antibody connects to the AE. Magnetic particles are
absorbed by the magnetic field, and the immune complex aggregates directionally.
Then, other substances that are not involved in the reaction can be removed
through washing. After the substrate is added, chemiluminescence reaction occurs
to the AE on the immune complex and the substrate. The chemiluminescence signal
can be measured with the instrument, and the chemiluminescence signal value is
directly proportional to the concentration of the test antibody in the sample.

3.2 Working Principles

3.2.1 Instrument Principle

The Automatic Chemiluminescence Analyzer adopts the controller area network

(CAN) bus technology to automatically implement the entire process of
chemiluminescence immunoassay reaction based on magnetic particles.

3.2.2 Actuator

By integrating precision fluid operation unit, temperature control unit, result test
unit and auto operation and transfer unit, the analyzer realizes the fully

21
automated process from cuvette loading, sample filling, and reagent filling, to
reaction liquid incubation reaction, reaction liquid washing, and reaction result
test and analysis.
The Automated Chemiluminescence Analyzer supports both one-step and two-
step approaches.

3.2.3 Analysis Procedure

Taking sandwich ELISA as an example, the analysis procedure is as shown in the

following figure:

Figure 3.2.3-1

3.3 Scope of Application

The product is based on the principle of direct chemiluminescence and is used in
conjunction with reagents for qualitative and/or quantitative analysis of analytes
from human serum, plasma, whole blood, urine or other body fluid samples,
including clinical immunization programs.

22
3.4 Hardware System
Structures
The product consists of the reagent arm module, sampling module, cuvette
transfer system, incubator module, cuvette auto loading module, reagent
compartment module, magnetic separation system, test compartment module,
and software (release version: V1).

Front view of the analyzer

Figure 3.4-1

No. Name Function

Analyzer status Displays the current state of the analyzer. Green:

1
indicator normal; Red: stop; Yellow: alarm.
Waste container
2 Light in green: removed; Off: normal.
status indicator
Light in green: sample rack exists in the channel;
Sample channel status
3 Off: no sample rack in the channel; Flashing:
indicator
sampling for the sample rack.
Substrate status
4 Light in green: removed; Off: normal.
indicator

Rear view of the analyzer

23
 Figure 3.4-2

Left view of the analyzer

Figure 3.4-3

SN Name Function

1 Wash buffer port Used to connect to the cleaning solution pipe.

24
 2 Purified water port Used to connect to the purified water pipe.

3 CAN port Used for communication with external dilution.

4 Waste liquid A port Used to connect to waste liquid pipe A.

5 Waste liquid B port Used to connect to waste liquid pipe B.

Purified water sensor Used to connect to the purified water container

6
port sensor.
Wash buffer sensor Used to connect to the cleaning solution
7
port container sensor.
Waste liquid sensor Used to connect to the waste liquid container
8
port sensor.

Right view of the analyzer

Figure 3.4-4

SN Name Function

A switch used to control the power supply to the

1 Power switch
instrument.

2 Power cable port Provides a port for power cable connection.

Used for communication with the analyzer

3 LAN port
computer.

Details of the analyzer

25
 Figure 3.4-5

SN Name Function

Position for adding

1 Used to add the cuvette.
cuvette

2 Solid waste container Used to collect the cuvettes after test.

3 Sampling channel The position where test samples are placed.

4 Substrate module Used to store substrate.

Reagent
5 Used to store reagent for test.
compartment

26
Chapter 4
Software
Introduction

27
4.1 Software Hierarchy and Function Keys
4.1.1 Layout

Upon successful login, an interface as shown in Figure 4.1.1-1 is displayed.

Figure 4.1.1-1

1 Title bar

The Company logo, sample rack status, analyzer status, submenu name, current
user, and system date and time are displayed.
Click the sample rack status icon to enter the interface as shown in Figure 4.1.1-2.

Figure 4.1.1-2

2 Functional menu area

This area includes menus and submenus. The five major menus are "Work",

28
"Reagent", "Calibration", "QC", and "Utility". Each menu has many submenus. For
example, the "Work" menu has submenus such as "Test Selection" and "Data
Review", which will be described in later chapters.

3 Consumable status area

This area displays information about consumables of the analysis module in real
time.

Icon Meaning

Available amount of the currently used two bottles of

substrate

Residual amount in the cuvette

Available amount of the currently used cleaning solution

Loading capacity of the solid waste container

Loading capacity of the waste liquid container

4 General menu area

Shortcuts are provided on the right side of the interface for ease of use. They are
"Start", "STAT", "Sampling Pause", "Stop", "Alarm", "Help", "Print", and "Exit".

Icon Meaning

Start the analyzer

Implement STAT sampling

Stop sampling

Implement emergency stop

Analyzer alarm information

View analyzer version information, user manual, etc.

Implement print

Turn off the instrument or switch to another user

29
5 Viewport

This area displays information corresponding to the selected submenu in the form
of a dialog box. Details about each viewport will be described in latter chapters.

6 Button area

This area displays commonly used buttons corresponding to the selected

submenu. The prompt after a function button is clicked is displayed before the
viewport.

Functional menus

Function Key
Menu Submenu Meaning or Use
/ Input Box

<sample item input>

Release Rack Release the sample rack where

sampling is completed or that is

ready for test

Patient Info Input the name, age and other

information

Test Retest Manually select the item for retest

Selection Batch Input Input multiple samples of the same

item in batches

Previous View the previous sample

information

Work Next View the next sample information

Save Save the selected information of the

current sample

<view sample information and

sample-related item information>

Patient Info Input the patient name, age and

other information (same as "Patient

Data
Info" in "Test Selection")
Review
Search Query samples based on the

configured search criteria

Manual Manually send the test results to the

Transmission report system

30
 Function Key
Menu Submenu Meaning or Use
/ Input Box

Delete Delete the selected sample

information

Delete All Delete all sample information

Print Print or export the selected sample

information via a printer

Review Review/Cancel the review of the

selected sample

Test Review View detailed item information

about the selected sample

History Data View history data in the background

database based on certain criteria

Data Export Export the sample test results to the

computer hard disk

<Display reagent carousel status,

reagent status, substrate residual

amount, wash buffer residual

amount, number of residual

cuvettes, and waste container

status>

Add Wash Add the wash buffer

Buffer

Reagent Empty Waste Empty the waste container

Reagent
Status Bin

Reagent Load or unload the reagent and

Replacement diluent in running or sampling stop

status

Add Cuvette Set the cuvette information

Priority Use Select the reagent to be firstly used

when many reagents of the same

type exist

31
 Function Key
Menu Submenu Meaning or Use
/ Input Box

<View detailed information about

reagent>

Reagent Load or unload the reagent and

Regent Replacement diluent in running or sampling stop

Info status

Priority Use Select the reagent to be firstly used

when many reagents of the same

type exist

<View detailed information about

Supplies all consumables of the module>

Add Cuvette Set the cuvette information

Calibration Status <View the calibration information

about all items under processing>

Cal. History View the calibration information of

the past 50 items

Cal. Result View the current calibration result of

the selected item

Instrument Input the calibration factor

Coefficient

Select Manually select the item to be

calibrated when the calibrator

barcode is damaged

Setting <Set the calibrator for calibration>

Scan Scan the calibrator barcode and

input the calibrator information

Delete Delete the scanned barcode

information

QC Status <View the control information of the

module item>

Default QC Set the default control item

information

32
 Function Key
Menu Submenu Meaning or Use
/ Input Box

Backup QC Select the control item to be

implemented by the standby

reagent bottle

Select Select or cancel the control item

information

Result <View the control data of each

item>

QC Chart Display the control graphs of the

selected item

Setting <Add or delete information related

to the control>

Manual Manually input the control

information

Scan Scan the control barcode

Download Download the control information

from the network

Modify Modify the control information

Delete Delete a control

Edit Edit the target value and standard

deviation of the selected control

Save Save the changed target value and

standard deviation

Utility Assay <Item parameter information>

Download Obtain item parameter information

Delete Delete item parameter information

Save Save the current change(s)

Maintain <View, set, and implement analyzer

maintenance>

Maintenance Display the maintenance

Log information

33
 Function Key
Menu Submenu Meaning or Use
/ Input Box

Instrument Run the instrument maintenance

Maintenance procedure

Alarm Info Display the alarm information

Temperature Display the temperature in different

Check areas

System <Mode settings, display settings,

user settings, and other common

settings>

Auto Startup Set the time for auto startup each

day

Alarm Setting Set the alarm threshold

User Set the user name, password and

Management operation rights

Combination Set the combination item

Setting

Assay Position Allocate keys for the test item

Calculation Set the calculation item

Item

Printing Set the content to be printed on the

Setting report

Sheet（1/2） Page up/down

Language Select the language for operating

Select the software

Host Comm. Set the communication

Remote Set network assistance parameters

Assistance

Calibration Set the item that needs to be

Mask shielded from calibration

Sheet（2/2） Page up/down

34
4.1.2 General Menu

General Function Key Use

Menu

Start Start Start up

Assay Mark Disable an item

Cancel Exit the menu

STAT Start STAT sample test

Sampling Stop sampling of the analyzer and continue

Pause to complete the test on the samples of

which the sampling is completed

Stop Stop all actions of the analyzer and switch it

to the stop status

Alarm Cancel Exit the menu

Help Embedded instructions

Print Print content related to the "Work" and

"Reagent" interfaces

Exit Exit Close the procedure

Switch User Log in with another account

4.2 Login Interface

Upon startup, the analyzer will automatically run the software of the Automatic
Chemiluminescence Analyzer. Then, a login interface as shown in Figure 4.2-1 is
displayed. You can log in by entering the correct user name and password.
Note: For initial login, use the default user name and password. Upon successful
login, please change the user name and password as soon as possible.
For the settings of user name and password, refer to Section 8.3 System.

35
 Figure 4.2-1

Enter the user name and password. Then, click the "LOGIN" button to log in to the
software.
To exit the software, on the left side of the "LOGIN" button, click “ ”.

4.3 Work Interface

Upon successful login, the "Work" interface is displayed by default. By clicking an
icon on this interface, you can access the corresponding function interface.

4.3.1 Test Selection

On this interface, you can manually add or delete general or STAT samples, set
test item or combination item (for settings of item or combination, refer to
Section 5.8 Test Selection, and set the sample tube type and dilution ration, as
shown in Figure 4.3.1-1.

Figure 4.3.1-1

36
1 Sample area
Normal: Select this item as a general sample to input the test item
STAT: Select this item as an STAT sample to input the test item
Samp. No: Input the sample SN; range: 1 to 99999. After the sample SN is saved,
the SN of the next sample will automatically increase by one (N+1).
Samp. ID: Scan or input the sample barcode; up to 22-digit 1D barcode is
supported.
Rack No: Set the sample rack number.
Pos. No: Set the sample position number.

2 Sample test conditions

Type: Serum, Plasma, Whole blood, Urine, Other
Tube: General sample tube, micro sample tube
Dil. Ratio: Select the dilution ratio of the item to be diluted.
Volume: Statistics of the sampling amount of all items of the current sample.

3 Item selection
Icons for selecting item viewports are described as follows:

Icon Meaning

No item

Gray, indicating unavailable item

Black, indicating normal and available item

Blue: indicating selected item

Displayed on the "Test Selection" button when the item will

be diluted
Displayed on the " Test Selection " button when the item
reagent is abnormal
Displayed on the " Test Selection " button when the item
calibration is abnormal
Displayed on the " Test Selection " button in case of
combination item

4.3.2 Data Review

This interface displays the sample items and results, as shown in Figure 4.3.2-1.

37
 Figure 4.3.2-1

1 Sample list
Sample status:
Displayed
Meaning
Content
H Processing and transmission completed

P Processing

O Waiting for processing

- Sample position is released

Nothing Sample position is to be released

Samp. No: Display the sample number.

Samp. ID: Display the sample barcode.
Note: When sample scanning is closed, the Samp. No is displayed. When sample
scanning is open, the Samp. ID is displayed.
Rack No: Display the sample rack number used for sample test.
Pos. No: Display the position of the sample during test.
End Time: The end time of test.
Retest End Time: The end time of retest.
Type: Display the sample type input during item selection.

2 Result list
This area displays all result information of the currently selected sample, including
"Assay", "Result", "Retest", "Unit", "Time Left", "Status" and etc.
Note: Only the latest retest result is displayed.

38
4.4 Reagent Interface
On this interface, you can view reagents, consumables and their details, and use
function keys to manage the reagents and consumables.

4.4.1 Reagent Status

As shown in the Figure 4.4.1-1.

Figure 4.4.1-1

1 Reagent compartment overview

This area displays the reagent position and status in the reagent compartment. By
selecting a reagent position, you can view details about the reagent at this
position.

2 Consumable overview
This area displays status of the substrate, cleaning solution, cuvette, and solid
waste.

4.4.2 Reagent Information

On this interface, you can view information about each bottle of reagent, such as
the item name and times of test, as shown in Figure 4.4.2-1.

39
 Figure 4.4.2-1
1 Reagent information list
This area displays details about reagents in the current reagent compartment.
Details are as follows:

Title Meaning

Pos. Display the reagent carousel position of the current reagent

bottle
Assay Display the item name

Available Display the times of tests that can be used for sample
reagent test
Residual Display the times of tests for loaded reagent of the current
item
Status Display the use status of the current reagent

Cal. Status Display the calibration status of the current reagent

Reag. Lot Display the batch No. of the current reagent

SN Display the bottle No. of the current reagent

Curve Val. Date Display the remaining effective days of the current
calibration curve
Open Val. Display the remaining effective days of the current reagent
after the bottle is opened
Reag. Val. Display the remaining effective days of the current reagent

Loading Time Display the first scanning time of the current reagent

2 Function keys on the reagent menu

Add Wash Buffer: Add cleaning solution.
Empty Waste Bin: Empty the waste container when the analyzer is in standby or
running status.
Reagent Replacement: Apply for reagent replacement when the analyzer is in
running or sampling stop status.

40
Add cuvette: Add cuvette.
Priority Use: Select a bottle of reagent from many standby reagents for an item.

4.4.3 Consumable information

On this interface, you can view the information of all consumables of which the
barcode is scanned, as shown in Figure 4.4.3-1.

Figure 4.4.3-1
1 Consumables list

Title Meaning

Type Display the type of consumable

Lot Display the batch No. of consumable

SN Display the unique SN of the substrate and cleaning

solution
Residual Volume Display the remaining amount of consumable

Expiry Date The date when the consumable is expired

Loading Date The time when the consumable is loaded to the instrument

Status The use status of the consumable

4.5 Calibration Interface

4.5.1 Calibration Status

Click the "Calibration" button from the functional menu to display the "Status"
interface, as shown in Figure 4.5.1-1.

41
 Figure 4.5.1-1

Title Meaning

Pos. Display the reagent carousel position of the current reagent

bottle
Assay Display the item name

Reag. Lot Display the batch No. of the reagent

Status Being used, Standby

Select Select a bottle of reagent for calibration

Cal. Status Calibrating, Not calibrate, Calibration succeeded, Calibration failed

Curve Val. Date Display the remaining effective days of the bottle/batch
calibration

4.5.2 Calibration Setting

Before manual calibration, you need to set information about the calibrator on
this interface, including using a handheld scanner to scan the calibrator barcode,
setting the position of the calibrator on the calibration rack, etc. The "Setting"
interface is as shown in Figure 4.5.2-1.

42
 Figure 4.5.2-1

Title Meaning

No. Display the serials number

Assay Display the scanned calibrator item name

Cal. Lot Display the scanned calibrator batch No.

Expiry Date Display the scanned calibrator expiration date

Calibrators Allocate positions for level calibrators (for details, refer to

Chapter 6 Calibration)

4.6 QC Interface
Click the "QC" button on the functional menu to access the "QC" interface.

4.6.1 QC Status

Click "QC". The "Status" menu is displayed by default, as shown in Figure 4.6.1-1.

43
 Figure 4.6.1-1

This interface displays the "Assay", "QC Name", "QC No.", "QC Lot", "Select" and
"Status".

4.6.2 QC Result

This interface displays the "Assay", "QC Name", "QC Lot", “Date”, "Target V.",
"SD", "Quant.", "Average", "Calc. SD" , "CV(%)" and etc., as shown in Figure 4.6.2-1.

Figure 4.6.2-1

4.6.3 QC Setting

This interface displays the control and the corresponding control item. Users can
set relevant information about the control. For example, adding or deleting the
current control as required. As shown in Figure 4.6.3-1.

44
 Figure 4.6.3-1

1 Control list

The list displays the "No.", "QC Name", "QC No.", "QC Lot", "Expiry Date", and
"Pos.".

2 Details about a selected control

This area displays information of all control items of the selected control,
including "Assay", "Target V.", "SD", "CV(%)" and "Unit".

4.7 Utility Interface

Click the "Utility" button on the menu to switch to the "Utility" interface. Three
modules included in the "Utility" interface are "Assay", "Maintain" and "System".

4.7.1 Assay

By default, the "Assay" menu is displayed, as shown in Figure 4.7.1-1.

45
 Figure 4.7.1-1

1 Item display list

This area displays the item parameter series number and item name. "No."
indicates the series number when the item is loaded, and "Assay" cannot be
changed.

2 Item parameters

This area displays detailed parameters of an item, such as "App Code", "Result
Unit", "Printing Name", "Days Open Vial", "Linear Range", "Reference Range",
"Auto Retest" and etc.

4.7.2 Maintain

Click "Maintain" to access the "Maintain" menu, as shown in Figure 4.7.2-1.

Figure 4.7.2-1

1 Maintenance Log

This tab displays the maintenance log.

2 Instrument Maintenance

This tab displays the on/off maintenance settings, auto maintenance, and other
maintenance information.

3 Alarm Info

This tab displays alarms generated by the analyzer to facilitate fault locating.

46
4 Temperature Check

This tab displays the temperature of parts of the analyzer.

4.7.3 System

This interface displays information related to system settings. Through relevant

function keys, you can implement functions such as auto power on setting, alarm
setting, user management, combination settings, assay position, calculation item,
printing setting, language settings, host communication, remote assist, and
calibration shield, as shown in Figure 4.7.3-1.

Figure 4.7.3-1

47
 Chapter 5
General
Operations

48
This chapter describes the routine operations of the analyzer from startup to
shutdown, including preparation before operation, startup, sample preparation,
test, and shutdown.

5.1 Working Procedure

The working procedure can be classified into that for test sample, calibrator and
control. The working procedure varies slightly with the test object.

5.1.1 Sample Working Procedure

Figure 5.1.1 1

5.1.2 Calibrator Working Procedure

Figure 5.1.2 1

49
5.1.3 Control Working Procedure

Figure 5.1.3 1

5.2 Preparation Before Startup

Before power on the analyzer, do the following checks to make sure that the
system is functional.
◼ Power supply
Check whether the external power supply is functional.
◼ Water supply
Check whether the external water supply equipment is running normally and
whether the water quality meets relevant requirements.
Note: For the use of water purifier, refer to the water purifier instructions.
◼ Filling needle and magnetic separation system
Make sure that the front end of the needle is clean, the needle is not bent or
deformed, and there is no obstacle on the movement track of the mechanics.
◼ Cuvette
Make sure that the number of cuvettes is sufficient and can meet the
requirements for analyzer running and sample test.
◼ Solid waste container and waste liquid container
Make sure that the solid waste container/waste liquid container has sufficient
space to meet the requirements for analyzer running and sample test.
◼ Wash buffer
Make sure the amount of cleaning solution is sufficient and can meet the
requirements for analyzer running and sample test.
◼ Substrate
Make sure the amount of substrate is sufficient and can meet the requirements
for analyzer running and sample test.

50
 Samples, calibrators, controls and waste have the risk of potential microbial
infectivity. During operation, be sure to comply with safe operation
requirements of the lab and wear proper personal protective equipment (such
as protective clothing and gloves).

Dispose of the reagent, waste liquid and waste sample in accordance with
regional and national regulations on the discharge and processing of materials
with microbial infectivity such as reagent and waste liquid.

5.3 Startup
Turn on the power supply to the analyzer. The analyzer starts up and the software
automatically operates.
◼ The switch of the analyzer is usually in the normally open status to supply
power for refrigeration of the reagent compartment.
◼ After the switch of the analyzer is turned on, the analyzer starts initialization
and displays the login interface. After maintenance upon startup (for details,
refer to Chapter 9 Maintenance), the analyzer enters the standby mode.

If the analyzer fails to start up, alarm will be generated. Troubleshoot based on
the alarm information. If the problem cannot be resolved, contact the Company
or an authorized dealer.

5.4 Checking and Preparing Reagents

The analyzer identifies reagents through RFID. The reagents can be placed at any
position in the reagent compartment. Each time when the reagent compartment
is closed, the analyzer will automatically scan and read the reagent RFID
information.

5.4.1 Checking Reagent Amount and Reagent Status

◼ Check the remaining amount of loaded reagent and refill the reagent kit that
has insufficient remaining amount in a timely manner.
◼ Check the calibration status of the loaded reagent.
◼ Check the use status of the loaded reagent. If the reagent kid with abnormal

51
 use status is used for tests, the system will generate alarm and provide marks
in the test results to suggest for replacing the reagent kit.
◼ When the remaining amount of diluent in reagent kit in the reagent
compartment is insufficient or unavailable, items related to diluent during
tests will be omitted and with relevant alarm generated.

5.4.2 Loading & Unloading Reagents

Reagents are loaded and unloaded manually.

Loading reagents

◼ When the analyzer is in standby state: Open the reagent compartment, put
the reagent kit into the reagent position, and close the reagent
compartment. The analyzer automatically scans the reagent and reads
reagent information. After scanning is complete, check reagent information
on the software to ensure that the reagent has been loaded successfully.
◼ When the analyzer is in running state: On the reagent overview/information
interface, click “Reagent Replacement”. In the displayed dialog box, click
“Yes（Y）” to confirm the request. Then, “In application” is displayed.
When the analyzer is ready, “Application succeeded” is displayed and the
reagent compartment indicator on the analyzer is on. In this case, open the
reagent compartment, put the reagent kit into the reagent position, and
close the reagent compartment. The analyzer automatically scans the
reagent and reads reagent information. After scanning is complete, check
reagent information on the software to ensure that the reagent has been
loaded successfully.

Unloading reagents

◼ When the analyzer is in standby state: Open the reagent compartment, take
out the reagent kit to be unloaded, and close the reagent compartment. The
analyzer automatically confirms reagent information.
◼ When the analyzer is in running state: On the reagent overview/information
interface, click “Reagent Replacement”. In the displayed dialog box, click
“Yes（Y）” to confirm the request. “In application” is displayed. When
the analyzer is ready, “Application succeeded” is displayed and the reagent
compartment indicator on the analyzer is on. In this case, open the reagent
compartment, take out the reagent kit, and close the reagent compartment.
The analyzer automatically scans the reagent and reads reagent information.
After scanning is complete, check reagent information on the software to
ensure that the reagent has been unloaded successfully.

52
 Do not open the reagent compartment when the analyzer is running. Click
"Reagent Replacement", after the analyzer status is "Application succeeded" and
the control indicator of the reagent compartment is on, you can open the reagent
compartment, as shown in the following figure.

To rotate the reagent carousel, press the reagent compartment control button on
the analyzer panel.

5.5 Checking Consumable Status

5.5.1 Checking Consumable Status

Consumables include cuvette, wash buffer and substrate. You can view the status
and refill each consumable on the interface, as shown in Figure 5.5.1-1.

53
 Figure 5.5.1-1

5.5.2 Replacing Consumables

On the "Reagent Status" or "Supplies" interface, click the "Add Cuvette" button. In
the displayed page, input the cuvette information. Then, the analyzer
automatically resolves the consumable specifications, batch No., and expiration
date. After information input, place the cuvette to the correct position, as shown
in Figure 5.5.2-1.

Figure 5.5.2-1

5.6 Calibration and Control Test

Before sample analysis, item calibration and control measurements need to be
performed to guarantee reliable analysis results. For details, refer to Chapter 6
Calibration and Chapter 7 Control.

54
5.7 Preparing Samples
5.7.1 Sample Tube

Sample tubes that can be used with this product are as follows:
Diameter: 13 mm or 16 mm; length: 75 mm or 100 mm.
Cuvette (standard cuvette and micro-cuvette)

Use of non-standard sample tubes may affect the analyzer operation and
sample test, and even lead to analyzer failure.

5.7.2 Barcode

The barcode label is attached to the outer side of the sample tube. The lower end
of barcode should be at least 7 mm away from the bottom of the tube.

5.7.3 Sample Rack

The gray ten-cell sample rack is provided.

5.7.4 Placing Sample Tubes into Sample Racks

Requirements for correct placement of sample tubes into sample racks are as
follows:

1. Place the samples into the proper sample racks.

Each sample rack has its SN. Place the sample into the sample rack with the
corresponding SN.

Correct insert the sample tube into the sample rack. Incorrect placement of
sample tube may damage the analyzer hardware.

2 Check each opening of the sample rack, and make sure that the barcodes
are center aligned.

If a sample tube with barcode label has been placed into a sample rack, do not
rotate the sample tube. Otherwise, the barcode may be contaminated or

55
 damaged, and thus lead to incorrect reading of the barcode. Use only the
sample rack provided together with the analyzer.

5.7.5 Preparing for Installation of Sample Rack on the Analyzer

The manufacturer provides multiple sample racks. Up to five sample racks can be
placed in the analyzer at the same time.

1 Place the sample rack on the analyzer.

1.1 Open the door to the sample rack sampling channel.

1.2 Push the sample rack into a vacant sampling channel until it cannot be further
pushed in.

The sample rack should be pushed in place.

5.8 Test Selection

5.8.1 Sample Number and Sample ID

The valid field of sample identification depends on the type of sample (STAT, or
general) and the mode used (sample scanning is enabled, or sample scanning is
disabled).
When sample scanning is disabled, you need to manually enter the sample
number and test item. When sample scanning is enabled, the added item can be
directly read through the scanned barcode.

5.8.2 Test Selection

Each page has 30 buttons. From the "Utility" menu, you can set the items
corresponding to the buttons. Up to 6 groups can be set. Each time, one group is
displayed on the "Assay Position" interface. You can click a button to select the
item, as shown in Figure 5.8.2-1

56
 Figure 5.8.2-1

5.8.3 Function Buttons

Release Rack: Release vacant sample racks, as shown in Figure 5.8.3-1.

Figure 5.8.3-1

Patient Info: Input patient information such as the age, gender and department,
as shown in Figure 5.8.3-2.

57
 Figure 5.8.3-2

Retest: Allocate sample racks for samples that need to be retested, as shown in
Figure 5.8.3-3.

Figure 5.8.3-3

Batch Input: Input multiple samples of the same item in batches, as shown in
Figure 5.8.3-4.

58
 Figure 5.8.3-4

Last No.: Input the last sample number.

Repeat Times: Input the repeat count (not greater than 100).

5.9 Starting Analysis

Click "Start" from the general menu on the right of the interface. An interface as
shown in Figure 5.9-1 is displayed.

Figure 5.9-1

On the "Start" interface, you can set the sample test conditions. Then, click the
"Start" button to start testing calibrators, controls and samples.
Host Comm.: When the host communication is connected, the test results will be

59
output based on the settings.
Auto Retest: When this feature is enabled, the analyzer will determine whether to
retest a sample based on the configured auto retest conditions.
Assay Mask: Suspend the use of loaded items on the analyzer.
Cancel: Exit.

When the "Auto Retest" feature is enabled, the system will determine whether a
retest is required after the sample test is completed. If the sample rack is not
removed and the system determines that a retest is necessary, the analyzer will
scan the sample tube again for auto retest.

5.10 Viewing Sample Result

All test data are saved. You can browse and query the test data.
Test data of the current data are displayed in "Work" → "Data Review". History
data can be queried by using the "History Data" key.

5.10.1 Data Review

On this interface, you can check the sample item and result information, and edit
sample information and print report with relevant function keys, as shown in
Figure 5.10.1-1.

Figure 5.10.1-1

5.10.2 Function Key

Patient Info: Same as "Patient Info" in "Test Selection".

Search: Query the sample information in the current sample database.

60
Manual Transmission: Manually transfer the selected sample information.
Delete: Delete the selected sample information.
Delete All: Delete all sample information.
Print: Select to print.
Review: Review the tested sample. Only reviewed sample can be printed and
cannot be modified.
Test Review: Browse the details of the selected sample, as shown in Figure 5.10.2-
1.

Figure 5.10.2-1
History Data: View the sample data in the history database.
Data Export: Export sample data to the computer hard disk.

5.11 Shutdown Maintenance

Shutdown maintenance needs to be performed each day before system
shutdown. (For details about shutdown maintenance, refer to Section 9.4 List of
Maintenance Items.)

5.12 Shutdown Procedure

Click "Exit" from the general menu on the right of the interface. An interface as
shown in Figure 5.12-1 is displayed.

61
 Figure 5.12-1

Select "Exit" to close the software and then close the computer system. Maintain
the connection to the analyzer main power for refrigeration of the reagent
compartment.

Empty the solid waste container in a timely manner and properly dispose of the
waste liquid.

62
 Chapter 6
Calibration

6.1 Calibration Settings

6.1.1 Inputting Calibrators

You may input the calibrator information in either of the following methods:
Method 1: For items with calibrators in the reagent kit, when the analyzer
successfully scans the reagent RFID, it automatically download the calibrator
information, including the calibrator name, batch No., expiration date,
concentration, etc.
Method 2: For items without calibrators in the reagent kit, go to the "Setting"
interface as shown in Figure 6.1.1-1, and click "Scan" to scan the 2D barcode
inside the calibrator reagent kit, so as to download the calibrator information.

63
 Figure 6.1.1-1

6.1.2 Calibrator Position

After the input of calibrator information, you can set the calibrator position on the
"Setting" interface. Click the blue block under "Calibrator X", and select the rack
number and position number. After changes, click "Save" to save the settings.

Calibrators of the same item must be placed onto the same sample rack in the
specified sequence one by one.
The calibration cycle may be different for different projects. Please operate
according to the calibration requirements on the kit manual of the
corresponding project. If the calibration fails, please contact the service
department of the company or authorized distributor.

6.2 Implementing Calibration

6.2.1 Selecting Calibration Item

The system can identify the 1D barcode on the calibrator and match it with the
corresponding reagent to implement auto calibration. If the calibrator is placed
onto the sample rack and put into the analyzer directly for auto calibration, the
reagent currently being used will be used for calibration by default. If the standby
reagent is selected for calibration, only the standby reagent will be calibrated. If
both the current bottle and standby bottle of the same batch are selected at the
same time, both bottles of reagents will be calibrated simultaneously.
When the calibrator barcode is damaged or missing, the auto calibration feature

64
 "Status
Setting" "interface,
interface,and
andset
then
thesave
position
the settings,
of the corresponding
As shown in Figure
calibrator
6.2.1-1.
on the

cannot be used. In this case, you can select the corresponding item from the

Figure 6.2.1-1

6.2.2 Placing Calibrators

After the calibration item is selected, prepare the corresponding calibrator and
put it to the corresponding sample rack. Then, place the calibrator rack into the
analyzer.

6.2.3 Starting Calibration

Figure 6.2.3-1

If the analyzer is in running status, it automatically starts calibration after the

calibrator rack is placed in. If the analyzer is in sampling stop or standby status,
you need to click the "Start" button to start the test.

65
The tests on calibrator and general sample can be implemented at the same time.

6.3 Calibration Result

Calibration history: View the recent 50 pieces of history information of an item, as
shown in Figure 6.3-1.
Signal values of calibrators of different concentrations will be separately
displayed. L1 indicates level 1, and L2 indicates level 2.
Click a calibration, the corresponding information will be displayed above the
graph.

Figure 6.3-1
Calibration Result: View the information related to the current calibration curve, as
shown in Figure 6.3-2.
The current working curve of the selected reagent bottle will be displayed in the
graph.

Figure 6.3-2

66
Instrument Coefficient: Calibration factor about differences between instruments,
as shown in Figure 6.3-3.

Chapter 7
Figure 6.3-3

Quality Control

67
7.1 QC Settings
With this module, you can set the controls, select control items, and view control
results, as shown in Figure 7.1-1

Figure 7.1-1

68
7.1.1 Adding Controls

Matching control: Download control information through barcode scanning or

downloading from the network.
Third-party control: Users may add control information as required by clicking the
"Manual" button at the bottom and filling in the corresponding control
information, as shown in Figure 7.1.1-1.

Figure 7.1.1-1

7.1.2 Setting Target Value and Standard Deviation

Barcode control: Download control target value and standard deviation through
barcode scanning or downloading from the network.
Control without barcode: From the list on the left, select the control to be edited,

and click "Edit", as shown in Figure 7.1.2-1. After change, click the "Save" button.
Figure 7.1.2-1

69
7.1.3 Control Position

As shown in Figure 7.1.2-1, on the "Setting" interface, click the blue block in the
"Pos." column, and select the available control position.

7.2 Implementing Control Test

7.2.1 Selecting Control Item

On the "Status" interface, select an item and click "Select". Click again and cancel
the selection, as shown in Figure 7.2.1-1.

Figure 7.2.1-1

◼ If the control item for each time is the same, you can set it to the default
control, as shown in Figure 7.2.1-2.

Figure 7.2.1-2

70
For the same item, if multiple bottles of reagents are placed, except for the
current bottle, the standby bottles can also be used to test the same control. On
the "Default QC" interface, select the corresponding standby reagent, as shown in
Figure 7.2.1-3.

Figure 7.2.1-3

7.2.2 Placing Controls

After the control item is selected, prepare the corresponding control and put it to
the corresponding sample rack. Then, place the sample rack into the analyzer.

7.2.3 Starting Control Test

If the analyzer is in running status, it automatically starts sampling. If the analyzer

is in sampling stop or standby status, you need to click the "Start" button to start
the test. The tests on calibrator and general sample can be implemented at the
same time.

7.3 QC Result
The "Result" interface displays information such as the "Assay", "QC Name", "QC
Lot", "Date", "Target V.", "SD", "Quant.", "Average", "Calc. SD", "CV(%)", and etc. as
shown in Figure 7.3-1. Each assay supports the viewing of "QC Chart".

71
 Figure 7.3-1

QC Chart: The system can display the control test results in graph mode. To access
the "QC Chart" interface, click the "QC Chart" button, as shown in Figure 7.3-2.
On this interface, you can select different assays to view the control test result
graph, and can click the "Print" button to print out the control test graph.

Figure 7.3-2

72
Chapter 8
Utility

73
8.1 Assay
Click "Utility". The "Assay" submenu is displayed by default, as shown in Figure
8.1-1.

Figure 8.1-1

1 Item list

Item parameter serials number and item name are displayed. The No. indicates
the parameter loading serials number of the item. The assay name refers to the
item parameter name and cannot be modified.

74
2 Item parameters

Detailed parameter information about the item is displayed, including "App

Code", "Result Unit", "Printing Name", "Days Open Vial", "Linear Range",
"Reference Range", "Auto Retest", etc.

3 Parameter Download

Click "Download". In the displayed "Download" dialog box, select "Flash Disk
Download", "RFID Download", or "Internet Download" as required to prompt the
corresponding download page, as shown in Figure 8.1-2.

Figure 8.1-2

4 Delete

Select the item name of the item parameter to be deleted, and click " Delete". In
the displayed "Please confirm whether to delete the parameter info." dialog box,
click "Yes（Y）" to delete the selected parameter.

5 Save

Save the changes to the item parameters.

8.2 Maintenance
Click "Utility". The "Maintain" submenu is displayed by default, as shown in Figure
8.2-1.

75
 Figure 8.2-1

1 Maintenance Log

This tab displays information about analyzer maintenance log.

2 Instrument Maintenance

This tab displays the maintenance name, maintenance item and other
information. You can select an item and click "Run" to start maintenance. In case
of emergency, you can click "Stop" to stop the maintenance item that is running.

3 Alarm Info

This tab displays all alarm codes, alarm types, alarm information and alarm dates.
Solutions are also provided for your reference.

4 Temperature Check

This tab displays the real-time temperature of the modules. Information such as
the monitored part, current temperature, temperature control range, and
temperature control status is included.

8.3 System
Access the "System" interface, as shown in Figure 8.3-1.

Figure 8.3-1
1 Version

Analyzer software version information.

76
2 System Time

Set the software system time.

3 Sample Scanning

Enable/Disable the sample barcode scanning feature.

4 Review

Enable/Disable the sample result review feature.

5 Ext. Dilu. Mod.

Whether to enable external dilution.

6 Auto Startup

To customize the auto startup time of the analyzer, click "Auto Startup". A dialog
box is displayed, as shown in Figure 8.3-2.

Figure 8.3-2

On this interface, set the auto startup time of the analyzer each day (with each
week as a time period), and click "Ok".

7 Alarm Setting

Set the alarm thresholds for reagents, supplies and waste, and set the alarm
volume. Click "Alarm Setting". A dialog box is displayed, as shown in Figure 8.3-3.

77
 Figure 8.3-3

8 User Management

To add/delete user accounts and manage account permissions, click "User

Management". A dialog box is displayed, as shown in Figure 8.3-4.

Figure 8.3-4

Enter the user name and password, and select the account permission. Then, click
"Add" to add a user. Or, select an existing use name, and click "Change Password"
to change the password. Or, select an existing user name to delete the user name.

9 Combination Setting

To set item combination and operate single items in combination, click

"Combination Setting". A dialog box is displayed, as shown in Figure 8.3-5.

78
 Figure 8.3-5

Select an empty location from the "Assay Combination" list on the left, and enter
a name in the "Name" field. Select an item combination, and click "Add -->" to
add the item in the "Assay" to the "Assay Combination" column. Select an item
combination and click "Add" to add the combination name. To remove an item
from the "Assay Combination" column, click "Delete". To save changes, click
"Update".

10 Assay Position

To customize the key position of "Work-Test Selection", click "Assay Position". In

the displayed "Assay & Combination List" dialog box, click the item key or a blank
key. As shown in Figure 8.3-6.

Figure 8.3-6

In " Assay & Combination List ", allocate items for the keys. If no items are to be

79
allocated, select "Unallocated".

11 Calculation Item

To set the item that is calculated based on the analyzer test results and to import
the calculation related item and edit the calculation formula, click "Calculation
Item". A dialog box is displayed, as shown in Figure 8.3-7.

Figure 8.3-7

Input the basic information such as the "Assay", "App Code", "Result Unit" and
"Decimal Digits", and click "Add" to add calculation item information to the
system. In the "Calculation Formula" area, select an item for calculation formula
editing, and set the reference value for this item within the reference range.

12 Printing Setting

In "Printing Setting", you can set the report template.

13 Language Select

This feature allows the settings of system language. To switch between English
and Chinese, click "Language Select". A dialog box is displayed, as shown in
Figure 8.3-8.

80
 Figure 8.3-8

Select a language and click "OK" to save the settings.

14 Host Communication

To set the communication parameters such as communication mode and

frequency, click "Host Comm.". A dialog box is displayed, as shown in Figure 8.3-9.

Figure 8.3-9

You can set serial port parameters, communications, and control auto data upload
and receipt of sample data.

15 Remote Assistance

With connection to a server through the Internet, operations such as remote

diagnosis, remote maintenance and remote operation (network connection is

81
required) are supported.

16 Calibration Mask

For items of which the calibration is shielded, calibration curves will not be
generated after failed calibration, and the original calibration curves will be used.

Figure 8.3-10

82
 Chapter 9
Maintenance

This chapter introduces details about routine maintenance procedures and the

83
maintenance schedule. Users need to carefully read this chapter to make sure that
the analyzer can operate normally.

9.1 Maintenance Precautions

9.1.1 Preventive Maintenance

To maintain the normal performance of the analyzers, preventive maintenance

needs to be carried out on a regular basis. Details are as follows:

1 Inspection:
Discover abnormalities at an earlier stage
◼ Routine inspection (before and after operation)
◼ Regular inspection

2 Scheduled maintenance:

Maintaining device performance

◼ Replacement or repair of aging parts

3 Spare parts storage:

Available in case of failures

◼ Keeping sufficient spare parts inventory

4 Environment improvement and control:

Taking measures from the following perspective to maintain performance:

◼ Temperature and humidity
◼ Water quality
◼ Dust and gas

9.1.2 Analyzer Maintenance

◼ Manual maintenance: Maintenance operations carried out by the users step

by step according to this chapter.
◼ System maintenance: Maintenance operations automatically carried out by
the analyzer after the relevant buttons on the "Maintain" interface are
clicked.

84
 Personnel for routine maintenance of the analyzer must be trained by the
Company before they can perform maintenance.

9.1.3 Safety Instructions to Maintenance and Troubleshooting

To safely maintain the analyzer and guarantee its proper performance, please
comply with the following requirements.

In the rest of this manual, the sign is added next to the title
where special attention needs to be paid. When you see this title, please check its
meaning in this section.

Contact with a certain instrument system can cause infection/damage

Contact with the magnetic separation system, test system or reagent arm
system may lead to damage or infection.
◼ Before manual maintenance or inspection, be sure to wear protective
equipment and follow instructions in the manual.
◼ If the sample, reagent or other solution contacts with the skin,
immediately wash with water and disinfect the contact site, and seek
medical help.
Scope of application: Section 9.3.2 Maintenance Interval.

Contact with a certain instrument system can cause infection/damage

Contact with the reagent arm system or sampling system may lead to damage
or infection.
◼ Before analyzer maintenance, be sure to close the front cover.
◼ During analyzer maintenance, do not open the front cover.
Scope of application: Instrument maintenance.

Direct contact with reagents can cause burns to the skin

Direct contact with the substrate A, substrate B, or cleaning solution may burn
your skin.
◼ When moving the cleaning solution, be sure to wear protective equipment
and follow the special instructions specified on the reagent package label.
◼ In case of any problem about the compatibility between the cleaning
solution and the instrument parts, or about the substances included,
consult the Company or an authorized dealer.

85
 Scope of application: Washing the flow path with cleaning solution.

Contact with samples can cause infection

Contact with samples may cause infection.
◼ Before manual maintenance, be sure to wear protective equipment.
◼ When samples contact with the skin, immediately wash with water and
disinfect the contact site, and seek medical help.
◼ When samples are found to be attached to the analyzer parts, immediately
wear protective equipment and then remove the samples and disinfect the
contact site.
Scope of application: Pump tube replacement.

Contact with waste liquid can cause infection

Contact with waste liquid may cause infection
◼ Before manual maintenance or inspection, be sure to wear protective
equipment.
◼ When waste liquid contacts with the skin, immediately wash with water
and disinfect the contact site, and seek medical help.
Scope of application: Waste liquid discharge.

Fire safety and avoiding burns

Ethanol/isopropanol is a flammable liquid that can trigger fires.
◼ When using such type of liquid for maintenance, keep the site away from
open fire. Otherwise, fire can be caused.
Scope of application: Cleaning the filling needle, the injection/aspirating needle
of the magnetic separation system.

Improper disposal of waste liquid or other waste can cause pollution

The waste contains samples (such as serum), therefore is very likely to be
infectious. They must be disposed of as instructed by relevant authorities of
infectious medical waste management based on applicable laws and
regulations. Besides, concentrated water contains high concentration of
reaction mixture, and should be disposed of as infectious waste.
◼ For details about substances subject to the management under laws and

86
 regulations included in reagents, calibrators or controls, consult your
reagent supplier. Also, please abide by the device drainage regulations.
Scope of application: Washing waste outlet and waste container.

Improper disposal of infectious waste

Waste and cuvette must be disposed of as infectious medical waste. They must
be disposed of as instructed by relevant authorities of infectious medical waste
management by referring to the device safe control procedure.
Scope of application: Disposal of used cuvette and waste.

9.2 Preparation for Maintenance

Preparation before maintenance is as follows:

9.2.1 Necessary Items

Item Use

Gauze For cleaning

Cotton swab For cleaning

Ethanol For wiping

Protective equipment (protective Required for maintenance

clothing, goggles, and protective
gloves)
Special cleaning solution For cleaning

Note: The cleaning agent or disinfectant that can have chemical reactions with
the materials of the device cannot be used. If you have any questions, please
contact the Company.

9.3 Maintenance Conditions and Frequency

9.3.1 Status of Analyzer During Maintenance

When cleaning the analyzer system or replacing any parts, follow the
procedures specified in this manual. Before parts replacement, be sure to
disconnect the analyzer from power supply.

87
 During the maintenance that is allowed to be performed with the analyzer
energized, make sure its upper cover is closed. When the front cover needs to
be opened, make sure to not contact any other parts except the target part.

9.3.2 Maintenance Interval

After the setting of the maintenance interval, you can monitor the maintenance
time on the interface.
If any maintenance item exceeds the actual maintenance time limit, the message
about timeout of maintenance may be displayed in yellow or red.

9.3.3 Maintenance Frequency

The maintenance frequency is determined based on the assumption that the

device runs for 4 hours a day, 25 days a month. Please refer to the following table
to perform regular maintenance.

SN Item Daily As Weekly Monthly Quarterl Every Annually

Required y Six
Months
1 Filling needle o o *1 o

2 Injection/aspiratin o o *1 o

g needle of the
magnetic
separation system
3 Device surface o

4 Cooling fan o

5 Dust filter at o

bottom of the
analyzer
1*: If the filling needle or pipeline is suspected to be blocked, clear clog if
necessary.

9.3.4 Regularly Replacing Parts

Certain parts need to be replaced regularly for preventive maintenance. The

replacement cycle is determined based on the assumption that the device runs for
4 hours a day, 25 days a month. Please determine your own replacement cycle
according to actual circumstances. At the time of purchase, provide the Company
or an authorized dealer with the relevant part number for replacement.

88
 SN Item Daily As Weekly Monthly Quarterly Every Annually
Required Six
Months
1 Filling o

needle

9.3.5 Maintenance of the Spare Parts Inventory

Spare parts for maintenance should be prepared for analyzer repair. At the time of
purchase, consult the Company or an authorized dealer.

9.3.6 Precautions for Continuous Running

If the analyzer is used for continuous running of over 24 hours without shutdown
to test STAT samples at night, be sure to manage the time cycles of the
maintenance items. In case of manual maintenance, be sure to prepare the
maintenance table and protective equipment. The maintenance cycle and time for
scheduled replacement are determined based on the assumption that the device
runs for 4 hours a day. This frequency can be adjusted based on the actual
running times.

9.3.7 Precautions for Operations after Long Idle Time

If the analyzer had been turned off for three or more days, wash and drain the
pipeline, and check and confirm its performance before startup. For details,
consult the Company or an authorized dealer.

9.4 List of Maintenance Items

Maintenance
SN Maintenance Item Maintenance Type
Frequency
Weekly maintenance Weekly System maintenance
1
Monthly maintenance Monthly System maintenance
2
Test end maintenance As required System maintenance
3
Startup maintenance Daily System maintenance
4
Shutdown Maintenance Daily System maintenance
5
Pipeline filling As required System maintenance
6
Pipeline washing As required System maintenance
7
Substrate filling As required System maintenance
8
Instrument reset As required System maintenance
9

89
 Magnetic beads mixing As required System maintenance
10
Removing cuvette As required System maintenance
11
Reagent scanning As required System maintenance
12
Soaking and washing As required System maintenance
13
needle

Figure 9.4-1 shows the "Maintain" interface.

Figure 9.4-1

This interface describes the maintenance procedures of various items.

Sections related to safe operations are identified with the

sign.

9.4.1 Startup/ Shutdown Maintenance of Flow Path

Contamination in the flow path of the inner wall of the filling needle can lead to
incorrect measurement results or cause clog.
The analyzer flow path is automatically maintained upon startup and
automatically cleaned before shutdown.

9.4.2 Filling Needle

Contamination on the inner or outer surface of the filling needle can lead to
incorrect measurement results or cause clog.

The following takes the removing of clog on the outer surface of the filling needle
as an example. In case a filling needle clog alarm is generated and the alarm
continues after auto washing is performed, you need to manually remove the

90
clog.

Soaking the surface of the filling needle

The soaking of the surface of the filling needle shall be performed each day after
tests are completed.
1. Make sure that the analyzer is in standby status. Put the special cleaning
solution into the reagent compartment.
2. Perform shutdown maintenance
3. The maintenance can be performed at any time as required. Select "Soak And
Clean For Pipettor" as the Maintenance Item.

9.4.3 Cooling Fan

The cooling fan is located at the back side of the analyzer. After long time of
use, a large amount of dust can accumulate on the fan and lead to temperature
control exception of the analyzer. Clean the cooling fan once every six months.
1. Disconnect the power supply of the analyzer.
2. Use a vacuum cleaner to clean the dust on the fan of the analyzer.

9.4.4 Dust Filter at Bottom of the Analyzer

The dust filter is located at the bottom of the analyzer. After long time of use, a
large amount of dust can accumulate on the filter and lead to temperature control
exception of the analyzer. Clean the dust filter once every quarter.
1. Disconnect the power supply of the analyzer.
2. Take out the dust filter, clean it with water, left it dry, and then install it back to
the analyzer.

9.4.5 Fuse and Overheat Protection Device

For short circuit protection and overcurrent protection, the power part of the
analyzer is equipped with four types of fuses, namely F250VAC 10A, F32VDC 2A,
F32VDC 25A, and F32VDC 30A. If the analyzer cannot operate normally due to
overcurrent or short circuit issues, contact the Company or an authorized dealer.
The heating and cooling part of the analyzer is equipped with temperature sensor
and temperature protection switch. To guarantee that they are functional all the
time, the Company or authorized dealers will carry out inspections regularly.

91
 Chapter 10
Troubleshooting

92
This chapter describes general information about analyzer faults, which can help
you determine the fault reason and mitigate the possibility of operational failures
due to human factors. For effective troubleshooting, please carefully read the
manual.

10.1 Troubleshooting

Faulty Module Fault Description Solution

1. Reset the instrument. If the

reset fails, go to step 2.
2. Restart the software and reset
Instrument power
the instrument.
supply exception
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Fan exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Check whether the room
temperature is within the
Abnormal ambient
System level failure specified range. If yes, go to step
temperature inside
2.
instrument
2. Contact the Company or an
authorized dealer.
1. Check whether the instrument
Instrument is powered on. If yes, go to step
communication 2.
exception 2. Contact the Company or an
authorized dealer.
1. Restart the software.
2. If the reset fails for three times,
Software exception
contact the Company or an
authorized dealer.
1. Check whether the serial cable
Failure to establish connection and serial port
connection with LIS parameter settings are correct. If
yes, go to step 2.

93
 2. Contact the Company or an
authorized dealer.
Command parameter 1. Contact the Company or an
error authorized dealer.
1. Restart the software. If the
problem persists, go to step 2.
CAN Receive error
2. Contact the Company or an
authorized dealer.
CAN
1. Restart the software. If the
communication
problem persists, go to step 2.
failure Task execution failure
2. Contact the Company or an
authorized dealer.
1. Restart the software. If the
problem persists, go to step 2.
Flash error
2. Contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Rotating disk
the instrument.
operation exception
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Add sufficient cuvette(s) and
try to start running again. If the
Insufficient cuvette in problem persists, go to step 2.
auto loading 2. Restart the software. If the
compartment problem persists, go to step 3.
Auto loading
3. Contact the Company or an
module failure
authorized dealer.
1. Restart the software. If the
Failure to obtain
problem persists, go to step 2.
photoelectric
2. Contact the Company or an
information
authorized dealer.
1. Reset the instrument. If the
problem persists, go to step 2.
2. Restart the software and reset
Cuvette loading failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.

94
 1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. When the instrument is shut
down, check whether the amount
of reagent in the corresponding
reagent kit is sufficient. If not,
replace the reagent kit. If yes, go
to step 2.
Insufficient reagent
2. Open the reagent compartment
Reagent arm sampling amount
cover, select a reagent position
module failure
where no reagent kit is placed.
Check whether the reagent
carousel is loosened. If yes,
contact the Company or an
authorized dealer.
1. When the instrument is shut
down, check whether the
remaining amount of the
corresponding sample is
Insufficient sampling insufficient, where there are
bubbles, and other exceptions.
2. If the sample is normal, contact
the Company or an authorized
dealer.
1. When the instrument is shut
down, check whether there is any
coagulum or other exception in
Sampling failure the corresponding sample.
2. If the sample is normal, contact
the Company or an authorized
dealer.

95
 1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. When the instrument is shut
down or standby, check whether
the position of the reagent kit is
No reagent kit at
correct. If yes, go to step 2.
specified reagent
2. Access the diagnostics view to
position
check the action of the reagent
carousel.
Reagent carousel
3. Rescan the reagent.
module failure
Opened reagent 1. Close the reagent compartment
compartment cover cover.
1. Place the reagent kit again and
perform reagent scanning. If the
problem persists, go to step 2.
2. Restart the software and
Failure to read reagent
perform reagent scanning. If the
information
problem still persists, go to step
3.
3. Contact the Company or an
authorized dealer.
Temperature control 1. Contact the Company or an
exception authorized dealer.
1. Check whether the reagent kit
is properly placed. If yes, go to
step 2.
Magnetic beads mixing 2. Check whether the rotor in the
failure reagent compartment is
loosened.
3. Contact the Company or an
authorized dealer.

96
 Temperature control 1. Contact the Company or an
exception authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
Incubator module contact the Company or an
failure authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
Sampling module
contact the Company or an
failure
authorized dealer.
1. Check whether the sample rack
and sample tube are correctly
placed. If not, place them
correctly.
2. Check whether the barcodes
Scanning failure on the sample rack and sample
tube are damaged. If yes, replace
the corresponding barcode.
3. If the scanning still fails, contact
the Company or an authorized
dealer.
External dilution Cleaning solution 1. Check whether the supply of
module failure preparation exception purified water is opened and

97
 whether the water pressure is
normal. If yes, go to step 2.
2. Restart the external dilution
module. If the problem persists,
contact the Company or an
authorized dealer.
1. Restart the external dilution
module.
2. Place the concentrated
solution bottle at the specified
position and make sure that the
Failure to read wash
RF label is correctly attached; or
buffer information
reload or replace the
concentrated solution.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
Substrate supply authorized dealer.
module failure 1. Reposition the substrate. If the
problem persists, go to step 2.
2. Restart the software. If the
Failure to read
problem still persists, go to step
substrate information
3.
3. Contact the Company or an
authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure
the instrument.
3. If the reset fails for three times,
Detection module
contact the Company or an
failure
authorized dealer.
1. Reset the instrument. If the
Substrate mixing
reset fails, go to step 2.
motor operation
2. Restart the software and reset
exception
the instrument.

98
 3. If the reset fails for three times,
contact the Company or an
authorized dealer.
Temperature control 1. Contact the Company or an
exception authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
Magnetic
1. Reset the instrument. If the
separation module
reset fails, go to step 2.
failure
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
Temperature control 1. Contact the Company or an
exception authorized dealer.
1. Reset the instrument. If the
reset fails, go to step 2.
2. Restart the software and reset
Reset failure the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
Cuvette transfer 1. Reset the instrument. If the
module failure reset fails, go to step 2.
2. Restart the software and reset
Operation exception the instrument.
3. If the reset fails for three times,
contact the Company or an
authorized dealer.
1. Contact the Company or an
Cuvette transfer failure
authorized dealer.

10.2 Contact Us
Contact information of the Company's service department

99
 Appendices

100
Specifications

Specification Description

Instrument type: fully automated, random tube-type analysis

Working principle: acridinium ester chemiluminescence
Entire system technology.
performance Test throughput: NP-CL 8: 180 tests per hour
Time required for generating the first result: less than 14
minutes

101
 Intra assay CV for clinical projects: intra assay CV of alpha
fetoprotein (AFP) ≤ 5.0%
Analyzer stability: The relative deviation of the test results of
alpha fetoprotein (AFP) at the fourth hour and the eighth hour
after the analyzer enters stable operation from the test result
when the analyzer first enters stable operation does not
exceed ±10%.
Linear correlation: For alpha fetoprotein (AFP), with no less
than 2 orders of magnitude covered by the concentration
range, the linear correlation coefficient (r) ≥ 0.99.
Up to 50 samples can be loaded at the same time. Continuous
Loading
loading is supported. STAS samples can be prioritized.
module
Auto retest is supported.
Sampling range: 5 μL to 100 μL
Sampling precision: when V ≤ 10μL, error ≤ ±1 μL, CV ≤ 5%;
when 10 μL < V ≤ 50 μL, error ≤ ±10%, CV ≤ 3%; V＞50μL,
error ≤ ±5%, CV≤2%.
Sample Carry-over rate: ≤ 2×10-7
module Filling needle: supports features such as liquid level detection,
block detection, amount-based tracking, and anti-collision
detection
Sample type: serum, plasma, whole blood, urine and other
body fluid
Sampling range: 20 μL to 100 μL
Sampling precision: when 10 μL < V ≤ 50 μL, error ≤ ±10%, CV
Reagent ≤ 3%; when V > 50 μL, error ≤ ±5%, CV ≤ 2%
module Number of reagent positions: 30
Reagent compartment refrigeration: 4℃ to 10℃
Reagent mixing: real-time mixing
Cuvette: auto loading, maximum capacity of 1200 cuvettes,
continuous loading is supported
Reaction Reaction temperature: 37℃±0.5℃, the fluctuation degree does
module not exceed 0.5℃
Reaction liquid mixing: contactless mixing
Magnetic separation: four-time magnetic separations
Instrument noise: signal value detected ≤ 150
Linear range of chemiluminescence signal value: with no less
than 3 orders of magnitude covered by the
Detection chemiluminescence signal value range, the linear correlation
module coefficient (r) ≥ 0.99
Repeatability of chemiluminescence signal value: Coefficient of
Variation (CV) ≤ 5.0%
Stability of chemiluminescence signal value: with agent

102
 adopted, the change in chemiluminescence signal value ≤
±10.0%
Computer system: Windows 7 and later version OS
System Remote diagnosis: supported, via network fault diagnosis
functions system
Auto on/off: supported, time can be customized
Temperature: 10℃ to 30℃; humidity ≤ 70%; altitude: –200 m
to +3700 m
Power supply: 100V-240V~, 50/60 Hz, 1000 VA
Environmental Net weight: approx. 170 kg
Requirements Dimensions: 1200×755×675 [L×W×H mm]
Waste disposal: direct discharge, and waste liquid container
Water consumption: ≤7 L/hour
Standby noise < 63 dB(A)

Accessories

NP-CL 8 NP-CL 8 NP-CL 8

Power cable EU plug (piece) 1 1 1

Power cable UK plug (piece) 1 1 1

Power cable USA plug (piece) 1 1 1

Network cable(piece) 1 1 1

Barcode reader (piece) Optional Optional Optional

Barcode reader rack (piece) Optional Optional Optional

Sample rack (gray) (set) 10 10 10

Purified water container (piece) 1 1 1

Cleaning solution container (piece) 1 1 1

Liquid container (piece) 1 1 1

Purified water bottle (piece) 2 2 2

Trash bin (piece) 1 1 1

Waste liquid container (piece) 1 1 1

DC fuse 2A (piece) 5 5 5

DC fuse 25A (piece) 5 5 5

DC fuse 30A (piece) 5 5 5

AC fuse 10A (piece) 10 10 10

103
 USB flash drive 1 1 1

Float switch for waste liquid container

1 1 1
(set)
Float switch for purified water container
1 1 1
(set)
Float switch for cleaning solution
1 1 1
container (set)
TPU pipe (piece) 3 3 3

Resin hose (piece) 1 1 1

Sample storage pipe (bag) 1 1 1

Enclosure cushion (piece) 2 2 2

Rubber pad for magnetic on front

6 6 6
compartment door of enclosure (piece)
Cuvette for Automated
1 1 1
Chemiluminescence Analyzer (bag)

EMC Instructions

I Declaration

Table 1

Guideline and manufacturer declaration —Electro Magnetic Interference

The Automatic Chemiluminescence Analyzer is expected to be used in the

electromagnetic environment as specified below. Purchasers or users must
guarantee the provision of such environment.
Electromagnetic
Emission test Compliance environment —
Guideline
The Automatic
Chemiluminescence
Analyzer uses radiated
energies only for its
Conducted Emissions
Group 1 internal functions. The
CISPR 11
radiated emission power
is very low and is highly
unlikely to interfere with
other electronic devices.
Radiated Emission CISPR The Automatic
Class A
11 Chemiluminescence

104
Harmonic Current Analyzer can be used in
Emissions Class A all non-household
IEC 61000-3-2 facilities and all
household facilities that
are not directly
Voltage Fluctuations and
connected to the public
Flicker Complies
low-voltage power
IEC 61000-3-3
supply network of
residential applications.

Table 2

Guideline and manufacturer declaration — Electro Magnetic Susceptibility

The Automatic Chemiluminescence Analyzer is expected to be used in the

electromagnetic environment as specified below. Purchasers or users must
guarantee the provision of such environment.
IEC 61326 Electromagnetic
Susceptibility
Test level Compliance level environment —
test
guideline Guideline
The ground should
be wooden,
concrete or tile
±2 kV, ±4 kV ±2 kV, ±4 kV
Electrostatic floors. If the
contact contact
Discharges ground is covered
discharge discharge
(ESD) by synthetic
±2 kV, ±4 kV, ±8 ±2 kV, ±4 kV, ±8
IEC 61000-4-2 materials, the
kV air discharge kV air discharge
relative humidity
should be at least
30%.
Power supply
network should be
Electrical Fast qualified to be used
Transients (EFT) ±1 kV ±1 kV in a typical
IEC 61000-4-4 commercial or
hospital
environment.
Power supply
±1 kV line to line network should be
Surge ±1 kV line to line
±2 kV line to qualified to be used
IEC 61000-4-5 ±2 kV line to line
earth in a typical
commercial or

105
 hospital
environment.
Power supply
network should be
qualified to be used
in a typical
commercial or
0 % UT* during 1 0 % UT* during 1
hospital
cycle cycle
environment. If the
40 % UT* during 40 % UT* during
Voltage Dips, user of the
5/6 cycles 5/6 cycles
Interruptions, Automated
70 % UT* during 70 % UT* during
and Variations Chemiluminescence
25/30 cycles 25/30 cycles
IEC 61000-4-11 Analyzer requires
0 % UT* during 0 % UT* during
continuous
250/300 cycles 250/300 cycles
operation during
power outage, it is
recommended to
use UPS or
batteries for power
supply.
In case of operation
exception, move
the analyzer away
from the power
frequency magnetic
field or install
Power-Frequency magnetic shield at
Magnetic Fields 3 A/m 3 A/m the site. Before
(50/60Hz) installation,
IEC 61000-4-8 measure to make
sure that the power
frequency magnetic
field in the
installation site is
lower than the
compliance level.
NOTE: UT is the a.c. mains voltage prior to application of the test level. 5 cycles,
25 cycles and 250 cycles for 50Hz; 6 cycles, 30 cycles, 300 cycles for 60Hz.

Table 3

106
 Table 3 declaration — electromagnetic susceptibility (continued table)

The Automatic Chemiluminescence Analyzer is expected to be used in the

electromagnetic environment as specified below. Purchasers or users must
guarantee the provision of such environment.

IEC 61326- Compliance Electromagnetic environment —

Immunity test
2-6 test level level Guideline
The distance from portable and
mobile RF communication
devices to any parts of the
Automated Chemiluminescence
Analyzer (including cables)
should be at least the
recommended isolation
distance, which is calculated
based on the formula

Conducted corresponding to the

Disturbances 3V 3V transmitter frequency.

IEC 61000-4-6 150 kHz to Recommended isolation

80 MHz distance
d=1.2√P
d=1.2√P 80 MHz to 800
MHz
d=2.3√P 800 MHz to 2.7

3V/m 3V/m GHz

80 MHz-1 80 MHz-1 Where,

Radio GHz GHz P: The maximum output rated

Frequency 3V/m 3V/m power of the transmitter

Electromagnetic 1.4 GHz-2 1.4 GHz-2 provided by the transmitter

Fields GHz GHz manufacturer, in Watt (W);

IEC 61000-4-3 1V/m 1V/m d: recommended isolation

2.0 GHz-2.7 2.0 GHz- distance, in meter (m).

GHz 2.7 GHz The field strength of fixed RF

transmitter is determined by the
surveya of the electromagnetic
place, and each frequency
rangeb should be lower than the
compliance level.
Devices with the following sign
marked may generate
interference.

107
 Note 1: At 80 MHz and 800 MHz, the formula of a higher frequency band
should be adopted.
Note 2: These guidelines may not be applicable to all scenarios.
Electromagnetic propagation is affected by the adsorption and reflection on
buildings, objects and human bodies.
a Theoretically, for fixed transmitter such as wireless (cellular/cordless) phone
and ground mobile radio base station, amateur radio, AM/FM radio and
telecast, the field strength cannot be correctly predicted. To evaluate the
electromagnetic environment of fixed RF transmitter, the survey of the
electromagnetic place should be taken into consideration. If the field strength
measured at the place where the Automated Chemiluminescence Analyzer is
situated is higher than the above-mentioned RF compliance level, observe to
check whether the Automated Chemiluminescence Analyzer is functional. In
case of any exception, additional measures must be adopted, for example, to
adjust the direction or position of the Automated Chemiluminescence Analyzer.
b Within the entire frequency range of 150 kHz to 80 MHz, the field strength
should be lower than 3 V/m.

Table 4

Recommended isolation distance from portable and mobile RF communication devices to

the Automatic Chemiluminescence Analyzer

The Automatic Chemiluminescence Analyzer is expected to be used in the

electromagnetic environment where RF radiated disturbances are under
control. Based on the maximum output power of the communication device the
purchaser or user of the Automatic Chemiluminescence Analyzer can prevent
EMI by maintaining a proper allowable distance from portable and mobile RF
communication devices to the Automatic Chemiluminescence Analyzer.

Maximum rated Isolation distance for transmitters of different

output power of frequencies (m)
transmitter
150 kHz～80 80 MHz～800 800 MHz～2.7
W
MHz MHz GHz

d=1.2√P d=1.2√P d=2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

108
 10 3.8 3.8 7.3

100 12 12 23

For the maximum rated power of transmitter that is not listed in the above
table, the recommended isolation distance d (in m) can be determined by the
formula in the corresponding transmitter frequency column. Where, P is the
maximum rated output power of the transmitter provided by the transmitter
manufacturer (in W).
Note 1: At 80 MHz and 800 MHz, the formula of a higher frequency band
should be adopted.
Note 2: These guidelines may not be applicable to all scenarios.
Electromagnetic propagation is affected by the adsorption and reflection on
buildings, objects and human bodies.

II EMC Instructions and Safety Warnings

This product has passed the EMC test, and complies with the IEC 61326-1 / EN
61326-1 - Electrical equipment for measurement, control and laboratory use-EMC
requirements -Part 1: General requirements, and IEC 61326-2-6 / EN 61326-2-6 -
Electrical equipment for measurement, control and laboratory use-EMC
requirements -Part 1: General requirements.
During use, please strictly follow these requirements. Otherwise, EMI may be
caused to other devices, and the electromagnetic immunity or basic functions of
the Automatic Chemiluminescence Analyzer may be deteriorated or even lost.
This product is a Group 1 Class A device as specified in CISPR 11, a device that is
not expected to be directly connected to the public network cable, a non-
permanently installed device, and a non-life support device.
Portable and mobile RF communication devices may affect the normal operation
of the product. Make sure that the distance from portable and mobile RF
communication devices to the Automated Chemiluminescence Analyzer meets
certain requirements. For details, refer to Table 4.
The device power cable is 2.5 meters long, without a shield layer. The network
cable is 2.5 meters long, with a shield layer. In case of any connection cable
failure, contact the Company for repair or replacement. Otherwise, excessive
electromagnetic interference can be generated. In case of device failure, contact
the Company in time. Do not repair it or replace any components by yourself.
Otherwise, excessive electromagnetic interference can be generated.
Warning: Use only the transducer and cable sold by device or system
manufacturer as spare parts for the internal components. The use of unauthorized
accessories, transducer and cable may increase the device or system emission or
decrease the immunity.
Warning: Do not keep the device or system near other devices. Do not stack the

109
device or system with other devices. If this cannot be avoided, observe and check
to make sure that the device or system is functional under such circumstances.
This product is a professional IVD device. Pay attention to the following
preventive warnings:
a) The emission and immunity requirements listed from Table 1 to Table 4 must be
followed.
b) This device is designed and tested as a Class A device as specified in CISPR 11.
In a family environment, the device may cause radio interference. Therefore,
preventive measures should be taken.
c) It is recommended to evaluate the electromagnetic environment before using
the device.
d) Do not use this device near a strong radiation source (such as unshielded RF
source). Otherwise, the normal operation of the device can be affected.
Basic performance: The production is functional, for alpha fetoprotein (AFP) test,
Coefficient of Variation (CV) ≤ 5.0%.
Test method: Use alpha fetoprotein (AFP)' calibrator and reagent kit, test the
corresponding normal value control or fresh patient sample, repeat the test for 20
times, and calculate the Coefficient of Variation (CV, %) of the test results. The CV
should meet the requirement for basic performance.
Working mode: Set the software to detection mode, and test the control of alpha
fetoprotein (AFP) repeatedly.
Note: In radiation emission and conduction emission tests, use purified water to
replace the sample and reagent.

110