Zybio EXI1800 User manual

Chemiluminescence Immunoassay
Analyzer
Operation Manual
Zybio Inc.

Intellectual Property
The intellectual property rights of this operation manual and its corresponding products
belong to Zybio Inc. (hereinafter referred to as “Zybio”).
Zybio Inc. all rights reserved.
Zybio reserves the right of final interpretation of this operation manual.
Zybio reserves the right to modify the contents of this operation manual without prior
notice.
Zybio reserves the right to change the technology without prior notice.
Zybio reserves the right to modify the product specification without prior notice.
is a registered trademark or brand of Zybio.
Statement
This operation manual was issued on 03/25, 2020 and is subject to be modified without
prior notice if applicable.
The illustrations provided in the operation manual are examples only and may not be
completely consistent with the actual product, and are not permitted to be used for other
purposes. Please refer to the actual product for accurate display.
Zybio will be responsible for the safety, reliability and performance of this product only if all
of the following requirements are met, namely:
1) The installing, debugging, expanding, and maintaining of this product shall be
carried out by personnel approved by Zybio;
2) All parts, accessories and consumables for maintenance shall be produced or
approved by Zybio;
3) The operation of this product shall be carried out in accordance with this operation
manual;
4) The relevant electrical equipment shall comply with the national standards and the
requirements of this operation manual.

After-sales Service Provider
Company Name: Zybio Inc.
Address:Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial
Park, Dadukou District, 400082 Chongqing, PEOPLE’S REPUBLIC OF CHINA.
Website: www.zybio.com
Tel: + 86-23 6865 5509
Fax: + 86-23 6869 9779
E-mail: [e-mail]
Warning
1) Your analyzer should only be operated by professionals, doctors
and laboratory personnel trained by Zybio or its agents;
2) Failure to prepare a complete set of maintenance/repair plans may
result in product malfunction or personal safety issues.
Attention
1) This operation manual is intended for the following personnel:
⚫Operators
⚫Maintenance staffs
⚫Trainees
2) When your analyzer is scrapped, please contact the technical
service engineers of Zybio for comprehensive overhaul and
maintenance.

Product Description
Thank you for purchasing Zybio Chemiluminescence Immunoassay Analyzer. Allow us to
express our appreciation.
Please read this operation manual carefully before use.
The pictures in this operation manual are used for illustrations or examples only and are not
intended for other purposes. Please consult the actual product for accurate display.
Please consult this operation manual whenever necessary.
Product name: Chemiluminescence ImmunoassayAnalyzer.
Specifications and models: EXI1800, EXI1810, EXI1820, EXI1830.
Administration class: Class II.
Production license No.: Chongqing NMPA Production License No. 20150016.
Registration certificate No./Product Technical Requirement No.: Chongqing Instrument
Registration and approval No. 20202220259.
Product composition: This product consists of analysis unit, operation unit and accessories.
The analysis unit is composed of a sample processing system, a reagent processing system,
a cuvette transportation system, a sample reagent injection system, a reaction solution
mixing system, a magnetic separation system, a substrate system, and a photometric and
reaction system; The operation unit includes a display, a hand-held barcode scanner and an
analysis software; The accessories include a wash buffer container, a wash buffer floating
ball sensor, a liquid waste container and a liquid waste floating ball sensor. The software of
this product is a control software.
Intended use: This product adopts a chemiluminescence method based on alkaline
phosphatase-catalyzed reaction, in combination with matching testing reagents, and is
clinically used for the qualitative or quantitative tests of the subjects in human serum,
plasma and urine samples, including subjects related to hormones, diabetes, cardiac
markers, tumor markers, and infectious diseases.
Registrant / manufacturer name: Zybio Inc.
Registrant / manufacturer address: Floor 1 to Floor 5, Building 30, No.6 of Taikang Road,
Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, PEOPLE’S
REPUBLIC OF CHINA.
Service life: 10 years, as determined by lifetime testing. During use, you shall maintain, care
and repair this product in accordance with the requirements in this manual to ensure the
safety and effectiveness.

５
Warranty and After-sales Services
The warranty period of your analyzer shall be subject to the sales contract.
Consumables: Refer to disposable materials or materials that need to be replaced regularly,
consumables have no warranty.
Product quality problems or design flaws in the warranty period can enjoy free
maintenance services. You only need to provide the “Warranty Card” to the technical
service engineers of Zybio. The warranty period starts from the “Date of installation” filled in
the “Warranty Card” attached to this product. The “Warranty Card” is the only warranty
certificate, and must not be lost. If the warranty card and other relevant regulations of
Zybio are in conflict with relevant laws and regulations of the state, the relevant laws and
regulations of the state shall be complied with.
During the warranty period, maintenance requests for the following non-product issues are
not within the scope of free warranty:
⚫Voltage mismatch
⚫Human error
⚫Issues not recognized by Zybio
⚫Force majeure such as natural disasters
⚫Other non-product issues
We promise to provide technical support and after-sales service to our products.

６
Introduction
This operation manual helps you to understand the safety, installation, structure and
function, analysis principle, operation process, maintenance and service, alarm and
troubleshooting, etc. of EXI1800 series Chemiluminescence Immunoassay Analyzers
(hereinafter referred to as EXI1800). To ensure proper use, please follow this operation
manual carefully.
Scope
This operation manual is intended for medical laboratory professionals or trained physicians,
nurses, or experimenters, for the use of:
⚫Learning to use the hardware and software of EXI1800
⚫Setting system parameters
⚫Performing routine operations
⚫Performing system maintenance and troubleshooting
Reading Guide
When you need to…
Please refer to…
Learn the safety information of EXI1800
CHAPTER 1 Safety Information
Learn the system overview of EXI1800
CHAPTER 2 System Overview
Learn the basic operations of EXI1800
CHAPTER 3 Basic Operating
Methods
Learn the software operation and software
parameter setting of EXI1800
CHAPTER 4 Software System and
Operation
Learn the parameter setting and the analysis
principle of EXI1800
CHAPTER 5 Analysis Principle and
Calculation Method
Learn the care and maintenance methods of
EXI1800
CHAPTER 6 Care and Maintenance
Learn to identify the causes of malfunction
and troubleshooting methods of EXI1800
CHAPTER 7 Alarm and
Troubleshooting
Learn the transportation and storage of
EXI1800
CHAPTER 8 Transportation and
Storage

７
Contents
Introduction............................................................................................６
Scope......................................................................................................................................６
Reading Guide........................................................................................................................６
1.Safety Information .......................................................................... １０
1.1. Symbols used in this manual.......................................................................................１０
1.2. Labels and screen printings on your analyzer..............................................................１０
1.3. Points of attention........................................................................................................１３
1.4. Pictures......................................................................................................................１９
2.System Overview............................................................................ ２０
2.1.Installer.........................................................................................................................２０
2.2.Damage examination....................................................................................................２０
2.3.Installation requirements ..............................................................................................２１
2.4.Structure of your analyzer ............................................................................................２５
2.5.Product composition.....................................................................................................２８
2.6.Software and network security instructions.................................................................. ３４
2.7.Software interface......................................................................................................... ３５
3.Basic Operating Methods............................................................... ３８
3.1.Overview ......................................................................................................................３８
3.2.Operation procedures....................................................................................................３９
3.3.Checking before analyzer start up ................................................................................ ３９
3.4.Analyzer start up........................................................................................................... ４１
3.5.Confirm your analyzer status........................................................................................４１
3.6.Confirm the maintenance alarm status .........................................................................４２
3.7.Reagent preparation...................................................................................................... ４２
3.8.Substrate preparation....................................................................................................４４
3.9.Wash buffer preparation................................................................................................４４
3.10.Calibration test............................................................................................................４５
3.11.QC test........................................................................................................................４９
3.12.Routine sample test.....................................................................................................５６
3.13.Start.............................................................................................................................６２
3.14.Pause...........................................................................................................................６３
3.15.Stop.............................................................................................................................６４
3.16.Logout.........................................................................................................................６４
3.17.Restart.........................................................................................................................６５
3.18.Operation after shutdown ...........................................................................................６５

８
3.19.Operation after shutdown and power off....................................................................６５
4.Software System Operation........................................................... ６６
4.1.Home page.................................................................................................................... ６６
4.2.Request.........................................................................................................................６９
4.3.Results ..........................................................................................................................７３
4.4.QC ................................................................................................................................７５
4.5.Reagents .......................................................................................................................７６
4.6.Maintenance .................................................................................................................８４
4.7.Alarm............................................................................................................................ ８８
4.8.System settings............................................................................................................. ８９
5.Analysis Principle and Calculation Method...............................１０５
5.1.Analysis method.......................................................................................................１０５
5.2.Calibration and result calculation............................................................................. １０６
5.3.QC ............................................................................................................................１０７
6.Maintenance and Service............................................................１０９
6.1Overview ...................................................................................................................１０９
6.2.Regular maintenance items....................................................................................... １０９
6.3. Repair parts list........................................................................................................ １１６
6.4.Maintenance log .......................................................................................................１１６
7.Alarm and Troubleshooting ........................................................１１９
7.1.Data alarm interface.................................................................................................. １１９
7.2.Analyzer alarm and troubleshooting.........................................................................１２０
8.Transportation and Storage........................................................１３０
8.1.Transportation instructions.......................................................................................１３０
8.2.Storage conditions ....................................................................................................１３０
8.3.Moving your analyzer............................................................................................... １３０
8.4.Packaging symbol explanation................................................................................. １３０
Appendix A......................................................................................１３２
A.1. Product classification..............................................................................................１３２
A.2. Common terminology.............................................................................................１３２
A.3. Packing list .............................................................................................................１３２
A.4. Basic parameters.....................................................................................................１３３
A.5. Performance parameters .........................................................................................１３４
A.6. Input/output equipment........................................................................................... １３５
A.7. Electromagnetic compatibility................................................................................１３５
A.8. Contamination grade...............................................................................................１３７
A.9. Working environment requirements........................................................................１３７
A.10. Storage environment.............................................................................................１３７

９
A.11. Transport environment..........................................................................................１３８
A.12. Dimensions, weight..............................................................................................１３８
A.13. Interface................................................................................................................１３８
A.14. Training.................................................................................................................１３９
A.15. Contraindications.................................................................................................. １３９

Safety Information
１０
1.Safety Information
This chapter introduces the safety symbols used in this manual, the meaning of the
labels and screen printings on this product, as well as the safety risks and points of
attention when using your analyzer.
Note: The following symbols are for reference only, see the operation manual for accurate
pictures.
1.1.Symbols used in this manual
Symbol
Meaning
Warning
The operator must follow the instructions corresponding to
this symbol or risk physical injury.
Caution
The operator must follow the instructions corresponding to
this symbol or risk product damage or malfunction, or
inaccurate test results.
Attention
The operator must follow the instructions corresponding to
this symbol, the symbol emphasizes important information
in the operation steps or the contents requiring special
attention.
Biological Risk
The operator must follow the instructions corresponding to
this symbol or risk biological infections.
1.2.Labels and screen printings on your analyzer
Numerous warning labels and screen printings are used on your analyzer to identify
product features or alert cautions when operating. The meanings, as well as the meaning
of the symbols for operation process are described below. Check the warning labels often
to make sure they are clean and complete; If the labels cannot be read properly due to
blurring or falling off, please contact the technical service engineers of Zybio for
replacement.
Note: The following labels or symbols are for reference only, refer to the actual product for

Safety
Information
１１
accurate pictures.
Symbol
Meaning
Moving Parts
Instrument operation, please don't open the lid and put his hand
in.
Electric Shock
The background color of this symbol is yellow, and the symbol
and outline are black.
When the power is turned on, unauthorized maintenance
personnel should not open the analyzer panel; avoid spilling
liquid on the table. If liquid enters the analyzer, please turn off the
power immediately and contact Zybio in time.
Biological Hazard
The background color of this symbol is yellow, the symbol itself
and the outline are black.
1) All test samples, calibrators, controls, etc. should be
considered infectious, and gloves shall be worn when in
contact with them;
2) All liquid waste s and product components that come into
contact with the test samples, such as suction nozzles,
measuring cups, etc. shall be considered infectious, and
gloves shall be worn when in contact with them;
3) All waste materials are considered infectious and should be
treated in accordance with the current regulations for medical
waste disposal;
4) When your analyzer reaches its life expectancy, it should be
disposed of according to the requirements of the
environmental protection department of the local
government, not as general wastes.
Laser Baffle
The background color of this symbol is yellow,and the symbol
and outline are black.
Class 2: CAUTION-Class 2 LASER RADIATION WHEN OPEN,
DO NOT STARE INTO THE BEAM.

Safety Information
１２
Symbol
Meaning
Corrosion Warning
The cleaning liquid or waste liquid is chemically corrosive, so you
should wear protective gloves during operation, and wear
protective glasses when necessary.
Warning
Mind Your Hands
Amateurs do not disassemble the instrument.
Clamshell Warning
The background color of this symbol is yellow, the outline is
black, and the prohibition symbol is red.
Do not flip the cover during exercise.
Electronic information product which contains some toxic and
harmful substances. The environmental-friendly use period is 20
years, Recycle or recover accordingly after that.
For in vitro diagnostic use only.
Serial No.
Date of manufacture
Alternating current
On (power supply)
Off (power supply)
Protective grounding
T6.3AL250V
Fuse
W1
Cleaning tank liquid waste outlet
W2
Washing tray liquid waste outlet
CW
Wash buffer inlet
W-D
Interface of wash buffer sensor

Safety
Information
１３
Symbol
Meaning
RS232
External communication port
USB port 1/2/3/4
External network port
Substrate button light
Solid waste container 2 button light
Solid waste container 1 button light
Reagent tray button light
Sample tray button light
Cuvettes observation window, to observe the number of cuvettes
in the cuvette compartment.
1.3.Points of attention
1.3.1.Scope of your analyzer
Caution
1) The EXI1800 series Chemiluminescence Immunoassay
Analyzer adopts a chemiluminescence method based on
alkaline phosphatase-catalyzed reaction, in combination with
matching testing reagents, to perform qualitative or
quantitative clinical tests for analysis objects in human serum,
plasma and urine samples, including objects related to
hormones, diabetes, cardiac markers, tumor markers, and
infectious diseases;
2) When making clinical judgment based on the test results of
this product, please also consider the clinical examination
results or other test results;

Safety Information
１４
3) The EXI1800 series Chemiluminescence Immunoassay
Analyzer must be used with the matched reagents provided
by Zybio.
1.3.2.Operator
Caution
The EXI1800 series Chemiluminescence Immunoassay Analyzer
should only be operated by personnels who are trained by Zybio or
its agents.
1.3.3.Operation environment
Attention
1) Please install your analyzer in accordance with the
requirements for installation environment specified in this
manual, installation and use of your analyzer not according to
the specified conditions may lead to unreliable results, and may
damage your analyzer;
2) If you need to change the working environment of your
analyzer, please contact the technical service engineers of
Zybio or its local agents.
1.3.4.Data backup
Attention
The system supports and stores the data in the work control chip. If
the data in the work control chip is deleted or damaged due to other
reasons, the data will be lost. It is advised to back up the analysis
data and analysis parameters to other mobile storage devices on a
regular basis.
1.3.5.Analysis parameters
Attention
Incorrect analysis parameters can lead to incorrect test results,
please consult the technical service engineers of Zybio.

Safety
Information
１５
1.3.6.Electromagnetic interference
Attention
1) Your analyzer is susceptible to electromagnetic interference
during operation, which may affect the test results and lead to
malfunction. Do not use equipments that generate
electromagnetic waves such as electric drills, mobile phones,
walkie-talkie, etc. during the use of your analyzer;
2) Electromagnetic waves will be radiated during the use of your
analyzer. Do not install or use electromagnetic sensitive
equipments near your analyzer.
1.3.7.Poor grounding
Attention
1) The power supply should be properly grounded, or having a
risk of electric shock;
2) The grounding impedance must be less than 100 mΩ. Poor
grounding will lead to unstable test results and electric
leakage, having a risk of electric shock.
1.3.8.Labels falling off
Attention
When the labels of your analyzer are blurred or fall off, please
contact the technical service engineers of Zybio or its local
agents to replace the labels.
1.3.9.Liquid leakage
Attention
1) The hand-tight joints of each tube should be carefully
inspected before testing to check for leakage of liquid, which
may lead to inaccurate liquid intake and discharge;
2) Do not place reagents and samples on the top cover or the
console of your analyzer to avoid splashing and leakage of
liquid.

Safety Information
１６
1.3.10.Probe blocking
Attention
Carefully inspect the reagents and samples to make sure there is
no insoluble floatage, such as cellulose, fibrin, etc. to avoid the
reagent & sample probe blocking.
1.3.11.Cuvette
Attention
EXI1800 series Chemiluminescence Immunoassay Analyzer
uses cuvettes (cuvettes or plastic cups). Please use cuvettes
specified by Zybio, to avoid unexpected effects.
1.3.12.System operations
Warning
1) Please use the system as per the instructions in the
operation manual. Incorrect use may result in incorrect test
results and may even lead to system damage or physical
injury;
2) The first test item, the item corresponding to the reagent
should be calibrated, then quality control to verify that the
system is working properly;
3) Daily QC procedures are recommended for routine use of
the system to ensure the reliability of test results;
4) Cover the caps of the sample tray and reagent tray before
analysis;
5) Do not touch the sample tray and the reagent sample tray
when they are rotating to prevent scratches;
6) Do not install any hardware or software on this system other
than those specified by Zybio, otherwise may hinder the
normal use of the system. Do not run other software while
using the system;
7) Do not use this system for other purposes. Incorrect use
may cause the system to be infected with a computer virus.
Computer viruses may transmit through USB, program,
network, etc;
8) There are two fuses with specification of T6.3AL250V near

Safety
Information
１７
the power socket of your analyzer. If they need to be
replaced, contact the technical service engineers of Zybio or
its local agents.
1.3.13.System maintenance
Warning
1) Please follow the instructions in this manual for system
maintenance. Incorrect maintenance methods may lead to
incorrect analysis results, system damage, or physical
injury;
2) Perform calibration analysis after replacing major
components such as PMT, reagent & sample probe, or
plunger pump;
3) If your analyzer is stopped due to malfunction or other
reasons and needs to be repaired or troubleshooting, please
contact the the technical service engineers of Zybio or it
local agents, and at the same time:
⚫Please take other measures, such as finishing the test
with other instruments or methods, to avoid delay of the
test results;
⚫Please take out the reagents from your analyzer and
store the reagents separately according to the
instructions in the reagent kit, or store the reagents in
the refrigerator to prevent reagents from deteriorating.
1.3.14.Sample
Warning
1) Please use completely separated serum samples and urine
samples without suspended solids or fibrin to avoid blocking
the reagent & sample probe, thus affecting the accuracy of
the analysis results;
2) The presence of drugs, anticoagulants, preservatives, etc. in
the sample may interfere with analysis results;
3) Lipidemia, jaundice and hemolysis in the sample may affect
the analysis results. Blank analysis of samples is
recommended;
4) Please store the samples correctly. Incorrect sample storage
conditions may affect the accuracy of the analysis results by

Safety Information
１８
changing the composition or content of the sample;
5) Do not open the samples for a long time to prevent sample
volatilization, or the analysis results may be affected;
6) This system has specific requirements for sample size. When
sampling, determine the appropriate sample size according to
the relevant instructions in this manual.
1.3.15.Reagents, calibrators and controls
Warning
1) Use appropriate reagent, calibrator and control when using
this system for analysis;
2) Please select the appropriate reagents to match this system.
If it is not possible to determine whether the reagent is
appropriate, consult the technical service engineers of Zybio
or its agents;
3) Refer to the reagents instructions for use and storage of the
reagents, calibrators and controls;
4) Inappropriate storage of reagents, calibrator and control may
result in failure to obtain correct test results even within their
shelf life;
5) Perform calibration analysis after changing reagents. Correct
analytical results may not be obtained without calibration and
QC analysis;
6) Cross contamination of reagents during testing may affect test
results. Consult the technical service engineers of Zybio or
agents for reagent cross-contamination information;
7) Verify that the reagents are positioned correctly before
analysis, otherwise the correct results cannot be obtained.
1.3.16.Disposal of your analyzer
Warning
Some substances from scrapped analyzers are regulated by the
contamination regulations. Please adhere to local waste disposal
standards for disposal of scrapped analyzers.

Safety
Information
１９
1.3.17.Laser safety
Warning
1) The barcode scanner located inside your analyzer is a laser
equipment. Please do not disassemble the device under any
circumstances. Otherwise, there is a risk of uncontrolled laser
radiation leakage;
2) The external handheld barcode scanner is a Class 2 laser
product, which is mainly used to scan item barcodes, master
calibration curves and substrate barcodes. When using a
barcode scanner, please do not face the laser of the scanner;
3) Barcode scanner BCL95 is a class 2 laser equipment.
Scanning rays (red) with an emission wavelength of 655 nm;
Maximum output (peak): 2.1 mW; Pulse duration: < 120 μs;
4) Carefully read the warning information on your analyzer to
avoid possible harmful laser radiation when installing,
debugging and maintaining your analyzer;
5) It is important to prevent laser rays or reflected laser rays!
Long-term visual exposure to laser radiation can cause retinal
injury.
1.4. Pictures
All pictures in this operation manual are used for illustrations or examples only, and are
not intended for other purposes.

System Overview
２０
2.System Overview
This chapter introduces the installation, hardware, software and specification parameters,
namely:
⚫Installation requirements and method
⚫System structure of the hardware
⚫Optional modules
⚫Introduction and use of the software interface
2.1.Installer
Warning
Installation of your analyzer can only be performed by technicians from
or authorized by Zybio.
The EXI1800 series Chemiluminescence Immunoassay Analyzer is only installed by the
technical service engineers of Zybio or its authorized agents, and you need to provide the
appropriate environment and space. When your analyzer needs to be relocated, please
contact the technical service engineers of Zybio or its local agents.
Upon receiving your analyzer, please notify the technical service engineers of Zybio and
its local agents immediately.
2.2.Damage examination
All products have passed strict inspection from Zybio before shipment. Upon receiving
your analyzer, please examine carefully before opening the packing box, and pay attention to
the presence of the following damage:
1) Inverted or deformed exterior package;
2) Obvious traces of wet water on the exterior package;
3) Obvious impingement on the exterior package;
4) The exterior package shows signs of being opened.
Please notify the technical service engineers of Zybio or its local agents as soon as the
above-mentioned damage is found. If the exterior package is intact, please open the packing
box in the presence of designated staffs from Zybio, and further examine:
1) The completeness of all components according to the packing list in the box;
2) The appearance of all devices for cracking, impingement, or deformation.