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