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Zybio EXI1800 Operation Manual

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Chemiluminescence Immunoassay
Analyzer
Operation Manual
Zybio Inc.

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jonathan
May 30, 2025

nom, type, marque, fournisseur, fonction, méthode, principe, plage de mesures, et, si nécessaire, joindre une photo. de l'équipement zybio?

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1 comments:
Mr. Anderson
May 30, 2025

The Zybio EXI1800 is a small, fully automated chemiluminescence immunoassay analyzer. Its specifications and features include:

- Comprehensive test menu covering SARS-CoV-2, thyroid, fertility, cardiac, inflammation, tumor markers, diabetes, and bone metabolism.
- Uses a chemiluminescence method based on alkaline phosphatase-catalyzed reaction.
- Performs qualitative or quantitative tests on human serum, plasma, and urine samples.
- Analytical module includes a Windows 10 embedded touch screen PC and user-friendly software.
- Operation unit includes a display, hand-held barcode scanner, and analysis software.
- Analysis unit components:
- Sample processing system
- Reagent processing system
- Cuvette transportation system
- Sample reagent injection system
- Reaction solution mixing system
- Magnetic separation system
- Substrate system
- Photometric and reaction system
- Accessories:
- Wash buffer container
- Wash buffer floating ball sensor
- Liquid waste container
- Liquid waste floating ball sensor.

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Summary of Contents for Zybio EXI1800

  • Page 1 Chemiluminescence Immunoassay Analyzer Operation Manual Zybio Inc.
  • Page 2 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;...
  • Page 3 Fax: + 86-23 6869 9779 E-mail: info@zybio.com 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 Warning result in product malfunction or personal safety issues.
  • Page 4 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.
  • Page 5 “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.

  • Page 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...

  • Page 7: Table Of Contents

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

  • Page 10: Safety Information

    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.
  • Page 11 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.
  • Page 12 Safety Information 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.

  • Page 13: Points Of Attention

    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 The EXI1800 series Chemiluminescence Immunoassay Analyzer adopts a chemiluminescence method based on alkaline phosphatase-catalyzed reaction, in combination with matching...
  • Page 14 The EXI1800 series Chemiluminescence Immunoassay Analyzer must be used with the matched reagents provided by Zybio. 1.3.2.Operator The EXI1800 series Chemiluminescence Immunoassay Analyzer should only be operated by personnels who are trained by Zybio or its agents. Caution 1.3.3.Operation environment Please...
  • Page 15 1.3.8.Labels falling off 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. Attention 1.3.9.Liquid leakage...
  • Page 16 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;...
  • Page 17 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 Warning local agents, and at the same time: ⚫...
  • Page 18 QC analysis; Cross contamination of reagents during testing may affect test results. Consult the technical service engineers of Zybio or agents for reagent cross-contamination information; Verify that the reagents are positioned correctly before analysis, otherwise the correct results cannot be obtained.

  • Page 19: Pictures

    Safety Information 1.3.17.Laser safety 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; 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.

  • Page 20: System Overview

    Obvious impingement on the exterior package; 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: The completeness of all components according to the packing list in the box;...

  • Page 21: Installation Requirements

    After opening the box, please carefully examine the appearance of your analyzer and verify completeness with the packing list. In case of transportation damage or missing components, please immediately declare to the technical service engineers of Zybio or its local agents. 2.3.Installation requirements 2.3.1.Site...
  • Page 22 System Overview 2.3.3.Humidity and temperature requirements ◼ Ambient temperature: 10° C - 30° C, temperature fluctuation <2℃/H; ◼ Ambient humidity: 30% ~ 85%, no frost. The system must be operated within the specified ambient temperature and humidity range, otherwise the test results may be unreliable. If the Caution ambient temperature and humidity are outside the specified range, use air conditioning equipment.
  • Page 23 Figure 2- 1 Installation space requirements 2.3.6.Liquid supply and discharge requirement ◼ Please use the wash buffer provided by the technical service engineers of Zybio or its agents; The wash buffer should be provided by the technical service engineers of Zybio or its agents, otherwise, the test results may be affected.
  • Page 24 System Overview Biological Contamination Always wear gloves and work clothes to prevent infection and, if Biological Risk necessary, wear protective glasses. After installing your analyzer, connect the liquid circuit correctly according to the following figure: Cleaning liquid inlet Waste tank sensor Waste liquid outlet 1 The back of the device Waste liquid outlet 2...

  • Page 25: Structure Of Your Analyzer

    System Overview 2.4.Structure of your analyzer 2.4.1.Front diagram Figure 2-3 Frontal structure 1.Touch screen 2. Solid waste container 1 button light 3. Solid waste container 2 button light 4. Substrate 1 button light 5. Substrate 2 button light 6. Substrate cabin flip cap 7.
  • Page 26 System Overview 2.4.2.Back diagram Figure 2-4 Posterior structure 1.Air outlet 1 2.Air outlet 2 3.Air outlet 3 4.LAN port and RS232 port 5.Air inlet 4 6.Air outlet 5 7.Power outlet 8.Air outlet 6 9.Wash buffer inlet 10.Liquid waste container sensor interface 11.Liquid waste outlet 1 12.Liquid waste outlet 2 ２６...
  • Page 27 System Overview 2.4.3.Side diagram ⚫ Left ⚫ Figure 2-5 Left side structure 1.Left handle 1 2.Instrument flip slide lock 3.Solid waste container flip cap 4.Left handle 2 ⚫ Right Figure 2-6 Right side structure 1. Instrument flip slide lock 2. USB port 3.

  • Page 28: Product Composition

    System Overview 2.5.Product composition Your analyzer is composed 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;...
  • Page 29 System Overview 2.5.1.2. Sample processing system The sample tray component is designed with a ring structure, positioned coaxially with the reagent tray, and is located in the outer ring of the reagent tray and the refrigeration system. 5 sample racks are suspended on the support ring of the sample tray; Each rack can be loaded with 10 sample tubes, and the sample tray rotates each sample tube individually to the intake position, waiting for the reagent &...
  • Page 30 System Overview The barcode scanning component is located outside the sample tray, which can scan the barcode of the sample and the reagent kit. 2.5.1.4. Sample and reagent dispensing system The sample/reagent probe component is composed of a sample/reagent probe, a sample/reagent probe rocker, a sample/reagent probe drive shaft, a sample/reagent probe syringe, a sample/reagent probe cleaning component and related liquid circuits.
  • Page 31 System Overview 2.5.2.1. Cuvette loading unit The cuvette loading unit, located on the right rear side of your analyzer, mainly completes the orderly arrangement of the cuvettes and place them in the reaction tray. The remaining cuvettes can be monitored through the inspection window in front of your analyzer; The cuvette replenishment flip cap on the top right of your analyzer can be opened to add the cuvette;...
  • Page 32 System Overview sample position, dispatching position or mixing position. The inner and outer ring of reaction tray has 50 holes respectively. The reaction tray is used to load the cuvettes so that the sample and reagent react in a temperature environment of 37 ± 0.3 ° C. 2.5.4.Magnetic separation system ◼...
  • Page 33 System Overview If the use mode is switched (only one substrate of substrate is used), the indicator light status is represented as follows: • On: The substrate is in use and is not allowed to be replaced; • Flash: The substrate is expired or is empty and needs to be replaced; •...

  • Page 34: Software And Network Security Instructions

    2.6.Software and network security instructions 2.6.1.Software requirements The software is a control software component. Software name: Chemiluminescence Immunoassay Analyzer Software. Model and specification: EXI1800, EXI1810, EXI1820, EXI1830. Release version: V1 Software running environment: Minimum hardware requirement: CPU: main frequency 2.0 GHz...

  • Page 35: Software Interface

    Windows leaves the factory, and the software security update should be verified by Zybio. 2.7.Software interface 2.7.1.Interface The operating interface of EXI1800 series Chemiluminescence Immunoassay Analyzer includes tool bar, status bar and function display area, as shown below: Figure 0 - 7 Software operation interface ◼...
  • Page 36 System Overview Instrument status: initialization, incubation, running, stop, shutdown, standby, maintenance. Instrument status Description Initialization Self-checking process of the instrument after startup The temperature reaches the requirement after 30 minutes of startup, and the self-check function of the instrument meets the Incubation requirements of the test (the self-check is normal), and the instrument is ready for testing.
  • Page 37 System Overview System date and time: The date and time are displayed in the lower right corner. (2) Alarm display area When there is an error message in the system, the error message or alarm information will be displayed in the error message area. Click the alarm information to open the alarm information details page.

  • Page 38: Basic Operating Methods

    Basic Operating Methods 3.Basic Operating Methods 3.1.Overview This chapter introduces the basic operation methods and routine operation procedures of your analyzer, including the following steps: ◼ Pre-inspection ◼ Start up ◼ Confirm your analyzer status ◼ Reagents load ◼ Calibration testing ◼...

  • Page 39: Operation Procedures

    Basic Operating Methods 3.2.Operation procedures Table 3-1 Operation procedures Steps Description Check the power supply, liquid waste connection, reagent & sample probe/stirring rod, wash buffer remaining. Substrate 1. Pre-inspection remaining, number of cuvettes, remaining capacity of solid waste container. 2. Start up Turn on the power switch and launch the operating software.
  • Page 40 Basic Operating Methods Check the power cable of your analyzer and confirm that it is firmly connected and there is no looseness. 3.3.2.Check probe Check the reagent & sample probe to confirm that there is no dirt or bending. ⚫ Wash reagent &...

  • Page 41: Analyzer Start Up

    Caution If the operator password is forgotten, contact the technical service engineers of Zybio or its local agents. Log in correctly and the software home page is displayed to complete the startup process of your analyzer.

  • Page 42: Confirm The Maintenance Alarm Status

    After starting up every day, check your analyzer status bar to confirm whether there is any error alarm. If there is any error alarm, try to resolve the issue according the displayed information, if it cannot be resolved, please contact the technical service engineers of Zybio or its local agents.
  • Page 43 5) Click [OK], the corresponding column of the master calibration curve in the [Reagent List] displays "Y", that is, the scanning of the master calibration curve is successful; If they are inconsistent, please contact the technical service engineers of Zybio ４３...

  • Page 44: Substrate Preparation

    If they are inconsistent, please contact technical service engineers of Zybio or its local agents. Always wear gloves, work clothes to prevent infection, if necessary, please wear protective glasses, and do not directly...

  • Page 45: Calibration Test

    Basic Operating Methods 1) Open a new wash buffer container; 2) Find the wash buffer inlet tube of the instrument; 3) Open the cap of the wash buffer connected to the instrument wash buffer inlet tube; 4) Lift out the opening cap and inlet tube of the wash buffer from the empty wash buffer container;...
  • Page 46 Basic Operating Methods ◼ Enter [Reagent] interface; ◼ Select reagent; ◼ Click [Calibration Request]; ◼ Confirm the application information is correct; ◼ Click [Request] to submit calibration test. The sample positions are insufficient: ◼ Click [Request] - [Request List]; ◼ Select completed or unstarted samples;...
  • Page 47 Basic Operating Methods Click [Request] - [Sample List] to confirm that the calibration request test has been deleted, and the calibration request test for the same batch of reagents will be deleted together. ⚫ Method 2: Click [Request] to enter the sample request interface; Select the calibration request to be deleted in the [Sample List];...
  • Page 48 Basic Operating Methods Parameters Meaning Operation Times of calibration test, the newest calibration record is No operation display at the top required No operation The current used calibration fitted concentration required No operation Lot No. Batch No. of calibrator required Calibration No operation The time when calibration test finished...

  • Page 49: Qc Test

    Basic Operating Methods Parameters Meaning Operation Average value after two calibration tests of the No operation Mean calibration points required No operation CV calculated from calibration points required No operation Expect Value Theoretical concentration value of the calibrator required Basic operations ◼...
  • Page 50 Basic Operating Methods Figure 0-3 QC settings Basic parameter explanation Parameters Meaning Operation Item name Items valid for test No operation required QC name Name of control No operation required Batch No. Batch number of control No operation required Expiration date Expiration date of control No operation required The order of the results in...
  • Page 51 Basic Operating Methods Parameters Meaning Operation value of the control Standard deviation of No operation required control currently used The QC test result is normal Today’s results No operation required in daily test Historical The test result is normal in No operation required results historical QC test...
  • Page 52 Basic Operating Methods Parameters Meaning Operation Select the control item to be canceled Cancel request Cancel QC request test and click [Cancel Request] directly. Basic operations ◼ Add new QC QC information is already available when the master calibration curve is scanned. If additional controls are needed, they can be added as follows: 1) Click [QC] and enter QC interface;...
  • Page 53 Basic Operating Methods ◼ The sample positions are sufficient: Click [QC] to enter QC interface; Select the item to be tested in [Item List]; Select the control to be tested in [QC List]; Click [QC request]; Click [OK] once confirmed the sample information; Enter [Request] interface to view the QC request test.
  • Page 54 Basic Operating Methods Click [QC] to enter the QC interface; Select items to be canceled in [Item List], Select the controls to be deleted in the [QC List]; Click [Cancel Request]; Confirm box of QC request cancel information will pop up; Click [OK] - [Request] - [Sample List] to confirm QC request was deleted.
  • Page 55 Basic Operating Methods Parameters Meaning Operation Item Name Item to QC test No operation required QC Name Name of control for QC test No operation required Result QC test results No operation required Photon quantity Photon quantity measured by QC test No operation required Lot No.

  • Page 56: Routine Sample Test

    Basic Operating Methods 3.12.Routine sample test This section describes how to request routine sample test. 3.12.1. Sample request When request sample test, you can choose by single or by batch. Sample request interface is as follows: Figure 0-6 Sample request - Item list ５６...
  • Page 57 Basic Operating Methods Figure 0-7 Sample request - Item list Basic parameter explanation Parameters Meaning Operation List of samples requested Sample List Click to display the sample list for test Position of the requested Position Click to select sample Barcode Barcode of the sample Click to input Patient name belongs to...
  • Page 58 Basic Operating Methods Parameters Meaning Operation Item name of the sample Item name No operation required test Number of Number of tests of the item No operation required tests for the sample Concentration value of item Result No operation required test Result mark Result mark of item test...
  • Page 59 Basic Operating Methods Figure 0-8 Sample request - Input Basic parameter explanation Parameters Meaning Operation Position Position of the sample No operation required Test mode of the Routine sample by default, select the "STAT" Test Mode sample checkbox as emergency sample Sample Type Plasma, serum, urine Click to select...
  • Page 60 Basic Operating Methods Parameters Meaning Operation samples with the same test information Save sample Save Click to save sample information information Not save sample Cancel No change information Note: Sample barcode The barcode is composed of numbers with a maximum length of 18 digits, which can be used as a sample number;...
  • Page 61 Basic Operating Methods Item in bright green Selected item The item has been selected Basic operation ◼ Single sample request [Request]- [New Sample], enter new sample input interface; Select the sample position in the position drop-down box; Select sample test mode, sample type; Input the sample barcode (an analyzer with barcode setting function connected to LIS, click the [Scan Sample Tray], scan the sample barcode to get sample barcode, EXI1830 does not have this function, only manual input);...

  • Page 62: Start

    Basic Operating Methods start the batch request. ◼ Cancel test items in sample request Click [Request] to enter the request interface; Select the item to be deleted in [Sample List]; Click [Edit], the sample edit interface will pop up, please refer to [Sample Request]; Click to select the test item, click once to select, and click again to cancel;...

  • Page 63: Pause

    Basic Operating Methods Figure 0-9 Test sample submit interface 3.14.Pause ◼ Function description If you need to add, replace, or unload reagents during the test; Add STAT samples, replace samples, or temporarily stop the test process for other reasons, you can click [Pause] to achieve these functions.

  • Page 64: Stop

    Basic Operating Methods a submit confirmation box will pop up; Check "Continue the sample test submitted before pause" to resume the test. After the pause, if new samples are added, and only the samples before the pause need to be resumed for testing. As mentioned above, you can check "Continue the sample tests submitted before pause"...

  • Page 65: Restart

    Basic Operating Methods Click the button in the upper right of the home page, option boxes [Shutdown], [Log out], [Restart] will pop up; Click [Log out] and [OK]; 4) Back to software log in surface, re-log in with old account and password or a new one.

  • Page 66: Software System Operation

    Software System Operation 3) Close the cover of sample tray and reagent tray; 4) Turn down the power switch to power off the analyzer; 5) Check whether there are stains on the surface of the analyzer. If yes, please wipe off the stains with a clean soft cloth;...
  • Page 67 Software System Operation Figure 0-1 Home page ① Function button area ② Status information area ③ Function display area ④ Equipment control area ⑤ Equipment status area Function button explanation: Function button Name Function Open the sample request functions page to sample test request. It supports the functions of batch request, patient Request information entry, sample position...
  • Page 68 Software System Operation Function button Name Function Enter the reagent management function page, which has the functions of transferring reagents to the specified Reagents position, reagent calibration, scanning, reagent loading, reagent unloading, residual testing, querying reagent calibration information, etc. Enter the QC function page to set up new QC items, request QC testing, set QC parameters and search the QC results.

  • Page 69: Request

    Software System Operation Control button Name Function Start Initiate test Pause Pause test Emergency stop Stop the currently ongoing test Exit Exit software Equipment status area explanation: The equipment status area mainly displays the connection status between the software and the LIS, temperature information and the network connection status of the analyzer.
  • Page 70 Software System Operation Figure 0-2 Sample request Basic operations ◼ New sample information entry Click [New Sample Entry], the sample entry page will pop up, and check 3.12.1 Sample request for specific operations. ◼ Patient information Select the samples to be applied, click [Patient Information], the patient entry interface will pop up or enter patient information interface through new sample entry interface.
  • Page 71 Software System Operation Parameters Meaning Operation Patient No. Patient ID of the sample Click to input Normal sample by default, check the Test Mode Test mode of the sample "STAT" checkbox as emergency sample. Name Patient name of the sample Click to input Sampling Sampling date of the patient...
  • Page 72 Software System Operation 2) The pop-up box will push the minimum free sample position and barcode input box by default; 3) Scan the barcode of the sample with an external barcode scanner; 4) After the barcode is successfully displayed, click [Acquire] to automatically obtain the sample information and test items that need to be tested from the LIS;...

  • Page 73: Results

    Software System Operation samples deleted from the [Item List] shall be performed in the [Results] page; Sample deletion should be performed in the [Results] page. 4.3.Results Click [Results] on the home page to enter the result research interface, as shown in the figure below: [Today’s Results] The interface displays the result of all samples applied and tested within 24 hours;...
  • Page 74 LIS or backup them to other mobile storage devices regularly. To read the backup, please contact the service technical service engineers of Zybio or its local agents. 1) Click [Backup]; 2) The backup setting box will pop up, select the mobile hard disk backup path;...
  • Page 75 Software System Operation ◼ Delete 1) Select one piece of sample result in [Sample List]; 2) Click [Delete] to delete the sample and all test items corresponding to the sample. 4.4.QC Click [QC] on the home page to enter the QC interface, as shown in the following figure: Figure 0-4 QC interface Basic operations...

  • Page 76: Reagents

    Software System Operation 3) Click [Edit], the editing interface will pop up, edit the QC information, same as [Add]. ◼ Delete QC 1) Select the QC items in [Item List]; 2) Select the QC in [QC List]; 3) Click the [Delete] to pop up the confirmation box; 4) Click the [OK] to delete, the corresponding QC test results are also deleted.
  • Page 77 Software System Operation Figure 0-3 Reagent management 4.5.1.Reagents The reagent page includes the reagent load and reagent unload, scan the master calibration curve, calibration request and rotor function as shown below: ７７...
  • Page 78 Software System Operation Figure 0-4 Reagent interface Note: Reagent tray status display: ⚫ Gray: Reagent is not loaded: Reagent position is null; ⚫ Green: Reagent is available: Calibration successful, calibration postponed; ⚫ Red: Reagent is unavailable: Reagent expired, calibration failed, calibration expired, the number of times is 0;...
  • Page 79 Software System Operation 1) Click [Reagent] - [Reagent List]; 2) Select the items need to be calibrated; 3) Click [Calibration Request], refer to 3.10.1.1 for specific operations. ◼ Cancel calibration Cancel the calibration request test, that is, delete the calibration request. refer to 3.10.1.2 for specific operations.
  • Page 80 Software System Operation 1) Select the reagent in the reagent list, and click [Reagent Unload] to unload the reagent; 2) Click [Reagent Unload] to unload the reagents. ◼ Calibration information Check all calibration results of the loaded batch of reagents, the calibration data, master calibration curve, backup and print the calibration results in [Calibration Information] interface.
  • Page 81 Software System Operation Figure 0-9 Other consumables interface Basic parameter explanation Parameters Meaning Operation Substrate Substrate group No operation required Vial 1 Substrate vial position 1 No operation required Vial 2 Substrate vial position 1 No operation required Substrate 1 Substrate 1 Autonomous switching Substrate 2...
  • Page 82 Software System Operation Parameters Meaning Operation Vial No. Vial number of the loaded substrate No operation required Total testable Remaining available times of loaded No operation required number reagent Solid waste Show which solid waste container is No operation required containers in use in use currently Solid waste...
  • Page 83 Software System Operation Basic operations ◼ Load; 1) To load the substrate, select the position where the substrate is loaded (Substrate 1 or Substrate 2); 2) Click [Load], substrate load scanning box will pop up; 3) Scan the QR code of the substrate with an external barcode scanner; 4) The batch number and vial number of the item will be loaded after scanning;...

  • Page 84: Maintenance

    Software System Operation 1) Manually pull out the solid waste container and place a new solid waste container; 2) Facing the analyzer and press the corresponding indicator light (close to the operator is the solid waste container 1 indicator light) to empty the count of solid waste container in software;...
  • Page 85 Software System Operation Figure 0-11 Maintenance interface Basic parameters explanation: Parameters Meaning Operation Whole machine reset components No operation required analyzer will reset after triggering Probe reset The probe module will reset, No operation required after triggering Gripper reset The gripper module will No operation required reset after triggering Cleaning tray reset...
  • Page 86 Software System Operation the perfusion operation Equip two trays Equip the cuvettes in No operation required incubation tray and cleaning tray. Clear incubation tray Equip the cuvettes in No operation required (tossing cuvettes) incubation tray Clear cleaning tray (tossing Equip the cuvettes in No operation required cuvettes) incubation tray...
  • Page 87 Software System Operation faults process logs, and at the same time, you can search and export logs for the corresponding time period according to time. All logs are recorded at time points, displayed in reverse order. Basic parameters explanation: Parameters Meaning Operation Log type...

  • Page 88: Alarm

    Software System Operation 4.6.4. Temperature curve The temperature control system includes reaction tray temperature control (heating) and reagent tray refrigeration, the reaction tray deploys a single temperature sensor for temperature sensing and data feedback, and the reagent tray refrigeration module includes a refrigeration unit composed of two refrigeration chips which work independently, one for temperature sensing and the other for data feedback.

  • Page 89: System Settings

    Software System Operation Basic operations ◼ Search Enter the fault search interface, the search fields will be displayed: faults can be searched by fault number, unit module, level, and time of occurrence. ◼ Reset Reset and clear the search conditions, and all data will be displayed by default after triggering the search.
  • Page 90 Software System Operation Figure 4-12 System settings and management 4.8.1.System settings System settings include lower computer communication settings, information settings and Initial setting. As shown in the figure below: Figure 4-13 System settings interface ９０...
  • Page 91 Software System Operation Basic parameter explanation Parameters Meaning Operation IP address for communication Enter the IP address of the lower IP address with the lower computer computer directly in the box Port number for Enter the port number of the lower Port communication with the lower computer directly in the box,...
  • Page 92 Software System Operation 4.8.2.Analyzer setting Related configuration of the analyzer is shown as below: 4.8.2.1 Routine maintenance setting [Routine maintenance] needs to manual maintenance by the user. The user can set the routine maintenance time in [Routine maintenance settings]. When the maintenance time is reached and the instrument is standby, the routine maintenance process will be executed.
  • Page 93 Software System Operation stop due to the fault. A total of 9 liquid level detection data of three-phase probe are recorded in the software log. 4) Scan the reagent tray to check if there is an enhanced wash buffer in the reagent position;...
  • Page 94 Software System Operation 1) Support additional sample tests during daily maintenance; 2) It is not allowed to suspend the test when adding the first test, otherwise the test item may be invalid; Attention 3) Remove the check box for automatic regular maintenance, and regular maintenance will not be performed.
  • Page 95 Software System Operation 4.8.2.4.Item parameter The system supports importing the default parameter list through an external file. If an imported closed reagent item is no longer needed, it is allowed to delete the item parameters by click [Delete] in [System Setting] - [Analyzer Setting]- [Item Parameter] interface to delete it.
  • Page 96 Software System Operation Basic operation 1) Select [System Settings]- [Analyzer Setting]- [Item Setting]; 2) Enter the item configuration interface, the interface will display: ◼ Combined item Combined item: Combining related items together to form a combined item with obvious clinical significance, such as: Hepatitis B, tumor, etc.
  • Page 97 Software System Operation When the project result is less than the lower limit of the measurement range and the concentration of the minimum concentration calibrator, it will be displayed as "<the greater value"; when the project result is greater than the upper limit of the measurement range and the concentration of the maximum concentration calibrator, it will be displayed Is ">...
  • Page 98 Software System Operation not, do not perform; if there is, perform the following steps; ◼ Yes: Needle reset-long cleaning (sample cleaning action), perform 3 one-step process tests, suck 120ul enhanced cleaning solution, incubate for 2 cycles, sample and other reagents are not added, no need to inject substrate for photometry;...
  • Page 99 Software System Operation Auto print patient report Auto print patient report Click to select after test Auto print QC report The QC report is Click to select automatically printed after QC test Auto print calibration report The calibration report is Click to select automatically printed after QC test...
  • Page 100 Software System Operation Parameters Meaning Operation LIS IP IP address of LIS server Click the input LIS port IP port of LIS server Click the input The LIS communication communication No operation required timeout will alarm after 5s timeout (S) Connection LIS Automatically connect to server...
  • Page 101 Software System Operation Figure 4-16 Department settings interface Basic parameter explanation Parameters Meaning Operation Department setting Display all department names No operation required Input the department name to Department name Click to input be added Basic operations If you need to add a department, fill in the name of the department to be added in the department name box;...
  • Page 102 Account types in user settings include system administrators, general users, and equipment maintenance personnel, among which the account of equipment maintenance is a special account for the customer service of Zybio. The equipment maintenance personnel account has all the permissions of the system administrator and debugs the parameters of the analyzer.
  • Page 103 Software System Operation Parameters Meaning Operation Confirm Confirm the password for Click to input password user login Add user Add a user Click Delete user Delete a user Click Edit password of Edit a password for user Click user login Basic operations ◼...
  • Page 104 Software System Operation Select the user name to be edited in the user name drop-down box, enter the new password, then reenter to confirm the password and then click [OK], and the next dialog will pop up. Figure 4-19 Password confirmation interface Enter the administrator password after “Please enter your password”, and then click [OK] to complete password editing.

  • Page 105: Analysis Principle And Calculation Method

    Analysis Principle and Calculation Method 5.Analysis Principle and Calculation Method This chapter briefly introduces the analysis principle of your analyzer, including: ⚫ Analysis method ⚫ Calibration and result calculation ⚫ Explanations for QC 5.1.Analysis method Introduction 5.1.1. The automatic chemiluminescence analyzer adopts the indirect chemiluminescence method based on alkaline phosphatase and use magnetic particles as a carrier to clean and separate by magnetic bead adsorption.

  • Page 106: Calibration And Result Calculation

    Analysis Principle and Calculation Method magnetic separation, addition of substrate, luminescence detection. The reaction process of the two-step method with two separations includes: adding the sample to be tested, labeling antibody (antigen), incubation, magnetic separation, adding labeled antibody (antigen), incubation, magnetic separation, adding substrate, and luminescence detection.
  • Page 107 5.3.QC 5.3.1.QC rules The default QC rule for EXI1800 series Chemiluminescence Analyzer is the Westguard multi-rule. User can choose one or more rules to determine the QC status for different items according to actual needs. The Westguard multi-rule contains 6 sub-rules, and the meaning of judgment of each...
  • Page 108 Lost control (random error). mean value consecutively (10 x) 5.3.2.QC chart The QC chart of EXI1800 series Chemiluminescence Immunoassay Analyzer is L-J QC diagram： Draw a horizontal line from the QC target value using the measured QC data value as the ordinate, and draw 6 lines parallel to the mean line above + 1SD (Standard Deviation, referred as SD), + 2SD, + 3SD and below -1SD, -2SD, -3SD, and ±...

  • Page 109: Maintenance And Service

    Maintenance and Service 6.Maintenance and Service This chapter introduces the maintenance methods of your analyzer, including common maintenance commands and regular maintenance. The purpose, timing of use, required supplies, analyzer status, precautions and operation steps of each maintenance item are described in detail.
  • Page 110 Maintenance and Service 6.2.1.Classification of maintenance period The period maintenance list is divided into the following maintenance period units: ◼ Daily —— 1 Day ◼ Weekly —— 7 Days ◼ Monthly —— 30 Days ◼ Other —— Irregular ◼ Command operation The system counts down the maintenance items from the current maintenance time of each maintenance item.
  • Page 111 7) Check if there are any rusts in the suction probe of the cleaning tray, if there are, please contact the technical service engineers of Zybio. 6.2.2.Maintenance content During the maintenance process, the internal tubes are mainly used for flushing the probes and tubes in the "Daily Maintenance"...
  • Page 112 Maintenance and Service 6.2.3.1. Check the connection between liquid waste and liquid waste container Improper connection of the liquid waste tube will cause the liquid waste to overflow and pollute the environment. Therefore, it is necessary to check the liquid waste connection of the analyzer frequently.
  • Page 113 Maintenance and Service Select [Reagent] - [Other Consumables]; Check the remaining of sample diluent, substrate, cuvette, solid waste container, wash buffer. 6.2.4. Irregular maintenance items 6.2.4.1. Clean the panel of the analyzer The places frequently touched of the analysis unit and the operation unit are very easy to become dirty.
  • Page 114 Maintenance and Service Clean the reagent tray components to keep the working environment and work surface tidy to reduce the risk of cross-contamination. ◼ Maintenance timing It is recommended that this maintenance operation should be performed before daily test. ◼ Maintenance supplies Clean cloth, deionized water, alcohol, cotton swab.
  • Page 115 Maintenance and Service ◼ Analyzer status When performing this maintenance operation, ensure that your analyzer is in incubation or standby status. Operation steps: 1) Click [Maintenance]-[Maintenance]; 2) Click [Empty two trays] / [Clear Incubation Tray (Cup tossing)] / [Clear cleaning tray (Cup tossing)].

  • Page 116: Repair Parts List

    Maintenance and Service 6.3. Repair parts list Table 6-1 Repair parts list Name of parts Remark Sample/reagent probe Four-way peristaltic pump 250μL plunger pump 2.50mL plunger pump 500μL plunger pump Injection tube Pipette 6.4.Maintenance log Software maintenance log management is mainly used to record the account-related operations of the analyzer and the faults.
  • Page 117 Maintenance and Service Table 6-2 Daily maintenance items Maintenance Maintenance records items (Daily) Check connection of liquid waste and liquid waste container Check the status of consumables Check the sample probe Perform “Daily Cleaning” _ _ _ _ _ _ _ Year _ _ _ _ Month １１７...
  • Page 118 Maintenance and Service Table 6-3 Other maintenance items Maintenance Maintenance records items (others) Clean the panel of analysis unit Clean the reagent tray Perform “Automatic emptying” Perform “Liquid circuit perfusion” _ _ _ _ _ _ _ Year _ _ _ _ Month １１８...

  • Page 119: Alarm And Troubleshooting

    Alarm and Troubleshooting 7.Alarm and Troubleshooting 7.1.Data alarm interface Data alarm is a mark for abnormal test results, and the corresponding mark is displayed on the software interface to prompt. The “Result Identification” in [Results] - [Sample Result List] shows all the marks of abnormal test results of the current sample in the project test, and if the display is empty, the test results are normal.

  • Page 120: Analyzer Alarm And Troubleshooting

    All fault alarm information and corresponding troubleshooting measures of the system are listed in this chapter. Please timely perform those measures. If the alarm is not cleared after taking measures, please contact the technical service engineers of Zybio or its local agent.
  • Page 121 Alarm and Troubleshooting Figure 7-1 Warning log Or click [Maintenance]-[Log] to view the running log of the analyzer, click [Warning Log] to view the alarm information. １２１...
  • Page 122 There is a problem in code action is successful; tooth optocoupler 3. If the fault still exists, please contact the technical service engineers of Zybio. 1.Check whether the sample or reagent is normal; The movement of the 2.Click [Maintenance]- [Reset of probe/incubation the whole machine];...
  • Page 123 Please contact the technical A07048 Stop calibration there is no liquid in the tube, service engineers of Zybio. failure liquid level detection board is damaged. 1.Check whether the sample is normal; 2.Click [Maintenance] - [Empty No liquid in two trays];...
  • Page 124 The probe Please contact the technical A07055 Stop blocking blocking detection board is service engineers of Zybio. detection damaged, and the air failure pressure detection sensor is faulty. 1.Check whether the sample and reagent is normal;...
  • Page 125 3.If the fault still exists, please contact the technical service engineers of Zybio. 1.Click [Maintenance]- [Reset of the whole machine]; 2. After the reset is successful, The gripper moves to the...
  • Page 126 3.If the fault still exists, please contact the technical service engineers of Zybio. 1.Click [Maintenance]- [Reset of the whole machine]; Something was detected There is a before the cup was grabbed, 2. After the reset is successful,...
  • Page 127 3.If the fault still exists, please contact the technical service engineers of Zybio. 1.Click [Maintenance]- [Reset of the whole machine]; The cleaning tray will cause 2. After the reset is successful, The stop...
  • Page 128 Invalid ent doesn’t moving. 2.If the fault still exists, please stop running contact the technical service engineers of Zybio. 1.Please perform the emptying The position where the probe operation: Click [Maintenance] - Running of stops, the reagent tray will [Empty Two Trays], restart the...
  • Page 129 Possible cause Solution code type information contact the technical service engineers of Zybio. 1.Click [Maintenance]- [Reset of the whole machine]; 2. After the reset is successful, The running steps of the click [Empty two trays], and the motor through the...

  • Page 130: Transportation And Storage

    If your analyzer is to be moved, it must be placed in the packaging box, and then carried by more than 4 person. Warning: Do not try to move the analyzer by yourself, Zybio will not be responsible for all the consequences caused by it.
  • Page 131 Transportation and Storage “No Stacking”: This “Avoid Rain”: The transportation transportation package package can only be shouldn’t be exposed to placed in a single rain layer “Do Not Roll”: This transportation package cannot be rolled １３１...

  • Page 132: Product Classification

    Appendix Appendix A A.1. Product classification According to IVDD 98-79, the Chemiluminescence Immunoassay Analyzer is an immunoassay device in the subdirectory of clinical test devices. The management category is others. A.2. Common terminology A.2.1. Photon number The signal value detected by the photomultiplier in your analyzer is the photon number.

  • Page 133: Basic Parameters

    1 pcs component Power cable 1 pcs A.4. Basic parameters Product model EXI1800 EXI1810 EXI1820 EXI1830 Throughput 180 T/h Sample positions Reagent positions 10-120 μL, with each increment of 0.1 μL Sample volume It has the functions of liquid level detection, volume Reagent &...

  • Page 134: Performance Parameters

    Appendix Release version automatic No sample No log emptying barcode Functional differences management function for setting function the whole function machine Remarks: The function difference of each model has no influence on the operation method for the operator. A.5. Performance parameters Parameter name Parameter content Temperature...

  • Page 135: Input/Output Equipment

    Appendix A.6. Input/output equipment External equipment such as printers must be compulsorily certified by CCC (S & E), and using unqualified external equipment may result Warning in abnormal operation of the system and personal injury. ◼ External barcode scanner (optional) ◼...
  • Page 136 Appendix d=1.2 d=1.2 d=2.3 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For the maximum rated power of the transmitter not listed in the above table, the recommended isolation distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency column, where P is the transmitter provided by the transmitter manufacturer The maximum rated output power, in watts (W).

  • Page 137: Contamination Grade

    Appendix This equipment should not be used in close proximity or overlap with other equipment, and if it must be used in close proximity or overlap, it should be verified to operate normally in the configuration that it Warning uses. Do not use the equipment next to a strong radiation source (e.g., an unshielded RF source), which may interfere with the normal operation Warning...
  • Page 138 Appendix Relative humidity range: 10% ~ 90% Atmospheric pressure range: 50 kPa ~ 106 kPa A.11. Transport environment Environment temperature range: -20° C ~ 55° C Transportation Environment Relative humidity range: 10% ~ 90% Atmospheric pressure range: 50 kPa ~ 106 kPa A.12.
  • Page 139 The use of RS232 port and 4 USB ports does not conflict, allowing simultaneous use. A.14. Training In order to use this product correctly and give full play to its performance, Zybio will provide professional technical training for you. A.15. Contraindications None １３９...

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