Intellectual Property © 2004-2021 Genrui Biotech Inc. All rights reserved. Genrui Biotech Inc. (hereinafter called Genrui) owns the intellectual property rights to this product and this manual. Without prior written consent of Genrui, any person or entity is strictly forbidden to use, disclose or allow others to obtain any information in this manual by any means, and any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
approved by Genrui. 3）Any associated electrical equipment complies with national standards and the requirements of this manual. 4）Use and operation of this product are performed in strict accordance with this manual. Warranty Genrui warrants that Genrui’ products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: ◼Damage caused by accidents.
If a product covered by this warranty is determined to be defective because of defective materials, components or workmanship, and the warranty claim is made within the warranty period, Genrui will, at its discretion, repair or replace the defective part(s) free of charge. Customer Service Department Manufacturer: Genrui Biotech Inc. Address: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Website URL: www.genrui-bio.com E-mail Address: service@genrui-bio.
⚫This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. ⚫This analyzer can only be operated by test professionals, doctors or laboratory technicians who have been trained by Genrui or its distributors. ⚫It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Introduction We would like to sincerely thank you for choosing to purchase Genrui product. Please read this manual carefully in order to ensure correct use of the product. After carefully reading this manual, please keep it safely stored so that you can refer to it when necessary.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Date of Manufacture: See the nameplate of the instrument Manual Preparation Date: August 22, 2019 Manual Revision Date: January 7, 2021 Item No.: P01.91.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Manual Overview This chapter introduces how to use the operation manual of your FA50 Quantitative Immunoassay Analyzer (hereinafter called the analyzer). This manual is supplied with the analyzer and contains detailed descriptions of the usage, function and operation of the analyzer.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 3.Perform daily operations. 4.Perform system maintenance and troubleshooting.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. How to Find Information If you want to... Please refer to... learn about the use of the analyzer 1.Precaution, note learn about the installation requirements 2.Installation learn about the intended use and measurement parameters of the analyzer 3.System Description learn about the measuring principle and process 4.Working Principle learn about the settings of date, time, parameters, units, etc. and result query 5.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. If you want to... Please refer to... learn about the maintenance, 7.Maintenance service and detection methods learn about fault causes and handling methods 8.Troubleshooting learn about the transportation and storage conditions of the analyzer 9.Transportation Storage and learn about common reagents and consumables for the analyzer 10.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Symbols You will find the following symbols in this manual: Symbols Meaning Alerts the operator to follow the statement below the symbol, otherwise it may take the risk of potential biohazard. Alerts the operator to follow the statement below the symbol while in operation, otherwise it may cause personal injury.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Symbols Meaning Consult accompanying documents. Inflammation Do not use inflammable hazardous articles near the instrument, such as alcohol, diethyl ether, etc. Electric Shock 1) When the power supply is turned on, unauthorized service technicians are prohibited to open the analyzer’s panel. 2) Avoid spilling any liquid onto the workbench.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Symbols Meaning Biohazard Description for this label: background color – yellow symbol and outline – black 1) All the test samples, calibrators, quality controls, etc. should be regarded as infectious. Gloves should be worn when handling them. 2) All the waste liquids should be regarded as infectious, gloves should be worn while in touch; All the items contacted with the test samples, such as test cards, pipette tips, etc.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Symbols Meaning Warning symbol for high temperature Corrosion Cleaning solution has potential chemical corrodibility. Wear protective gloves while in operation.
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Symbols Meaning Refer to the Operation Manual This electronic product contains some poisonous and harmful substances. The environmental protection use period is 20 years, after this period, it should be put into the recycling system.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Table of Contents Introduction .......................................................................................... i Manual Overview ............................................................................. iii Who Should Read This Manual ....................................................... iii How to Find Information .................................................................... v Symbols...................
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 3.2 Back View ............................................................................ 11 3.3 Function of the Parts ........................................................... 12 4 3.3.1 LCD screen .................................................................. 12 3.3.2 Test slot ....................................................................... 12 3.3.3 Magcard induction zone ..............................
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.7.1 QC Setup ..................................................................... 32 5.7.2 QC Reagent ................................................................. 32 5.7.3 QC Card ....................................................................... 34 5.7.4 QC Data ....................................................................... 37 5.7.5 L-J Graph .......................................................
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 7.6 8 Components’ Replacing List ................................................ 67 7.6.1 Consumables that can be replaced by users .............. 67 7.6.2 Parts need to be replaced by service engineers ......... 68 Troubleshooting ........................................................................ 69 8.1 Overview .............................................................................. 69 8.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. A.3 Test Parameter Information ...................................................... 78 A.4 Instrument’s Basic Parameters ................................................. 79 A.5 Working Environment ............................................................... 80 A.6 Product’s Outer Packaging Illustration ..................................... 81 A.7 Dimension and Weight.........................................................
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 1 Precaution, warning and note (1) Potential safety hazards and use restrictions There is a potential biohazard when testing samples with this instrument, follow the related testing safety requirements of hospitals during sample processing and operations. Do not put your hands or any objects into the moving assembly of the instrument during the test.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. (6) Diagnosis and treatment can not only rely on this instrument’s test results, taking into account the clinical history and other laboratory test results. Each laboratory is recommended to establish its own reference range based on the detected patient population.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 2 Installation 2.1 Introduction The analyzer is tested and packed with care before it is shipped from the factory. Inspect the carton carefully when you receive your analyzer. If any sign of damage is found, contact Genrui customer service department or your local distributor immediately. 2.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Content Requirements inflammable gases, without heat source and wind source, without mechanical vibration; 3) Good ventilation, avoid direct sunlight. Space Environment temperature Relative humidity Atmospheric pressure 4 Has enough space to place the analyzer, with a minimum area of 0.8m 2 . 10℃-30℃ ≤ 70% 70.0kPa-106.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Content Requirements Electromagnetic interference The analyzer is susceptible to electromagnetic interference during running, which may affect the test results and lead to incorrect operation. During its running, do not use devices generating electromagnetic waves, such as electric drill, mobile phone, intercoms, etc., and keep it far away from strong electromagnetic interference.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. socket should not be blocked by any objects. In case of emergency, the operator can easily pull out the power cord from the socket to disconnect the power immediately. 2.The equipotential ground terminal at the rear panel of the instrument must be connected with the ground cable, if possible, connected to a dedicated ground cable.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. If all the items are there, carefully take out the analyzer and put it on a stable countertop. Do not place the analyzer near the wall or other places where are difficult for disconnection, for it is a non-permanently connected device. 2.3.2 Connecting the power cable Make sure the power switch at the rear panel is turned off.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 2)Put in the new paper roll (take out the empty scroll and put in the new paper roll) and make sure the free end is at the bottom. 3)Put one end of the paper roll into the printer head (i.e., between the metal plate and black plastic printer head), the printing paper is drawn in and one end is revealed through the printer head’s narrow slot. 4)Close the printer cover and pull the paper out from the exit.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Contact with the printer head and its surrounding metal parts can cause scald. Turn off the analyzer and wait for 20 minutes to replace the printing paper.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 3 System Description The analyzer is mainly composed of the host, which includes microprocessor, detection system, LCD screen and printer. 3.1 Front View 10 1. LCD screen 2. Test slot 3. Magcard induction zone 4. Printer 5. Upper housing cover 6.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 3.2 Back View 1. Vents 2. Equipotential terminal 3. USB connector 4. Network port 5. Power port 6.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 3.3 Function of the Parts 3.3.1 LCD screen The touch screen is used to perform interface operations and display information. 3.3.2 Test slot This analyzer provides one test slot, which is used to carry the test card. 3.3.3 Magcard induction zone Magcard induction zone is used to read the relevant information for different items of different batches to the instrument. 3.3.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. connect the analyzer and the LIS system. 3.3.6 Power switch The power switch is located at the rear of the analyzer and used to turn on and off the required power to control the analyzer’s switch. ⚫Use the instrument when it is properly grounded. ⚫To avoid electric shock, disconnect the power supply before servicing. ⚫To prevent fire, use the fuse with specified model and current.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 4 Working Principle 4.1 Overview This analyzer uses immunofluorescence technique to quantitatively measure the concentration of the analyzer. Under certain conditions, the fluorescence emission intensity is proportional to the concentration of the analyzer. 4.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. chromatographic process. When the test card is inserted into the analyzer, light source illuminates to the testing zone and control zone of the test card, and excites the attached fluorescent substance, the emitted light is collected and converted into electrical signals, the intensity of the electrical signals is strictly related to the number of fluorescent molecules.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5 Interface and Operation 5.1 Overview The analyzer has been initialized before it is shipped from the factory, after the first-time startup, the system default interface displays. In order to meet different needs in practical applications, you can reset some of the parameters of the analyzer. 5.2 Common Interface Operations Name Executed Operation Click Slightly click “xx” by finger on the touch screen.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.3 Startup Turn on the power switch at the rear of the analyzer, the analyzer starts initializing, as shown in Fig. 5-3-1. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.4 Main Menu The instrument enters the main menu after the power-on self-test is completed, as shown in Fig. 5-4-1: Fig. 5-4-1 Main menu interface Directly click the menu item to enter the corresponding interface to perform the operation.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.5 Test Click “Test” in the main menu to enter the measurement interface as shown in Fig. 6-5-1: Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.5.1 Item Set When the scan code setting status of the reagent card is automatic, no item setting is required before measuring the reagent card; when the scan code setting status of the reagent card is manual, you need to manually select the item before measuring the reagent card, and click the item setting, as shown in Fig. 6-5-2, click on the item to be tested, and then click “Confirm” to select the item to be tested. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.5.2 ID Set You can set the ID number before measuring the sample. The ID number can be set to 1-99999999999999999999. You can also use the default ID serial number, as shown in Fig. 5-5-3. Fig. 5-5-3 5.5.3 STD Mode If the current reagent batch has already been swiped, you do not need to swipe it; if you replace the new batch of reagent cards, you need to swipe the card again for the first measurement.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. need to change the sample type, click “Cancel”. After reselecting the sample type, click “STD Mode” to start the test again. If the current test item is the same as the last test item, the analyzer will enter the standard measurement process, as shown in Fig. 5-5-5.
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-5-7 5.5.4 Fast Mode If the current reagent batch has already been swiped, there is no need to swipe the card; if you replace the new batch of reagent cards, when you replace the new batch of reagent cards, you need to swipe the card again. For details on the card swiping process, see 5.8.3.6 Swipe card.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. current test item is the same as the last test item, the analyzer will start directly, as shown in Fig. 5-5-9; if the current test item is different from the last test item, the instrument will prompt “Item information changed, please confirm the information before starting the test”. After confirming the item information is correct, click “Fast Mode” again.
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. The instrument automatically stores the test data after each sample is tested. Users can review, query, and print sample data through the results introduced in this section. The instrument can store 50,000 test records, which can be connected to the inspection department system to achieve unlimited storage. On the main menu, click “Result” to enter the results review menu, as shown in Fig. 5-6-1. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-6-2 2、Find the sample results by entering the time range. After clicking the first time input box, a numeric keyboard will pop up. Enter the starting point of the search time, click button to save, as shown in Fig. 5-6-3, click the second time input box, a numeric keyboard will pop up to enter the end point of the search time, as shown in Fig. 5-6-4.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-6-3 Fig. 5-6-4 3、Delete results Select the sample results that need to be deleted and click “Delete”.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. dialog box “Confirm delete” will pop up, as shown in Fig. 5-6-5. Click “Confirm” to delete the currently selected results. Click button to return to the main menu. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.7 QC In the main interface, click the QC button to enter the QC test interface, as shown in Fig. 5-7-1. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.7.1 QC Setup Before the QC test, you need to perform QC setup. Click “QC setup” button to enter the QC setup interface. As shown in Fig. 5-7-2, select the QC items to be set, click the target value input box, and enter the target value, click the limit input box and enter the relative deviation range. Fig. 5-7-2 5.7.2 QC Reagent Click “QC Test” button to enter the QC Test interface, as shown in Fig. 5-7-3.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. select the item before measuring the reagent card, and click “Item Set”, as shown in Fig. 5-7-4, click the item that needs to be tested at present, and click “Confirm” to select the item to be tested. Select QC2 and click “QC Reagent” button to start QC reagent test. (Note: QC Reagent is fast measurement. Please insert the reagent card that has been incubated to start the test) Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-7-4 5.7.3 QC Card Before the QC card test, please enter the maintenance menu to use the QC magnetic card to swipe the card. For details, refer to 5.8.3.6 Swipe card. Click “QC Card” button, the interface prompts “Insert the QC cassette”, as shown in Fig. 5-7-5.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. contact the after-sales service department of the company. Fig. 5-7-5 Fig.
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.7.4 QC Data Click “QC data” on the QC interface to enter the QC data query interface, as shown in Fig. 5-7-8. You can view the QC data of different items by selecting the item and QC type. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.7.5 L-J Graph Click “L-J Graph” on the QC interface to enter the LJ QC graph interface, as shown in Fig. 5-7-9. You can view the L-J QC graphs of different items by selecting the item and QC type. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8 Setup Click the “Setup” button under the main interface to enter the setup menu, as shown in Fig. 5-8-1. The setup menu is divided into four submenus: System Set, Item Set, Maintenance and Version. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1 System Set Click “Setup” button under the main interface. After entering the setup menu, the default interface is the system set interface, as shown in Fig.5-8-1. The interface is divided into Basic Set, Communication, and Time Setting. 5.8.1.1Standby Click “Standby” drop-down box, as shown in Fig. 5-8-2. The standby setting time is 15 Min, 30 Min, and 60 Min.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1.2Print Click the “Print” drop-down box, as shown in Fig. 5-8-3. The print settings are divided into Auto printing and Manual printing. When the setting status is Auto, when the sample measurement and QC reagent measurement, after each test is finished, real-time printing will be performed. If the print setting status is Manual, real-time printing will not be performed during sample measurement and QC reagent measurement.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1.3Upload Click the “Upload” drop-down box, as shown in Fig. 5-8-4. There are Manual upload and Auto upload. When the setting status is Auto, the instrument will upload the results to the LIS system in real time when the sample is measured. If the upload is set to Manual, the results will not be automatically uploaded to the LIS system during sample measurement. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1.4Scan Click “Scan” drop-down box, as shown in Fig. 5-8-5. The scan code setting is divided into Auto and Manual. When the setting state is Auto, the instrument will automatically switch to the item currently being tested by scanning the barcode on the reagent card when the sample is measured; when the setting status is Manual, the item needs to be manually switched before the sample can be measured for sample measurement.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1.5Theme Click “Theme” drop-down box, as shown in Fig. 5-8-6, to set the skin color of the instrument operation interface. Set the colors to five colors such as Azure, Blue, Orange, Red, and Rose. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.1.6Communication Communication settings are divided into network communication settings and LIS settings, as shown in Fig. 5-8-7. Click the address to be modified, press the key, delete the currently displayed content, enter the IP address to be set, and then click the key to save. Fig. 5-8-7 5.8.1.7Time Setting The “Time Setting” is divided into year, month, and day format settings and date and time settings.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. dd-MM-yyyy and mm-dd-yyyy. The time and date can be set in the time and date settings. 5.8.2 Item Set In the settings menu, click “Item Set” to enter the item set interface, as shown in Fig. 5-8-8. Item Set is divided into Ref. Range and Correct. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.2.1Ref. Range In the “Item Set” menu, click the “Ref. Range” and select the item to be set. Taking PCT as an example, click PCT item, as shown in Fig. 5-8-9. In the reference range input box, you can enter the reference range according to the actual situation, and click the “Reset” button to restore the reference range to the initial value. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.2.2Correct In the “Item Set” menu, click the “Correct” button and select the item to be calibrated. Taking PCT as an example, click the PCT item, as shown in Fig. 5-8-10. In the reference range input box, you can enter the correction parameters according to the actual situation, and click the “Reset” button to restore the correction parameters to the initial values. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Take two calibrators, respectively test each one for 5 times on the analyzer to get the average value, and then calculate according to the following calibration formula: Y=KX+B Y stands for the calibrator’s target value X stands for the calibrators’ average values tested on the reference machine Substitute these two groups of data into the formula to calculate the calibration coefficient K and B.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. results. Please confirm the necessity of the operation. 5.8.3 Maintenance Click the "Maintenance" button in the setup menu to enter the "Maintenance" interface, as shown in Fig. 5-8-11. This interface can complete Screen Calibration, Delete result, Delete QC, Export results, In, Out, card Swipe card and Upgrade maintenance operations. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.3.1Screen Calibration Screen calibration is used to calibrate the sensitivity of the touch screen. Click the "Screen Calibration" button, the interface prompts whether to enter screen calibration, as shown in Fig. 5-8-12, click "Confirm" to enter the calibration interface, and then click the cross icon to complete the screen calibration. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.3.2Delete result In the maintenance interface, click the “Delete result” button, the instrument maintenance interface will prompt “Confirm to delete all test results ?”, as shown in Fig. 5-8-13, after clicking "Confirm", the instrument will delete all sample measurement results. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.3.3Delete QC In the maintenance interface, click the “Delete QC” button, the instrument maintenance interface will prompt “Confirm to delete all QC results ?”, as shown in Fig. 5-8-14, after clicking "Confirm", the instrument will delete all QC measurement results. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.3.4Export results Click the “Export results” button in the maintenance interface, the instrument maintenance interface will prompt “Confirm to export the results?”, as shown in Fig. 5-8-15. To export the measurement results, first insert the USB flash drive into the USB interface of the instrument, and then click the "Confirm" of dialog box to export the test results. Fig. 5-8-15 5.8.3.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 5.8.3.6Swipe card When replacing a new batch of reagents, you need to perform a swipe operation. On the maintenance interface, click the “Swipe card” button. The interface prompts “Please put the magnetic card on the card swiping area, card is reading.”, as shown in Fig. 5-8-16. When the reagent magnetic card is placed in the card swiping area, it will prompt “Reading Succeed”. As shown in Fig. 5-8-17. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-8-17 5.8.3.7Upgrade Before preparing to upgrade the software, first place the software upgrade package in the root directory of the USB flash drive, insert the USB flash drive into the USB interface on the back panel of the instrument, and click the “Upgrade” button in the maintenance interface. The current interface will prompt “Program upgrade may cause data loss. Please back up your data.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Fig. 5-8-18 5.8.4 Version In the “Setup” menu, click “Version” to view the current model, SN number, driver version, software version and other related information.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 6 Sample Test Process The operator should check whether the instrument’s power cable is safely and reliably plugged into the power port. 6.1 Startup If there is externally connected device, like scanner, turn on its power and make sure the device is ready, then turn on the power switch at the rear of the analyzer, the analyzer starts initializing, as shown in Fig. 6-1. Fig.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. The analyzer will automatically perform a self-test during the startup process. After initialization, the instrument enters the main interface as shown in Fig. 6-2: Fig. 6-2 Main menu Directly click the menu item to enter the corresponding interface to perform the operation. 6.2 Sample analysis 6.2.1 Sample Blood, Serum, Plasma, Others. The specific sample types are different according to the different reagents.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. description of the sample types in the instructions of each reagent. The type of anticoagulant is generally EDTA or sodium citrate, which varies depending on the supporting reagents. For details, see the description in the supporting reagent instructions. 6.2.2 Sample analysis Take procalcitonin (PCT) as an example: 1.Place the test card and sample at room temperature. Use the unpacked test card within 1 hour. 2.
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Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. different from the last test item, the instrument will prompt “Item information changed, please confirm the information before starting the test”. After confirming that the item information is correct, click “Fast Mode” again. The analyzer will skip the waiting time. Start the measurement directly. After the measurement is completed, the result is displayed in the result display box in the lower right corner of the interface. 5.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 6.3 Shutdown When the tests finished, make sure the test slot is inside the analyzer, preventing dust and other substances falling into it, then directly turn off the power switch at the rear of the analyzer.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 7 Maintenance 7.1 Overview In order to get a good performance of the analyzer, ensure its reliability and extend its lifetime, please strictly follow this chapter to perform maintenance for this analyzer. 7.2 Clean the Instrument’s Surface The analyzer’s workbench is easily spattered with reagents, reaction fluid and serum, which should be removed in time.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Cleaning solution is corrosive, protective gloves should be worn while in operation. Workbench should be deemed to be infectious, protective gloves should be worn while in operation. 7.3 Fuse Replacement The instrument’s fuse must be replaced by maintenance personnel. The specified specification is F3AL250V. 7.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Provide the responsible person with an instruction to eliminate or reduce disuse and risks involved in transportation or disposal. The instruction should contain the requirement to minimize the biohazard: Serum, reagents or other liquids are deemed to be infectious.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. use this instrument, otherwise it may damage the protection provided by the instrument or greatly affect the testing results. 7.5 Preventive Maintenance and Inspection for Safety Purposes Check whether the power cable is well connected and grounded or not before starting up the instrument. Check whether the equipotential rod is well connected or not before starting up the instrument.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 7.6.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 8 Troubleshooting 8.1 Overview This chapter introduces the solutions and steps for the common faults. After referring to these instructions in this chapter, if the problems cannot be solved or need more and detailed information, please contact with Genrui customer service department. ⚫This operation manual is not a service manual, only provides measures that should be taken for operators facing instrument fault alarm. 8.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. detection related errors Data collection exception Motor out of warehous e abnormal Motor entering warehous e is abnormal 70 cation failure there are internal or external interference network port signals Light source failure 1. Check whether the light source power cord is loose, the light source is burned out, or the sample concentration is too high and the magnification is reduced. 2.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. optocoupler with an object, then move the object away, and observe whether the status display of the photocoupler on the host computer changes. 8.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 9 Transportation and Storage 9.1 Storage Condition The packaged analyzer should be stored in a well-ventilated room that has the environmental temperature of -10℃ to +55℃, relative humidity not greater than 93% and is free from corrosive gases. 9.2 Transportation Condition The analyzer can be delivered by general transportation, however, fierce impact, vibration, or exposure in rain or snow should be avoided during shipment.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 10 Reagents and Consumables 10.1 Common reagents No.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. No.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. No. Name Peptide (NT-proBNP) Test Kit (Immunofluorescence) Specification 25T/kit 50T/kit 100T/kit 10T/kit 7 Heart-type Fatty Acid-binding Protein (H-FABP) Test Kit (Immunofluorescence) 25T/kit 50T/kit 100T/kit 10T/kit 8 Cardiac Troponin I/Creatine Kinase Isoenzyme/Myoglobin (cTnI/CK-MB/Myo) Test Kit (Immunofluorescence) 25T/kit 50T/kit 100T/kit 10.1.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. 10.1.2 Calibration The calibration parameters are written directly into the magnetic card, and no separate calibration is required by the customer. 10.2 Sample Type Sample type: Whole blood, serum, urine and other body fluids. The specific sample types vary depending on the ancillary reagents, refer to the corresponding reagent instruction for more details.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Appendix A. Specifications A.1 Performance Indicators A.1.1 Repeatability The repeatability of the analyzer shall comply with one of the following requirements: (1)QC card: repeatedly test the reflection ratio of the quality control (QC) card, the coefficient of variation (CV) of the test results should not be more than 1%.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. A.1.3 Stability After turning on the analyzer for 4 hours and 8 hours, test the reference material (calibrator) with a fixed value, the bias (B) of its average value and marked value should not be greater than 10%. A.1.4 Linearity The correlation coefficient γ2 should be equal or greater than 0.990. A.2 Supporting Reagents There are corresponding test cards for different items. A.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Category Cardiac Item No.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Parameter Light source LED Wavelength 365±10nm Light power 60-150mW Test method Immunofluorescence Reagent card Disposable Power ≤50VA Work type Continuous operation equipment Barcode device Support barcode scanning input A.5 Working Environment Ambient temperature: 10℃-30℃ Relative humidity: ≤70% Atmospheric pressure: 70.0kPa-106.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. ⚫Strictly follow the specified environment requirement to store and use the analyzer. A.6 Product’s Outer Packaging Illustration ——“Fragile”: Carefully carry and place. ——“Up”: Upward to place and transport the product. —— “Rain proof”: Protect the package from the rain. ——“Layer limit”: Maximum pile up layers of the same package.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. ——“Humidity limit”: Humidity limit for transportation and storage environment. ——“Temperature limit”: Temperature transportation and storage environment. limit for Note: The illustrations are for reference only, subject to pictures on the outer package. A.7 Dimension and Weight Box size 350mm(length)x350mm(width)x282 mm(height) Instrument size: 300mm(length)x270mm(width x160 mm(width Net weight: 4Kg Gross weight: 6Kg A.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Appendix B.
Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. Hazardous substances Parts name Labels Closure Accessories assembly Maintenance tools Package Packaging materials Pb Hg Cd Cr(VI) PBB PBDE ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○: means the content of the hazardous substance in all homogeneous materials of the part is in the limited requirement according to the standard of SJ/T 11363-2006.
