BioNote Vcheck V200 User Manual
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BioNote Vcheck V200 User Manual

Fluorescent immunoassay systems for veterinary use
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V200
Fluorescent Immunoassay systems

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Summary of Contents for BioNote Vcheck V200

  • Page 1: User Manual

    For veterInary use only user manual V200 Fluorescent Immunoassay systems...
  • Page 2 Suwon-si, Gyeonggi-do, 16690, Republic of Korea Manufacturing site 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbukdo, 28161, Republic of Korea Tel: +82-31-300-0400 l Fax: +82-31-300-0499 www.sdbiosensor.com Distributed by 22, Samsung 1-ro 4-gil, Hwaseong-si, Gyeonggi-do 18449, Republic of Korea Tel: +82-31-211-0516 l Fax: +82-31-8003-0618 www.bionote.co.kr...
  • Page 3 Thank you for your purchase of the BIONOTE V200 This user manual contains all the information needed to use the analyzer and keep it ready to operate. Please read this user manual carefully before using the analyzer. Familiarize yourself with the required preparations and the measure- ment procedure before performing the first measurement.

  • Page 4: Table Of Contents

    TABLE Of CONTENTs CHAPTER 01. General Information Main Menu Structure ............................6 Symbols and Abbreviation ..........................10 Brief Precautions and Limitations........................12 CHAPTER 02. Introduction Intended Use ..............................13 Product Description ............................13 Before You Start Testing ..........................13 System Components ............................15 CHAPTER 03. settings and Performance Operating the Analyzer ...........................19 Performing a Measurement ...........................34 CHAPTER...

  • Page 5: Table Of Contents

    CHAPTER 08. screen Messages and Troubleshooting Warning Messages ............................53 Error Messages ..............................55 ANNEX 01. Information for Healthcare Professionals Protection against Infections .........................58 ANNEX 02. Reference Warranty .................................59 Return ................................59 Disposal ................................59...

  • Page 6: Main Menu Structure

    CHAPTER 01. General Information Main Menu structure Main Standard Test Read Only Review Patient Calibration Login Login Results Result Results Detailed Search Insert Device Insert Device Results Send Device Check Device Check Select Results Apply Sample Analyze Select All Sample Check Finish Delete Analyze...
  • Page 7 Calibration Supervisor Login Login Password Manage Load/ Insert Device Insert Device Update Operator Save Device Check Eject Device Setting Info Apply Sample Insert Device Sample Check Eject Device Analyze Insert Device Finish Analyze Finish...
  • Page 8 Send Results Manage Operator Send Unsent Result Send All Results Edit Send All Q.C Results Delete Send Last Results Send All Patients Results Send Selected Result Load / Save Settings Load Save Operator ID Load Save Save Test Records Update Info S/W Update View Version...
  • Page 9 Settings Set Print Option Set Timeout Set Calibration and Q.C Date/Time Language General Settings Units Network Volume/ Instrument Name Parameters Brightness...

  • Page 10: Symbols And Abbreviation

    Abbreviation symbols These symbols and abbreviations may appear on the packaging, on the labels, and in the instructions for the BIONOTE V200. Symbol Description Manufacturer Consult instructions for use Reference number Date of manufacture To indicate the date of analyzer manufacture...
  • Page 11 Abbreviation Abbreviation Description Canine C-Reactive Protein cCRP Feline Serum Amyloid A fSAA Communication Comm Laboratory Information System Hospital Information System Graphic User Interface Software Firmware BioNote, Inc.

  • Page 12: Brief Precautions And Limitations

    Brief Precautions and Limitations To reduce the risk of analyzer damage · Keep the BIONOTE V200 analyzer on a flat and dry surface and avoid direct sunlight Caution when operating · The analyzer has internal correction for normal levels of ambient light, but highly...

  • Page 13: Intended Use

    The BIONOTE V200 analyzer automatically recognizes the lot of the specific test devices in use by reading their 2D barcodes. While the test device is inserted into the BIONOTE V200 analyzer, the application well of the test device is illuminated by UV or RGB LED (light-emitting diode) with scanning. Before performing the measurement, the type of the light reflected determines the way the test device is analysed.
  • Page 14 Operating conditions To ensure proper function of the BIONOTE V200 analyzer, observe the following guidelines. · Operate the analyzer only within the acceptable environmental conditions. Within the above range, the acceptable temperature range varies depending on the reagent. · To perform a measurement, place the analyzer on a flat surface.

  • Page 15: System Components

    Labeling Barcode Scanner Barcode Scanner (Optional) · The AC/DC power adaptor is not supplied by BioNote, Inc. All users must use approved Adaptor. (VDE, UL, TUV and etc.) Note · Do not connect to the power supply other than AC/DC adaptor specified rating in the specification.
  • Page 16 Overview of BIONOTE V200 analyzer...
  • Page 17 Use for connecting the keyboard, barcode scanner and USB drive I. LAN Use for communicating through the local area network J. Mini UsB Use for upgrading the F/W upgrade by connecting to a PC K. Additional Device Port Use for connecting to specific devices manufactured by BioNote, Inc.
  • Page 18 Accessories of the BIONOTE V200 analyzer Included Calibration set Test device Barcode scanner (For patient ID recognition) Optional 12V/5A AC/DC power adaptor Print paper...

  • Page 19: Operating The Analyzer

    CHAPTER 03. setting and Performance Operating the Analyzer sTEP 1. Connect AC/DC adaptor jack 1-1. Place the analyzer on a bench top within reach of an electrical outlet. The unit is portable and can be moved to a suitable location for testing. Ensure the bench top is stable, flat and dry. Also ensure the bench provides adequate space for the analyzer and barcode scanner stand.
  • Page 20 1st step: Entering setup mode 1. First, touch the 'Supervisor' button on the screen in the main menu to enter setup mode and begin the test. 2016. 10. 26 16:18:57 2. Input the password and press ‘OK’ for entry. The initial password is 0000. Press ‘Cancel’ if you want to return to the previous setting.
  • Page 21 2. To add the operator's ID, press ' A dd' . Use the touch panel keyboard or a USB connected keyboard to add the operator's ID. 2016. 10. 26 16:19:13 3. After adding the operator's ID, it will be registered in the analyzer. Press ‘OK’ to confirm. BIONOTE 2016. 10. 26 16:19:20...
  • Page 22 4. To edit the name of an operator currently registered in the analyzer, press ‘Edit’ . BIONOTE 2016. 10. 26 16:19:24 BIONOTE 2016. 10. 26 16:19:30 5. To delete the name of an operator currently registered in the analyzer, press ‘Delete’ .
  • Page 23 3rd step: supervisor > Load/save The software including GUI can be updated by USB memory, and the firmware can be updated by mini USB with PC connection. The USB can be connected at any time with the analyzer’ s power on. Note 1.
  • Page 24 3. When the data is loaded, the screen will promptly show a message indicating that the data has loaded successfully. Press ‘OK’ to confirm. 2016. 10. 26 16:19:50 4. To save analyzer settings that are cloned or duplicate settings from another device, press ‘Save’ . When the data save procedure is completed, press ‘OK’...
  • Page 25 6. When the operator's ID is loaded, the screen will promptly show a message indicating that the operator's ID has loaded successfully. Press ‘OK’ to confirm. 2016. 10. 26 16:20:00 7. In addition, the operator can save the operator's ID by pressing ‘Save’ . When operator's ID is saved, press ‘OK’ to confirm.
  • Page 26 4th step: supervisor > Update 1. To update the analyzer's software or firmware, enter the ‘Update’ menu after connecting the USB device containing the S/W or F/W update. 2016. 10. 26 16:20:08 2. To update the new analyzer software, press ‘OK’ . The analyzer will read the new software to be installed. 2016.
  • Page 27 5th: supervisor > settings 1. To set the print option, automatic turn-off time, calibration and Q.C date, general settings or instrument name, enter the ‘Settings’ menu. Press ‘Back’ to return to the previous menu. 2016. 10. 26 16:20:25 2. To set the number of printed sheets as 1, 2 or auto-printing mode (ON/OFF) enter the ‘Set Print Option’ menu. Auto-printing means the built-in printer will automatically print all test results at the end of each test.
  • Page 28 3. To control the analyzer's automatic turn-off time for power saving, enter the ‘Set Timeout’ menu. Insert test device stage procedure means that the user doesn't require any action after inserting test device in to the analyzer, and when the test is finished. Standby mode means the user doesn't require any action even when inserting a test device into the analyzer.
  • Page 29 5. To set the date/time, language, test unit parameters, network, LIS parameters, sound volume, or LCD brightness, enter the ‘General Settings’ menu. Especially, under unit settings, test parameters corresponding to the test type can be set and the parameters can be adjusted by updating the analyzer software. 2016.
  • Page 30 <setting the test parameter's unit> Canine CRP ㎎/L fSAA ㎍/㎖ <setting the network> 192.168.33.100 192.168.33.1 <setting the LIs parameter> 192.168.33.200 5005 Consult a technician for the network settings information or the LIS parameters. Note...
  • Page 31 <setting the sound volume/LCD brightness> <setting the instrument name> V200...
  • Page 32 6th: supervisor > Info 1. To display and view the analyzer's current software version, firmware or network, enter the ‘Info’ menu. 2016. 10. 26 16:22:30 2016. 10. 26 16:23:10...
  • Page 33 2. When ‘View Version’ is selected, the version information for the software and firmware will be displayed. Press ‘OK’ to confirm. S/W Version : V1.00_R003.9(6) F/W Version : 0.4 Serial NO. : FA20A02AA0027 3. When ‘View Network’ is selected, information about the network will be displayed. Press ‘OK’ to confirm. 192.168.33.100 192.168.33.1 5005...

  • Page 34: Performing A Measurement

    Performing a Measurement Check the following before performing a measurement: · Is the analyzer connected to the AC/DC adaptor? · Are date and time correct? · Have you checked the analyzer settings? select the desired test mode The Standard Test mode may be the most convenient for reading a single patient sample, as the user can perform a Standard Test during the analysis period.
  • Page 35 3. Once ‘Insert Device’ is displayed on the screen, insert the specified test device into the analyzer’ s test slot. The analyzer automatically reads the information for the test device. 4. When inserting the test device into the analyzer, the analyzer will automatically check whether the device has been used or not.
  • Page 36 5. When the test device has been checked, apply the specimen to the sample well and press the ‘START’ button immediately. If the ‘START’ button is not pressed within 20 seconds after applying the specimen, the analyzer will display an error message indicating that the test cannot be performed. Canine CRP 6.
  • Page 37 8. Once the analysis is finished, the test results will be displayed. The analyzer will print the test results if auto- printing is enabled. [ Canine CRP ] Patient ID: Date: 2016/11/25 17:36:47 Operator ID: guest Order #: Canine CRP: 15.8 ㎎/L Procedural Control: Valid 9.
  • Page 38 Read Only mode 1. First, select Read Only’ mode. Refer to the assay specific package insert when collecting the specimen for the test and preparing the test procedure. 2016. 11. 25 17:31:12 2. Input operator's ID, patient ID, and order #. The operator's ID can also be input with the barcode scanner. If the ID is not input into the analyzer, the analyzer will regard the operator as a guest user.
  • Page 39 4. When inserting the test device into the analyzer, the analyzer will automatically check whether the test device has been used previously or not. The analyzer also reads the barcode data and confirms the test device is valid before starting the test.
  • Page 40 5. The analyzer will automatically scan the test device and analyze the test results on the screen within 10 seconds. [ Canine CRP ] Patient ID: Date: 2016/11/25 17:36:47 Operator ID: guest Order #: Canine CRP: Canine CRP: 15.8 ㎎/L Procedural Control: Valid 6.

  • Page 41: Displaying Stored Measured Values

    Displaying stored Measured Values 1. The BIONOTE V200 analyzer can store 3000 records together with date, time and flags, allowing the records to be reviewed in order from the most recent to the oldest. When the memory is full and a new result is added, the analyzer will delete the oldest record.

  • Page 42: Send Results

    send Results 1. With several options available for sending the test results, you can choose the most appropriate method to communicate with data server. <Sending the unsent results> <Sending the last result>...
  • Page 43 <Sending all results> <Sending selected results>...

  • Page 44: Control Test

    When to use the control · Before using the BIONOTE V200 analyzer for the first time. · To check the test device when you unpack a new device. · If you drop the analyzer.

  • Page 45: How To Perform Quality Control

    How to Perform Quality Control 1. To perform quality control according to the specific test type, refer to the assay-specific package insert when preparing the test with the appropriate Q.C control solution for each type of test device. Enter the operator ID and CS Info before starting.
  • Page 46 3. When the test device is inserted into the analyzer, the analyzer will automatically check whether the device is unused or not. Also, the analyzer will read the barcode data and confirm the test device is valid before starting the test. 4.
  • Page 47 6. The analyzer will automatically scan and analyze the test results. 7. Once the analysis is finished, the test results will be displayed. The analyzer will print the test results if auto- printing is enabled. 8. After the procedure of analyzing the test device is completed, 'Eject Device' will be displayed. The test device can then be removed from the analyzer.

  • Page 48: Calibration Set Test

    CHAPTER 06. Calibration Calibration set Test The calibration set test is a required function that ensures optimal performance by checking the designated method. When to use calibration set · Whenever the analyzer is powered on · When you drop the analyzer ·...

  • Page 49: How To Use The Calibration Set Test

    How to Use the Calibration set Test 1. To run the calibration set test, select the ‘Calibration’ menu. Enter the operator's ID before starting the calibration set test. The operator's ID can be entered into the analyzer with the touch panel or a USB keyboard. The ID can also be entered with the BN barcode reader, which is sold separately.
  • Page 50 3. When the device is inserted into the analyzer, the analyzer will automatically check whether CAL-1 is unused or not. Additionally, the analyzer will read the barcode data and confirm the device is valid before starting the calibration set test. Calibration 4.
  • Page 51 6. Insert CAL-3 for RGB-LED testing. Ensure that CAL-2 and CAL-3 are inserted in order. Never change the order. 7. If the measured value is within the normal range, ‘OK’ will be displayed on the screen. 8. If the measured value is not within the normal range, ‘EEE’ will be displayed on the screen.

  • Page 52: Cleaning The Analyzer

    CHAPTER 07. Cleaning and Maintenance Cleaning the Analyzer To prevent analyzer malfunction, keep the test slot free from blood, moisture or dust. Use lint-free cloth. For cleaning, suitable solutions are mild suds, 70 % ethanol or isopropyl alcohol. For professional use (e.g.surgery), a mixture of 1-propanol, 2-propanol and glutaraldehyde is recommended.

  • Page 53: Warning Messages

    CHAPTER 08. screen Messages and Troubleshooting Warning Messages Indication Warning description Warning: Operator ID. Pressed `OK' without entering the Operator ID. solution Enter the operator's ID first, then press ‘OK’ . Warning: UsB not connected USB device is not connected. solution Confirm USB device is connected correctly.
  • Page 54 Indication Warning description Warning: Review No selection in the review data list. solution Press ‘Send selected result’ after selecting the result. Warning: Unregistered Operator ID Entered operator ID is not registered. solution Add operator ID in set mode. Warning: Out of Paper There is no printer paper in the analyzer.

  • Page 55: Error Messages

    Error Messages Indication Error description E01: Test Device Error The test device is damaged or inserted improperly. solution Discard the test device and retest with a new test device and a new specimen. E02: Blood specimen Error An insufficient amount of blood has been applied. solution Retest with a new test device with enough blood, ensuring that the sample is placed in the narrow channel at the top of the test device.
  • Page 56 Reconnect the analyzer and the external device. If the error continues after turning the analyzer ON/OFF, please contact BioNote, Inc. E06: Total hemoglobin out of range The measured total hemoglobin is outside the range of 7 to 23g/dL.
  • Page 57 E12: Calibration Overdue The calibration is overdue. solution If the error continues after turning the analyzer ON/OFF, please contact BioNote, Inc. E13: Unsupported Test Device Loaded test device is not appropriate for the analyzer. solution Check the type of test device and confirm it is manufactured by BioNote, Inc.

  • Page 58: Protection Against Infections

    Protection against Infections There is a potential risk of infection. Medical staff using the BIONOTE V200 analyzer to perform measurements for more than one patient must be aware that any object coming into contact with the patient sample is a potential source of infection.

  • Page 59: Warranty

    Warranty You are a valued customer of BioNote, Inc. It is important to us that you are completely satisfied with the BIONOTE V200 analyzer. BioNote, Inc. guarantees the analyzer will be free from defects in materials and workmanship for a period of two years from the date of original purchase. If the analyzer does not work properly during this period because of a defect in materials or workmanship, BioNote, Inc.
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