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BBB MARK-B User Manual

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IVD
MARK-B analyzer
User Manual
Immunoassay analyzer
MARK-B Analyzer(
)
*Model No: MB-200
MARK-B analyzer detects specific biomarkers via immunoassay (MESIA; Magnetic
Electrochemical Sandwich ImmunoAssay) from a small amount of test sample (e.g.
whole blood). MARK-B analyzer is intended to be used as an in vitro diagnostic
medical device. Please read this user manual thoroughly for correct use and keep it for
future reference.

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  • Page 1 Electrochemical Sandwich ImmunoAssay) from a small amount of test sample (e.g. whole blood). MARK-B analyzer is intended to be used as an in vitro diagnostic medical device. Please read this user manual thoroughly for correct use and keep it for...

  • Page 3: Table Of Contents

    1-1. Intended Use ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-2. Principle∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-3. Precautions ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-4. Components∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-5. Symbol Guide∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Product Description 2-1. MARK-B Analyzer ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 2-2. Check Cartridge∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Screen Description∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Initial Setup∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ ∙ ∙∙∙∙∙∙∙∙∙∙∙∙∙∙ ∙∙∙∙ Running a Test 5-1. How to perform RUN TEST∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 5-2. Result Management∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙...

  • Page 4: Intended Use

    1-2. Principle The MARK-B analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic Electrochemical Sandwich Immunoassay). MARK-B analyzer can be used to analyze a single or multiple analyte(s) by detecting electrochemical signals on the test cartridge, which is for a one-time in vitro diagnostic (IVD).

  • Page 5: Components

    1. Product Introduction 1-4. Components The following are the components you should check upon opening the package of MARK-B analyzer. Please check that all components are included in the box. Please contact the purchase location if any of the following components are not included or damaged •...
  • Page 6 1. Product Introduction...

  • Page 7: Product Description

    2. Product Description 2-1. MARK-B analyzer Screen Interface that the user can touch to operate the analyzer and check the results. Power button Buttons to turn the device on or off. Tray (closed) A component to insert the test cartridge.
  • Page 8 The check cartridge is used to evaluate instrumental and electronic operations of the analyzer. An alignment sensor is embedded in the check cartridge to check the alignment of magnets at the top and bottom of the analyzer. Cartridge contact pad Contact pad for the operation check of MARK-B analyzer...

  • Page 9: Screen Description

    3. Screen Description Status bar Run QC Test Indicates MARK-B analyzer’s network Touch the button to run the QC test. connection, battery level and time. Status indicating icon QC Test interval and test information Check QC Test intervals and recent/next...
  • Page 10 4. Initial Setup STEP 1. Connect the power adapter. STEP 2. Touch the ‘power’ button to start.
  • Page 11 4. Initial Setup STEP 3. Time Zone Setting a. Touch the ‘Select Time Zone’ → Select the time zone where the user is located. b. When connected, the 'DONE' button is activated c. touch the ‘DONE’ button → Complete the setting...
  • Page 12 4. Initial Setup STEP 4. Wi-Fi Setting a. ‘Click the 'Connect Wi-Fi' → Select the Wi-Fi to connect to b. When connected, the 'DONE' button is activated c. touch the ‘DONE’ button → Complete the setting 아 이 콘 연 결 상 태 설...

  • Page 13: Lock Settings

    4. Initial Setup STEP 5. Create Admin Password a. Enter admin password b. Touch the ‘OK’ button → Complete the setting c. Go to Lock Settings • Administrator ID is automatically set as ‘Admin’. • Please set your own admin password. •...
  • Page 14 4. Initial Setup STEP 7. Device Registration Enter hospital code. Touch the ‘DONE’ button to connect to hospital server. Once connected to server, initial setup is completed. If there is no hospital for device registration, touch the ‘Register device later’ button. •...
  • Page 15 4. Initial Setup Barcode Scanner Connection Connect the barcode scanner to the USB Port on the back of MARK-B analyzer. Barcode scanner automatically starts operation when connected to the USB port. Barcode scanner is sold separately. Printer Connection a. Turn the printer on.
  • Page 16 5. Running a Test 5-1. How to Perform RUN TEST STEP 1. Touch the ‘RUN TEST’ button to start test • Test temperature range is 15℃~30℃. Run test within the specified range of temperature. • If the temperature is out of range, the test cannot be run. •...
  • Page 17 5. Running a Test 5-1. How to Perform RUN TEST STEP 3. Patient code scan Scan the patient code with a barcode scanner. When the code is inputted, proceed to the cartridge insertion. If you do not have a barcode scanner, touch the ‘Input patient code manually’...
  • Page 18 5. Running a Test 5-1. How to Perform RUN TEST STEP 4. Test cartridge insertion a. Ensure the correct operator and test sample code are entered before inserting a cartridge. b. Insert a test cartridge to the tray according to the instructions on the screen. c.
  • Page 19 5. Running a Test 5-1. How to Perform RUN TEST STEP 6-1. When a sample of blood is injected , a. Injecting the prepared blood sample into the cartridge b. After injection, click the'OK' button c. Start inspection STEP 6-2. When a sample except blood is injected, Injecting the prepared blood sample into the cartridge b.
  • Page 20 5. Running a Test 5-1. How to Perform RUN TEST STEP 7-1. Start plasma separation When the blood separation starts, please wait until analysis reaches ‘100%’. STEP 7-2. Start sample analysis When the sample analysis starts, please wait until analysis reaches ‘100%’. f the tray is not inserted into analyzer within 2 minutes after injected sample, start •...
  • Page 21 5. Running a Test 5-1. How to Perform RUN TEST STEP 8-1. Check the result of the blood test. a. Touch the ‘DONE’ button → Save result → Return to the home screen. • For printer connection, select [Settings → Printer settings] STEP 8-2.
  • Page 22 5. Running a Test 5-2. Check the test result history a. Touch the ‘TEST RESULTS’ from the home screen b. All test results sorted in recent test c. Click a specific result from the list of test results d. Check the details of a specific result Blood test result history Sample test result history...
  • Page 23 6. Running a QC Test (Control Solution Test) QC Test (control solution test) In order to test the normal operation of the test cartridge, the three steps to proceed. STEP 1. Touch the ‘QC TEST’ button. STEP 2. Touch the ‘Run QC Test’ button. Click the ‘Run QC Test’...
  • Page 24 6. Running a QC Test (Control Solution Test) STEP 3. Operator code scan Scan the code with a barcode scanner or type it using the keypad. button Touch the ‘OK’ If you do not have a barcode scanner, touch ‘Input operator ID manually’...
  • Page 25 6. Running a QC Test (Control Solution Test) STEP 4. Test cartridge insertion a. Follow the information on the screen to insert the test cartridge. b. When the cartridge is properly inserted, it automatically moves to the control solution injection step. •...
  • Page 26 6. Running a QC Test (Control Solution Test) STEP 5. Positive control solution injection a. Prepare positive control solution of the same marker as the inserted test cartridge. b. Draw control solution to inject → Touch the ‘OK’ button. c. When it reaches 100%, the positive control solution test is completed d.
  • Page 27 6. Running a QC Test (Control Solution Test) STEP 7. Check the result of QC Test When test is completed, result of QC test is displayed on the same screen. Check the result and remove the cartridge from the tray. Touch the ‘DONE’...
  • Page 28 7. Function Settings 7-1. Settings Screen Settings → Enter setting menu Setting menu • Administrator Settings • Wi-Fi Settings • Printer Settings • Date & Time Settings • Lock Settings • System Check • Version Information • Device Registration • Power Off Settings...
  • Page 29 7. Function Settings 7-2. Administrator Settings Input admin password → Enter admin menu Administrator Information Click the ‘Administrator Information’ → Check the administrator Change Administrator Password Touch the ‘Reset Password’ button Enter the current password Enter a new password in ‘New password’ and ‘Re-enter password’. Touch the →...
  • Page 30 7. Function Settings 7-2. Administrator Settings Forgot Password If you forgot admin password, touch ‘Forgot password? Master password input screen will be displayed. Input the Master Password Type the master password. Enter the new admin password. Touch the ‘OK’ button. →...
  • Page 31 7. Function Settings 7-3. Wi-Fi Settings Turn Wi-Fi On or Off & Connect to a Wi-Fi. Wi-Fi Setting → On/Off] : Turn Wi-Fi network on or off. a. [ Select ‘On’ : Select Wi-Fi to connect to.
  • Page 32 USB printer. • Printing may be unavailable if you use a mobile printer incompatible with MARK-B analyzer. • Changing printer connection mode may cause a delay for two seconds.
  • Page 33 7. Function Settings 7-5. Date & Time Settings Date & Time Settings Enter the admin password to access ‘Date & Time Settings’. Adjust ‘Set Date & Time’. → Touch the ‘OK’ button.
  • Page 34 When all settings of QC Lock are turned OFF, a test can be • run even if QC Test result is ‘fail’. BBB is not responsible for the test results run under settings • with all QC Lock Settings turned OFF.
  • Page 35 7. Function Settings 7-6. Lock Settings STEP 3. QC Test interval setting A sample test is available after conducting QC test at the intervals you set up. [ON ] You can continue QC test without setting up intervals. [OFF] You can set the intervals for QC test. •...

  • Page 36: Maintenance

    8. Maintenance 8-1. System Check System Check The purpose of the check cartridge test is to verify proper operation of MARK-B analyzer. STEP 1. Touch the ‘Run System Check’ button STEP 2. Insertion of check cartridge tray Insert a check cartridge to the tray according to instructions on the screen.
  • Page 37 8. Maintenance 8-1. System Check STEP 3. Start ‘System Check’ A check cartridge test takes about 1 minute. STEP 4. Confirm the check cartridge test results The test results are displayed upon completion. After checking the results, remove the used cartridge from the tray. Touch the ‘DONE’...
  • Page 38 8. Maintenance 8-1. System Check STEP 5. System Check Result History. a. Click the ‘System Check Result’ The System Check Result is displayed in order from latest to earliest.

  • Page 39: Version Information And

    8. Maintenance 8-2. Version Information and Update STEP 1. Check the Version Information Input the admin password Confirm the latest version → Enter Version Information → b. Touch the ‘Version Update’ → Update to the latest software...

  • Page 40: Update

    Select ‘WI-FI Network update’. (A message to update to new version will be displayed if the software needs to be updated.) Touch the ‘OK’ button to update to the latest software • The update starts when MARK-B analyzer’s battery level is 15% or higher.

  • Page 41: Registration

    8. Maintenance 8-3. Device Registration Device Registration If you have already registered the device during initial setup, you do not need to proceed again. STEP 1. Device registration Input the admin password access ‘Device registration’ menu → Enter the hospital code The device will try to access the hospital server.
  • Page 42 8. Maintenance 8-4. Auto Power Off Settings Power Off Settings Input the admin password Select ‘Power Off Settings’ → → Setting the power On/Off Default auto power off time is • 10 hours when the function is enabled ‘On’. Auto power off time can be changed •...

  • Page 43: Auto Power Off

    Select the ‘Power off’ button. Touch the ‘YES’ button to finally turn the power of the device off. • It is recommended to turn MARK-B™ 1 analyzer off, if the instrument is not used for a long period of time.

  • Page 44: Cleaning

    Make sure to turn off when cleaning the device. Test Tray Cleaning The blood, moisture or dust that enters the tray may lead to failure of the MARK-B analyzer. Wipe the tray carefully with an alcohol-moistened swab if needed. Make sure to turn off the device when cleaning •...

  • Page 45: Error Messages

    9. Error Messages 9-1. Notifications Notifications Description and Measure Admin password is not inputted. Displayed when touching the ‘DONE’ button without entering the admin password. Please input the admin password. ▶ Input the admin password and then touch the ‘DONE’ button. Hospital code is not inputted.
  • Page 46 9. Error Messages 9-1. Notifications Notifications Description and Measure System Check is not performed. The system check was failed or has Displayed when system check is not performed. an error. Please check the results again. [Setting screen → System Check → Run System Contact the system administrator.
  • Page 47 Notifications Description and Measure Fan activated The fan is activated due to increased Displayed when the fan is activated by MARK-B™ 1 internal temperature of the analyzer. analyzer’s temperature sensor operation. Fan activated Invalid ID. Please check the ID again.
  • Page 48 9. Error Messages 9-1. Notifications Notifications Description and Measure Current password mismatch Incorrect password. Displayed when you do not enter currently set Please input the password correctly. password. New password mismatch The new password and re-entered Displayed on the Change Administrator Password password do not match.

  • Page 49: Pop-Ups

    9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Inappropriate temperature Pops up when the ‘RUN TEST’ button is touched on the home screen, or the ‘RUN QC TEST’ button is touched. Pops up when the temperature is out of test range.
  • Page 50 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure QC Test error Pops up when the ‘RUN TEST’ button is touched on the home screen under the condition that QC lock settings are turned ‘ON’, and/or QC TEST result is ‘Fail’.
  • Page 51 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Invalid cartridge QR code Pops up when an invalid QR code is scanned. Expired cartridge QR code Pops up when expired cartridge QR code is scanned. QR code of check cartridge is scanned. Pops up when the check cartridge’s QR code is scanned instead of the test cartridge.
  • Page 52 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Insert used cartridges Pops up when used cartridge is inserted. Plasma separation during test , blood analysis failure Plasma separation failed (blood sample use test cartridge Only) Occurs when plasma separation fails due to insufficient blood injection Analytical preparation failed ( non-blood sample use test cartridge Only)
  • Page 53 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Analysis failure Occurs when analysis fails during analysis Pops up when the printer cover is open. Pops up when there is no paper left in the printer. Printer disconnection Pops up when the printer is not connected and the user touched the ‘Print’...
  • Page 54 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Solution separation error or insufficient solution Pops up when solution separation fails due to either timeout, insufficient solution injection, or solution reading failure. QR code of test cartridge is scanned. Pops up when the QR code of test cartridge is scanned during System Check process.
  • Page 55 9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Pops up when firmware update failed. Repetitive update failure Pops up when firmware update failed more than 3 times. Low battery during software update Pops up upon touching ‘Update’ when battery level is 15% or lower.

  • Page 56: Technical Information

    10. Technical Information Model Name MB-200 MT8163B (Quad core) Display type 5.5” HD display, Touch screen Memory capacity 8GB ROM /1GB RAM Battery 2,500mAh 14.4V (3.7V 18650 4cell) rating : 12VDC, 2A Power plug interface : 5.5mm * 2.5mm Dimension/weight 262.7 x 226 x 146.4(mm) / 3.6kg Android 7.0 LOT code reading...

  • Page 57: Product Warranty

    11. Product Warranty Product Warranty BBB Inc. offers product warranty in accordance with “Regulations on Consumer Dispute Resolution” as follows. Within the warranty period, if the product fails due to manufacturing defect(s) or spontaneous failure, it will be replaced without any charges.
  • Page 58 FCCID: 2AKGP-MB200 FCC Compliance Information : 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.
  • Page 60 BBB Inc. (+82) 2- 565 -9653 . Fax. (+82) 2-565-9654 . www.bbbtech.com BMD011AMUS-0AIssue date:2020.07...

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