IVD MARK-B™ 1 analyzer User Manual MARK-B™ 1 analyzer (Immunoassay analyzer) *Model: MB-100 MARK-B™ 1 analyzer detects specific biomarkers via immunoassay (MESIA; Magnetic Electrochemical Sandwich ImmunoAssay) from a small amount of test sample (e.g. whole blood). MARK-B™ 1 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.
Table of Content 1. Product Introduction ﹒﹒﹒﹒﹒ ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 4 1-1. Intended Use ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ ﹒ 4 1-2. Principle﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒4 1-3. Precautions & Warnings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 4 1-4. Components﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 5 1-5. Symbol Guide﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 5 1. Product Description ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒7 2-1. MARK-B™ 1 analyzer ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒7 2-2. Check Cartridge ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 8 2.
1. Product Introduction 1-1. Intended Use The MARK-B™ 1 analyzer is an instrument that performs immunoassay on test cartridges. It reads specific biomarkers within the test sample. 1-2. Principle MARK-B™ 1 analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic Electrochemical Sandwich Immunoassay).
1. Product Introduction 1-4. Components The following are the components you should check upon opening the package of MARK-B™ 1 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. ✔ MARK-B™ 1 analyzer, 1EA ✔ User manual ✔ Quick guide 1-5. Symbol Guide Please refer to the following symbols that can be found on the external package, package descriptions, enclosed papers, etc.
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2. Product Description 2-1. MARK-B™ 1 analyzer 1 Screen Interface that the user can touch to operate the analyzer and check the results. 2 3 Power button Buttons to turn the device on or off. Tray (closed) A component to insert the test cartridge. Opening and closing of the tray are controlled by the software. 4 Air vent A component to control temperature inside the analyzer. 5 Power supply connector An adapter connection port to supply power to the device.
2. Product Description 2-2. Check Cartridge 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.
3. Screen Description 3-1. Home Screen 1 Status bar Indicates MARK-B™ 1 analyzer’s network connection, battery level and time. 1 2 Status indicating icon is displayed when QC test result shows “fail” or the QC test is not carried out. 2 is displayed when battery level is 15% 3 or lower. is displayed when temperature is either 4 15℃ or lower, or at least 30℃. is displayed when the first System Check is not performed, or System Check result is Fail. 5 3 6 4 Time Displays day, date and month.
4. Initial Setup STEP 1. Connect the power adapter. STEP 2. Touch the ‘power’ button to start. STEP 3. Time Zone setting Touch the ‘Select Time Zone’ → Select the time zone where the user is located. → When setting is completed, touch the ‘DONE’ button.
4. Initial Setup STEP 4. Wireless network (Wi-Fi) setting Connect Wi-Fi → Select the Wi-Fi to connect to. → When connected, the ‘DONE’ button is activated.→ Touch the ‘DONE’ button. Icon Connection Status Connected Wi-Fi is connected and active. Requesting Please wait as the Wi-Fi signal is being acquired. In the connection case of no response, touch ‘Reconnect Wi-Fi’ to try again. Connection Failure Network not connected 11 Description Wi-Fi connection has failed.
4. Initial Setup STEP 5. Create Admin Password Enter admin password → Touch the ‘OK’ button • Administrator ID is automatically set as ‘Admin’. • Please set your own admin password. • Password is case-sensitive and must be a combination of letters and numbers. • Your password cannot contain spaces and must be less than 45 characters long. • Touch the eye-shaped icon to check entered password. STEP 6.
4. Initial Setup STEP 7. Device registration a. Enter hospital code in the window. b. After entering hospital code, touch the ‘DONE’ button to connect to hospital server. c. Once connected to server, initial setup is completed and the home screen will be displayed. • If there is no hospital for device registration, touch the ‘Register device later’ button. • Device registration is available later in [‘Settings’ → ‘Device registration’] (see Page 44).
4. Initial Setup Barcode Scanner Connection a. Connect the barcode scanner to the USB Port on the back of MARK-B™ 1 analyzer. b. Barcode scanner automatically starts operation when connected to the USB port. Barcode scanner is sold separately. Printer Connection a. Turn the printer on. b. USB Connection The printer is automatically recognized once USB cable is connected. c. Bluetooth Connection Please refer to [Function settings → Printer setting] on Page 32 of this manual. Printer is sold separately.
5. Running a Test 5-1. How to Perform RUN TEST STEP 1. Touch the ‘RUN TEST’ button to start test • Operating temperature(Device without a cartridge) is -10 ~ 45°C (14 ~ 113°F). • Run test within the specified range of temperature. • If the temperature is out of range, the test cannot be run. • When the battery level becomes 15% or lower, the test cannot be run. • Fully charge the battery before running a test. STEP 2. Operator code scan a.
5. Running a Test 5-1. How to Perform RUN TEST STEP 3. Patient code scan a. Scan the patient code with a barcode scanner. b. When the code is inputted, proceed to the cartridge insertion. If you do not have a barcode scanner, touch the ‘Input patient code manually’ to enter the code using the keypad. STEP 4. Cartridge QR code scan a. Scan the QR code on the cartridge pouch with a barcode scanner. b. After scanning the QR code, cartridge type and LOT code are displayed on the screen.
5. Running a Test 5-1. How to Perform RUN TEST STEP 5. Test cartridge insertion a. Insert a test cartridge to the tray according to the instructions on the screen. b. When the cartridge is inserted in the correct position, the screen automatically instructs to inject test sample. • Ensure the correct operator and test sample code are entered before inserting a cartridge. • Ensure the QR code of the cartridge to be inserted is scanned.
5. Running a Test 5-1. How to Perform RUN TEST STEP 6. Test sample injection and starting test a. Prepare a test sample. b. Before injecting the sample, check injection location of the test sample and whether a sufficient amount of test sample is prepared. c. Inject the test sample within 2 minutes after inserting a cartridge. d. After injection of the test sample is completed, touch the ‘OK’ button. • When the analysis starts, please wait until analysis reaches ‘100%’.
5. Running a Test 5-1. How to Perform RUN TEST STEP 7. Check the result of the test. a. When test is completed, the result of the test is displayed on the same screen. b. Check the result and remove the cartridge from the tray. c. Touch the ‘DONE’ button → Return to the home screen. TEST RESULT: Positive or Negative - Normal operation of test cartridge If the warning sign is displayed as shown: “ * warning: unexpected signal detected.”, a retest is recommended. STEP 8. Discard the used cartridge.
5. Running a Test 5-2. Result Management Check the results of the test. - The results can be checked by touching the ‘TEST RESULTS’ button on the home screen.
6. Running a QC Test (Control Solution Test) STEP 1. Touch the ‘Run QC Test’ button. STEP 2. Operator code scan a. Scan the code with a barcode scanner or type it using the keypad. b. Touch the ‘OK’ button. If you do not have a barcode scanner, touch ‘Input operator ID manually’ to enter the code using the keypad.
6. Running a QC Test (Control Solution Test) STEP 3. Test cartridge QR code scan a. Scan the QR code on the cartridge pouch with a barcode scanner. b. After scanning the QR code, test level, cartridge type and LOT code are displayed on the screen. • Barcode scanner has to be purchased separately. • If QR code recognition fails, scan a new cartridge pouch. • Please check if the test marker is correct. STEP 4.
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 it into the cartridge within 2 minutes. c. Touch the ‘OK’ button. STEP 6. Discard the used cartridge. a. Refer to the images below to eject the cartridge from the tray. Discard used cartridge in a safe place under relevant laws and regulations. b. Touch the ‘OK’ button.
6. Running a QC Test (Control Solution Test) STEP 6. Discard the used cartridge. (continued) b. When touching the ‘OK’ button, the screen will proceed to the ‘QR Code Scan’ screen. STEP 7. Test cartridge QR code scan a. Scan the QR code on the cartridge pouch with a barcode scanner. b. After scanning the QR code, cartridge type and LOT code are displayed on the screen. • Barcode scanner has to be purchased separately. • If QR code recognition fails, scan a new cartridge pouch.
6. Running a QC Test (Control Solution Test) STEP 8. Test cartridge insertion • Ensure the correct operator and test sample code are entered before inserting a cartridge. • Check that you scanned the QR code of the cartridge to be inserted. • Double check whether you are using the test cartridge for the correct marker. • Before inserting a cartridge, ensure that you are not using a used one.
6. Running a QC Test (Control Solution Test) STEP 10. Check the result of QC Test a. When test is completed, result of QC test is displayed on the same screen. b. Check the result and remove the cartridge from the tray. c. Touch the ‘DONE’ button → Return to the home screen. TEST RESULT: Pass Normal operation of test cartridge TEST RESULT: Fail Accuracy of the actual test is not verified. Conduct the test again or contact the administrator. STEP 11. Discard the used cartridge. a.
7. Function Settings 7-1.
7. Function Settings 7-2. Administrator Settings Administrator Information a.Enter admin password to proceed to administrator settings. b.Touch the ‘Administrator Information’ button to check the administrator information. Change Administrator Password a. Touch the ‘Reset Password’ button. → Enter the current password. b. Enter a new password in ‘New password’ and ‘Re-enter password’. → Touch the ‘OK’ button. • Password is case-sensitive and must be a combination of letters and numbers.
7. Function Settings 7-2. Administrator Settings Forgot Password a. If you forgot admin password, touch ‘Forgot password?’. b. Master password input screen will be displayed. Input the Master Password Type the master password. → Enter the new admin password. → Touch the ‘OK’ button. • Master password is the ‘serial number of the device’ + ‘0001’. • Serial number is written in the label on the bottom of the device.
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. Select ‘On’ : Select Wi-Fi to connect to.
7. Function Settings 7.4. Printer Settings Print Setting Select ‘Auto’ or ‘Manual’ button in Print Setting. Printer Connection a. Find a printer model to link from the ‘Connectable Devices’ list. b. Select the model. c. The printer is connected and displayed in Connected Device. c. To disconnect, touch the ‘Disconnect’ button. • Printer is automatically linked when you connect USB port. • To find a printer’s model number, remove the battery of printer. Then, check the product label.
7. Function Settings 7-5. Date & Time Settings STEP 1. Date & Time Settings Enter the admin password to access ‘Date & Time Settings’. ● 32 Touch ‘Date & Time Settings’. → Touch ‘Select Time Zone’. → Select the location.
7. Function Settings 7-5. Date & Time Settings ● 33 Adjust ‘Set Date & Time’. → Touch the ‘OK’ button.
7. Function Settings 7-6. Lock Settings STEP 1. Lock Settings Enter the admin password to access Lock Settings. STEP 2. Lock Settings and QC Test [ON] The QC Test result must be a ‘PASS’ to be able to run a test. [OFF] A test can be run regardless of QC Test result. QC Lock is to lock or unlock the RUN TEST. • When all settings of QC Lock are turned OFF, a test can be run even if QC Test result is ‘fail’.
7. Function Settings 7-6. Lock Settings STEP 3. QC Test interval setting [ON] A sample test is available after conducting QC test at the intervals you set up. [OFF] You can continue QC test without setting up intervals. • You can set the intervals for QC test. • When the interval is set up, it will be shown under Run QC Test on the home screen. STEP 4. Date interval setting a. Touch the input box and then select using the numeric keypad shown on the screen. b.
8. Maintenance 8-1. System Check System Check : The purpose of the check cartridge test is to verify proper operation of MARK-B™ 1 analyzer. STEP 1. Touch the ‘Run System Check’ button STEP 2. Scan QR code of the check cartridge a. Scan QR code on a check cartridge with a barcode scanner. b. After scanning the QR code, the screen proceeds to ‘Insert Check Cartridge’. • Barcode scanner has to be purchased separately. • If you scan QR code of the test cartridge, the test will not proceed.
8. Maintenance 8-1. System Check STEP 3. Insertion of check cartridge tray a. Insert a check cartridge to the tray according to instructions on the screen. b. Insert the check cartridge in the correct position. c. Touch the ‘OK’ button. STEP 4. Start ‘System Check’ A check cartridge test takes about 1 minute.
8. Maintenance 8-1. System Check STEP 5. Confirm the check cartridge test results a. The test results are displayed upon completion. b. After checking the results, remove the used cartridge from the tray. c. Touch the ‘DONE’ button to move to the home screen. Pass : A message that the device is working properly and a ✓ mark is displayed on the screen. Fail : An error message and an X mark is displayed on the screen. Try out the test again or contact the administrator.
8. Maintenance 8-1. System Check System Check → System Check Result The System Check Result is displayed in order from latest to earliest.
8. Maintenance 8-2. View Version Information and Update STEP 1. Check the Version Information 40 a. Type the admin password and access device registration menu. b. Confirm the latest version.
8. Maintenance 8-2. Version Information and Update STEP 2. Update new version Option 1. Software update by USB connection a. Connect the USB containing the updated version to the USB port on the back of the analyzer. b. Select ‘USB Update’. (A message to update to new version will be displayed if the software needs to be updated.) c. Touch the ‘OK’ button to update to the latest software. • USB connection → The above message pops up. → Check the pop-up box. → Touch OK.
8. Maintenance 8-2. Version Information and Update STEP 2. Update new version Option 2.Wireless update of software a. Select ‘WI-FI Network update’. (A message to update to new version will be displayed if the software needs to be updated.) b. Touch the ‘OK’ button to update to the latest software. • The update starts when MARK-B™ 1 analyzer’s battery level is 15% or higher. • Unstable wireless network connectivity may cancel the update.
8. Maintenance 8-3. Device Registration STEP 1. Settings → Device Registration a. Input the admin password to access device registration menu. b. Enter the hospital code on the device registration screen. c. Type the hospital code and touch the ‘DONE’ button. The device will try to access the hospital server. If you have already registered the device during initial setup, you do not need to set it up again. STEP 2. Registration Completed When registration is completed: 43 a.
8. Maintenance 8-4. Auto Power Off Settings a. b. c. Select the ‘Power Off Settings’ button. Input the admin password. Select ‘Power Off’ Option 1. On/Off Setting of Auto Power Off Select on or off by touching [Auto Power Off Settings → On/Off] to enable or disable the function. • Default auto power off time is 10 hours when the function is enabled ‘On’. • Auto power off time can be changed by selecting Auto Power off Time.
8. Maintenance 8-4. Auto Power Off Settings On/Off setting → Select the ‘On’ button →Select the ‘Auto power off time’ After selecting the duration time for the screen to be displayed, the device will be automatically turned off after that duration time. Option 2. Power Off a. Select the ‘Power off’ button. b. 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.
8. Maintenance 8-5. Cleaning Clean the analyzer periodically with a soft and dry cloth. Clean the analyzer periodically with a soft and dry cloth. Do not use highly corrosive cleaning solution or chemicals, or a cleaning tissue contains chemical substances that may damage the device. 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™ 1 analyzer.
9. Error Messages 9-1. Notifications Notifications Description and Measure Admin password is not inputted. Displayed when touching the ‘DONE’ button without Please input the admin password. entering the admin password. ▶Input the admin password and then touch the ‘DONE’ button. Hospital code is not inputted. Displayed when touching the ‘DONE’ button without Please input the hospital code. entering the hospital code. ▶Input the hospital code and then touch the ‘DONE’ button.
9. Error Messages 9-1. Notifications Notifications The system check was failed or has an error. Please check the results again. Contact the system administrator. Description and Measure System Check is not performed. Displayed when system check is not performed. [Setting screen → System Check → Run System Check] QC not performed. The QC was failed or has an error. Please check the results again. Displayed when touching QC! icon on the home screen in the case of when the QC Test has not been performed.
9. Error Messages 9-1. Notifications Notifications Description and Measure Fan activated The fan is activated due to increased internal temperature of the analyzer. Invalid ID. Please check the ID again. Displayed when the fan is activated by MARK-B™ 1 analyzer’s temperature sensor operation. Wrong operator code Displayed when wrong operator code is entered. Operator code is not inputted. Please input the operator ID. Displayed when touching DONE without entering the operator code.
9. Error Messages 9-1. Notifications Notifications Description and Measure Current password mismatch Incorrect password. Please input the password correctly. Displayed when you do not enter currently set password. New password mismatch The new password and re-entered Displayed on the Change Administrator Password password do not match. Please input the screen when newly entered password does not match passwords again. with the one typed in the new password confirm box.
9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Inappropriate temperature Case1. Pops up when the ‘RUN TEST’ button is touched on the home screen, or the ‘RUN QC TEST’ button is touched. Case2. Pops up when the temperature is out of test range. Low battery Case1. Pops up when the ‘RUN TEST’ button is touched on the home screen, or the ‘RUN QC TEST’ button is touched. Case2.
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’. A check cartridge test has not been performed. Pops up when the ‘RUN TEST’ button is touched on the home screen under the condition that the system check has not been performed.
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. Tray ejection failure Pops up within 10 seconds after tray ejection fails.
9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Pops up when used cartridge is inserted. Failure of plasma separation or test sample test Pops up when test sample test fails due to errors in sample separation including timeout, insufficient test sample injection, etc. Pops up when the printer cover is open. Pops up when there is no paper left in the printer.
9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure Printer disconnection Pops up when the printer is not connected and the user touched the ‘Print’ button. 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.
9. Error Messages 9-2. Error pop-ups Error Pop-ups Description and Measure USB Device Connection Error The alert pops up when USB is removed or disconnected during software update. 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.
10. Technical Information Model Name MB-100 CPU MT8163B (Quad core) Display type 5.5” HD display, Touch screen Memory capacity 8GB ROM / 1GB RAM Battery Main battery : 2,700mAh 3.8V Sub battery : 2,500mAh 14.4V (3.7V 18650 4cell) Power rating : 12VDC, 1.5A plug interface : 5.5mm * 2.5mm Dimension/weight 114 x 206 x 86mm / 1,300g OS Android 7.
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. Warranty Period : One year from the purchase date Manufacturer Information BBB Inc.
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. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
(+82) 70-4407-8808 . Fax. (+82) 2-565-9654 . www.bbbtech.com BMD006AMEU-0A Issue date:2020.
