IVD MARK-B analyzer User Manual MARK-B Analyzer(Immunoassay 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.
Table of Content 1. Product Introduction 4 4 4 5 5 1-1. Intended Use ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-2. Principle∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1-3.
1. Product Introduction 1-1. Intended Use The MARK-B analyzer is an instrument that performs immunoassay on test cartridges. It reads specific biomarkers within the test sample. 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).
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 • MARK-B analyzer, 1EA • Check Cartridge, 1EA • User manual 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 analyzer 1 Screen Interface that the user can touch to operate the analyzer and check the results. 2 Power button Buttons to turn the device on or off. 3 Tray (closed) 4 Air vent A component to insert the test cartridge. Opening and closing of the tray are controlled by the software. A component to control temperature inside the analyzer. 5 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 2 1 3 6 8 5 1 Status bar Indicates MARK-B analyzer’s network connection, battery level and time. 2 Status indicating icon is displayed when QC test result shows “fail” or the QC test is not carried out. is displayed when battery level is 15% is displayed when temperature is either 15℃ or lower, or at least 30℃. is displayed when the first System Check is not performed, or System Check result is Fail. 3 Time Displays day, date and month.
4. Initial Setup STEP 1. Connect the power adapter. STEP 2. Touch the ‘power’ button to start.
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.
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 아이콘 설명 연결 상태 Connected Wi-Fi is connected and active. Requesting Please wait as the Wi-Fi signal is being acquired. In the case connection of no response, touch ‘Reconnect Wi-Fi’ to try again. Connection Failure Network not connected Wi-Fi connection has failed.
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. • 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. Lock Settings a.
4. Initial Setup STEP 7. Device Registration a. Enter hospital code. b. Touch the ‘DONE’ button to connect to hospital server. c. Once connected to server, initial setup is completed. • 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 42). STEP 8. Initial setup completed a. Initial setup is completed and the home screen will be displayed.
4. Initial Setup Barcode Scanner Connection a. Connect the barcode scanner to the USB Port on the back of MARK-B 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. connect the printer ○ [USB connection] The printer is automatically recognized once USB cable is connected.
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. • 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. Scan the code with a barcode scanner → Touch the ‘OK’ button.
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.
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. The machine scans the QR code of the cartridge. STEP 5. Cartridge QR code scan a. After the scan is completed, check the cartridge type to see if the cartridge of the marker to be tested is correct.
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, a. Injecting the prepared blood sample into the cartridge b. After injection, click the'OK' button c.
5. Running a Test 5-1. How to Perform RUN TEST STEP 7-1. Start plasma separation a. When the blood separation starts, please wait until analysis reaches ‘100%’. STEP 7-2. Start sample analysis a. When the sample analysis starts, please wait until analysis reaches ‘100%’. • If the tray is not inserted into analyzer within 2 minutes after injected sample, start over with a new cartridge. • When an error occurs in analyzing mode, start over with a new cartridge.
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. Check the result of the test. a. Touch the ‘DONE’ button → Save result → Return to the home screen. STEP 9. Discard the used cartridge. a.
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.
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. a.
6. Running a QC Test (Control Solution Test) STEP 3. 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 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. • Ensure the correct operator and test sample code are entered before inserting a cartridge. • 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 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. Discard the cartridge (according to STEP 8) STEP 6. Negative control solution injection 26 a. Insert new cartridge b.
6. Running a QC Test (Control Solution Test) STEP 7. 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. QC Test Result Positive, Negative test All Pass : Normal operation of test cartridge. One or more of the Positive, Negative test Fail : Accuracy of the actual test is not verified.
7. Function Settings 7-1.
7. Function Settings 7-2. Administrator Settings Input admin password → Enter admin menu Administrator Information a. Click the ‘Administrator Information’ → Check the administrator Change Administrator Password a. Touch the ‘Reset Password’ button b. Enter the current password c. 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’ • 30 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. a. [Wi-Fi Setting → On/Off] : Turn Wi-Fi network on or off. b. Select ‘On’ : Select Wi-Fi to connect to.
7. Function Settings 7-4. Print Settings Print Settings Click the ‘Printer Settings’ → 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. → 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.
7. Function Settings 7-5. Date & Time Settings Date & Time Settings a. Enter the admin password to access ‘Date & Time Settings’. b. Adjust ‘Set Date & Time’. → Touch the ‘OK’ button.
7. Function Settings 7-6. Lock Settings STEP 1. Lock Settings Enter the admin password → 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 analyzer. STEP 1. Touch the ‘Run System Check’ button STEP 2. Insertion of check cartridge tray a. Insert a check cartridge to the tray according to instructions on the screen. b. Automatically start scanning when the cartridge is recognized • It does not proceed when a test cartridge is inserted.
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 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.
8. Maintenance 8-1. System Check STEP 5. System Check Result History. a. Click the ‘System Check Result’ b. The System Check Result is displayed in order from latest to earliest.
8. Maintenance 8-2. Version Information and Update STEP 1. Check the Version Information a. Input the admin password → Enter Version Information → Confirm the latest version b.
8. Maintenance 8-2. Version Information and Update STEP 2. Update new version If there is a version to update, an update popup occurs on the home screen ① a. Wireless update of software 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 analyzer’s battery level is 15% or higher.
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 a. Input the admin password → access ‘Device registration’ menu b. Enter the hospital code c. Click the ‘OK’ button → The device will try to access the hospital server. STEP 2. Registration Completed a. Hospital server connection completed → The message ‘Successfully Registered’ is displayed. b.
8. Maintenance 8-4. Auto Power Off Settings Power Off Settings a. 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 by selecting Auto Power off Time.
8. Maintenance 8-4. Auto Power Off Settings Auto Power Off a. Select the ‘On’ button, Select the ‘Auto power off time’ b. After selecting the duration time for the screen to be displayed, the device will be automatically turned off after that duration time. 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 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.
9. Error Messages 9-1. Notifications Notifications Description and Measure Fan activated The fan is activated due to increased internal temperature of the analyzer. Displayed when the fan is activated by MARK-B™ 1 analyzer’s temperature sensor operation. Fan activated Invalid ID. Please check the ID again. Displayed when the fan is activated by MARK-B™ 1 analyzer’s temperature sensor operation. Operator code is not inputted. Please input the operator ID.
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 screen when newly entered password does not the passwords again. match 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 1) Pops up when the ‘RUN TEST’ button is touched on the home screen, or the ‘RUN QC TEST’ button is touched. 2) Pops up when the temperature is out of test range. Low battery 1) Pops up when the ‘RUN TEST’ button is touched on the home screen, or the ‘RUN QC TEST’ button is touched.
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 Insert used cartridges Pops up when used cartridge is inserted.
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’ button.
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. New version installation failure Pops up upon new version installation failure during software update.
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.
10. 56 Technical Information Model Name MB-200 CPU 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) Power rating : 12VDC, 2A plug interface : 5.5mm * 2.5mm Dimension/weight 262.7 x 226 x 146.4(mm) / 3.6kg OS Android 7.0 LOT code reading QR Code Operating temperature (Device without a cartridge) -10~ 45℃ Storage environment -10~ 45℃, less than 80% of relative humidity Wi-Fi 2.4GHz (IEEE 802.
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.
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. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
BBB Inc. (+82) 2- 565 -9653 . Fax. (+82) 2-565-9654 . www.bbbtech.com BMD011AMUS-0AIssue date:2020.
