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BBB markB, User Manual

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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.

MARK-B analyzer

User Manual

IVD

Summary of Contents for markB

Page 1: ...ssay 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...

Page 2: ......

Page 3: ...nt 6 QC Test Control Solution Test 7 Function Setting 7 1 Setup Screen 7 2 Administrator Settings 7 3 Wi Fi Settings 7 4 Printer Settings 7 5 Date Time Settings 7 6 Lock Settings 8 Maintenance 8 1 Sys...

Page 4: ...AC power connection to operate for an extended period of time and charge Please ensure your power supply is compatible with the analyzer s power specifications Increasing the inner temperature activat...

Page 5: ...heck 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...

Page 6: ...1 Product Introduction 6...

Page 7: ...check the results Tray open The tray is open with the cartridge inserted Air vent A component to control temperature inside the analyzer Power supply connector An adapter connection port to supply pow...

Page 8: ...rations 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 2 2 Check Cartridge 8 Cartridge contact pad Conta...

Page 9: ...utton to run the QC test Test results Check all test results Admin login logout Login to logout of the admin account Settings Change settings Check device information and update it 1 2 3 4 5 6 7 8 9 9...

Page 10: ...10 STEP 1 Connect the power adapter STEP 2 Touch the power button to start 4 Initial Setup...

Page 11: ...EP 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 4 Initial...

Page 12: ...Connection Failure Wi Fi connection has failed Check wireless connection status or select other Wi Fi Network not connected The icon indicates that Wi Fi is not connected Select the Reconnect Wi Fi to...

Page 13: ...t date OFF Disables QC Test interval Interval setting Set up QC Test interval within 1 to 365 days Administrator ID is automatically set as Admin Please set your own admin password Password is case se...

Page 14: ...mpleted STEP 7 Device Registration If there is no hospital for device registration touch the Register device later button Device registration is available later in Settings Device Registration see Pag...

Page 15: ...port a Turn the printer on b connect the printer USB connection The printer is automatically recognized once USB cable is connected Bluetooth connection Please refer to Function settings Printer sett...

Page 16: ...ature 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 Full...

Page 17: ...ner b When the code is inputted proceed to the cartridge insertion STEP 3 Patient code scan If you do not have a barcode scanner touch the Input patient code manually to enter the code using the keypa...

Page 18: ...he QR code of the cartridge STEP 4 Test cartridge insertion If the tray does not move out the device displays Contact System Administrator In that case follow the instructions and contact the administ...

Page 19: ...ample check injection location of the test sample and whether a sufficient amount of test sample is prepared Inject the test sample within 2 minutes after inserting a cartridge STEP 6 2 When a sample...

Page 20: ...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 STEP 7 1 Start plasma separati...

Page 21: ...e the used cartridge from the tray to go to the home screen If the used cartridge is not removed a new test cannot be performed STEP 8 2 Check the result of the test a Touch the DONE button Save resul...

Page 22: ...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 histor...

Page 23: ...button QC Test control solution test In order to test the normal operation of the test cartridge the three steps to proceed STEP 2 Touch the Run QC Test button a Click the Run QC Test 6 Running a QC...

Page 24: ...canner 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 STEP 3 Operator code scan 24 6 Running...

Page 25: ...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 ens...

Page 26: ...he positive control solution test is completed d Discard the cartridge according to STEP 8 STEP 6 Negative control solution injection a Insert new cartridge b Prepare negative control solution of the...

Page 27: ...me screen a Remove the cartridge from the tray referring to the figure below and place it in a safe place STEP 8 Discard the used test cartridge QC Test Result Positive Negative test All Pass Normal o...

Page 28: ...tting menu Administrator Settings Wi Fi Settings Printer Settings Date Time Settings Lock Settings System Check Version Information Device Registration Power Off Settings 28 Settings Enter setting men...

Page 29: ...tton 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 Your pass...

Page 30: ...d input screen will be displayed 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...

Page 31: ...31 a Wi Fi Setting On Off Turn Wi Fi network on or off b Select On Select Wi Fi to connect to Turn Wi Fi On or Off Connect to a Wi Fi 7 3 Wi Fi Settings 7 Function Settings...

Page 32: ...connect USB port To find a printer s model number remove the battery of printer Then check the product label If you try to connect with another printer via USB while Bluetooth has been connected prior...

Page 33: ...33 Date Time Settings 7 5 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...

Page 34: ...ust be a PASS to be able to run a test OFF A test can be run regardless of QC Test result When all settings of QC Lock are turned OFF a test can be run even if QC Test result is fail BBB is not respon...

Page 35: ...et the intervals for QC test When the interval is set up it will be shown under Run QC Test on the home screen STEP 3 QC Test interval setting 7 6 Lock Settings a Touch the input box and then select u...

Page 36: ...se of the check cartridge test is to verify proper operation of MARK B analyzer 8 1 System Check 8 Maintenance a Insert a check cartridge to the tray according to instructions on the screen b Automati...

Page 37: ...king 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 Fai...

Page 38: ...STEP 5 System Check Result History 38 8 1 System Check a Click the System Check Result b The System Check Result is displayed in order from latest to earliest 8 Maintenance...

Page 39: ...ck the Version Information a Input the admin password Enter Version Information Confirm the latest version b Touch the Version Update Update to the latest software 8 2 Version Information and Update 8...

Page 40: ...updated c Touch the OK button to update to the latest software If there is a version to update an update popup occurs on the home screen a Select WI FI Network update A message to update to new versi...

Page 41: ...tton The device will try to access the hospital server Device Registration If you have already registered the device during initial setup you do not need to proceed again STEP 2 Registration Completed...

Page 42: ...assword 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...

Page 43: ...tialized Time is automatically set up once the instrument is connected to Wi Fi 43 8 4 Auto Power Off Settings a Select the On button Select the Auto power off time b After selecting the duration time...

Page 44: ...issue contains chemical substances that may damage the device Make sure to turn off when cleaning the device Test Tray Cleaning Make sure to turn off the device when cleaning the tray Avoid contact wi...

Page 45: ...al code is entered Failed to connect to network Please try again No response from server Displayed when device registration fails due to lost network connection or other errors which make server commu...

Page 46: ...4 QC not performed Displayed when touching QC icon on the home screen in the case of when the QC Test has not been performed The admin account automatically logged out Administrator account logout Di...

Page 47: ...nsor operation Please input the operator ID Operator code is not inputted Displayed when touching DONE without entering the operator code Please input the patient code Patient code is not inputted Dis...

Page 48: ...ord is not inputted Displayed when new administrator password is not inputted in the password setting screen Please disconnect the device first and then try connecting the device Bluetooth disconnecti...

Page 49: ...Low battery 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 battery level is 15 or lower and the user touched Next to proceed...

Page 50: ...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 System Check Error Pops up when th...

Page 51: ...xpired 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 Tra...

Page 52: ...plasma separation fails due to insufficient blood injection Analytical preparation failed non blood sample use test cartridge Only Failure of plasma separation or test sample test Pops up when test s...

Page 53: ...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 u...

Page 54: ...lution 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...

Page 55: ...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...

Page 56: ...DC 2A plug interface 5 5mm 2 5mm Dimension weight 262 7 x 226 x146 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 l...

Page 57: ...rea Manufacturing site Samseong Center 7F 22 Teheran ro 81 gil Gangnam gu Seoul Republic of Korea Tel 82 70 4407 8808 E mail CS bbbtech com Product Warranty BBB Inc offers product warranty in accordan...

Page 58: ...e to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception...

Page 59: ......

Page 60: ...BMD011AMUS 0AIssue date 2020 07 BBB Inc 82 2 565 9653 Fax 82 2 565 9654 www bbbtech com...

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