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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

vitro

diagnostic medical device. Please read this user manual thoroughly for

correct use and keep it for future reference.

IVD

Содержание MARK-B 1

Страница 1: ...cific 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 diagnost...

Страница 2: ......

Страница 3: ...Result Management 20 3 Running a QC Test Control Solution Test 21 4 Function Setting 27 7 1 Setup Screen 27 7 2 Administrator Settings 28 7 3 Wi Fi Settings 30 7 4 Printer Settings 31 7 5 Date Time S...

Страница 4: ...rating the analyzer The analyzer needs 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 I...

Страница 5: ...ease 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...

Страница 6: ...6 1 Product Introduction...

Страница 7: ...d check the results Tray open The tray is open with the cartridge inserted Component as closed status shown in Air vent A component to control temperature inside the analyzer Power supply connector An...

Страница 8: ...erations 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 2 Product Description Cartri...

Страница 9: ...least 30 is displayed when the first System Check is not performed or System Check result is Fail Time Displays day date and month Run test Touch the button to start the test QC Test interval and tes...

Страница 10: ...Touch the Select Time Zone Select the time zone where the user is located When setting is completed touch the DONE button STEP 1 Connect the power adapter STEP 2 Touch the power button to start STEP 3...

Страница 11: ...nected Wi Fi is connected and active Requesting connection Please wait as the Wi Fi signal is being acquired In the case of no response touch Reconnect Wi Fi to try again Connection Failure Wi Fi conn...

Страница 12: ...tings according to each item Touch the OK button QC Lock On In the case of when QC Test result shows FAIL the test is unavailable until the result shows PASS Conduct QC test regularly as scheduled oth...

Страница 13: ...ice later button Device registration is available later in Settings Device registration see Page 44 13 a Enter hospital code in the window b After entering hospital code touch the DONE button to conne...

Страница 14: ...de 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 a Turn the printer on b USB Connection The printer is automa...

Страница 15: ...ually to enter the code using the keypad STEP 2 Operator code scan 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 t...

Страница 16: ...ut patient code manually to enter the code using the keypad a Scan the patient code with a barcode scanner b When the code is inputted proceed to the cartridge insertion Barcode scanner is sold separa...

Страница 17: ...serted 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...

Страница 18: ...ing 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 If the tray is not inserted into analyzer within 2...

Страница 19: ...d regulations 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 scree...

Страница 20: ...20 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...

Страница 21: ...1 Touch the Run QC Test button a Scan the code with a barcode scanner or type it using the keypad b Touch the OK button STEP 2 Operator code scan If you do not have a barcode scanner touch Input opera...

Страница 22: ...em Administrator message is displayed after inserting a cartridge stop using it and contact the administrator 6 Running a QC Test Control Solution Test a Scan the QR code on the cartridge pouch with a...

Страница 23: ...he cartridge within 2 minutes c Touch the OK button 6 Running a QC Test Control Solution Test STEP 5 Positive control solution injection STEP 6 Discard the used cartridge a Refer to the images below t...

Страница 24: ...ype 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 7 Te...

Страница 25: ...ve control solution injection 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...

Страница 26: ...in or contact the administrator STEP 11 Discard the used cartridge 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...

Страница 27: ...s 7 1 Setup Screen Setting menu Administrator Settings Wi Fi Settings Printer Settings Date Time Settings Lock Settings System Check Version Information Device Registration Power Off Settings Settings...

Страница 28: ...administrator information 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 m...

Страница 29: ...in password touch Forgot password b Master password input screen will be displayed Type the master password Enter the new admin password Touch the OK button Forgot Password Master password is the seri...

Страница 30: ...30 7 3 Wi Fi Settings 7 Function Settings Wi Fi Setting On Off Turn Wi Fi network on or off Select On Select Wi Fi to connect to Turn Wi Fi On or Off Connect to a Wi Fi...

Страница 31: ...utomatically linked when you 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 Bluet...

Страница 32: ...32 7 5 Date Time Settings 7 Function Settings Touch Date Time Settings Touch Select Time Zone Select the location Enter the admin password to access Date Time Settings STEP 1 Date Time Settings...

Страница 33: ...33 7 5 Date Time Settings 7 Function Settings Adjust Set Date Time Touch the OK button...

Страница 34: ...be a PASS to be able to run a test OFF A test can be run regardless of QC Test result STEP 1 Lock Settings QC Lock is to lock or unlock the RUN TEST When all settings of QC Lock are turned OFF a test...

Страница 35: ...STEP 4 Date interval setting a Touch the input box and then select using the numeric keypad shown on the screen b Enter a number between 1 and 365 to set up QC Test intervals You can set the intervals...

Страница 36: ...s to verify proper operation of MARK B 1 analyzer 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...

Страница 37: ...to instructions on the screen b Insert the check cartridge in the correct position c Touch the OK button 8 Maintenance 8 1 System Check STEP 3 Insertion of check cartridge tray STEP 4 Start System Che...

Страница 38: ...screen Fail An error message and an X mark is displayed on the screen Try out the test again or contact the administrator If the test fails under QC Test Settings QC Lock ON a test cannot be run a The...

Страница 39: ...8 Maintenance 8 1 System Check System Check System Check Result 39 The System Check Result is displayed in order from latest to earliest...

Страница 40: ...40 8 2 View Version Information and Update 8 Maintenance a Type the admin password and access device registration menu b Confirm the latest version STEP 1 Check the Version Information...

Страница 41: ...Touch the OK button to update to the latest software 41 Option 1 Software update by USB connection STEP 2 Update new version USB connection The above message pops up Check the pop up box Touch OK Allo...

Страница 42: ...15 or higher Unstable wireless network connectivity may cancel the update If the update continuously fails please contact the system administrator STEP 2 Update new version a Select WI FI Network upd...

Страница 43: ...to set it up again 43 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...

Страница 44: ...assword c Select Power Off Option 1 On Off Setting of Auto Power 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...

Страница 45: ...wer off time After selecting the duration time for the screen to be displayed the device will be automatically turned off after that duration time It is recommended to turn MARK B 1 analyzer off if th...

Страница 46: ...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 8 6 Storage Requirements Make sure to turn off...

Страница 47: ...ed when unregistered hospital 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 err...

Страница 48: ...operational range Current temperature 38 100 4 Inappropriate temperature Displayed when touching temperature icon on the home screen which pops up when temperature is out of range for test The admin a...

Страница 49: ...is entered Please input the operator ID Operator code is not inputted Displayed when touching DONE without entering the operator code Please input the test sample code Test sample code is not inputted...

Страница 50: ...in password New administrator password is not inputted Displayed when new administrator password is not inputted in the password setting screen Please disconnect the device first and then try connecti...

Страница 51: ...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 Pops up when the battery level is 15 or lower and the user...

Страница 52: ...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...

Страница 53: ...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 t...

Страница 54: ...ed 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 et...

Страница 55: ...eparation 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 P...

Страница 56: ...rror 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 Lo...

Страница 57: ...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 0 LOT code reading QR Code Operating temperature Device without a cartridge 1...

Страница 58: ...nam gu Seoul Republic of Korea Tel 82 70 4407 8808 e mail CS bbbtech com European Authorised Representatives Obelis SA Boulevard G n ral Wahis 53 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732...

Страница 59: ...nd can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interf...

Страница 60: ......

Страница 61: ...BMD006AMEU 0A Issue date 2020 05 82 70 4407 8808 Fax 82 2 565 9654 www bbbtech com...

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