markB Analyzer(Model No.: MB-100) User Manual Analyzer Immunoassay Analyzer Thank you for purchasing markB Analyzer. Please read the user manual carefully for adequate use. Please keep this manual carefully. markB Analyzer is an in-vitro diagnostic medical device that can perform biomarker immunoassay with a small amount of blood.
Chapter 1. Understanding of markB Anlayzer 1.1. Intended use 1.2. Principle 1.3. Precautions before use 1.4. Components 1.5. Symbols Chapter 2. Introduce of markB Analyzer 2.1. Product Description Chapter 3. How to use markB Analyzer 3.1. Initial Settings 3.2. How to measure 3.3. QC test 3.3.1 Control Solution Test 3.4. Test result management 3.5. Printer 3.6. Settings 3.6.1 Wi-Fi Setting 3.6.2 Bluetooth Setting 3.6.3 Printer Setting 3.6.4 Device Registration 3.6.5 Version information Chapter 4.
markB Analyzer is designed for markB test cartridges which the in vitro quantitative measurement of the biomarkers contained in fresh capillary whole blood, venous whole blood in heparinized tubes, heparinized plasma, and serum. 1.2. Principle ● markB Analyzer is a portable POCT(Point of Care Testing) device.
The following components are available upon purchase of the markB Analyzer. Please make sure that all components are included as soon as you receive them. If the components are missing or damaged, contact the place of purchase. ● ● ● ● markB Analyzer, 1EA Check cartridge, 1EA markB User manual markB Quick manual To use markB Analyzer, you need to purchase consumables and accessories sold separately. Please contact the place of purchase.
1.5. Symbol markB for details of the symbol mark included in the PSA’s outer packaging, external description, attachments, etc., please refer to the explanation below.
Chapter 2. markB products 2.1. Product Description 2.1.1 markB Analyzer Name Description ① Power button It turns the device on or off. ② Tray (closed) It holds a test cartridge. Opening and closing of the tray are controlled by application. ③ Screen It is for the user to operate the analyzer and check the result through the screen. ④ Tray Same as ②.(Tray opened with cartridge inserted) ⑤ Fan It is the air circulation to control the temperature inside of the analyzer.
⑥ Power connector ⑦ Test cartridge connector ⑧ Cartridge recognition switch ⑨ USB port It allows the analyzer to be connected to the power source through an adapter for supplying power and charging the battery. Connections for cartridge measurement. Switch for checking cartridge insertion. USB-A port for connection of Barcode Reader and Mobile Printer. 2.1.2 Check cartridge MarkB check cartridge is used to assess analyzer’s mechanical and electronic malfunction.
3.1. Initial Setting (1) Connect the markB Analyzer’s power adaptor. (2) Power on the markB Analyzer in the direction shown in the picture. (3) The first time you turn on markB, the Wi-Fi settings screen appears. First, tap the Connect Wi-Fi button to turn on Wi-Fi and connect it to the Wi-Fi you want to connect to. When connected properly, the "Done" button at the bottom of the screen is activated.
Icon Status Description Connected Wi-Fi is connected normally. Requesting connection Connecting WiFi. wait a minute please. If you do not get any response after waiting, please press the ‘Reconnect Wi-Fi’ button to retry the WiFi connection. Connection Failure The icon appears when Wi-Fi connection fails. Check the wireless connection status of Wi-Fi, or grab another Wi-Fi. Network not Connected The icon appears when Wi-Fi can not be connected.
Caution! - The measurable temperature range is 18℃ ~ 28℃. Please make measurement environment and than start. It is not possible to measure out of the measurable temperature range. - If the Battery remaining less than 15%, measurement can not be started. Please fully charge the battery and start measurement. (2) Scan the patient code using the barcode reader or enter it directly using the keypad and press the OK button.
* Reference -The barcode reader is an optional item. - If you do not have a barcode reader, tap the field and enter the patient code directly on the keypad. (3) When the patient code entry is completed, the tray at the bottom of the device will automatically.
Caution! - If the tray does not come out, a popup message "Please contact system administrator" will appear. Please contact the administrator according to the popup instructions. (4) Insert the cartridge of the marker you want to measure into the tray according to the instructions on the screen. Caution! - Please double-check that you have entered the patient code correctly before inserting the cartridge. - Before inserting the cartridge, please make sure that the marker you want to measure is correct.
(6) Capillary whole blood is sampled using a lancing device. * Capillary whole blood collection preparations: blood lancet, lanceter, alcohol swab Caution! - This procedure is necessary for capillary blood collection. For venous blood, serum, plasma, please refer to the sample collection and handling procedure of test cartridge. - Before drawing blood, wipe hands and blood with warm water and soap, and let it dry before proceeding. - The lancet is disposable. Do not reuse.
Caution! - This procedure is a procedure for taking capillary blood as an example. Venous blood When using whole blood, serum, or plasma, follow the instructions of the micropipette. - Make sure that the cartridge is filled with the correct amount of blood before injecting the blood and enough blood (up to the marking of the eyedropper). - Please inject blood within 2 minutes after inserting the cartridge. (8) After injecting blood, press the “OK” button to start measurement.
Caution! - If the tray still does not come in 2 minutes after the blood injection is complete, please try again with the new cartridge. (9) When preparation for measurement is completed, start blood analysis. Please wait for up to 10 minutes. Caution! - If there is an error during measurement or blood analysis, remove the cartridge, insert a new cartridge, and try the measurement again.
(10) When the blood analysis is completed, the result is displayed on the screen together with the patient code and the LOT number, and the tray at the bottom of the device comes out. Please remove the used cartridge from the tray. (11) Moves to measurement start screen when tap the DONE button.
Caution! - If you do not remove the cartridge from the tray, no new measurements are possible. Remove the cartridge from the tray. * Reference - This device always enables the GPS function, so the GPS data could be transmitted with the test data to the server if this device is used in the outdoor. - You can not use GPS because it can not receive GPS signals in GPS signal shading areas such as indoors. 3.3. QC Test 3.3.1.
(2) Tap the control solution button.
*Reference - When using a new meter, when the meter is dropped, it is recommended that try Control solution test when the result is very different from what you expected. - Before proceeding with the test, check the low and high control solution test sections for each parameter. If you use an invalid control solution, an error screen is displayed. (3) Insert the markB Test cartridge.
Caution! - Please confirm that the marker of the cartridge you want to inspect is inserted correctly. (5) Insert 1 ~ 2 drops of low control solution of the same marker as the inserted test cartridge into the cartridge. (ex.
(6) After injecting solution, press OK button to start measurement.
- If the tray does not come in 2 minutes after the solution injection is completed, please try again with a new cartridge. (7) After preparation for measurement is completed, start blood analysis. Please wait for up to 10 minutes. Caution! - If an error occurs during preparation or during the analysis process, remove the cartridge, insert a new cartridge, and then retry the control solution. (8) Low When the control solution is completed normally, a screen appears that the analysis is completed.
(9) Insert the same Test cartridge as in the low solution test.
Caution! - Be sure to insert the same test cartridge as the marker used in the Low Solution test. - Measurement does not proceed when inserting cartridges. - If you want to check the control solution of other markers, please press the X button on the upper left corner to discard the existing test and start again. (10) When the check of the validity of the cartridge is completed normally, the screen for injecting the high control solution is automatically generated.
(11) When the analysis is completed, the Low and High test result screen will be displayed on the screen. The whole test result is displayed as “PASS”, “FAIL”. After removing the cartridge from the tray, Press the “Done” button to move to the measurement start screen.
3.4. Measurement results 3.4.1. measurement results (1) Tap the test results button on the main screen.
(2) All measured results are recorded and displayed in order of recent measurement.
(3) Tap the result in the measurement list to see the detailed screen and print the result. 3.5. Printer (1) Tap the print icon on the upper right of the screen and the results are printed by connected mobile printer.
* Reference - The mobile printer is an optional item. - Please refer to 3.6.3. For connection method of mobile printer. Notice! - Mobile printers that are incompatible with markB may not print. - If the printer is out of paper, replace it with a new paper and then use the printer. - If the cover of the printer is open, it may not print. Close the cover and print. 3.6.
3.6.2. Bluetooth Settings (1)This screen allows Bluetooth to be connected to an on/off Bluetooth enabled device.
3.6.3. Printer Setting 3.6.3.1. USB Connection (1) Connect the mobile printer to the USB-A port and please turn on the printer. (2) Tap Printer Setting in setting menu and change to USB mode. If the connection is successful, a “Printer Connected” toast will appear at the bottom of the screen. 4.6.3.2. Bluetooth connection (1) Turn on the mobile printer device and prepare it for Bluetooth connection.
(2) First, turn on the Bluetooth in the Bluetooth Setting menu and select the printer to connect and pair with the analyzer. Pairing password: 0000 or 1234 (3) When pairing is complete, go to the Printer Setting menu of the setting and set it to Bluetooth mode. When the setting is completed, “Printer Connected” toast occurs at the bottom of the screen.
3.6.4. Device Registration Enter the hospital code you want to register by tapping the input field. (2) When the registration is completed, the message “Registered Successfully” will be displayed and the main screen will be displayed when the “Done” button is tapped.
3.6.5. Version Information (1) You can find the latest version the Version Information menu. (2) If there is a version to update, the Update button is enabled. The update button will be updated when the Update button is clicked. Chapter 4.
4.1 Check cartridge test Check Cartridge Inspection allows you to check that the markB meter is functioning normally. (1) Tap the QC test button. (2) Tap the Check Cartridge test button.
*Reference - Check cartridge test is used to verify the hardware performance of Analyzer itself. - It is recommended that you do this when you first receive the unit, or when you suspect that the unit’s hardware performance has failed. (3) Insert the check cartridge. If it is inserted normally, it will start scanning automatically. Caution! - Be sure to insert the check cartridge. - Check cartridge test is not possible when inserting test cartridge.
(5) When the device is operating normally, a message is displayed on the screen that the check image is working properly. (6) When an error occurs during check cartridge test, an exclamation point image and message appear on the screen.
Please contact the administrator. 4.2. Cleaning of markB Analyzer 4.2.1 Cleaning of analyzer ● Clean the markB Analyzer periodically using a soft, dry cloth. ● Do not clean with strong cleansing agents, chemicals, or cleansing tissues containing chemicals that can damage the equipment.
Caution! - Be sure to turn off the power before cleaning. 4.2.2 Cleaning the tray If blood, moisture, or dust enters the tray, it may cause the device to malfunction. If necessary, wipe with a cotton swab moistened with water or alcohol. Caution! - Be sure to turn off the power before cleaning. - In case of electrode part, it is recommended to wipe away the electrode part because it is a sensitive part. 4.3. Precautions ● ● ● ● Protect the Analyzer from dust.
Error Message Description 1 (Pop-up) Out of temperature range Measurement temperature error The temperature is not within operational range. For accurate readings, please try again at room temperature. If the ambient temperature is higher or lower than the operating temperature range of the analyzer, this message will be generated. Leave it for 10 minutes at a place between 18 and 28 degrees and measure again. At this time, however, the meter should not be heated or cooled artificially.
3-2(화면) Device error 내용: Error(ER1)! Please contact the system administrator. Check if the measured value in the cartridge is out of the error range. 4.(Screen) Measurement error error(ER1)! Please contact the system administrator. Check if the measured value in the cartridge is out of the error range. 5. (Pop-up) Title: Wrong catridge Incorrect cartridge insertion (when inserting Check Cartridge or Check Cartridge test cartridge) The wrong type of cartridge has been inserted.
6. (Pop-up) Title: Used cartridge The cartridge has already been used. Please insert a new cartridge. Button: OK 7. (Pop-up) Title: Error NFC tag reading has failed. After three errors of cartridge insertion, please try again with a new cartridge. If you fail, please contact the system administrator. Used cartridge error The inserted cartridge is a used cartridge or a contaminated cartridge. Discard and re-measure using the new cartridge.
9. (Pop-up) Title: Error Restart with a new cartridge containing sufficient control solution. Blood analysis process error (Firmware error) Blood analysis Discard used cartridges and try again with new cartridges to inject enough blood.a Button: OK 10. (Pop-up) The amount of injected control solution is not sufficient. Discard the used cartridge and re-measure it with a new cartridge by injecting enough solution. Start with a new cartridge with a sufficient amount of control solution. Button:OK 11.
12. (Pop-up) Cartridge expiration Title: Expired cartridge This error message occurs when inserting an expired cartridge. If the cartridge has expired, please use the new cartridge after discarding it. The cartridge has expired. Please insert a new cartridge. Button: OK 13. (Pop-up) Cartridge remove pop-up Remove cartridge This is a pop-up message that appears when you tap the ‘OK’ button in the popup without removing the cartridge before moving to the main screen.
15. (Pop-up) Insert another check sheet Title:Error When inserting a Test cartridge from the Insert Check Cartridge screen during the measurement process. The wrong type of cartridge has been inserted. Please insert the Check cartridge. Button: OK 16. (Pop-up) Timeout or When injected Control Solution is inadequate. Title: error Please restart with a new cartridge containing sufficient Control Solution. Button:OK 17.
18.(Pop-up) Title: Cover open Printer cover is open. Please close the cover and try agian. Cover open when connecting printer This error message occurs when the cover is open when connecting the printer. Please close the cover and print. Button:OK 19.(Pop-up) When the paper is not enough. Title: Paper empty This error message occurs when the printer is out of paper. Please insert new paper and print. There is no paper left. Please input more and try again. Button: OK 20.
21.(Toast) When you enter an unregistered hospital code. Unregistered hospital code. Please contact administrator. This error message occurs when entering a hospital code not registered in the server. Please check the hospital code again. 22.(Toast) If there is no response from the hospital server. Registration failed because there was no response from the server. Please try again. If there is no response from hospital server, error message about connection failure.
23. (Pop-up) Battery is low when attempting to update Title:battery low If the battery level is less than 15%, a low battery notification pops up on the “Update” button tab. When the battery is charged to 15% or more, the pop-up closes. The battery is low and can not be updated. Please connect the charger and update it when charging 24. (Pop-up) If the version installation fails, the popup will occur. Click the Retry button tab again to proceed with the update.
25.(Pop-up) Wi-Fi connection is unstable during update Title: Installation failed. Software update in progress Error message when Wi-Fi connection is unstable. Press the Wi-Fi connect button to check the Wi-Fi status in the Wi-Fi settings and try again. Installation was canceled bacause the Wi-Fi connection is unstable. Please check your Wi-Fi and try again. 26. (Pop-up) If you try to update to USB, remove USB or disconnect Title: Installation failed.
28-1. (Pop-up) If the firmware update fails Title: Update failed. Proceed with firmware update when the software update is finished and the device is restarted. If the firmware update fails during the process, the corresponding error message occurs. Please try the firmware update again by pressing the ‘Try again’ button. Firmware update failed. Would you like to try again? Button:Try again 28-2 (Pop-up) Firmware update failure repeated error message Title: Update failed.
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 NFC Tag NFC Reader ISO/IEC 14443 A/B Type, ISO/IEC 15693, 3.3V, 13.56MHz Operation temperature - sole analyzer operation condition(without test cartridge) -10 ~ 45℃ Storage conditions -10 ~ 45℃, lower than 80% of relative humidity condition Wi-Fi 2.4GHz (IEEE 802.11/b/g/n) Bluetooth 4.0 GPS Support GPS and AGPS USB port USB A Software version v1.0.
-Warranty 1 year from date of purchase. - Warranty contents -Contact BBB Service center (070-4047-8282 / cs@bbbtech.com) BBB Inc. 28, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea TEL: 070-4047-8282 | FAX: 02-565-9654 www.bbbtech.com BMD006AMEU-0B Issue date:2019.
FCC Information to User This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
