NanoEnTek Frend System User Manual
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NanoEnTek Frend System User Manual

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  • Page 1 System User manual...

  • Page 2: Read Me First

    Thank you for purchasing the FREND System. Read me Please take a few minutes to read this user manual. first If you have any questions at any time, please contact NanoEntek, Inc. customer support. Tel: +82-2-6220-7942 Fax: +82-2-6220-7999 E-mail: ivdst@nanoentek.com...

  • Page 3: Table Of Contents

    System operating procedure ........28-34 FREND System data management ........35-38 Maintenance ................39-58 FREND System maintenance ..........39-44 Cleaning and storage ............... Troubleshooting ................ 46-56 General specification-normal environmental conditions ..Customer support information ..........FREND System © 2012 NanoEntek, Inc.

  • Page 4: Introduction

    NanoEntek Inc., not regularly maintained, used with device not approved by NanoEntek, Inc. or used for purposes for which it was not designed. This warranty does not apply to damages incurred during the initial shipment of the instrument and associated auxiliary materials.

  • Page 5: Introduction

    The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone. The principle of the fluorescence detection and calculation of the analyte concentration (drawing from the manual). FREND System © 2012 NanoEntek, Inc.

  • Page 6: Intended Use

    Introduction The FREND System is designed to accommodate the FREND Intended use cartridge, which helps in clinical management of patients by quantitatively or qualitatively measuring or diagnosing specific antigen or antibodies in vitro in human specimens.

  • Page 7: Product Components

    Note also that the mobile printer is included only if it was specifically ordered. Main device Adaptor / Power cord Q.C. Cartridge Q.C. Code chip User manual Quick manual USB drive Optional Optional Pipettor Mobile printer FREND System © 2012 NanoEntek, Inc.
  • Page 8 Introduction The following symbols are found on the FREND System user manual Safety and FREND cartridge package inserts. Please note the meanings of symbols & the symbols and always use the device in a safe manner. abbreviations Symbol Definition Warning or caution Biohazard Class I laser product CLASS 1 LASER PRODUCT...

  • Page 9: Symbols And Abbreviations

    For more detailed information about disposal of your old appliance, please contact local distributor, waste disposal service or call the number listed in the manual. FREND System © 2012 NanoEntek, Inc.

  • Page 10: Safety Precautions

    • result in an electrical shock, personal injury and device damage. insert only qualified and authorized devices supplied by NanoEntek Inc. Do not insert any foreign materials into the air vent or the speaker. Always set the main switch to the ‘off’ position before connecting •...
  • Page 11 N'insérez pas d'objets métalliques dans FREND™ System car cela pourrait provoquer un choc électrique, des blessures corporelles et des dommages matériels. Insérez uniquement des appareils quali- fiés et autorisés fournis par NanoEntek Inc. • N'insérez aucun matériau étranger dans l'évent ou dans le haut-parleur.

  • Page 12: General Safety Warnings

    Introduction • Before using the device, read this manual and be certain you thoroughly General understand it’s contents. safety • Please follow the instructions in this manual to assure proper operation warnings of the device. When not in use, unplug the device from the electrical outlet. •...
  • Page 13 Introduction • Do not attempt to disassemble/modify the device. General • Do not insert foreign objects into the device and insert only NanoEntek safety Inc. provided cartridges. warnings • Do not handle the device or the power cord with wet hands.

  • Page 14: Frend Tm

    Introduction FREND Name Function Cartridge slot Slot for FREND cartridge insertion and System ejection description Screen Show the operating status and results Ventilation Pathway to dissipate internal heat to the outside Speaker Screen touch, results and error tones Power switch Power on/off ...

  • Page 15: The Function Of The Code Chip And Associated Cartridge

    The cartridge contains reagents and microstructures to support a lateral flow assay, where analytes of interest form immune complexes while the specimen is moving and being separated. Ratio between test zone and reference zone is calculated. FREND System © 2012 NanoEntek, Inc.

  • Page 16: Software Keys

    Introduction Main screen Software keys Purpose Button Initiates a test sequence for an analyte TEST using that analyte-specific cartridge. Check and search results. Back up the data and transfer the data to a USB DATA drive. Set up the FREND™ System SETUP parameters specific for the site and operator.
  • Page 17 Allows the user to check the cartridge ID and its associated lot number. Allows for software updates. Location to adjust the time and date for the FREND system. Allows entry requirements and Lab ID. Move to the main screen. (HOME) FREND System © 2012 NanoEntek, Inc.
  • Page 18 Introduction Data screen Software keys Purpose Button Enter the file name to later identify the data. Search files or data. Home button. Move to the main screen. View the information of the selected file or data. Print the detailed data, using the optional printer if it is connected to the system.
  • Page 19 Delete all the saved data. (confirmation required) Delete one selected piece of data. Select data by moving one file at a time. Select data by moving one page at a time. Display the selected data. FREND System © 2012 NanoEntek, Inc.

  • Page 20: Setup

    Setup 1. Carefully examine the box for damage. Remove all components of FREND the FREND System from the box. System setup procedure 2. Plug the power cord into the adaptor. 3. Carefully examine the adaptor and make certain it is compatible with the power at the plug location.
  • Page 21 9. Set the local date and time. 2012 AM 00 10. After setting the date and time, press the OK button to return to the setup screen. 11. Press the General Setting button on the setup screen. FREND System © 2012 NanoEntek, Inc.
  • Page 22 Setup FREND 12. Set the option of Entry Requirements and edit Lab ID. Press the OK button to save the settings you specified. System setup procedure 13. Insert the Q.C. Code chip into the code chip slot in the direction of the arrow.
  • Page 23 16. When the Q.C. Code chip installation is complete, press the OK button to go to the setup screen. 17. Press the Item button on the setup screen. 18. Check the Q.C. Cartridge lot number and the installation date of the Q.C. Code chip. FREND System © 2012 NanoEntek, Inc.
  • Page 24 Setup 19. If the Q.C. Code chip installation is complete, press the back FREND button to go to the setup screen. System setup procedure 20. After all settings are done, press the button and move to the main screen. 21. Press the TEST button on the main screen.
  • Page 25 23. The Q.C. check that the instrument is operating correctly will complete automatically and the Q.C. Cartridge will be expelled. Please wait patiently. • The system automatically checks three steps while reading. Step1. Laser power Step2. Laser alignment Step3. Calculate ratio FREND System © 2012 NanoEntek, Inc.
  • Page 26 Setup 24. When the Q.C. check is done, the Q.C. Cartridge automatically FREND emerges and the results from all the three steps are displayed. There System setup will be three Passes, if the system is properly operating. procedure Caution: If all tests do not pass, try steps 21-24 again. If the instrument does not pass all three steps, please contact customer support via email.
  • Page 27 FREND System setup procedure Caution: Press the Q.C. Code chip into the slot slightly in order to release it and remove the Q.C. Code chip from the slot. The FREND System setup is complete!!! FREND System © 2012 NanoEntek, Inc.

  • Page 28: Operation

    Operation 1. Turn the power switch to the ‘ON’ position. FREND System operating procedure Power switch 2. The FREND logo will display this screen while the software boots. 3. Check the main screen. Caution: Please double check the direction of the cartridge code chip before insertion.
  • Page 29 5. Press the Code Chip button on the setup screen. 6. The information in the cartridge is automatically saved. 7. If the cartridge code chip installation is complete, press the OK button to go to the setup screen. FREND System © 2012 NanoEntek, Inc.
  • Page 30 Operation 8. Press the Item button on the setup screen. FREND System operating procedure 9. Check the cartridge lot number and the installation date of the cartridge code chip. If the cartridge code chip installation is mplete, press the OK button to go to the setup screen. •...
  • Page 31 Caution: Please be careful not to overfill and not to make bubbles. 13. Press the TEST button on the main screen and the system moves to the ‘Patient ID’ screen automatically. FREND System © 2012 NanoEntek, Inc.
  • Page 32 Operation 14. Type the 'Patient ID', 'User ID' and 'Order #' and press the Enter FREND button. To start a test, press the OK button. System operating procedure ☞ If you setted the Entry Requiremnts as optional on General setting screen, press the OK button to skip this step.
  • Page 33 Do not turn off the FREND™ System, while there is a cartridge in the system. This is a common cause of malfunction. 18. When the test is done, the cartridge is expelled and the results are displayed automatically. FREND System © 2012 NanoEntek, Inc.
  • Page 34 Operation 19. If the FREND System is connected to an optional printer, press FREND the Print button and the results will be printed out. System operating procedure • Printers is optional and if needed should be purchased separately. 20. The test is complete. If another sample is to be run, repeat again steps 12-19.
  • Page 35 Search If you click the search box on the top left, it will be switched into the input window. Click the Enter button after entering the Patient ID on the input window. FREND System © 2012 NanoEntek, Inc.

  • Page 36: Frend Tm System Data Management

    Operation FREND Once the input is complete, it will return to the DATA screen. Click the Search button in the top center of the DATA screen to complete System data the search. management Result confirmation After selecting the data, click the result button to check the results. Print If the printer is connected, click the Print button to print the result.
  • Page 37 If you want to receive the backup only for a selected data, click the green Select button in the center after selecting the data. If you want to receive the backup for all of the data, click the green All button in the upper center. FREND System © 2012 NanoEntek, Inc.
  • Page 38 Operation Data deletion FREND System data management If you want to delete only a selected data, click the black Select button after selecting the data and the selected data will be deleted. If you want to delete all of the data, click the black all button and all of the data will be deleted.

  • Page 39: Maintenance

    • using the device immediately and contact the supplier’s customer support. The FREND™ System maintenance supplies Q.C. Cartridge Q.C. Code chip The FREND™ System checklist 1. Laser power 2. Laser alignment 3. Calculate ratio FREND System © 2012 NanoEntek, Inc.
  • Page 40 Maintenance FREND 1. Turn the power switch to the ‘ON’ position. System maintenance Power switch 2. Insert the Q.C. Code Chip into the code chip slot in the direction of the arrow. Caution: Please check the direction of the code chip before insertion. The Q.C.
  • Page 41 8. Check the Q.C. Cartridge lot number, the installation date of the Q.C. Code Chip, and the expiration date of cartridge. 9. If the Q.C. Code chip installation is complete, press the OK button to go to the setup screen. FREND System © 2012 NanoEntek, Inc.
  • Page 42 Maintenance FREND 10. After all settings are edited, press the button and move to the main screen. System maintenance 11. Press the TEST button on the main screen. 12. Insert the Q.C. Cartridge into the cartridge slot. Caution: Please check the direction of the Q.C. Cartridge before insertion.
  • Page 43 Passes, if the system is properly operating. Caution: If you do not pass all tests, try again (11-14). But if you do not pass again, please contact the Customer support. FREND System © 2012 NanoEntek, Inc.
  • Page 44 Maintenance 15. Press button and move to the main screen. FREND System maintenance 16. Remove the Q.C. Cartridge. 17. Remove the Q.C. Code chip. Caution: Press the Q.C. Code chip first to remove the Q.C. Code chip. The FREND System check is complete!!!

  • Page 45: Cleaning And Storage

    To move the device, carefully pick it up and put it down gently to • avoid impact. Do not place heavy materials on top of the device. • Wrap or cover the device when in storage to protect from dust. • FREND System © 2012 NanoEntek, Inc.

  • Page 46: Troubleshooting

    Maintenance If the FREND System malfunctions, please check the following Trouble- before you contact Customer Support. shooting Cartridge insertion issues EMCI-01 - The cartridge is not inserted. • Re-insert the cartridge within 30 seconds after pressing OK button on TEST screen. EMCI-02 - The cartridge is not inserted completely.
  • Page 47 • Manually enter the lot number of the cartridge using the keypad. The lot number is printed directly above the barcode on the cartridge. FREND System © 2012 NanoEntek, Inc.
  • Page 48 Maintenance Barcode issues (cont.) Trouble- shooting EMBR-03 - The lot number entered for the cartridge does not match the lot number on the code chip. • Carefully enter the lot number of the cartridge again. If the same message is repeated, check the lot number on the installed code chip.
  • Page 49 • Back up the data stored in the FREND System to a version 1.1 USB drive. Then, delete the data stored in the FREND System so space is again available on the system. FREND System © 2012 NanoEntek, Inc.
  • Page 50 Maintenance Code chip install issues Trouble- shooting EMCC-01 - The code chip is not inserted properly, the code chip has somehow been damaged or the FREND System does not recognize the code chip. • Check that the code chip is installed properly. If it appears to be properly installed, remove the code chip from the system, locate another code chip from the same lot number and restart the code chip installation process.
  • Page 51 • Load the same sample into a new cartridge and load the cartridge into the system. If the problem is repeated, try a sample from a different source (different patient). If the problem continues, contact customer support. FREND System © 2012 NanoEntek, Inc.
  • Page 52 Maintenance Test result issues (cont.) Trouble- shooting EMTF-03 - Unable to output a test result because the reference signal is stronger than the baseline • Load the same sample into a new cartridge and load the cartridge into the system. If the problem is repeated, try a sample from a different source (different patient).
  • Page 53 If the problem persists, try a different sample. If the problem still continues, contact customer support. FREND System © 2012 NanoEntek, Inc.
  • Page 54 Maintenance Test result issues (cont.) Trouble- shooting EMTF-07 - Time-out error • Load the sample into a new cartridge and restart the test. If the same error message is displayed, centrifuge the sample to remove particulate matter and fibrin clots and retry with a new cartridge. If the problem persists, try a different sample.
  • Page 55 • Save the executable file, FREND.exe, transfer it to the USB drive and then retry the update process. EMUF-02 -There is no executable file (FRENDUPDATE.exe) on the USB drive. • Save the executable file, FRENDUPDATE.exe, transfer it to the USB drive and then retry the update process. FREND System © 2012 NanoEntek, Inc.
  • Page 56 Maintenance No entry requirements Trouble- shooting EMER-01-The entry requirements are not entered. •Enter the Patient ID, User ID, and Order #. If you want not to enter the entry requirements, change the setting on the General setting screen. NOTE: In addition to the above, for any reason, if the instrument does not work, please turn off and turn on again.

  • Page 57: General Specification-Normal Environmental Conditions

    Operating condition: • Temperature: 15 ~ 30 °C, Humidity: 10 % ~ 80 % Storage condition: • Temperature: 15 ~ 30 °C, Humidity: 10 % ~ 80 % FREND System © 2012 NanoEntek, Inc.

  • Page 58: Customer Support Information

    Every effort has been made to avoid errors in text and diagrams. How- ever, NanoEntek Inc. assumes no responsibility for any unintentional errors which may appear in this publication. Information and specifi- cations contained in this document are subject to change at any time without prior notice.
  • Page 60 Manufactured by NanoEntek, Inc. 851-14, Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 18531, Korea Tel : +82-2-6220-7942 Fax : +82-2-6220-7999 NanoEntek America, Inc. 220 Bear Hill Road, Suite 102, Waltham, MA 02451, USA Tel: +1-781-472-2558 , Fax: +1-781-790-5649 MT Promedt Consulting GmbH Altenhofstrasse 80, 66386 St. Ingbert, Germany Email ivdst@nanoentek.com...

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