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Bioneer ExiCycler V5 User Manual

Real-time pcr system
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A-2065-1 / A-2065-2 / A-2065-3 / A-2065-4
Version 2.0 (2024-07-24)
© Copyright 2024. BIONEER Corporation. All rights reserved.
ExiCycler
™ V5
Real-Time PCR System
ExiCycler
™ V5 96
ExiCycler
™ V5 96 Fast
ExiCycler
™ V5 384
ExiCycler
™ V5 384 Fast
ExiPrep
™96Lite
USER GUIDE
40℃
0℃
REVISION 3 (2022-02-22)

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  • Page 1 ™ V5 96 ExiCycler ™ V5 96 Fast ExiCycler ™ V5 384 ExiCycler ™ V5 384 Fast USER GUIDE A-2065-1 / A-2065-2 / A-2065-3 / A-2065-4 40℃ 0℃ Version 2.0 (2024-07-24) © Copyright 2024. BIONEER Corporation. All rights reserved. REVISION 3 (2022-02-22)
  • Page 2 REVISION 3 (2022-02-22)

  • Page 3: Table Of Contents

    Remove the PCR Tube / Plate after Run ..............48 MAINTENANCE ....................49 Instrument Cleaning & Calibration ................49 Updating the Program ..................50 Installation of ExiCycler V5 program ................ 52 Copying and Saving Files ..................56 Moving of the Instrument ..................56 Storage Conditions ..................... 56 Storing the Instrument ..................
  • Page 4 Change ......................62 Inquiries ......................62 WARRANTY ......................63 KEY TO SYMBOLS ....................64 APPENDIX A: Decontamination Certificate ..............66 APPENDIX B: Service Request Form ................68 ExiCycler APPENDIX C: ™ V5 Maintenance Log .............. 70 www.bioneer.com REVISION 3 (2022-02-22)
  • Page 5 Table 9. Protocol Description ................22 Table 10. Step Options Description ..............23 Table 11. Open Experiment Description ..............28 Table 12. Run - Flu. Graph Description ..............29 Table 13. Run - Select Wells Description ............... 30 www.bioneer.com REVISION 3 (2022-02-22)
  • Page 6 Table 14. Settings Description................33 Table 15. System Settings Description ..............34 Table 16. Network Description ................36 Table 17. Utility Description ................37 www.bioneer.com REVISION 3 (2022-02-22)

  • Page 7: Intended Purpose

    This instrument shows a result of gene amplification for the samples, and it is an in vitro diagnostic medical instrument that helps to diagnose diseases. Nonetheless, the final interpretation and diagnosis should be determined by a diagnostic specialist. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 8: Product Information

    (Ramping rate: Normal thermal block 8 ℃/sec, Fast thermal block 10 ℃/sec) • Small and compact design and stand-alone operation enable it to take up less space. • Easy to operate with touch screen and simple protocol operation. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 9: Product Specifications

    20 – 80 %, no condensation Over voltage category Over voltage Category: Ⅱ Software Specifications Software version 5.10.xx Operating Specifications Operating system Built-in (Window 10 IoT) Networking TCP/IP, USB User interface display 10.1 Inch touch screen LCD Data storage 128 GB www.bioneer.com REVISION 3 (2022-02-22)
  • Page 10 SYBR and TexasRed are a registered trademark of Molecular Probes, Inc. FAM, JOE, ROX, and TAMRA are trademark of Applera Corporation or its subsidiaries in the US and/or certain other countries. ATTO is a trademark of ATTO-TEC GmbH. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 11 ™ V5 as unsorted municipal waste. Follow local municipal waste ordinances for proper disposal provisions to reduce environmental impact of waste from electrical and electronic instrument. European Union customers: Call your local European office for Bioneer instruments pick-up and recycling. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 12: Product Components

    (5 plates) • Opaque White 8-Strip PCR Tube, Service products for PCR 0.1 mL (12 strips) * Gap Plate, Opaque White PCR Plate, and Opaque White 8-Strip PCR Tube are only available in the 96 type. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 13: Functional Description

    Do not modify the components mentioned in this User Guide or use those that are not mentioned. We are not responsible for any problems arising therefrom. Figure 3. Product View – Front (Left), Rear (Right) Figure 4. Product View – Side www.bioneer.com REVISION 3 (2022-02-22)

  • Page 14: Instrument State Display

    Table 3. LED Color Description LED Color Description LED Color Description Error or Yellow Self-Test Self-Test Failed Blue In standby Cyan In operation Green Ready to operate Purple Door opened www.bioneer.com REVISION 3 (2022-02-22)

  • Page 15: Warnings And Precautions

    10) Since this instrument contains sensitive optical parts, do not subject it to severe impacts or drop it. It can cause instrument failure and safety concerns. 11) When the instrument is not in use for a long period of time, turn off the power and unplug the www.bioneer.com REVISION 3 (2022-02-22)
  • Page 16 7) When distributing a computer security policy, check beforehand if it affects the instrument or its operation. 8) Use a USB memory stick to transmit/receive, and store data. Using an inappropriate USB memory stick or excessive network may affect the performance of the instrument. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 17: Use And Care

    24) It is recommended to store samples and positive control of kit in separate freezers to prevent cross- contamination. 25) Be careful when using sharp objects such as scissors or knives. 26) Seal used tube / plate in a disposable zipper bag. Refer to bio-waste and bio- chemical-waste www.bioneer.com REVISION 3 (2022-02-22)
  • Page 18 5) If the power is turned off while transmitting the results of a completed action, the transmission may fail. Be careful not to turn off the power while using the instrument and related devices. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 19: Installation

    • Components: Ensure all components are included by checking the list in the user guide. If there are any abnormalities with the items mentioned above, contact BIONEER Customer Service with a detailed description of the issue. Checking the installation requirements Before installing the instrument, ensure that the following conditions are met: •...

  • Page 20: Unpacking

    – Get into a comfortable position to avoid undue back strain. – Bend your knees and use your legs to lift the instrument. – While holding the instrument, do not twist your body or perform other tasks. – Wear protective equipment as needed. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 21: Operation

    Display the currently logged-in account. Account Display If a user is not logged in with a specific account, they are automatically displayed as a Guest account. Date / Time Display of the current date and time. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 22: Account Screen

    Go to the account creation screen. Delete Account Go to the account deletion screen. Change Password Go to the screen to change the account password. Login User Shows the ID of the currently logged in account. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 23: Figure 8. Login

    Figure 9. Create an Account C. Change Password 1) Select Account -> Change Password. 2) The currently logged-in User ID is displayed. 3) Change the password by setting it in the same way as Create an Account. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 24: Create Experiment Screen

    Go to the screen for adding, deleting and modifying Mange Probes probe colors. A list of probes assigned to the selected channel is Filter Channel displayed. Select All to display the probe list for all channels. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 25: Figure 11. Manage Probes

    3) A list of registered probes is displayed and can be modified using the Add, Delete, and Update Probes Color buttons. • Add: Add a new probe. • Delete: Remove the selected probe from the list. • Update Probe Color: Save the modified probe color. Figure 11. Manage Probes www.bioneer.com REVISION 3 (2022-02-22)

  • Page 26: Figure 12. Select Wells

    Select Wells - 384 well Assign In the case of 384 wells, you can select each row or column by clicking the Row header (A - P) and Column header (1 - 24), and then select the corresponding area. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 27: Figure 13. Probe Details

    ExiCycler ™ V5 A. Probe Details 1) Select Create Experiment -> Select Wells -> Probe Details. 2) Details of the probes assigned to the selected well are displayed. Figure 13. Probe Details www.bioneer.com REVISION 3 (2022-02-22)

  • Page 28: Figure 14. Protocol

    Go to the screen to load a previously saved protocol. Save Protocol with a different name. Save As Protocol Selecting the button will bring up a keyboard to name the file. Go to the Run screen. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 29: Figure 15. Step Options

    Set the detailed options of the Step. Depending on the step, the Step Setting detailed options are displayed differently. Options In the Incubate step, you can set the detailed incubation option. Keypad Keypad to set the value of the step. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 30: Figure 16. Incubate

    1) This step is to set the repetition section and number of cycles in the protocol. • Step Number: Enter the step number to repeat. • Cycle: Enter the number of cycles you want to repeat. Figure 17. Goto www.bioneer.com REVISION 3 (2022-02-22)

  • Page 31: Figure 18. Melting

    2) When the Store function starts, it maintains the previously set temperature until it is stopped by pressing the Stop button on the Run screen. 3) When using the Store function, it does not automatically terminate the PCR run at the end, and you must press the Stop button. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 32 This function increases or decreases the incubation time in the selected step section by the designated time (sec.) at each cycle cumulatively. d. Temperature Increase / Decrease This function increases or decreases the incubation temperature in the selected step section by designated temperature at each cycle cumulatively. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 33: Figure 19. Load Experiment

    2) If you select a file from the list on the left, protocol information will be displayed on the right. 3) After selecting the desired protocol file and clicking the OK button, the selected protocol will be loaded. Figure 20. Load Protocol www.bioneer.com REVISION 3 (2022-02-22)

  • Page 34: Open Experiment Screen

    Delete the selected experiments in ③. Delete Template experiments cannot be deleted. Edit Go to the screen to edit the selected experiment. Probes Details Displays probe details assigned to each well. Confirm the experiment and proceed to the Run screen. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 35: Run Screen

    Run / Pause / Stop • Pause: Pause the ongoing PCR run. • Stop: Stop the PCR run. Flu. Graph Display the PCR amplification graph. Probe You can select the checkbox to display the desired probes. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 36: Figure 23. Run - Select Wells

    Sample Name + Probes: Displays sample information and probe information together. Well Information • Sample Name: Displays sample information only. • Probes: Displays probe information only. • Well ID: Displays well ID identifying each well. • Well Number: Displays the number of each well. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 37: Figure 24. Run - Protocol

    The remaining time for the ongoing step is displayed and counts down. Figure 24. Run - Protocol 4. Run - Time Running time, Remaining time, Start time, End time, Progress (%) is displayed. Figure 25. Run - Time www.bioneer.com REVISION 3 (2022-02-22)

  • Page 38: Open Data File Screen

    Figure 26. Open Data File 2) After selecting the data and pressing the OK button, the screen transition to the Flu. Graph view, enabling you to review the PCR graph. Figure 27. Open Data File – Flu. Graph www.bioneer.com REVISION 3 (2022-02-22)

  • Page 39: Settings Screen

    Go to the utility main screen. Utility There are items for moving log files and data. Options Go to the option setting screen. This tab is for instrument maintenance, and is accessible only Factory Settings to engineers. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 40: Figure 29. System Settings

    Network screen. Software Mode Select either research mode or diagnosis mode. Choose between 0.1mL and 0.2mL tube types. Tube Type * The set values are applied as default values. Software Update Starts the software update function. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 41: Figure 30. Language / Location

    4) Note that, if you select an unsupported language, it will default to English (United States). Figure 30. Language / Location B. Date / Time 1) Click Settings -> System Settings -> Date / Time button. 2) Set the date and time. Figure 31. Date / Time www.bioneer.com REVISION 3 (2022-02-22)

  • Page 42: Figure 32. Network

    To change the IP Address, you must press the Set IP Set IP Address Address button to modify it. The IP Address supports both automatic IP allocation Ethernet using DHCP and manual IP input of static IP. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 43: Figure 33. Utility

    Go to the Log File Export screen. Export Data Files Go to the Data File Export screen. Export Scan Backup Files Go to the scan backup image file Export screen. Go to the additional function screen Add-Ons (Self-Test, Transport Mode, etc.). www.bioneer.com REVISION 3 (2022-02-22)

  • Page 44: Figure 34. Export Data Files

    The user can perform a self-diagnosis to check whether the instrument is operating normally. ② Transport Mode To prevent damage to the Bath block during instrument movement, it is used to secure the Bath block in place. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 45: Running The Software

    2) After selecting the probe to use, click the Next button. 3) Designate the well to use and click the Assign Probes button. 4) Click the Next button to move to the Protocol screen. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 46 6) Set the desired conditions in the temperature and time, then click the OK button. 7) Afterwards, it moves to the Run screen. Open Experiment 1) If select Open Experiment button, default experiments are displayed. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 47 6. You check real-time amplification graph in the Flu. Graph, and also check other details in the Select Wells, Protocol, and Time sections. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 48 7. When the PCR Step is completed, a message will appear. 8. Press the OK button. 9. If you wish to transfer the data file immediately after the experiment ends, you can do so by inserting a USB stick, enabling immediate data transfer. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 49: Changing Cycle During Run

    It cannot be changed if the progress has already reached the initially set number of cycles or under certain conditions where the number of cycles cannot be changed. • If cycle change fails, the following message is displayed. “Cycle cannot be changed.” www.bioneer.com REVISION 3 (2022-02-22)

  • Page 50: Sample Preperation And Experiment

    Use the recommended volume for each tube / plate. Do not use less than the minimum volume Type Volume (μL) Product Opaque White 0.1ml PCR 8-tube Strip (Bioneer, Cat.No.3111-54) 96 well-0.1 ml 10-50 Opaque White 96-Well Skirted, Low Profile PCR Plate (Bioneer, Cat.No.3111-53) Opaque White 0.2 ml PCR 8-tube Strip (Bioneer, Cat.No.3111-50)
  • Page 51 MSDS attached to the product, and if it gets on your eyes or skin, wipe it off with a large amount of water or detergent. If ingested or inhaled, following the instructions on MSDS for vomiting, or seek medical advice immediately. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 52: Running The Pcr

    In case that PCR cannot start right after preparing the plate, store it after blocking the light until the PCR reaction begins. • It is recommended to run immediately after preparing the PCR plate for accurate results. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 53 Gap Plate.) C. 384-Well Plate • Align the 384-well plate with the well of the bath block and insert the PCR Plate. • Ensure that the A1 well is positioned in the upper left corner. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 54: Remove The Pcr Tube / Plate After Run

    Since the temperature of the PCR reaction rises to around 100 ℃, the thermal block and the tube / plate may become hot after run. Therefore, it is advisable to wait until they have cools down to room temperature before handling them. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 55: Maintenance

    If temperature calibration is required, contact us. The head office or agency will visit and perform the calibration. 5. Optical Calibration • If optical calibration is required, contact us. The head office or agency will visit and perform the calibration. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 56: Updating The Program

    Select the item you want to update and press the Update button. 4. A confirmation window will appear asking if you want to proceed with the update. Click the OK button to start the update. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 57 Once the update is complete, the updated software will run automatically. • The Calibration file is automatically copied to the updated program. • After the update is complete, version information can be checked through Settings -> About. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 58: Installation Of Exicycler V5 Program

    The connection between the instrument and the computer is established through the network and is facilitated by our engineers or authorized dealers. Installation Precautions The ExiCycler V5 program is provided via USB. Insert the USB stick into your computer and run the installation file following to the provided instructions. •...
  • Page 59 ExiCycler ™ V5 Install the ExiCycler V5 PC Package Program Run the ExiCycler V5 PC Package file, and when the following window appears, click the Next button to begin the installation. When the window for installing the program appears, click the Next button to proceed to the next step for installation.
  • Page 60 Install the ExiCycler V5 Program Run the ExiCycler V5 Setup file, and when the following window appears, click the Next button to begin the installation. 2. When the window for installing the program appears, click the Next button to proceed to the next step for installation.
  • Page 61 Copy and use the calibration file of the instrument provided on the USB. After copying is complete, run the ExiCycler V5 program to use it. After copying to the appropriate path on your computer is complete, run the ExiCycler V5 program to use it.

  • Page 62: Copying And Saving Files

    Temperature: 0-40 ℃ (32 -104 ℉) Humidity: 20-80 % (non-condensed) Storing the Instrument When the instrument is not in operation, follow the storage guidelines outlined in the User Guide. It must be stored following all of the storage conditions specified above. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 63: Troubleshooting

    1. Ensure tube / plate in mounted correctly. Tube / Plate cannot be mounted on 2. Check for foreign substance in the block. thermal block. 3. Contact technical support or local distributor for service. www.bioneer.com REVISION 3 (2022-02-22)
  • Page 64 2. Ensure tube / plate is properly loaded. USB data transfer issue. 1. Ensure the USB storage device is inserted correctly. 1. Check for compatibility conflicts between BIONEER software and other software applications, such as security Abnormal software termination. programs.

  • Page 65: Technical Support

    If the issue persists, document any abnormalities with the instrument and complete the Service Request Form (Refer to Appendix B). Please submit the completed Service Request Form to our technical support department at (ds@bioneer.com). Sending the Instrument for Service First, please inform your local distributor or us about the required service.

  • Page 66: Revision History About This Guide

    REVISION HISTORY ABOUT THIS GUIDE Version Date Description September 2023 New document Update for July 2024 - ExiCycler V5 program installation www.bioneer.com REVISION 3 (2022-02-22)

  • Page 67: Ordering Information

    ™ qPCR Master Mix (-ROX dye) ® AccuPower Plus DualStar K-6603 ™ qPCR Master Mix (2X) Related Instrument Cat. No. Product ExiPrep A-5050 ™16 Dx ExiPrep A-5150 ™48 Dx ExiPrep A-5250 ™96 Lite For more information, please visit our website (www.bioneer.com). www.bioneer.com REVISION 3 (2022-02-22)

  • Page 68: Legal Information

    User Guide, failure or damage caused by repairs performed by an entity other than Bioneer or a repair shop designated by Bioneer, normal wear and tear, or any defect caused by a natural disaster.

  • Page 69: Warranty

    ▪ Matters not specifically stated in this clause shall be governed by Bioneer’s A/S and customer support principles and internal regulations, and other matters shall be reviewed and processed with consideration for the user’s convenience.

  • Page 70: Key To Symbols

    Do not discard as unclassified waste. To minimize the effect of electric or electronic instruments on the environment, follow the regulations on proper disposal of such items. European Union customers Call your local Europe office for Bioneer instruments pick-up and recycling. Manufacturer Date of Manufacture...
  • Page 71 Indicates the on/off position of the main power switch. Indicates ground terminal for the main protective ground of the instrument. Indicates a terminal that receives or supplies alternating current or voltage. Indicates a terminal that receives or supplies direct current or voltage. www.bioneer.com REVISION 3 (2022-02-22)

  • Page 72: Appendix A: Decontamination Certificate

    □ Radioactive substance Specifics of the contamination Decontamination process Date Name/signature If radioactive material is used, the signature of the Radiation Safety Officer is required to certify that the radioactive contamination has been removed. Date Name/signature www.bioneer.com REVISION 3 (2022-02-22)
  • Page 73 ExiCycler ™ V5 www.bioneer.com REVISION 3 (2022-02-22)

  • Page 74: Appendix B: Service Request Form

    Catalog No. A-2065-1 □ A-2065-2 □ A-2065-3 □ A-2065-4 □ Serial No. Date of Request Date of Purchase Date Part Description Problem Additional Information (if needed) Name of Institution Address Department Customer Name Contact Phone Information E-mail www.bioneer.com REVISION 3 (2022-02-22)
  • Page 75 ExiCycler ™ V5 www.bioneer.com REVISION 3 (2022-02-22)

  • Page 76: Appendix C: Exicycler ™ V5 Maintenance Log

    Clean the lab bench and clean bench Decontaminate thermal block Annually or as needed - Engineer Clean Hot-lid Thermal calibration Optical calibration * Required Materials: Distilled Water, 70% Ethanol, Nucleic Acid Degradation Solution, Swab, Lint-Free Cloth/Paper Towel, Powder-Free Disposable Glove www.bioneer.com REVISION 3 (2022-02-22)
  • Page 77 www.bioneer.com...
  • Page 78 BIONEER Corporation Address Bioneer Global Center, 71, Techno 2-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea Telephone +82-42-939-6333 +82-42-939-6444 E-mail sales@bioneer.com Website www.bioneer.com Information about our headquarters and branches can be found in the Customer Support section of our website REVISION 3 (2022-02-22)
  • Page 79 BIONEER Corporation Bioneer Global Center, 71, Techno 2-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea MT Promedt Consulting GmbH Ernst-Heckel-Straße 7, 66386 St. Ingbert, Germany Phone: +49 6894 581020 A-2065-1 / A-2065-2 / A-2065-3 / A-2065-4...

This manual is also suitable for:

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