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STEMCELL RoboSep-16 User's Reference Manual

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USER REFERENCE MANUAL
RoboSep™-16

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Summary of Contents for STEMCELL RoboSep-16

  • Page 1 USER REFERENCE MANUAL RoboSep™-16...

  • Page 3: Table Of Contents

    User Profiles ........................ 16 3.1 Adding a User Profile ........................16 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...
  • Page 4 8.1 Maintenance ........................... 34 8.2 Replacing the Fuses ........................36 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...
  • Page 5 Software Updates ......................40 12.0 Related Products ......................40 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...

  • Page 6: Overview Of Safety Symbols

    Safety Information and Warnings STEMCELL Technologies is not responsible for any injury or damage caused by the use of this instrument for purposes other than those for which it is intended, or by modifications of the instrument or software not performed by an authorized STEMCELL Technologies representative.

  • Page 7: Safety Precautions

    Waste may contain biohazardous or chemical-contaminated material. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...

  • Page 8: Maintenance

    Do not remove the instrument side covers under any circumstances. Always have the door closed when executing runs. During operation, the instrument arm may move suddenly causing bodily harm. Contact STEMCELL Technologies Technical Support anytime you believe the instrument has lost accuracy or precision in any motion axis. Maintenance If RoboSep™-16 becomes contaminated with biohazardous or chemical...

  • Page 9: Computer

    This manual is applicable to RoboSep™-16 software version 1.2.2.0. For other software versions, contact us at techsupport@stemcell.com for the applicable manual. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 11: Introduction

    After completion of the cell isolation procedure, cells of interest are immediately available for any downstream application. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 12: Robosep™-16 System Overview

    Uses an alternate set of reagents if insufficient amounts are detected in the primary set STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 13: Liquid Pipetting Robot

    The deck components are shown in Figure 2. Figure 2. The Deck STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 14: Buffer Solution Bottle Holders

    Round-Bottom Polystyrene Tubes are recommended (5 mL [Catalog #38007] and 14 mL [Catalog #38008]). STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 15 Note: The negative fraction rack should only be placed back onto the deck when the tray is fully stowed in place. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 16: Disposable Tip Racks

    [Exit] on the Home screen and wait until the RoboSep™-16 application turns off. 2. Turn off the RoboSep™-16 system using the instrument power switch. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 17: Reagent Vial Rack

    Figure 6. Reagent Symbols and Protocol Group Numbers on the Reagent Vial Rack STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 18: Barcode Scanner

    Five screens can be accessed using the TaskBar on the left of the application window, as shown in Figure 7. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 19 Figure 7. Screens Accessed from the Home Screen STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE 1 800 667 0322...

  • Page 20: Icons

    Add protocols View archive Diagnostic Package STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE 1 800 667 0322...

  • Page 21: Clean Air Protection (Cap) System Overview

    Figure 8. CAP System Air Flow STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 22: Installation

    Successful operation of RoboSep™-16 requires correct installation. An authorized STEMCELL Technologies representative will be present to help unpack, connect, and install the instrument as well as the computer. The STEMCELL representative will also provide laboratory staff with training on the proper operation of RoboSep™-16.

  • Page 23: Configuring The Computer To Access Robosep™-16

    Subnet mask box and click once. The number 255.255.255.0 will automatically be generated. 7. Select OK to configure the settings. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...

  • Page 24: Configuring The Computer To Access The Barcode Scanner

    8. Click Port Settings and then click the “Advanced…” button, and change the COM Port Number to COM4. 9. Click OK. The device should be configured to COM4. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 25: Startup

    [Exit] on the Home screen and wait until the RoboSep™-16 application turns off. 3. Log off or shut down the computer. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 26: User Profiles

    [Save]. The new copied user profile will be added to the list of all user profiles. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 27: Deleting A User Profile

    Note: Once the desired user profile has been selected, the Preferences screen can be accessed directly from the Home screen by selecting [Preferences]. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...
  • Page 28 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 29: Administrator Settings

    [Admin Mode]. 2. Enter the Admin Password and select OK. Note: The default Admin Password is “RoboSep-16”. You may change this to your preferred password. If you forget your password, contact us at techsupport@stemcell.com for assistance in recovering it. “Admin Mode Enabled” will now appear on the upper left side of the screen.

  • Page 30: Robosep™-16 Operation

    (15 - 25°C). 5.1.1 Adding New Protocols to RoboSep™-16 New RoboSep™ protocols can be added to RoboSep™-16 using a USB flash drive. Contact STEMCELL Technologies Technical Support for more information on how to customize and add new protocols to RoboSep™-16.
  • Page 31 Removal of a protocol group is pictured in Figure 14. Figure 14. Removing a Protocol Group from the Home Screen STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 32: Protocol Presets

    2. Select [Edit] from the User Profile screen. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...

  • Page 33: Preparing The Cells

    STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 34 (Figure 17). RoboSep™-16 homing will occur as well as barcode scanning (section 1.4). STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 35 Figure 17. Run Progress Screen STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 36: Collecting Isolated Cells

    Figure 18. Collecting Isolated Cells. The isolated cells are located in the tubes highlighted in dark purple under each protocol group of the Unloading screen. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 37: Cap System Operation

    CAP system back on. Figure 20. ‘The fans are currently busy’ Message STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 38: User Interface

    Figure 22. System Configuration Options The four options—Schedule, Filter Change, System, and Alerts—are described below. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 39: Schedule

    Figure 23. CAP Event Schedule Figure 24. CAP Event Edit Schedule Screen STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 40: Filter Change

    3. Update the filter change status for the Pre-filter as described in section 6.3.2. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 41: Replacing Hepa Filters

    Figure 27. Secured Kickstand in Bracket with Handle Extended 2. Remove used HEPA filter by sliding filter out and dispose. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 42 5. Update the filter change status for the HEPA filter as described in section 6.3.2. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 43: End Of Run Report Files

    These files may be retrieved by selecting [View Archive]. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE...

  • Page 44: Care And Maintenance

    This version of the eject plate does not require removal to perform maintenance tasks. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.
  • Page 45 Figure 30. Cleaning Pipette Channels STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 46: Replacing The Fuses

    5. Plug in the instrument and start up RoboSep™-16 (section 2.3) to ensure it turns back on. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 47: Specifications

    RoboSep™-16 has been designed for easy dismantling and recycling. Contact STEMCELL Technologies regarding end-of-life care for RoboSep™-16. STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES.

  • Page 48: Cap System

    Installation category II CSA Certification Pollution degree 2 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. TOLL FREE PHONE 1 800 667 0322...

  • Page 49: Troubleshooting

    Contact STEMCELL Technologies Technical Support for troubleshooting assistance. 10.1 Service Logs To assist with troubleshooting and diagnostics, a STEMCELL Technologies representative may ask to receive the Service Logs. To access RoboSep™-16 Service Logs and save them on a USB flash drive: 1.

  • Page 50: Software Updates

    Scientists, RoboSep, and EasySep are trademarks of STEMCELL Technologies Inc. Falcon is a registered trademark of Corning Incorporated. All other trademarks and registered trademarks are property of their respective holders. While STEMCELL has made all reasonable efforts to ensure that the information provided by STEMCELL and its suppliers is correct, it makes no warranties or representations as to the accuracy or completeness of such information.
  • Page 52 USER REFERENCE MANUAL RoboSep™-16 TOLL-FREE PHONE 1 800 667 0322 PHONE +1 604 877 0713 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #10000005574 VERSION 01 OCT 2019 | FOR INTERNAL USE: MATERIAL #28200...

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