STEMCELL RoboSep-S User's Reference Manual

The fully automated cell separator

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USER REFERENCE MANUAL
RoboSep™-S:
The Fully Automated
Cell Separator

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Summary of Contents for STEMCELL RoboSep-S

  • Page 1 USER REFERENCE MANUAL RoboSep™-S: The Fully Automated Cell Separator...
  • Page 3: Table Of Contents

    4.3.1 Selecting a Cell Separation Protocol..................20     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 Appendix A: Running RoboSep™-S: Quick Start Instructions ..........37     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 5: Safety Information And Warnings

    Vancouver BC, Canada V6A 1B6. Call 1-604-877-0713 or toll-free 1-800-667-0322 within North America. 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: Introduction

    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 8: Robosep™-S System

    Instrument Overview Figure 1. Front View of RoboSep™-S with the Lid Open 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 9 Figure 2. Back View of RoboSep™-S with the Lid Open 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 10: Robotic Arm And Carousel

    Figure 3. (A) Robotic Arm and (B) RoboSep™ Filter Tip Rack. Note that the lid of the RoboSep™ Filter Tip Rack needs to be removed prior to use. 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 (Figure 6), ensure that the reagent vials are centered within their respective positions in the carousel. 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: Tip Stripping Arm

    Figure 8 illustrates the automated 5 mL pipette tip stripping process. 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: Hydraulic System

    Note: RoboSep™-S will automatically monitor the volume of deionized water in the hydraulic fluid bottle and a dialog box will notify you if priming is required (section 3.5). 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: User Interface Overview

    (Figure 9). Figure 9. 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.
  • Page 15: Icons

    Sort from A to Z Power Sort from Z to A 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: Robosep™-S Installation

    Figure 10. Removing the Lid. The lid (A) in place and (B) removed. Note that only four thumb screws are shown in this diagram. 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: Power And Network Connections

    4. On the separate networked computer, go to Start > Run and then enter two backslashes followed by the Network address (e.g. //192.168.59.127). Figure 12. Help 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 18: Startup

    (e.g. when cleaning the instrument; section 6.2). 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 19: Priming The Hydraulic System

    1. Open the access panel located at the front of the instrument and remove the hydraulic fluid bottle using the white quick connect (Figure 14A). Note: Do NOT touch the black switch behind the access panel. This is to be used only by a STEMCELL Technologies representative for servicing purposes.
  • Page 20: Running Robosep™-S

    [Save]. The new 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 21: Deleting A User Profile

    Note: The User Preferences screen can be accessed directly from the Home screen by simply selecting [Edit user profile] once the desired user profile has been selected. 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 This setting deletes all the saved carousel video camera log files video camera log files 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 23: Privacy Settings

    Sensitive information includes any information concerning personal/material circumstances of an identified individual. Users shall not hold STEMCELL Technologies liable for any data or sensitive information that is disclosed. To comply with your region and institution’s privacy policies, update these settings as needed.
  • Page 24: Adding Protocols To A User Profile

    All Protocols tab. Figure 17. Adding a Protocol to a User Profile 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: Removing Protocols From A User Profile

    Figure 18. Removing a Protocol from a User Profile 4.2.3 Adding New Protocols to RoboSep™-S New RoboSep™ protocols can be added to RoboSep™-S simply by using a USB drive. Contact STEMCELL Technologies at techsupport@stemcell.com for more information on how to customize existing protocols or add new protocols to RoboSep™-S.
  • Page 26: Setting Up A Run

      Figure 19. Selecting a Protocol and Assigning it to a Quadrant 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: Preparing The Cells

    Figure 21. RoboSep™ Service Rack. Tubes and vials placed in the rack before loading the carousel. Quadrant numbers are noted on the side of the 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 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 Figure 22. Loading the Carousel and Running a Protocol 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 30: Scanning Barcodes

    No barcode detected; Catalog # was expected “NONE_DETECTED” based on chosen protocol 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 31: Collecting Isolated Cells

    #1 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 32: Report Files

    Note: Multiple reports can be selected and saved onto a USB drive by simply selecting “Save Reports to USB”. 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 33: Care And Maintenance

    70% ethanol be sprayed on a soft, clean towel prior to wiping down the touchscreen. Do not allow excess fluid to pool at the margins of the touchscreen. 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: Internal Surface

    5. Plug in the instrument and start up RoboSep™-S (section 3.3) to check if 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 35: Help Videos

    Help Videos screen. Note: RoboSep™-S software version 1.2.0.2 or later is required to play Help Videos. If Help Videos are not available or cannot be played, they can be viewed online. Contact us at techsupport@stemcell.com for additional assistance in accessing the videos.
  • Page 36: Specifications

    For more information on RoboSep™-S warranties, refer to www.stemcell.com or contact us at techsupport@stemcell.com. 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: Troubleshooting

    Troubleshooting Log Files To assist with troubleshooting and diagnostics, a STEMCELL Technologies representative may ask to receive the log files. To access RoboSep™-S log files: 1. Select [Maintenance] from the Home screen. 2. Select [Diagnostic Package]. 3. Insert a USB drive into one of the USB ports of the RoboSep™-S (Figure 1).
  • Page 38: Software/Hardware Issues

    Physical damage to screen or Touchscreen not functioning Contact Technical Support recalibration problem 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 39: Mechanical Performance Issues

    Support to change the default one minute with tip attached instrument. threshold time. 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 40: Liquid Handling Performance Issues

     250 µL in tubes tube in question and contact Technical Support   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 41: Barcode Scanning Issues

    No barcode detected; Catalog # was expected “NONE_DETECTED” based on chosen protocol   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 42: Software And Hardware Updates

    Cell Isolation Kits. This carousel requires software version 1.2.0.2 or later. Contact us at techsupport@stemcell.com for more information. 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: Related Products

    For easy access, the Quick Start Guide can be stored in the document tray located underneath RoboSep™-S. 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 44   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 PHONE +1 604 877 0713 VERSION 02  ...
  • Page 45 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 PHONE +1 604 877 0713 VERSION 02  ...
  • Page 46   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 PHONE +1 604 877 0713 VERSION 02  ...
  • Page 47 Helping Scientists, RoboSep, and EasySep are trademarks of STEMCELL Technologies Canada Inc. Falcon is a registered trademark of Corning Incorporated. All other trademarks are the 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 48 TECHNICAL MANUAL RoboSep™-S: The Fully Automated Cell Separator 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 #10000005578 VERSION 02 OCT 2019 | FOR INTERNAL USE: MATERIAL #29792  ...

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