STEMCELL RoboSep 20000 Technical Manual

The fully automated cell separator
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T E C H N I C A L M A N U A L
V E R S I O N 2 . 4 . 0
RoboSep™
The Fully Automated Cell Separator

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Summary of Contents for STEMCELL RoboSep 20000

  • Page 1 T E C H N I C A L M A N U A L V E R S I O N 2 . 4 . 0 RoboSep™ The Fully Automated Cell Separator...
  • Page 2 THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 3: Notice

    In case of malfunction, call STEMCELL Technologies Inc for service. Contact information is located at the back of this manual. Do not attempt to fix the instrument yourself. Never remove the outer casing of RoboSep™. There are no user-serviceable parts inside the instrument.
  • Page 4: Table Of Contents

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 5 THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 6: 1  Introduction

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 7: Robotic System Overview

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 8: The Robotic Arm And Carousel

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 9: The Tip Stripping Arm

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 10: Instrument Set-Up

    INSTRUMENT SET-UP 1.2.1 Unpacking the Instrument A STEMCELL Technologies authorized agent will be present to help you unpack and install the instrument. Please note that proper operation of RoboSep™ requires the correct installation of the instrument. 1.2.2 Instrument Placement To ensure adequate cooling of RoboSep™, the instrument should be placed on a clean flat surface with at least a 10 cm (4 in) clearance around each side.
  • Page 11: Priming The System

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 12: 2  Running Robosep™: Detailed Instructions

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 13: Preparing Cells

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 14: Loading The Carousel

    IDs, first select the item on the list and then select the grey box under the “Reagent Lot ID” heading. Alternatively, STEMCELL offers a barcode reader (Catalog #20501) that can scan barcodes on reagent vials and sample tubes to record reagent lot # and sample IDs (see Section 2.2.6).
  • Page 15: Entering Reagent Lot Id With A Barcode Scanner

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 16: Removing The Carousel

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 17: Instrument Care

    Note: The Service software and Package for Diagnosis can be launched from this window, allowing for calibration adjustment and diagnostics. This is not necessary unless requested by a STEMCELL Technologies representative. 2.3.2 Aseptic Operation of RoboSep™...
  • Page 18: Report Files

    ID and user ID information should be entered during experiment set-up (see Section 2.2.5). 2.4.2 Log Files Log files are used by authorized STEMCELL Technologies personnel to assist with troubleshooting and diagnostics. 2.4.3 Accessing Report Files The “Run Log” page, under the Instrument Tasks tab, lists diagnostic and run information.
  • Page 19: 3  Customizing Robosep

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 20: Custom Protocols - Robosep™ Protocol Editor

    The Label should include a Protocol Number in the name. Generally, this is the 5-digit number corresponding to the STEMCELL Technologies catalog number for the product used with the protocol. For more information, see Section 3.3.1. THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS.
  • Page 21: Writing A New Protocol

    Writing a New Protocol Please contact STEMCELL Technologies Technical Support for assistance if you are using this for the first time. In the “File” menu, click on “New.” A list of preset standard separation templates will appear (Figure 26). Select the desired separation type from the list and click “OK”.
  • Page 22: Protocol Structure

    The label should include a Protocol Number in the name. This is the 5-digit number corresponding to the STEMCELL Technologies catalog number for the product used with the protocol. Only letters, numbers, and dashes ( ) should be used in the label name for proper processing by the RoboSep™...
  • Page 23 THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 24 THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 25 THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 26: Advanced Protocol Editor Features

    The “Multiple Samples Selection” menu allows the advanced user to create customized protocols to process multiple samples. Please contact STEMCELL Technologies for more information. Figure 36 – The Check Protocol dialog (A) before and (B) after a successful protocol check. The file cannot be saved until the check is successful.
  • Page 27: 4  Communications And File Transfer

    SET-UP FOR NETWORK CONNECTION When a STEMCELL representative installs your instrument, RoboSep™ can be set up to automatically obtain an IP address from the local network. This will allow access to shared folders on RoboSep™ from any other computer on the network. If needed, consult the local network administrator to verify that this is allowed and that the correct permissions are available.
  • Page 28: 5  Care And Maintenance

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 29: Tip Strip Failure Detection

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 30: 6  Troubleshooting

    THIS PRODUCT IS MANUFACTURED AND CONTROLLED UNDER A QUALITY MANAGEMENT SYSTEM 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 2.4.0 INFO@STEMCELL.COM TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM DOCUMENT #28940...
  • Page 31: 7  Specifications

    RoboSep™ software, and may require IT support. Additional user profiles can also be set up on stand- alone units, as RoboSep™ operates on a Windows XP platform. This is not the standard set-up; contact STEMCELL Technologies Technical Support for additional information.
  • Page 32: 8  Robosep™ Spare Parts And Accessories

    (if applicable). Copyright © 2013 by STEMCELL Technologies Inc. All rights reserved including graphics and images. STEMCELL Technologies & Design, STEMCELL Shield Design, Scientists Helping Scientists, EasySep, and RoboSep are trademarks of STEMCELL Technologies Inc.
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  • Page 36 TECHSUPPORT@STEMCELL.COM FOR GLOBAL CONTACT DETAILS VISIT OUR WEBSITE FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. DOCUMENT #28940 VERSION 2.4.0 STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS.

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