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Promega Maxwell CSC Instrument Technical Manual

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T E C H N I C A L M A N U A L
Maxwell
®
with Version 2.X Software
Operating Manual
Instruc ons for use of the Maxwell® CSC Instrument,
Model Number AS4000.
This product is for sale in the United States
and Canada Only.
Note: Please ensure that all sealing tape
and any residual adhesive are removed from
the Maxwell® CSC system cartridges before
placing the cartridges into the instrument.
CSC Instrument
Revised 02/15
TM424

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Summary of Contents for Promega Maxwell CSC Instrument

  • Page 1 T E C H N I C A L M A N U A L Maxwell ® CSC Instrument with Version 2.X Software Operating Manual Instruc ons for use of the Maxwell® CSC Instrument, Model Number AS4000. This product is for sale in the United States and Canada Only.

  • Page 2: Table Of Contents

    5.C. Clean Up ........................46 5.D. Running Reports ...................... 49 5.E. Sanitizing ......................... 51 Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 3 9.C. Related Products ...................... 62 10. Certifi cate of Decontamination ................... 63 Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 4: Introduction

    Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 5: Product Use Limitations

    Average lifetime approximately 6,000 hours, length 135.9mm, diameter 16mm, 4W, 0.17A current, 29V, Spectral Peak F 253.7, UV output 0.9W Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 6: Product Components

    Tablet PC, Tablet PC Holder and Bar Code Reader for the Maxwell ® CSC Instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...

  • Page 7: Precautions

    CSC Instru- ment. Additional programs may cause the application to slow down. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 8: Safety Symbols And Marking

    Warning. UV light hazard. Do not look directly at the UV light. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 9 FCC Compliance Marked KCC Compliance Marked In Vitro Diagnostic Medical Device Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 10: Environmental Requirements (Operating, Shipping And Storage Conditions)

    Hardware Overview Figure 2. Front of Maxwell ® CSC Instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 11 CSC Instrument. The magnet and plunger bars, which are used for sample processing, and the platform containing the deck tray are evident. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 12: Unpacking The Maxwell Csc Instrument

    Save the packaging material in case the instrument needs to be returned for service or repair later. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 ·...

  • Page 13: Setting Up The Maxwell Csc Instrument

    CSC Instrument door is spring-loaded and will close itself once the foam pieces are removed from the inside of the instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 14: Setting Up The Tablet Pc

    Remove the Tablet PC Holder from its packaging, and place it on top or adjacent to the Maxwell ® Instrument (Figure 9). Figure 9. Tablet PC Holder. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 15 ® Figure 11. Tablet PC installed on the Maxwell CSC Instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 16 CSC Instrument with the Tablet PC and Bar Code Reader installed. The Maxwell ® CSC Instrument is now ready to use. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...

  • Page 17: Switching On The Maxwell ® Csc Instrument

    Note: The Tablet PC must be shut down at least once a week to allow Windows to reset memory usage. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 18 When not in use for a prolonged period of time, the Tablet PC should be shut down and unplugged. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 ·...

  • Page 19: Confi Guring The Tablet Pc

    11. Close the ‘Control Panel’ by touching the red X button in the upper right corner of the screen. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 20 Figure 16. Selecting Groups from Computer Management Screen. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 21 PromegaUsers group. Close the Computer Management window. Figure 18. Adding users to the PromegaUsers group. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 22 Remove... button. Touch OK to remove users from the PromegaUsers group. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 23: Maxwell Csc User Interface Screens

    Figure 20. Instrument Name Window. Administrators can manually enter the instrument name from the instrument name window. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 24 Help. Pressing the Help button will activate the context-sensitive help for the current page of the Maxwell ® CSC User Interface. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 25 CSC ‘Settings’ screen from which bar code entry options can be confi gured. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 26 CSC Administrator page. The ‘Administrator’ page is only visible to administra- tors and gives access to sample entry and additional options. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 27 To return to the ‘Home’ screen touch the Home button in the upper left corner of the ‘Administrator’ page. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 28 Figure 26. Export folder settings that can be changed by the Administrator. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 29 Figure 27. Changing export folder settings to a diff erent folder. Figure 28. Touch ‘Save’ to save the settings for the new export folder. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 30 (in minutes) and other settings such as Sanitize after extraction and/or Sanitize on instrument startup for a specifi ed amount of time. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 31 fi les are displayed as blue rectangles. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 32 CSC Settings screen. From this screen you can perform Self Test for the Maxwell ® CSC Instruments. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 33 Plungers are not present in any cartridges in the deck tray. • Deck tray has been placed in the instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 34: Instrument Calibration

    CSC Instrument is calibrated at the manufacturing site prior to use. No user calibration is necessary. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 35: Operating The Maxwell ® Csc Instrument

    OK button to get to the Cartridge Setup screen. You can touch the Back button to return to the ‘Home’ screen. Scanning or entering the bar code automatically selects the protocol to be run. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 36 Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 37 Important. There are two bar codes on the kit label. Enter the bar code at the top of the label. You will receive an error message if you scan the wrong bar code. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 38 Proceed button to move to the ‘Door’ screen (Figure 41). Press the OK button to open the Maxwell ® CSC Instrument door. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 39 ‘Extraction Checklist’ and should be performed prior to this stage according to the technical manual for the kit being processed. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 40 Place the deck tray in the instrument as shown in Figure 44. Ensure that the deck tray is completely seated inside the instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 41 (see Section 6.B) and the cartridges containing the samples discarded. The samples will be lost. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 42 If you wish to abort the current run, touch the Abort button in the lower right corner of the screen. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 ·...
  • Page 43 Do not reuse reagent cartridges, Plungers or Elution Tubes. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 44 UV sanitization (see Section 5.E). Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 45 After a protocol is aborted the Current Step will list the reason for aborting the protocol. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 46: Clean Up

    If the plunger cleanup fails, you should contact Promega Technical Services for further assistance. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 47 Fit the Report to screen width • View the Whole Page of the report Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 48 fi le is shown in Figure 54. An example of the PDF format is shown in Figure 55. Figure 54. Example of a fi le in the tab-separated format. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 49: Running Reports

    Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...
  • Page 50 Figure 58. Extraction Report. An example of the sample tracking information present in an extraction report as well as Exporting reports. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 51: Sanitizing

    UV treatment is not a substitute for cleaning. Using the UV Sanitization protocol alone may not provide suffi cient decontamination. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 52: Cleaning And Maintenance

    2. If the magnetic rod assembly cannot be cleaned, please contact Promega Technical Services for assis- tance. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 53: Dealing With Spills

    Bleach should not be used to clean Maxwell ® CSC reagent spills. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 54: Troubleshooting

    Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 55: Errors And Warnings

    If error still persists, contact Promega Technical Services. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 56: Use Of A Usb Flash Drive

    If the tablet controller becomes unresponsive after inserting a USB fl ash drive, shut down and restart the tablet and the instrument. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 57: Appendix

    ® CSC Instrument only with Promega packaging to avoid any damages. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 58 This is by design. Do not try to force the door to close, or the door can break. Place the instrument back in the plastic bag. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...
  • Page 59 Place the top foam packaging over the top of the instrument as shown (Figure 63). Figure 63. Foam packing on top of box. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com...

  • Page 60: Instrument Disposal

    2 business days. We will repair your instrument and return it to you performing to original factory specifi cations. It also includes one Preventive Maintenance visit. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...

  • Page 61: Warranty And Service Agreement Options

    • Complete customer specifi c log book, instrument sticker and OQ documentation Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

  • Page 62: Related Products

    For In Vitro Diagnostic Use. This product is only available in certain countries. For the most up-to-date list of related products, visit: www.promega.com/products/instruments/maxwell-csc-system-for-ivd-use/ Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15 www.promega.com...

  • Page 63: Certifi Cate Of Decontamination

    This instrument is certifi ed by the undersigned to be free of radioactive contamination. Date: Place: Signature: Name (block capital letters): Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...
  • Page 64 Product claims are subject to change. Please contact Promega Technical Services or access the Promega online catalog for the most up-to-date informa on on Promega products. Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 TM424 · Revised 2/15...
  • Page 65 Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516 www.promega.com TM424 · Revised 2/15...

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