Roche cobas c 111 Installation Manual
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Roche cobas c 111 Installation Manual

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R
Installation Manual
Version 3.0
29-Sep-2009
04906900001
Last printed: 7 January 2010
Page 1 of 43
INSTALLATION-MANUAL cobas c 111

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Summary of Contents for Roche cobas c 111

  • Page 1 Installation Manual Version 3.0 29-Sep-2009 04906900001 Last printed: 7 January 2010 Page 1 of 43 INSTALLATION-MANUAL cobas c 111...
  • Page 2 111 Installation Manual This page has been left empty intentionally 04906900001 Version 3.0 Page 2 of 43 INSTALLATION-MANUAL cobas c 111...

  • Page 3: Table Of Contents

    Packing procedure for instrument without ISE:..........39 10. Disposal of the instrument ...................42 10.1 Disposal of external components..............42 11. Installation Report Form ..................42 12. Installation Report cobas c 111 ................43 04906900001 Version 3.0 Page 3 of 43 INSTALLATION-MANUAL cobas c 111...

  • Page 4: Preface

    However, Roche Diagnostic Ltd. reserves the right to make any changes necessary without notice as part of ongoing product development. 1.2 Copyrights and trademarks cobas c 111, and the R® logo are registered trademarks of F. Hoffmann- La Roche cobas c cobas c cobas c Ltd.

  • Page 5: Manufacturer

    CH-6343 Rotkreuz Switzerland 1.4 Intended use The cobas c 111 instrument is a continuous random-access analyzer intended for the in- vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood. (Only HbA1c application) It is important that the operators read this manual thoroughly before using the system.

  • Page 6: About This Manual

    111 Installation Manual 2. About this manual This manual is to be used for unpacking, installing and registering the cobas c 111. For detailed instrument information, see the cobas c 111 Operator’s Manual. 2.1 Conventions used in this manual The conventions used in this manual are as follows: 1., 2., 3., represents sequential steps in a procedure.

  • Page 7: Acronyms

    Federal Communications Commission European Norm 3. Safety information Before operating the cobas c 111, it is essential that you read and understand the safety information listed here. 3.1 Safety classifications The safety precautions and important user notes are classified according to ANSI Z535 resp.
  • Page 8 Recommendations Check any data carrier (e.g. USB memory stick) with an anti-virus program (on another computer) to ensure that they are virus free before using them on the cobas c 111. Optical Safety Loss of sight! The intense light of the LEDs may severely damage your eyes.
  • Page 9 Location The cobas c 111 is designed for indoor use and the instrument must be located on a stable and level surface that is not subject to vibration. The instrument should not be placed in a position where strong or variable light conditions exist (e.g. direct sunlight).
  • Page 10 111 Installation Manual Environmental conditions The cobas c 111 is designed to operate in a controlled environment. In particular the room temperature, relative humidity and atmospheric pollution conditions must be maintained within the limits specified above (par. 4.3). Operation outside of the spe- cified ranges may cause erratic operation or, in exceptional circumstances, component failure.

  • Page 11: Overview

    111 Installation Manual 4. Overview 4.1 Introduction The cobas c 111 analyzer is intended for in vitro quantitative or qualitative determi- nation of a wide range of analytes in serum, plasma and urine. (Whole blood only with HbA1c application.) The cobas c 111 is intended for professional use only.

  • Page 12: Instrument Internal Layout

    111 Installation Manual 4.2 Instrument internal layout The major components of the analyzer are shown below in fig 1. 04906900001 Version 3.0 Page 12 of 43 INSTALLATION-MANUAL cobas c 111...

  • Page 13: Technical Specifications

    111 Installation Manual 4.3 Technical specifications Operating System LINUX Software and data VX Works handling Memory DM- Module 32 MB Flash ROM PXA 255 32 MB DRAM Memory RT-CPU 32 MB Flash ROM PXA 255 32 MB DRAM...
  • Page 14 111 Installation Manual Ion-Selective Electrode Indirect measurement Sample volume 15 µl (Dilution 1:6) © OMNI -Style Electrodes Na, K, Cl, Reference Physical Width /(with ISE) 590 mm / (720 mm) dimensions (max.) Depth / (with ISE) 550 mm / (550 mm)
  • Page 15 111 Installation Manual Safety approval UL 61010-1 EN/IEC 61010-1 EN/IEC 61010-2-101 CAN/CSA C22.2 No. 61010-1 Regulatory compliance Complies with European Union (EU) Directive 98/79/EC (in vitro medical device) FCC: This equipment complies with the requirement in part 15 of FCC rules for a class A computing device.

  • Page 16: Delivery, Unpacking And Set-Up Of The Analyzer

    Please check the items supplied against the packing list and retain the list for future reference. 5.2 Additional items required To be able to install and set up the cobas c 111 correctly it is necessary to provide the following additional items: Power supply cord, either: US-Type: Cable Power Mains US STD: No.

  • Page 17: Unpacking

    5.3 Unpacking Important: Do not allow unqualified personnel to unpack, set up, or perform first time operation of the cobas c 111. Unauthorized action taken by the customer in this regard could void the warranty on the analyzer. The original shipping containers must be transferred unopened to the installation site.
  • Page 18 111 Installation Manual Remove the standard accessories. Lift the carton off the pallet to get access to the instrument. Remove the upper cardboard cover. Remove the plastic transport protection covering the instrument. Remove 04906900001 Version 3.0 Page 18 of 43...

  • Page 19: Unpacking Procedure For Instrument Without Ise

    Lift the cobas c 111 instrument from the pallet. Caution: The instrument weighs around 38 kg (~80 lbs.) Place the cobas c 111 on flat and stable surface. Notice: Keep the packing pieces in a safe place to use again whenever the instru- ment has to be transported any significant distance.
  • Page 20 Remove the plastic transport protection covering the instrument. Remove 1. Turn 2. Remove Plastic transport protection Lift the cobas c 111 instrument from the pallet. Caution: The instrument weighs around 35 kg (~75 lbs.) Empty palette 04906900001 Version 3.0 Page 20 of 43...

  • Page 21: Location Of Switches And Connectors

    111 Installation Manual Place the cobas c 111 on flat and stable surface. Notice: Keep the packing pieces in a safe place to use again whenever the instru- ment has to be transported any significant distance. 5.4 Location of switches and connectors Locations and use of all the switches, fuses and connectors are listed here, (See also Fig.

  • Page 22: Rs232 Serial Connectors

    RS232 Serial connectors There are 2 serial interface connectors intended for use with a Barcode scanner and Host interface respectively. Please refer to the cobas c 111 Operator Manual and the corresponding instructions before attempting to connect up. external connections...

  • Page 23: Start-Up Of The Instrument

    111 Installation Manual 6. Start-up of the Instrument 6.1 Instrument with ISE unit 6.1.1 Instrument placement & preparation: Follow all steps of procedure 6.2.1 below (see Instrument without ISE Unit) Connect the ISE power supply cable into an appropriate AC wall socket.
  • Page 24 111 Installation Manual Notice: There will be no Applications which will be ready to install. All wanted Applications must be imported first (via BTS or USB Stick) to be ready to install them. With Software Version 3.0 and higher the database will be delivered empty. The only to Profiles which will be available are ISE-I and ISE –U.
  • Page 25 Any factory-set calibration data found on the instrument may be outdated and therefore cause wrong results! Cross-check the calibration results and the application producing correct results by running qualified control material. Refer Warning to the cobas c 111 Operator’s Manual for more handling information. 04906900001 Version 3.0 Page 25 of 43...

  • Page 26: Instrument Without Ise Unit

    111 Installation Manual 6.2 Instrument without ISE unit 6.2.1 Instrument placement & preparation: Place the instrument in a suitable position for operation (refer to location and environmental conditions above). Unpack all accessory components like Water and Waste Reservoir, Reagent Disk, Barcode Scanner, Printer paper, etc.

  • Page 27: Starting The Instrument

    111 Installation Manual cobas c 111 external connections 13. Plug one end of the power connector cable into the power socket at the rear of the instrument and the other end into an appropriate AC wall socket. 6.2.2 Starting the instrument...
  • Page 28 Any factory-set calibration data found on the instrument may be outdated and therefore cause wrong results! Cross-check the calibration results and the application producing correct results by running qualified control material. Refer Warning to the cobas c 111 Operator’s Manual for more handling information. 04906900001 Version 3.0 Page 28 of 43...

  • Page 29: Single Ise Unit

    111 Installation Manual 6.3 Single ISE unit 6.3.1 Attaching the ISE unit to the base instrument (if applicable) Unpack the ISE unit and preposition all ISE accessory parts, like Electrodes, Calibrator indirect, Reference solution and Solution 1-2. Remove left and right side panel of the base instrument.
  • Page 30 111 Installation Manual ISE Module fixation screws Connect the flat ribbon cable to the PCB ISE Controller J2. Flat ribbon cable connection 10. Remove the power box guard plate. Power box guard plate fixation 04906900001 Version 3.0 Page 30 of 43...
  • Page 31 111 Installation Manual 11. Connect the ground strap using the provided screw and serrated lock washer. ISE ground strap fixation 12. Connect the waste tube to the corresponding plug. ISE waste connection 04906900001 Version 3.0 Page 31 of 43...
  • Page 32 111 Installation Manual 13. Connect the low voltage end cable to the connector of the PCB ISE Control. Then fix the cable with the pull relief. ISE power supply 14. Mount the power box guard plate back into place.
  • Page 33 111 Installation Manual Notice: Take care not to squeeze the waste tube at any position! 19. Mount the tube from the ISE tower overflow adaptor to the rear connector of the internal waste tank. Connection of overflow adaptor to waste tank 20.

  • Page 34: Running The Analyzer And Everyday Tasks

    111 Installation Manual 7. Running the analyzer and everyday tasks Refer to the cobas c 111 Operator’s Manual to see what tasks you must do each day before running tests and for information on day-to-day running of the analyzer.

  • Page 35: Packing Procedure For Instrument With Ise

    111 Installation Manual 9.3 Packing procedure for instrument with ISE: Notice: Use only the original packing pieces to prevent any damage of the instrument. Notice: The packing instructions are also shown on a label outside of the box Packing instruction Start with preparing the palette.
  • Page 36 111 Installation Manual Lift the cobas c 111 instrument and place it into the cellular material Caution: The instrument weighs around 38 kg (~80 lbs.) Palette with C111 instrument Apply the protection plastic foil and the plastic bag over the transfer head...
  • Page 37 111 Installation Manual Impose on the surrounding carton. Packed in surrounding carton Put on the cardboard cover. Applied Cardboard cover Cardboard cover Make sure to have the transfer head protection correctly mounted Transfer head protection 04906900001 Version 3.0...
  • Page 38 111 Installation Manual Pack the accessories in the box as shown and the fluid rack incl. remaining fluid bottles into the other box. Accessoires box Bottle rack Accessoires Packed accessories + fluid rack boxes If the TIP-N-TELL indicator applied on the cardboard cover (iniside box) and outside are still ok, leave them, otherwise cancel the corresponding one with a pen (??).

  • Page 39: Packing Procedure For Instrument Without Ise

    Packing instruction Start with preparing the palette. Empty palette Lift the cobas c 111 instrument and place it into the cellular material Caution: The instrument weighs around 35 kg (~75 lbs.) and mount the protection foil. Palette with C111 instrument and protection foil 04906900001 Version 3.0...
  • Page 40 111 Installation Manual Apply the protection plastic foil and the plastic bag over the transfer head. Set up the left and right protection pieces (just turn the one on the left side by 180 degrees) Instrument with protection plastic pieces Impose on the surrounding carton.
  • Page 41 111 Installation Manual Pack the accessories in the box as shown and the fluid rack incl. remaining fluid bottles into the other box. Accessoires box Bottle rack Accessoires Packed accessories + fluid rack boxes If the TIP-N-TELL applied on the cardboard cover (inside box) and outside are still ok, leave them, otherwise cancel the corresponding one with a pen.

  • Page 42: Disposal Of The Instrument

    111 Installation Manual 10. Disposal of the instrument If the instrument is to be scrapped then all parts maybe disassembled according to the procedures in the service manual to allow separate disposal of differing materials according to local regulations.

  • Page 43: Installation Report Cobas C 111

    111 Installation Manual 12. Installation Report cobas c 111 Instrument Serial No. Installation Date: Country: City: Responsible FSE: Main Power Supply Voltage: Frequency: Subject: Not OK. OK. Comments: Package Accessories Chassis / Housing Robotic Transfer Fluid / Pipetting...

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