Cianna Medical SCOUT Check Operation Manual
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Cianna Medical SCOUT Check Operation Manual

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SCOUT® Check Console
Operation Manual

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Summary of Contents for Cianna Medical SCOUT Check

  • Page 1 SCOUT® Check Console Operation Manual...
  • Page 2 Copyrights and Trademarks ©2017 Cianna Medical, Inc. All rights reserved. Patents pending. Cianna Medical and SAVI SCOUT are registered trademarks of Cianna Medical, Inc. Manufactured for: Cianna Medical, Inc. 6 Journey, Suite 125 Aliso Viejo, CA 92656 USA Tel: 949.360.0059 URL: www.ciannamedical.com...

  • Page 3: Table Of Contents

    Operating the Console ..........................10 After Surgery ............................10 CLEANING ............................. 11 TROUBLESHOOTING ..........................12 MAINTENANCE AND SERVICE ....................... 13 SYMBOLS .............................. 14 SPECIFICATIONS ............................ 15 EMC Statement............................. 16 Electromagnetic Compliance (EMC) Tables .................... 17 SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 4: Introduction

    Indications for Use SCOUT Check The SCOUT Check system is an accessory to the SAVI SCOUT System. The SAVI SCOUT is intended to be used to confirm the functionality of the SAVI SCOUT Reflector subsequent to percutaneous placement in Radiology.

  • Page 5: Compatible Components

    Compatible Components The following items are required for the proper use of the SCOUT Check Console. Use of other parts and materials not listed below is contraindicated.  SAVI SCOUT Reflector  SCOUT Check Handpiece SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 6: Warnings And Cautions

     Electric Shock Hazard – No modification of this equipment is allowed. Do not remove the cover. Removal of the cover may cause electrical shock. Contact Cianna Medical for service.  Electric Shock Hazard – Do not connect wet accessories to the Console.
  • Page 7 Do not clean the Console with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the unit.  The Console, Handpiece, and the Delivery System of the SCOUT Check System are MR Unsafe and should not be used in the MR environment ...

  • Page 8: Controls, Indicators And Receptacles

    Console produces a signal output in the form of an audible tone that represent the presence of the Reflector. POWER LED SYSTEM READY DETECT MODE Front Panel Start/Stop Button Handpiece receptacle connector Rear Panel Power cord receptacle Fuse Drawer Power on/off switch SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 9: Console Setup And Operation

    Read the instructions, warnings, and cautions provided with the Handpiece and Reflector before using. IMPORTANT The SCOUT Check Console is intended for use by suitably qualified, trained and authorized physicians and/or operating room staff. Cianna Medical Inc. takes no responsibility for the possible misuse or use by inadequately qualified staff.

  • Page 10: Operating The Console

    10. Turn off the Console by pressing the power switch off ( O ). 11. Clean and disinfect the SAVI SCOUT Handpiece per the cleaning procedure provided with the handpiece. 12. Unplug the power cord from the wall outlet. SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 11: Cleaning

    Follow universal, generally accepted practices when handling components that have come in contact with blood or tissue. Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the Console. The Console cannot be sterilized. SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 12: Troubleshooting

    If symptom persists, the Console may require service. Contact Cianna Medical.  Tone during nonuse of Press START/STOP button, put system in SYSTEM READY.  handpiece Move handpiece away from other cables, devices.  Turn the Console off, then on again. SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 13: Maintenance And Service

    MAINTENANCE AND SERVICE The SCOUT Check Console must be serviced by Cianna Medical Inc. To ensure proper performance, the Console should be checked for any signs of damage or wear before each use and storage. This includes the housing, integrity of switches, and power cord. Should abnormalities be discovered by the user, the user should contact Cianna Medical, Inc.

  • Page 14: Symbols

    The following are descriptions for the symbols shown on the rear panel of the Console. Symbol Description Manufacturer of the device Serial number Catalog Number Warning: risk of electric shock. No user serviceable parts inside. General warning See instructions for use Identifies a type BF applied part SCOUT Check Operation Manual 220-0011-B (2017-11)

  • Page 15: Specifications

    Audio volume 70 dB Sound Pressure Level at 1 meter Sound indicator Fixed tone. Visual Indicators LEDs Instrument make / model Cianna Medical Inc. / SCOUT Check Console Dimensions 12 inches width 6 inches height 12 inches depth Weight 6 lbs.

  • Page 16: Emc Statement

    Nevertheless, special precautions need to be observed:  The use of accessories and cables other than those specified by Cianna Medical, may result in increased emission or decreased immunity of the device.  The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.

  • Page 17: Electromagnetic Compliance (Emc) Tables

    Guidance and manufacturer's declaration - electromagnetic emissions The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or user of the SCOUT Check System should assure that it is used in such an environment.
  • Page 18 Guidance and manufacturer's declaration - electromagnetic immunity The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or the user of the SCOUT Check System should assure that it is used in such an environment. Electromagnetic environment...
  • Page 19 The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or the user of the SCOUT Check System should assure that it is used in such an environment. *NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
  • Page 20 The SCOUT CheckSystem is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SCOUT Check System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SCOUT Check System as recommended below, according to the maximum output power of the communications equipment.

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