Boston Scientific AnjioJet Ultra 5000A Operator's Manual
Boston Scientific AnjioJet Ultra 5000A Operator's Manual

Boston Scientific AnjioJet Ultra 5000A Operator's Manual

Thrombectomy system console
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AngioJet
5000A Console
Thrombectomy System Console
Operator's Manual ����������������������������������������3
CV01
Ultra
Black (K) ∆E ≤5.0

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Summary of Contents for Boston Scientific AnjioJet Ultra 5000A

  • Page 1 AngioJet Ultra ™ 5000A Console Thrombectomy System Console Operator’s Manual ����������������������������������������3 CV01 Black (K) ∆E ≤5.0...
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  • Page 3: Table Of Contents

    TABLE OF CONTENTS DEVICE DESCRIPTION����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 4 Contents ..............................................................4 AngioJet™ Ultra 5000A Console (Console or AngioJet Ultra Console) ........................................4 Figure 1. AngioJet Ultra Console .................................................... 4 AngioJet Thrombectomy Set (Thrombectomy Set) ................................................ 5 Figure 2. Thrombectomy Set ....................................................5 INTENDED USE/INDICATIONS FOR USE ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������...
  • Page 4: Device Description

    AngioJet ™ Ultra 5000A Console Bag Hook Control Panel Thrombectomy System Console ONLY Drawer Open/Close Caution: Federal Law (USA) restricts this device to sale by or on the order of a Button physician. The AngioJet Ultra Console is intended for use only in conjunction with an AngioJet Thrombectomy Set.
  • Page 5: Angiojet Thrombectomy Set (Thrombectomy Set)

    Collection Disposal The user should follow local and national regulations for disposal of electronics when disposing of this unit. Contact Boston Scientific Customer Service for product returns. POTENTIAL ADVERSE EFFECTS Refer to the individual Thrombectomy Set Directions for Use manual for specific Figure 2�...
  • Page 6: Using The Angiojet Ultra Console

    Switch Action Required Prime Catheter Install Pump System Ready Contact Connect Saline Boston Scientific Customer Service Figure 3� Provides instructions, procedure status, Heparinize a bag of sterile, room-temperature saline at a suggested rate of Status Panel and alarm resolution strategies.
  • Page 7: Load Pump

    Precaution: When drawer is extended from Console, avoid knocking or leaning on the drawer. This may damage the device. Load Pump Sterile technician: Remove the catheter and sufficient tubing for ease of use from the sterile package and inspect for damage. Hand the tray with the rest of the Thrombectomy Set to the nonsterile technician for installation into the Console (Figure 5).
  • Page 8: Prime The Catheter

    Catheter priming time is determined by the catheter model and is automatically set by the Console. Prime the catheter by completely submerging the tip in heparinized saline and pressing the foot switch (Figures 11 and 12). Figure 9� Reference Only The Console will automatically pull saline into the pump.
  • Page 9: Angiojet System Dismantling

    Precaution: In the event the foot switch is stuck in the “on” position (inadvertent activation), press the POWER button or pull the power cord from the wall outlet to deactivate the system. Contact Boston Scientific Customer Service. AngioJet System Dismantling Follow proper precautions for the handling of infectious waste.
  • Page 10: Maintenance, Troubleshooting And Service

    Figure  19). Turn off the power, then restart before contacting Boston Scientific Non-Ionizing Electromagnetic Radiation Customer Service for further instructions. Make note of each system error title and number to report to Boston Scientific MEDICAL - GENERAL MEDICAL EQUIPMENT AS Customer Service.
  • Page 11: Specifications

    Check Saline Supply Alarm: A recoverable condition occurring when an abnormally ELECTRONIC AND ELECTROMAGNETIC GUIDANCE low pressure has been detected. Replacement of the Thrombectomy Set may Table 1� Guidance and manufacturer’s declaration – electromagnetic emissions be necessary. The AngioJet System is intended for use in the electromagnetic environment specified Collection Bag: The bag which collects the extracted thrombus being removed by the below.
  • Page 12 If degradation of performance is observed, move the equipment away from the high frequency surgical equipment or contact Boston Scientific for assistance. For additional corrective actions, refer to "Maintenance, Troubleshooting and Service" Section. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 13: Warranty

    WARRANTY Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose.
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  • Page 16 Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA Customer Service 888-272-1001 Do not use if package is damaged. Recyclable Package 0086 2019-02 © 2019 Boston Scientific Corporation or its affiliates. All rights reserved. 50779353-01 Black (K) ∆E ≤5.0...

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