Boston Scientific AngioJet Ultra 5000A Operator's Manual

Boston Scientific AngioJet Ultra 5000A Operator's Manual

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AngioJet
Ultra 5000A Console
Operator's Manual
Directions for Use
Instrucciones de uso
Mode d'emploi
Gebrauchsanweisung
Istruzioni per l'uso
Gebruiksaanwijzing
Instruções de Utilização
Brugsanvisning
Οδηγίες χρήσης
Instruções de uso
Bruksanvisning
Használati útmutató
Návod k použití
Sposób użycia
Bruksanvisning
사용 지침
Kullanma Talimatları
Käyttöohjeet
Instrucțiuni de utilizare
Руководство по применению
Návod na použitie
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Summary of Contents for Boston Scientific AngioJet Ultra 5000A

  • Page 1 AngioJet Ultra 5000A Console ™ Operator’s Manual Directions for Use Instrucciones de uso Mode d’emploi Gebrauchsanweisung Istruzioni per l’uso Gebruiksaanwijzing Instruções de Utilização Brugsanvisning Οδηγίες χρήσης Instruções de uso Bruksanvisning Használati útmutató Návod k použití Sposób użycia Bruksanvisning 사용 지침 Kullanma Talimatları...
  • Page 2 Black (K) ∆E ≤5.0...
  • Page 3: Table Of Contents

    Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions ..................11 Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity ..................12 Table 3. Recommended separation distances between portable and mobile RF communications equipment and the AngioJet Ultra 5000A Console ..13 Black (K) ∆E ≤5.0...
  • Page 4: Device Description

    Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use manual for specific clinical applications. DEVICE DESCRIPTION This manual provides instructions for operating the AngioJet™ Ultra System, with specific focus on the AngioJet Ultra 5000A Console. Roller Pump The AngioJet Ultra System consists of the following components: Pump Drawer The AngioJet Ultra 5000A Console (Console) The Console is a multiple-use device that controls the Thrombectomy Set.
  • Page 5: The Angiojet™ Ultra Thrombectomy Set (Thrombectomy Set - Several Models Available)

    • Portable and mobile radio frequency (RF) communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. • The use of accessories and cables other than those specified, with the exception of accessories and cables sold by Boston Scientific as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Ultra 5000A Console. • MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding...
  • Page 6: Using The Angiojet™ Ultra System

    USING THE ANGIOJET™ ULTRA SYSTEM Note: You cannot use the COUNTER RESET Button to override the time needed for priming the catheter. Time Display Counter Reset Button Clinician Use Information A thorough understanding of the Ultra System components is required for proper operation.
  • Page 7: Load Pump

    Load Pump 4. Push the drawer button to close the Console drawer (Figure 7). 1. 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: Ultra System Dismantling

    1. Prime the catheter by completely submerging the tip in heparinized saline and Ultra System Dismantling pressing the foot switch (Figures 10 and 11). Follow proper precautions for the handling of infectious waste. Reuse of Thrombectomy Set is prohibited due to risk of contamination by blood waste products. After use, disassemble the components as follows: 1.
  • Page 9: Angiojet Ultra 5000A Console Symbol Translation Key

    Warranty, if applicable, for information on servicing the AngioJet Ultra 5000A Turkey Local Contact Console. Boston Scientific recommends annual inspection and calibration. There are no user serviceable parts inside the Console. The Console cabinet panels Do not use if package should only be opened by trained service personnel.
  • Page 10: Ultra System Errors

    A system failure will result in a system error (wrench icon lights red, shown in any abnormality is detected. Figure  17). Turn off the power, then restart before contacting Boston Scientific Total Infused Volume: The numerical display on the control panel which displays the Customer Service for further instructions.
  • Page 11: Specifications

    The AngioJet Ultra 5000A Console is intended for use in the electromagnetic Frequency requirements 50/60 Hz environment specified below. The customer or the user of the AngioJet Ultra 5000A Power requirements 900VA Console should assure that it is used in such an environment.
  • Page 12 (IEC 61000-4-8) Portable and mobile RF communications equipment should be used no closer to any part of the AngioJet Ultra 5000A Console, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 13 Table 3. Recommended separation distances between portable and mobile RF communications equipment and the AngioJet™ Ultra 5000A Console The AngioJet Ultra 5000A Console is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or...
  • Page 14 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 2015-04 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. 91024738-01 Black (K) ∆E ≤5.0...

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