Medrad AngioJet Ultra Operation Manual
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Medrad AngioJet Ultra Operation Manual

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Summary of Contents for Medrad AngioJet Ultra

  • Page 1 System Console Operations Manual...

  • Page 2: Table Of Contents

    CONSOLE OPERATIONS MANUAL TABLE OF CONTENTS 1. DEVICE DESCRIPTION ..........2 The Console The Thrombectomy Set 2.

  • Page 3: The Console

    CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician. 1. DEVICE This manual provides instructions for operating the AngioJet® Ultra Thrombectomy System, with specific focus on the AngioJet Ultra Console. DESCRIPTION The AngioJet Ultra System consists of the following components: A.

  • Page 4: The Thrombectomy Set

    The waste tubing transports the thrombus debris from the catheter to the collection bag for ultimate disposal. The Console is intended for use only in conjunction with an AngioJet Ultra 2. INDICATIONS AND USAGE Thrombectomy Set. Refer to the individual Thrombectomy Set Information for Use manual for specific clinical applications.

  • Page 5: Adverse Events

    • The Console contains no user-serviceable parts. Refer service to qualified personnel. • Removal of outer covers may result in electrical shock. • This device may cause electromagnetic interference with other devices when in use. Do not place Console near sensitive equipment when operating.

  • Page 6: Console Specifications

    220/240V, 6.3A, 250V, 5X20 mm Time lag NOTE: Replace fuse with the type and rating specified. Failure to do so may result in device damage or risk of fire. The AngioJet Ultra Console is compliant with EN60601-1, UL60601-1, and CAN/CSA-C22.2 No. 601-1-M90.

  • Page 7: Clinician Use Information

    Icons: Display the progress of set-up and operation steps and also indicate when an alarm or Ultra System error has occurred. -Please Wait. -Install Pump. -Connect Saline. -Prime Catheter. -Ultra System Ready. -Contact MEDRAD Technical Support.

  • Page 8: Prepare Console

    Status Panel: Provides instructions, procedure status, and alarm resolution strategies. Power Button: Press to activate the control panel. Alarm Reset Button: Press to clear or override an alarm. Catheter Button: Displays catheter model installed in the AngioJet Ultra Console. Press this button to see a 3-second display of catheter model.

  • Page 9: Load Pump

    All indicators on the control panel will illuminate. The status panel will display ANGIOJET ULTRA while the Console performs a self-test. The drawer will open, indicating a successful self- test. The status panel will display the next step (Figure 5).

  • Page 10: Prime The Catheter

    The Console will load the pump and process information from a bar code located on the pump. After the Console successfully identifies the catheter, the status panel will display the model of catheter in use (Figure 9). The Console will automatically prime the pump. Place the foot pedal within easy access of the physician.
  • Page 11 Status panel displays READY and green icon is illuminated (Figure 14). The AngioJet Ultra System is now ready to use. During operation, the infused volume will be displayed on the status panel, the green icon remains lit, and the time display will keep track of the total time that the foot pedal is activated.

  • Page 12: Ultra System Dismantling

    7.4 Ultra System Follow proper precautions for the handling of infectious waste. Reuse of Thrombectomy Set is prohibited due to risk of contamination by blood Dismantling waste products. After use, disassemble the components as follows: Push the drawer button to open the drawer. Carefully remove Thrombectomy Set from Console.

  • Page 13: Alarms And Error Messages

    7.6 Ultra System Errors A system failure will result in a system error (wrench icon lights red, shown in Figure 18). Turn off the power, then restart before contacting MEDRAD Technical Service for further instructions. It is helpful to make a note of each system error title and number to report to MEDRAD Technical Service.

  • Page 14: Glossary

    7.8 Glossary Alarm: A recoverable or nonrecoverable fault occurring when one of the Ultra System safety sensors responds to abnormal operation of a component. Waste Tubing: The tubing which is inserted in the roller pump and transports the extracted thrombus from the effluent tubing to the collection bag. Collection Bag: The bag which collects the extracted thrombus being removed by the Catheter.

  • Page 15: Symbols

    7.9 Symbols Symbol Description (one or more of these symbols may appear on the Console) ON (power: connection to mains) OFF (power: disconnection to mains) Standby Eject (Open/close drawer) Consult Instructions For Use See Warnings and Precautions Defibrillator proof type CF equipment IPX 1 Protection against dripping water IPX 8...
  • Page 16 Warranty, if applicable. MEDRAD and AngioJet are federally registered trademarks and MEDRAD Interventional is a trademark of MEDRAD, INC. The AngioJet Ultra System includes several catheter models, which are variously marketed for thrombectomy of AV access conduits, peripheral arteries and veins, coronary arteries, and/or saphenous vein grafts.

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