ABIOMED

Circulatory Support Systems

Impella Ventricular Systems Instructions for Use and Clinical Reference Manual Rev C Aug 2016

Instructions for Use and Clinical Reference Manual

215 Pages

TABLE OF CONTENTS Introduction...  1 INDICATIONS, CONTRAINDICATIONS, AND POTENTIAL ADVERSE EVENTS Indications (United States)...  1... Contraindications (United States)... 1... Potential Adverse Events (United States)...  1... 2 WARNINGS AND CAUTIONS Warnings... 2... Cautions...  2... 3 THE IMPELLA® CATHETER AND AUTOMATED IMPELLA® CONTROLLER Overview... 3... Impella® Catheter... Automated Impella® Controller... 3...  Purge Cassette...  3...  Accessories... 3...  4 USING THE AUTOMATED IMPELLA® CONTROLLER Overview... 4... Automated Impella® Controller Features...  4... Home Screen...  4... Placement Screen... 4... Purge Screen...  4...  Infusion History Screen... 4...  Mobile Operation... 4...  5 USING THE AUTOMATED IMPELLA® CONTROLLER WITH THE IMPELLA® CATHETER Pre-support Evaluation... 5... Startup...  5... Case Start... Impella® 2... Catheter Insertion (Wired)...  Wireless Insertion of the Impella® 2... Catheter... 5...  Impella CP® Catheter Insertion... 5...  Axillary Insertion of the Impella® 2...  5...  or Impella CP® Catheter...  Alternate Insertion Technique for the Impella® 5... Catheter...  5...  Implanting and Starting the Impella® LD Catheter...  Positioning and Starting the Impella® 2... and Impella CP® Catheters...  Positioning and Starting the Impella® 5... Catheter... 5...  Positioning and Starting the Impella® LD Catheter...  5...  Purge Cassette Procedures...  5...  Troubleshooting the Purge System...  5...  Patient Weaning...  5...  Removing the Impella® 2...  5...  or Impella CP® Catheter...  Explanting the Impella® LD Catheter...  5...  6 CLINICAL EXPERIENCE Cardiac shock after acute myocardial infarction... summary of primary clinical studies... 6... SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION... Cardiac shock after open heart surgery... 6...  summary of primary clinical studies... 6...  SUMMARY OF SUPPLEMENTAL CLINICAL INFORMATION...  7 PATIENT MANAGEMENT TOPICS Patient Management Overview... 7... General Patient Care Considerations ... 7... Transport Within the Hospital...  Right Heart Failure...  7... ECG Interference...  7... Latex...  7... Use of Echocardiography for Positioning of the Impella® Catheter... Understanding and Managing Impella®Catheter Position Alarms... 7...  Impella Stopped...  Suction... 7...  Hemolysis...  Operating the Impella® Catheter without Heparin in the Purge Solution...  7...  Placement Signal Lumen (for Impella® 2... and Impella CP®)...  7...  Pressure Sensor Drift and Placement Signal Not Reliable (for Impella® 5... and LD)...  7...  Enabling Purge Flow Notifications...  Disabling Audio for Placement Signal Lumen Blocked Alarm (Impella® 2... and Impella CP®)...  7...  Disabling Audio for SUCTION ALARM...  DISABLING AUDIO FOR PLACEMENT SIGNAL NOT RELIABLE ALARM ...  7...  Disabling Audio for PURGE PRESSURE HIGH AND PURGE SYSTEM BLOCKED ALARMS...  7...  Surgical Mode...  Timed Data Recording...  Operating the Impella® Catheter in Electromagnetic Fields... 7...  Transferring from the Automated Impella® Controller to a New Automated Impella® Controller... 7...  Emergency Shutdown Procedure...  7...  8 A  UTOMATED IMPELLA® CONTROLLER ALARMS Alarms Overview...  8... Alarm Message Summary... 8... 9 G  ENERAL SYSTEM INFORMATION Terminology, Abbreviations, and Symbols... Automated Impella® Controller Mechanical Specifications...  9... Automated Impella® Controller Electrical Specifications... Equipment Design... Equipment Classifications... Federal Communications Commission (FCC) Notice... 9... Electromagnetic Compatibility...  9... Transport Between Hospitals... 9... VGA Monitor Connection... 9...  Alarm Delay Information...  9...  Patient Environment...  White Connector Cable... 9...  Impella® Catheter Parameters...  Impella® 2... Catheter Dimensions...  Impella CP® Catheter Dimensions...  Impella® 5... Catheter Dimensions...  9...  Impella® LD Catheter Dimensions... 9...  Cleaning...  9...  Storing the Automated Impella® Controller... 9...  Returning an Impella® Catheter to Abiomed (United States)...  9...  APPENDICES Appendix A: Impella VENTRICULAR SUPPORT SystemS Limited Service Warranty (United States)...  A... Appendix B: Abiomed-Approved Guidewires and Introducers (Impella® 2... and Impella CP®)...  B... Appendix C: Automated Impella® Controller Menu Structure...
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