ABIOMED

Circulatory Support Systems

Impella 2.5 Instructions for Use and Clinical Reference Manual Rev C Aug 2016

Instructions for Use and Clinical Reference Manual

168 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... Inserting the Impella® Catheter (Wired Insertion)... 5...  Wireless Insertion of the Impella® 2... Catheter... 5...  Positioning and Starting the Impella® Catheter... 5...  Modes of Operation...  Use of the Repositioning Sheath and the Peel-Away Introducer... 5...  Transfer to Standard Configuration... 5...  Purge Cassette Procedures...  5...  Troubleshooting the Purge System...  5...  Patient Weaning...  5...  Removing the Impella® Catheter...  5...  6 CLINICAL EXPERIENCE Clinical Experience Overview... 6... PROTECT I Clinical Study ... 6... PROTECT II Pivotal Clinical Study Design...  6... Accountability of PROTECT II Cohort...  6... Limitations of Interpretation of Study Results... 6... Study Population Demographics and Baseline Characteristics... Procedural Characteristics... Safety and Effectiveness Results...  6...  Secondary Safety Results... 6...  Secondary Effectiveness Results...  Summary of Supplemental Clinical Information... 6...   7 PATIENT MANAGEMENT TOPICS Patient Selection and the Heart Team... Patient Management Overview... 7... General Patient Care Considerations ... 7... Transport Within the Hospital... Right Heart Failure...  7... ECG Interference...  7... Latex...  7... 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...  7...  Enabling Purge Flow Notifications...  Disabling Audio for Placement Signal Lumen Blocked Alarm...  7...  Disabling Audio for SUCTION ALARM...  Disabling Audio for placement signal not reliable alarm...  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... Slave Monitor Connection...  Alarm Delay Information...  9...  Patient Environment...  White Connector Cable... 9...  Impella® Catheter Parameters...  Impella® 2... Catheter Dimensions...  Cleaning...  9...  Storing the Automated Impella® Controller... 9...  Returning an Impella® Catheter to Abiomed (United States)...  9...  APPENDICES Appendix A: Appendix B: Appendix C: Appendix D:  Impella® System Limited Service Warranty (United States)...  A... Abiomed-Approved Guidewires and Introducers...  B... Automated Impella® Controller Menu Structure... Axillary Insertion Technique...
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