ABIOMED

Circulatory Support Systems

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

Instructions for Use and Clinical Reference Manual

118 Pages

TABLE OF CONTENTS INTRODUCTION Introduction...  1 I NDICATIONS, 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 RP® CATHETER AND AUTOMATED IMPELLA® CONTROLLER Overview... 3... Impella RP® Catheter... 3... Automated Impella® Controller... 3... Purge Cassette...  3... Accessories... 3... 4 USING THE AUTOMATED IMPELLA® CONTROLLER Overview... 4... Automated Impella® Controller Features...  4... Automated Impella® Controller Display... 4... Placement Screen... 4... Purge Screen...  4... Infusion History... 4...  Mobile Operation... 4...  5 USING THE AUTOMATED IMPELLA® CONTROLLER WITH THE IMPELLA RP® CATHETER Startup...  5... Case Start... Inserting the Impella RP® Catheter...  5...  Positioning and Starting the Impella RP® Catheter...  5...  Use of the Repositioning Sheath and the 23 Fr Peel-away Introducer... 5...  Performance Levels... 5...  Suction... 5...  Purge Cassette Procedures...  5...  Troubleshooting the Purge System...  5...  Patient Weaning...  5...  Removing the Impella RP® Catheter...  6 C  LINICAL EXPERIENCE Pivotal Clinical Study Design – RECOVER RIGHT...  6... Accountability of Cohort...  6...  7 A  UTOMATED IMPELLA® CONTROLLER ALARMS Alarms Overview...  7... Alarm Message Summary... 7... 8 G  ENERAL SYSTEM INFORMATION Terminology, Abbreviations, and Symbols... Automated Impella® Controller Mechanical Specifications...  8... Automated Impella® Controller Electrical Specifications... Equipment Design... Equipment Classifications... Federal Communications Commission (FCC) Notice... 8... Electromagnetic Compatibility...  8... Transport Between Hospitals... 8...  Transport Within the Hospital...  Slave Monitor Connection...  Alarm Delay Information...  8...  Patient Environment...  White Connector Cable... 8...  Impella RP® Catheter Parameters... 8...  Cleaning...  8...  Storing the Automated Impella® Controller... 8...  Returning an Impella RP® Catheter to Abiomed (United States)...  8...  APPENDICES Appendix A: Automated Impella® Controller Menu Structure...
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