ABIOMED

Circulatory Support Systems

Impella 2.5 Instructions for Use & Clinical Reference Manual Rev B Sept 2010

Instructions for Use & Clinical Reference Manual

144 Pages

Table of Contents INTRODUCTION Introduction...  1 Warnings and Cautions Warnings... 1... Cautions...  1... 2 Indications, Contraindications, and Potential Adverse Events Indications (United States)...  2... Contraindications (United States)... 2... Potential Adverse Events (United States)...  2... 3 The Impella® 2... Catheter and Impella® Controller Overview... 3... Impella® 2... Catheter... Impella® Controller... 3... Purge Cassette...  3... Accessories... 3... 4 Using the Impella® Controller Overview... 4... Impella® Controller Features...  4... Impella® Controller Home Screen... 4... Selecting Performance Level...  4... Impella® Controller Waveform Screen...  Impella® Controller Infusion Screen... 4...  Mobile Operation... 4...  5 Using the Impella® Controller With the Impella® 2... Catheter Startup...  5... Case Start... Inserting the Impella® 2... Catheter... 5...  Positioning and Starting the Impella® 2... Catheter... 5...  Use of the Repositioning Sheath and the 13 Fr Peel-Away Introducer... 5...  Transfer to Standard Configuration... 5...  Purge Cassette Procedures...  5...  Troubleshooting the Purge System...  5...  Patient Weaning...  5...  6 Patient Management Topics Patient Management Overview... 6... General Patient Care Considerations...  6... Transport Within the Hospital... Transport Between Hospitals... 6... Right Heart Failure...  6... ECG Interference...  6... Latex...  6... Use of Echocardiography for Positioning of the Impella® 2... Catheter... Understanding and Managing Impella® 2... Catheter Position Alarms...  Suction... 6...  Hemolysis...  Operating the Impella® 2... Catheter without Heparin in the Purge Solution...  6...  Repositioning Guide...  Placement Signal Lumen...  6...  Data Snap Shot Recording...  Infusion History... 6...  How to Change to a Backup Controller... 6...  Emergency Shutdown Procedure...  6...   7 I mpella® Controller Alarms Alarms Overview...  7... Alarm Message Summary... 7... 8 General System Information Terminology, Abbreviations, and Symbols... Impella® Controller Mechanical Specifications...  8... Impella® Controller Electrical Specifications... Equipment Design... Equipment Classifications... Federal Communications Commission (FCC) Notice... 8... Electromagnetic Compatibility...  8... Alarm Delay Information...  8... Patient Environment... White Connector Cable... 8...  Impella® 2... Catheter Parameters...  Impella® 2... Catheter Dimensions...  Anatomic Considerations... 8...  Cleaning...  8...  Storing the Impella® Controller... 8...  Returning an Impella® 2... Catheter to Abiomed (United States)...  Appendices Appendix A: Appendix B: Appendix C: Appendix D:  Impella® System Limited Service Warranty (United States)...  A... Technical Safety Inspections, Maintenance, and Repair... B... Abiomed-Approved Guidewires and Introducers...  C... Impella® Controller Menu Structure...
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