ABIOMED

Circulatory Support Systems

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

Instructions for Use & Clinical Reference Manual

136 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... System Overview... 3... Impella® 2... Catheter... Impella® Console... 3... Impella® Power Supply and Power Supply Cable...  3... Purge System... 3... Quick Set-up Kit...  Introducer Kit... 3...  Additional Impella® 2... Catheter Components...  3...  4 Using the Impella® Console Overview... 4... Impella® Console Function Keys... Impella® Console Connections...  4... Impella® Console Display... 4... Selecting Performance Level...  4... Positioning Aids and Other Displays... Mobile Operation... 4...  5 Using the Impella® 2... System Startup...  5... Preparing the Impella® 2... System...  5... 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...  Transferring from Quick Set-up to Standard Configuration...  5...  Replacing the Purge Tubing... 5...  Purge System Troubleshooting...  5...  Patient Weaning...  5...   6 Patient Management Topics Patient Management Overview... 6... General Patient Care Considerations...  6... Transport Within the Hospital... Right Heart Failure...  6... ECG Interference...  6... Latex...  6... Positioning and Placement Devices... 6... Use of Echocardiography for Positioning of the Impella® 2... Catheter... Understanding and Managing Impella® 2... Catheter Position Alarms...  Suction... 6...  Hemolysis...  Maintaining the Placement Signal...  Operating the Impella® 2... Catheter Without Heparin in the Purge Solution...  6...  How to Change to A Backup Console... 6...  7 I mpella® Console Alarms and Warnings Impella® 2... Console Alarms...  7... Impella® 2... Console Warnings... 7... 8 General System Information Terminology, Abbreviations, and Symbols... Ambient Conditions... Impella® 2... Catheter Parameters... Impella® Console and Power Supply Parameters...  8... Connector Cable Parameters...  8... Impella® 2... Catheter Dimensions... Anatomic Considerations... 8... Cleaning...  8... Storing the Impella® Console and the Power Supply... Returning an Impella® 2... Catheter to Abiomed (United States)... Appendices Appendix A: Impella® System Limited Service Warranty (United States)...  A... Appendix B: Technical Safety Inspections, Maintenance, and Repair... B... Appendix C: Abiomed-approved Guidewires and Introducers... Appendix D: Setting Up the Impella® 2... Catheter Without the Quick Set-up Kit... Index
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File Name: impella_2-5_instructions_for_use___clinical_referen.pdf

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