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... I 1 Warnings and Cautions Warnings... 1.1 Cautions... 1.2 2 Indications, Contraindications, and Potential Adverse Events Indications (United States)... 2.1 Contraindications (United States)... 2.1 Potential Adverse Events (United States)... 2.1 3 The Impella® 2.5 System Overview... 3.1 Impella® 2.5 Catheter... 3.4 Impella® Console... 3.6 Impella® Power Supply and Power Supply Cable... 3.6 Purge System... 3.8 Quick Set-up Kit... 3.10 Introducer Kit... 3.10 Additional Impella® 2.5 Catheter Components... 3.11 4 Using the Impella® Console Overview... 4.1 Impella® Console Function Keys... 4.2 Impella® Console Connections... 4.4 Impella® Console Display... 4.5 Selecting Performance Level... 4.6 Positioning Aids and Other Displays... 4.7 Mobile Operation... 4.11 5 Using the Impella® 2.5 System Startup... 5.1 Preparing the Impella® 2.5 System... 5.3 Inserting the Impella® 2.5 Catheter... 5.10 Positioning and Starting the Impella® 2.5 Catheter... 5.14 Use of the Repositioning Sheath and the 13 Fr Peel-Away Introducer... 5.15 Transferring from Quick Set-up to Standard Configuration... 5.16 Replacing the Purge Tubing... 5.17 Purge System Troubleshooting... 5.19 Patient Weaning... 5.24  6 Patient Management Topics Patient Management Overview... 6.1 General Patient Care Considerations . ... 6.1 Transport Within the Hospital... 6.2 Right Heart Failure... 6.2 ECG Interference... 6.3 Latex... 6.3 Positioning and Placement Devices... 6.3 Use of Echocardiography for Positioning of the Impella® 2.5 Catheter... 6.4 Understanding and Managing Impella® 2.5 Catheter Position Alarms... 6.11 Suction... 6.17 Hemolysis... 6.17 Maintaining the Placement Signal... 6.19 Operating the Impella® 2.5 Catheter Without Heparin in the Purge Solution... 6.20 How to Change to A Backup Console... 6.21 7 I mpella® Console Alarms and Warnings Impella® 2.5 Console Alarms... 7.1 Impella® 2.5 Console Warnings... 7.3 8 General System Information Terminology, Abbreviations, and Symbols... 8.1 Ambient Conditions... 8.3 Impella® 2.5 Catheter Parameters... 8.3 Impella® Console and Power Supply Parameters... 8.4 Connector Cable Parameters... 8.4 Impella® 2.5 Catheter Dimensions... 8.5 Anatomic Considerations... 8.6 Cleaning... 8.6 Storing the Impella® Console and the Power Supply... 8.7 Returning an Impella® 2.5 Catheter to Abiomed (United States)... 8.7 Appendices Appendix A: Impella® System Limited Service Warranty (United States)... A.1 Appendix B: Technical Safety Inspections, Maintenance, and Repair... B.1 Appendix C: Abiomed-approved Guidewires and Introducers... C.1 Appendix D: Setting Up the Impella® 2.5 Catheter Without the Quick Set-up Kit...D.1 Index
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