HeartWare Ventricular Assist System Instructions For Use Manual page 4

HeartWare
14.0 SURGICAL IMPLANT PROCEDURE ................................................................................ 22
14.1 HeartWare
14.2 HVAD
14.3 Outflow Graft Attachment ................................................................................................ 25
14.4 Pump Implantation Preparation ........................................................................................ 25
14.5 Left Ventricle (LV) Apex Cannulation .................................................................................. 25
14.6 Outflow Graft Anastomosis ............................................................................................... 26
14.7 Driveline Placement .......................................................................................................... 26
14.8 De-Airing Procedure ......................................................................................................... 27
14.9 Programming the Back-Up Controller to Match the Primary Controller ............................... 27
15.0 HVAD
15.1 At Transplant .................................................................................................................... 27
15.2 Myocardial Recovery/Pump Exchange................................................................................ 27
16.0 PATIENT MANAGEMENT .............................................................................................. 28
16.1 Postoperative Management .............................................................................................. 28
16.2 Emergency Management .................................................................................................. 28
16.3 Anticoagulation ................................................................................................................ 28
16.4 Infection Control Guidelines.............................................................................................. 28
16.5 Driveline Care................................................................................................................... 29
16.6 Arrhythmias ...................................................................................................................... 29
16.7 Right Heart Failure............................................................................................................ 29
16.8 Blood Pressure Maintenance ............................................................................................. 29
16.9 Physical Rehabilitation ...................................................................................................... 29
16.10 Patient Education ........................................................................................................... 29
16.11 External Accessories ....................................................................................................... 30
16.12 Recommended Equipment for Use at Home .................................................................... 30
16.13 Electrostatic Discharge (ESD). .......................................................................................... 30
17.0 EQUIPMENT INSPECTION, CLEANING AND MAINTENANCE ......................................... 31
17.1 General Care .................................................................................................................... 31
17.2 Controller ......................................................................................................................... 31
17.3 Batteries .......................................................................................................................... 31
17.4 Battery Charger ................................................................................................................ 31
17.5 HeartWare
17.6 Expected Useful Life of HeartWare
17.7 Product Disposal .............................................................................................................. 32
Appendix A: Quick Reference Guide for Alarms ................................................................................. 32
Appendix B: System Components ..................................................................................................... 34
Appendix C: Product Specifications................................................................................................... 34
Appendix D: EMC Manual Requirements Guidance Document .......................................................... 35
Appendix E: Symbol Definitions ........................................................................................................ 37
Ventricular Assist System Setup ...................................................................... 23
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Pump Pre-Implant Test .......................................................................................... 24
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PUMP EXPLANT ................................................................................................. 27
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16.11.1 Patient Pack .......................................................................................................... 30
16.11.2 HeartWare Shower Bag ........................................................................................ 30
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Monitor ......................................................................................................... 31
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System Components .................................................. 32
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