HVAD® Instructions for Use
10
9
8
7
6
5
4
3
2
1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
5.0 Using the HeartWare
®
Monitor ................................................................................................................ 85
5.1 General Overview .............................................................................................................. 85
5.2 Informational Screens ......................................................................................................... 87
5.3 System Screens .................................................................................................................... 89
5.4 Downloading Controller Log Files ................................................................................... 100
5.5 Updating Software on the HVAD
®
Controller ................................................................ 101
5.6 Monitor Shutdown ............................................................................................................. 105
5.7 HeartWare
®
Monitor Care ................................................................................................ 105
6.0 Surgical Implant and Explant of the HVAD
®
Pump ..................................................................... 107
6.1 Preparing for Implantation ............................................................................................... 107
6.2 Programming HVAD
®
Controllers .................................................................................... 109
6.3 HVAD
®
Pump Pre-Implant Test and Pump Assembly ................................................... 111
6.4 Surgical Implant Procedure ............................................................................................. 115
6.5 HVAD
®
Pump Explant........................................................................................................ 121
7.0 Patient Management and Education ..................................................................................................123
7.1 Postoperative Management ........................................................................................... 123
7.1.1 Setting Speed with HVAD
®
Pump .......................................................................... 124
7.1.2 Blood Pressure Maintenance ................................................................................. 125
7.1.3 Anticoagulation ...................................................................................................... 125
7.1.4 Right Heart Failure ................................................................................................... 126
7.1.5 Arrhythmias .............................................................................................................. 126
7.1.6 Infection Control Guidelines .................................................................................. 126
7.2 Driveline Care .................................................................................................................... 127
7.3 Emergency Management ............................................................................................... 128
7.4 Physical Rehabilitation .................................................................................................... 128
7.5 Patient Education ............................................................................................................. 128
8.0 HeartWare
™
HVAD
™
System Alarms and Emergencies.............................................................129
8.1 Alarm Overview ................................................................................................................ 129
8.2 High Priority Alarms ............................................................................................................ 130
8.3 Medium Priority Alarms ..................................................................................................... 132
8.4 Low Priority Alarms ............................................................................................................ 134
8.5 Multiple Alarms .................................................................................................................. 135
8.6 How to Silence (Mute) Alarms ......................................................................................... 136
8.7 How to Change the Controller ........................................................................................ 137
9.0 Quick Reference Guide for Alarms .........................................................................................................141
10.0 Appendix .................................................................................................................................................................145
Appendix A System Components ............................................................................................ 145
Appendix B ........................................................................................ 146
Appendix C EMC Manual Requirements Guidance Document ......................................... 148
Appendix D ............................................................................................... 152