HeartWare HVAD Pump - Default Chapter; Table of Contents

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
®
PumpOverviewIntroduction
Table of Contents
1.0 Introduction .............................................................................................................................................................. 1
1.1 Introduction ........................................................................................................................... 2
1.2 Indications for Use ................................................................................................................. 2
1.3 Contraindications ................................................................................................................. 2
1.4 Warnings ......................................................................................................................... 3
1.5 Precautions .................................................................................................................... 7
1.6 Potential Complications ..................................................................................................... 10
1.7 Pivotal US Clinical Study: Bridge-to-Transplant ................................................................ 11
1.8 US Clinical Study: Destination Therapy ............................................................................. 20
1.9 Destination Therapy Supplemental Study ........................................................................ 38
2.0 HeartWare
™
HVAD
™
System Overview .................................................................................................... 51
2.1 HVAD
®
Pump and Surgical Tools ....................................................................................... 51
2.2 HVAD
®
Controller ................................................................................................................ 52
2.3 HeartWare
®
Monitor ............................................................................................................ 53
2.4 HVAD
®
Controller Power Sources ...................................................................................... 53
2.5 HeartWare
®
Battery Charger ............................................................................................. 54
2.6 Carrying Cases and Shower Bag ...................................................................................... 54
3.0 HeartWare
™
HVAD
™
System Pump ...........................................................................................................57
3.1 Principles of Operation ....................................................................................................... 57
3.2 Physiologic Control Algorithms .......................................................................................... 59
3.2.1 Flow Estimation .......................................................................................................... 59
3.2.2 [Ventricular Suction Detection] Alarm ................................................................... 60
3.3 HVAD
®
Pump Operating Guidelines ................................................................................. 63
3.4 Expected Useful Life of the HVAD
®
Pump ........................................................................ 63
3.5 Device Tracking and Reporting Requirements ............................................................... 63
4.0 HeartWare
™
HVAD
™
System Peripherals and Accessories ...................................................... 65
4.1 HVAD
®
Controller Connections ....................................................................................... 65
4.2 HVAD
®
Controller ............................................................................................................... 69
4.3 Using the HeartWare
®
Batteries ....................................................................................... 73
4.4 Using the HeartWare
®
Battery Charger .......................................................................... 79
4.5 Using the HVAD
®
Controller AC Adapter or DC Adapter ............................................. 82
4.6 Carrying Cases .................................................................................................................. 83
4.7 Recommended Equipment for Use at Home ................................................................ 84
Table of Contents