HeartWare REF1510 Ventricular System Manuals

Manuals and User Guides for HeartWare REF1510 Ventricular System. We have 1 HeartWare REF1510 Ventricular System manual available for free PDF download: Instructions For Use Manual

HeartWare REF1510 Instructions For Use Manual (158 pages)

HVAD System

Brand: HeartWare | Category: Health Care Products | Size: 13 MB

Table of Contents
3
1 Introduction

5
- Introduction
  
  6
  - Indications for Use
    6
- Contraindications
  
  6
  - Warnings
    7
- Precautions
  
  11
- Potential Complications
  
  14
- Pivotal US Clinical Study: Bridge-To-Transplant
  
  15
- US Clinical Study: Destination Therapy
  
  24
- Destination Therapy Supplemental Study
  
  42
2 Heartware HVAD ™ System Overview

55
- HVAD Pump and Surgical Tools
  55
- HVAD ® Controller
  56
- Heartware ® Monitor
  
  57
  - HVAD ® Controller Power Sources
    57
- Heartware Battery Charger
  
  58
- Carrying Cases and Shower Bag
  
  58
3 Heartware™ HVAD™ System Pump

61
4 Heartware™ HVAD™ System Peripherals and Accessories

69
- HVAD ® Controller Connections
  69
- HVAD ® Controller
  73
- Using the Heartware ® Batteries
  77
- 5 Using the Heartware® Monitor
  
  89
  - General Overview
    89
  - Informational Screens
    91
  - System Screens
    93
  - Downloading Controller Log Files
    104
  - Updating Software on the HVAD ® Controller
    105
    
    Heartware ® Monitor Care
    109
    
    Monitor Shutdown
    109
- 6 Surgical Implant and Explant of the HVAD ® Pump
  
  111
  - Preparing for Implantation
    111
  - Programming HVAD ® Controllers
    113
    
    HVAD ® Pump Pre-Implant Test and Pump Assembly
    115
  - Surgical Implant Procedure
    119
    
    HVAD ® Pump Explant
    125
- 7 Patient Management and Education
  
  127
  - Postoperative Management
    127
    
    Setting Speed with HVAD ® Pump
    128
    
    Anticoagulation
    129
    
    Blood Pressure Maintenance
    129
    
    Arrhythmias
    130
    
    Infection Control Guidelines
    130
    
    Right Heart Failure
    130
  - Driveline Care
    131
  - Emergency Management
    132
  - Physical Rehabilitation
    132
  - Patient Education
    132
- 8 Heartware HVAD System Alarms and Emergencies
  
  133
  - Alarm Overview
    133
  - High Priority Alarms
    134
  - Medium Priority Alarms
    136
  - Low Priority Alarms
    138
  - Multiple Alarms
    139
    
    How to Silence (Mute) Alarms
    140
  - How to Change the Controller
    141
- 9 Quick Reference Guide for Alarms
  
  145
10 Appendix

149
- Appendix A System Components
  
  149
Appendix B Product Specifications

150
- Appendix C EMC Manual Requirements Guidance Document
  
  152
Appendix D Symbol Definitions

156

HeartWare Categories

Medical Equipment Health Care Products

More HeartWare Manuals

HeartWare REF1510 Ventricular System Manuals

HeartWare REF1510 Instructions For Use Manual (158 pages)

Table of Contents

1 Introduction

Introduction

Contraindications

Precautions

Potential Complications

Pivotal US Clinical Study: Bridge-To-Transplant

US Clinical Study: Destination Therapy

Destination Therapy Supplemental Study

2 Heartware HVAD ™ System Overview

Heartware ® Monitor

Heartware Battery Charger

Carrying Cases and Shower Bag

3 Heartware™ HVAD™ System Pump

Principles of Operation

Expected Useful Life of the HVAD ® Pump

Device Tracking and Reporting Requirements

4 Heartware™ HVAD™ System Peripherals and Accessories

5 Using the Heartware® Monitor

6 Surgical Implant and Explant of the HVAD ® Pump

7 Patient Management and Education

8 Heartware HVAD System Alarms and Emergencies

9 Quick Reference Guide for Alarms

10 Appendix

Appendix A System Components

Appendix B Product Specifications

Appendix C EMC Manual Requirements Guidance Document

Appendix D Symbol Definitions

Related Products

HeartWare Categories