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HeartWare Ventricular Assist System - User Manual

HeartWare Ventricular Assist System
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HeartWare
®
Ventricular Assist System
Instructions For Use

Table of Contents

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Summary

3.0 Warnings

4.0 Precautions

5.0 Potential Complications

6.0 System Components Overview

7.0 Principles of Operation

8.0 Using the HeartWare Monitor

9.0 Using the HeartWare Controller

9.3 How to Change the Controller

Step-by-step guide for replacing the controller in case of malfunction.

10.0 Using the HeartWare Batteries

10.1 Changing a Battery

Procedure for disconnecting a depleted battery and connecting a charged one.

11.0 Using the HeartWare Battery Charger

12.0 Using the HeartWare Controller AC Adapter or DC Adapter

13.0 Alarms

13.1 High Alarms

Details high priority alarms, their meanings, indicators, and sounds.

13.2 Medium Alarms

Details medium priority alarms, their meanings, indicators, and sounds.

13.3 Low Alarms

Details low priority alarms, their meanings, indicators, and sounds.

14.0 Surgical Implant Procedure

14.1 HeartWare Ventricular Assist System Setup

Steps for setting up battery charger, monitor, and backup controller.

14.2 HVAD Pump Pre-implant Test

Procedure for preparing and testing the HVAD® Pump before implant.

14.3 Outflow Graft Attachment

Steps for attaching the outflow graft to the HVAD® Pump and aorta.

14.5 Left Ventricle (LV) Apex Cannulation

Steps for cannulating the LV apex with the inflow cannula.

14.6 Outflow Graft Anastomosis

Procedure for sewing the outflow graft to the aorta.

14.7 Driveline Placement

Steps for tunneling and securing the driveline exit site.

14.8 De-airing Procedure

Steps to remove air from the pump and conduits before starting.

15.0 HVAD Pump Explant

16.0 Patient Management

16.1 Postoperative Management

Guidelines for managing patients post-implantation in the ICU.

16.2 Emergency Management

Procedures for managing emergencies like cardiac arrest.

16.3 Anticoagulation

Guidance on anticoagulation therapy (heparin, warfarin, aspirin) post-implantation.

16.4 Infection Control Guidelines*

Recommendations for preventing infection during and after HVAD® Pump implantation.

16.5 Driveline Care*

Instructions for daily driveline exit site care and dressing changes.

16.10 Patient Education

Importance of patient training for system operation and emergency response.

17.0 Equipment Inspection, Cleaning and Maintenance

Appendix A: Quick Reference Guide for Alarms

HeartWare Ventricular Assist System Specifications

General IconGeneral
Device TypeVentricular Assist Device (VAD)
Flow RateUp to 10 liters per minute
Pump TechnologyCentrifugal, continuous flow
Power SourceExternal batteries or AC adapter
Drive UnitExternal
ControllerExternal
MaterialTitanium
ImplantationIntrapericardial
CompatibilityCompatible with MRI under specific conditions
Intended UseBridge-to-transplant or destination therapy for patients with advanced heart failure
Control SystemAutomatic speed adjustment based on patient's needs
MonitoringContinuous monitoring of pump function and alarms for abnormal conditions

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