HeartWare

Ventricular Assist Systems

HeartWare Ventricular Assist System Instructions for Use Rev 15 Nov 2012

Instructions for Use

104 Pages

HeartWare® Ventricular Assist System Instructions for Use  TABLE OF CONTENTS 1.0  INTRODUCTION ... 1  2.0  INDICATIONS FOR USE ... 2  3.0  CONTRAINDICATIONS ... 2  4.0  WARNINGS ... 2  5.0  PRECAUTIONS ... 6  6.0  POTENTIAL COMPLICATIONS ... 8  7.0  CLINICAL TRIAL RESULTS ... 9  7.1  PIVOTAL CLINICAL STUDY DESIGN ... 9  7.2  STUDY OBJECTIVES ... 9  7.3  STUDY POPULATION DEMOGRAPHICS AND BASELINE PARAMETERS ... 9  7.4  SAFETY AND EFFECTIVENESS RESULTS ... 11  7.5  OVERALL CONCLUSIONS FROM CLINICAL DATA ... 24  8.0  SYSTEM COMPONENT OVERVIEW ... 24  8.1  HEARTWARE® VENTRICULAR ASSIST SYSTEM ... 24  8.2  HEARTWARE® CONTROLLER ... 25  8.3  HEARTWARE® MONITOR ... 25  8.4  HEARTWARE® CONTROLLER POWER SOURCES ... 25  8.5  HEARTWARE® BATTERY CHARGER ... 26  8.6  EQUIPMENT FOR IMPLANT ... 26  9.0  PRINCIPLES OF OPERATION ... 27  9.1  BACKGROUND ... 27  9.2  BLOOD FLOW CHARACTERISTICS ... 28  9.3  PHYSIOLOGICAL CONTROL ALGORITHMS ... 28  9.3.1  Flow Estimation ... 29  9.3.2  Ventricular Suction Detection Alarm ... 29  9.4  HVAD® PUMP OPERATING GUIDELINES ... 31  10.0 USING THE HEARTWARE® MONITOR ... 33 10.1 CLINICAL (HOME) SCREEN ... 34 10.2 ALARM SCREEN ... 35 10.3 TREND SCREEN ... 36 10.4 SYSTEM SCREEN ... 36 10.4.1  Speed/Control Tab ... 37 i
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