Table Of Contents - HeartWare Ventricular Assist System Instructions For Use Manual

Table of Contents

1.0 INTRODUCTION .............................................................................................................. 1
2.0 INDICATIONS AND CONTRAINDICATIONS FOR USE ....................................................... 1
3.0 WARNINGS .................................................................................................................... 1
4.0 PRECAUTIONS ................................................................................................................ 2
5.0 POTENTIAL COMPLICATIONS ......................................................................................... 3
6.0 SYSTEM COMPONENTS OVERVIEW ................................................................................ 4
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6.1 HeartWare Ventricular Assist System .................................................................................... 4
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6.2 HeartWare Controller .......................................................................................................... 4
6.3 HeartWare ® Monitor ............................................................................................................. 4
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6.4 HeartWare Controller Power Sources ................................................................................... 4
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6.5 HeartWare Battery Charger ................................................................................................. 4
6.6 Equipment for Implant .......................................................................................................... 5
7.0 PRINCIPLES OF OPERATION ........................................................................................... 5
7.1 Background .......................................................................................................................... 5
7.2 Blood Flow Characteristics .................................................................................................... 5
7.3 Physiological Control Algorithms ........................................................................................... 6
7.3.1 Flow Estimation ........................................................................................................... 6
7.3.2 Ventricular Suction Detection Alarm ............................................................................. 6
7.3.3 Lavare Cycle ................................................................................................................ 7
8.0 USING THE HEARTWARE
8.1 Selecting a Language for the Monitor ................................................................................... 8
8.2 Monitor Overview ................................................................................................................. 8
8.3 Clinical (Home) Screen .......................................................................................................... 9
8.4 Alarm Screen ........................................................................................................................ 9
8.5 Trend Screen ......................................................................................................................... 9
8.6 System Screen ...................................................................................................................... 9
8.6.1 Speed/Control Tab ..................................................................................................... 10
8.6.2 Setup Tab .................................................................................................................. 10
8.6.2.1 Patient Tab ..................................................................................................... 10
8.6.2.1.1 Downloading Controller Log Files ................................................................. 10
8.6.2.2 VAD Tab ......................................................................................................... 11
8.6.2.3 Controller Tab ................................................................................................. 11
8.6.2.4 Monitor Tab .................................................................................................... 12
8.6.3 Alarm Settings Tab ..................................................................................................... 13
8.7 Monitor Shut Down ............................................................................................................ 14
9.0 USING THE HEARTWARE
9.1 Connector Layout ............................................................................................................... 14
9.2 Controller Display and Operation ........................................................................................ 14
9.3 How to Change the Controller ............................................................................................ 15
10.0 USING THE HEARTWARE
10.1 Changing a Battery........................................................................................................... 16
10.2 Care of Batteries .............................................................................................................. 17
11.0 USING THE HEARTWARE
11.1 Connecting the Battery to the Battery Charger .................................................................. 17
11.2 Disconnecting the Battery from the Battery Charger .......................................................... 18
12.0 USING THE HEARTWARE
12.1 Operating the Power Adapters .......................................................................................... 18
12.2 Connecting the AC Adapter or DC Adapter ........................................................................ 18
12.3 Disconnecting from the AC Adapter or DC Adapter ............................................................ 19
13.0 ALARMS ....................................................................................................................... 19
13.1 High Alarms ..................................................................................................................... 19
13.2 Medium Alarms ................................................................................................................ 20
13.3 Low Alarms ...................................................................................................................... 21
13.4 Multiple Alarms ................................................................................................................ 22
13.5 How to Silence (Mute) Alarms ........................................................................................... 22
13.6 Status Message Display .................................................................................................... 22
Ventricular Assist System
® MONITOR .............................................................................. 8
CONTROLLER ...................................................................... 14
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BATTERIES ............................................................................ 16
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BATTERY CHARGER .............................................................. 17
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CONTROLLER AC ADAPTER OR DC ADAPTER ....................... 18
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