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HeartMate III Left Ventricular Assist System Instructions for Use
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Percutaneous
: Percutaneous means “through the skin.”
Pump Cable
: One of the two cables that make up the Driveline. The Pump Cable is
permanently attached to the pump housing. The other end of the Pump Cable exits the patient’s
abdomen and is connected to the Modular Cable which connects to the System Controller.
The Pump Cable contains wires that carry power and data to the pump, and that control and
monitor pump operation.
Polyester Velour
: A synthetic biocompatible material that lets skin tissue grow into the soft
covering of the Driveline. This material covers the Driveline inside the body at the exit site and
is on the external portion of the Pump Cable. Skin growth into the velour covering helps create
a barrier that reduces the risk of Driveline infections.
Power Cable
: A cable containing electrical wires that transfers electrical power to the System
Controller from a routine power source (two 14 Volt Lithium-Ion batteries or the Power Module
or the Mobile Power Unit).
Power Module
: The Power Module connects to an AC electrical outlet. It provides AC
electrical power to the Left Ventricular Assist System. Patients must always connect to the Power
Module or the Mobile Power Unit for sleep (or when sleep is possible). Connecting to the
Power Module is also appropriate when patients are stationary or relaxing indoors.
Power Module Backup Battery
: A backup power source inside the Power Module that
gives up to 30 minutes of support if power to the Power Module fails or is disconnected. The
backup battery works only if it is charged and properly connected.
Power Saver Mode
: In power saver mode, the System Controller slows pump speed to save
power. If power is removed or fails, the System Controller gives 15 minutes of full power before
entering power saver mode. Alarms cannot be silenced while in power saver mode.
Power Sources
: Three power sources can power the HeartMate III Left Ventricular Assist
System:
• A pair of wearable, rechargeable 14 Volt Lithium-Ion batteries worn in battery clips
• The Power Module that plugs into an AC electrical outlet
• The Mobile Power Unit that plugs into an AC electrical outlet
Pulsatility Index (PI)
: Pulsatility Index (PI) is a calculation related to the amount of
assistance provided by the pump. PI values typically range from 1 to 10.
Pulse Mode
: The HeartMate III LVAS automatically develops an induced pulse X times per
minute by increasing/decreasing rotor speed in a rapid fashion. The (
) symbol indicates
the pump is operating in Pulse Mode.
Pump Running Symbol
: A green-colored symbol (
) on the System Controller user
interface that illuminates when the pump is receiving power and running.
Pump Speed
: Pump speed is measured in revolutions per minute (RPM). The number of RPMs
reflects how fast the Pump’s internal rotor turns.
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Summary of Contents for HeartMate III
Page 1: ...Instructions for Use ...
Page 2: ......
Page 3: ...Thoratec Corporation HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM Instructions for Use ...
Page 4: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ii ...
Page 6: ...HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE iv ...
Page 10: ...Contents viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE ...
Page 12: ...1 Introduction 1 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 28: ...1 Introduction 1 18 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 30: ...2 System Operations 2 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 88: ...3 Powering the System 3 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 112: ...3 Powering the System 3 26 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 166: ...4 System Monitor 4 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 208: ...4 System Monitor 4 44 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 210: ...5 Surgical Procedures 5 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 378: ...A A 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 390: ...B B 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 420: ...C C 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 426: ...C C 8 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 428: ...D D 2 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 448: ...E E 10 HeartMate III Left Ventricular Assist System Instructions for Use ...
Page 457: ......