Thoratec HeartMate III, Instructions For Use Manual, Page: 17 / 458

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-7
The HeartMate III System Controller is also part of the Left Ventricular Assist System (LVAS).
The System Controller is an extracorporeal interface device that receives power from the
Power Module, the Mobile Power Unit, or portable batteries. It appropriately delivers power to
the LVAD. It is the primary user interface and has several important functions:
• Operating condition display
• Source of audible and visible alarms
• Communication link for transferring event/period log and alarm information
• Battery backup in the case of full power disconnection
WARNING !
• A thorough understanding of the technical principles, clinical applications, and risks
associated with left ventricular support is necessary before using the HeartMate III
Left Ventricular Assist System. Read this entire manual before attempting implantation of the
Left Ventricular Assist Device or before caring for HeartMate III patients. Completion of the
Thoratec Corporation HeartMate III Surgical Training Program is also required prior to use.
• Understanding the operating and safety aspects of the HeartMate III Left Ventricular Assist
System is critical for safe and successful use.
• All users, including clinicians, patients, and caregivers, must be trained on system operation
and safety before use.
• All users, including clinicians, patients, and caregivers, must be trained on any
HeartMate III power accessories (Power Module, Mobile Power Unit, Battery Charger, or
HeartMate
®
14 Volt Lithium-Ion batteries) before use.
• Do not use the HeartMate III Left Ventricular Assist Device in pregnant women or in women
likely to become pregnant. A growing fetus may dislodge the Pump, which may result in
device failure, catastrophic bleeding, or death. Instruct women of childbearing age to use
reliable contraception if sexually active. Blood thinners have been associated with birth
defects. Anticoagulation regimens are contraindicated during pregnancy.
• Do not modify this equipment without authorization from Thoratec Corporation. The use of
unauthorized replacement parts may affect the electromagnetic compatibility of the
Mobile Power Unit with other devices. Potential interference may occur between the
Mobile Power Unit and other devices.
• Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with
other HeartMate systems. Only use HeartMate III parts with the HeartMate III system.
• The HeartMate III Pump may cause interference with implantable cardiac defibrillators
(ICD). If electromagnetic interference occurs, it may lead to inappropriate ICD therapy. The
occurrence of electromagnetic interference with ICD sensing may require adjustment of
device sensitivity and/or repositioning the lead.