Thoratec HeartMate III, Instructions For Use Manual, Page: 18 / 458

1 Introduction
1-8 HeartMate III Left Ventricular Assist System Instructions for Use
Indications
The HeartMate III Left Ventricular Assist System is intended to provide long term hemodynamic
support in patients with advanced, refractory left ventricular heart failure. It is intended either for
temporary support, such as a bridge to cardiac transplantation (BTT), or as permanent destination
therapy (DT). The
HeartMate
III is intended for use inside or outside the hospital.
Contraindications
The HeartMate III Left Ventricular Assist System is contraindicated for patients who cannot tolerate,
or who are allergic to, anticoagulation therapy.
CAUTION !
• Clinical procedures (including LVAS settings) should be conducted under the direction of
the prescribing physician (Authorized Personnel) only.
• Do not try to repair any of the HeartMate III system components. If components need
service, contact the appropriate personnel.
• Notify the appropriate personnel if there is a change in how the Pump works, sounds, or
feels.
• Counsel the patient to avoid contact sports and jumping activities while implanted with the
Pump. Contact sports or jumping can cause bleeding or damage the Pump.
• Care should be taken when small children or pets are present. There is a potential for
strangulation from the system’s cables.
• If HeartMate III patients are approved for showering, they must always use the
Shower Bag. When installed properly, the Shower Bag protects external system
components from water or moisture. If external system components have contact with
water or moisture, the Pump may stop.