System Overview
Description
The HeartMate II is a left ventricular
assist system (LVAS) consisting of a blood
pump, external System Controller, and
external power supply components
(
Figure 1
). The HeartMate II is implanted
just below the heart. The flexible inflow
conduit is attached to the apex of the left
ventricle and the outflow graft is attached
to the ascending aorta. The HeartMate II
pumps blood from the weakened left ven-
tricle to the aorta. Both the inflow conduit
and outflow elbow feature textured
blood-contacting surfaces clinically
proven on the HeartMate XVE to be
thrombo-resistant.
Warnings and Precautions
General Warnings
·
A thorough understanding of the technical principles, clinical applications, and
risks associated with left ventricular support is necessary before using this
product.
·
Keep the Power Base Unit (PBU) away from water. If the PBU has contact with
water, shower spray, or wet surfaces, the pump may stop, or the patient may
receive a serious electrical shock.
·
Do NOT use the PBU in the presence of flammable anesthetic agents or an
explosion could occur.
·
Connect the PBU and any peripheral devices only to properly tested, grounded
and dedicated AC outlets. Do NOT use an adapter for ungrounded wall outlets
or multiple portable socket outlets (power strips), or the risk of electrocution
increases.
·
Do NOT connect the PBU to an outlet controlled by a wall switch or the PBU
may be left inoperable.
·
Do NOT use this device in pregnant women or any woman likely to become
pregnant during her period of LVAS support. A growing fetus will dislodge the
pump, which may result in device failure or fatal hemorrhage. In addition, anti-
coagulation regimens are contraindicated during pregnancy.
·
Do NOT subject patients implanted with the HeartMate II LVAS to Magnetic
CLINICAL OPERATION AND PATIENT MANAGEMENT
2
Figure 1
Implanted and worn components of the
HeartMate II LVAS (shown using battery power for unteth-
ered operation).
