13
HVAD
®
Patient Manual
2.2 Warnings and Precautions
This section explains safety-related information related to the proper handling of the
HeartWare
™
HVAD
™
System. Read these passages carefully.
WARNINGS
A Warning is a statement about the possibility of injury, death or other serious
adverse reaction associated with the use or misuse of the device.
1. WARNING! Serious and life threatening adverse events, especially stroke, have
been associated with use of this device. The risk of death as a result of stroke
has been observed in randomized clinical trials to be higher with the HVAD
than with alternative treatment options. The overall rate of stroke was shown
in randomized clinical trials to be higher with the HVAD than with alternative
treatment options; however, one of the trials suggested that closely following
a blood pressure treatment plan as recommended by your physician may
reduce your stroke risk. You must fully consider and discuss with your physician
the risks of this device with that of other treatment modalities before deciding
to proceed with device implantation.
2. WARNING! Please read this entire manual before using the HeartWare
™
HVAD
™
System outside of the hospital. It is not safe to use the system away from trained
professionals until you understand the information in this manual.
3. WARNING! DO NOT become pregnant while you have the HeartWare
™
HVAD
™
System. If you are a woman of childbearing age, use birth control if you are
sexually active. Blood thinners (which most VAD patients receive) have been
associated with birth defects. If you do become pregnant, tell your clinician
immediately.
4. WARNING! DO NOT use any components other than those supplied by HeartWare
with the HeartWare
™
HVAD
™
System, as this may affect HeartWare
™
HVAD
™
System operation.
5. WARNING! ALWAYS connect an AC Adapter to the controller before relaxing or
sleeping. Power from an electrical outlet (AC Adapter) provides power for an
unlimited period of time.
6. WARNING! DO NOT operate the controller in temperatures less than -20°C (-4°F)
or greater than +50°C (+122°F) or the controller may fail.
7. WARNING! DO NOT disconnect the driveline from the controller or the pump
will stop. If this happens, reconnect the driveline to the controller as soon as
possible to restart the pump.
8. WARNING! DO NOT attach the alarm adapter to a controller that is connected
to a running pump. The alarm adapter silences the [No Power] alarm and
should only be attached to a controller that has failed or malfunctioned and
is no longer connected to a pump.
9. WARNING! ALWAYS keep a spare controller and fully charged spare batteries
available at all times in case of an emergency.
10. WARNING! ALWAYS replace a controller if it has a blank display and/or no
audible alarms.
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