Warnings And Precautions; Warnings - HeartWare Ventricular Assist System Patient Manual

3 WARNINGS and PRECAUTIONS
3.1 Warnings
1. WARNING! Serious and life threatening adverse events, including stroke, have been associated
with use of this device. A user must fully consider 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® 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® System. If you are a
woman of childbearing age, use birth control if you are sexually active. Blood thinners (which
most LVAS patients receive) have been associated with birth defects. If you do become
pregnant, tell your physician and hospital contact person immediately.
4. WARNING! DO NOT operate the controller in temperatures less than ‐4°F (‐20°C) or greater than
122°F (50°C) or the controller may fail.
5. 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.
6. WARNING! ALWAYS investigate, and if possible, correct the cause of any alarm. Silencing an
alarm does not resolve the alarm condition.
7. WARNING! ALWAYS keep a spare controller and fully‐charged spare batteries available at all
times in case of an emergency.
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! DO NOT plug the AC adapter into an electrical outlet that is not properly grounded
or you may receive a serious electrical shock.
10. WARNING! ALWAYS replace a controller with a blank display and/or no audible alarms.
11. WARNING! NEVER disconnect both power sources (batteries, AC adapter, DC adapter) at the
same time since this will stop the pump and activate the No Power alarm. At least one power
source must be connected at all times.
12. WARNING! ALWAYS switch to the backup controller if there is a "Controller Failed" alarm.
13. WARNING! DO NOT drop the controller or other equipment. Dropping the controller could
cause sudden stoppage of the pump. Dropped equipment should be reported and inspected.
14. WARNING! ALWAYS check the controller display for any information regarding an alarm when
using loud machinery or in the vicinity of loud noises since under these conditions, the controller
and battery alarms may not be audible.
15. WARNING! DO NOT have a magnetic resonance imaging (MRI) procedure while implanted with
the HVAD® System. Doing so could harm you or cause the pump to stop.
HeartWare® Ventricular Assist System Patient Manual
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