14
2.0 HeartWare
™
HVAD
™
System Overview
2.2 Warnings and Precautions (continued)
WARNINGS continued
11. WARNING! ALWAYS switch to the back-up controller if there is a [Controller
Failed] alarm.
12. WARNING! ALWAYS respond to low battery alarms. Silencing an alarm does not
resolve the alarm condition and will eventually deplete the batteries.
13. 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.
14. WARNING! DO NOT plug the HeartWare
®
Battery Charger AC adapter into an
electrical outlet which is not properly grounded or you may receive a serious
electrical shock.
15. WARNING! ALWAYS investigate, and if possible, correct the cause of any
alarm. Silencing an alarm does not resolve the alarm condition.
16. 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.
17. WARNING! DO NOT have a magnetic resonance imaging (MRI) procedure
while implanted with the HeartWare
™
HVAD
™
System. Doing so could harm you
or cause the pump to stop.
18. WARNING! Keep mobile phones at least 20 inches (50 centimeters) away from
the controller, as mobile phones may interfere with controller operation.
19. WARNING! DO NOT undergo procedures requiring high power electrical
treatment while the pump is implanted. High power electrical treatments
are typically prescribed for joint conditions such as rheumatoid arthritis and
osteoarthritis and use high frequency electrical current to produce deep heat
inside the body intended to decrease inammation and pain. Consult your
clinician before having any deep tissue heating procedures.
20. WARNING! AVOID exposure to therapeutic levels of ultrasound energy. Consult
your clinician before having lithotripsy procedures to treat kidney stones or
any treatments involving high intensity ultrasound. The implanted device may
inadvertently concentrate the ultrasound eld and cause harm.
21. WARNING! AVOID therapeutic ionizing radiation. Consult your clinician before
having any nuclear medicine procedures or radiation therapy for cancer.
Radiation may damage the device and may not be immediately detectable.
22. WARNING! AVOID devices and conditions that may induce strong static
discharges (e.g., television or computer monitor screens) as electrostatic
discharges can damage the electrical parts of the system and cause the
VAD to perform improperly or stop.
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