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1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
7Introduction
1.4 Warnings (continued)
1.5 Precautions
PRECAUTIONS
1. CAUTION: Safety and effectiveness in persons less than 18 years of age and in
persons with a BSA of less than 1.5 m
2
have not been established.
2. CAUTION: The HeartWare
™
HVAD
™
System has had limited use in patients with
HeartWare
™
HVAD
™
System therapy.
3. CAUTION:
®
Controllers on one patient to avoid risks associated with
an inadvertent mismatch of controller pump speed settings.
4. CAUTION: The HeartWare
®
Waist Pack and the HeartWare
®
Shoulder Pack contain
should keep the pack away from their chest, including when sleeping. Per
pacemaker and ICD manufacturer guidelines, magnets should be kept at least 6
inches (15 centimeters) away from the pacemaker or ICD (please refer to manufacturer
guidelines for additional information).
5. CAUTION:
damage the driveline. Special care should be taken not to twist the driveline while
sitting, getting out of bed, adjusting controller or power sources, or when using the
shower bag.
6. CAUTION:
™
HVAD
™
System. If HeartWare
™
HVAD
™
System equipment malfunctions, contact
HeartWare.
7. CAUTION: Manual changes to the speed will immediately disable the [Ventricular
Suction Detection] alarm. An “Sx Off” will be displayed on the monitor screen below the
“Fixed” mode display. The [Ventricular Suction Detection] alarm will have to be
re-activated.
8. CAUTION:
in a suction condition. To optimize operation of the suction detection the patient should
be hemodynamically stable prior to enabling the [Ventricular Suction Detection] alarm.
9. CAUTION: ALWAYS keep all connectors free of liquid, dust and dirt, or the
HeartWare
™
HVAD
™
System may not function as intended.
56. WARNING! ALWAYS switch to the back-up controller if there is a [Controller Failed] alarm
since the HVAD
®
Pump may not be running.
57. WARNING! ALWAYS respond to low battery alarms. Silencing an alarm does not resolve
the alarm condition and will eventually deplete the batteries.
58. WARNING!
a controller that has failed or malfunctioned and is no longer connected to a pump.
59. WARNING! ALWAYS keep a spare controller and fully-charged spare batteries available at
all times in case of an emergency.
WARNINGS
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