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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
3Introduction
1.4 Warnings
WARNINGS
1. WARNING! Serious and life threatening adverse events, including 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 HVAD has been associated with a rate of stroke of 22% at one
year and 29.7% at two years. A blood pressure management protocol may reduce
the overall incidence of stroke to 16.9% at one year and may reduce the incidence
of disabling strokes at one year from 8.1% to 6.5%. A user must fully consider the risks of
this device with that of other treatment modalities before deciding to proceed with
device implantation. Please refer to section 1.8 (“Safety and Effectiveness Results”)
for a summary of the stroke data. To mitigate the risk of stroke, please adhere to the
following patient management guidelines:
tolerated.
®
this generally does not need exceed 2.6 L/min/m
2
.
adjust ASA mono-therapy accordingly or consider combination therapy such as ASA
81 mg plus Aggrenox
®
(ASA plus extended –release dipyridamole) or daily ASA 81 mg
plus Plavix 75 mg.
2. WARNING! Carefully read this entire manual prior to implanting or operating the
device. Improper operation of the system and potential harm to the patient and to
the user could result.
3. WARNING! use the HeartWare
™
HVAD
™
System in pregnant women. Any
woman receiving an HeartWare
™
HVAD
™
System who is of childbearing age and
sexually active should use a reliable method of birth control. Use of anticoagulants
during pregnancy has been associated with birth defects and bleeding.
4. WARNING! The Instructions for Use (IFU) is intended to be used by physicians, nurses,
and other clinical professionals. Setup and operation of this device should only be
undertaken by personnel who have completed an HeartWare
™
HVAD
™
System
product training program. A thorough understanding of technical principles, clinical
applications and risks associated with the HeartWare
™
HVAD
™
System is required
before using this product. Failure to understand these principles, applications and risks
may result in improper operation of the system and potential harm to the patient or to
the user.
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!
at the same time since this will stop the pump. At least one power source must be
connected at all times.
7. WARNING!
their clinician to do so. Patients who shower must use the HeartWare
®
Shower Bag.
8. WARNING!
close by to hear alarms.
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