63HeartWare™ HVAD™ System Pump
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
3.3 HVAD
®
Pump Operating Guidelines
The HVAD
®
Pump speed can be set between 1800 and 4000 RPM, however the recommended
clinical operating speed range is 2400 to 3200 RPM. Speeds below 2400 RPM should only be used
during the implant procedure when weaning from cardiopulmonary bypass. Speeds above
3200 RPM are seldom needed and may increase the risk of suction events. HVAD
®
Pump power
ranges from 2.5 to 8.5 Watts when operating within the recommended speed range. Power
Table 23: Expected Average HVAD
®
Pump Parameters
Speed (rpms) Power (Watts) Flow (L/min)
2400 2.5 3.0
3200 8.5 8.0
3.4 Expected Useful Life of the HVAD
®
Pump
The HVAD
®
Pump was designed and tested to function for two years.
3.5 Device Tracking and Reporting Requirements
The HVAD
®
Pump is considered a life-sustaining medical device and must be tracked per
US Food and Drug Administration (FDA) and other foreign regulatory agency regulations.
Compliance is mandatory. Accordingly, all device tracking paperwork must be completed
and promptly returned to HeartWare. In addition, any device malfunctions must be reported to
HeartWare by the implanting center.
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