Expected Useful Life Of Heartware ® System Components; Product Disposal; Appendix A: Quick Reference Guide For Alarms - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
17.6 Expected Useful Life of HeartWare
The HeartWare ® System components were designed and tested to function without failing for the following periods:
HVAD Pump at least two years.
®
◗ ◗
The controller is expected to function for at least one year.
◗ ◗
The battery charger is expected to function for at least one year.
◗ ◗
The battery is expected to function through a minimum of 500 charge and discharge cycles; this will provide patient support for at least one year.
◗ ◗

17.7 Product Disposal

Specific product disposal considerations for certain HeartWare-supplied equipment appears below. Otherwise, dispose of all expired or damaged equipment according to applicable local,
regional, and federal laws and regulations. For additional product disposal support and information, contact HeartWare.
Batteries
HeartWare Li-Ion battery cells DO NOT contain lead. Dispose of/recycle HeartWare batteries in compliance with all applicable local, regional, and federal laws and regulations. DO NOT
incinerate.
Monitor
The HeartWare ® Monitor contains a lithium battery (replaceable). Dispose of/recycle the monitor's internal battery in compliance with all applicable local, regional, and federal laws and
regulations. DO NOT incinerate discarded monitor batteries.
Medical Waste Disposal
The explanted HVAD Pump and associated implantable components must be disposed of in compliance with all applicable local, state, and federal laws and regulations concerning
®
medical waste.

APPENDIX A: QUICK REFERENCE GUIDE FOR ALARMS

Alarm Alarm
Symbol Tone
None Continuous loud -
unable to mute
Flashing Loud, Two-toned
Red alarm-unable to mute
I
32 HeartWare Ventricular Assist System
®
System Components
®
LCD Display LCD Display
Line 1 Line 2
Alarm Type: High (Critical)
(no (no • No power to pump
message) message)
• Pump has stopped
VAD Connect • Driveline disconnected
Stopped Driveline
• Driveline fracture
• Connector malfunction/ breakage
• VAD electrical failure
VAD Change
• Controller failure
Stopped Controller
• VAD failure
• Thrombus or other materials (e.g.,
tissue fragments) in the device
Controller Change
• Controller component failed
Failed Controller
Critical Replace • Limited battery 1 or battery 2 time
Battery 1 Battery 1
remaining
• Battery malfunction
Critical Replace
Battery 2 Battery 2
Potential Causes
• Connect two new power sources
• Replace controller
• Contact HeartWare Clinical Support
• Reconnect driveline
• Contact HeartWare Clinical Support
• Download/email patient log files
• Exchange controller
• Contact HeartWare Clinical Support
• Download/email patient log files
• Exchange controller
• Contact HeartWare Clinical Support
• Replace critical battery with fully charged
battery or the AC or DC adapter
• Change controller if new power sources do not
correct alarm
Potential Actions