Product Info
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Table of Contents
Device and Product Description ...................................................................1
Essential Performance ...................................................................................1
System Clinical Summary .............................................................................1
Subperception Therapy - Clinical Summary ................................................ 5
Contraindications ........................................................................................... 5
Safety Information .......................................................................................... 5
Instructions for the Patient .................................................................................................. 6
Adverse Effects ...................................................................................................................9
Instructions for the Physician ............................................................................................ 10
Quality of Wireless Service ............................................................................................... 10
Wireless Security .............................................................................................................. 11
Telemetry Information ....................................................................................................... 12
Wireless Charging Information ......................................................................................... 12
Electromagnetic Compatibility - EN 60601-1-2 Classication Information ........................ 12
Sterilization ....................................................................................................................... 16
FCC Rules .....................................................................................................17
FCC ID .............................................................................................................................. 17
Technical Service .........................................................................................17
End of Programmed Service .......................................................................18
IPG Battery Life ................................................................................................................ 19