Product Info
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
92366224-01 iii of iv
Table of Contents
Device Description .......................................................................................... 1
Intended Use / Indications for Use .......................................................................... 1
Safety Information ........................................................................................... 2
Contraindications..................................................................................................... 2
Warnings ................................................................................................................. 3
Precautions ............................................................................................................. 6
Adverse Events ....................................................................................................... 12
Service and Maintenance................................................................................ 14
External Trial Stimulator (ETS) Maintenance .......................................................... 14
Cleaning the Charging System ................................................................................ 15
Cleaning the Remote Control .................................................................................. 15
Cleaning the Programming Wand ........................................................................... 15
Electromagnetic Compatibility ....................................................................... 16
EN 60601‑1‑2 Classication Information ................................................................. 16
Essential Performance ............................................................................................ 22
Telemetry Information .............................................................................................. 22
Quality of Wireless Service ..................................................................................... 23
Troubleshooting Wireless Coexistence Issues ........................................................ 24
Wireless Security ..................................................................................................... 25
FCC Compliance ..................................................................................................... 27
Rechargeable Stimulator Battery ................................................................... 28
Stimulator Battery .................................................................................................... 28
Recharge Estimate .................................................................................................. 28
Non‑Rechargeable Stimulator Battery........................................................... 29
Stimulator Battery .................................................................................................... 29
Elective Replacement .............................................................................................. 29
End of Service ......................................................................................................... 29