Introduction .................................................................................................................................................. 1
Description of the System ..................................................................................................................................2
Rechargeable IPG Battery Information ..............................................................................................................4
Safety Information ....................................................................................................................................... 6
Indications for Use .............................................................................................................................................6
Patient Population ..............................................................................................................................................6
Intended Use ......................................................................................................................................................7
Clinical Benefit ...................................................................................................................................................7
Device Lifetime ...................................................................................................................................................7
Contraindications (When the Vercise Gevia DBS System Should Not Be Used)...............................................8
Warnings ............................................................................................................................................................9
Precautions ......................................................................................................................................................16
Adverse Events ................................................................................................................................................25
Electromagnetic Compatibility ................................................................................................................. 30
EN 60601‑1‑2 Classification Information ..........................................................................................................30
Notice to the User Per Industry Canada Radio Standards Specifications: ......................................................35
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Information for Patients
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