Table of Contents
Introduction .................................................................................................... 1
Overview of Manual ................................................................................................1
Intended Use / Indications for Use ..........................................................................1
System Description .................................................................................................1
Safety Information ......................................................................................... 2
Contraindications ....................................................................................................2
Warnings .................................................................................................................3
Precautions .............................................................................................................6
Adverse Events ..................................................................................................... 11
Package Contents ....................................................................................... 13
Contents of the Implantable Pulse Generator Kit .................................................13
Contents of the Lead Kit .......................................................................................13
Contents of the Extension Kit ...............................................................................13
Contents of the Tunneling Tool Kit ........................................................................13
Contents of the Spares Kit ....................................................................................14
Other Components ...............................................................................................14
DBS Lead Implantation ............................................................................... 15
Pre-Conditions ......................................................................................................16
Implanting the DBS Lead ......................................................................................16
Intraoperative Stimulation Testing .........................................................................18
Securing the DBS Lead ........................................................................................20
Stimulator Implantation .............................................................................. 24
Exposing the DBS Lead ........................................................................................24
Connecting the DBS Lead to the DBS Extension .................................................25
Assembling the Tunneling Tool .............................................................................27
Tunneling the DBS Lead and Extension ...............................................................28
Connecting the Stimulator ....................................................................................30
Vercise™ DBS System Revisions & Explantation .................................... 34
Explanting the DBS Lead ......................................................................................34
Explanting the DBS Extensions ............................................................................35
Explanting or Replacing the Stimulator .................................................................36
The Vercise™ Stimulator ............................................................................ 37
Stimulator Battery .................................................................................................38
Stimulator Battery Messages ................................................................................38
The Charging System.................................................................................. 39
Charging the Charger ...........................................................................................40
Charging the Stimulator ........................................................................................40
Using the Charging Collar .....................................................................................41
Using the Adhesive Patch .....................................................................................42
Properly Aligning the Charger ...............................................................................43
The Remote Control .................................................................................... 45
Basic Operation ....................................................................................................45
Vercise™ DBS Physician Manual
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