User Manual

Table of Contents
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Table of Contents
Introduction ............................................... 1
Manual Overview ........................................................... 1
Product Description .......................................................... 1
Indications for Use ...........................................................3
Precision System Clinical Summary .....................................3
Contraindications ..........................................................10
Safety Information ................................... 11
Warnings .................................................................... 11
Precautions .................................................................. 12
Adverse Effects .............................................................14
Instructions for the Physician .............................................16
Package Contents .................................... 17
Lead Kit - Model SC-2108 ............................................. 17
Lead Extension Kit - Model SC-3108 ................................17
Sterilization and Handling ........................ 18
Sterilization ..................................................................18
Handling .....................................................................18
Storage .......................................................................19
Guidelines for Trial-phase Implantation .... 20
Pre-op Instructions ..........................................................20
Lead Placement ............................................................ 21
Connecting the OR Cable Assembly ................................. 23
Intraoperative Stimulation Testing ......................................26
OPTION A: Temporary Lead Trial ....................................26
OPTION B: Permanent Lead Trial ..................................... 28