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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
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
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
Lead Extension Kit - Model SC-3108 ................................ 17
Sterilization and Handling ........................ 18
Sterilization .................................................................. 18
Handling ..................................................................... 18
Storage ....................................................................... 19
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
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