Boston Scientific Precision - Table of Contents

Clinician Manual
97035873-01 iii of iv
Table of Contents
Manual Overview ........................................................................................................................... 1
Device and Product Description ..................................................................................................2
Implantable Pulse Generator ...........................................................................................................2
Leads ...............................................................................................................................................2
Lead Extension ................................................................................................................................3
Lead Splitter ......................................................................................................................................3
Indications for Use ........................................................................................................................4
Precision System Clinical Summary ................................................................................................4
Safety Information .......................................................................................................................... 9
Instructions for the Patient ................................................................................................................9
Warnings .......................................................................................................................................... 9
Precautions .................................................................................................................................... 10
Adverse Effects ..............................................................................................................................11
Instructions for the Physician ......................................................................................................... 12
Essential Performance ...................................................................................................................13
Telemetry Information ....................................................................................................................13
Package Contents .......................................................................................................................14
IPG Kit ...........................................................................................................................................14
Percutaneous Permanent Lead Kit ................................................................................................ 14
Percutaneous Trial Lead Kit ............................................................................................................14
Lead Extension Kit ......................................................................................................................... 14
2x4 Splitter Kit .................................................................................................................................15
Surgical Paddle Lead Kit ...............................................................................................................15
Innion 16 Lead Kit .........................................................................................................................15
Innion 16 Trial Lead Kit .................................................................................................................15
Innion CX Lead Kit ........................................................................................................................15
Innion CX Lead Trial Lead Kit .......................................................................................................16
Splitter 2x8 Kit .................................................................................................................................16
Innion 16 Trial Conguration Kit .................................................................................................... 16
Innion 16 Conguration Kit ............................................................................................................16
Sterilization, Handling, and Storage .......................................................................................... 17
Sterilization ....................................................................................................................................17
IPG Handling and Storage ............................................................................................................. 17
Lead, Lead Extension, and Splitter Handling and Storage .............................................................18
Pre-Op Instructions ..................................................................................................................... 19
Percutaneous Lead Placement in the Epidural Space .............................................................20
Innion CX Lead Placement in the Epidural Space with Entrada™ Needle ...................................21
Lead Connection to Splitter ............................................................................................................26
Surgical Paddle Lead Placement in the Epidural Space ..........................................................28
Connecting the OR Cable Assembly ......................................................................................... 29
Intraoperative Stimulation Testing .............................................................................................30
Securing the Trial Lead ............................................................................................................... 31