Boston Scientific Precision SCS System Series Manual

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Precision™ Spinal Cord
Stimulator System
Clinician Manual
Directions for Use
91173656-02
Content: 92070399 REV B
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Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their respective holders.
Additional Information
For other device-specic information not included in this manual or labeling symbols, refer to
the appropriate DFU as listed on your Reference Guide.
Product Model Numbers
Model Description
SC-1110 Precision Implantable Pulse Generator
SC-2016-xx Innion™ 16 Lead and Splitter 2x8 Kit
SC-2016-xxE Innion™ 16 Lead and Splitter 2x8 Trial Kit
SC-2138-xx Linear™ xxcm 8 Contact Lead
SC-2158-xx Linear™ xxcm 8 Contact Lead
SC-2158-xxE Linear xxcm 8 Contact Lead
SC-2208-xx Linear™ ST xxcm 8 Contact Lead
SC-2218-xx Linear™ ST xxcm 8 Contact Lead
SC-2218-xxE Linear ST xxcm 8 Contact Lead
SC-2316-xx Innion™ 16 xxcm 16 Contact Lead Kit
SC-2316-xxE Innion™ 16 xxcm 16 Contact Trial Lead Kit
SC-2317-xx Innion CX xxcm 16 Contact Lead Kit
SC-2317-xxE Innion CX xxcm 16 Contact Trial Lead Kit
SC-2352-xx Linear 3-4 xxcm 8 Contact Lead
SC-2352-xxE Linear 3-4 xxcm 8 Contact Lead
SC-2366-xx Linear 3-6 xxcm 8 Contact Lead
SC-2366-xxE Linear 3-6 xxcm 8 Contact Lead
SC-3138-xx xxcm 8 Contact Extension
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Model Description
SC-3304-xx D4 Splitter 2x4
SC-3354-xx W4 Splitter 2x4
SC-3400-xx xxcm Splitter 2x8 Kit
SC-5210 Precision Remote Control
SC-5212 Precision Remote Control
SC-5305 Precision Base Station
SC-5312 Precision Charger
SC-8120-xx Artisan 2x8 Surgical Lead
SC-8216-xx Artisan 2x8 Surgical Lead
Note: xx = length (cm), xxE = length (cm) Trial Lead
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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
Contraindications ................................................................................................................4
Safety Information..........................................................................................5
Instructions for the Patient ..................................................................................................5
Warnings ............................................................................................................................5
Precautions ........................................................................................................................ 6
Adverse Effects ..................................................................................................................8
Instructions for the Physician ............................................................................................. 9
Package Contents .......................................................................................10
IPG Kit ............................................................................................................................. 10
Percutaneous Permanent Lead Kit .................................................................................. 10
Percutaneous Trial Lead Kit .............................................................................................. 10
Lead Extension Kit ........................................................................................................... 11
2x4 Splitter Kit ................................................................................................................... 11
Surgical Paddle Lead Kit .................................................................................................. 11
Innion™ 16 Lead Kit ....................................................................................................... 11
Innion™ 16 Trial Lead Kit ................................................................................................ 12
Innion CX Lead Kit ..........................................................................................................12
Innion CX Lead Trial Lead Kit .........................................................................................12
Splitter 2x8 Kit ...................................................................................................................12
Innion™ 16 Lead and Splitter 2x8 Trial Kit ...................................................................... 12
Innion™ 16 Lead and Splitter 2x8 Kit ............................................................................. 13
Sterilization, Handling, and Storage ..........................................................14
Sterilization ...................................................................................................................... 14
IPG Handling and Storage ............................................................................................... 14
Lead, Lead Extension, and Splitter Handling and Storage ..............................................15
Pre-Op Instructions .....................................................................................16
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Percutaneous Lead Placement in the Epidural Space .............................17
Innion CX Lead Placement in the Epidural Space with Entrada Needle .........................19
Lead Connection to Splitter .............................................................................................. 24
Surgical Paddle Lead Placement in the Epidural Space ..........................27
Connecting the OR Cable Assembly .........................................................28
Intraoperative Stimulation Testing .............................................................30
Securing the Trial Lead ...............................................................................32
Securing the Innion CX Trial Lead............................................................33
Permanent Lead Anchoring and Tunneling ...............................................34
Anchoring the Lead ..........................................................................................................35
Tunneling the Lead or Lead Extension ............................................................................36
Connecting the Lead Extension ....................................................................................... 39
Connecting to the Trial Stimulator .............................................................41
Removal of Trial Leads, Extensions, and Splitters ...................................43
Option A: Percutaneous Lead Removal after Temporary Trial .........................................43
Option B: Lead Extension Removal after Permanent Trial ..............................................43
Option C: Splitter Removal after Trial ...............................................................................44
IPG Implantation ..........................................................................................45
Connecting to the IPG .................................................................................46
For Percutaneous Lead - Dual Lead Connection ............................................................46
For Innion™ 16 Lead Connection ...................................................................................46
For Innion CX Lead Connection ......................................................................................46
For Percutaneous Lead - Single Lead Connection .......................................................... 46
For Surgical Paddle Lead Connection .............................................................................47
Programming with the Innion™ 16 Lead and Innion CX Lead ......................................49
IPG Explant or Replacement ......................................................................50
Rechargeable Stimulator System ..............................................................51
IPG Battery Status ...........................................................................................................51
Charging Steps ................................................................................................................52
Patient Remote Control .................................................................................................... 54
Device Linking ................................................................................................................. 60
Searching .........................................................................................................................62
Clinician Options ............................................................................................................... 62
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Specications and Technical Data .............................................................68
Materials .......................................................................................................................... 68
Max Current Amp. per Electrode vs. Impedance ............................................................. 69
Registration Information..............................................................................73
Registering the Stimulator and Leads ..............................................................................73
Technical Service ........................................................................................74
EN 60601-1-2 Classication Information....................................................75
Limited Warranty - IPG ................................................................................76
Limited Warranty - Leads ............................................................................78
Limited Warranty - Externals.......................................................................80
Appendix .......................................................................................................81
Contact Information .....................................................................................88
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Manual Overview
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Manual Overview
This manual provides basic information for the trial, implantation, and operation of the Boston
Scientic Precision Spinal Cord Stimulator (SCS) system.
General surgical guidelines are presented in this manual for temporary and permanent
implantation of Boston Scientic percutaneous leads, lead extensions, splitters, surgical paddle
leads, and implantable pulse generator (IPG). These products are designed to aid in the
management of chronic intractable pain.
This manual also provides an overview of accessories for programming and charging the
IPG, clinical and surgical considerations, storage and handling requirements, and relevant
precautions concerning an implanted neurostimulator. Additional information on system
components and operation can be found in the Bionic Navigator Software Guide.
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Device and Product Description
The Precision system consists of an implantable pulse generator, temporary and permanent
percutaneous leads, surgical paddle leads, and lead extensions, each packaged as a separate
kit. Single use accessories and disposable tools are also included in these kits.
Features of the Precision SCS System include:
• Stimulation electrode eld navigation
• Sixteen independent current-controlled electrodes
• Four programmable stimulation areas per program; four possible
programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Implantable Pulse Generator
The Precision Implantable Pulse Generator (IPG) system is intended to treat chronic pain by
electrically stimulating the spinal cord. The multi-channel, multi-electrode device capability
provides exibility in conjunction with ease of programming. A rechargeable battery increases
IPG longevity and output capability while reducing size and device replacement surgeries. The
IPG is controlled by a handheld Remote Control, and can be engaged by a clinician computer
using proprietary Bionic Navigator software. Periodically, the IPG battery requires replenishing
with an RF charging device provided separately in the Patient Charging Kit.
Leads
The percutaneous and surgical paddle leads function as a component of the Precision SCS
system by delivering electrical stimulation to the nerve structures in the dorsal aspect of the
spinal cord, resulting in an inhibition of pain sensation.
Surgical Paddle Lead
The 2x8 Surgical Paddle Lead is available in lengths of 50 cm and 70 cm. The distal (paddle)
end of the lead has two columns of eight evenly spaced planar electrodes. Each electrode is
3x2 mm2 in area. On the proximal side, this lead employs 2 lead tails. The end of each tail has
eight evenly spaced contacts, identical to the percutaneous leads. The right tail of the Paddle
Lead is laser-etched to allow for ease of right and left identication. Each tail can be inserted
into an IPG or into a lead extension.
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