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 with
MultiWave Technology
Clinician Manual
Directions for Use
91173657-02
Content: 92070434 REV B
en defr nl
Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 1 of 386

Clinician Manual
91173657-02 ii of viii
Precision™ SCS System with MultiWave Technology Clinician Manual
en
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-1112 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
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 2 of 386

Clinician Manual
91173657-02 iii of viii
en
Model Description
SC-3304-xx D4 Splitter 2x4
SC-3354-xx W4 Splitter 2x4
SC-3400-xx xxcm Splitter 2x8 Kit
SC-5213 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
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 3 of 386

Clinician Manual
91173657-02 iv of viii
Precision™ SCS System with MultiWave Technology Clinician Manual
en
This page intentionally left blank.
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 4 of 386

Clinician Manual
91173657-02 v of viii
Table of Contents
en
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 ............................................................................................. 8
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 ............................................................................................... 15
Lead, Lead Extension, and Splitter Handling and Storage ..............................................15
Pre-Op Instructions .....................................................................................16
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 5 of 386

Clinician Manual
91173657-02 vi of viii
Precision™ SCS System with MultiWave Technology Clinician Manual
en
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 ..........................26
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 ...........................................................................................................52
Charging Steps ................................................................................................................52
Patient Remote Control .................................................................................................... 55
Device Linking ................................................................................................................. 61
Searching .........................................................................................................................63
Clinician Options ............................................................................................................... 63
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 6 of 386

Clinician Manual
91173657-02 vii of viii
Table of Contents
en
Specications and Technical Data..............................................................70
Materials ..........................................................................................................................70
Frequencies of 1,200Hz or Lower .....................................................................................70
Max Current Amp. per Electrode vs. Impedance <= 1,200 Hz ........................................71
Frequencies Greater than 1,200Hz .................................................................................. 72
Max Current Amp. per Electrode vs Impedance > 1,200Hz..............................................73
Registration Information..............................................................................77
Registering the Stimulator and Leads ..............................................................................77
Technical Service ........................................................................................78
EN 60601-1-2 Classication Information....................................................79
Limited Warranty - IPG ................................................................................80
Limited Warranty - Leads ............................................................................82
Limited Warranty - Externals.......................................................................84
Contact Information .....................................................................................86
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 7 of 386

Clinician Manual
91173657-02 viii of viii
Precision™ SCS System with MultiWave Technology Clinician Manual
en
This page intentionally left blank.
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 8 of 386

Clinician Manual
91173657-02 1 of 377
Manual Overview
en
Manual Overview
This manual provides basic information for the trial, implantation, and operation of the Boston
Scientic Precision™ Spinal Cord Stimulator System (SCS) with MultiWave Technology.
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 HR 1.0 Software Guide and, when using 1,200Hz or below, the Bionic Navigator™
1.2 Software Guide.
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 9 of 386

Clinician Manual
91173657-02 2 of 377
Precision™ SCS System with MultiWave Technology Clinician Manual
en
Device and Product Description
The Precision™ SCS System with MultiWave Technology 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 with MultiWave Technology include:
• Stimulation electrode eld navigation
• Sixteen independent current-controlled electrodes
• Four programs
• Four possible programmable stimulation areas per program when operating at
frequencies at or below 1,200Hz
• 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
CAUTION: The Precision™ SCS System with MultiWave Technology may only be used with
surgical paddle leads if operated at frequencies of 1,200Hz or below.
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070434 B.2
Precision MultiWave Clinician Manual NEU
Page 10 of 386