Boston Scientific Vercise PC Manual de usuario

Boston Scientific

Deep Brain Stimulation

Reference Guide

Guide de référence

Referenzhandbuch

Referentiehandleiding

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Guida di riferimento

Manual de Referência

Οδηγός αναφοράς

Håndbok

Referencevejledning

Viiteopas

Referensguide

Referenční příručka

Referenčná príručka

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Справочник

Referentni vodič

Ghid de referință

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92497814-02

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Boston Scientic Deep Brain Stimulation Systems - Reference Guide

Reference Guide

92497814-02 Page ii of iv

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.

Trademarks

All trademarks are the property of their respective holders.

The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston

Scientic Neuromodulation Corporation is under license.

Contacting Boston Scientic

To contact Boston Scientic, see the “Technical Support” section of this manual.

Reference Guide

92497814-02 Page iii of iv

Table of Contents

Introduction....................................................................................................................................................................1

How to Use this Reference Guide................................................................................................................................1

Vercise™ PC, Vercise Gevia™, and Vercise Genus™ DBS Systems .......................................................................2

List of Directions for Use (DFU) ................................................................................................................................2

Compatible Products .................................................................................................................................................4

Vercise DBS System......................................................................................................................................................6

List of Directions for Use (DFU) ................................................................................................................................6

Compatible Products .................................................................................................................................................8

Technical Support .......................................................................................................................................................10

Boston Scientic Deep Brain Stimulation Systems - Reference Guide

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Introduction

Reference Guide

92497814-02 Page 1 of 277

Introduction

The Reference Guide provides the list of Directions for Use (DFU) available for each Boston Scientic Deep Brain Stimulation (DBS) System.

These manuals are designed for clinicians and other health care providers. The Reference Guide also provides device-specic information, such

as the list of compatible leads for each DBS System.

You will only receive products appropriate for your region.

Important: Please note that only the DFUs that are appropriate for your region will be provided with your DBS System.

The Boston Scientic DFUs are provided either online (as directed in your product packaging) or with your DBS System.

How to Use this Reference Guide

In this Reference Guide, information is provided for each DBS System in a table format. Follow the instructions below to nd information for your

DBS System:

1. Find the appropriate table for your DBS System. For example, if you are using the Vercise Genus DBS System, nd the table labeled

“Vercise™ PC, Vercise Gevia™, and Vercise Genus™ DBS Systems.”

2. Use the highlighted rows to locate the information of interest to you (e.g. indications, implantable pulse generator, or programming). The

DFU containing the information of interest to you is then listed in the right side column entitled “DFU.”

Boston Scientic Deep Brain Stimulation Systems - Reference Guide

Reference Guide

92497814-02 Page 2 of 277

Vercise™ PC, Vercise Gevia™, and Vercise Genus™ DBS Systems

List of Directions for Use (DFU)

Information DFU

Intended Use/Indications for Use

• Indications for Use

Vercise™ DBS Systems Information for Prescribers DFU

Vercise Genus™ P8 Information for Prescribers DFU (for Vercise

Genus P8 System Only)

Contraindications, Safety Information, General Device Information

• Adverse Events Summary

• Component Disposal

• Contraindications

• Device Description

• Device Registration

• Electromagnetic Compatibility

• Information for Contacting Boston Scientic

• Medical Devices/Therapies

• MRI Information

• Precautions

• Service and Maintenance of External Devices

• Sterilization

• Stimulator Battery Information

• Storage and Handling

• Telemetry Information

• Warnings

• Wireless Security

Vercise™ DBS Systems Information for Prescribers DFU

Vercise Genus™ P8 Information for Prescribers DFU (for Vercise

Genus P8 System Only)

MRI Guidelines

• MRI Guidelines ImageReady™ MRI Guidelines for Boston Scientic DBS Systems

Implantable Components: Implantable Pulse Generators (IPGs), Lead Extensions, and DBS Leads (Standard and

Directional Leads)

• Explant of Leads, Extensions, and IPG

• IPG and Extension Implantation

• IPG Revisions and Replacement

• Kit Contents

• Lead Implantation

• Product Compatibility

• Product Descriptions

• Specications and Technical Data

Vercise™ DBS Systems Surgical Implant Manual

Vercise Genus™ P8 DBS System Surgical Implant Manual (for

Vercise Genus P8 System Only)

OR Cable, OR Cable Extensions, External Trial Stimulator (ETS), and ETS Adapter

• Connection of OR Cable to Lead

• Connection of OR Cable to External Trial Stimulators (ETS)

and ETS Adapter

• Intraoperative Testing of DBS Leads Using the OR Cable

Assembly, ETS, and ETS Adapter

Vercise™ DBS Systems Surgical Implant Manual

Vercise Genus™ P8 DBS System Surgical Implant Manual (for

Vercise Genus P8 System Only)

Vercise™ PC, Vercise Gevia™, and Vercise Genus™ DBS Systems

Reference Guide

92497814-02 Page 3 of 277

Programming: Clinician Programmer, Wand, and Remote Control

• Clinician Programmer

• Energy Use Index and Recharge Estimate

• Programming Leads, Selecting Contacts, and Parameter

Adjustments

• Stimulator Programmable Characteristics

• Visualization

Vercise Neural Navigator 4 Programming Manual

• Instructions for Installing Programming Software Vercise Neural Navigator 4.0 Installer Installation Guide

• Connection of the Clinician Programmer to the External Trial

Stimulator 3 and Vercise Genus IPGs using wireless Bluetooth

connection

• Magnet Pairing of the Vercise Genus IPG to Clinician

Programmer or Remote Control

Vercise Neural Navigator 4 Programming Manual

Vercise DBS Remote Control 4 DFU (Clinician)

• Connection of the Clinician Programmer to the External Trial

Stimulator 2, Vercise PC IPG, or Vercise Gevia IPG using the

Programming Wand

Vercise DBS Programming Wand DFU

Vercise Neural Navigator 4 Programming Manual

• Instructions for Using the Remote Control

• Linking a Remote Control to the Stimulator

• MRI Mode

Vercise DBS Remote Control 4 DFU (Clinician) (for Model DB‑5270

Only)

Vercise DBS Remote Control 3 DFU (Clinician) (for Models DB‑5250

and DB‑5250‑S Only)

Vercise DBS Remote Control 2 DFU (Clinician) (for Model DB‑5240

Only)

Charging and Charging Systems (Rechargeable IPGs Only)

• Using the Charging System to Charge the Stimulator Vercise DBS Charging Handbook

Vercise DBS Charging Handbook Charging System with Belt

• Using the Charging Collar Vercise DBS Charging Handbook

• Using the Charging Belt Vercise DBS Charging Handbook Charging System with Belt

Adapters

• Vercise M8 Adapter Vercise M8 Adapter DFU

• B26 Pocket Adapter B26 Pocket Adapter DFU

Surgical Tools and Accessories

• GUIDE™ GUIDE Manual

• GUIDE™ XT GUIDE XT Manual

• SureTek™ Burr Hole Cover

Burr Hole Cover DFU

Vercise™ DBS Systems Surgical Implant Manual

Vercise Genus™ P8 DBS System Surgical Implant Manual (for

Vercise Genus P8 System Only)

• Suture Sleeves

• Lead Boot

• Lead Stop

Vercise™ DBS Systems Surgical Implant Manual

Vercise Genus™ P8 DBS System Surgical Implant Manual (for

Vercise Genus P8 System Only)

• Tunneling Tool

Vercise™ DBS Systems Surgical Implant Manual

Vercise Genus™ P8 DBS System Surgical Implant Manual (for

Vercise Genus P8 System Only)

Labeling Symbols

• Labeling Symbols Labeling Symbols

Boston Scientic Deep Brain Stimulation Systems - Reference Guide

Reference Guide

92497814-02 Page 4 of 277

Compatible Products

Model Description

Implantable Products

Implantable Pulse Generators (IPGs)

• DB-1216

• DB-1232

• DB-1408

• DB-1416

• DB-1432

• DB-1200

• DB-1140

Vercise Genus™ R16 Implantable Pulse Generator Kit

Vercise Genus™ R32 Implantable Pulse Generator Kit

Vercise Genus™ P8 Implantable Pulse Generator Kit

Vercise Genus™ P16 Implantable Pulse Generator Kit

Vercise Genus™ P32 Implantable Pulse Generator Kit

Vercise Gevia™ 16 Contact Implantable Pulse Generator Kit

Vercise™ PC Implantable Pulse Generator Kit

Leads and Burr Hole Cover

• DB-2201-30-DC

• DB-2201-45-DC

• DB-2202-XX

• DB-4600-C

30cm Lead Kit

45cm Lead Kit

Vercise™ Cartesia™ 30 or 45 cm 8 Contact DBS Directional Lead Kit

SureTek Burr Hole Cover Kit

Lead Extensions

• NM-3138-55

• DB-3128-XX

55cm 8 Contact Extension Kit

2x8 Contact Lead Extension Kit, 55 cm or 95 cm

Adapters

• DB-9418-15

• DB-9218-15

• DB-9218-55

B26 Pocket Adapter

15cm Vercise M8 Adapter

55cm Vercise M8 Adapter

Accessories and Spares

• DB-5170

• DB-5132

• DB-9315

• DB-4120-08

• DB-4100-A and SC-4100-A

• DB-2500-C

• DB-4605-C

• SC-4401

• SC-4275

• DB-4252 and SC-4252

• DB-4254 and SC-4254

Vercise DBS External Trial Stimulator 3 (ETS 3)

Vercise DBS External Trial Stimulator 2 (ETS 2)

Vercise ETS Adapter

8 Contact Push-Button OR Cable

OR Cable 1X8 and Extension

Vercise Physician’s Spare Kit

SureTek Burr Hole Cover Spares Kit

Port Plug, Spares

Hex Wrench (Torque Wrench)

28cm Straw Tunneling Tool

35cm Long Tunneling Tool

Patient Products

Vercise Genus Patient Kits

• DB-5572-1A

• DB-5270

Vercise DBS Remote Control 4 Kit

Vercise DBS Remote Control 4

Vercise Gevia Patient Kits

• DB-5552-1A

• DB-5250

Vercise DBS Remote Control 3 Kit

Vercise DBS Remote Control 3

Vercise PC Patient Kits

• DB-5542-1A

• DB-5240

• DB-5552-1A

• DB-5250

Vercise DBS Remote Control 2 Kit

Vercise DBS Remote Control 2

Vercise DBS Remote Control 3 Kit

Vercise DBS Remote Control 3

Vercise™ PC, Vercise Gevia™, and Vercise Genus™ DBS Systems

Reference Guide

92497814-02 Page 5 of 277

Vercise Charging Systems (Rechargeable IPGs Only)

• DB-64125

• DB-64126

Vercise Charging System

Vercise Charging System with Belt

Patient Product Accessories and Spares

• NM-6210

• DB-6315 and NM-6315

• NM-6310

• NM-6600

• DB-6300-C

• DB-6200-C

• DB-6100-C

• NM-6358-SP0

• DB-6358-0BK

• DB-6358-1K

• DB-6358-5BK

• DB-6358-9BK

• NM-6350

• NM-5312

• NM-5305

• NM-6305

Remote Control Holster

USB Power Supply, Remote Control, Universal

USB Power Supply, Remote Control, Nor. Am

Patient Travel Case

Vercise Charger Collar Accessories

Vercise Charger Collar, Small

Vercise Charger Collar, Medium

Charger Spacer

Charger Belt, Small, Black

Charger Belt, Medium Black

Charger Belt Extension, Black

Charger Belt Loops, Replacement, Black

Adhesive Kit

Charger

Base Station

Power Supply & Adapter For Charger (EU)

Clinician Programming

• DB-7164 and NM-7164

• DB-7164-R and NM-7164-R

• DB-7105-N4A

• DB-6386

• DB-7190 and NM-7190

• NM-6316

• NM-7165

• NM-7171

Clinician Programmer

Clinician Programmer (refurbished)

Vercise Neural Navigator 4 Installer

Pairing Magnet

Programming Wand

International Power Converter

Keyboard

Power Supply for Tablet Computer

GUIDE XT DBS System

• DB-7161 and NM-7161

• DB-7161-R and NM-7161-R

• DB-7106-G2

• DB-7162 and NM-7162

• NM-7113

• NM-6317

Clinician Programmer

Clinician Programmer (refurbished)

GUIDE XT Installer

Keyboard

Tablet Pen

Power Supply for Tablet Computer

GUIDETM DBS System

• DB-7154

• DB-7104

• DB-7114

• DB-7124

CP, ASUS with GUIDE DBS

Optical Drive, GUIDE DBS

Mouse, GUIDE DBS

Flash Drive, GUIDE DBS

A System that includes the Vercise PC, Vercise Gevia, or Vercise Genus IPG and Vercise Cartesia Directional Lead(s) forms the Vercise

Directional System.

Boston Scientic Deep Brain Stimulation Systems - Reference Guide

Reference Guide

92497814-02 Page 6 of 277

Vercise DBS System

List of Directions for Use (DFU)

Information DFU

Intended Use/Indications for Use

• Indications for Use Vercise DBS Physician Manual

Contraindications, Safety Information, General Device Information

• Adverse Events Summary

• Component Disposal

• Contraindications

• Device Description

• Information for Contacting Boston Scientic

• MRI Information

• Precautions

• Sterilization

• Storage and Handling

• Warnings

Vercise DBS Physician Manual

MRI Guidelines

• MRI Guidelines ImageReady™ MRI Guidelines for Boston Scientic DBS Systems

Vercise Implantable Pulse Generator (IPG) and Lead Extensions

• Explant of Leads, Extensions, and IPG

• IPG and Extension Implantation

• IPG Registration

• Specications and Technical Data

• Stimulator Programmable Characteristics

• Vercise System Revisions and Replacement

Vercise DBS Physician Manual

OR Cable, OR Cable Extensions, External Trial Stimulator

• Connection to 1x8 OR Cable

• Connection to External Trial Stimulator Vercise DBS Physician Manual

Programming: Clinician Programmer and Remote Control

• Clinician Programmer

• Programming Leads Vercise DBS Programming Manual

• Instructions for Using the Remote Control Vercise DBS Physician Manual

Leads: Standard

• Intraoperative Testing Using the OR Cable Assembly and

External Trial Stimulator

• Kit Contents

• Lead Implantation

• Specications and Technical Data

Vercise DBS Physician Manual

Adapters

• Vercise M8 Adapter Vercise M8 Adapter DFU

• B26 Pocket Adapter B26 Pocket Adapter DFU

Otros manuales para Vercise PC

Este manual sirve para los siguientes modelos

Tabla de contenidos

Idiomas:

Otros manuales de Equipo médico de Boston Scientific

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Boston Scientific Vercise PC Implantable Pulse Generator Manual

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Boston Scientific Vercise DB-5572-1A Manual

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Boston Scientific SC-2016 Series Manual

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Boston Scientific VERCISE DBS Manual de usuario

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Boston Scientific DB-1110-C Manual

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Boston Scientific Precision Manual

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