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Boston Scientific Vercise DBS Series

Boston Scientific Vercise DBS Series
342 pages
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Vercise™
Deep Brain Stimulation
System
Physician Manual
91098825-02
Content: 91098833 REV AB
Vercise™ Deep Brain
Stimulation System
Physician Manual
en de fr nl

Table of Contents

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Boston Scientific Vercise DBS Series Specifications

General IconGeneral
ManufacturerBoston Scientific
Device TypeDeep Brain Stimulation System
IndicationsParkinson's disease, Essential Tremor, Dystonia
Electrode Optionsdirectional leads
MRI CompatibilityMR Conditional
Target AreasSubthalamic Nucleus (STN), Globus Pallidus interna (GPi), Ventral Intermediate nucleus of the thalamus (VIM)
Pulse Amplitude0 to 10.5 mA
Lead Typedirectional leads
Stimulation Channels8 independent channels
Remote ControlPatient remote control available for limited adjustments
ProgrammingMultiple independent current control (MICC), Directional stimulation
ProgrammabilityMultiple independent current control (MICC), Directional stimulation

Summary

Guarantees

Trademarks

Additional Information

Product Model Numbers

Lists Vercise DBS System models and their descriptions.

Introduction

Manual Overview and Purpose

Describes the manual's content for implanting and using the Vercise DBS System.

Intended Use and System Description

Details indications for use and explains the Vercise DBS System components.

Safety Information

Contraindications, Warnings, and Precautions

Lists conditions for non-use, potential risks, and necessary preventative measures.

Adverse Events

Lists known risks and potential negative outcomes of using the DBS system.

Package Contents

Kit Component Listings

Lists components for IPG, Lead, Extension, Tunneling Tool, and Spares kits.

DBS Lead Implantation Procedures

Pre-Conditions and Lead Implantation

Covers prerequisites and the surgical procedure for implanting the DBS Lead.

Intraoperative Testing and Securing

Details stimulation testing during surgery and securing the DBS Lead post-implantation.

Stimulator Implantation and Connections

Stimulator Implantation Steps

Outlines the procedure for implanting the Vercise Stimulator and related tasks.

Lead and Extension Connections

Details connecting the DBS Lead to the Extension and assembling tools.

Vercise DBS System Revisions & Explantation

Explantation Procedures

Describes how to remove the DBS Lead, Extensions, and Stimulator.

The Vercise Stimulator

Stimulator Battery Management

Discusses battery life, status, and messages for the Vercise Stimulator.

The Charging System

Charging Components and Procedures

Covers charging the Charger, Stimulator, and using accessories like the collar/patch.

The Remote Control

Basic Operation and Features

Covers basic use, position, linking, on/off, signal strength, and amplitude.

Program Management

Instructions for selecting, modifying, and saving programs.

Advanced Options

Includes Clinician Options, Restore, and Searching functions.

Clinician Options

Programmer Communication Modes

Details CP Mode, Impedances, Clear Link, and Language settings.

Stimulation Guidelines

Charge Density Management

Explains charge density limits and warnings for programming stimulation.

Detailed Device Description

System Components Overview

Describes Stimulator, Leads, Extensions, Lead Boot, Suture Sleeve, and Tunneling Tool.

Programmer Communication

Explains how the Clinician Programmer communicates with the Stimulator.

Vercise DBS System Registration

Technical Support

Regulatory Classification Information

Limited Warranty Information

IPG Warranty

Details the limited warranty for the Implantable Pulse Generator (IPG).

Leads and Externals Warranty

Covers warranties for Leads, Extensions, Boots, Remote Control, and Charger.

Appendix

Stimulator Battery Longevity

Discusses the expected lifespan of the rechargeable Stimulator battery.

Battery Longevity Worksheets

Provides methods for calculating battery longevity with multiple areas/programs.

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