Introduction; About This Manual - Boston Scientific Spectra WaveWriter Mode D'emploi

Introduction

About this Manual

This manual is intended for use by physicians and other healthcare professionals (HCPs) involved in
managing patients with a Spectra WaveWriter™ Spinal Cord Stimulator (SCS) System with ImageReady™
MRI Technology, as well as radiologists and other HCPs involved in performing magnetic resonance
imaging (MRI) scans on such patients.
Boston Scientific ImageReady MRI Technology makes safe MRI head scans possible. The Spectra
WaveWriter SCS System with ImageReady MRI Technology is "MR Conditional" only when exposed to the
MRI environment under the specific conditions defined in this manual.
Caution: The instructions in this manual apply only to the following:
• On-label indications (epidural placement) of the Spectra WaveWriter SCS System. Other
configurations have not been evaluated.
• A complete and functional Spectra WaveWriter SCS System comprised only of components listed
in "Table 1. Components that are eligible for Spectra WaveWriter SCS System with ImageReady
MRI Technology" on page 2, including the Implantable Pulse Generator (IPG), Leads, and
surgical accessories.
This manual is a supplement to the Spectra WaveWriter SCS System product manuals and focuses
specifically on the use of a transmit/receive radiofrequency (RF) head coil of an Eligible 1.5T MRI Head Coil
Setup for patients implanted with the Spectra WaveWriter SCS System.
Throughout this manual, the term "Eligible 1.5T MRI Head Coil Setup" is used to indicate specifically a
1.5 Tesla horizontal closed-bore whole-body MRI system that is configured to use its transmit/receive RF
head coil for the MRI examination.
Warning: Before using the head coil, check to ensure it is clearly labeled as a "Transmit/Receive
radio frequency head coil" (for example, via a label fixed to the body of the coil). Receive-only head
coils are not safe because they require the use of a radio frequency body coil to transmit.
MRI procedures should be performed using ONLY a transmit/receive RF head coil in an Eligible
1.5T MRI Head Coil Setup. Do not use MRI systems that are open-sided, vertical-field, or are
operating at other static magnetic field strengths. The risks of using MRI systems operating at other
static magnetic field strengths or using an RF body coil have not been determined and could be
significant.
ImageReady MRI Guidelines for Spectra WaveWriter Spinal Cord Stimulator System
Introduction
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