Introduction; About This Manual - Boston Scientific ImageReady 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 Precision Spectra™ Spinal Cord Stimulator 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's ImageReady MRI Technology makes safe MRI head scans possible. The Precision
Spectra 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 Precision Spectra Spinal Cord Stimulator System.
Other configurations have not been evaluated.
• A complete and functional Precision Spectra System comprised only of components listed in
"Table 1. Components that are eligible for Precision Spectra System with ImageReady™ MRI
Technology" on page 2, including IPG, leads, and surgical accessories.
This manual is a supplement to the Precision Spectra System product manuals and focuses specifically
on the use of a transmit/receive radio frequency (RF) head coil of an Eligible 1.5T MRI Head Coil Setup for
patients implanted with the Precision Spectra 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 radio
frequency (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" (e.g., 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 Precision Spectra™ Spinal Cord Stimulator System
Introduction
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