Introduction; About This Manual - Boston Scientific WaveWriter Alpha Manual Del Usuario

Introduction

About this Manual

This manual is intended for use by physicians and other healthcare professionals (HCPs) involved in
managing patients with a WaveWriter Alpha™ or WaveWriter Alpha™ Prime Spinal Cord Stimulator
Systems with ImageReady™ MRI Full Body Technology, as well as radiologists and other HCPs involved in
performing magnetic resonance imaging (MRI) scans on such patients.
References to WaveWriter Alpha Spinal Cord Stimulator (SCS) System include the following implantable
pulse generators (IPG):
• WaveWriter Alpha IPG
• WaveWriter Alpha 16 IPG
• WaveWriter Alpha Prime IPG
• WaveWriter Alpha Prime 16 IPG
WaveWriter Alpha and WaveWriter Alpha 16 are rechargeable IPGs. References to the Charging System or
charging process are applicable only when using a rechargeable SCS Stimulator.
WaveWriter Alpha Prime and WaveWriter Alpha Prime 16 are non-rechargeable IPGs.
Boston Scientific's ImageReady MRI Full Body Technology makes safe MRI scans possible. The
WaveWriter Alpha SCS System with ImageReady MRI Full Body Technology are "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 WaveWriter Alpha Spinal Cord Stimulator System.
Other configurations have not been evaluated.
• A complete and functional WaveWriter Alpha System composed only of components listed in
"Table 1. Components that are eligible for WaveWriter Alpha System with ImageReady MRI Full
Body Technology" on page 3, including IPG, Leads, and surgical accessories.
This manual is a supplement to the WaveWriter Alpha System product manuals and focuses specifically
on the use of 1.5T horizontal closed bore MRI systems for patients implanted with the WaveWriter Alpha
System.
MRI procedures should be performed using ONLY a 1.5T horizontal closed bore MRI system. Do not
use MRI systems that are open-sided, vertical-field, or are operating at other static magnetic field
strengths. The risks of using these MRI systems have not been determined and could be
significant.
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
Introduction
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