Boston Scientific WaveWriter Alpha Series User Manual

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CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Read this manual in its entirety before performing a full body scan on patients who are implanted with the WaveWriter Alpha and
WaveWriter Alpha Prime Systems with ImageReady MRI Full Body Technology. Refer to the WaveWriter Alpha and WaveWriter
Alpha Prime System product manuals for detailed information about non-MRI aspects of implantation, features, programming,
and use of the components of the WaveWriter Alpha and WaveWriter Alpha Prime Systems.
92395577-02
Content: MP92395577-02 REV A
ImageReady™ MRI
Full Body Guidelines for
WaveWriter Alpha™ and
WaveWriter Alpha™ Prime
Spinal Cord Stimulator
Systems
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Boston Scientific WaveWriter Alpha Series Specifications

General

Manufacturer	Boston Scientific
Implantable	Yes
Rechargeable	Yes
Device Type	Spinal Cord Stimulator
MRI Conditional	Yes
Connectivity	Bluetooth
Programs	Multiple customizable programs
MRI Compatibility	1.5T and 3.0T (conditional)

Summary

Introduction

About this Manual

This manual is for physicians and healthcare professionals managing patients with WaveWriter Alpha SCS Systems during MRI scans.

MR Conditional System Description

MR Conditions of Use

SCS Implant System Conditions

Conditions for implant system eligibility for MRI scans, including component configuration and lead placement.

Radiology

Safety Information

Warnings

Lists potential risks and dangers associated with MRI scans for patients with the WaveWriter Alpha SCS System.

Limitations

Outlines restrictions and scenarios not evaluated for the WaveWriter Alpha SCS System during MRI scans.

Image Artifacts and Distortion

Discusses how the SCS system can affect MRI image quality and how to minimize artifacts.

Adjusting for B1+rms or SAR Below Normal Mode

Provides guidelines for adjusting MRI scanner parameters to meet safety limits for B1+rms or SAR.

Patient Screening and Preparation

MR System Preparation

Supervision

Ensures a qualified person monitors the MRI scan, parameters, and patient condition throughout the procedure.

Enabling MRI Mode

Instructions for activating MRI Mode on the Boston Scientific MR Conditional Stimulator using the Remote Control.

Disabling MRI Mode

Steps to deactivate MRI Mode on the Stimulator using the Remote Control after the MRI scan.

Impedances Out of Range Screen

Error messages displayed when system impedances are outside the acceptable range.

MRI Basic Concepts

Glossary

Appendix A

WaveWriter Alpha Systems ImageReady MRI Full Body Patient Eligibility

Form to document patient's implanted system configuration for MRI eligibility.