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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ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating to its
products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Trademark
All trademarks are the property of their respective owners.
Additional Information
For Indications and related information, see the Indications DFU. For contraindications, warnings,
precautions, adverse events summary, physician instructions, sterilization, storage and handling,
component disposal, and contact information for Boston Scientic, refer to the Information for Prescribers
DFU for your spinal cord stimulator system. For other device-specic information not included in this
manual, labeling symbols, and warranty information, refer to the appropriate DFU for your SCS System as
listed on your Reference Guide.
Boston Scientic recommends that implanting physicians read all product labeling prior to using our
devices.

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Table of Contents
Introduction.........................................................................................................................1
About this Manual ............................................................................................................................................1
MR Conditional System Description.................................................................................3
MR Conditions of Use ........................................................................................................5
SCS Implant System Conditions.....................................................................................................................5
Radiology ..........................................................................................................................................................7
Safety Information..............................................................................................................9
Warnings ...........................................................................................................................................................9
Limitations ......................................................................................................................................................10
Image Artifacts and Distortion ...................................................................................................................... 11
Warnings.................................................................................................................................................. 11
Adjusting for B1+rms or SAR Below Normal Mode.................................................................................12
Patient Screening and Preparation.................................................................................13
MR System Preparation ...................................................................................................16
Supervision.....................................................................................................................................................17
Post-MRI Examination Review ......................................................................................................................18
ERI or EOS Screens During MRI Mode ..................................................................................................27
MRI Basic Concepts.........................................................................................................32
Glossary............................................................................................................................33
Appendix A........................................................................................................................34
WaveWriter Alpha Systems ImageReady MRI Full Body Patient Eligibility ..............................................34

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Introduction
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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 Scientic’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 specic conditions dened 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 congurations 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 specically
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-eld, or are operating at other static magnetic eld
strengths. The risks of using these MRI systems have not been determined and could be
signicant.

Introduction
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Patient ID card
Advise the patient to bring the most up-to-date patient ID card to all MRI appointments. MRI personnel can
then use the patient ID card to identify Boston Scientic as the manufacturer of the patient’s Spinal Cord
Stimulator System and to conrm the model number of the implanted IPG and Leads.
Obtain the latest MRI guidelines DFU
This manual may be updated periodically. Always obtain the latest version of this manual. Refer to the con-
tact information at the back of this manual or go to www.bostonscientic.com/imageready.

MR Conditional System Description
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MR Conditional System Description
The following table lists model numbers of components that may comprise a Full Body MR Conditional
WaveWriter Alpha System.
Warning: The WaveWriter Alpha SCS System can be “Full Body MR Conditional” only when exposed to the
MRI environment under the specic conditions dened in this manual.
Table 1. Components that are eligible for WaveWriter Alpha System with ImageReady MRI Full Body
Technology
Component Description Model Number(s) MRI System Settings
Implantable
Pulse Generator
(IPG)
WaveWriter Alpha IPG SC-1232
Follow the MRI System Settings
used with the implanted Lead(s).
WaveWriter Alpha 16 IPG SC-1216
WaveWriter Alpha Prime IPG SC-1432
WaveWriter Alpha Prime 16 IPG SC-1416
Percutaneous
Leads
Avista™ MRI Percutaneous Leads, 56 cm SC-2408-56 Normal Operating Mode
(See “Radiology” section of this
manual, MRI System Settings)
Avista MRI Percutaneous Leads, 74 cm SC-2408-74
Linear™ Percutaneous Leads, 50 cm SC-2158-50
Normal Operating Mode with
B1+RMS limits (See “Radiology”
section of this manual, MRI
System Settings)
Linear Percutaneous Leads, 70 cm SC-2158-70
Linear ST Percutaneous Leads, 50 cm SC-2218-50
Linear ST Percutaneous Leads, 70 cm SC-2218-70
Linear 3-4 Percutaneous Leads, 50 cm SC-2352-50
Linear 3-4 Percutaneous Leads, 70 cm SC-2352-70
Linear 3-6 Percutaneous Leads, 50 cm SC-2366-50
Linear 3-6 Percutaneous Leads, 70 cm SC-2366-70
Innion™ CX Percutaneous Leads, 50cm SC-2317-50
Innion CX Percutaneous Leads, 70cm SC-2317-70
Surgical Leads Artisan™ MRI Surgical Leads, 50 cm SC-8416-50
Artisan MRI Surgical Leads, 70 cm SC-8416-70
Artisan Surgical Leads, 50 cm SC-8216-50
Artisan Surgical Leads, 70 cm SC-8216-70
CoverEdge™ 32 Surgical Paddle Lead, 50 cm SC-8336-50
CoverEdge 32 Surgical Paddle Lead, 70 cm SC-8336-70
CoverEdge X 32 Surgical Paddle Lead, 50 cm SC-8352-50
CoverEdge X 32 Surgical Paddle Lead, 70 cm SC-8352-70
CoverEdge 32 MRI Surgical Paddle Lead, 50 cm SC-8436-50
CoverEdge 32 MRI Surgical Paddle Lead, 70 cm SC-8436-70
CoverEdge X 32 MRI Surgical Paddle Lead, 50 cm SC-8452-50
CoverEdge X 32 MRI Surgical Paddle Lead, 70 cm SC-8452-70

MR Conditional System Description
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Component Description Model Number(s) MRI System Settings
Surgical
Accessories
IPG Port Plugs SC-4401
Surgical Accessories should
follow the MRI System Settings
used with the associated
implanted lead(s).
Clik Anchor SC-4316
Clik X Anchor SC-4318
Clik™ X MRI Anchor SC-4319
Silicone Suture Sleeves N/A, included
in kit
Med-A SC-4320
Note: The system must be fully implanted and must include both an IPG and a Lead(s), at a minimum, to be MR Conditional.
The Lead(s) should be connected to the IPG, no Lead Extensions, Splitters, and Adapters are allowed. Leads implanted
without the IPG are not MR Conditional.
Note: For patients implanted with SC-2138-50, SC-2138-70 or SC-2208-50, SC-2208-70 Lead models:
• SC-2138-50 is the same Lead as SC-2158-50
• SC-2138-70 is the same Lead as SC-2158-70
• SC-2208-50 is the same Lead as SC-2218-50
• SC-2208-70 is the same Lead as SC-2218-70

MR Conditions of Use
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MR Conditions of Use
The WaveWriter Alpha System with ImageReady MRI Full Body Technology is MR Conditional. A patient
with this system may be scanned only under very specic conditions. Scanning under different conditions
may result in severe patient injury or device malfunction. The following Conditions of Use must be met in
order for a patient with a WaveWriter Alpha System with ImageReady MRI Full Body Technology to undergo
an MRI scan. Adherence to the Conditions of Use must be veried prior to each scan to ensure that the
most up-to-date information has been used to assess the patient’s eligibility and readiness for an MRI scan.
SCS Implant System Conditions
Appendix A, “ImageReady MRI Full Body Patient Eligibility,” contains a form that may be used by the
physician managing the patient’s SCS system to conrm the patient meets the SCS Implant System
Conditions for MRI Scans as described in this manual.
1. The patient is implanted with a WaveWriter Alpha SCS 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 of this manual.
Note: Full body MRI Leads should be connected directly into the IPG. Patients should not be implanted with Lead
Extensions, Splitters, or Adapters.
2. The Lead implant location is epidural.
3. The patient has no abandoned Leads or IPGs (i.e. Leads or IPGs that are not connected to the
functioning WaveWriter Alpha System).
4. The IPG is implanted in the upper buttock or the lower ank.
5. No evidence of fractured Leads or compromised IPG-Lead system integrity.
6. The patient has been informed of what to do or expect in preparation for their MRI scan:
a. If the patient has a rechargeable IPG: Prior to arrival at the MRI Center, the patient should
ensure that the IPG is fully charged (IPG charge shown as three (3) bars on the Remote
Control) for the MRI scan. The patient should bring the Charger (in case charging is
necessary) to the MRI center. The Charger is MR Unsafe and must not be brought into the
MRI Scanner Room.
b. At the MRI Center, prior to entering the scanner room, the patient should enable MRI mode
using the Remote Control. The Remote Control is MR Unsafe and must not be brought into
the MRI Scanner Room.

MR Conditions of Use
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c. The patient should be aware of the potential perceptible effects of undergoing MRI with
an SCS System, which are as follows: vibration or tugging (moving) sensation in the
IPG pocket, warming of the implanted system, and sensation of stimulation. The patient
should be directed to immediately notify the MRI personnel if any of these effects become
uncomfortable or intolerable. See “Potential Interactions with MRI Environment” in the
“Safety Information” section of this manual for additional information.