Boston Scientific WaveWriter Alpha Series User manual

en
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
en fr de nl es it pt-EU  el no da sv sk hu pl bg hr ro sl cs

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 ii of iv
en
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.

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 iii of iv
en
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

ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 iv of iv
en
This page intentionally left blank

Introduction
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 1 of 797
en
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
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 2 of 797
en
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
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 3 of 797
en
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
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 4 of 797
en
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
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 5 of 797
en
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
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 6 of 797
en
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.

MR Conditions of Use
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 7 of 797
en
Radiology
1. MRI systems that meet the following criteria:
• MRI magnet strength of 1.5T only, in a horizontal closed bore system (no vertical-eld,
standing, or extremity systems).
• Gradient systems with a maximum gradient slew rate per axis less than or equal to 200 T/m/s.
• Maximum spatial eld gradient less than or equal to 40 T/m (4000 gauss/cm).
2. MRI coil setup:
• Transmit coil: 1.5T Full Body transmit/receive, Head transmit/receive, or Extremity transmit/
receive. RF quadrature1 only.
• Receive-only coil: Any type.
• Hydrogen/proton imaging only.
3. Patient status and positioning:
• The patient is in supine or prone position only.
• The Lead implant location is epidural.
• The IPG is implanted in the upper buttock or the lower ank.
• The patient has enabled MRI mode using the Remote Control.
1 RF Quadrature coil – RF Quadrature Coils produce an RF eld with circular polarization perpendicular to the static magnetic eld.

MR Conditions of Use
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 8 of 797
en
4. MRI system settings:
Full System with All Leads listed in Table 1 Full System with SC-2408 Avista Leads only
Head Transmit/
Receive Coil
Normal Operating Mode limits for RF and Gradient Exposure:
Head SAR must be (≤) 3.2 W/kg
Note: Whole Body SAR is not applicable for Head Transmit/Receive scanning.
Full Body Transmit/
Receive Coil or
Extremity Transmit/
Receive Coil
B1+rms ≤ 3.2 uT
If B1+rms is not available, then scan sequence
must have Whole body and Head SAR less
than or equal to (≤) 0.4 W/kg
Note: Using the SAR value may result in a
more restrictive MRI scan.
Normal Operating Mode limits for RF
and gradient exposure:
Whole Body SAR must be (≤) 2.0 W/kg
Head SAR must be (≤) 3.2 W/kg
Warning: Apply the required B1+rms (or SAR) limit in the Normal Operating Mode. Do not conduct MRI
scans in the First Level and Second Level Controlled Operating Modes as it may increase the risk of unin-
tended stimulation and excessive heating.
5. Monitoring:
• The patient must be under continuous audio/visual monitoring during the MRI.
6. Exposure Time:
• Cumulative active scan time (with RF On) should be limited to 30 minutes or less per imaging
session. If 30 minutes of active scan time is reached, allow 60 minutes of non-active time
before proceeding.

Safety Information
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 9 of 797
en
Safety Information
Warnings
The WaveWriter Alpha System with ImageReady MRI Full Body Technology have been shown through non-
clinical testing to minimize the potential interactions with MRI when the appropriate conditions described in
this manual are followed.
If an MRI scan is performed in a condition other than advised in the MR Conditions of Use section it may
result in serious risks such as tissue damage or severe patient injury.
Only use 1.5T Full Body transmit/receive, Head transmit/receive, or Extremity transmit/receive coils.
RF quadrature only. Hydrogen/proton imaging only: Do not use other transmit/receive coils (eg, linear
coils). Local receive-only coils may be used. Only 1.5T coils have been evaluated.
Gradient Systems: Do not use gradient systems producing gradient slew rates per axis greater than
200 T/m/s because they have not been tested and could cause increased risk of induced stimulation (resulting
in shocking or jolting sensations, discomfort, or pain for the patient) or warming of the neurostimulator.
MRI Mode: MRI Mode must be enabled on the Stimulator before performing an MRI scan. Performing an MRI
scan without MRI Mode enabled may lead to unintended stimulation and patient harm.
Impedance Out of Range: Higher or lower than normal impedances could indicate compromised Stimulator-
Lead integrity. Scanning under these conditions may increase the risk of potential adverse effects listed under
“Potential Interactions with MRI Environment.”
Potential Interactions with MRI Environment: During an MRI examination there are potential interactions
with the system that may result in heating, magnetic eld effects, induced stimulation, or damage to the
device, requiring its replacement. Following the safety conditions designated in this manual will minimize
potential interactions described in this section.
• Heating – The MRI elds may interact with the Spinal Cord Stimulation System causing warming
of the IPG and Leads. This may cause discomfort, pain, or burns.
• Mechanical effects – The MRI magnetic eld may exert force or torque on the Spinal Cord
Stimulation System. Patients may feel a tugging or vibration sensation. Patients with recent
implant incisions may feel surgical wound discomfort.
• Induced stimulation – An MRI may induce energy onto the implanted Leads, potentially causing
unintended or uncomfortable sensations (e.g., tingling, shocking, or jolting).
If these interactions cause the patient discomfort, stop the MRI scan.
Body Temperature: The MRI conditional evaluation has been performed for patients with a typical body
temperature of 37 °C. Elevated body temperature in conjunction with tissue heating caused by an MRI scan
increases the risk of excessive tissue heating, which could cause tissue damage.

Safety Information
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 10 of 797
en
No Blankets: Do not cover the patient with blankets or heated blankets. Blankets raise the patient’s body
temperature and increase the risk of tissue heating, which could cause tissue damage.
Patient Positioning: Only place the patient in the prone or supine position. Do not position the patient in
other positions, e.g., on his or her side (called the lateral decubitus position) within the MRI bore. Scanning
patients in positions other than prone or supine has not been evaluated and could cause excessive tissue
heating during an MRI scan.
External Devices: External components (External Trial Stimulator and OR Cables, Remote Control and
accessories) are MR Unsafe. They must not be taken into any MR environment such as the MRI Scanner
Room.
Supervision: A person with expert knowledge about MRI must ensure all procedures in this manual are
followed and that the MRI scan parameters during both the pre-scan and the actual MRI examination are
within the recommended settings listed in this manual.
Limitations
• Boston Scientic has not evaluated the effect of other implanted devices in combination with or in
proximity to the Boston Scientic System described in this manual. Contact the appropriate device
manufacturers with questions regarding other systems.
• Physicians should not prescribe MRI for patients undergoing trial neurostimulation and/or having
systems that are not fully implanted.

Safety Information
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 11 of 797
en
Image Artifacts and Distortion
The WaveWriter Alpha systems have minimal image distortion when the device is out of the eld of view.
Signicant image distortion can result from the presence of the device within the eld of view. Image
artifacts and distortion resulting from the presence of the device and the Leads within the eld of view
must be considered when selecting the eld of view and imaging parameters. These factors must also be
considered when interpreting the MRI images.
Careful choice of pulse sequence parameters and location of the imaging plane may minimize MR image
artifacts. However, the reduction in image distortion obtained by adjustment of pulse sequence parameters
will usually compromise signal-to-noise ratio.
The following general principles should be followed:
• Avoid using the body receive coil if possible. Use a local receive-only coil instead.
• Use imaging sequences with stronger gradients for both slice and read encoding directions. Use
higher bandwidth for both radio-frequency pulse and data sampling.
• Choose an orientation for the read-out axis that minimizes the appearance of in- plane distortion.
• Use a shorter echo time for gradient echo technique, whenever possible.
• Be aware that the actual imaging slice shape can be curved in space due to the presence of the
eld disturbance of the neurostimulator.
• Identify the location of the implant in the patient, and when possible, orient all imaging slices away
from the implanted neurostimulator.
Warnings
• If the MRI targeted image area is near the neurostimulator, it may be necessary to move the
neurostimulator to obtain an image, or use alternate imaging techniques. MRI images may be
severely distorted or image target areas can be completely blocked from view near the implanted
neurostimulation system components, especially near the neurostimulator.
• If the neurostimulator is removed, remove the entire neurostimulation system. Do not remove the
neurostimulator and leave the Lead system implanted as this can result in higher than expected
Lead heating under MRI exposure. Testing has not been completed to demonstrate safety of this
conguration under MRI exposure. Excessive heating can result in tissue damage or serious
patient injury.

Safety Information
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 12 of 797
en
Adjusting for B1+rms or SAR Below Normal Mode2
Some pulse sequences may exceed the implant safety limits for the Boston Scientic SCS System. The
below guidelines will enable lower B1+rms or SAR levels to be achieved. If, at any point prior to completing
the full workow, an acceptable B1+rms or SAR level has been achieved, no further parameter adjustments
are necessary. If adjusting or checking B1+rms is possible on the scanner, this is likely to be a preferable
option over adjusting or checking SAR because B1+rms tends to be less restrictive and more accurate.
Once a sequence has been optimized for reduced B1+rms, saving the parameters for the sequence locally
may be helpful for use with other patients with similar implants.
Note: Some scanners provide the user with an updated estimate of B1+rms or SAR while the user
changes the sequence parameters. If a scanner does not provide this information in real time,
one option is to initiate a scan each time after changing a parameter. At the time of a sequence
initiation, the scanner should provide the new adjusted B1+rms or SAR level with the chosen
parameters.
• If the scanner provides an ‘implant option,’ this option can be utilized to input scan conditions.
• If the scanner does not provide an ‘implant option,’ many pulse sequences under Normal Mode,
especially in the gradient Echo family, have low B1+rms or SAR levels without any modications.
• If the required pulse sequence exceeds the implant B1+rms or SAR limit, the RF pulse type may
be set to ‘Low SAR’ if this option is available on the scanner. ‘Low SAR’ is available on most
scanners and helps to reduce B1+rms or SAR without affecting image quality.
• If the ‘Low SAR’ option is unavailable or the B1+rms or SAR levels still exceed the manufacturer
limits after setting the RF pulse type to ‘Low SAR,’ two additional options that can help reduce
RF exposure are listed below. These two options are trade-offs and can be exercised together to
achieve a good common trade-off.
○Increasing TR. In some cases, 20%, e.g., from 2500 ms to 3000 ms could be sufcient, but
this could be increased by 100% if need be e.g., from 550 ms to 1100 ms.
▪ Choose this option when reducing the number of slices is not acceptable.
▪ Avoid this option in T1-SE sequences as this impacts contrast.
▪Also avoid this option if longer scan time is not acceptable.
○Reducing number of slices.
• If B1+rms or SAR levels still exceed the implant limit, reducing RF can still be achieved with:
○Reducing ip-angle (alpha), reducing refocusing ip angle, or using fewer RF saturation
bands.
○Reducing number of echoes (echo train length/ turbo factor/ shot factor).
2 References
McRobbie, et al. “MRI from Picture to Proton.” 2007. Cambridge university press.
Faulkner W.. “New MRI Safety Labels & Devices, B1+rms as a Condition of Use.” SMRT Signals, Feb 2016 V5, Nol.
https://www.ismrm.org/smrt/E-Signals/2016FEBRUARY/eSig_5_1_hot_2.htm
Franceschi A.M. et al. “Optimized, Minimal Specic Absorption Rate MRI for High-Resolution Imaging in Patients with Implanted Deep
Brain Stimulation Electrodes.”
AJNR Am J Neuroradio1. 2016 Nov; 37(11): 1996-2000.

Patient Screening and Preparation
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 13 of 797
en
Patient Screening and Preparation
The following table summarizes the WaveWriter Alpha Systems/Patient-related Conditions of Use that
must be met in order for an MR Conditional scan to be performed. For each condition or requirement,
suggested methods to determine eligibility are listed. It is not required to use all suggested methods. Any or
a combination of the suggested methods may be used.
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.
Table 2. WaveWriter Alpha Systems/Patient Screening and Preparation Conditions
# Condition for Scanning Suggested Methods to Determine
Eligibility
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: Leads should be connected directly into the IPG.
Patient should not be implanted with Lead Extensions,
Splitters, or Adapters.
• Check patient records
• Check the Patient ID card
• Check model numbers in Table 1 of this manual or
by contacting Boston Scientic Neuromodulation
Technical Services.
• Conrm with the physician responsible for
managing the Patient’s SCS System.
2. The Lead implant location is epidural. • Check patient records
• Verify by X-Ray
3. The patient has no abandoned Leads or IPGs (Leads
or IPGs that are not connected to the functioning WaveWriter
Alpha System).
• Check patient records
• Verify by X-Ray
4. The IPG is implanted in the upper buttock or the lower ank • Check patient records
• Examine the patient by palpation to determine the
location of the IPG
• Verify by X-Ray
5. For rechargeable systems, IPG is fully charged prior to the
MRI scan. Make sure three bars are displayed at the
top right of the Home screen on the Remote Control.

Patient Screening and Preparation
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 14 of 797
en
# Condition for Scanning Suggested Methods to Determine
Eligibility
6 MRI Mode is enabled on the Stimulator.
Note: Stimulation is automatically turned OFF when
MRI Mode is enabled. Refer to MRI Mode Section
for more information on MRI Mode including
instructions for enabling MRI Mode.
Ensure that the Home screen of the Patient Remote
Control displays the MR Conditional symbol
with the Stimulation turned OFF.

Patient Screening and Preparation
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 15 of 797
en
# Condition for Scanning Suggested Methods to Determine
Eligibility
7. No evidence can be found of fractured Leads or compromised
IPG-Lead system integrity.
Note: An Impedance check is automatically performed
for Stimulator-lead integrity when MRI Mode is
enabled on the the device. Refer to MRI Mode
Section for more information on MRI Mode.
• Check patient records
• Stimulator-lead integrity or impedance check
is automatically performed when MRI Mode
is enabled. If impedances are not within the
acceptable range the Remote Control will display
an error message before asking the user if they
would like to continue with enabling MRI Mode.
• If this error is displayed, we recommend not
proceeding with the MRI scan. Patients should
contact their physician to arrange an evaluation of
the system.
• Verify by X-Ray
Note: If there are any unused ports on the IPG, a
red “X” will display for those unused ports.
Red “X” on unused ports do not constitute
fractured leads or compromised IPG-Lead
system integrity.
8. 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. Refer to the “Potential Interactions with MRI
Environment” in the “Safety Information” section of this
manual for additional information.
Direct the patient to immediately notify the MRI personnel if
any of these effects become uncomfortable or intolerable.
N/A

MR System Preparation
ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems
92395577-02 16 of 797
en
MR System Preparation
Table 3 summarizes the MR Scanner-related Conditions of Use that must be met in order for an MR
Conditional scan to be performed. For each condition or requirement, recommended actions to determine
conformance are listed.
Table 3. MR System Conditions
# Condition for Scanning Actions
1. MRI systems that meet the following criteria:
• MRI magnet strength of 1.5T only, in a horizontal closed
bore system (no vertical-eld, standing, or extremity
systems).
• Gradient systems with a maximum gradient slew rate per
axis less than or equal to 200 T/m/s.
• Maximum spatial eld gradient less than or equal to
40 T/m (4000 gauss/cm).
Check the technical specications of the MRI Scanner.
2. MRI coil setup:
• 1.5T Full Body transmit/receive coil, head transmit/receive
coil, or Extremity transmit/receive coil
• Receive only coil: Any type
• Hydrogen/proton imaging only
Check the technical specications of the MRI Coil.