Appendix B: Pre-Mri Scan Condition Checklist; Lead-Only System Eligibility - Boston Scientific ImageReady MRI Mode D'emploi

ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

Appendix B: Pre-MRI Scan Condition Checklist

Lead-Only System Eligibility

Table 12. Lead-Only Conditions and Methods to Determine Eligibility
Condition for Scanning
The patient is implanted with a fully implanted or externalized Leads‑
Only configuration whose components are listed in Table 2.
Note: This step does not need to be completed if the MRI Patient
Eligibility Form (Appendix A) is already complete.
The patient's DBS System meets the Lead‑Only System configuration
requirements listed in Table 3.
Note: This step does not need to be completed if the MRI Patient
Eligibility Form (Appendix A) is already complete.
MRI systems that meet the following criteria:
• MRI magnet strength of 1.5 Tesla (T) only, in a horizontal closed
bore system (no open‑sided, vertical‑field, standing). The risks of
using these MRI systems have not been determined and could be
significant.
• Gradient systems with a maximum gradient slew rate per axis less
than or equal to 200 T/m/s.
• Maximum spatial field gradient less than or equal to
40 T/m (4000 gauss/cm).
MRI coil setup:
• Transmit coil: 1.5T full body
transmit/receive (RF quadrature only), 1.5T head transmit/receive
(RF quadrature only), or 1.5T lower extremity transmit/receive (RF
quadrature only).
• Receive‑only coil: Any type.
• Hydrogen/proton imaging only.
If using either full body or head transmit/receive coil (RF quadrature
only) and patient is implanted with either DB‑2201 or DB‑2202 Leads,
scan sequence throughout the scan must have B1+rms less than or
equal to (≤) 2.0 µT.
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.
Patient must be positioned in supine or prone position during the scan.
If possible, patient should be in a psychological condition and mental
state to be able to provide immediate feedback of any problems during
the examination.
13 Specific Absorption Rate (SAR) – radio frequency power absorbed per unit of mass (W/kg).
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
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Suggested Methods to Determine Eligibility
□
Check patient records and ensure that the model numbers of the
implanted components match the model numbers listed in Table 2
of this manual.
OR
□
Confirm with the physician responsible for implanting the patient's
DBS System and ensure that the model numbers of the implanted
components match the model numbers listed in Table 2 of this
manual.
□
Check patient records and ensure that the system configuration
meets the requirements listed Table 3 of this manual.
OR
□
Confirm with the physician responsible for implanting the patient's
DBS System and ensure the system configuration meets the
requirements listed in Table 3 of this manual.
□
Check the technical specifications of the MRI Scanner.
□
Check the technical specifications of the MRI head coil and/or
full body coil.
□
Ensure MRI Scanner is operated at or below (≤) B1+rms of
2.0 µT throughout the scan.
□
If B1+rms is not available then ensure MRI scanner is operated at
or below (≤) whole body and head SAR of 0.1 W/kg
Note: Using the SAR
value may result in a more restrictive MRI
13
scan.
□
Check the active scan time on the MRI scanner.
□
Continuously monitor the patient to ensure the patient is in the
correct position during scan.
□
Maintain visual and audio monitoring of the patient throughout the
MRI scan. If possible, verify that the patient is feeling normal and
is responsive during and between each MRI scan. Discontinue
the MRI immediately if the patient experiences any adverse
events listed under "Potential Interactions with MRI Environment"
in the "Safety Information" section of this manual, or if an awake
patient becomes unresponsive to questions.