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ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
Safety Information
Warnings
MRI System: Only use 1.5T Full Body transmit/receive (RF quadrature only), Head transmit/receive (RF quadrature
only), or lower extremity transmit/receive (RF quadrature only) coils. Use hydrogen/proton imaging only. Do not
use other transmit/receive coils (e.g., linear coils). Local receive‑only coils may be used. Only 1.5T coils have been
evaluated.
Active Scan Time: Do not exceed cumulative active scan time (with RF On) of 30 minutes per imaging session. If
30 mins of active scan time is reached allow 60 mins of non‑active time before proceeding. Exceeding the active scan
time increases the risk of tissue heating.
MRI Scanner Operating Mode: 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
potential adverse effects listed below under "Potential Interactions with MRI Environment."
MRI Mode (Applicable to Full System Only): 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.
Impedances 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
implanted DBS System. Following the safety conditions designated in this manual will minimize the potential interactions
described in this section.
• Heating – The MRI RF field interacts with the implanted system and can produce significant heating effects
at the Lead‑electrode‑tissue and/or Stimulator‑tissue interface. This can cause tissue damage, edema,
burns, discomfort, pain, nerve injury, inadequate stimulation, device damage and/or the need for additional
intervention.
• Main Magnetic Field Interactions – The MRI magnetic field may exert translation and torque effects on the
implanted Lead and/or Stimulator. Patients may feel a tugging sensation, discomfort or pain at the site of the
Lead or Stimulator implant. Patients with recent implant incisions may feel surgical wound discomfort.
• Induced Stimulation – An MRI may induce energy into the implanted Leads, potentially causing unintended or
uncomfortable stimulation or unusual sensations.
If interactions occur and cause the patient discomfort, stop the MRI scan.
If an MRI scan is performed outside of the conditions advised in this manual, it may increase the risks of the potential
interactions described above or result in more serious risks. These may include unintended stimulation, pain, tissue
damage, burns, nerve injury, cerebrovascular accidents, coma, paralysis, or death.
Gradient Systems: Do not use gradient systems producing gradient slew rates greater than 200 T/m/s because they
have not been evaluated and could cause increased risk of induced stimulation.
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.
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.
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
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