Safety Information; Warnings - Boston Scientific ImageReady MRI Mode D'emploi

MR Conditional System Description

Safety Information

Warnings

MRI System: Only use 1.5T Full Body transmit/receive or Head 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.
Potential Interactions with MRI Environment: During an MRI examination, there are potential
interactions with the implanted DBS lead. Following the safety conditions designated in this manual will
minimize the potential interactions described in this section.
• Heating – The MRI RF field induces voltages onto the lead system that can produce significant
heating effects at the lead-electrode-tissue interface. This can cause tissue damage, burns, pain,
nerve injury, paralysis, 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. Patients may feel a tugging sensation at the site of the lead 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 these interactions cause the patient discomfort, stop the MRI scan.
If an MRI scan is performed outside of the conditions advised in this manual, it may result in 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.
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.
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
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