Precautions; Limitations; Image Artifact - Boston Scientific ImageReady MRI Mode D'emploi

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 (i.e., Charger, Remote Control, External Trial Stimulator, ETS Adapter, and OR
Cables) are MR Unsafe. They must not be taken into any MRI 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 prescan and the actual MRI examination are within the recommended
settings listed in this manual.

Precautions

Explant of Non-MR Conditional Extensions and Stimulators for MRI :The fully implanted Lead‑Only MR conditional
system is comprised of a booted Leads system comprised of Leads, Lead Boots, and Burr Hole Covers listed in Table 2.
The risk of explant to create a Leads‑Only MR conditional configuration outlined in this manual should be evaluated by a
health care professional.
Return of Symptoms: Patients may become anxious or their symptoms may return once stimulation is turned OFF.
Ensure that the patient has been given the appropriate medical care to manage the return of symptoms before
performing an MRI scan.

Limitations

Other Implanted Devices: An MRI can also be performed safely if, instead of the Burr Hole Cover, a mini plate similar
to a Stryker 12 mm titanium mini plate with Stryker titanium screws, is used to secure the DBS Leads to the skull in
either the Leads‑Only or Full System configurations. Boston Scientific has not evaluated the effect of other implanted
devices in combination with or in proximity to the Boston Scientific System described in this manual. Boston Scientific
does not recommend an MRI scan if other implanted devices are present.

Image Artifact

Artifacts and distortions may be produced in the MR image by any DBS System components. Users must be aware of
these when selecting imaging parameters or interpreting MR images. Careful selection of pulse sequence parameters,
and location of the imaging plane may minimize MR image artifacts. Although reduction of image distortion can be
obtained by adjusting pulse sequence, this may compromise signal‑to‑noise ratio. The following guidelines will help
minimize image artifacts and distortions:
• Use a local receive‑only coil instead of a body receive coil whenever possible.
• Use imaging sequences with stronger gradients for both slice and read encoding directions.
• Use a higher bandwidth for radio‑frequency pulse and data sampling.
• Select an orientation for the read‑out axis that minimizes the in‑plane distortion.
• Use a shorter echo time for gradient echo technique, whenever possible.
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
Safety Information
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