Do not bring your patient controller into the scanner
magnet room. It can be affected by the MRI magnet,
may present a projectile hazard, and is MR Unsafe.
For more information about what you need to do to
prepare for an MRI scan, refer to “Using the MRI Mode
Feature” (page 40) in this guide.
Warnings
The following warnings apply to these components.
NOTE: For nontherapy-related warnings for the
NeuroSphere™ Patient Controller, refer to the user
guide available at support.apple.com/manuals for the
Apple‡ iOS‡ device you are using to run the patient
controller app.
System Warnings
Pregnancy and nursing.
Safety and effectiveness of
neurostimulation for use during pregnancy, nursing, the
unborn fetus, or delivery have not been established.
Pediatric use.
Safety and effectiveness of
neurostimulation for pediatric use have not been
established.
Back pain.
The safety and efficacy for the treatment of
patients who have back pain as the greatest region of
pain have not been evaluated.
Medical tests and procedures.
Before undergoing
medical tests or procedures (such as therapeutic
radiation or electrolysis), contact your physician to
determine if the procedure will cause you injury or
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