Safety Information; Indications For Use; Contraindications; Warnings - Boston Scientific SC-5210 Manuel

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Safety Information

Indications for Use

The Boston Scientific Precision™ System is indicated as an aid in the management of chronic intractable pain.

Contraindications

Patients contraindicated for permanent SCS or PNS therapy are those who:
• are unable to operate the SCS or PNS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant

Warnings

Heat Due to Charging. Do not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It
should be handled with care. Failure to use the Charger with either the Charger Belt or an adhesive patch, as shown, may result in a
burn. If you experience pain or discomfort, cease charging and contact your healthcare professional.
Magnetic Resonance Imaging (MRI).
MRI Transmit or Transmit/Receive RF Body Coil. You should not be exposed to a MRI transmit or transmit/receive RF body coil.
Exposure to this diagnostic technology may result in dislodgement of your Stimulator or lead(s), heating of the Stimulator, severe
damage to the Stimulator electronics and/or increased voltage through the leads or Stimulator which can cause an uncomfortable or
"jolting" sensation.
MRI Transmit/Receive RF Head Coil. An MRI examination of the head only (no other part of the body) can be conducted safely
using only a transmit/receive RF head coil of a 1.5-Tesla horizontal bore MRI system when your physician follows all of the
instructions in Appendix A: 1.5 Tesla MRI Guidelines to Physicians for Patients with Precision Systems, of the Clinician's Manual.*
The use of a transmit/receive RF head coil constrains the majority of the RF fields to the head region and away from the implanted
components of the Precision System. MRI examinations performed on patients with the Precision System using open-sided MRI
systems, or other types of MRI systems operating at other static magnetic field strengths (higher or lower) have not been assessed
and, as such, should not be performed.
* Please have your health care professional contact Boston Scientific for these guidelines. Contact information is found on the last page and back cover of this manual.
Patient System Handbook
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