Safety Information; Indications For Use; Contraindications; Warnings - Boston Scientific Precision SC-5213 Manuel D'utilisation

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Safety Information

Indications for Use

The Boston Scientific Precision™ Spinal Cord Stimulator System with MultiWave Technology is indicated as an aid in the
management of chronic intractable pain.

Contraindications

Patients contraindicated for permanent SCS therapy are those who:
• are unable to operate the SCS 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, may result in a burn. If you
experience pain or discomfort, cease charging and contact your healthcare professional.
Magnetic Resonance Imaging (MRI). The Precision SCS System is "MR Conditional" when exposed to the magnetic resonance
imaging (MR) environment under the specific conditions defined in the supplemental manual "Precision™ Spinal Cord Stimulator
System 1.5 Tesla MRI Guidelines." It is important that the Physician read this information in its entirety before conducting or
recommending an MRI examination on a patient with a Precision SCS System. This supplemental manual relates specifically to the
use of a transmit/receive radio frequency (RF) head coil of a 1.5 Tesla horizontal bore MRI system for patients implanted with the
Boston Scientific Precision SCS System. The "Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines" supplemental
manual also appears on the Boston Scientific website (www.bostonscientific.com). 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.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
Patient System Handbook
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