Safety Information; Instructions For The Patient; Warnings - Boston Scientific Precision SC-1110 Mode D'emploi

Safety Information

Safety Information

Instructions for the Patient

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 Charging Belt or an adhesive patch, as shown, may result in a burn. If you experience pain or
discomfort, cease charging and contact Boston Scientific.
Magnetic Resonance Imaging (MRI). The Precision SCS System is "MR Conditional" when
exposed to the magnetic resonance imaging (MRI) environment under the specific conditions
defined in the supplemental manual "1.5 Tesla MRI Guidelines to Physicians for Patients with
Precision Spinal Cord Stimulator System". It is important to 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 1.5 Tesla MRI Guidelines to Physicians for
Patients with Precision Spinal Cord Stimulator System supple mental manual also appears on the
Boston Scientific website (www.bostonscientific.com). MRI exposure may result in dislodgement
of implanted components, heating of the neurostimulator, damage to the device electronics and/or
voltage induction through the leads and Stimulator causing an uncomfortable or "jolting" sensation.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for
pediatric use.
Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used
on SCS patients. The energy generated by diathermy can be transferred through the Stimulator
system, causing tissue damage at the lead site and resulting in severe injury or death. The IPG,
whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of
implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects of
implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced and patient
tissue is exposed to battery chemicals. Do not implant the device if the case is damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements may
cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Patients
should be advised to turn down the amplitude or turn off the IPG before making posture changes. If
unpleasant sensations occur, the IPG should be turned off immediately.
Clinician Manual
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