Safety Information; Instructions For The Patient; Warnings - Boston Scientific Precision SC-1110 Serie Manual De Uso

Precision™ System Clinician Manual

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)
MRI Transmit or Transmit/Receive RF
Body Coil. Patients implanted with the
Precision System should not be subjected
to a MRI transmit or transmit/receive RF
body coil. 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.
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
all instructions in Appendix A: 1.5 Tesla MRI
Guidelines to Physicians for Patients with
Precision System are followed. 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
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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.
NOTE: MRI Transmit/Receive RF Head Coil
is not approved for use with Peripheral
Nerve Stimulation
Pediatric Use. The safety and effectiveness
of spinal cord stimulation or peripheral nerve
stimulation has not been established for
pediatric use.
Diathermy. Shortwave, microwave and/or
therapeutic ultrasound diathermy should not
be used on SCS or PNS 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 or peripheral nerve
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.