Safety Information; Instructions For The Patient; Warnings - Boston Scientific Precision Manuel

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.
Electromagnetic Interference. Strong
electromagnetic fields can potentially turn the
Stimulator off, or cause uncomfortable or jolting
stimulation. Patients should be counseled to
avoid or exercise care around:
• Theft detectors or security screeners
such as those used at entrances/
90607862-22 Rev A
Safety Information
Clinician Manual
11 of 303