Boston Scientific Spectra WaveWriter Informacion Para Medicos página 7

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 using therapy that does not produce a sensation, postural changes are less
likely to affect the patient.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn the
Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the
Remote Control communication. Patients should be counseled to avoid or exercise care around
the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department
stores, libraries, and other public establishments. The patient should proceed with caution,
ensuring to move through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government
buildings, including hand-held scanners. The patient should request assistance to bypass
the device. If the patient must pass through the security screener, they should move quickly
through the device staying as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems
that can broadcast a radio frequency (RF) signal. The high energy fields produced by these
systems may interfere with the operation of the Remote Control and its ability to control
stimulation.
• Other sources of electromagnetic disturbance, such as RF transmitters at television or radio
broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio
Service band transceivers.
Note: When in close proximity, equipment that generate strong electromagnetic fields might
cause uncomfortable or jolting stimulation or interfere with wireless communication even
if they comply with CISPR requirements.
Spectra Wavewriter™ System Information for Prescribers
92089818-02
Safety Information
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