User's Manual

Safety Information
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 7 of 15
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 defi brillators. 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.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fi elds 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/exits of department
stores, libraries, and other public establishments, and/or airport security screening devices.
It is recommended that patients request assistance to bypass the device. If they must
proceed through the device, the patient should turn off the Stimulator and proceed with
caution, moving through the center of the screener as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large, magnetized stereo speakers