Boston Scientific Precision Novi Guia De Informacion página 7

Electromagnetic Interference. Strong electromagnetic fields can potentially turn the
Stimulator off, or cause uncomfortable or jolting stimulation or affect wireless communication.
Patients should be counseled to avoid or exercise care around the following:
• 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
• Tag deactivators such as those found in retail stores and libraries
If the patient is near these devices, he may become aware of changing stimulation levels. In
rare instances, if the stimulation is on, the patient could experience an increase in stimulation
level to the point that the sensation is uncomfortably strong or possibly "jolting." If this happens,
the patient should turn off the Stimulator. If the Stimulator suddenly turns off by itself, the patient
should first move away from the area. Next, check the stimulation status with the Remote
Control by pressing the Unlock button and observing the screen.
The patient should be counseled to always be aware of his surroundings, particularly near theft
detectors/security screeners. He should ask for assistance to go around these devices if he
feels at all uncomfortable.
Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in close
proximity to the device:
• lithotripsy
• electrocautery (See "Instructions for the Physician" on page 7)
• external defibrillation
• radiation therapy (Any damage to the device by radiation may not be immediately
detectable.)
• ultrasonic scanning
• high-output ultrasound
X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT Scans are
unlikely to damage the Stimulator if stimulation is turned off.
Precision Novi™ System Information for Prescribers
90962628-03 Rev A
Safety Information
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