effectiveness and perception of paresthesia. Specifically, for stimulation frequencies
above 1,200 Hz, amplitudes that produce paresthesias have not been evaluated and
therefore it is unknown whether injury may occur.
Stimulation at vertebral levels above T8
– The safety of program settings above 1,200
Hz have not been studied above the T8 vertebral level.
Pediatric Use
– The safety and effectiveness of spinal cord stimulation has not been
established for use in children.
Other Active Implanted Devices – Please let your doctor know if you have any other
active implanted devices in your body. The Senza system may interfere with other
implanted stimulators, such as cardiac pacemakers and defibrillators which have
sensing features, and may result in sensing problems or inappropriate responses. The
effect of other implanted devices, including deep brain stimulators, peripheral nerve
stimulators, implanted drug delivery pumps, and cochlear implants on the Senza
system are unknown.
Sleep
– If you are using therapy that generates paresthesia (tingling sensations caused
by stimulation) you may choose to turn stimulation off to avoid uncomfortable
sensations during sleep (see Warning regarding Stimulation Frequency). If you are
using therapy at 10 kHz which does not generate paresthesia, stimulation can remain
on during sleep.
Operation of Vehicles (e.g., driving) or Machinery
– If you are using therapy that
generates paresthesia you should not operate motorized vehicles such as automobiles
or potentially dangerous machinery and equipment with the stimulation on when
using paresthesia-causing programs. Stimulation must be turned off first in such cases.
Any sudden stimulation changes may distract you from proper operation of the
vehicle, machinery, or equipment. If you are using therapy at 10 kHz which does not
generate paresthesia, it is less likely that sudden stimulation changes resulting in
distraction could occur.
Heat from Charging
– You will have to recharge the battery in your device. Always use
the special Charger Belt when recharging. During recharging, the Charging Coil may
become warm or even burn you. If you feel warmth or discomfort when recharging
Patient Manual 11052 Rev A (2015-01-16) 9
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