Product Info

10001045 REV B 19
Stimulation at 10 kHz does not generate paresthesia, so patients should not experience unpleasant sensations
caused by posture changes or movement. As such, patients would not need to change amplitudes in their
programs for posture changes or abrupt movements.
6.8 Patient Activities Related to Lead Movement
Patients should not make sudden and excessive bending, stretching, or twisting movements. An implanted lead
can move from its original location during such movements, which might affect delivery of therapy. In such cases,
the Trial Stimulator may need to be reprogrammed or the lead(s) may need to be repositioned through another
operation.
6.9 Hyperbaric Chambers
The Senza
®
Bluetooth
®
Trial System is sensitive to high pressure. Patients should not enter hyperbaric chambers
with pressure greater than 4.5 ATM. Pressure greater than 4.5 ATM may damage the Senza
®
Bluetooth
®
Trial
System.
HYPERBARIC CHAMBER. A special chamber or compartment in which 100% oxygen is delivered to a person
under very high pressures, far above the normal atmospheric pressure. Hyperbaric therapy is used for some
medical treatments, such as wound healing.
6.10 Transcranial Magnetic Stimulation and Electroconvulsive Therapy
Safety has not been established for Transcranial Magnetic Stimulation (TMS) or Electroconvulsive Therapy (ECT)
in patients who have an implanted SCS system. Induced electrical currents may cause heating, especially at the
lead electrode site, resulting in tissue damage.
TRANSCRANIAL MAGNETIC STIMULATION. A non-invasive way that uses magnetic fields to stimulate
nerve cells in the brain.
ELECTROCONVULSIVE THERAPY. A procedure in which electric currents are passed through the brain to
intentionally cause a seizure.
6.11 Transcutaneous Electrical Nerve Stimulation
Do not place transcutaneous electrical nerve stimulation (TENS) electrodes so that the TENS current passes over
any part of the SCS system. If a patient feel that the TENS may be interfering with the implanted SCS system, the
patient should discontinue using the TENS and consult with their doctor.
TENS. A TENS unit is a device that sends small electrical currents to targeted body parts. These currents are
used to relieve pain.