pairs that enable the physician or medical professional to focus the signals to different locations on the body.
In addition, the BiowavePRO system provides an option of either noninvasive surface or percutaneous electrodes. The percutaneous electrode is
a 2.5 inch round sterile, single use electrode containing 1014 0.75mm long microneedles which facilitate the delivery of the signals through
the skin. The percutaneous electrode set may only be used under the supervision of a physician.
Biowave Deep Tissue Signal Technology
Biowave’s signal technology is based on the discovery that when two sinusoidal high frequency signals are summed (added) together in the
device and then delivered into the body through a single electrode, the signals will pass into deep tissue and travel to a second opposing
electrode. As the summed signals pass through the body, polarized structures like the membrane of the C-fiber, A-delta fiber and muscle tissue
act in a non - linear fashion and force the further multiplication of these signals, resulting in a new spectrum of signals.
Multiplication of the high frequency signals results in the formation of a therapeutic low frequency electrical field that inhibits action
potential propagation along pain fibers. This field is focused in a 2-3 inch diameter hemisphere in the volume of tissue under and surrounding
each electrode. Since the nerve
fibers and muscle tissue under and surrounding the electrodes are encompassed by the low frequency field, at least one electrode must be placed
directly over the center of the painful area.
Biowave devices deliver the two summed signals to the first electrode; they mix in the
tissue beneath that electrode, then pass to the second electrode and return to the device, completing the circuit. Instantaneously, the summed
signals are delivered to the second electrode; they mix in the tissue beneath that electrode, then pass to the first electrode and return to
the device. The device alternates the delivery of the summed signals so quickly between the two electrodes that the patient cannot distinguish
that the signals left either location. The net effect is there are two active electrodes, each of which can treat a distinct volume of tissue
and there is no noxious twitching sensation.
Focusing of the Biowave Signals and Electrode Placement
With Biowave, depending on the nature and location of the painful area, the electrical signals can be focused to different parts of the
body by pairing electrodes of different sizes and types with one another. If two electrodes of equal area are used, then two distinct volumes
of tissue can be treated equally. For example, if a patient has bilateral low back pain, two equal area electrodes can be placed over the
respective painful areas on each side of the spine. Additionally, by moving these
electrodes closer together so that there is only 0.5 to 1.0 inch of space between them, the pair can be used to treat one larger volume of
tissue.
By pairing an electrode of smaller area with an electrode of larger area, the density of the therapeutic low frequency field is greater in
the volume of tissue beneath the smaller area electrode. Therefore, the smaller electrode needs to be placed directly over the primary painful
area. The larger electrode is still active (it is not a grounding pad) and should be placed over a secondary point of pain. If there is no
secondary point of pain, then the larger electrode must be placed over the bony prominence near the treatment site. Placement of the larger
electrode over a bony prominence allows the patient to more comfortably increase the intensity of the signal to higher levels allowing a
stronger electric field to encompass the pain site under the smaller primary electrode.
With the BiowavePRO system, the electrical signals can be focused by not only pairing different area electrodes with each other, but also by
combining percutaneous with noninvasive electrodes. Since the summed high frequency signals pass through the skin more easily when using the
percutaneous electrode, the impedance is lower in this area than at the opposing surface electrode. By having an impedance difference between
the electrodes, the therapeutic low frequency field is more concentrated where the impedance is lower. Therefore, the field in the volume of
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