1600751-4D
• Treatment of the thyroid, as well as lymph nodes in the neck, may expose the patient to
as yet undetermined effects inasmuch as the safety of such treatments has not yet been
established.
Potential Adverse Effects:
• Cataracts.
• Male sterility.
• Enhanced drug activity.
• Thermal stress.
5.1.2 Parameters
Ultrasound Frequency, expressed in MHz, is the frequency of the ultrasound waves. The
ultrasound frequency determines the penetration depth, which has the largest value at 1 MHz.
The ultrasound frequency can be set at 1 MHz or 3 MHz.
Duty Cycle, expressed in %, defines the ratio of the pulse duration to the pulse repetition time.
Ultrasound can be applied in pulsed or in continuous mode. When the Duty Cycle is set to
100%, the apparatus operates in continuous mode.
Effective Radiation Area (ERA) expressed in cm², defines the cross-sectional area of the
ultrasound beam (See technical specifications for details). The Effective Radiation Area is fixed
and defined by the size of the ultrasound applicator.
Ultrasound Power is the ultrasound output expressed in W. The ultrasound output display can
be toggled between W and W/cm². In pulsed mode the power during the pulse is displayed. The
time averaged power can be obtained by multiplying this value with the Duty Cycle.
Ultrasound Amplitude, expressed in W/cm², is the quotient of Ultrasound Power and Effective
Radiation Area. The ultrasound output display can be toggled between W and W/cm². In pulsed
mode the Amplitude during the pulse is displayed. The time-averaged Amplitude can be
obtained by multiplying this value with the Duty Cycle.
5.2 Combination Therapy
Combination therapy is the combined application of ultrasound and electrical stimulation. With
combination therapy the metal surface of the ultrasound treatment head becomes the negative
electrical stimulation electrode, while the lead wire with the red connector remains the positive
electrical stimulation electrode. Combination therapy is available with all current waveforms, but
limited to channel 2.
Combination therapy is typically used for the reduction of muscle spasm.
The combined Contraindications and Adverse Effects of paragraph 4 and 5 apply.
5.3 StatUS Therapy
StatUS stands for Stationary Ultra Sound: the application of ultrasound without moving the
ultrasound treatment head (= stationary). In the normal course of events, ultrasound energy is
administered by moving (‘making circles’) the treatment head. This moving of the treatment
head (also called the dynamic or semi-stationary method) is essential because a few
unfavourable phenomena occur both within an ultra-sound bundle as well as in the tissue, which
may lead to tissue, damage (so-called ‘hot spots’). StatUS-therapy, on the other hand, makes
use of two special forms of modulation that ensure that the peaks in intensity in the ultra-sound
bundle are strongly reduced, diminishing the risk of cavitation and preventing the occurrence of
‘hotspots’.
These modulation forms are:
1. Duty Cycle Modulation
2. Amplitude Modulation
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