Ultrasound Regulation - Dynatronics Dynatron 850 Plus Service Manual

The Dynatron 850plus complies with the following:
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Pursuant to FDA 21CFR 1050.10(f)(1), the uncertainties in magnitude, expressed in
percentage error, of the ultrasonic frequency, effective radiating area, and the ratio of the
temporal-maximum to temporal-average effective intensity, pulse duration, and pulse
repetition rate for the Dynatron 850plus are as follows:
Ultrasound Technical Information
Dynatron

Ultrasound Regulation

IEC 601-2-5: 1984. Medical Electrical Equipment Part 2: Particular requirements
for the safety of ultrasonic therapy equipment.
FDA 21CFR 1050(c)(1)(i). The error in indication of the temporal-average
ultrasonic power shall not exceed ±20 percent for all emissions greater than 10
percent of the maximum emission.
FDA 21CFR 1050(c)(1)(ii). The sum of the errors in the indications of temporal-
maximum ultrasonic power and the ratio of the temporal-maximum effective
intensity to the temporal-average effective intensity shall not exceed ±20 percent for
all emissions greater than 10 percent of the maximum emission.
FDA 21CFR 1050.10(c)(2). The treatment timer must be accurate to within 0.5
minute of the preset duration of emission for settings less than 5 minutes, to within
10 percent of the preset duration of emission for settings of from 5 minutes to 10
minutes, and to within 1 minute of the preset duration of emission for settings greater
than 10 minutes.
NOTE: The Dynatron 850plus is accurate to within ±1% of any treatment time.
(1) Ultrasonic frequency ..................................... ±15%
(2) Effective Radiating Area............................... ±50%
(3) Ratio of the temporal-maximum to
temporal-average effective intensity ............. ±20%
(4) Pulse duration................................................ ±10%
(5) Pulse repetition rate....................................... ±10%
850plus & 550plus
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