Dynatron® 850plus & 550plus
Ultrasound Technical Information
100
Ultrasound Regulation
The Dynatron 850plus complies with the following:
• 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.
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:
(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%
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