ULTRASOUND PROBLEM SOLVING
DYNATRON SOLARIS
®
PLUS SERIES | SERVICE MANUAL REV. 6 | AUGUST 29, 2017 88
• FDA 21CFR 1050(c)(1)(i). e 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). e sum of the errors in the indications of temporal-maximum ultrasonic power and the
ratio of the temporal-maximum eective intensity to the temporal-average eective intensity shall not exceed ±20
percent for all emissions greater than 10 percent of the maximum emission.
• FDA 21CFR 1050.10(c)(2). e 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.
Pursuant to FDA 21CFR 1050.10(f)(1), the uncertainties in magnitude, expressed in percentage error, of the ultrasonic
frequency, eective radiating area, and the ratio of the temporal-maximum to temporal-average eective intensity, pulse
duration, and pulse repetition rate for the Dynatron Solaris Plus 708 and 709 are as follows:
(1) Ultrasonic frequency .......................................................................................................±15%
(2) Eective Radiating Area .................................................................................................±20%
(3) Ratio of the temporal-maximum to temporal-average eective intensity ............... ±20%
(4) Pulse duration .................................................................................................................. ±10%
(5) Pulse repetition rate ........................................................................................................ ±10%
NOTE: e Dynatron Solaris Plus 708 and 709 are accurate to within ±1% of any treatment time.
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