Dynatronics Dynatron 825 - Ultrasound Specifications; Ultrasound Regulation and Technical Information

ULTRASOUND PROBLEM SOLVING
DYNATRON® 25 SERIES™ | OPERATOR’S MANUAL 60
Ultrasound Specications
Ultrasound Power output:
2cm
2
head: .........................1 MHz, 2 MHz, 3 MHz ..................... 0-4 watts; 0-2.0 w/cm
2
± 10%
5cm
2
head: .........................1 MHz, 2 MHz, 3 MHz ................... 0-10 watts; 0-2.0 w/cm
2
± 10%
10cm
2
head: .............................1 MHz, 2 MHz .......................... 0-20 watts; 0-2.0 w/cm
2
± 10%
10cm
2
head: ....................................3 MHz .................................. 0-10 watts; 0-1.0 w/cm
2
± 10%
Ultrasound Regulation and Technical Information
For the Dynatron 825, and 925 Only
e Dynatron 825, and 925 comply with the following:
• 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 eective intensity to the temporal-average eective 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, eective radiating area, and the ratio of the temporal-maximum to temporal-average eective intensity, pulse
duration, and pulse repetition rate for the Dynatron 25 Series 825 and 925 are as follows:
(1) Ultrasonic frequency .......................................................................................................±15%
(2) Eective Radiating Area .................................................................................................±20%
(3) Ratio of the temporal-maximum to temporal-average eective intensity ............... ±20%
(4) Pulse duration .................................................................................................................. ±10%
(5) Pulse repetition rate ........................................................................................................ ±10%
NOTE: e Dynatron 25 Series 825 and 925 are accurate to within ±1% of any treatment time.