Product Manual
GENERAL SPECIFICATIONS
DYNATRON
®
125 | OPERATOR’S MANUAL REV. 3 | 8/29/2017 35
• 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 125 is 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%
Care and Cleaning Instructions
Dynatron 125 Console
• Clean the outer surface of the Dynatron 125 devices with a slightly damp or lightly moistened cloth. Mild household
cleaners work well on the frame, but do not use cleaners on the display windows. Do not spray the solution directly
on the unit. Solvents, caustic solutions and harsh or abrasive cleaners must never be used.
• Do not attempt to sterilize the device or the soundheads using any type of sterilization equipment including
autoclaves.
• Avoid stretching cords to full length, bending cords sharply or wrapping cords tightly. Undue stress on cords can
damage connections.
• Keep all food and drinks away from the machine and its accessories; spills can cause costly damage to the machine
and repairs for this type of damage are not covered by the warranty.
• Do not place hot packs or any items with moisture content on top of the console.
NOTE: e Dynatron 125 is accurate to within ±1% of any treatment time.