Radiation Emitting Devices Regulations — 2
2 (1) Every ultrasound therapy device shall be designed and constructed in such a manner that, under the conditions of use specified by the manufacturer, it functions in accordance with section 3 for as long as the device has its original components or replacement components recommended by the manufacturer. (2) Every ultrasound therapy device shall be designed in such a manner that (a) all marks, labels and signs are permanently affixed thereon and clearly visible; and (b) all user controls, meters, lights or other indicators are clearly visible, readily discernible and clearly labelled to indicate their function. (3) Every ultrasound therapy device shall bear (a) on the external surface of its housing (i) the name and address of the manufacturer, (ii) the name and address of the distributor, if the distributor is not the manufacturer, (iii) the type and model designation, (iv) the serial number, (v) the month and year of manufacture, (vi) the ultrasonic frequencies in kilohertz (kHz) or megahertz (mHz), (vii) a statement indicating whether the wave produced by the device is a continuous wave or an amplitude modulated wave, (viii) in the case of a device that produces an amplitude modulated wave, (A) the pulse repetition rate, the pulse duration, the ratio of the temporal maximum effective ultrasonic intensity to the temporal average effective ultrasonic intensity, and a description of the wave shape, where these parameters do not vary depending on the power, and (B) the pulse repetition rate, the pulse duration, the ratio of the temporal maximum effective ultrasonic intensity to the temporal average effective ultrasonic intensity, and a description of the wave shape, all at temporal maximum ultrasonic power where these parameters do vary depending on the power, (ix) the line voltage used for normal operation, and (x) the ultrasound radiation warning sign described in section 4; and (xi) to (xiii) [Revoked, SOR/84-930, s. 3] (b) on the external surface of each applicator (i) the identification of the type and model of the ultrasound therapy device for which it is designed, (ii) where an applicator is a focussing applicator, the focal length and the focal area, (iii) a unique serial number or other unique identification, and (iv) the effective radiating area in square centimetres (cm 2 ). (4) Every ultrasound therapy device shall be designed and constructed to include the following safety features: (a) on the control panel, separate indicator lights or other equivalent indicators that have an expected lifetime of at least 5000 hours, (i) to show when the line voltage is “ON” or “OFF”, and (ii) to show when the ultrasonic power is being applied to the applicator; (b) a power indicator that (i) in the case of a device that produces a continuous wave, shows by a direct reading the level of the temporal average ultrasonic power and the temporal average effective ultrasonic intensity, (ii) in the case of a device that produces an amplitude modulated wave, shows by a direct reading the level of the temporal maximum ultrasonic power and the temporal maximum effective ultrasonic intensity, and (iii) functions in accordance with section 3; (c) a clear and reliable indicator of the range used, if the power indicator described in paragraph (b) utilizes two or more different ranges of measurement; and (d) a timer that (i) terminates the generation of ultrasound after a preset time interval and then returns to zero, (ii) does not allow the generation of ultrasound with the timer set at zero, (iii) is adjustable to settings in increments not greater than one minute, and (iv) functions in accordance with section 3. (5) Where an ultrasound therapy device is equipped with an ultrasonic power control, that control shall (a) allow the adjustment of ultrasonic power; (b) have a minimum and maximum adjustment that directly relates to the ultrasonic power level indicator; and (c) function in accordance with section 3.