10857.1The provisions of this section are applicable as specified herein to any ultrasonic therapy product for use in physical therapy manufactured on or after February 17, 1979.
10857.2As used in this section the following definitions apply:
(a)Amplitude modulated waveform - a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the root-mean-square pressure amplitude spatially averaged over the effective radiating surface is greater than one and five hundredths (1.05);(b)Applicator - that portion of a fully assembled ultrasonic therapy product that is designed to emit ultrasonic radiation and which includes one or more ultrasonic transducers and any associated housing;(c)Beam cross-section - the surface in any plane consisting of the points at which the intensity is greater than five percent (5%) of the spatial-maximum intensity in that plane;(d)Beam nonuniformity ratio - the ratio of the temporal-average spatial-maximum intensity to the temporal-average effective intensity;(e)Centroid of a surface - the point whose coordinates are the mean values of the coordinates of the points of the surface;(f)Collimating applicator - an applicator that does not meet the definition of a focusing applicator as specified in the paragraph "Focusing applicator" of this section and for which the ratio of the area of at least one beam cross-section, whose centroid is twelve centimeters (12 cm) from the centroid of the effective radiating surface, to the area of the effective radiating surface is less than two (2);(g)Continuous-wave waveform - a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the root-mean-square pressure amplitude spatially averaged over the effective radiating surface is less than or equal to one and five hundredths (1.05);(h)Diverging applicator - means an applicator that does not meet the definition of a collimating applicator or a focusing applicator as specified in paragraphs "Collimating applicator" and "Focusing applicator" of this section;(i)Effective intensity - the ratio of the ultrasonic power to the focal area for a focusing applicator. For all other applicators, the effective intensity is the ratio of the ultrasonic power to the effective radiating area. Effective intensity is expressed in watts per square centimeter (W/cm2);(j)Effective radiating area - the area consisting of all points of the effective radiating surface at which the intensity is five percent (5%) or more of the maximum intensity at the effective radiating surface, expressed in square centimeters (cm2);(k)Effective radiating surface - the surface consisting of all points five millimeters (5 mm) from the applicator face;(l)Focal area - the area of the focal surface, expressed in square centimeters (cm2);(m)Focal length - the distance between the centroids of the effective radiating surface and the focal surface, for a focusing applicator, expressed in centimeters (cm);(n)Focal surface - the beam cross-section with smallest area of a focusing applicator;(o)Focusing applicator - an applicator in which the ratio of the area of the beam cross-section with the smallest area to the effective radiating area is less than one-half (1/2);(p)Generator - that portion of a fully assembled ultrasonic therapy product that supplies electrical energy to the applicator. The generator may include, but is not limited to, a power supply, ultrasonic frequency oscillator, service controls, operation controls, and a cabinet to house these components;(q)Maximum beam non-uniformity ratio - the maximum value of the beam non-uniformity ratio characteristic of a model of an ultrasonic therapy product;(r)Operation control - any control used during operation of an ultrasonic therapy product that affects the ultrasonic radiation emitted by the applicator;(s)Pressure amplitude - the instantaneous value of the modulating waveform, and is p1(t) in the expression for a pressure wave, p(t)=p1(t) p2(t), where p(t) is the instantaneous pressure, p1(t) is the modulating envelope, and p2(t) is the relative amplitude of the carrier wave normalized to a peak height of one (1). All are periodic functions of time (t0 at any point in space. The period of p1(t) is greater than the period of p2(t);(t)Pulse duration - a time interval, expressed in seconds, beginning at the first time the pressure amplitude exceeds the minimum pressure amplitude plus ten percent (10%) of the difference between the maximum and minimum pressure amplitudes, and ending at the last time the pressure amplitude returns to this value;(u)Pulse repetition rate - the repetition frequency of the waveform modulating the ultrasonic carrier wave expressed in pulses per second (pps);(v)Service control - any control provided for the purpose of adjustment that is not used during operation and can affect the ultrasonic radiation emitted by the applicator, or can alter the calibration or accuracy of an indicator or operation control;(w)Ultrasonic frequency - the frequency of the ultrasonic radiation carrier wave, expressed in Hertz (Hz), kilohertz (kHz), or megahertz (MHz);(x)Ultrasonic power - the total power emitted in the form of ultrasonic radiation by the applicator averaged over each cycle of the ultrasonic radiation carrier wave, expressed in watts;(y)Ultrasonic therapy product -(1) Any device intended to generate and emit ultrasonic radiation for therapeutic purposes at ultrasonic frequencies above sixteen kilohertz (16kHz.); or(2) Any generator or applicator designed or specifically designated for use in a device as specified in Paragraph (a); and(z)Ultrasonic transducer - a device used to convert electrical energy of ultrasonic frequency into ultrasonic radiation or vice versa.10857.3The requirements of this section are applicable to each ultrasonic therapy product as defined in Paragraphs (a) and (b) of § 10857.2 when the generator and applicator are designated or intended for use together, or to each generator when the applicator(s) intended for use with the generator does not contain controls that affect the functioning of the generator.
10857.4A means shall be incorporated to indicate the magnitudes of the temporal-average ultrasonic power and the temporal-average effective intensity when emission is of continuous-wave waveform. The error in the indication of the temporal-average ultrasonic power shall not exceed plus or minus twenty percent (+/- 20%) for all emissions greater than ten percent (10%) of the maximum emission.
10857.5A means shall be incorporated to indicate the magnitudes of the temporal-maximum ultrasonic power and the temporal-maximum effective intensity when the emission is of amplitude-modulated waveform. The sum of the errors in the indications of the temporal-maximum ultrasonic power and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity specified in § 10857.14 of this section shall not exceed plus or minus twenty percent (+/-20%) for all emissions greater than ten percent (10%) of the maximum emission.
10857.6A means shall be incorporated to enable the duration of emission of ultrasonic radiation for treatment to be preset and such means shall terminate emission at the end of the preset time. Means shall also be incorporated to enable termination of emission at any time. Means shall be incorporated to indicate the magnitude of the duration of emission (expressed in minutes) to within one-half minute (0.5) minute of the preset duration of emission for setting less than five (5) minutes, to within ten percent (10%) of the preset duration of emission for settings of from five (5) minutes to ten (10) minutes, and to within one (1) minute of the preset duration of emission for settings greater than ten (10) minutes.
10857.7A means shall be incorporated for indicating the magnitudes of pulse duration and pulse repetition rate of the emitted ultrasonic radiation, if there are operation controls for varying these quantities.
10857.8A means shall be incorporated for indicating the magnitude of the ultrasonic frequency of the emitted ultrasonic radiation, if there is an operation control for varying this quantity.
10857.9A means shall be incorporated to provide a clear, distinct, and readily understood visual indicator when and only when electrical energy of appropriate ultrasonic frequency is being applied to the ultrasonic transducer(s).
10857.10In addition to the labeling requirements in Chapter 103 and the requirements of §§ 10845 and 10846, each ultrasonic therapy product shall be subject to the applicable labeling requirements of this section.
10857.11Each operation control shall be clearly labeled identifying the function controlled and, where appropriate, the units of measure of that function. If a separate control and indicator are associated with the same function, then labeling the appropriate units of measure of that function is required for the indicator but not for the control.
10857.12Each service control that is accessible without displacement or removal of any part of the ultrasonic therapy product shall be clearly labeled identifying the function controlled and shall include the phrase "for service adjustment only."
10857.13Each generator shall bear a label that states:
(b) Model designation, and unique serial number or other unique identification so that it is individually identifiable;(c) Ultrasonic frequency (unless there is an operation control for varying this quantity); and(d) Type of waveform (continuous wave or amplitude modulated).10857.14Generators employing amplitude-modulated waveforms shall also bear a label that provides the following information: Pulse duration and pulse repetition rate (unless there are operation controls for varying these quantities), an illustration of the amplitude-modulated waveform, and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. (If this ratio is a function of any operation control setting, then the range of the ratio shall be specified, and the waveform illustration shall be provided for the maximum value of this ratio.).
10857.15Each applicator shall bear a label that provides the following information:
(a) The brand name, model designation, and unique serial number or other unique identification so the applicator is individually identifiable;(b) A designation of the generator(s) for which the applicator is intended; and(c) The ultrasonic frequency, effective radiating area, maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and for a focusing applicator the focal length and focal area.10857.16Labels required by this section shall be permanently affixed to or inscribed on the ultrasonic therapy product; they shall be legible and clearly visible. If the size, configuration, or design of the ultrasonic therapy product would preclude compliance with the requirements of this paragraph, the Director, Center for Devices and Radiological Health, may approve alternate means of providing such labels.
10857.17Tests on which certification pursuant to § 10845 is based shall account for all measurement errors and uncertainties. Such tests shall also account for increases in emission and degradation in radiation safety that occur with age.
10857.18Except as provided in § 10849, tests for compliance with each of the applicable requirements of this section shall be made:
(a) For all possible combinations of adjustments of the controls listed in the operation instructions;(b) With the ultrasonic radiation emitted into the equivalent of an infinite medium of distilled, degassed water at thirty degrees Celsius (30 °C) for measurements concerning the ultrasonic radiation; and(c) With line voltage variations in the range of plus or minus ten percent (+/-10%) of the rated value specified by the manufacturer.10857.19Measurements for determination of the spatial distribution of the ultrasonic radiation field shall be made with a detector having dimensions of less than one (1) wavelength in water or an equivalent measurement technique.
10857.20The manufacturer of an ultrasonic therapy product shall provide or cause to be provided to servicing dealers and distributors, and to others upon request, at a cost not to exceed the cost of preparation and distribution adequate instructions for operations, service, and calibration, including a description of those controls and procedures that could be used to increase radiation emission levels, and a schedule of maintenance necessary to keep equipment in compliance with this section. The instructions shall include adequate safety precautions that may be necessary regarding ultrasonic radiation exposure.
10857.21The manufacturer of an ultrasonic therapy product shall provide as an integral part of any user instruction or operation manual that is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each ultrasonic therapy product, and to others upon request, at a cost not to exceed the cost of preparation and distribution the following:
(a) Adequate instructions concerning assembly, operation, safe use, any safety procedures and precautions that may be necessary regarding the use of ultrasonic radiation, and a schedule of maintenance necessary to keep the equipment in compliance with this section. The operation instructions shall include a discussion of all operation controls, and shall describe the effect of each control;(b) Adequate description of the spatial distribution of the ultrasonic radiation field and the orientation of the field with respect to the applicator. This will include a textual discussion with diagrams, plots, or photographs representative of the beam pattern. If there is more than one (1) ultrasonic transducer in an applicator and their positions are not fixed relative of each other, then the description must specify the spatial distribution of the ultrasonic radiation field emitted by each ultrasonic transducer and present adequate examples of the combination field of the ultrasonic transducers with regard to safe use. The description of the ultrasonic radiation field shall state that such description applies under conditions specified in § 10857.18(b);(c) Adequate description, as appropriate to the product, of the uncertainties in magnitude expressed in terms of percentage error, of the ultrasonic frequency effective radiating area, and, where applicable, the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity, pulse duration, pulse repetition rate, focal area, and focal length. The errors in indications specified in §§ 10857.4 and 10857.5 shall be stated in the instruction manual; and(d) A listing of controls, adjustments, and procedures for operation and maintenance, including the warning "Caution--use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.".D.C. Mun. Regs. tit. 22, r. 22-B10857
Final Rulemaking published at 60 DCR 10252 (July 12, 2013)Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.