HAR §11-45-117. All diagnostic x-ray systems

(a) The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed." (b) On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation. (c) The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed one hundred milliroentgens (25.8 §11-45-117 45-92 microcoulombs per kilogram) in one hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters with no linear dimension greater than twenty centimeters. (d) The radiation emitted by a component other than the diagnostic source assembly shall not exceed two milliroentgens (0.516 microcoulombs per kilogram) in one hour at five centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters with no linear dimension greater than twenty centimeters. (e) Beam quality: (1) The half-value layer of the useful beam for a given x- ray tube potential shall not be less than the appropriate value specified in Appendix C of this subchapter under "specified dental systems," for any dental system designed for use with intraoral image receptors and manufactured after December 1, 1980; and under "other x-ray systems," for all other x-ray systems subject to this section. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Appendix C, linear interpolation or extrapolation may be made. Positive means shall be provided to insure that at least the minimum filtration needed to achieve the above beam quality requirements is in the useful beam during each exposure. (2) For capacitor energy storage equipment, compliance with the requirements of paragraph (1) shall be determined with the maximum quantity of charge per exposure. This shall be deemed to have been met if an milliamperes-second of ten has been used. (3) The required minimal half-value layer of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient. (4) For x-ray systems which have variable kilovoltage peak and variable filtration for the useful beam, a device shall link the kilovolts peak selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration necessary to produce the half-value layer required by paragraph (1) is in the useful beam for the given kilovolts peak which has been selected. (f) Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated before initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected. (g) The tube housing assembly supports shall be adjusted such that the tube housing assembly shall remain stable during an exposure unless tube housing movement is a designed function of §11-45-118 45-93 the x-ray system. (h) Technique indicators: (l) The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set before the exposure shall be indicated. (2) The requirement of paragraph (l) may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist. (i) Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the federal x- ray equipment performance standard, 21 C.F.R. Part 1020, shall be maintained in compliance with applicable requirements of that standard and this subchapter. (j) All position locking, holding, and centering devices on x-ray system components and systems shall function as intended. (k) The exhibit at the end of chapter 11-45 entitled, "Appendix C of Subchapter 6, Half-Value Layer (7/25/96)", is made a part of this section. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)