S.C. Code Regs. § § 61-64.IV.RHB 4.3
Current through Register Vol. 48, No. 10, October 25, 2024
Section 61-64.IV.RHB 4.3 - General Requirements for all Diagnostic X-ray SystemsAll diagnostic x-ray systems shall meet the following requirements.
4.3.1 Warning Label. The control panel containing the main power switch shall bear the warning statement: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed." 4.3.1.1 The warning label shall be legible and its view unobstructed.4.3.2 Battery Charge Indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate that the battery is adequately charged.4.3.3 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed one hundred milliRoentgen (100 mR) in one (1) hour when the x-ray tube is operated at its maximum technique factors.4.3.4 Radiation from Capacitor Energy Storage Equipment in Standby Status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of two milliRoentgen (2 mR) per hour at five centimeters (5 cm) from any accessible surface of the diagnostic source assembly, with the beam limiting device fully open.4.3.5 Beam Quality. The half-value layer (HVL) of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table I, linear interpolation or extrapolation may be made. TABLE I
X-Ray Tube Voltage (kilovolt peak) |
Designed Operating Range | Measured Operating Potential | Minimum HVL (mm in Aluminum) |
Specified Dental Systems 1 | Other X-Ray Systems 2 | Other X-Ray Systems 3 |
Below 51 | 30 | 1.5 | 0.3 | 0.3 |
40 | 1.5 | 0.4 | 0.4 |
50 | 1.5 | 0.5 | 0.5 |
51 to 70 | 51 | 1.5 | 1.2 | 1.3 |
60 | 1.5 | 1.3 | 1.5 |
70 | 1.5 | 1.5 | 1.8 |
Above 70 | 71 | 2.1 | 2.1 | 2.5 |
80 | 2.3 | 2.3 | 2.9 |
90 | 2.5 | 2.5 | 3.2 |
100 | 2.7 | 2.7 | 3.6 |
110 | 3.0 | 3.0 | 3.9 |
120 | 3.2 | 3.2 | 4.3 |
130 | 3.5 | 3.5 | 4.7 |
140 | 3.8 | 3.8 | 5.0 |
150 | 4.1 | 4.1 | 5.4 |
1 Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. 3 All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. |
4.3.5.1 Beryllium window tubes shall have a minimum of 0.5 mm aluminum equivalent filtration permanently mounted in the useful beam.4.3.5.2 For capacitor energy storage equipment, compliance with RHB 4.3.5 shall be determined with the maximum quantity of charge per exposure.4.3.5.3 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.4.3.5.4 All intraoral dental units manufactured after December 1, 1980, shall have at least one and one-half millimeters (1.5 mm) aluminum equivalent filtration permanently installed in the useful beam.4.3.6 Filtration Controls. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by RHB 4.3.5 is in the useful beam for the given kVp which has been selected.4.3.7 Multiple Tubes. Where two (2) or more radiographic tubes are controlled by one (1) exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure.4.3.7.1 This indication shall be on both the x-ray control and at or near the tube housing assembly.4.3.8 Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless the tube housing movement is a designed function of the x-ray system.4.3.9 Technique Indicators. 4.3.9.1 The technique factors, whether manual or automatic exposure control, shall be indicated before the exposure begins. This requirement may be met by permanent markings on equipment having fixed technique factors.4.3.9.2 Technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.4.3.9.3 The x-ray control shall provide visual indication of the production of x-rays.4.3.9.4 X-ray systems utilizing arbitrary number or letter designators for kVp, time and milliAmperage shall be accompanied by a chart giving the value of physical factors for each arbitrary designator.4.3.10 Focal Spot Indication. The focal spot shall be denoted in such a manner and area as to be easily seen on the tube housing.4.3.11 Mechanical Timers. Use of mechanical timers is prohibited.4.3.12 Imaging Systems other than Screen/Film. The provisions of this Part are in addition to, and not in substitution for, applicable provisions of this regulation.4.3.12.1 Users of digital imaging acquisition systems shall follow protocol established by the manufacturer of the digital imaging acquisition system. Records documenting adherence to this protocol shall be kept for at least two (2) years or until the next Department inspection, whichever is later.4.3.12.2 The manufacturer's current operating manual shall be available for Departmental review.S.C. Code Regs. § 61-64.IV.RHB 4.3
Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.