California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 4 - Radiation › Group 3 - Standards for Protection Against Radiation › Article 4 - Special Requirements for the Use of X-Ray in the Healing Arts › Section 30307 - Fluoroscopic Installations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						user shall ensure fluoroscopic equipment meets the following:
(1) The tube housing shall be of diagnostic
						type.
(2) The target-to-panel or
						target-to-table top distance should not be less than 18 inches and shall not be less
						than 12 inches.
(3) The total filtration
						permanently in the useful beam shall not be less than 2.5 millimeters aluminum
						equivalent. This requirement may be assumed to have been met if the half-value layer
						is not less than 2.5 millimeters aluminum at normal operating voltages.
(4) The equipment shall be so constructed that the
						entire cross-section of the useful beam is attenuated by a primary protective
						barrier. This barrier is usually the viewing device, either a conventional
						fluoroscopic screen or an image intensification mechanism.
(A) The lead equivalent of the barrier of
						conventional fluoroscopes shall be at least 1.5 millimeters for equipment capable of
						operating up to 100 kVp, at least 1.8 millimeters for equipment whose maximum
						operating potential is greater than 100 kVp and less than 125 kVp, and at least 2.0
						millimeters for equipment whose maximum operating potential is 125 kVp or greater.
						Special attention must be paid to the shielding of image intensifiers so that
						neither the useful beam nor scattered radiation from the intensifier can produce a
						radiation hazard to the operator or personnel. With the fluorescent screen 14 inches
						(35 cm) from the panel or table top, the exposure rate 2 inches (5 cm) beyond the
						viewing surface of the screen shall not exceed 30 mR/hr for each R per minute at the
						table top with the screen in the useful beam without a patient and with the
						fluoroscope operating at the highest potential employed.
(B) Collimators shall be provided to restrict the
						size of the useful beam to less than the area of the barrier. For conventional
						fluoroscopes this requirement is met if, when the adjustable diaphragm is opened to
						its fullest extent, an unilluminated margin is left at all edges of the fluorescent
						screen with the screen centered in the beam at a distance of 35 cm (14 inches) from
						the panel or table top.
For image intensified fluoroscopy, shutters shall be
						  provided which can be adjusted to restrict the X-ray field to the visible portion of
						  the image receptor during fluoroscopy. For systems employing rectangular X-ray
						  fields and circular image receptors, this requirement is met if the collimated beam
						  forms a square which circumscribes, and is tangent to, the circular margin of the
						  image receptor.
(C) The tube
						mounting and the carrier shall be so linked together that the carrier always
						intercepts the entire useful beam. The X-ray exposure shall automatically terminate
						when the carrier is removed from the useful beam.
(D) Collimators and adjustable diaphragms or
						shutters to restrict the size of the useful beam shall provide the same degree of
						protection as is required of the tube housing.
(5) The exposure switch shall be of the dead-man
						type.
(6) Each fluoroscopic unit shall
						be equipped with a manual-reset cumulative timing device, activated by the exposure
						switch, which will either indicate elapsed exposure time by a signal audible to the
						fluorocopist or turn off the apparatus when the total exposure exceeds a
						predetermined limit not exceeding five minutes in one or a series of
						exposures.
(7) Useful beam exposure
						rate.
(A) All fluoroscopic equipment. For routine
						fluoroscopy, the exposure rate measured at the point where the center of the useful
						beam enters a typical patient shall be as low as is practicable and shall not exceed
						5 roentgens per minute under the conditions specified herein. This limit shall not
						apply during magnification procedures or the recording of fluoroscopic images where
						higher exposure rates are required. Compliance with this paragraph shall be
						determined using the measuring specifications of subsection (a)(7)(D), plus the
						following procedures when the automatic exposure rate control is used:
1. The useful beam exposure rate shall be measured
						with a phantom equivalent to 9 inches of water or 7 7/8 inches of lucite,
						intercepting the entire useful beam.
2.
						If the X-ray source is below the table, the X-ray exposure rate shall be measured
						with the nearest part of the imaging assembly located at 14 inches above the table
						top.
3. The field size at the point of
						exposure rate measurement shall be at least 6 1/4 square inches in area in the plane
						perpendicular to the central ray.
(B) Fluoroscopic equipment manufactured after
						August 1, 1974, and equipped with automatic exposure rate controls. Fluoroscopic
						equipment which is provided with automatic exposure rate control shall not be
						operable at any combination of tube potential and current which will result in an
						exposure rate in excess of 10 roentgens per minute at the point where the center of
						the useful beam enters the patient, except during recording of fluoroscopicimages,
						or when an optional high level control is provided. When so provided, the equipment
						shall not be operable at any combination of tube potential and current which will
						result in an exposure rate in excess of 5 roentgens per minute at the point where
						the center of the useful beam enters the patient unless the high level control is
						activated. Special means of activation of high level controls shall be required. The
						high level control shall only be operable when continuous manual activation is
						provided by the operator. A continuous signal audible to the fluoroscopist shall
						indicate that the high level control is being employed.
(C) Fluoroscopic equipment manufactured after
						August 1, 1974, without automatic exposure rate controls. Fluoroscopic equipment
						which is not provided with automatic exposure rate control shall not be operable at
						any combination of tube potential and current which will result in an exposure rate
						in excess of 5 roentgens per minute at the point where the center of the useful beam
						enters the patient, except during recording of fluoroscopic images, or when an
						optional high level control is activated. Special means of activation of high level
						controls shall be required. The high level control shall only be operable when
						continuous manual activation is provided by the operator. A continuous signal
						audible to the fluoroscopist shall indicate that the high level control is being
						employed.
(D) Measuring useful beam
						exposure rate compliance.
1. If the X-ray tube is
						below the table, the exposure rate shall be measured 1 centimeter above the tabletop
						or cradle.
2. If the X-ray tube is above
						the table, the exposure rate shall be measured at 30 centimeters above the tabletop
						with the end of the beam-limiting device or spacer positioned as closely as possible
						to the point of measurement.
3. In a
						C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters
						from the input surface of the fluoroscopic imaging
						assembly.
(8) Mobile
						fluoroscopic equipment shall meet the requirements of this section where applicable,
						except that:
(A) Inherent provisions shall be made
						so that the machine is not operated at a source-skin distance of less than 30 cm (12
						inches).
(B) Image intensification shall
						always be provided. Conventional fluoroscopic screens shall not be used.
(C) It shall be impossible to operate a machine
						when the collimating cone or diaphragm is not in place.
(D) It shall be impossible to energize the useful
						beam of a mobile fluoroscope unless the entire useful beam is intercepted by the
						image receptor.
(9) Devices
						which indicate the X-ray tube potential and current shall be provided, and should be
						located in such a manner that the operator may monitor the tube potential and
						current during fluoroscopy.
(10) A
						shielding device of at least 0.25 millimeters lead equivalent shall be provided for
						covering the bucky-slot during fluoroscopy.
(11) Whenever practicable, protective drapes, or
						hinged or sliding panels, of at least 0.25 millimeters lead equivalent shall be
						provided between the patient and the fluoroscopist to intercept scattered radiation
						which would otherwise reach the fluoroscopist and others near the machine. Such
						devices shall not substitute for wearing of a protective apron.