44:03:01:08.08. Equipment standards for computed tomography systems. The standards for computed tomography systems are as follows:
(1) A visible signal must indicate when the X ray exposure has been terminated. The operator must be able to terminate the X ray exposure at any time during a scan or series of scans under CT X ray system control of greater than one-half second duration;
(2) For any single slice tomogram system, a means must be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. For any multiple slice tomogram system, a means must be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes. If a device using a light source is used to satisfy this subdivision, the light source must provide illumination levels of not less than 160 lux (15.0 foot-candles) above the room ambient illumination level;
(3) The X ray control and gantry must visually indicate whenever X rays are produced and, if applicable, whether the shutter is open or closed. Any emergency button or switch must be clearly labeled as to its function. A means shall be provided to require operator initiation of each individual scan or series of scans;
(4) The CT X ray system shall be designed to indicate the CT conditions of operation to be used during a scan or a scan sequence prior to the initiation of a scan or a scan sequence. On equipment having any of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible;
(5) The system shall perform in such a manner that the radiation produced adjacent to the tube housing assembly, including the tube port, during periods of time scans are not being performed does not exceed 100 milliroentgen in one hour;
(6) For CT X ray systems containing a gantry manufactured after September 3, 1985:
(a) The total error in the indicated location of the tomographic plane or reference plane may not exceed five millimeters;
(b) If the X ray production period is less than one-half second, the indication of X ray production shall be actuated for at least one-half second. Any indicator at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible; and
(c) The deviation of indicated scan increment versus actual increment may not exceed plus or minus one millimeter with any mass from 0 to 100 kilograms, inclusive, resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increments may be taken anywhere along this line travel;
(7) The system must provide for two-way oral communication between the patient and the operator at the control panel;
(8) Leaded windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel;
(9) If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system.
Source: 26 SDR 96, effective January 23, 2000.
General Authority: SDCL 34-21-4.1, 34-21-15.
Law Implemented: SDCL 34-21-4.1, 34-21-15.
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