Section 410 IAC 5-6.1-120 - Fluoroscopic x-ray systemsAuthority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 120.
(a) Fluoroscopic x-ray systems shall be evaluated at least once each twelve (12) months by a diagnostic imaging physicist or x-ray machine inspector approved by the department and shall comply with applicable sections of this rule. Radiation therapy simulation systems are exempt from compliance with subsections (c) through (e), (g) through (l), and (p) if the following are met: (1) Such systems are designed and used in such a manner that no individual other than the patient is in the x-ray room when the system is producing x-rays.(2) Systems which do not comply with subsection (p) are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. In such cases, procedures shall require that the timer be reset between examinations.(b) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. An x-ray tube used for fluoroscopy shall not produce x-rays unless the primary protective barrier is in position to intercept the entire useful beam.(c) Means shall be provided for stepless adjustment of the field size. In addition, the following requirements must be met: (1) The minimum field size at the greatest SID shall be no greater than five (5) cm by five (5) cm.(2) For equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(d) For image-intensified fluoroscopic equipment, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three percent (3%) of the SID. The sum of the excess length and the excess width shall be no greater than four percent (4%) of the SID. In addition, the following requirements must be met: (1) Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than three hundred (300) square cm shall be provided with means for stepless adjustment of the x-ray field.(2) All equipment with a fixed SID and a visible area of three hundred (300) square cm or less shall be provided with either stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to one hundred twenty-five (125) square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of five (5) cm by five (5) cm or less.(3) For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor.(4) Compliance with this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. For rectangular x-ray fields used with circular image reception, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.(e) Spot film devices which are certified components shall comply with the following additional requirements: (1) Means shall be provided between the source and the patient for adjustment of the field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option.(2) It shall be possible to adjust the field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be no greater than five (5) cm by five (5) cm.(3) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within two percent (2%) of the SID.(4) For spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.(f) X-ray production in the fluoroscopic mode shall be controlled by a dead-man switch. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in process.(g) The exposure measured at the point where the center of the useful beam enters the patient and at a kVp typical of clinical use of the x-ray system shall not exceed ten (10) roentgens per minute, except during recording of fluoroscopic images or when provided with optional high-level control. Compliance shall be determined in accordance with subsection (j).(h) When equipment is provided with a high-level control, it shall not be operable at any combination of tube voltage and current which will result in an exposure rate in excess of five (5) roentgens per minute at the point where the center of the useful beam enters the patient unless the high-level control is activated. The high-level control shall be operable only through a dead-man switch. Additionally, a continuous signal audible to the fluoroscopist shall indicate when the high-level control is being employed. Compliance shall be determined in accordance with subsection (j).(i) Certified systems which do not incorporate an automatic exposure control shall not be operable at any combination of tube voltage and current which will result in an exposure rate in excess of five (5) roentgens per minute, at the point where the center of beam enters the patient except during recording of fluoroscopic images or when the equipment is provided with an optional high-level control. Compliance shall be determined in accordance with subsection (j).(j) Compliance with subsections (g) through (i) shall be determined as follows: (1) Movable grids and compression devices shall be removed from the useful beam during the measurement.(2) If the source is below the table, the exposure rate shall be measured one (1) cm above the table top or cradle.(3) If the source is above the table, the exposure rate shall be measured at thirty (30) cm above the table top with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.(4) For C-arm type fluoroscopes, the exposure rate shall be measured thirty (30) cm from the input surface of the fluoroscopic imaging assembly.(k) Periodic measurement of entrance exposure rate shall be performed in accordance with the following: (1) Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate.(2) Such measurements shall be made under conditions that satisfy the requirements of subsection (j).(3) The kVp shall be the kVp typical of clinical use of the x-ray system.(4) An x-ray system that incorporates automatic exposure control shall have sufficient material placed in the useful beam to produce a milliamperage typical of the use of the x-ray system.(5) An x-ray system that does not incorporate an automatic exposure control shall utilize a milliamperage typical of the clinical use of the x-ray system.(6) Results of such measurements shall be posted where any fluoroscopist has ready access to such results, and in the record required by section 118(aa)(5) of this rule. Such measurements shall be stated in roentgens per minute, and shall include the technique factors used in determining such results. The name of the person who performed the measurements and the date the measurements were performed shall be included with the results.(l) The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed two (2) mR per hour at ten (10) cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate. The exposure rate shall be determined by measurements averaged over an area of one hundred (100) square cm with no linear dimension greater than twenty (20) cm. During such measurements, movable grids and compression devices shall be removed from the useful beam, and the attenuation block shall be positioned in the useful beam between the input surface of the fluoroscopic imaging assembly and a point ten (10) cm from the point of measurement of the entrance exposure rate. Exceptions to the measurement shall be as follows: (1) If the source is below the table top, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty (30) cm above the table top.(2) If the source is above the table top and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the table top as possible, but no closer than thirty (30) cm.(m) During fluoroscopy and cinefluorography, kV and mA shall be continuously indicated. (n) The SSD shall be no less than:(1) thirty-eight (38) cm on stationary fluoroscopes installed after June 25, 1978;(2) thirty-five and five-tenths (35.5) cm on stationary fluoroscopes which were in operation prior to June 25, 1978;(3) thirty (30) cm on all mobile fluoroscopes; or(4) twenty (20) cm for image intensified fluoroscopes used in specific surgical applications.(o) For image intensified fluoroscopes used in specific surgical applications, written safety procedures must be provided which state precautionary measures to be adhered to during use of such equipment.(p) Means shall be provided to preset the cumulative ontime of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative ontime. Such signal shall continue to sound while x-rays are produced until the timing device is reset.(q) Mobile fluoroscopes shall provide intensified imaging.(r) Scattered radiation shall be controlled in accordance with the following: (1) Fluoroscopic table designs, when combined with procedures utilized, shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation which originates from under the table. The attenuation required shall be no less than twenty-five hundredths (0.25) mm lead equivalent.(2) Equipment configuration, when combined with procedures, shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the table top, unless that individual: (A) is at least one hundred twenty (120) cm from the center of the useful beam; or(B) the radiation has passed through not less than twenty-five hundredths (0.25) mm lead equivalent material, including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in section 118(t)(2) of this rule.(3) The commissioner may grant an exemption to subdivision (2) where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for protective barriers is practical, the commissioner shall not permit such exemption.Indiana State Department of Health; 410 IAC 5-6.1-120; filed Oct 29, 1993, 5:00 p.m.: 17 IR 372; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFAReadopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA