Current through Register No. 45, November 7, 2024
Section He-P 4046.05 - Fluoroscopic X-Ray Systems - Additional Requirements(a) During fluoroscopy and cine-fluorography the kV and the mA shall be continuously indicated.(b) The source to skin distance (SSD) shall not be less than: (1) 38 centimeters on stationary fluoroscopic systems manufactured on or after August 1, 1974;(2) 35.5 centimeters on stationary fluoroscopic systems manufactured prior to August 1, 1974;(3) 30 centimeters on all mobile fluoroscopes; or(4) 20 centimeters for all mobile fluoroscopes manufactured before June 10, 2006 when used for specific surgical applications;(5) 19 centimeters for all stationary mobile C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to image distance (SID) less than 45 centimeters and labeled for extremity use only; or(6) 10 centimeters for all stationary mobile C-arm fluoroscopes manufactured on or after June 10, 2006 with a source to image distance (SID) less than 45 centimeters and not labeled for extremity use only.(c) Fluoroscopic timers shall: (1) Be provided to reset the cumulative on-time of the fluoroscopic x-ray tube;(2) Not exceed 5 minutes without resetting for the maximum cumulative time of the timing device;(3) Indicate the completion of any preset cumulative on-time with a signal audible to the fluoroscopist; and(4) Continue to have such signal sound while x-rays are produced until the timing device is reset.(d) With the exception of C-arm fluoroscopes, fluoroscopic table designs in combination with procedures shall be such that no unprotected part of any staff or ancillary person's body is exposed to unattenuated scattered radiation generated under the table.(e) The attenuation required by He-P 4046. 05(d) shall not be less than 0.25 millimeter lead equivalent.(f) With the exception of C-arm fluoroscopes, equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary person's body, except the extremities, is exposed to the unattenuated scattered radiation generated above the tabletop unless either: (1) That person is at least 120 centimeters from the center of the useful beam; or(2) The radiation has passed through not less than 0.25 millimeter 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.(g) Upon receipt of a written request, DHHS/RHS shall grant exemptions to He-P 4046.05(f) where a required sterile field will not permit the use of normal protective barriers for any fluoroscopic procedures.(h) Fluoroscopic systems equipped with spot-film mode shall meet the exposure reproducibility requirements of He-P 4046 when operating in the spot-film mode.(i) Radiation therapy simulation systems shall be exempt from: (1) All the requirements of He-P 4046.03;(2) The requirements of He-P 4046.02 and He-P 4046.04 provided that no person other than the patient is in the x-ray room when the system is producing x-rays; and(3) The requirements of He-P 4046.05(c) if such systems are capable of indicating cumulative exposure times for individual patients.(j) Procedures for radiation therapy simulation systems shall require that the timer be reset between treatments.(k) All fluoroscopic equipment displays manufactured on or after June 10, 2006 shall: (1) Be equipped with means to display the last image hold (LIH) following exposure termination; and(2) Display the air kerma rate and cumulative air kerma at the fluoroscopist's working position.N.H. Admin. Code § He-P 4046.05
#6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07
Amended byVolume XXXV Number 06, Filed February 12, 2015, Proposed by #10763, Effective 1/23/2015, Expires7/22/2015.Amended by Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10893, Effective 7/21/2015, Expires7/21/2025.