DHS 157.76(10)(a)(a) When the x-ray tube is activated and the number of images produced per unit time is greater than 6 images per second, the air kerma rate in mGy/min shall be continuously displayed and updated at least once every second.

DHS 157.76(10)(b)(b) The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds.

DHS 157.76(10)(c)(c) The display of the air kerma rate shall be clearly distinguishable from the display of the cumulative air kerma.

DHS 157.76(10)(d)1.1. The air kerma rate and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the referenced locations.

DHS 157.76(10)(d)2.2. For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in sub. (4) for measuring compliance with air kerma rate limits.

DHS 157.76(10)(d)3.3. For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient’s skin.

DHS 157.76 NoteNote: The reference location is identified and described specifically in the information provided to users according to 21 CFR 1020.30 (h) (6) (iii).

DHS 157.76(10)(e)(e) Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

DHS 157.76(10)(f)(f) The displayed air kerma rate and cumulative air kerma shall not deviate from the actual values by more than ±35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of air kerma rate and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds.

DHS 157.76(11)(a)(a) The registrant shall ensure that only a licensed practitioner or a radiologic technologist who is trained in the safe use of fluoroscopic x-ray systems is allowed to operate these systems. All fluoroscopic x-ray images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner.

DHS 157.76(11)(b)(b) The use of fluoroscopic x-ray systems by radiologic technologists shall be performed under the supervision of a licensed practitioner for the purpose of localization to obtain images for diagnostic purposes.

DHS 157.76(11)(c)(c) Radiologic technology students may not operate fluoroscopic x-ray systems except under the direct supervision of a licensed practitioner or radiologic technologist.

DHS 157.76(11)(d)(d) Fluoroscopic x-ray systems may not be used as a positioning tool for general purpose radiographic examinations.

DHS 157.76(11)(e)(e) The registrant shall require the operator of a fluoroscopic x-ray system to meet either of the following requirements:

DHS 157.76(12)(12) Air kerma measurements. Annual measurements of both typical and maximum air kerma shall be made by a medical physicist or a person approved by a medical physicist.

DHS 157.76 NoteNote: Materials should be placed in the useful beam to protect the imaging system when conducting these periodic measurements. Air kerma measurements do not include backscatter.

DHS 157.76 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: r. and recr. Register October 2006 No. 610, eff. 11-1-06; CR 09-062: cr. (11) and (12) Register April 2010 No. 652, eff. 5-1-10; CR 16-078: r. and recr. (7) (c), cr. (7) (d), am. (11) (a) Register January 2018 No. 745, eff. 2-1-18; correction in (7) (c) 2. made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (intro.), (2) (b), (8) Register June 2023 No. 810, eff. 7-1-23.