DHS 157.76 Note Note: 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) (11) Equipment operations.

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(11)(e)1. 1. Is certified by the American Board of Radiology or board eligible.

DHS 157.76(11)(e)2. 2. Has completed training to include the following:

DHS 157.76(11)(e)2.a. a. Principles and operation of the fluoroscopic x-ray system.

DHS 157.76(11)(e)2.b. b. Biological effects of x-ray.

DHS 157.76(11)(e)2.c. c. Principles of radiation protection.

DHS 157.76(11)(e)2.d. d. Fluoroscopic outputs.

DHS 157.76(11)(e)2.e. e. High level control options.

DHS 157.76(11)(e)2.f. f. Dose reduction techniques for fluoroscopic x-ray systems.

DHS 157.76(11)(e)2.g. g. Applicable state and federal regulations.

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 Note Note: 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 History History: 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.

DHS 157.77 DHS 157.77 General purpose radiographic systems.

DHS 157.77(1) (1) Beam limitation.

DHS 157.77(1)(a) (a) Collimation. The useful beam shall be limited to the area of clinical interest. This requirement is met if a positive beam-limiting device meeting manufacturer’s specifications has been properly used or if evidence of collimation is shown on at least 3 sides or 3 corners of the film. Mammography systems are exempt from the collimation requirement.

DHS 157.77(1)(b) (b) General purpose stationary and mobile x-ray systems. General purpose stationary and mobile x-ray systems, including veterinary systems other than portable, shall meet both of the following requirements:

DHS 157.77(1)(b)1. 1. Only x-ray systems provided with means for independent stepless adjustment of at least 2 dimensions of the x-ray field may be used.

DHS 157.77(1)(b)2. 2. A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field may not exceed 2% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

DHS 157.77(1)(c) (c) Stationary general purpose x-ray systems. Stationary general purpose x-ray systems, both certified and non-certified, shall meet all the following requirements:

DHS 157.77(1)(c)1. 1. A method shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2% of the SID and to indicate the SID to within 2%.