DHS 157.76(9)(d) (d) Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

DHS 157.76(9)(e) (e) The predetermined or selectable options for producing the LIH radiograph shall be described in the information required by 21 CFR 1020.30 (h). The information shall include a description of any technique factors applicable for the selected option and the impact of the selectable options on image characteristics and the magnitude of radiation emissions.

DHS 157.76(10) (10) Displays of values of air kerma rate and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist’s working position the air kerma rate and cumulative air kerma. Each x-ray tube used during an examination or procedure shall meet all the following requirements:

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) (d)

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 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.