DHS 157.76(7)(a)(a) Fluoroscopic equipment manufactured before June 10, 2006, shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative Irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. DHS 157.76(7)(b)(b) As an alternative to the requirements of par. (a), radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations. DHS 157.76(7)(c)(c) For x-ray controls manufactured on or after June 10, 2006, all of the following shall be provided for each fluoroscopic tube: DHS 157.76(7)(c)1.1. A display of the fluoroscopic irradiation time at the fluoroscopist’s working position. DHS 157.76(7)(c)2.2. The display required in subd. 1. shall function independently of the audible signal described in par. (a) and meet all the following requirements: DHS 157.76(7)(c)2.a.a. When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds. DHS 157.76(7)(c)2.b.b. The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset. DHS 157.76(7)(c)2.c.c. Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure. DHS 157.76(7)(c)3.3. A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least 2 seconds. DHS 157.76(8)(8) Mobile and portable fluoroscopes. Mobile and portable fluoroscopes shall use image-intensification or a direct-digital receptor. DHS 157.76(9)(a)(a) Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display the last image following termination of the fluoroscopic exposure. DHS 157.76(9)(b)(b) For an LIH obtained by retaining pre-termination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure. DHS 157.76(9)(c)(c) For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure. 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)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.