//(k) Displays of values of AKR and cumulative air kerma//

Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:
* (1) When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.
* (2) 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.
* (3) The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.
* (4) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to 1020.30(h)(6)(iii).
** (i) 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 1020.32(d)(3)(i), (d)(3)(ii), or (d)(3)(v) for measuring compliance with air-kerma rate limits.
** (ii) 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.
* (5) Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.
* (6) The displayed AKR 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 AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds.
bag
fda_public
created
Fri, 20 Nov 2015 11:49:07 GMT
creator
dirkjan
modified
Fri, 20 Nov 2015 11:50:00 GMT
modifier
dirkjan