//(1) Fluoroscopic equipment manufactured ''before May 19, 1995''//
* (i) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (ii) Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (iii) Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (iv) Equipment may be modified in accordance with 1020.30(q) to comply with 1020.32(d)(2). When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:
** ''Modified to comply with 21 CFR 1020.32(h)(2).''
* (v) Exceptions:
** (A) During recording of fluoroscopic images, or
** (B) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of the rates specified in 1020.32(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) at the measurement point specified in 1020.32(d)(3), unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
bag
fda_public
created
Fri, 20 Nov 2015 11:24:03 GMT
creator
dirkjan
modified
Fri, 20 Nov 2015 11:24:03 GMT
modifier
dirkjan