NAC459.574. Fluoroscopic X-ray systems: Indication of potential and current; source-skin distance; exceptions for fluoroscopy imaging system.

     1. During fluoroscopy and cinefluorography, X-ray tube potential and current must be continuously indicated.

     2. Except as otherwise provided in subsection 3, the source to skin distance must not be less than:

     (a) Thirty-eight centimeters on stationary fluoroscopes installed after February 28, 1980;

     (b) Thirty-five and five-tenths centimeters on stationary fluoroscopes which are in operation before February 28, 1980;

     (c) Thirty centimeters on all mobile fluoroscopes; and

     (d) Twenty centimeters for image intensified fluoroscopes used for specific surgical application. The users’ operating manual must provide precautionary measures to be followed during the use of this device.

     3. A fluoroscopy imaging system, including a small format type and miniature C-arm type, used to perform low power, X-ray image intensified fluoroscopy on extremities must:

     (a) Be operated only by a licensed practitioner of the healing arts.

     (b) Possess a positive, nonremovable means to ensure a source-skin distance during operation of not less than 9 centimeters, unless a different distance is approved by the Food and Drug Administration.

     (c) Be clearly labeled as for use only on extremities.

     (d) Bear a certification label that includes:

          (1) The statement “This product is in conformity with the performance standards for diagnostic X-ray systems and their major components set forth in 21 C.F.R. § 1020”; and

          (2) If the Food and Drug Administration grants a variance from any performance standards for diagnostic X-ray systems and their major components set forth in 21 C.F.R. § 1020, a statement of the variance and the identification number assigned to the variance by the Food and Drug Administration.

     (e) Include an operating manual that contains:

          (1) Any special instructions that may be necessary because of the unique features of the system, including, without limitation, special instructions concerning exposure rates, safety procedures and precautions; and

          (2) Recommended machine settings for representative sample fluoroscopic examinations for which the system is designed, including data on skin and tabletop exposures resulting from these settings.

     [Bd. of Health, Radiation Control Reg. §§ 6.5.5-6.5.6.4, eff. 2-28-80]—(NAC A by Dep’t of Human Resources by R137-01, 5-30-2003)