64E-5.506. Intraoral Dental Radiographic Systems

(1) Source-to-Skin Distance. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than:

(a) Eighteen centimeters if operable at or above 50 kVp, or

(b) Ten centimeters if not operable above 50 kVp.

(2) Field Limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

(a) If the minimum source-to-skin distance (SSD) is 18 centimeters or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 7 centimeters; and

(b) If the minimum SSD is less than 18 centimeters, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 6 centimeters.

(c) An open-ended position indicating device shall be used on machines procured after September 19, 1972. The attenuation shall be equivalent to that required for the diagnostic source assembly as described in subsection 64E-5.503(3), F.A.C.

(3) Timers. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time (mAs), a preset number of pulses, or a preset radiation exposure to the image receptor. In addition:

(a) Termination of exposure shall cause automatic resetting of the timer to its initial setting or to 0; and

(b) It shall not be possible to make an exposure when the time is set to a 0 or off position, if either position is provided.

(4) X-Ray Exposure Control Switch.

(a) A control shall be incorporated into each x-ray system such that an exposure can be terminated at any time. This switch shall be of the dead-man type.

(b) Each x-ray control shall be located in such a way as to meet the following criteria:

1. The operator shall observe the patient during an exposure.

2. The operator shall stand as far as practicable and at least 6 feet (1.8 m) from the patient and tube head and outside the useful beam or behind a protective barrier during exposures.

(c) The x-ray control shall provide visual indication observable at or from the operator’s position whenever x-rays are produced.

(d) A sound audible to the operator shall indicate that the exposure has terminated or is in progress.

(5) Operating Controls.

(a) The dentist, operator or assistant shall not hold the film in place for the patient during the exposure. Patient and film holding devices shall be used when the techniques permit.

(b) No person other than the patient shall be exposed to the useful beam.

(c) Neither the tube housing nor the position indicating device shall be held during an exposure.

(d) The x-ray system shall be arranged and operated in such a manner that the useful beam at the patient’s skin does not exceed the dimensions specified in (2)(a), above.

(e) Dental fluoroscopy without image intensification is prohibited.

(f) Each user of intraoral units that are specifically designed to be handheld shall:

1. Have and use individual monitoring devices to document safe use practices; and

2. Successfully complete training provided by the manufacturer using electronic media such as CD/DVD or a website.  Training on the safe use of the unit shall be documented and include at a minimum:

a. Proper positioning of the unit to ensure an adequate protected position;

b. Limitations on the use of position indicating devices that require longer distances to the patients face;

c. Diagrams (i.e., drawings, illustrations, schematics, etc.) of protected position and location in relationship to the unit;

d. Diagrams (i.e., drawings, illustrations, schematics, etc.) of the effect of improper distance or removal of shielding device; and

e. Diagrams (i.e., drawings, illustrations, schematics, etc.) of common examples of improper positioning of the unit and or location of the operator.

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.022, 404.051, 404.22 FS. History–New 7-17-85, Amended 4-4-89, Formerly 10D-91.607, 8-16-07.