Ohio Administrative Code|Rule 3701:1-66-06 | Dental radiation-generating equipment.

                                                
(A) Dental equipment shall meet the
		  following equipment standards:
(1) For dental intraoral
			 equipment, a means shall be provided to limit the source-to-skin distance (SSD)
			 to not less than eighteen centimeters;
(2) For dental intraoral
			 equipment, the x-ray field at the minimum SSD shall be containable in a circle
			 having a diameter of no more than seven centimeters;
(3) A means shall be
			 provided to terminate the exposure at a preset time interval, a preset product
			 of current and time, a preset number of pulses, or a preset radiation exposure
			 to the image receptor;
(4) The exposure control
			 switch shall meet the following requirements:
(a) The switch shall be of the "dead-man"
				type;
(b) The operator shall be able to terminate the exposure at any
				time during an exposure of greater than one-half second. Except during
				panoramic radiography, termination of the exposure shall cause automatic
				resetting of the timer to its initial setting or to zero; and
(c) It shall not be possible to make an exposure when the timer
				is set to "zero" or "off" position if either position is
				provided;
(5) The kVp accuracy
			 shall be within plus or minus ten per cent of the indicated value;
(6) For manual exposures,
			 the accuracy of the timing device shall be within plus or minus ten per cent of
			 the indicated setting. The timing device shall be tested at a minimum of two
			 settings within the operative range of fifty milliseconds to one thousand
			 milliseconds;
(7)  Visual indication
			 shall be provided whenever x-rays are produced. Certified equipment also shall
			 provide audible indication to the operator while x-rays are produced or on
			 termination of the exposure; and
(8) The coefficient of
			 variation for reproducibility of kVp, timing, and radiation exposure shall not
			 exceed 0.05 for four consecutive exposures.
(B) In addition to other structural
		  shielding requirements in rule 3701:1-66-02 of the Administrative Code,
		  handlers of dental equipment shall comply with the following:
(1) Intraoral and panoral
			 units shall be provided with primary barriers at all areas struck by the useful
			 beam. Consideration may be given to the attenuation provided by the patient as
			 a result of direct interaction with the useful beam;
(2) When intraoral or
			 panoral units are in adjacent human patient occupied rooms or areas, protective
			 barriers shall be provided between the rooms or areas, unless safety procedures
			 are documented and implemented to require that no human patients shall be
			 present in the adjacent rooms or areas while exposures are being
			 made;
(3) Intraoral and panoral
			 units shall be provided with a protective barrier for the operator or shall be
			 so arranged that the operator is located at a minimum distance of six feet from
			 the patient and out of the useful beam. The operators position shall be
			 arranged so that the operator views the patient during the entire exposure;
			 and
(4) When the operator is
			 behind a protective barrier, a viewing system shall be provided large enough
			 and so placed that the operator can see the patient without having to leave the
			 protected area during exposure.
(C) In addition to the radiation safety
		  requirements listed in rule 3701:1-66-02 of the Administrative Code, handlers
		  of dental equipment shall not permit any individual to hold any part of the
		  x-ray tube housing, cone, or mechanical support of the x-ray tube during
		  exposure.
(D) In addition to the quality assurance
		  requirements of rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code,
		  handlers of dental radiation-generating equipment shall conduct annual
		  evaluations of x-ray operators to include the following:
(1) Positioning of the
			 x-ray tube;
(2) Image
			 processing;
(3) Operator location
			 during x-ray exposure;
(4) Appropriate
			 radiologic protocol; and
(5) applicable regulatory
			 requirements.
(E) Handlers of dental panoral equipment
		  shall comply with all requirements of paragraphs (A) to (D) of this rule,
		  except for paragraphs (A)(1) and (A)(2) of this rule, and must comply with the
		  following:
(1) Dental panoral x-ray
			 machines shall be certified pursuant to 21 C.F.R. part 1020 (as effective on
			 the effective date of this rule); and
(2) The x-ray field shall be limited to
			 the dimensions of the slit in the image receptor holder or limited to the
			 dimensions of the active portion of the image receptor.
(F) Except for dental equipment used for
		  panoral use, handlers of radiographic equipment used for extraoral dental
		  procedures shall comply with the requirements of paragraphs (A) and (B) of rule
		  3701:1-66-05 of the Administrative Code.
(G) Fluoroscopy without image
		  intensification shall not be used for dental examinations. Handlers of image
		  intensified fluoroscopic equipment shall comply with the applicable
		  requirements of rule 3701:1-66-07 of the Administrative Code.
(H) Handlers of dental cone-beam CT
		  radiation-generating equipment shall comply with the applicable requirements of
		  rule 3701:1-66-10 of the Administrative Code.
(I) Handlers of hand-held
		  radiation-generating equipment used for dental procedures shall meet the
		  requirements of paragraphs (A), (B), and (D) of this rule, and shall develop
		  and implement safe operating procedures as part of the quality assurance
		  program specified in rule 3701:1-66-04 of the Administrative Code, which shall
		  address at least the following:
(1) Hand-held
			 radiation-generating equipment shall be used for intraoral purposes
			 only;
(2) Operators of the
			 hand-held radiation-generating equipment shall wear a full lead apron of not
			 less than 0.25 millimeter lead equivalent;
(3) Hand-held
			 radiation-generating equipment shall be equipped with a backscatter shield of
			 not less than 0.25 millimeters lead equivalent and 15.2 centimeters in diameter
			 that is positioned as close as practicable to the distal end of the
			 device;
(4) Storage and security procedures shall
			 be developed and implemented to assure hand-held radiation-generating equipment
			 is secured against unauthorized use or removal when not under the control and
			 constant surveillance of the registrant;
(5) Operator training, as required in
			 paragraph (B)(5) of rule 3701:1-66-04 of the Administrative Code, shall include
			 documented specific instruction to the x-ray operator regarding the prohibition
			 on placing any part of their body into the useful beam and ensuring there are
			 no bystanders within a radius of at least six feet from the patient being
			 examined during exposure; and
(6) Hand-held
			 radiation-generating equipment shall not be used in hallways or waiting
			 rooms.
(J) Dental equipment shall not be operated at less than a
		  measured fifty-one kVp.
(K) Dental equipment used by veterinarians shall comply with all
		  requirements of this rule except paragraphs (A)(1), (D), (E), (I) and (J) of
		  this rule. Additionally, the useful beam shall be limited to the area of
		  clinical interest.
(L) Extraoral dental equipment used by veterinarians shall follow
		  the requirements of paragraph (F) of rule 3701:1-66-05 of the Administrative
		  Code.