Ohio Administrative Code|Rule 3701:1-66-07 | Fluoroscopic radiation-generating equipment.

                                                
(A) Fluoroscopic equipment shall meet the
		  following standards:
(1) Unless the United
			 States food and drug administration (FDA) has granted a variance for specific
			 fluoroscopic equipment, the source-to-skin distance (SSD) for fluoroscopy
			 equipment shall not be less than:
(a) Thirty-eight centimeters on stationary fluoroscopic equipment
				unless a particular procedure application prohibits that distance, in which
				case the SSD shall not be less than twenty centimeters;
(b) Thirty centimeters on mobile fluoroscopic equipment unless a
				particular procedure prohibits that distance, in which case it shall not be
				less than twenty centimeters; and
(c) Nineteen centimeters for c-arm type fluoroscopic equipment
				having a maximum source-to-image distance (SID) less than forty-five
				centimeters unless a particular procedure prohibits that distance, in which
				case it shall not be less than ten centimeters. Such systems shall be used for
				extremity or dental purposes only;
(2) For c-arm fluoroscopic equipment
			 equipped with a removable spacer cone, the spacer cone shall be attached to the
			 x-ray source during use at all times unless it interferes with the clinical
			 procedure;
(3) The fluoroscopic imaging assembly
			 shall be provided with a primary protective barrier which intercepts the entire
			 cross-section of the useful beam at any SID and shall prevent further exposures
			 when the primary barrier is not in the path of the entire x-ray
			 beam;
(4) All fluoroscopic equipment shall
			 provide intensified imaging. As used in this rule "intensified
			 imaging" will include the use of digital image receptors;
(5) Fluoroscopic equipment shall meet the
			 following field limitation specifications:
(a) For fluoroscopic equipment manufactured before June 10, 2006,
				the following applies:
(i) Neither the length
				  nor the width of the x-ray field in the plane of the image receptor shall
				  exceed that of the visible area of the image receptor by more than three per
				  cent of the SID. The sum of the excess length and the excess width shall be no
				  greater than four per cent of the SID; and
(ii) For rectangular
				  x-ray fields used with circular image receptors, the error in alignment shall
				  be determined along the length and width dimensions of the x-ray field which
				  pass through the center of the visible area of the image receptor;
(b) For fluoroscopic equipment with a circular image receptor
				manufactured on or after June 10, 2006, the maximum area of the x-ray field in
				the plane of the circular image receptor shall conform with one of the
				following requirements:
(i) When any linear
				  dimension of the visible area of the image receptor measured through the center
				  of the visible area is less than or equal to thirty-four centimeters in any
				  direction, at least eighty per cent of the area of the x-ray field shall
				  overlap the visible area of the image receptor; or
(ii) When any linear
				  dimension of the visible area of the image receptor measured through the center
				  of the visible area is greater than thirty-four centimeters in any direction,
				  the x-ray field measured along the direction of greatest misalignment with the
				  visible area of the image receptor shall not extend beyond the edge of the
				  visible area of the image receptor by more than two centimeters;
(c) For fluoroscopic equipment with a rectangular image receptor
				manufactured on or after June 10, 2006, the following applies:
(i) Neither the length
				  nor the width of the x-ray field in the plane of the image receptor shall
				  exceed that of the visible area of the image receptor by more than three per
				  cent of the SID. The sum of the excess length and the excess width shall be no
				  greater than four per cent of the SID; and
(ii) The error in
				  alignment shall be determined along the length and width dimensions of the
				  x-ray field which pass through the center of the visible area of the image
				  receptor;
(d) If the fluoroscopic x-ray field size is adjusted
				automatically as the SID or image receptor size is changed, a capability may be
				provided for overriding the automatic adjustment in case of system failure. If
				it is so provided, a signal visible at the operator's position shall
				indicate whenever the automatic field adjustment is overridden. Each such
				system failure override switch shall be clearly labeled as
				follows:
"For X-ray Field Limitation System
				Failure;"
(e) Beam-limiting devices shall be provided with a means for
				stepless adjustment of the x-ray field; and
(f) Stepless adjustment shall, at the greatest SID, provide
				continuous field sizes from the maximum obtainable to a field size of five
				centimeters by five centimeters or less;
(6) Timers shall meet the following
			 specifications:
(a) A means shall be provided to preset the cumulative on-time
				timer of the fluoroscopic tube. The maximum cumulative time of the timer shall
				not exceed five minutes without resetting; 
(b) The timer shall terminate the exposure or emit a signal
				audible to the operator when the exposure time reaches a maximum of five
				minutes. The signal shall continue to sound while x-rays are produced until the
				timer is reset;
(c) For x-ray controls manufactured on or after June 10, 2006,
				there shall be provided for each fluoroscopic tube:
(i) A display of the
				  fluoroscopic irradiation time at the operator's working position. This
				  display shall function independently of the audible signal described in
				  paragraph (A)(6)(c)(ii) of this rule. The following requirements
				  apply:
(a) When the x-ray tube
					 is activated, the fluoroscopic irradiation time in minutes and tenths of
					 minutes shall be continuously displayed and updated at least once every six
					 seconds;
(b) The fluoroscopic
					 irradiation time shall also be displayed within six seconds of termination of
					 an exposure and remain displayed until reset; and
(c) Means shall be
					 provided to reset the display to zero prior to the beginning of a new
					 examination or procedure;
(ii) A signal audible to
				  the operator shall sound for each passage of five minutes of fluoroscopic
				  irradiation time during an examination or procedure. The signal shall sound
				  until manually reset or, if automatically reset, for at least two
				  seconds;
(7) X-ray production in the fluoroscopic
			 mode shall be controlled by a device which requires continuous pressure by the
			 operator for the entire time of any exposure. When recording serial
			 fluoroscopic images, the operator shall be able to terminate the x-ray exposure
			 at any time, but means may be provided to permit completion of any single
			 exposure of the series in progress;
(8) Fluoroscopic systems shall meet the
			 following air kerma rate limits:
(a) Fluoroscopic equipment provided with only automatic exposure
				rate control, or provided with both automatic exposure rate control and manual
				mode capabilities, shall not exceed an air kerma rate of eighty-eight milligray
				per minute (ten roentgens per minute exposure rate) in either mode at any
				combination of tube potential and current, at the measurement point specified
				in paragraph (C)(6) of this rule;
(b) Fluoroscopic equipment provided with only manual mode
				capabilities shall not exceed an air kerma rate of forty-four milligray per
				minute (five roentgens per minute exposure rate) at any combination of tube
				potential and current, at the measurement point specified in paragraph (C)(6)
				of this rule; and
(c) For fluoroscopic equipment that is provided with high-level
				control, and the high-level control is activated, the air kerma rate shall not
				exceed one hundred seventy-six milligray per minute (twenty roentgens per
				minute exposure rate) at any combination of tube potential and current, at the
				measurement point specified in paragraph (C)(6) of this rule;
(i) For all fluoroscopy
				  equipment that is provided with high-level control, special means of activation
				  of high level control, such as manual pressure applied continuously by the
				  operator, shall be required to avoid accidental use; and
(ii) A continuous signal
				  audible to the operator shall indicate that high level control is being
				  employed;
(9) During fluoroscopy
			 and cinefluorography the x-ray tube potential and current shall be continuously
			 indicated;
(10) For undertable
			 fluoroscopic equipment, a shielding device of at least 0.25 millimeter lead
			 equivalent shall cover the bucky-slot;
(11) For undertable
			 fluoroscopic equipment, protective drapes, or other devices, at least 0.25
			 millimeter lead equivalent shall be provided between the patient and the
			 individual operating the fluoroscopic equipment to intercept scattered
			 radiation which would otherwise reach the fluoroscopist and others near the
			 x-ray unit, except when such drapes or other devices would compromise the
			 sterile field. Such devices shall not substitute for wearing required
			 protective apparel;
(12) Radiography using
			 the fluoroscopic imaging assembly shall meet the following
			 specifications:
(a) A means shall be provided between the source and the patient
				which will automatically limit the x-ray field at the time the exposure is
				initiated to no more than the portion of the image receptor selected by the
				operator for spot films or radiographic images. If the x-ray field size is less
				than the size of the selected portion of the image receptor, the field size
				shall not open automatically to the size of the selected portion of the image
				receptor unless the operator has selected such a mode of
				operation;
(b) Neither the length nor the width of the x-ray field in the
				plane of the image receptor shall differ from the corresponding dimensions of
				the selected portion of the image receptor by more than three per cent of the
				SID when adjusted for full coverage of the selected portion of the image
				selector;
(c) The center of the x-ray field in the plane of the image
				receptor shall be aligned with the center of the selected portion of the image
				receptor to within two per cent of the SID; and
(d) Means shall be provided to reduce the x-ray field size in the
				plane of the image receptor to a size smaller than the selected portion of the
				image receptor. The minimum field size at the greatest SID shall not exceed
				five centimeters by five centimeters;
(13) Fluoroscopic equipment manufactured
			 on or after June 10, 2006, shall display at the operator's working
			 position the air kerma rate (AKR) and cumulative air kerma in accordance with
			 the following requirements:
(a) 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
				milligrays per minute shall be continuously displayed and updated at least once
				every second;
(b) The cumulative air kerma in units of milligrays shall be
				displayed either within five seconds of termination of an exposure or displayed
				continuously and updated at least once every five seconds;
(c) The display of the AKR shall be clearly distinguishable from
				the display of the cumulative air kerma;
(d) 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;
(i) For fluoroscopes with
				  x-ray source below the x-ray table, x-ray source above the table, or of lateral
				  type, the reference location shall be the respective locations specified in
				  paragraph (C)(6)(a), (C)(6)(b) or (C)(6)(d) of this rule; or
(ii) For C-arm
				  fluoroscopes, the reference location shall be fifteen centimeters 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
				  patients skin;
(e) Means shall be provided to reset to zero the display of
				cumulative air kerma prior to the commencement of a new examination or
				procedure; and
(f) The displayed AKR and cumulative air kerma shall not deviate
				from the actual values by more than plus or minus thirty-five per
				cent;
(14) Fluoroscopic
			 equipment manufactured on or after June 10, 2006 shall be equipped with means
			 to display a last image hold (LIH) image following termination of the
			 fluoroscopic exposure:
(a) For a LIH image obtained by retaining pre-termination
				fluoroscopic images, if the number of images and method of combining images are
				selectable by the user, the selection shall be indicated prior to initiation of
				the fluoroscopic exposure;
(b) For a LIH image obtained by initiating a separate
				radiographic exposure at termination of the fluoroscopic imaging, the technique
				factors for the LIH image shall be selectable prior to the fluoroscopic
				exposure, and the combination selected shall be indicated prior to initiation
				of the fluoroscopic exposure; and
(c) Means shall be provided to clearly indicate to the user
				whether a displayed image is the LIH radiograph or fluoroscopy. Display of the
				LIH radiograph shall be replaced by the fluoroscopic image concurrently with
				re-initiation of the fluoroscopic exposure unless separate displays are
				provided.
(B) In addition to other applicable radiation safety rules
		  adopted pursuant to Chapter 3748. of the Revised Code, handlers of fluoroscopic
		  radiation-generating equipment shall comply with the following:
(1) Any individual who is
			 in the room during the fluoroscopic procedure shall be adequately protected by
			 standing behind a whole body protective barrier or shall be required to wear a
			 protective lead apron of not less than 0.25 millimeter lead
			 equivalent;
(2) Protective lead or
			 lead equivalent gloves shall be used by individuals who are required to have
			 their hands in or near the useful beam; and
(3) Handlers of fluoroscopic equipment
			 used for interventional or cardiac procedures or on pediatric or pregnant
			 patients shall maintain a record of:
(a) Cumulative air kerma or dose area product used for each
				examination, if the display of either is available on the fluoroscopic
				equipment; or
(b) The following items if the cumulative air kerma or dose area
				product is not displayed on the fluoroscopic equipment:
(i) Mode of operation
				  such as high-level or pulsed mode;
(ii) Cumulative
				  fluoroscopic exposure time; and
(iii) Number of
				  radiographs and number of acquisitions.
(C) In addition to other applicable quality assurance
		  requirements of Chapter 3701:1-66 of the Administrative Code, handlers of
		  fluoroscopic equipment shall comply with the following:
(1) Handlers shall
			 designate and utilize a radiation expert who shall develop in writing and
			 perform fluoroscopic image quality evaluations appropriate for the fluoroscopic
			 equipment including written procedures to include time intervals and system
			 conditions for the evaluation of image quality;
(2) On new installations
			 or reinstallations of existing equipment prior to patient exposure, handlers
			 shall utilize a radiation expert to perform the following:
(a) Radiographic device tests to determine compliance with
				allowable limits as specified in paragraph (A)(12) of this rule;
(b) Fluoroscopic image quality evaluations as specified in
				paragraph (C)(1) of this rule; 
(c) Air kerma rate tests as specified in paragraph (C)(6) of this
				rule;
(d) High contrast and low contrast resolution evaluations
				in both fluoroscopic and radiographic modes;
(e) Five minute timer evaluations; and
(f) Evaluation of the accuracy of technique factor
				indicators and integrated radiation dose displays;
(3) After initial
			 evaluations of fluoroscopic equipment have been performed, the test and
			 evaluations in paragraph (C)(2) of this rule shall be performed by a radiation
			 expert annually;
(4) After repair or
			 replacement of any component of the fluoroscopic equipment which may alter the
			 radiation output or image quality, prior to patient use, a radiation expert
			 shall perform and document measurements of air kerma rates as specified in
			 paragraph (C)(6) of this rule and image quality as specified in paragraph
			 (C)(1) of this rule unless in the documented determination of a radiation
			 expert, the repair or replacement will not cause a significant change in
			 radiation output or significant degradation of image quality as specified in
			 the quality assurance program;
(a) The radiation expert may designate qualified individuals to
				perform and document the measurements specified in paragraphs (C)(6) and (C)(1)
				of this rule;
(b) The radiation expert shall provide the criteria for
				qualifying these designees in the quality assurance program; and
(c) The radiation expert's approval of the designee's
				test results shall be documented within thirty days;
(5) The results of all tests performed in
			 accordance with paragraphs (C)(2) to (C)(4) of this rule shall:
(a) Include the technique factors used in determining such
				results;
(b) Include the name of the individual performing the
				measurements; 
(c) Include the date the measurements were performed;
				and
(d) Be maintained by the IRRP between inspections for review by
				the department;
(6) Compliance with air
			 kerma rate allowable limits in paragraph (A)(8) of this rule shall be
			 determined as follows:
(a) If the source is below the x-ray table, the air kerma rate
				shall be measured at one centimeter above the tabletop or cradle;
(b) If the source is above the x-ray table, the air kerma rate
				shall be measured at thirty centimeters above the tabletop with the end of the
				beam limiting device or spacer positioned as closely as possible to the point
				of measurement;
(c) For c-arm type fluoroscopic equipment, the air kerma rate
				shall be measured at thirty centimeters from the input surface of the image
				receptor with the source positioned at any SID;
(d) For fixed SID lateral fluoroscopes attached to the x-ray
				table, the maximum air kerma rate shall be measured at a point fifteen
				centimeters from the centerline of the x-ray table and in the direction of the
				x-ray source with the end of the beam-limiting device or spacer positioned as
				closely as possible to the point of measurement. If the table top is moveable,
				it shall be positioned as closely as possible to the lateral x-ray source, with
				the end of the beam-limiting device or spacer no closer than fifteen
				centimeters to the centerline of the table;
(e) For c-arm type fluoroscopic equipment having a SID less than
				forty-five centimeters, the air kerma rate shall be determined at the minimum
				SSD; and
(f) The maximum air kerma rate shall be determined with the kVp,
				mA and/or other selectable parameters adjusted to those settings which give the
				maximum air kerma rate. X-ray systems that incorporate automatic exposure
				control shall have sufficient attenuative material placed in the useful beam to
				produce the maximum exposure rate of the system.
(D) Handlers of mobile fluoroscopic equipment shall not be
		  required to comply with the requirements of paragraphs (A)(10), and (A)(11) of
		  this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative
		  Code.
(E) Handlers of c-arm fluoroscopic equipment having a maximum SID
		  less than forty-five centimeters shall not be required to comply with the
		  requirements of paragraphs (A)(5)(e), (A)(5)(f), (A)(10), (A)(11), and (A)(12)
		  of this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative Code.
		  In addition, if a radiation expert has specified in the registrant's
		  quality assurance program that an individual is unlikely to receive a total
		  effective dose equivalent of greater than two millirem in any one hour or one
		  hundred millirem in a year, the handler shall not be required to comply with
		  the requirements of paragraph (B)(1) of this rule.
(F) All individuals operating fluoroscopic equipment, and
		  individuals likely to receive an annual effective dose equivalent in excess of
		  one millisievert (one hundred millirem) from participating in fluoroscopic
		  procedures, shall receive at least two hours of radiation protection training
		  specific to fluoroscopy in addition to the training required by rule
		  3701:1-38-10 of the Administrative Code prior to performing or participating in
		  fluoroscopic procedures. Additionally, each individual shall receive one hour
		  of re-training whenever the individual receives in excess of thirty per cent of
		  the allowable occupational dose measured over one calendar year.
(G) The training required by paragraph (F) of this rule shall be
		  approved by the registrant's designated radiation expert, and be specific
		  to the type of fluoroscopic equipment used. Documentation of receiving the
		  training required by paragraph (F) of this rule shall be retained by the
		  registrant and be available for review upon inspection. At a minimum, training
		  topics shall include, but not be limited to:
(1) Principles and
			 operation of the fluoroscopic equipment to be used;
(2) Fluoroscopic and
			 radiographic outputs of each mode of operation, including high-level control
			 options clinically used;
(3) Dose management,
			 including dose reduction techniques for fluoroscopic equipment; 
(4) Safe operating
			 procedures of each piece of fluoroscopic equipment that may be used by each
			 individual.
(5) Units of measurement
			 and dose, including dose-area product values and air kerma;
(6) Radiation protection
			 methods for patient and staff;
(7) Basic properties of
			 radiation; and
(8) Biological effects of
			 radiation.
(H) Fluoroscopic equipment used for radiation therapy procedures
		  is regulated pursuant to rule 3701:1-67-09 of the Administrative
		  Code.
(I) Computed tomography scanners equipped with fluoroscopic
		  capabilities are regulated pursuant to rule 3701:1-66-10 of the Administrative
		  Code.