§ 175.53 Fluoroscopic Equipment.
RCNY § 175.53
Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.
(a)Acceptance testing of fluoroscopic x-ray units. Acceptance testing of fluoroscopic x-ray units must include all quality assurance tests that are mandated to be done at any frequency (for example, all daily, monthly, and annually required tests, etc.) as per the manufacturer's specifications, or as required by this Article. Each registrant must have acceptance testing conducted on x-ray units with the exception of fluoroscopic mini c-arms of II sizes less than 6 inches prior to clinical patient exams being conducted with the designated x-ray units. The acceptance testing must be conducted by a QMP and the report provided to the registrant. All non-compliance issues noted in this report must be corrected prior to clinical use of the unit. The acceptance testing report must verify the stated manufacturer's tolerances for all machine testing. If manufacturer tolerances are absent, the QMP must develop tolerances that must be used in subsequent quality assurance testing by the registrant and must be so noted in the facility's quality assurance manual.
(b)Primary protective barrier.
(1)Limitation of useful beam. The fluoroscopic imaging assembly must be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy must not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor must not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems are exempt from this requirement provided the systems are intended only for remote control operation.
(2)Measuring compliance. The AKR must be measured in accordance with subdivision (i) of this section. If the source is below the tabletop, the measurement must be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement must be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it is not closer than 30 cm. Movable grids and compression devices must be removed from the useful beam during the measurement. For all measurements, the attenuation block must be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.
(c)Field limitation.
(3)Spot-film devices. In addition to the applicable requirements of 24 RCNY Health Code §§ 175.47 and 175.48, the following requirements also apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system: (i) Means must be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment must be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size must not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.
(ii)Neither the length nor 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 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences must not exceed 4 percent of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means must be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(iii)The center of the x-ray field in the plane of the image receptor must be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID.
(iv)Means must 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 such that: (A) for spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or (B) for spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, must be containable in a square of 5 cm by 5 cm.
(d)A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position must indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch must be clearly labeled as follows: "For X-ray Field Limitation System Failure".
(e)Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.
(f)Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies: (1) Neither the length nor 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 3 percent of the SID. The sum of the excess length and the excess width must be no greater than 4 percent of the SID.
(g)Override capability. 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 fluoroscopist's position must indicate whenever the automatic field adjustment is overridden. Each such system failure override switch must be clearly labeled as follows: "For X-Ray Field Limitation System Failure".
(h)Activation of tube. X-ray production in the fluoroscopic mode must be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator must 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 process.
(i)Air kerma rates. For fluoroscopic equipment, the following requirements apply: (1) Fluoroscopic equipment manufactured before May 19, 1995.
(j)Fluoroscopy equipment with optional high-level control. When high-level control is selected and the control is activated, in which case the equipment must not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in paragraph (2) of subdivision (m) of this section. Special means of activation of high-level controls shall be required. The high-level control must 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 employed.
(k)With the system configured in the non-mag mode of operation for the most frequently performed fluoroscopic procedure including the grid orientation in or out and the dose adjustment selection set the same as the most common exam, the exposure rates must be measured with each of the following attenuators in the beam: (1) 0.75 inches (19 mm) of aluminum (pediatric patient), (2) 1.50 inches (38 mm) of aluminum (small adult patient), (3) 1.50 inches (38 mm) of aluminum and 0.02 inches (0.5 mm) of copper (average adult patient), (4) 1.50 inches (38 mm) of aluminum and 0.08 inches (2.0 mm) of copper (large adult patient), (5) 1.50 inches (38 mm) of aluminum and 0.08 inches (2.0 mm) of copper and 0.12 inches (3.0 mm) of lead (for maximum fluoroscopic exposure rate only). This report of fluoroscopic exposure rates for the most frequently performed procedure must be posted so that they are conspicuous to the operator.
(l)For all fluoroscopic x-ray systems having an Automatic Brightness system, for phantom measurements conducted in subdivision (k) paragraphs (1) through (4), simulating clinical conditions, the automatic brightness system must function according to manufacturer's specifications as to adjusting the fluoroscopic techniques of kVp and/or mA. If manufacturer's specifications are not available, the specifications must be present in the facility's QA manual. In all cases for measurements required by paragraphs (2) through (4) in subdivision (k), there must be a continuous increase in the fluoroscopic exposure rate for each step from the previous step.
(m)Entrance exposure rate limits.
(v)In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm 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 tabletop is movable, 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 15 cm to the centerline of the x-ray table.
(n)Resolution tests.
(o)Indication of potential and current. During fluoroscopy and cinefluorography, x- ray tube potential and current must be continuously indicated. Deviation of x-ray tube potential and current from the indicated value must not exceed the maximum deviation as stated by the manufacturer.
(p)Source-skin distance.
(q)Fluoroscopic irradiation time, display, and signal.
(r)Display of last-image-hold (LIH).
(s)Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, must display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure: (1) When the x-ray tube is activated and the number of images produced per unit time is greater than 6 images per second, the AKR in mGy/min must be continuously displayed and continually updated.
(4)The AKR and cumulative air kerma must represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.
(t)Protection from scatter radiation.
(u)Operator qualifications.
(5)The registrant must either provide a minimum of 2 hours in-service training every 2 years for all individuals operating or supervising the operation of fluoroscopy systems during clinical FGI procedures, or require evidence of continuing medical education meeting the conditions of this subdivision.
(6)Documentation pertaining to the requirements of this section must be maintained for review for 5 years.
(w)Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures.
(7)Procedures for maintaining records.
