Kansas Administrative Regulations
Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT
Article 35 - RADIATION
Section 28-35-243a - Fluoroscopic X-ray systems
Universal Citation: KS Admin Regs 28-35-243a
Current through Register Vol. 43, No. 52, December 26, 2024
Each fluoroscopic X-ray system used shall be image-intensified and shall meet the following requirements:
(a) Limitation of useful beam.
(1) Primary barrier.
(A) The fluoroscopic imaging assembly shall
be provided with a primary protective barrier that intercepts the entire cross
section of the useful beam at any SID.
(B) The X-ray tube used for fluoroscopy shall
not produce X-rays unless the barrier is in position to intercept the entire
useful beam.
(2)
Fluoroscopic beam limitation.
(A) For
certified fluoroscopic systems with or without a spot film device, 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
percent of the SID. The sum of the excess length and the excess width shall be
no greater than four percent of the SID.
(B) For uncertified fluoroscopic systems with
a spot film device, the X-ray beam with the shutters fully opened during
fluoroscopy or spot filming shall be no larger than the largest spot-film size
for which the device is designed. Measurements shall be made at the minimum SID
available but at a distance of not less than 20 centimeters from the tabletop
to the film plane.
(C) For
uncertified fluoroscopic systems without a spot film device, the requirements
of this regulation shall apply.
(D) Other requirements for fluoroscopic beam
limitation shall include the following:
(i) A
means shall be provided to permit further limitation of the field.
Beam-limiting devices manufactured after May 22, 1979 and incorporated in
equipment with a variable SID or a visible area of greater than 300 square
centimeters, or both, shall be provided with a means for stepless adjustment of
the X-ray field.
(ii) All
equipment with a fixed SID and a visible area of 300 square centimeters or less
shall be provided either with stepless adjustment of the X-ray field or with a
means to further limit the X-ray field size, at the plane of the image
receptor, to 125 square centimeters or less.
(iii) If provided, stepless adjustment shall,
at the greatest SID, provide continuous field sizes from the maximum attainable
to a field size of five centimeters by five centimeters or less.
(iv) For equipment manufactured after
February 25, 1978, if the angle between the image receptor and beam axis is
variable, a means shall be provided to indicate when the axis of the X-ray beam
is perpendicular to the plane of the image receptor.
(v) For noncircular 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 that pass through the center of
the visible area of the image receptor.
(3) Spot-film beam limitation. Each spot-film
device shall meet the following requirements:
(A) A means shall be provided between the
source and the patient for adjustment of the X-ray field size in the plane of
the film, to the size of that portion of the film that has been selected on the
spot film selector. This adjustment shall be automatically accomplished except
when the X-ray field size in the plane of the film is smaller than that of the
selected portion of the film. For spot-film devices manufactured after June 21,
1979, if the X-ray field size is less than the size of the selected portion of
the film, the means for adjustment of the field size shall be only at the
operator's option.
(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 percent of the SID when adjusted for full
coverage of the selected portion of the image receptor. The sum of the length
and width differences, without regard to sign, shall not exceed four percent of
the SID.
(C) It shall be possible
to adjust the X-ray field size in the plane of the film to a size smaller than
the selected portion of the film. The minimum field size at the greatest SID
shall be equal to or less than five centimeters by five centimeters.
(D) The center of the X-ray field in the
plane of the film shall be aligned with the center of the selected portion of
the film to within two percent of the SID.
(E) For spot-film devices manufactured after
February 25, 1978, if the angle between the plane of the image receptor and
beam axis is variable, a means shall be provided to indicate when the axis of
the X-ray beam is perpendicular to the plane of the image receptor, and
compliance shall be determined with the beam axis indicated to be perpendicular
to the plane of the image receptor.
(4) Override. Each method used to override
any of the automatic X-ray field size adjustments required in paragraphs (a)(2)
and (3) shall meet the following requirements:
(A) Be designed for use only if system
failure occurs;
(B) incorporate a
signal visible at the fluoroscopist's position that indicates whenever the
automatic field size adjustment is overridden; and
(C) be clearly and durably labeled with the
following, or equivalent wording:
FOR X-RAY FIELD LIMITATION SYSTEM FAILURE
(b) Activation of the fluoroscopic tube. All X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous manual activation by the fluoroscopist during the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the X-ray exposure or exposures at any time, but a means may be provided to permit completion of any single exposure of the series in process.
(c) Exposure rate limits.
(1) Allowable limits for the entrance
exposure rate.
(A) Fluoroscopic equipment
that is provided with an automatic exposure rate control shall not be operable
at any combination of tube potential and current that will result in an
exposure rate in excess of 2.6 mC/kg (10 roentgens) per minute at the point
where the center of the useful beam enters the patient, except under either of
the following conditions:
(i) When
fluoroscopic images are being recorded; or
(ii) when an optional high-level control is
provided. When provided, the X-ray system shall not be operable at any
combination of tube potential and current that will result in an exposure rate
in excess of 1.3 mC/kg (5 roentgens) per minute at the point where the center
of the useful beam enters the patient, unless the high-level control is
activated. A special means of activation of high-level controls shall be
required. The high-level control shall 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 being employed.
(B) Fluoroscopic
equipment that is not provided with an automatic exposure rate control shall
not be operable at any combination of tube potential and current that will
result in an exposure rate in excess of 1.3 mC/kg (5 roentgens) per minute at
the point where the center of the useful beam enters the patient, except during
either of the following:
(i) When
fluoroscopic images are being recorded; or
(ii) when an optional high-level control is
activated. A special means of activation of the high-level control shall be
required. The high-level control shall 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 being employed.
(C) Fluoroscopic
equipment that is provided with both an automatic exposure rate control mode
and a manual mode shall not be operable at any combination of tube potential
and current that will result in an exposure rate in excess of 2.6 mC/kg (10
roentgens) per minute in either mode at the point where the center of the
useful beam enters the patient, except under either of the following
conditions:
(i) When fluoroscopic images are
being recorded; or
(ii) when the
mode or modes have an optional high-level control. The mode or modes shall not
be operable at any combination of tube potential and current that will result
in an exposure rate in excess of 1.3 mC/kg (5 roentgens) per minute at the
point where the center of the useful beam enters the patient, unless the
high-level control is activated. A special means of activating of the
high-level control shall be required. The high-level control shall 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 being employed.
(D) Fluoroscopic equipment manufactured after
May 19, 1995 that can exceed 1.3 mC/kg (5 roentgens) per minute shall be
equipped with an automatic exposure rate control. All entrance exposure rate
limits shall be 2.6 mC/kg (10 roentgens) per minute with an upper limit of 5.2
mC/kg (20 roentgens) per minute when the high-level control is activated.
(E) Compliance with the
requirements of this subsection shall be determined as follows:
(i) If the source is below the X-ray table,
the exposure rate shall be measured at one centimeter above the tabletop or
cradle.
(ii) If the source is
above the X-ray table, the exposure rate shall be measured at 30 centimeters
above the tabletop with the end of the beam-limiting device or spacer
positioned as closely as possible to the point of measurement.
(iii) For any fluoroscopy system capable of
changing the X-ray beam orientation, which is also known as a C-arm system, the
exposure rate shall be measured at 30 centimeters from the input surface of the
fluoroscopic imaging assembly. The source may be positioned at any available
SID, if the end of the beam-limiting device or spacer is no closer than 30
centimeters from the input surface of the fluoroscopic imaging assembly.
(iv) For a lateral-type
fluoroscope, the exposure rate shall be measured at a point that is 15
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. A moveable tabletop 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 centimeters to the
centerline of the X-ray table.
(2) Periodic measurements of the entrance
exposure rate shall be taken by a qualified expert for both the typical and the
maximum values according to all of the following requirements:
(A) The measurements shall be taken annually
and after any maintenance of the system that might affect the exposure rate.
(B) The results of these
measurements shall be posted at a location where any fluoroscopist has ready
access to the results while using the fluoroscope and in the record required by
this regulation. The measurement results shall be stated in coulombs per
kilogram (roentgens) per minute and shall include the technique factors used in
determining the results. The name of the individual performing the measurements
and the date on which the measurements were performed shall be included in the
results.
(C) The conditions under
which periodic measurements of the entrance exposure rate are taken shall meet
the following requirements:
(i) Each
measurement shall be made under the conditions that meet the requirements of
this regulation.
(ii) The kVp, mA,
and other selectable parameters shall be adjusted to those settings typical in
clinical use for a patient with an abdomen that is 23 cm thick.
(iii) Each X-ray system that incorporates any
automatic exposure rate controls shall have sufficient attenuative material
placed in the useful beam to produce milliamperage and kilovoltage that meet
the requirements of this regulation.
(D) The conditions under which periodic
measurements of the maximum entrance exposure are taken shall meet the
following requirements:
(i) The measurement
shall be made under the conditions that meet the requirements of this
regulation.
(ii) The kVp, mA, and
other selectable parameters shall be adjusted to those settings that produce
the maximum entrance exposure rate.
(iii) Each X-ray system that incorporates
automatic exposure rate controls shall have sufficient attentuative material
placed in the useful beam to produce the maximum entrance exposure rate of the
system.
(d) Barrier-transmitted radiation rate limits.
(1) The exposure rate due to
transmission through the primary protective barrier with the attenuation block
in the useful beam, combined with radiation from the image intensifier, if
provided, shall not exceed 0.5 µC/kg (2 milliroentgens) per hour at 10
centimeters from any accessible surface of the fluoroscopic imaging assembly
beyond the plane of the image receptor for each mC/kg (4 roentgens) per minute
of entrance exposure rate.
(2)
Measuring compliance of barrier transmission.
(A) The exposure rate due to transmission
through the primary protective barrier combined with radiation from the image
intensifier shall be determined by measuring the radiation averaged over an
area of 100 square centimeters, with no linear dimension greater than 20
centimeters.
(B) If the source is
below the tabletop, the measurement shall be taken with the input surface of
the fluoroscopic imaging assembly positioned at 30 centimeters above the
tabletop.
(C) If the source is
above the tabletop and the SID is variable, the measurement shall be taken with
the end of the beam-limiting device or spacer placed as close to the tabletop
as possible, but not closer than 30 centimeters.
(D) All movable grids and compression devices
shall be removed from the useful beam during the measurement.
(e) Indication of potential and current. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated.
(f) Source-to-skin distance (SSD). Unless otherwise approved by the food and drug administration, the SSD shall not be less than the following:
(1) 38 centimeters
on stationary fluoroscopic systems manufactured on or after August 1, 1974;
(2) 35.5 centimeters on stationary
fluoroscopic systems manufactured before August 1, 1974;
(3) 30 centimeters on all mobile
fluoroscopes; and
(4) 20
centimeters for all mobile fluoroscopes when used for specific surgical
applications.
(g) Fluoroscopic timer.
(1) A method shall be
provided to preset the cumulative amount of time during which the fluoroscopic
X-ray tube is on. The maximum cumulative amount of time during which the
fluoroscopic X-ray tube is on shall not exceed five minutes without resetting
the timing device.
(2) A signal
audible to the fluoroscopist shall indicate the completion of any preset
cumulative time. The signal shall continue to sound while X-rays are produced
until the timing device is reset.
(h) Control of scattered radiation.
(1) Each fluoroscopic table, when combined
with the medical procedures performed, shall be such that no unprotected part
of the body of any staff member or ancillary individual shall be exposed to
unattenuated scattered radiation that originates from under the table. The
attenuation required shall be not less than 0.25 millimeter lead-equivalent.
(2) The equipment configuration
and operating procedures used shall prevent any portion of the body of any
staff member or ancillary individual, except the extremities, from being
exposed to the unattenuated scattered radiation emanating from above the
tabletop, unless either of the following conditions is met:
(A) The individual is at least 120
centimeters from the center of the useful beam.
(B) The radiation has passed through not less
than 0.25 millimeter of lead-equivalent material including drapes, a bucky-slot
cover panel, and self-supporting curtains, in addition to any lead equivalency
provided by any protective apron.
(3) Exemptions to paragraph (h)(2) may be
granted by the secretary if a sterile field does not permit the use of the
normal protective barriers. If the use of prefitted sterilized covers for the
barriers is practical, an exemption shall not be granted. Exceptions shall be
automatically granted for the following fluoroscopic procedures only if a
sterile field does not permit the use of the normal protective barriers:
(A) Angiograms;
(B) arthrograms;
(C) biliary drainage procedures;
(D) fluoroscopic biopsy procedures;
(E) myelograms;
(F) percutaneous cholangiograms;
(G) percutaneous nephrostomies;
(H) sinograms or fistulograms; and
(I) T-tube cholangiograms.
(i) Spot-film exposure reproducibility. Each fluoroscopic system equipped with a spot-film mode shall meet the exposure reproducibility requirements of K.A.R. 28-35-244a when operating in the spot-film mode.
(j) Radiation therapy simulation systems. Each radiation therapy simulation system shall be exempt from the requirements of subsection (c) of this regulation. In addition, this type of system shall be exempt from the following:
(1) The
requirements of subsections (a) and (d) of this regulation, if the system is
designed and used so that no individual other than the patient is in the X-ray
room when the system is producing X-rays; and
(2) the requirements of subsection (g) of
this regulation, if the system is provided with a means of indicating the
cumulative time that an individual patient has been exposed to X-rays.
Procedures shall be established to require that the cumulative time be reset
between examinations.
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