Current through Register No. 40, October 3, 2024
(a)
Fluoroscopic equipment manufactured on or before May 19, 1995 provided with
manual mode only, shall not be operable at any combination of tube potential
and current which will result in an exposure rate in excess of 5 roentgens per
minute (i.e. air kerma rate in (AKR) excess of 44 mGy per minute) at the point
where the center of the useful beam enters the patient except as follows:
(1) During recording of fluoroscopic images;
or
(2) When an optional high level
control is provided, in which case the limit shall be 10 roentgens per minute
(i.e. AKR 88 mGy per minute) .
(b) Fluoroscopic equipment manufactured on or
before May 19, 1995 provided with automatic exposure rate control with or
without manual mode shall not be operable at any combination of tube potential
and current which will result in an exposure rate in excess of 10 roentgens per
minute (i.e. AKR in excess of 88 mGy per minute) at that point where the center
of the useful beam enters the patient, except during recording of fluoroscopic
images.
(c) Fluoroscopic equipment
manufactured after May 19, 1995 provided with manual mode only, shall not be
operable at any combination of tube potential and current which will result in
an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44
mGy per minute) at the point where the center of the useful beam enters the
patient.
(d) Fluoroscopic equipment
manufactured after May 19, 1995 provided with automatic exposure rate control
with or without manual mode shall not be operable at any combination of tube
potential and current which will result in an exposure rate in excess of 10
roentgens per minute (i.e. AKR in excess of 88 mGy per minute) at that point
where the center of the useful beam enters the patient, except when an optional
high level control which was an option at the time of purchase is provided and
activated, in which case the limit shall be 20 roentgens per minute (i.e. AKR
176 mGy per minute) .
(e) The
exposure rate limits expressed in
He-P
4046.04(c) and (d) shall not apply
to:
(1) Fluoroscopic equipment manufactured
after May 19, 1995 but before June 10, 2006 when recording images with film or
video camera with the tube in pulsed mode; and
(2) Fluoroscopic equipment manufactured after
June 10, 2006 when recording images from the Image Intensifier for the user
after exposure termination.
(f) If a high level control is provided, it
shall:
(1) Have a separate means of
activation;
(2) Be operable only
when continuous manual activation is provided by the operator; and
(3) Provide a continuous signal audible to
the fluoroscopist when in use.
(g) Any fluoroscopic equipment manufactured
after May 19, 1995 which can produce an exposure rate in excess of 5 roentgens
per minute (i.e. AKR in excess of 44 mGy per minute) shall be equipped with an
automatic exposure rate control.
(h) Compliance with
He-P
4046.03 shall be determined as follows:
(1) If the source is below the x-ray table,
the exposure rate shall be measured one centimeter above the tabletop or
cradle;
(2) 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;
(3) For a C-arm/O-arm type of fluoroscope
with fixed SID, the exposure rate shall be measured 30 centimeters from the
input surface of the fluoroscopic imaging assembly, provided that the end of
the beam-limiting device or spacer is no closer than 30 centimeters from the
input surface of the fluoroscopic imaging assembly;
(4) In a C-arm type fluoroscope having an SID
less than 45 centimeters, the AKR shall be measured at the minimum
SSD;
(5) For a dedicated lateral
type fluoroscope, the exposure rate shall be measured at a point 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. If the tabletop, required in
He-P
4046.04(g) (4) is movable, the table
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; and
(6) For a special procedures type C-arm
fluoroscope (angiography, interventional fluoro) with variable SID, the
exposure rate shall be measured at the patient support located 30 cm from the
image intensifier at minimum SID.
(i) Periodic measurement of entrance exposure
rate shall be performed by a qualified expert for both typical and maximum
values as follows:
(1) Such measurements
shall be made annually or after any maintenance of the system which might
affect the exposure rate;
(2)
Results of these measurements shall be posted in the vicinity of the control
panel to allow the fluoroscopist ready access to them while using the
fluoroscope;
(3) Results of the
measurements shall be posted in the record required in
He-P
4045.05(c) ;
(4) The measurement results shall be stated
in roentgens per minute and include the technique factors used in determining
such results;
(5) The name of the
person performing the measurements and the date the measurements were performed
shall be included in the results;
(6) Conditions of periodic measurement of
typical entrance exposure rate are as follows:
a. The measurement shall be made under the
conditions that satisfy the requirements of
He-P
4046.03(h) ;
b. The kVp, mA, and/or other selectable
parameters shall be adjusted to those typical of clinical use on a 23 cm thick
abdomen; and
c. Any x-ray system
with automatic exposure rate control shall have sufficient attenuating material
placed in the useful beam to produce kVp, mA, and other selectable parameters
to satisfy the conditions of
He-P
4046.04(i) (6) b; and
(7) Conditions of periodic
measurement of maximum entrance exposure rate are as follows:
a. The measurement shall be made under the
conditions that satisfy the requirements of
He-P
4046.04(h) ;
b. The kVp, mA, and other selectable
parameters shall be adjusted to those settings which give the maximum entrance
exposure rate; and
c. Any x-ray
system(s) that incorporates automatic exposure rate control shall have
sufficient attenuative material placed in the useful beam to produce the
maximum entrance exposure rate of the system.
#6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06,
EXPIRES: 2-2-07; ss by #8808, eff
1-24-07
