N.J. Admin. Code § 7:28-15.5

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:28-15.5 - Medical fluoroscopic x-ray systems

(a) The provisions of this section are in addition to and not in substitution for the applicable provisions of N.J.A.C. 7:28.

(b) No person shall operate or permit the operation of certified or uncertified fluoroscopic x-ray equipment used in the healing arts unless the equipment meets the following requirements:

1. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any source-to-image receptor distance.

i. The x-ray tube used for fluoroscopy shall not produce x-rays unless the primary protective barrier is in position to intercept the entire useful beam. Radiation therapy simulator systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required to be in the manufacturer's specifications manual and provides the registrant with precautions concerning the importance of remote control operation.

ii. The exposure rate due to transmission through the primary protective barrier with an attenuation block in the useful beam combined with the radiation from the image intensifier, if provided, shall not exceed 5.2 E-6 Coulombs per kilogram (two milliroentgens per hour) at 10 centimeters (four inches) from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each Roentgen per minute of entrance exposure rate. The attenuation block shall be a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters (eight inches by eight inches by 1.5 inches), of type 1100 aluminum alloy or aluminum alloy having equivalent attenuation. Radiation therapy simulator systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required to be in the manufacturer's specifications manual and provides the registrant with precautions concerning the importance of remote control operation.

iii. The exposure rate due to transmission through the primary barrier combined with radiation from the image intensifier, if provided, shall be determined by measurements averaged over an area of 100 square centimeters (15.5 square inches) with no linear dimension greater than 20 centimeters (eight inches). If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters (12 inches) above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall 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 shall not be closer than 30 centimeters (12 inches). Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 centimeters (four inches) from the point of measurement of entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly. For C-arm fluoroscopy equipment, the measurement shall be made with the end of the beam-limiting device at the minimum SID and the attenuation block not closer than 30 centimeters (12 inches) from the imaging assembly.

iv. For uncertified fluoroscopic equipment only, the fluoroscopic screen shall be covered with a transparent protective material such that under normal operating conditions the dose rate measured five centimeters from the viewer's side of the screen shall not be more than 20 milliroentgens per hour (5.2 E-6 Coulombs per kilogram) without a patient and with the screen 20 centimeters (eight inches) from the tabletop or panel);

2. For fluoroscopic equipment that does not have image intensification, the following field limitation requirements shall be met:

i. The x-ray field shall not extend beyond the visible area of the image receptor;

ii. Means shall be provided for stepless adjustment of the field size;

iii. The minimum field size at the greatest SID shall be equal to or less than five centimeters by five centimeters (two inches by two inches); and

iv. Equipment manufactured after February 25, 1978, which permits a variable angle between the image receptor and the axis of the x-ray beam shall be provided with a means to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

3. Except for fluoroscopic systems used for radiation therapy simulation, image-intensified fluoroscopic equipment shall meet the following field limitation requirements:

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 percent of the SID;

ii. The sum of the excess length and the excess width shall be no greater than four percent of the SID. Compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor;

iii. For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined by comparison of the length and width of the x-ray field with the diameter of the visible area of the image receptor which parallels each;

iv. Equipment manufactured after February 25, 1978, in which the angle between the image receptor and beam axis is variable, shall be provided with a means to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

v. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters (46.5 square inches) shall be provided with a means for stepless adjustment of the x-ray field;

vi. Equipment with a fixed SID and a visible area of 300 square centimeters (46.5 square inches) or less shall be provided with either stepless adjustment of the x-ray field or with some other means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters (19.4 square inches) or less;

vii. 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 (two inches by two inches) or less; and

viii. Fluoroscopic x-ray equipment that automatically adjusts the field size as the SID is changed may be provided with a capability for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE";

4. 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(s) at any time, but means may be provided to permit completion of any single exposure of the series in progress;

5. Fluoroscopic equipment which is provided with automatic exposure rate control or with both automatic exposure rate control and manual mode (dual mode units) shall not be operable at any combination of tube potential and current which will result in an entrance exposure rate in excess of 10 Roentgens per minute (2.6 E-3 Coulombs per kilogram per minute) at the point where the center of the useful beam enters the patient except:

i. During the recording of fluoroscopic images; or

ii. When an optional high-level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an entrance exposure rate in excess of 5 Roentgens (1.3 E-4 Coulombs/kilogram/minute) at the point where the center of the useful beam enters the patient unless the high-level control is activated;

6. Fluoroscopic equipment which is not provided with automatic exposure rate control (manual mode) shall not be operable at any combination of tube potential and current which will result in an entrance exposure rate in excess of five Roentgens per minute (1.3 E-4 Coulombs/kilogram/minute) at the point where the center of the useful beam enters the patient, except:

i. During recording of fluoroscopic images; or

ii. When an optional high-level control is activated;

7. For equipment provided with high-level control, the following requirements shall be met:

i. Special means of activation of high-level controls shall be required (for example, two-step foot pedal);

ii. Continuous manual activation of the high-level control shall be provided by the operator; and

iii. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed;

8. Measuring compliance of entrance exposure rates shall be determined as follows:

i. When the source is below the table, the entrance exposure rate shall be measured one centimeter (0.4 inch) above the tabletop or cradle;

ii. When the source is above the table, the entrance exposure rate shall be measured at 30 centimeters (12 inches) above the tabletop with the end of the beam-limiting device or spacer positioned as close as possible to the point of measurement;

iii. For stationary and mobile c-arm types of fluoroscopes, the entrance exposure rate shall be measured 30 centimeters (12 inches) from the input surface of the fluoroscopic imaging assembly.

iv. In a lateral type of fluoroscope, the entrance exposure rate shall be measured 15 centimeters (5.9 inches) 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 centimeters (5.9 inches) to the centerline of the x-ray table;

9. Fluoroscopic radiation therapy simulation systems are exempt from the entrance exposure rate requirements of (b)5 and (b)6 above;

10. The x-ray tube potential and current shall be continuously indicated to the operator and/or at the control panel during fluoroscopy and cinefluorography. Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer;

11. A means shall be provided to limit the source-to-skin distance to not less than 38 centimeters (15 inches) on stationary fluoroscopes and to not less than 30 centimeters (12 inches) on mobile and portable fluoroscopes.

i. Image-intensified fluoroscopes intended for specific surgical applications that would be impossible to perform at the source-to-skin distances specified above, may be operated at shorter source-to-skin distances but in no case less than 20 centimeters (eight inches);

12. The following requirements shall apply to a fluoroscopic timer:

i. A means shall be provided to preset the cumulative on-time of the fluoroscopic tube. The maximum cumulative time of the timer shall not exceed five minutes without resetting;

ii. The timer shall either terminate the exposure or emit a signal audible to the fluoroscopist when the exposure time reaches five minutes. Such signal shall continue to sound while x-rays are produced until the timer is reset; and

iii. As an alternative to the requirements of (b)12ii above, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations;

13. Mobile and portable fluoroscopes shall be provided with image intensification;

14. The fluoroscopy table that is provided with an undertable tube and a bucky shall have a bucky slot cover that provides protection equivalent to at least 0.5 millimeters of lead. Radiation therapy simulation systems are exempt from the requirements of this paragraph;

15. Protective shielding, such as a drape, shall be in place between the patient and fluoroscopist and shall provide protection equivalent to at least 0.5 millimeters of lead;

16. When a sterile field will not permit the use of the normal protective barriers, the requirements of (b)15 above may be omitted;

17. A mobile fluoroscopic unit used routinely in one location shall be considered a permanent installation and shall comply with the shielding and survey requirements in 7:28-15.10; and

18. The following requirements shall apply to spot-film devices except when the spot-film device is provided for use with a radiation therapy simulator system:

i. 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 that portion of the image receptor chosen by the operator on the spot-film selector. 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;

ii. 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 differences in length and width, without regard to the sign, shall not exceed four percent of the SID. Spot-film devices manufactured after February 25, 1978, which permit a variable angle between the plane of the image receptor and beam axis, shall be provided with a means to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

iii. 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 percent of the SID;

iv. 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 such that:

(1) For spot-film devices used on fixed-SID fluoroscopic systems which are not required to provide, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, shall not exceed five by five centimeters (two by two inches); or

(2) For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, each dimension of the minimum field size, and the greatest SID, shall not exceed five centimeters (two inches); and

v. 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 shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE.

(c) No person shall operate or permit the operation of fluoroscopic x-ray equipment used in the healing arts unless the registrant has developed and continuously implements a quality assurance program that meets the applicable requirements of N.J.A.C. 7:28-22, Quality Assurance Programs for Medical Diagnostic X-ray Installations.

N.J. Admin. Code § 7:28-15.5

Amended by R.2001 d.37, effective 1/16/2001.
See: 32 New Jersey Register 1459(a), 33 New Jersey Register 292(b).
Added (c).