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RULE §289.227Use of Radiation Machines in the Healing Arts

    (L) PCI (percutaneous coronary intervention) (single or multiple vessel).

  (37) Focal spot--The area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

  (38) General purpose x-ray system--Any x-ray system that is not limited by design to radiographic examinations of specific anatomical regions.

  (39) Gonadal shield--A protective barrier for the testes or ovaries.

  (40) Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate (air kerma rate) is reduced to one-half of its original value.

  (41) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.

  (42) Healing arts screening--The testing of asymptomatic human beings using radiation machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

  (43) High level control for fluoroscopy--Any selected mode having an entrance exposure rate (air kerma rate) above 10 roentgens per minute (R/min) or (100 mGy/min). This mode shall meet the high level requirements in subsection (m)(3)(A)(i)(II), (ii)(II), or (iii)(II) of this section.

  (44) Image intensifier--A device, installed in its housing that instantaneously converts an x-ray pattern into a corresponding light or digital image.

  (45) Image receptor--Any device, such as a fluorescent screen or radiographic film that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

  (46) Irradiation--The exposure of matter to ionizing radiation.

  (47) kV--Kilovolt.

  (48) kVp--Kilovolt peak (See definition for peak tube potential).

  (49) kWs--Kilowatt-second. It is equivalent to 10 E 3 watt-second, where 1 watt-second = 1 kV x 1 milliampere (mA) x 1 second.

  (50) Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.

  (51) Leakage radiation--Radiation emanating from the diagnostic source assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated.

  (52) Leakage technique factors--The technique factors associated with the diagnostic source assembly that is used in measuring leakage radiation. They are defined as follows:

    (A) for diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (10 milliampere-second (mAs)) or the minimum obtainable from the unit, whichever is larger;

    (B) for diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; or

    (C) for all other diagnostic source assemblies, the maximum-rated peak tube potential and the continuous tube current for the maximum-rated peak tube potential.

  (53) Licensed medical physicist--An individual holding a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, with a specialty in diagnostic medical physics.

  (54) mA--Milliampere.

  (55) mAs--Milliampere-second.

  (56) Medical research--The investigation of various health risks and diseases.

  (57) Mobile service operation--The provision of x-ray systems and personnel at temporary sites for limited time periods. The x-ray systems may be fixed inside a motorized vehicle or may be a radiation machine that may be removed from the vehicle and taken into a facility for use.

  (58) Multiple slice tomogram system--A computed tomography x-ray system that obtain x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

  (59) Nominal tomographic section thickness--The full-width at half-maximum of the sensitivity profile taken at the center of the cross sectional volume over which x-ray transmission data are collected.

  (60) Non-certified x-ray systems--X-ray systems manufactured and assembled prior to certification requirements of Title 21, CFR, effective as specified in Title 21, CFR, Part 1020.30(a).

  (61) Patient--An individual subjected to healing arts examination, diagnosis, or treatment.

  (62) Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure.

  (63) Phantom--A volume of material behaving in a manner that can be related to tissue with respect to the attenuation and scattering of radiation.

  (64) Phototimer--A method for controlling exposures to image receptors by the amount of radiation that reaches a radiation detection device. The radiation detection device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control).

  (65) Physician--An individual licensed by the Texas Medical Board.

  (66) Portable x-ray systems--X-ray systems that are mounted on a permanent base with wheels and/or casters for moving while completely assembled. Portable x-ray systems may also include x-ray systems designed to be hand-carried.

  (67) Practitioner of the healing arts (practitioner)--A person licensed to practice healing arts by either the Texas Medical Board as a physician, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatric Medical Examiners.

  (68) Primary protective barrier--(See definition for protective barrier).

  (69) Protective apron--An apron made of radiation attenuating materials used to reduce radiation exposure.

  (70) Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:

    (A) primary protective barrier--A barrier sufficient to attenuate the useful beam to the required degree.

    (B) secondary protective barrier--A barrier sufficient to attenuate the stray radiation to the required degree.

  (71) Protective glove--A glove made of radiation attenuating materials used to reduce radiation exposure.

  (72) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

  (73) Radiation oncologist--A physician with a specialty in radiation therapy.

  (74) Radiograph--An image receptor on which the image is created directly or indirectly by an x-ray exposure and results in a permanent record.

  (75) Radiologist--A physician with a specialty in using ionizing and non-ionizing radiation for medical imaging and interpretation for diagnostic and treatment purposes.

  (76) Reference level--The suggested levels at which a facility should review its methods and determine if acceptable image quality can be achieved at a lower radiation output level as determined by measurements taken from a selected phantom. The specific purpose of the reference level is to provide a benchmark for comparison of imaging equipment performance under prescribed conditions and is not intended to define a maximum or minimum exposure limit for any patient.

  (77) Reference plane--A plane that is displaced from and parallel to the tomographic plane.

  (78) Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10-4 C/kg of air.

  (79) Scan--The complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

  (80) Scan increment--The amount of relative displacement of the patient with respect to the CT system between successive scans measured along the direction of such displacement.

  (81) Scan sequence--A preselected set of 2 or more scans performed consecutively under preselected CT conditions of operation.


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