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KMID : 0357520220450020127
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Journal of Radiological Science and Technology
2022 Volume.45 No. 2 p.127 ~ p.134
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A Study on Establishment of Essential Performance Evaluation Criteria for C-arm Computed Tomography
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Kim Eun-Hye
Park Hye-Min
Kim Jung-Min
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Abstract
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In order to overcome the image quality limitations of the conventional C-arm, a flat panel detector (FPD) is used to enhance spatial resolution, detective quantum efficiency, frame rate, and dynamic range. Three-dimensional (3D) visualized information can be obtained from C-arm computed tomography (CT) equipped with an FPD, which can reduce patient discomfort and provide various medical information to health care providers by conducting procedures in the interventional procedure room without moving the patient to the CT scan room. Unlike a conventional C-arm device, a C-arm CT requires different basic safety and essential performance evaluation criteria; therefore, in this study, basic safety and essential performance evaluation criteria to protect patients, medical staff, and radiologists were derived based on International Electrotechnical Commission (IEC) standards, the Ministry of Food and Drug Safety (MFDS) standards in Korea, and the rules on the installation and operation of special medical equipment in Korea. As a result of the study, six basic safety evaluation criteria related to electrical and mechanical radiation safety (leakage current, collision protection, emergency stopping device, overheating, recovery management, and ingress of water or particulate matter into medical electrical (ME) equipment and ME systems: footswitches) and 14 essential performance evaluation criteria (accuracy of tube voltage, accuracy of tube current, accuracy of loading time, accuracy of current time product, reproducibility of radiation output, linearity and consistency in radiography, half layer value in X-ray equipment, focal size and collimator, relationship between X-ray field and image reception area, consistency of light irradiation versus X-ray irradiation, performance of the mechanical device, focal spot to skin distance accuracy, image quality evaluation, and technical characteristic of cone-beam computed tomography) were selected for a total of 20 criteria.
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KEYWORD
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C-arm CT, Basic safety, Essential performance, Evaluation criteria, Radiation protection
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