• 제목/요약/키워드: Used Medical Equipment

검색결과 495건 처리시간 0.036초

결합 의료기기 관리제도의 규제관련 법률에 관한 연구 (A Study on Regulatory Law for Management System of Combined Medical Device)

  • 최용전;최미림;이정찬;정용규
    • 서비스연구
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    • 제4권2호
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    • pp.1-10
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    • 2014
  • 최근 우리나라 기술발전과 글로벌화 경향에 맞추어, 의료기기산업도 국제적인 의료기기관리제도에 적합하도록 체질을 개선해 가고 있으며, 국제적인 규제수준에 도달할 수 있도록 완화의 가닥을 잡고 있다. 또한 최근의 입법 경향을 보면 의료기기 산업의 각종 규제는 최소한의 범위에 머물고 새로운 기술의 결합 내지 융합에 개방적인 자세를 취하고 있다. 결합 의료기기에 활용된 의료기술은 대부분이 인체나 환경에 위해성이 없는 의료기술일 가능성이 크므로, 이렇게 위해성이 제로에 가까운 의료기기를 1등급으로 분류하여 위해성이 거의 없는 의료기기와 같이 취급함으로써 발생하는 불필요한 행정력과 시간의 낭비를 최소화할 수 있다. 이를 통하여 의료기기 취급자 특히 판매업자에 포함되는 사업자의 영역이 넓혀지므로, 사업자들의 사업의지를 고양할 수 있으며, 국민의 의료기기에 대한 선택권과 접근권이 제고될 수 있다. 본 논문에서는 결합 의료기기의 중고 수리 및 유통질서를 확립하고 공정한 거래를 촉진하기 위한 제반의 법률을 조사하고 규제를 개선하는 방향을 제시한다.

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C-arm CT의 필수 성능평가 기준 마련을 위한 연구 (A Study on Establishment of Essential Performance Evaluation Criteria for C-arm Computed Tomography)

  • 김은혜;박혜민;김정민
    • 대한방사선기술학회지:방사선기술과학
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    • 제45권2호
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    • pp.127-134
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    • 2022
  • 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.

무면허의료행위에 대한 형사법적 쟁점 - 한의사의 초음파기기 사용을 중심으로 - (A Study in the Crimes of the Medical Practice without License - Case of Oriental Medicine's use of Ultrasounds -)

  • 장준혁
    • 의료법학
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    • 제15권1호
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    • pp.35-57
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    • 2014
  • Recently, there has been fierce argument between oriental and western doctors in the medical field. The use of medical devices has particularly come to the fore lately. Appropriate medical devices are required to diagnose and treat patients' conditions or illnesses accurately. At issue recently in medical device sector are diagnostic instruments using radiation, magnetic resonance imaging, ultrasound, IPL(Intense Pulse Light), and instruments used for tonometry. Relating to this issue, Association of Korean Oriental Medicine and The Association of Korean Medicine are sharply opposed. It is predicted that more accusations of this kind will be seen in the future. As oriental medicine contends, ultrasonic imaging itself seems to cause no harm to humans and its use may have an advantage for national health. The use of western diagnostic equipment can expand the diagnostic range of oriental doctors. However, unless new legislation is made, it is against the law for oriental doctors to use this equipment. Both law and medical science require grounds and predictability on the correctness of a decision and all of its consequences. Additionally, oriental medicine's use of ultrasounds and other medical devices should be established by standards and grounds which make same the diagnosis with repetition. Therefore, the scope of oriental medicine can be expanded following a revision of the Oriental Medicine Promotion Act and it is estimated that the state of national health will be greatly improved by the mutual respect of both sides of the health profession.

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A Minimally Invasive lumbar Spine Surgery Technique Using a Modified Thoracoport : Proposal of a New Tubular Retractor

  • Park, Kwang-Woo;Park, Chan-Woo;Park, Jin-Soo;Lee, Sang-Gu
    • Journal of Korean Neurosurgical Society
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    • 제40권4호
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    • pp.296-299
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    • 2006
  • Recently the trend of surgical procedure for treatment of lumbar benign disease is a minimally invasive surgery due to small incision, minimal blood loss, and a short hospital day. By using a microscope or an endoscope, and other surgical equipment, a delicate manipulation in a narrow space became feasible, consequently, to secure a wider view with small incision, appropriate retractors are required. But the various tubular retractor systems are expensive and have some problems. We modified Thoracoport [Auto Suture Co., Norwalk, CT] by making a window at the distal end of trocar and used it as a tubular retractor in surgical procedure for treatment of lumbar benign disease. This modified tubular retractor is docked closely on the curved lamina and provides a wider view. We used it as a tubular retractor also in lumbar bilateral decompression involving a unilateral approach. But this trocar has the limited sizes [diameter and length], and also it is difficult to fix the retractor or change the direction of retractor. And then, we propose a more modified Thoracoport with various sizes and attaching the settling holders to the head of tubular retractor to be able to fix the retractor.

Development of a Web-Based Program for Cross-Calibration and Record Management of Radiation Measuring Equipment

  • Park, So Hyun;Lee, Rena;Kim, Kyubo;Ahn, Sohyun;Lim, Sangwook;Cho, Samju
    • 한국의학물리학회지:의학물리
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    • 제30권2호
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    • pp.59-63
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    • 2019
  • Purpose: To manage radiation measurement equipment, a web-based management program has been developed in this study. Materials and Methods: This program is based on a web service and Java Server Pages (JSP) and employs compatibility and accessibility. Results: The first step in the workflow has been designed to create accounts for each user or organization and to log in. The program consists of two parts: fields for listed instruments, and measurement information. The instruments for measuring radiation listed in this program are as follows: ionization chambers, survey meters, thermometers, barometers, electrometers, and phantoms. Instrument properties can be put in the recording fields and browsing for associated instruments can be performed. The main part of the program is the cross-calibration for each ion chamber. For instance, the ionization chamber to be used as a relative dosimeter can be registered by cross-calibration data with a reference chamber calibrated by an accredited laboratory. This program supports methods using the central axis transfer theory for cross-calibration for the ionization chambers. The reference and field ionization chambers were placed in a solid water phantom along the beam central axis at two different depths, and then the positions were switched. Each measured value was used for calculating the cross-calibration factor. Conclusions: Because many instruments are used and managed in radiation oncology departments, systematic, traceable recording is very important. The web-based program developed in this study is expected to be used effectively in the maintenance of radiation measurement instruments.

일개지역 치과위생사의 감염관리 실태에 관한 연구 (Actual status of infection control by the dental hygienist in Korea)

  • 윤경옥
    • 한국치위생학회지
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    • 제13권3호
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    • pp.369-376
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    • 2013
  • Objectives : The objectives of this study is to investigate the handwashing and use of personal protection equipment in dental hygienists and provide the basic data for dental infection control guideline. Methods : A questionnaire survey was performed in the dental hygienists who participated in the continuing education by the Daejeon City Commission in October 2012. The collected data were analyzed using PASW 18.0. Results : Handwashing was well practiced in group working for 3 to 5 years of employment. Those who took the infection cnotrol training used liquid soap, paper towel, dental mask, protective goggles, face shield, and gloves. Conclusions : Infection control is the most important practice in dental hygienists. So it is necessary to emphasize the inportnace of personal protection equipment including medical gloves, dental mask, and goggles.

Effect of 8 mW 525 nm LEDs Light Irradiation on the Defect Reduction in the Skin Wound of SD-rat

  • Cheon, Min-Woo
    • Transactions on Electrical and Electronic Materials
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    • 제9권3호
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    • pp.116-119
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    • 2008
  • The purpose of this study is to develop the Photodynamic Therapy Equipment for medical treatment. We developed the equipment which was helpful in palpating wound healing by using 525 nm LEDs. The equipment was assembled with a micro-controller and green color LEDs, and designed to enable us to control light irradiation time, intensity and so on. In this study, the designed device was used to find out how 525 nm LEDs light affected the skin wound of SD-Rat(Sprague-Dawley Rat). We divided the participants into two groups; irradiation group which was irradiated one hour a day for 9 consecutive days, and none irradiation group. The results showed that the study group had lower incidence of inflammation and faster recovery, compared with the control group.

고성능 단상 선로응동형 DVR(Dynamic Voltage Restorer) (Development of High-Performance Single-Phase Line-Interactive Dynamic Voltage Restorer)

  • 배병열;이동근;곽노홍;박상호;한병문
    • 전기학회논문지
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    • 제56권11호
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    • pp.1947-1954
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    • 2007
  • This paper describes the development of a high-performance single-phase line-interactive Dynamic voltage Restorer, which is composed of an H-bridge inverter and super-capacitors. The operational feasibility was verified through computer simulations with PSCAD/EMTDC software, and experimental works with 3kVA prototype. The developed system can compensates the input voltage sag and interruption within 2ms, in which the maximum allowable duration of voltage interruption is 1.5 seconds. It can be effectively used to compensate the voltage interruption in the sensitive load, such as computer, communication equipment, automation equipment, and medical equipment. The developed system has a simple structure to be easily implemented with commercially available components and to be highly reliable in operation.

H-브리지 인버터와 수퍼커패시터로 구성된 단상 DVR(Dynamic Voltage Restorer)의 개발 (Development of Single-Phase DVR(Dynamic Voltage Restorer) Composed of H-Bridge Inverter and SuperCapacitor)

  • 이동근;이두영;양승철;배병열;한병문
    • 대한전기학회:학술대회논문집
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    • 대한전기학회 2007년도 제38회 하계학술대회
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    • pp.160-161
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    • 2007
  • This paper describes the development of a single-phase DVR(Dynamic voltage Restorer), which is composed of H-bridge inverter and super-capacitors. The operational feasibility was verified through computer simulations with PSCAD/EMTDC software, and experimental works with 3kVA prototype. The developed system can compensates the input voltage sag and interruption within 2ms, in which the maximum allowable duration of voltage interruption is 1.5 seconds. It can be effectively used to compensate the voltage interruption in the sensitive load, such as computer, communication equipment, automation equipment, and medical equipment. The developed system has a simple structure to be easily implemented with commercially available components and to be highly reliable in operation.

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Ensemble Deep Learning Model using Random Forest for Patient Shock Detection

  • Minsu Jeong;Namhwa Lee;Byuk Sung Ko;Inwhee Joe
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • 제17권4호
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    • pp.1080-1099
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    • 2023
  • Digital healthcare combined with telemedicine services in the form of convergence with digital technology and AI is developing rapidly. Digital healthcare research is being conducted on many conditions including shock. However, the causes of shock are diverse, and the treatment is very complicated, requiring a high level of medical knowledge. In this paper, we propose a shock detection method based on the correlation between shock and data extracted from hemodynamic monitoring equipment. From the various parameters expressed by this equipment, four parameters closely related to patient shock were used as the input data for a machine learning model in order to detect the shock. Using the four parameters as input data, that is, feature values, a random forest-based ensemble machine learning model was constructed. The value of the mean arterial pressure was used as the correct answer value, the so called label value, to detect the patient's shock state. The performance was then compared with the decision tree and logistic regression model using a confusion matrix. The average accuracy of the random forest model was 92.80%, which shows superior performance compared to other models. We look forward to our work playing a role in helping medical staff by making recommendations for the diagnosis and treatment of complex and difficult cases of shock.