• 제목/요약/키워드: Medical equipment

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하지 로봇재활의료기기의 안전성 및 필수성능 평가 기준 개발 (The Development of Safety and Essential Performance Criteria for Lower Extremity Robotic Assisted Gait Training System)

  • 강용완;권지연
    • 대한의용생체공학회:의공학회지
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    • 제44권3호
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    • pp.190-203
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    • 2023
  • The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

환자 감시장치의 국산화 개발에 관한 연구 (A Study on the Development of Patient Monitoring System)

  • 홍승홍;김재현
    • 대한의용생체공학회:의공학회지
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    • 제2권2호
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    • pp.117-126
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    • 1981
  • Patient monitoring system, which is one of widly used medical electronic equipment in clinics, is developed. This prototype bedside monitor is considered that can measure electrocardiograph, photoplethysmograph, heart rate, respiratory, body temperature, and etc. Some clinical tests are performed and considered with its usefulness for patient monitoring items.

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휴대용 XRF를 이용한 서울시 학교 내 어린이용품 중 일부 유해물질 함량 조사 (Measurement of Hazardous Substances in Children's Goods at Schools in Seoul)

  • 김규상;박현경;최길용;임완령;신규진
    • 한국환경보건학회지
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    • 제43권3호
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    • pp.176-184
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    • 2017
  • Objectives: Excluding in their homes, children spend most of their time at an elementary school, daycare center, and/or kindergarten. For educational or recreational purposes, they make use of many children's goods at these places. Some children's goods contain phthalates and heavy metals with polyvinyl chloride (PVC), so due to their physiological and behavioral characteristics children are exposed to high concentrations of phthalates and heavy metals. This study aims to measure PVC and heavy metals, which are harmful substances in children's goods which can have an effect on children's health. Methods: Six samples of children's goods were selected through cases of detected harmful substances and the results of previous research, including assembly blocks, model toys, household toys, bags, indoor play equipment, and floor mats. The selected items were measured using X-Ray Fluorescence (XRF), and the presence and content of environmentally harmful substances such as PVC or heavy metals in the materials of children's goods were examined. Results: The highest detection rate for PVC was observed in floor mats, and bags and indoor play equipment were higher than other goods in this regard. The highest detection rate for heavy metals was found in bags, followed by indoor play equipment, assembly blocks, household toys, model toys and floor mats. Except for bags containing heavy metals, five goods showed the highest level of Pb compared to other heavy metals. Floor mats contained the highest level of Pb, Cr, and Cu among all goods. Conclusion: Many children's goods contain PVC and heavy metals, and high levels of heavy metals have been detected in some goods. It is necessary to manage children's goods to support their health.

Verification of Periodical Calibration for Iso-center Positions using Quality Assurance System for Irradiation Equipment Position Established at PMRC

  • Yasuoka, Kiyoshi;Ishikawa, Satoko
    • 한국의학물리학회:학술대회논문집
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    • 한국의학물리학회 2002년도 Proceedings
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    • pp.192-194
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    • 2002
  • We present the results on the calibration of iso-center positions using the quality assurance system established at PMRC for determination of center position in X-ray and proton irradiation fields. Details on the system are presented in another presentation in this session. The equipment in the system is mounted on a patient treatment bed in each proton exposure room, G1 or G2. A center of a stainless ball on the equipment is set at a cross of laser markers located around the iso-center and fixed on the room and on the snout in the gantry. A proton beam or an X-ray beam is exposed onto the ball through a brass collimator of 100 mm ${\times}$ 100 mm and projected onto the imaging plate set at I cm behind the ball. On the axis perpendicular to the thrust axis of the gantry on the imaging plate, a distance between a center of the collimator image and a center of the ball image varies as a cosine function of gantry angles unless the ball is set on the iso-center. An amplitude of the cosine curve shows the distance between the ball and the iso-center, an offset the offset of the collimator, and a phase shift at a zero crossing point the ball direction viewed from the iso-center. We present the relation among the iso-center position, the laser maker position, and the center of proton and X-ray irradiation fields. Its stability and its reproducibility are discussed.

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코로나19 의심 또는 확진 환자가 병원 밖 심정지 발생 시 구조자의 개인 보호장비(PPE) 착용에 의한 가슴압박 효과 비교 : 무작위 교차 시뮬레이션 연구 (Effect of level D personal protective equipment on chest compression for pre-hospital arrest patients with suspected or confirmed COVID-19 : A randomized crossover simulation trial)

  • 홍석환;양연수;한상균
    • 한국응급구조학회지
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    • 제25권1호
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    • pp.23-36
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    • 2021
  • Purpose: The purpose of this study was to determine how the use of level D personal protective equipment (PPE) and cardiopulmonary resuscitation (CPR) feedback equipment affects chest compression (CC). Furthermore, this study provides basic data for developing Korean CPR guidelines that can be applied to patients with suspected or confirmed COVID-19. Methods: This randomized, single-blinded, crossover simulation trial included 26 student paramedics who performed 2-minute chest compressions using three different methods: Method A involved performing traditional CC for two minutes without donning level D PPE, Method B involved performing CC while donning level D PPE, and Method C involved performing CC with a CPR feedback device while donning level D PPE. Results: The use of a CPR feedback device during the 2-minute CC increased the exercise intensity of the subjects, but donning level D PPE didn't affect the quality of CC and the exercise intensity. The results of methods A and B showed changes in the quality of compression 80 seconds after the start of CC. No significant changes occurred in 2-minute CC when using the CPR feedback device. Conclusion: Using a CPR feedback device could prevent deterioration in the quality of CC while donning level D PPE.

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.

블루투스 통신을 이용한 의료정보 전송 시스템의 개발 (The Development of the Medical Information's Transmission System Using the Bluetooth)

  • 홍승범;지민석
    • 한국항행학회논문지
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    • 제13권5호
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    • pp.787-792
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    • 2009
  • 최근 유망한 응용분야 중 U-Health와 건강 모니터링에 관심이 집중되고 있다. 이는 무선통신과 의료장비를 접목하여 원거리에서 환자의 상태를 관찰할 수 있기 때문이다. 만약 긴급 상황이 발생한다면, 빨리 대처하기 위한 것이다. 본 논문에서는 블루투스를 탑재한 의료정보 전송 시스템과 새로운 데이터 포맷을 제안한다. 이 시스템은 각기 독립적으로 존재하는 개인 의료측정 장비 중 혈압과 혈당 측정기를 통합하였고, 통합 혈압 혈당 단말기에 블루투스 모듈을 탑재하였다. 그리고 블루투스 통신에 의해 수집된 의료 정보는 유선망을 통하여 의료서버로 전송된다. 제작된 원격의료정보 전송시스템을 실험실 환경에서 테스트하여 그 성능을 평가하였고 우수한 성능을 확인하였다.

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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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의료서비스를 위한 자동협상 스케줄링 시스템 설계 (Design of Automated Negotiation Scheduling System for Medical Services)

  • 김경환
    • 인터넷정보학회논문지
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    • 제9권3호
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    • pp.59-67
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    • 2008
  • 본 연구에서는 의료서비스의 복잡한 스케줄링문제 해결을 위한 새로운 시스템을 제안하였다. 기존 FCFS 시스템은 병원의 입장만 고려하였으나 제안 시스템은 병원의 사정과 환자들의 선호시간을 자동협상으로 반영하였다. 본 시스템은 개인의 서비스이용 희망시간을 우선도로 표현하였고 개인이 선택한 협상전략에 따라 변화되는 우선도를 기준으로 스케줄을 조정할 수 있도록 설계하였고 병원의 정책에 따라 스케줄을 확정 할 수도 있게 하였다. 따라서 제안시스템은 장비의 유휴시간만을 고려하는 기존시스템과 달리 장비의 효율성뿐만 아니라 환자의 대기시간까지 고려할 수 있도록 하여 의료서비스의 고객만족경영을 지원할 수 있을 것이다.

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중환자실 소음도와 소음에 대한 환자의 인지 (Noise Levels in Intensive Care Units and Patient's Perception)

  • 김민영;박의준
    • 중환자간호학회지
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    • 제8권1호
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    • pp.41-49
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    • 2015
  • Purpose: The purpose of this study was to measure the noise levels in intensive care units (ICUs) and to analyze the causes of the noise and patient perceptions of the noise. Methods: Noise levels were recorded in adult ICUs for 24 h over a week from the patients' bedside with a sound level meter. Noise sources were categorized into three groups: medical equipment, health care providers, and the environment. Noises from the environment were recorded in an empty ICUs side room. Perceptions of the noise of 125 patients admitted to the ICUs were recorded using a questionnaire. Results: The mean level of noise in the ICUs was 58.5 dBA (range: 34.2-80.2 dBA). The causes of noise higher than 70 dBA were nebulizers and infusion/syringe pumps among medical equipment, and drawer slamming, phone ringing, and stripping packages of medical fluids among environmental noises. According to the questionnaire, 64.0% of the patients responded that the ICUs were noisy and that they suffered from sleep disturbance because of the noise. Conclusion: Noise is considerably high in ICUs and is an annoying factor for the patients. Most noise sources are adjustable, and we should try to reduce noise whenever possible to make the ICUs environment more pleasant.