• 제목/요약/키워드: A Safety Device

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호흡보조의료기기의 사용목적 및 대상에 따른 규격적용 방안 및 성능에 관한 연구 (A Study for Application of Standard and Performance Test According to Purpose and Subject of Respiratory Medical Device)

  • 박준현;호예지;이덕희;최재순
    • 대한의용생체공학회:의공학회지
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    • 제40권5호
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    • pp.215-221
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    • 2019
  • The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

MAS 기반 대피시뮬레이션을 활용한 안전약자 대피지원 개선방안 연구 (A Study for Evacuation Assistance to Vulnerable People by MAS Based Evacuation Simulation)

  • 정태호;박상현;장재순
    • 한국안전학회지
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    • 제32권1호
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    • pp.121-127
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    • 2017
  • Recently, many patients in a hospital are threatened life by fire disaster. Because many patients like vulnerable people have more evacuation problem than ordinary person. So a patient who can escape by oneself with walking assistance device like crutches or wheelchair and another patient who can't escape by oneself are should be supported safety technologies and service. Earlier research of 'hospital evacuation' led by actual experiments or computer evacuation simulation. Actual experiment is effective to gain credibility of result but it is difficult for patients to experiment repeatedly and it requires consideration for spatial problem and economic problems. Although computer evacuation simulation have been used to solve these problems, almost have concluded only results based on velocity without evacuation device. In this study, evacuation results with support device application or not are analysed used by computer evacuation simulation based on MAS(Multi Agent System). As a result, it is drawn through proof of efficiency of evacuation device in the vertical space like stairs that can improve the evacuation plan for vulnerable people in the hospital.

심혈관계 시뮬레이터 개발 동향 분석을 통한 맥파검사용기기 성능평가 시뮬레이터 연구개발 방향 모색 (A Study on the Direction of Developing a Simulator for Performance Evaluation of Pulse Wave Detectors Through a Review of the Development Status of Cardiovascular Simulators)

  • 이주연;김재영;고동현;이지원;이태희;박창원;이수경
    • 대한의용생체공학회:의공학회지
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    • 제43권3호
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    • pp.136-146
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    • 2022
  • In this study, it is intended to provide basic data that can help develop a cardiovascular simulator for performance evaluation of pulse wave detectors by identifying the development status of domestic and overseas cardiovascular simulators. A total of 119 papers were selected by excluding duplicate literature, gray literature, and literature not related to a cardiovascular simulator. Based on the selected literature, the research trend of cardiovascular simulators was analyzed. As a result of analyzing the purpose of the study, most of the simulators were developed to evaluate the hemodynamic properties of artificial hearts and valves. In addition, it was used for simulation evaluation or hemodynamic studies such as pulse wave studies. As a result of analyzing configurations of the simulators, a heart most often consisted of only one left ventricle. For blood vessels, the Windkessel model was most often constructed using chambers and valves. In most studies, blood was reproduced by mixing glycerin and water to reproduce both density and viscosity. In addition, as a result of analysis from the perspective of medical device performance evaluation, simulators for evaluating artificial heart and artificial valves have been studied a lot, whereas simulators for blood pressure, pulse wave, and blood flow devices have been relatively insignificant. Based on the review results, we suggested considerations when developing a simulator for performance evaluations of a pulse wave detector.

안전 강화를 위한 자전거 장치 개발 (Development of bicycle device to strengthen safety)

  • 오병욱
    • 산업융합연구
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    • 제17권4호
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    • pp.125-129
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    • 2019
  • 자전거를 이용하는 사람들의 수가 증가함에 따라 자전거 사고의 수도 증가하고 있습니다. LED 조명을 사용하면 자전거를 탈 때 자전거 사고를 최대 11 % ~ 44 %까지 줄일 수 있습니다. 자전거의 헤드라이트는 자전거 라이더의 반대쪽에 노출 효과를, 미등은 후면 자전거 라이더에 노출 효과를 제공하여 안전성을 향상시킵니다. 본 연구에서는 제어 버튼 신호에 응답하여 LED에 의한 방향 전환을 표시 할 수 있는 자전거 안전장치를 구현 하였다. 이 신호는 고정 된 시간 동안 자전거의 페달과 휠에 장착 된 LED 조명을 모듈 유형의 발광 또는 깜박임으로 만듭니다. 야간에 자전거를 타는 사람이 자전거를 타는 경우 LED를 사용하여 안전을 향상시킬 수 있는 페달의 자전거 보조 장치가 본 연구에서 개발되었습니다. 무선 통신 기술을 적용한 자전거 안전장치는 미래에 에너지, 환경 및 안전과 같은 사회적 문제를 해결하기 위한 대체 기술이 될 것으로 예상됩니다.

쌍둥이 인접구조물의 진동 제어를 위한 비대칭 지진격리 연결 제어시스템의 매개변수연구 (Parametric Study of Asymmetric Base-Isolation Coupling Control System for Vibration Control of Adjacent Twin Buildings)

  • 김다위;박원석;옥승용
    • 한국안전학회지
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    • 제37권3호
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    • pp.45-51
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    • 2022
  • This paper focuses on a recently proposed asymmetric base-isolation coupling control system (ABiCS) for the vibration control of adjacent twin buildings. The ABiCS consists of inter-story diagonal dampers, a connecting damper between the two buildings, and a seismic isolation device at the base floor of one building. To investigate the control characteristics of ABiCS, a parametric study was performed by numerically simulating the 20-story twin buildings. In the parametric study, the control capacities of the inter-story diagonal dampers, connecting damper, and seismic isolation device were considered as varying parameters. The parametric study results indicate that the connecting damper between the two buildings reduces the responses of both buildings only at optimal or near-optimal capacity. In addition, adjusting the stiffness of the base isolation is found to be the most effective method for improving seismic performance and achieving cost-effectiveness. Accordingly, we presented a scenario-based performance improvement approach in which reducing the stiffness of the base isolation device could be an effective technique to improve the seismic performance of both buildings. However, note that checking the maximum allowable displacement of the base isolation device is essential.

의료기기 안전에 관한 대학병원 의료인들의 인식과 행동에 관한 연구 (Perception and Behavior Regarding the Safety of Medical Devices among Medical Personnel at a Tertiary Care Hospital)

  • 임지혜;김규성;김새롬;김영순;이훈재
    • 재활복지공학회논문지
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    • 제11권4호
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    • pp.287-297
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    • 2017
  • 본 연구는 의료기기 안전성에 관한 의료인들의 인식(지식, 태도)과 행동에 관한 기초현황을 파악하여 보고, 직종 간 차이를 평가해보기 위한 탐색적 조사연구이다. 인천광역시에 소재한 900병상 규모의 상급종합병원을 대상으로 설문지를 배포하여 220명의 응답 자료를 분석에 사용하였다. 연구결과, 연구대상 의료인들은 대체적으로 의료기기 종류에 따른 잠재적 위험성에 대한 인식이 갖춰져 있고, 의료기기 안전성 교육의 필요성을 느끼고 있었다. 또한 의료진들의 직종 간 의료기기 안전성에 관한 인식의 차이를 살펴봤을 때, 등급 높은 의료기기를 주로 사용하지만 의료기기 안전에 관한 인식이 가장 낮은 전공의를 대상으로 하는 의료기기 안전교육의 필요성이 크다는 것을 알 수 있었다. 향후 전국규모의 연구를 통하여 자료의 질을 향상하고 결과의 수준을 높이며, 이를 바탕으로 의료기기 안전성 관리에 있어 정책적, 교육적 기반으로 활용할 필요가 있다.

저강도 초음파 치료기기의 안전성 및 성능평가 가이드라인 수립을 위한 연구 (A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device)

  • 김주영;김재영;노시철;최흥호
    • 대한의용생체공학회:의공학회지
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    • 제36권5호
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    • pp.162-168
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    • 2015
  • In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

어선안전 모니터링 다기능 센서 모듈의 구현 (Implementation of Multi-function Sensor Module for Vessel Safety Monitoring)

  • 최조천;조승일;김성권;김재현;최규석;차재상
    • 한국인터넷방송통신학회논문지
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    • 제9권6호
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    • pp.135-139
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    • 2009
  • 어선의 안전을 실시간으로 모니터링하고 위험요소가 발생했을 경우에 사용자에게 이를 경보하고 통보해줄 수 있는 장치에 대한 필요성이 크게 대두되고 있다. 위험요소를 감지하는 다기능 센서를 사용하기 위해서 임베디드 모듈에서는 Device driver와 Application program을 구현해야 하는 문제가 있다. 본 논문에서는 Device driver와 Application program의 구현 없이 다기능 센서의 입출력 데이터를 관리 및 처리하기 위해서 PIC18F를 이용하여 센서부의 하드웨어 설계 및 제어프로그램 구현을 하였다. 센서의 동작에 따라 데이터를 출력하는 동작 확인을 통하여 성능검증을 하였다.

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최적계산코드를 이용한 대형 냉각재상실사고시 유량조절기 성능평가에 관한 연구 (Computational Study for the Performance of Fludic Device during LBLOCA using TRAC-M)

  • 전우청;이재훈;이상종
    • 에너지공학
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    • 제14권1호
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    • pp.54-61
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    • 2005
  • 한국형 신형원자로1400(APR1400)은 3983MWt급의 2×4 루프 개량형 가압경수로(PWR)로서 대형 냉각재상실사고 발생시 안전주입수의 원자로용기 직접주입(DVI) 방식을 채택하고 있으며, 안전주입수탱크(SIT) 내부에 유량조절기(Fluidic Device, FD)를 장착하고 있다. 본 연구에서는 신형원자로 1400의 안전주입계통에 새로이 적용된 주요 특징 중 하나인 유량조절기에 대하여 최적안전해석코드인 TRAC-M/F90, 3.782버전을 이용한 성능평가 및 민감도 분석을 수행하였다. 연구결과 유량조절기가 안전주입수의 원자로 유입을 적절하게 조절하고 있음을 확인하였으며, 안전주입수탱크 내부의 압축질소체적 감소가 안전 주입수체적 감소에 비하여 노심의 급냉 완료 시점을 빠르게 하였다. 또한 안전주입계통의 전체 저항계수(K factor)가 최소 또는 최대일 때 노심의 급냉 완료 시점은 평균값인 경우보다 다소 늦어졌으나, 피복재 최고온도(PCT)는 상대적으로 큰 차이가 발생하지 않았다.

M125 부스터 메카니즘의 해석 및 응용 (Simplified Parametric Study on M125 Booster Mechanism and its Application for Determining the Characteristic Constant of Arming Distance)

  • 임완권;김성식;방재원
    • 한국군사과학기술학회지
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    • 제18권4호
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    • pp.409-414
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    • 2015
  • M125 booster is one of the reliable S&A device(safety and arming device) to determine the arming distance of fuze for gun ammunitions from 90 mm to 8 inch in diameter. And it is also well known that the arming distance of M125 booster is determined by the multiplication value of the gun tube property(traveled distance per turn of projectile) and the S&A device property(number of turns to arm), not by the projectile muzzle velocity. We have tried and succeeded in executing a proper analysis on M125 booster to figure out its characteristic constant of arming distance by considering only the gun tube properties and the S&A device properties. More detailed arming distance will be analyzed in the future by considering dynamic characteristics on all elements in the S&A device with vector analysis.