• 제목/요약/키워드: Compliance Device

검색결과 109건 처리시간 0.027초

SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발 (Development of Guideline for Heuristic Based Usability Evaluation on SaMD)

  • 김종엽;김정현;김재호;정명진
    • 대한의용생체공학회:의공학회지
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    • 제44권6호
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    • pp.428-442
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    • 2023
  • In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

Validation of a smart structural concept for wing-flap camber morphing

  • Pecora, Rosario;Amoroso, Francesco;Amendola, Gianluca;Concilio, Antonio
    • Smart Structures and Systems
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    • 제14권4호
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    • pp.659-678
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    • 2014
  • The study is aimed at investigating the feasibility of a high TRL solution for a wing flap segment characterized by morphable camber airfoil and properly tailored to be implemented on a real-scale regional transportation aircraft. On the base of specific aerodynamic requirements in terms of target airfoil shapes and related external loads, the structural layout of the device was preliminarily defined. Advanced FE analyses were then carried out in order to properly size the load-carrying structure and the embedded actuation system. A full scale limited span prototype was finally manufactured and tested to: ${\bullet}$ demonstrate the morphing capability of the conceived structural layout; ${\bullet}$ demonstrate the capability of the morphing structure to withstand static loads representative of the limit aerodynamic pressures expected in service; ${\bullet}$ characterize the dynamic behavior of the morphing structure through the identification of the most significant normal modes. Obtained results showed high correlation levels with respect to numerical expectations thus proving the compliance of the device with the design requirements as well as the goodness of modeling approaches implemented during the design phase.

인버터 기반 신재생 에너지 발전 시스템의 계통 지원 운전을 위한 계통 전압 검출 방법 (A Detection Method of Grid Voltage for Grid Support Operation of an Inverter-based Renewable Energy Generation System)

  • 안현철;송승호
    • 신재생에너지
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    • 제9권2호
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    • pp.51-57
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    • 2013
  • The Grid code is being strengthen as increase of renewable energy ratio. Especially, the grid connection regulations are continuously being updated for stable operation of power grids. Static grid support and Dynamic grid support must make an accurate measure at Grid connected point because they needs control algorithm individually. It has to exactly measure voltage including switching ripple at the output of the inverter generating system. In addition, it is necessary to have an accurate voltage measurement when the situation rapidly changing the grid impedance is caused by the input of serial impedance of transformer and line impedance as well as Grid Fault Device. In this paper, We propose a new detection method of grid voltage to calculate accurately the r.m.s voltage of the grid connection point along the standard required by the low voltage regulation. We verified performance through simulation grid fault device.

휴대용 대공 유도무기 추진시스템의 동적연소시험 기법 연구 (A Study on the Technique for Dynamic Firing Test of Propulsion System of Personal Surface to Air Missile)

  • 김준엽;한태균;김인식
    • 한국추진공학회지
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    • 제4권3호
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    • pp.19-28
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    • 2000
  • 고체추진 로켓모타의 개발이나 성능평가 때에는 추진기관의 추력, 연소실 압력, 온도, 연소시간 등 정적연소시험을 통해서 필요한 데이터론 측정한다. 그러나 휴대용 대공 유도무기의 경우에는 추진기 관의 화염으로부터 사수를 보호하기 위해 대단히 까다로운 안전규정을 요구하고 있다. 이러한 안전 규정들을 만족시키기 위해 설계된 분리장치나 점화안전장치의 개발 및 성능평가를 위해서는 이들 장치들이 결합된 추진기관에 대해 실제 비행 환경 하에서 설계목표의 신뢰도를 시험하기 위한 동적연소시험이 수행되어야 한다. 본 연구에서는 이러한 휴대용 대공 유도무기 추진시스템의 개발이나 성능평가를 위한 동적연소시험 기법 및 동적시험대의 설계 및 제작에 관한 연구를 수행하였다.

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인공호흡기 중앙감시시스템 소프트웨어의 사용적합성 총괄평가 (Summative Usability Assessment of Software for Ventilator Central Monitoring System)

  • 정지용;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제44권6호
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    • pp.363-376
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

월성 2,3,4호기 열수송계통의 비정상 운전 해석 (Abnormal Operation Analysis of the Wolsong 2,3,4 Heat Transport System)

  • 신정철
    • 에너지공학
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    • 제25권1호
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    • pp.15-22
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    • 2016
  • 월성 2,3,4호기의 비정상 운전 중 열수송계통의 과도변화해석이 수행되었다. 중수로에 대한 캐나다의 규제문서인 AECB R-77 요구조건에 대한 만족성을 평가하였다. 해석 결과 여러 비정상 운전시 과도변화에 의한 원자로 모관의 최고압력값은 ASME 코드의 제한치 이내로 만족되었다. 고압시 보호장치인 LRV의 영향은 미미한 것으로 나타났다.

Resistive Switching in Vapor Phase Polymerized Poly (3, 4-ethylenedioxythiophene)

  • ;성명모
    • 한국진공학회:학술대회논문집
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    • 한국진공학회 2012년도 제43회 하계 정기 학술대회 초록집
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    • pp.384-384
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    • 2012
  • We report nonvolatile memory properties of poly (3, 4-ethylenedioxythiophene) (PEDOT) thin films grown by vapor phase polymerization using FeCl3 as an oxidant. Liquid-bridge-mediated transfer method was employed to remove FeCl3 for generation of pure PEDOT thin films. From the electrical measurement of memory device, we observed voltage induced bipolar resistive switching behavior with ON/OFF ratio of 103 and reproducibility of more than 103 dc sweeping cycles. ON and OFF states were stable up to 104 seconds without significant degradation. Cyclic voltammetry data illustrates resistive switching effect can be attributed to formation and rupture of conducting paths due to oxidation and reduction of PEDOT. The maximum current before reset process was found to be increase linearly with increase in compliance current applied during set process.

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Design of a Dual-Drive Mechanism for Precision Gantry

  • Park, Heung-Keun;Kim, Sung-Soo;Park, Jin-Moo;Daehie Hong;Cho, Tae-Yeon
    • Journal of Mechanical Science and Technology
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    • 제16권12호
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    • pp.1664-1672
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    • 2002
  • Gantry mechanisms have been widely used for precision manufacturing and material handling in electronics, nuclear, and automotive industries. Dual-drive servo mechanism is a way to increase control bandwidth, in which two primary axes aligned in parallel are synchronously driven by identical servo motors. With this mechanism, a flexible coupling (compliance mechanism) is often introduced in order to avoid the damage by the servo mismatch between the primary drives located at each side of gantry. This paper describes the design guidelines of the dual-drive servo mechanism with focus on its dynamic characteristics and control ramifications. That is, the effect on the system bandwidth which is critical on the system performance, the errors and torques exerted on guide ways in case of servo mismatch, the vibration characteristics concerned with dynamic error and settling time, and the driving force required at each axis for control are thoroughly investigated.

줄 꼬임 기반 팔꿈치 외골격 (Twisted Strings-based Elbow Exoskeleton)

  • ;이광현;;유지환
    • 로봇학회논문지
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    • 제8권3호
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    • pp.164-172
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    • 2013
  • This paper presents a new concept of a 1-DOF elbow exoskeleton driven by a twisted strings-based actuator. A novel joint actuation mechanism is proposed and its kinematic model is presented along with its experimental evaluation, and guidelines on how to choose the strings suitable for such an exoskeleton are given. We also proposed and experimentally verified a human intention detection method which takes advantage of intrinsic compliance of the mechanism. The study showed that the developed twisted strings-driven elbow exoskeleton is light, compact and have a high payload-to-weight ratio, which suggests that the device can be effectively used in a variety of haptics, teleoperation, and rehabilitation applications.

On the Control of Re-Structured Electric Power Systems

  • Feliachi Ali
    • International Journal of Control, Automation, and Systems
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    • 제3권spc2호
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    • pp.363-375
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    • 2005
  • The paper describes some of the challenges that face the control of nonlinear interconnected power systems. The challenges include the selection of appropriate control and information structures that could range from a completely decentralized to a fully centralized structure. Once a structure is proven to be feasible, the effectiveness of control signals needs to be assessed. Analytical tools are derived for this purpose in the first part of the paper, and they are illustrated with a case study that involves the design of a damping decentralized controller using a Thyristor Controlled Series Compensation device. The second part of the paper deals with the load following and tracking problem through automatic generation control for a system that has been re-structured or deregulated. This problem can be solved using a completely decentralized scheme. It is solved here using fuzzy rules and with an emphasis on compliance with NERC's standards and reduction of wear and tear of the equipment. It is illustrated with a test system that has three interconnected control areas. Finally, comments on the economics of control and the author's vision are presented.