• 제목/요약/키워드: Single Device

검색결과 1,730건 처리시간 0.031초

ISO14971:2019 Detailed Analysis and Periodic Safety Update Report Establishment Method for the Single Use Medical Device - Focusing on Medical Device Regulation 2017/745 requirements (일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 - Medical Device Regulation 2017/745 요구사항 중심으로)

  • Sang Min, Park;Gyu Ha, Ryu
    • Journal of Biomedical Engineering Research
    • /
    • 제44권1호
    • /
    • pp.1-10
    • /
    • 2023
  • With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

XML BASED SINGLE SIGN-ON SCHEME FOR DEVICE CONTROL IN UBIQUITOUS ENVIRONMENT

  • Jeong, Jong-Il;Lee, Seung-Hun;Shin, Dong-Il;Shin, Dong-Kyoo
    • Proceedings of the Korean Society of Broadcast Engineers Conference
    • /
    • 한국방송공학회 2009년도 IWAIT
    • /
    • pp.298-302
    • /
    • 2009
  • This paper proposes a single sign-on scheme in which a mobile user offers his credential information to a home network running the OSGi (Open Service Gateway Initiative) service platform, to obtain user authentication and control a remote device through a mobile device using this authentication scheme, based on SAML (Security Assertion Markup Language). Especially by defining the single sign-on profile to overcome the handicap of the low computing and memory capability of the mobile device, we provide a clue to applying automated user authentication to control a remote device via a mobile device for distributed mobile environments such as a home network based on OSGi.

  • PDF

Hot Carrier Induced Device Degradation in GAA MOSFET (Hot carrier에 의한 GAA MOSFET의 열화현상)

  • 최락종;이병진;장성준;유종근;박종태
    • Proceedings of the IEEK Conference
    • /
    • 대한전자공학회 2002년도 하계종합학술대회 논문집(2)
    • /
    • pp.5-8
    • /
    • 2002
  • Hot carrier induced device degradation is observed in thin-film, gate-all-around SOI transistor under DC stress conductions. We observed the more significant device degradation in GAA device than general single gate SOI device due to the degradation of edge transistor. Therefore, it is expected that the maximum available supply voltage of GAA transistor is lower than that o( bulk MOSFET or single gale SOI device.

  • PDF

The Influence of The Starting Permanent Magnet on Average Torque of The Salient Pole Rotor Type Single Phase SRM (영구자석 기동장치가 회전자 돌극형 단상 SRM의 평균 토오크에 미치는 영향)

  • Kim, Jun-Ho;Lee, Eun-Woong;Lee, Chung-Won;Seo, Jung-Min;Kim, Gyeon-Muk
    • Proceedings of the KIEE Conference
    • /
    • 대한전기학회 2003년도 하계학술대회 논문집 B
    • /
    • pp.1030-1032
    • /
    • 2003
  • Single phase SRM(switched reluctance motor) can not be start by itself because positive torque is generated in limited section. Therefore single phase SRM need starting device which is place the rotor in positive torque section when motor is begun to start. The prototype of salient pole rotor type single phase SRM, fabricated in previous research, has permanent magnet starting device. It is installed in bottom of the rotor for starting by itself. But, it is affected the motor when driving and cause the decrease of torque and speed. On this paper, average torque of the prototype was measured according to installation of the starting device or not. And influence of the staring device on average torque was confirmed by comparison of the results.

  • PDF

Development of the Intelligent Switchgear Prototype with Arc Fault Detection Capability (아크고장 검출 기능을 가지는 지능형 분전반 개발)

  • Ko, Yun-Seok;Lee, Seo-Han
    • The Journal of the Korea institute of electronic communication sciences
    • /
    • 제11권1호
    • /
    • pp.59-64
    • /
    • 2016
  • This paper aims at the prototype-making of the intelligent switchgear with arc fault diagnosis function required to prevent the electrical fire. The main control unit of the intelligent switchgear consists of a single-phase power management device and a arc fault diagnosis device. The prototype of the single-phase power management device and the prototype of the arc fault diagnosis device in this paper. In the device, the cooperation function with the arc fault diagnosis device is developed to transmit the cause of the electrical fire to the remote server system.

The Fabrication of A Semi-conducting Single-walled Carbon Nanotube Device Using A Burning Technique (연소 기술을 이용한 반도체성 단일벽 탄소 나노튜브 장치 제작)

  • 이형우;한창수;김수현;곽윤근
    • Proceedings of the Korean Society of Precision Engineering Conference
    • /
    • 한국정밀공학회 2004년도 추계학술대회 논문집
    • /
    • pp.881-885
    • /
    • 2004
  • We report a method for making a device on which semi-conducting single-walled carbon nanotubes are attached selectively between two metal electrodes. This method is divided two processes. First we can connect a rope of single-walled carbon nanotubes(SWNTs) between two electrodes using the electric field. But a SWNTs' rope obtained by the first process was composed of a few of metallic and semi-conducting SWNTs together. The second process is to burn the metallic and semi-conducting nanotubes through applying a voltage. As a result, we can obtain a semi-conducting SWNT device. To make the patterned electrodes, we deposited $SiO_2$(150nm) on a wafer. After then, we made a patterned samples with Ti(200 $\AA$)/Au(300$\AA$). We empirically obtained a electric condition 0.66 $V_{pp}$ /${\mu}{\textrm}{m}$@5MHz. From this result, we verified that most of current go through the metallic nanotubes in this device. When we apply DC voltage between two electrodes, the metallic carbon nanotubes are burnt. Finally, we can obtain a semi-conducting nanotube device which we desire to make. We got the I-V characteristic graph which has shown the semi-conducting property. We hope to apply to the various applications using this selective semi-conducting carbon nanotube deposition method.ethod.

  • PDF

Electromagnet Starting Device used in the Single-Phase SRM (단상 SRM에 사용되는 전자석 기동 장치)

  • Kim, Jun-Ho;Lee, Eun-Woong;Lee, Jong-Han
    • Proceedings of the KIEE Conference
    • /
    • 대한전기학회 2006년도 제37회 하계학술대회 논문집 B
    • /
    • pp.813-814
    • /
    • 2006
  • The squirrel case induction motor has widely used in the driving of the blowers but it is low efficiency and hard to control. So, the damper is used for the control of a flow and it cause to low the driving efficiency. Our laboratory has proposed the single-phase SRM(switched reluctance motor) for driving blowers. It has salient pole structure and can be reduced a number of semiconductors than three-phase SRM. But it can not be starting by itself and has heavier torque ripple than three-phase SRM. For self-starting the single-phase SRM is required the starting device which place the rotor at the rising inductance slope. On this paper, the electromagnet starting device is designed to generate the starting torque and to fix the rotating direction of the single-phase SRM which is fabricaed to use a blower.

  • PDF

Scale Invariant Single Face Tracking Using Particle Filtering With Skin Color

  • Adhitama, Perdana;Kim, Soo Hyung;Na, In Seop
    • International Journal of Contents
    • /
    • 제9권3호
    • /
    • pp.9-14
    • /
    • 2013
  • In this paper, we will examine single face tracking algorithms with scaling function in a mobile device. Face detection and tracking either in PC or mobile device with scaling function is an unsolved problem. Standard single face tracking method with particle filter has a problem in tracking the objects where the object can move closer or farther from the camera. Therefore, we create an algorithm which can work in a mobile device and perform a scaling function. The key idea of our proposed method is to extract the average of skin color in face detection, then we compare the skin color distribution between the detected face and the tracking face. This method works well if the face position is located in front of the camera. However, this method will not work if the camera moves closer from the initial point of detection. Apart from our weakness of algorithm, we can improve the accuracy of tracking.

The Optimum Design of The Permanent Starting Device used in The Single-Phase SRM (단상 SRM에 사용되는 영구자석 기동장치의 최적 설계 I)

  • Kim, Jun-Ho;Lee, Eun-Woong;Lee, Jong-Han;Lee, Min-Myung;Kim, Myung-Hwan
    • Proceedings of the KIEE Conference
    • /
    • 대한전기학회 2005년도 제36회 하계학술대회 논문집 B
    • /
    • pp.1279-1281
    • /
    • 2005
  • Generally a single-phase SRM(switched reluctance motor) has several stator and rotor poles but these are excited by one regulated current at the same time. It has only one inductance variation. It means that the positive torque is only generated in the positive slope of the inductance variation. The single-phase SRM can not be started by itself. The single-phase SRM can be started by itself if the rotor is placed in the positive slope of the inductance variation. Then, the starting device is required to place the rotor in the starting position before start. On this paper, the equation of the force requisite for the starting device is derived using by the frictional force of the rotor

  • PDF

Link Scheduling Method Based on CAZAC Sequence for Device-to-Device Communication (D2D 통신 시스템을 위한 CAZAC 시퀀스 기반 링크 스케줄링 기법)

  • Kang, Wipil;Hwang, Won-Jun;Choi, Hyung-Jin
    • The Journal of Korean Institute of Communications and Information Sciences
    • /
    • 제38A권4호
    • /
    • pp.325-336
    • /
    • 2013
  • FlashLinQ, one of the typical D2D communication systems developed by Qualcomm, considers a single-tone communication based distributed channel-aware link scheduling method to realize the link scheduling process with low control overheads. However, considering the frequency selective fading effect of practical multi-path channel, the single-tone based SIR estimation causes a critical scheduling error problem because the received single-tone signal has quite different channel gain at each sub-carrier location. In order to overcome this problem, we propose a novel link scheduling method based on CAZAC (Constant Amplitude Zero Auto-Correlation) sequence for D2D communication system. In the proposed method, each link has a unique offset value set for the generation of CAZAC sequences. CAZAC sequences with the cyclic offsets are transmitted using multiple sub-blocks in the entire bandwidth, and then each device can obtain nearly full-band SIR using a good cyclic cross-correlation property of CAZAC sequence.