• Title/Summary/Keyword: Medical equipment

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

  • Yong Wan Kang;Ji Yean Kwon
    • Journal of Biomedical Engineering Research
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    • v.44 no.3
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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.

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

  • 홍승홍;김재현
    • Journal of Biomedical Engineering Research
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    • v.2 no.2
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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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Measurement of Hazardous Substances in Children's Goods at Schools in Seoul (휴대용 XRF를 이용한 서울시 학교 내 어린이용품 중 일부 유해물질 함량 조사)

  • Kim, KyooSang;Park, Hyunkyung;Choi, Gilyoung;Lim, Wanryong;Shin, Kyoojin
    • Journal of Environmental Health Sciences
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    • v.43 no.3
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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
    • Proceedings of the Korean Society of Medical Physics Conference
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    • 2002.09a
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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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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 (코로나19 의심 또는 확진 환자가 병원 밖 심정지 발생 시 구조자의 개인 보호장비(PPE) 착용에 의한 가슴압박 효과 비교 : 무작위 교차 시뮬레이션 연구)

  • Hong, Seok-Hwan;Yang, Yeun Soo;Han, Sang-Kyun
    • The Korean Journal of Emergency Medical Services
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    • v.25 no.1
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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.

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

  • Kim, Eun-Hye;Park, Hye-Min;Kim, Jung-Min
    • Journal of radiological science and technology
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    • v.45 no.2
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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.

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

  • Hong, Seung-Beom;Jie, Min-Seok
    • Journal of Advanced Navigation Technology
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    • v.13 no.5
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    • pp.787-792
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    • 2009
  • A number of very promising applications such as health monitoring and U-Health of ubiquitous techniques has attracted interest in recent years. Because it can observes the condition of patient from long distance using the equipment which combines with radio communication and medical monitoring system. If it is at emergency situation, it can disposes the condition of the patient. In this paper, we propose the new data format and the transmission communication system of combination medical information with the bluetooth. And we produce the on-board system which transmits the medical information. This system integrated the blood pressure and glucose monitor of personal medical equipment, and the medical information which obtained from on-board system acquires through the gateway with the bluetooth. Medical information is transmitted to the tele-monitor server by the wireline network. We evaluated the proposed system under the laboratory environment and confirmed the excellent performance of transmission of the medical information.

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

  • Jang, Jun Hyuk
    • The Korean Society of Law and Medicine
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    • v.15 no.1
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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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Design of Automated Negotiation Scheduling System for Medical Services (의료서비스를 위한 자동협상 스케줄링 시스템 설계)

  • Kim, Kyoung-Hwan
    • Journal of Internet Computing and Services
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    • v.9 no.3
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    • pp.59-67
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    • 2008
  • New system solves scheduling problem in medical services. The existing scheduling system by FCFS is for a hospital but new system expresses the condition of a hospital and the profit of separate system's parties by the automated negotiation. This system expresses user preference time as a priority number and is designed that the schedule is changed according to the priority number with a negotiation strategy for a patient. And a hospital makes a schedule according to the policy. The system supports customer satisfaction in medical services by considering not only equipment efficiency but also the patent waiting time unlike the existing system considering the idle time for a equipment.

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

  • Kim, Min Young;Park, Ui-Jun
    • Journal of Korean Critical Care Nursing
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    • v.8 no.1
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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.