• 보건의료산업학회지
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• 제7권3호
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• 정보처리학회논문지D
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• 제10D권5호
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• pp.781-792
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• 2003

오늘날 소프트웨어가 중심이 죄는 의료기기의 폭발적 증가로 인해 의료용 소프트웨어는 의료 서비스의 경쟁력 확보를 위한 중요한 수단이 되고 있으며 의료 서비스의 품질이 의료기기뿐만 아니라 의료용 소프트웨어의 품질에 지대한 영향을 받게 되었다. 그러나 의료용 소프트웨어의 품질에 관한 국내의 관련 연구ㆍ개발이 아직 미흡한 실정이며 의료용 소프트웨어의 품질저하로 인한 의료 서비스의 질적 저하를 유발할 수 있는 문제점이 발생할 수 있다. 따라서, 의료기기의 발전과 아울러 의료용 소프트웨어의 품질 향상을 통해 의료 서비스의 질적 수준을 제고할 필요가 있다. 따라서, 본 논문에서는 ISO/IEC 12119를 기반으로 의료용 소프트웨어를 시험하여 결과론 산출할 수 있는 시험모듈과 품질검사표를 개발하여 의료용 소프트웨어 시험에 적용할 수 있도록 하였다.

• 전기학회논문지P
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• 제64권3호
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• pp.175-181
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• 2015

In this paper, the neuromuscular electrical stimulation medical devices for non-implantable incontinence treatment other than vaginal insertion type was developed and commercialized. The structure of medical devices for electrical stimulation based on the anatomy of the pelvic floor muscle designed. Then, the optimum parameters that may be effective in pelvic floor muscle electrical stimulation was set. The circuit system based on the optimum parameters were designed and manufactured. The frequency of the pulse voltage for electrical stimulation is 75[Hz], the pulse width is 300[${\mu}s$], the development of medical devices was to have seven program functions to the various treatments. The circuit system of medical devices was composed of microcontroller, comparator and converter. The performance of the developed circuit system in KTC(Korea Testing Certification) were carried out medical equipment inspection test. Test results, test specifications were satisfied with the medical device, the performance was verified to be commercialized as a medical device. The development of medical devices were validated risk assessment and product performance through a software validation. Commercialization of medical equipment was acquired to enable the certification standards of the international standard IEC 60601-1.

• International Journal of Computer Science & Network Security
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• 제22권6호
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• pp.63-66
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• 2022

The article discusses the application of the IoT concept in the sensitive field of medical devices on the example of a developed prototype of a mechanotherapeutic simulator. Mechanotherapy is a complex of therapeutic, preventive, and restorative exercises conducted using simulators, specially designed for developing movements in individual joints. Mechanotherapy is used for the early and painless restoration of joint mobility, to prevent complications associated with prolonged immobilization of the injured area of extremities. Using the mechanotherapy simulator allows developing the joint painlessly, which accelerates the metabolism in the injured area, and soft tissues are restored to normal. The article provides information about the electronic components that ensure the wireless operation of the device and describes in detail the applied software as well as the client application for a mobile device.

• 대한의용생체공학회:의공학회지
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• 제42권6호
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• 한국멀티미디어학회논문지
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• 제9권12호
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• pp.1580-1587
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• 2006

The term molecular imaging can be broadly defined as the in vivo characterization and measurement of biologic processes at the cellular and molecular level. Optical imaging that has highly reproducibility and repetition used in molecular imaging research. In the bioluminescence imaging, animals carrying the luciferase gene are imaged with a cooled CCD(Charge-Coupled Device) camera to pick up the small number of photons transmitted through tissues. Molecular imaging analysis will allow us to observe the incipience and progression of the disease. But hardware device for molecular imaging and software for molecular image analysis were dependent on imports. In this paper, we suggest image processing methods and designed software for bioluminescence signal analysis. And we demonstrated high correlation(r=0.99) between our software's photon counts and commercial software's photon counts. ROI function and processing functions were accomplished without error. This study have the importance of the development software for bioluminescence image processing and analysis. And this study built the foundations for creative development of analysis methods. We expected this study lead the development of image technology.

• 대한임베디드공학회논문지
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• 제7권5호
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• pp.219-226
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• 2012

The rises of the life index quality together with the medical technology improvement lead to a longer life expectancy. Then a better health care program, especially for elderly, is needed. The common health problems facing those senior citizens are changed from acute diseases to chronic diseases, such as diabetes, hypertension. Then u-Health takes center stage in medical industry. Although u- Health medical device manufacturers have been improving their instruments, these instruments still rely on proprietary technologies without fixed platform. Even if the interface has been provided by the manufacturer, there is no widely-accepted uniform data model to access data of various u-Health devices. IEEE 11073 is a standard attempting to unify the interfaces of all medical devices. In this paper we have proposed a conversion software platform that assures interoperability among medical devices for ubiquitous sensor network. This module uses in order to develop a standard platform of medical system.

• 한국정보처리학회:학술대회논문집
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• 한국정보처리학회 2015년도 추계학술발표대회
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• pp.1388-1389
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• 2015

Electropulsegraphy is a medical device that was invented by an orient medical physician and a few engineers to help the physicians to diagnose patients in more systematic way by analyzing waveforms generated from the device. Data generated form the device has been collected for over several decades, and undergoes functional upgrades today. The device generates 33 waveforms that reflect the states of patients. As one of those upgrading efforts, we strive to develop an intelligent algorithm that makes the diagnostic process automatically, which was previously done manually for a long period of time. The logistic regression algorithm is used for our classification problems, which is one of those well-known algorithms for various classification problems such as character recognition systems. Out of the 33 waveforms, we only use 5 waveform data (Type1 toType5) as training data sets to estimate the parameters of the logistic regression. And the parameters are used to classify waveform inputs chosen at random.

• 산업기술연구
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• 제24권A호
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• pp.83-90
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• 2004

Generally, electronic appliances are used on the basis of normal power source supply. The power source inevitably includes the abnormal condition, such as, sudden voltage sagging, power interrupt, and induced noises. As the electronic appliances which include micro-controller-based circuits are being increased recently, the controller circuit sometimes malfunctions by the abnormal condition of the power source. This situation causes serious problems such as hitch of electric appliance, fire and medical instrument glitch, which produces serious situations. In this paper, development of power interrupt tester which is highly suitable for an endurance test device under abnormal power source to microprocessor-based circuits is proposed 89C2051 microcontroller is performed to make power interrupt signal, and software controls peripheral hardwares and built-in functions. Experimental results of this study will offer a good application to electronic appliance maker as a test device of hardware and software debugging use.

• Journal of Information Processing Systems
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• 제13권6호
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• pp.1602-1612
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• 2017

Since rapidly disseminating of Internet of Things (IoT) as the new communication paradigm, a number of studies for various applications is being carried out. Especially, interest in the smart medical system is rising. In the smart medical system, a number of medical devices are distributed in popular area such as station and medical center, and this high density of medical device distribution can cause serious performance degradation of communication, referred to as the coexistence problem. When coexistence problem occurs in smart medical system, reliable transmitting of patient's biological information may not be guaranteed and patient's life can be jeopardized. Therefore, coexistence problem in smart medical system should be resolved. In this paper, we propose a distributed coexistence mitigation scheme for IoT-based smart medical system which can dynamically avoid interference in coexistence situation and can guarantee reliable communication. To evaluate the performance of the proposed scheme, we perform extensive simulations by comparing with IEEE 802.15.4 MAC protocol which is a traditional low-power communication technology.