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김산,장무영,황윤수,이기훈,허찬회,홍충만,Kim, San,Jang, Moo-Young,Hwang, Yoon Su,Lee, Ki-Hun,Hur, Chan-Hoi,Hong, Choongman 대한전자공학회 2013 전자공학회논문지 Vol.49 No.11
선진국의 고령사회 도래 및 웰빙 확산, 중국, 인도 등 후발 공업국의 급성장에 따라 최근 전자의료기기시장이 크게 확대 되고 있다. 이중 다소비 생활밀착형 전자의료기기중 하나인 개인용전기자극기는 통증완화, 재활치료, 근육운동 등의 목적으로 사용되는 전기자극기로써 가정에서 개인적으로 사용하는 만큼 그 안전성 및 성능 확보는 사용자의 측면에서 매우 중요하다고 볼 수 있다. 그러나 현재 개인용전기자극기에 대한 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 따라서 본 연구에서는 국제수준에 부합하는 개인용전기자극기의 안전성과 성능을 평가하기위해 관련 국내외 규격을 검토하였고 시험항목, 기준 및 방법을 제안하였다. 또한 제안된 시험항목에 대한 시험검증을 통하여 최종적으로 국제 조화된 안전성 및 성능 평가 항목을 도출하였다. 본 연구 결과를 통하여 개인용전기자극기의 품질 및 안전성 향상을 도모함으로써 국내 전자의료기기산업의 국제 경쟁력 확보에 기여할 수 있을 것으로 기대된다. The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.
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뇌 대사물질 팬텀을 이용한 뇌의 자기공명 온도측정법에 관한 기초 연구
한용희,장무영,문치웅,Han, Yong-Hee,Jang, Moo-Young,Mun, Chi-Woong 대한의용생체공학회 2010 의공학회지 Vol.31 No.5
In this study, we measured the chemical shift change of metabolite peaks in the brain-metabolite phantom according to the temperature variation using nuclear magnetic resonance(NMR). The temperature range in NMR system was controled from 25 to 80 (5 step) by internal temperature controller. Temperature coefficients of each metabolite peaks were also calculated from the measured chemical shift depending on the temperature. The chemical shift changes depending on temperature were validated by linear regression method for each metabolite peaks. The temperature coefficients of $_{tot}Cr$, Cho, Cr, NAA, and Lac were 0.0086, 0.0088, 0.0091, 0.0089, and 0.0088ppm/$^{\circ}C$, respectively. This study shows that chemical shift change of brain metabolite and temperature variation have linear relationship each other. This also makes authors believe that brain temperature measurement is possible using MR spectroscopic imaging technique.
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김산(San Kim),장무영(Moo-Young Jang),황윤수(Yoon Su Hwang),이기훈(Ki-Hun Lee),허찬회(Chan-Hoi Hur),홍충만(Choongman Hong) 대한전자공학회 2013 전자공학회논문지 Vol.50 No.3
선진국의 고령사회 도래 및 웰빙 확산, 중국, 인도 등 후발 공업국의 급성장에 따라 최근 전자의료기기시장이 크게 확대 되고 있다. 이중 다소비·생활밀착형 전자의료기기중 하나인 개인용전기자극기는 통증완화, 재활치료, 근육운동 등의 목적으로 사용되는 전기자극기로써 가정에서 개인적으로 사용하는 만큼 그 안전성 및 성능 확보는 사용자의 측면에서 매우 중요하다고 볼 수 있다. 그러나 현재 개인용전기자극기에 대한 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 따라서 본 연구에서는 국제수준에 부합하는 개인용전기자극기의 안전성과 성능을 평가하기위해 관련 국내외 규격을 검토하였고 시험항목, 기준 및 방법을 제안하였다. 또한 제안된 시험항목에 대한 시험검증을 통하여 최종적으로 국제 조화된 안전성 및 성능 평가 항목을 도출하였다. 본 연구 결과를 통하여 개인용전기자극기의 품질 및 안전성 향상을 도모함으로써 국내 전자의료기기산업의 국제 경쟁력 확보에 기여할 수 있을 것으로 기대된다. The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.
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핵자기공명분광법에 사용되는 D2O 및 TSP의 세포 독성 평가
문치웅 ( Chi Woong Mun ),곽소영 ( So Young Kwak ),장무영 ( Moo Young Jang ) 한국조직공학·재생의학회 2012 조직공학과 재생의학 Vol.9 No.2s
Nuclear magnetic resonance (NMR) spectroscopy has been being used to identify cell metabolite and differentiation with reference material (TSP) and locking solvent (D2O). The aim of this study is to evaluate the cytotoxicity of TSP and D2O which have been widely used for NMR research. MG-63 and hMSC were selected and cultured in 3-dimensions on alginate bead for cytotoxicity test. The statistical analysis was performed after identifying the cell viability in accordance with various concentrations and exposure time of TSP and D2O. There was significant difference of cell viability between two concentrations (40% and 100%) of locking solvent (D2O). Our results indicate that the increased concentration of D2O effects the reduction of cell viability on two different cell types (MG-63: 4%, hMSC:14~40%). However, there was no significant difference by concentration of TSP. The statistical significance and cytotoxicity of concentration were found on D2O but not on TSP except for exposed hMSC for 24 hours from TSP. No statistical significance was found according to exposure time of D2O and TSP. We concluded that TSP still can be used for NMR but the use of D2O should be prohibited when identifying cell metabolite and differentiation. So, another locking solvent except D2O is needed.
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