• 제목/요약/키워드: Medical equipment

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중고 의료기기의 유통에 대한 법적 규제 개선 (Legal and Regulating Improvement for Distribution of Used Medical Equipments)

  • 최용전;권준철;정용규
    • 서비스연구
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    • 제4권1호
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    • pp.109-121
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    • 2014
  • 의료기기는 공산품의 일종으로서, 공산품 중에서 특정한 목적과 기능에 해당하는 의료용으로 사용되는 공산품으로서, 공산품 중에서 국민의 생명과 신체에 중대한 영향을 미치는 공산품이므로 의료관련법에서 특별히 규정하여 관리하고 있는 제품들이라고 할 수 있다. 그러나 중고 의료기기에 활용된 의료기술은 대부분이 인체나 환경에 위해성이 없는 의료기술일 가능성이 크므로, 이렇게 위해성이 제로에 가까운 의료기기를 1등급으로 분류하여 위해성이 거의 없는 의료기기와 같이 취급함으로써 발생하는 불필요한 행정력과 시간의 낭비를 최소화할 수 있다. 의료기기 취급자 특히 판매업자에 포함되는 사업자의 영역이 넓혀지므로, 사업자들의 사업의지를 고양할 수 있으며, 국민의 의료기기에 대한 선택권과 접근권이 제고될 수 있다. 본 논문에서는 중고의료기기의 유통질서를 확립하고 공정한 거래를 촉진하기 위한 제반의 법률을 조사하고 규제를 개선하는 방향을 제시한다.

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이동형 방사선 발생장치 차폐물 설치에 관한 연구 (A study on Protector Performance Evaluation According to X-ray Scattering Distribution of Portable Radiation System)

  • 김형균;성동근;조경미;김상범;김재영;최준호
    • 대한디지털의료영상학회논문지
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    • 제11권2호
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    • pp.85-92
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    • 2009
  • This study, "The study about performance evaluations of mobile cover for X-ray's diffusion and distribution in mobile radiation" is based on the rules of mobile defense apparatus for radiation producer in 2006. To use the mobile cover for X-ray for diagnosis has been compulsory in common wards except operation rooms, emergency rooms and intensive care units. we have confirmed the effect in arbitrary shielding material after Qualitiy Control was carried out for accuracy in an experiment of mobile photographing equipment. The performance evaluation was conducted with the fabrics of selenium, 0.2 mmPb, 0.1 mmPb and aluminiums. Considering the result, we choosed 0.1 mmPb and attached cover to mobile photographing equipment. We have finished making the cover after drew up the draft to attach cover to mobile photographing equipment through the modeling and the structural analysis. the process of the study is that we assembled the manufactured structures and carried out the practical experiment to take the photograph after attaching the fabric of 0.1 mmPb to mobile photographing equipment. It is need of additional thesises hereafter that we compare the result between the part to improve for safety besides convenience in photographic experiment about clinical radiation and the effect of covering the diffusion in condition attached the cover.

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초음파팬텀(ATS-539)을 이용한 의료용 초음파장비의 성능검사(대구지역을 중심으로) (Performance Testing of Medical US Equipment Using US Phantom(ATS-539) (Focusing on Daegu Region))

  • 김도형;권덕문
    • 대한방사선기술학회지:방사선기술과학
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    • 제37권4호
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    • pp.295-305
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    • 2014
  • 초음파장비는 인체 병변의 유무를 검사하는 의료장비로서 정확한 의료영상정보를 제공해야 한다. 의료용 초음파장비 성능측정을 위해 초음파팬텀(ATS-539)의 측정방법과 기준으로 대구지역 의료기관의 초음파장비 성능의 실태를 알아보고, 초음파팬텀을 이용한 장비성능검사의 기본 자료를 제시하고자 한다. 초음파팬텀의 측정방법과 기준인 불응영역, 수직거리정확성측정, 수평거리정확성측정, 축방향/측 해상도, 민감도, 회색조 및 동적범위를 사용하였다. 그리고 국소영역, 기능적 해상도를 추가해서 총 8개 항목으로 측정하고 평가하였다. 결과분석을 위해 평균, 표준편차, 빈도 및 백분율을 제시하였고, Mann-Whiney test와 t-test를 실시하였으며, 유의수준은 0.05로 하였다. 본 연구의 결과는 다음과 같다. 1. 초음파팬텀 측정결과는 총 35대 중 합격은 31대 88.6%, 불합격은 4대 11.4%였다. 2. 합격기준이 제시되지 않은 국소영역과 기능적 해상도 4 mm가 통계적으로 유의하게 합격군과 불합격군간의 평균의 차이가 있었다. 3. 불합격한 장비의 평균 사용연수는 7.25년으로 합격한 장비 4.13년보다 차이가 있었다. 대구지역내 임상에 실제 사용되는 의료용 초음파장비의 성능 실태를 파악해 보았고, 합격기준이 제시되지 않은 2항목에 대한 기초자료를 제시하였다. 초음파장비 사용연한이 장비성능과 관계가 있었다. 의료용 초음파장비 성능검사를 위한 초음파팬텀측정은 장비의 최적의 성능 유지를 위하여 제도적인 대책 마련이 필요하다.

한방 의료행위의 개념과 그 한계 - 법령과 판례를 중심으로 - (The Concept of Practice of Korean Medicine and the Limitations - Focusing on Legislations and Precedents -)

  • 권순조;엄석기
    • 한국의사학회지
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    • 제28권1호
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    • pp.121-133
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    • 2015
  • Objectives : The purpose of this study is to suggest how to interpret the 'practice of Korean Medicine', differentiating it from 'medical practice'. Methods : I analyze the legislations and precedents regarding the practice of Korean Medicine. Results : The Korean Medicine and Pharmaceutics Promotion Act defines 'practice of Korean Medicine' and it clearly differentiates it from the definition of 'medical practice'. However, the scope of this definition is somewhat restricting and it can violate doctors of Korean Medicine's right to equality and their academic freedom. Thus, the application of this definition of the 'practice of Korean Medicine' should be limited to the field of research and development. Meanwhile, criteria of distinguishing 'practice of Korean Medicine' from 'medical practice', which used to make a sharp distinction between Medicine and Korean Medicine by rigorously applying their academic standards, are now focusing more on protecting and improving health of the people. Discussions & Conclusions : I suppose that the distinction between the 'practice of Korean Medicine' and 'medical practice' will be more focused on public health rather than the academic stance of those two medical fields. Meanwhile, in accordance with dualistic medical system, the mutual usage of medical equipment in the area of 'treatment' should be limited while it should be allowed in the area of 'diagnosis' if it satisfies requirements suggested by the Constitutional Court.

가정간호환자의 치료적 간호서비스 제공과 의료기구 사용 및 요구도 (Use of Home Nursing Therapy and Need of Home Care Equipments)

  • 유호신;박재순;김인아;권영대;강성욱
    • 지역사회간호학회지
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    • 제19권2호
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    • pp.157-166
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    • 2008
  • This study was conducted with whole home care nurses nationwide to provide secondary analyzed data to understand on their usage of medical equipments and their need of them for a month. This study found that treatments given by home care nurses were nelaton catheterization, bladder washing/urethral washing, newborn care, exchange and care for nasogastric tube and suction in that order of frequency. Second, instruments and equipments used for home care were reported to be stethoscope, patient monitor, blood pressure measuring equipment, air flotation mattresses, beds for patients, mattresses, suctioning device sets, enteral feeding equipment and dressing set in that oder of frequency. Moreover, need assessment of medical instruments and equipments showed renal dialysis was most needed and patient monitor, blood pressure measuring equipment, enteral feeding equipment, solution and other supplies for renal dialysis and beds for patient were necessary in that order. In conclusion, the results of this study investigating special treatments and medical instruments and equipments used for home care patients and analyzing patients' need, were expected to be useful for expansion of application of long-term care insurance for the elderly and health insurance as well as for quality control of home care and development of medial instruments and equipments used at home.

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휴대용 RFID 리더기를 활용한 분실 의료자산 최적 검색 경로 결정과 천정 고정식 리더기 설치위치 선정 방안 연구 (A Study on Optimal Searching Path Using Handheld RFID Reader and Deployment of a Stationary Reader to Maximize the Efficiency of the Search Process for Missing Medical Assets)

  • 김각규;조성진;윤봉규
    • 한국경영과학회지
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    • 제37권4호
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    • pp.95-109
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    • 2012
  • Being able to quickly locate valuable medical equipment is critical inside hospitals. In order to utilize limited budget and resources efficiently, accurate locating or tracking is required in many fields. In this research, we focus on how to find the location of missing assets by using RFID in real time indoors to track equipment. When equipment needs to be searched, the purpose of a RFID device is to minimize the time, investment cost and effort spent searching for the equipment. Thus, this research presents a mathematical model of using RFID (both handheld reader and stationary reader) for efficient asset location. We derive the expected time of locating RFID-tagged objects in a multi-area environment where hand-held RF readers are used. We then discuss where to deploy stationary RF readers in order to maximize the efficiency of the search process.

Nanocomposite reinforced structures to deal with injury in physical sports

  • Guojiao Wang;Kun Peng;Hui Zhou;Guangyao Liu;Zhiguo Lou;Feng Pan
    • Advances in nano research
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    • 제14권6호
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    • pp.541-555
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    • 2023
  • The extensive use of polymeric matrix composites in the athletic sector may be attributed to its high strength-to-weight ratio, production economy, and a longer lifespan than conventional materials. This study explored the impact of carbon nanotubes on the properties of different composite field sports equipment components. The test specimens were fabricated using the compression molding technique. The insertion of carbon nanotubes increases mechanical properties related to the process parameters to account for an improvement in the stick sections' overall performance. The dynamic response of functionally graded reinforced nanocomposite wire structure is examined in this paper on the bases of high-order hyperbolic beam theory lined to the size-dependent nonclassical nonlocal theory under the external mechanical load due to the physical activities. Finally, the impact of different parameters on the stability of nanocomposite structures is discussed in detail.

비이식형 요실금 치료용 신경근 전기자극 의료기기 개발 (The Development of Neuromuscular Electrical Stimulation Medical Devices for The Treatment of Non-implantable Urinary Incontinence)

  • 이재용;이창두;권기진
    • 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.

응급의료체계와 스포츠손상에서 휴대용 X-ray 장치의 도입 필요성 (The Necessary of Portable X-ray Equipment for Emergency Medical Service System and Sports Injures)

  • 조동헌;구경완;조진만
    • 한국응급구조학회지
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    • 제8권1호
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    • pp.189-197
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    • 2004
  • The fate of a emergency patient is decided upon the extent of first aid in one hour after accident. Suitable diagnosis and treatment can raise the possibility of patient's life and reduce the recuperation time. We surveys papers which were The Korean Society Of Sports Medicine(1993-2004 yeas 405papers)and The Korean Society Of Emergency Medicine (1990-2004 yeas 797 papers). This paper got the following results through analyses of problems in emergency medical service system and of injures from sports. First, portable X-RAY equipment is needed to apply it to emergency. Second, it should have small and light structure compared with old equipments and have high voltage generator unit for X-RAY using inverter. Third, it should be able to send the shot data that is digital detector type without film to doctors in emergency center.

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The first private-hospital based proton therapy center in Korea; status of the Proton Therapy Center at Samsung Medical Center

  • Chung, Kwangzoo;Han, Youngyih;Kim, Jinsung;Ahn, Sung Hwan;Ju, Sang Gyu;Jung, Sang Hoon;Chung, Yoonsun;Cho, Sungkoo;Jo, Kwanghyun;Shin, Eun Hyuk;Hong, Chae-Seon;Shin, Jung Suk;Park, Seyjoon;Kim, Dae-Hyun;Kim, Hye Young;Lee, Boram;Shibagaki, Gantaro;Nonaka, Hideki;Sasai, Kenzo;Koyabu, Yukio;Choi, Changhoon;Huh, Seung Jae;Ahn, Yong Chan;Pyo, Hong Ryull;Lim, Do Hoon;Park, Hee Chul;Park, Won;Oh, Dong Ryul;Noh, Jae Myung;Yu, Jeong Il;Song, Sanghyuk;Lee, Ji Eun;Lee, Bomi;Choi, Doo Ho
    • Radiation Oncology Journal
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    • 제33권4호
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    • pp.337-343
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    • 2015
  • Purpose: The purpose of this report is to describe the proton therapy system at Samsung Medical Center (SMC-PTS) including the proton beam generator, irradiation system, patient positioning system, patient position verification system, respiratory gating system, and operating and safety control system, and review the current status of the SMC-PTS. Materials and Methods: The SMC-PTS has a cyclotron (230 MeV) and two treatment rooms: one treatment room is equipped with a multi-purpose nozzle and the other treatment room is equipped with a dedicated pencil beam scanning nozzle. The proton beam generator including the cyclotron and the energy selection system can lower the energy of protons down to 70 MeV from the maximum 230 MeV. Results: The multi-purpose nozzle can deliver both wobbling proton beam and active scanning proton beam, and a multi-leaf collimator has been installed in the downstream of the nozzle. The dedicated scanning nozzle can deliver active scanning proton beam with a helium gas filled pipe minimizing unnecessary interactions with the air in the beam path. The equipment was provided by Sumitomo Heavy Industries Ltd., RayStation from RaySearch Laboratories AB is the selected treatment planning system, and data management will be handled by the MOSAIQ system from Elekta AB. Conclusion: The SMC-PTS located in Seoul, Korea, is scheduled to begin treating cancer patients in 2015.