• 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.

• 한국조명전기설비학회:학술대회논문집
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• 한국조명전기설비학회 2009년도 춘계학술대회 논문집
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• pp.281-284
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• 2009

In this paper, we review the effects of RF interference of medical equipment or other electric equipment which can emit radio frequency in the general hospitals environments which are in many cases being under the influence of various electromagnetic field. Using spectrum analysis method we found some devices could effect on the frequency of telemetry system. We also investigate the relationship between intensity of the signal and distance for the selected equipment used in hospitals.

• Journal of Electrical Engineering and Technology
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• 제9권2호
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• pp.569-575
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• 2014

A highly efficient class E power amplifier is demonstrated for application to wireless power transfer system. The amplifier is designed with an L-type matching at the output for harmonic rejection and output matching. The power loss and the effect of each component in the amplifier with the matching circuit are analyzed with the current ratio transmitted to the output load. Inductors with a quality factor of more than 120 are used in a dc feed and the matching circuit to improve transmission efficiency. The single-ended amplifier with 20 V supply voltage shows 7.7 W output power and 90.8% power added efficiency at 6.78 MHz. The wireless power transfer (WPT) system with the amplifier shows 5.4 W transmitted power and 82.3% overall efficiency. The analysis and measurements show that high-Q inductors are required for the amplifier design to realize highly efficient WPT system.

• 대한방사선기술학회지:방사선기술과학
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• 제38권4호
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• pp.331-336
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• 2015

식품의약품안전처 고시 "의료기기의 전기 기계적 안전에 관한 공통기준규격"이 IEC 60601-1 [3판] 따라 개정되었고 IEC-60601-1의 개별규격인 IEC 60601-2-54 또한 촬영 및 투시용 X선 장치의 기본 안전과 필수 성능에 관한 개별 기준규격으로 고시화 될 예정이다. 따라서 개별 규격의 도입에 앞서 주요 요건을 소개하고자 이 기술보고서를 작성하였다. IEC 60601-2-54의 목적은 촬영 및 투시를 위한 의료용 전기기기(이하 ME 기기) 및 ME 시스템에 요구되는 기본 안전과 필수 성능 요구사항을 확보하려는 것이다. IEC 60601-2-54는 방사선 촬영 및 투시장치의 X선 고전압장치, X선 기계장치, 방사선 방어 등에 관한 내용이다. 의료기기의 전기 기계적 안전에 관한 공통기준규격, 의료기기의 전자파 안전에 관한 공통기준규격, 의료기기의 방사선안전에 관한 보조기준 규격이 본 규격에 적용되었다. IEC-60601-2-54가 고시화될 경우 촬영 및 투시용 X선 장치의 기본 안전과 필수 성능에 관한 이해를 넓히고 국내 의료기기 산업의 국제화에 일조할 것이라고 판단된다.

• 한국신뢰성학회지:신뢰성응용연구
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• 제15권1호
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• pp.27-32
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• 2015

Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.

• 한국전기전자재료학회:학술대회논문집
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• 한국전기전자재료학회 2007년도 하계학술대회 논문집 Vol.8
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• pp.480-480
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• 2007

This paper performed the basic study for developing the light therapy equipment for medical treatment. We developed the equipment for medical therapy using a high brightness LED. This equipment was fabricated using a micro-controller and a high brightness LED, and designed to enable us to control light irradiation time, intensity, frequency and so on. Especially, to control the light irradiation frequency, and to control the change of output value, TLC5941 was used. Control stage is divided into 4 step by program. Consequently, the current value could be controlled by the change of level in Continue Wave(CW) and the output of a high brightness LED could be controlled, stage by stage.

• 한국소음진동공학회:학술대회논문집
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• 한국소음진동공학회 2009년도 추계학술대회 논문집
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• pp.472-472
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• 2009

The safety of cultural properties, medical treatment and electrical communication equipments in a building was hardly considered against the earthquake induced vibration, while the integrity of the building structure has been taken into account through the resistant earthquake design. This paper presents design of a seismic isolation table for both indoor and outdoor electrical communication equipment. First of all, artificial earthquake waves compatible with floor and ground response spectra for electrical communication equipments are generated using previously recorded seismic waves. Two kinds of one-degree-of-freedom seismic isolation table systems: spring-linear damper and spring-friction damper systems are considered and their responses to artificial earthquake waves are simulated. Design parameter study for two seismic isolation tables are performed through simulations and a seismic isolation table for both indoor and outdoor electrical communication equipment is designed considering the simulation results.

• 재활복지공학회논문지
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• 제8권2호
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• pp.79-88
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• 2014

국내에서 전기적 자극방식 삼킴 보조 치료기는 높은 보급률과 사용빈도를 가진 전문 의료기기임에도 불구하고 기기에 대한 관리체계가 전무하여 유지 보수의 측면에 있어서도 매우 큰 취약성을 노출해 왔다. 이에 본 연구는 전기적 자극방식 삼킴 보조 치료기의 장비관리 및 안전진단 매뉴얼 개발에 목적을 두고 프로그램을 개발하였다. 이를 위하여 국제전기기술위원회(International Electrotechnical Commission, IEC)등의 기관에서 공시한 표준화된 프로그램 수집과 문헌고찰을 통해 매뉴얼 개발의 근거를 마련하고, 프로토콜을 개발하여 제시하였다. 완성된 알고리즘과 프로토콜, 지표 등의 자료를 전문가 및 현장 실무자의 자문을 통하여 수정 및 보완하고 유지보수 워크시트(Maintenance Worksheet)의 5지표 18항목, 삼킴 보조 전자 의료기기 장비관리/안전진단 절차 매뉴얼(Equipment Procedure Manual)에서 4개 지표 32항목으로 구성된 점검 매뉴얼을 최종적으로 완성하였다. 완성된 지표는 장비의 고장률을 줄이고 의료기록 문서화의 체계성 제고에 도움을 줄 것이며, 의료서비스의 효율성, 적절성을 유지하는데 기여할 수 있을 것이라 생각된다.

• 대한디지털의료영상학회논문지
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• 제11권2호
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• pp.69-77
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• 2009

This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

• 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.