• The Transactions of the Korean Institute of Electrical Engineers P
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• v.64 no.3
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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.

• Proceedings of the Korean Institute of IIIuminating and Electrical Installation Engineers Conference
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• 2009.05a
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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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• v.9 no.2
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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.

• Journal of radiological science and technology
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• v.38 no.4
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• pp.331-336
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• 2015

Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipments.

• Journal of Applied Reliability
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• v.15 no.1
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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.

• Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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• 2007.06a
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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.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2009.10a
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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.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.8 no.2
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• pp.79-88
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• 2014

In Republic of Korea, there are considerable vulnerability in electrical stimulating swallowing-assist equipments even though they are professional medical equipments and have high penetration rate with heavy frequency of use. Therefore, in this article, we developed Device Management and Safety Diagnosis Manual for Electrical Stimulating Swallowing-Assist Equipments system. For achieving this, we collected and analysed international standard data from international organizations like International Electrotechnical Commission(IEC). After literature reviews, we build maintenance worksheet and equipment procedure manual for electrical stimulating swallowing-assist equipments according to evidences we collected. These manual and protocol would be used as standard process and contribute to sustain accuracy, effectiveness of the devices, also decrease failure rate and assist to save medical documents.

• Korean Journal of Digital Imaging in Medicine
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• v.11 no.2
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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.

• The Korean Journal of Health Service Management
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• v.7 no.3
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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.