• 대한의용생체공학회:의공학회지
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• 제39권6호
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• pp.256-267
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• 2018

The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

• Safety and Health at Work
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• 제13권4호
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• pp.500-506
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• 2022

This study evaluated the consistency between two quantitative fit test devices with different methods of ambient aerosol counting. Three types of respirators (N95, half mask, and full facepiece) were worn by 50 participants (male, n = 25; female, n = 25), PortaCount (Pro+ 8038) and MT (05U) were connected to one probe to one mask, and fit factors (FFs) were measured simultaneously with the original and modified protocols. As a result of comparing MT FFs with PortaCount FFs as references and by applying for the pass/fail criteria (FF = 100), the consistency between the two devices for half masks and full facepieces was very high. N95 was somewhat weaker than the two type of respirators in the consistency; however, the correlation between the two devices was very strong (p < 0.0001). The results showed that an FF of 100 as measured by PortaCount was likely to be measured as 75 by the MT. Therefore, when performing the fit test for N95 using the MT and pass level of FF 100, a certain level of adjustment is necessary, whether end-user or putting a scaling factor by manufacturer.

• International Journal of Advanced Culture Technology
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• 제11권2호
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• pp.310-314
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• 2023

In this paper, we show that the limitations of Holter monitoring and Wearable Electrocardiogarphy Devices and their arrhythmia detection. Sudden death caused by cardiovascular disease, often referred to as the "silent killer" due to its unpredictable nature, is a major health concern. Electrocardiography (ECG) is a basic diagnostic tool for detecting heart disease, but its limitations make it difficult to detect arrhythmia, a significant indicator of an irregular heart state. To address this limitation, a long-term continuous ECG recording device has been developed, Holter ECG device and wearable device. A significant number of studies have focused on the differences between Holter monitoring and wearable devices. The Holter tests were useful for detecting regularly occurring arrhythmias, whereas wearable patches were better at detecting random and infrequent arrhythmias. Wearable patches were effective in detecting episodes of arrhythmia and myocardial ischemia. Despite the concern, wearable devices had less signal loss than Holter monitoring and patients also preferred wearable devices over Holter monitoring due to convenience. These results could mean that the wearable devices can perfectly replace the Holter test.

• 한국전기전자재료학회논문지
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• 제34권4호
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• pp.221-228
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• 2021

With the advent of the IoT (internet of things) era, there has been discussion on how to efficiently use various information from daily life. In academic and industrial society, various smart devices such as smart watches, smart phones, and smart glasses have been developed and commercialized for narrowing the physical/psychological distance with user information. According to recent developments of smart devices, the contemporary people have desired to check their body information and treat disease by themselves. According to the needs of the time, biological researches by phototherapy/monitoring have been actively conducted. Among various light sources, microLEDs have been spotlighted due to their superior optoelectric properties and stability. In this paper, we would like to review the state-of-the research results on the next-generation biological therapy devices via microLEDs.

• 대한전기학회:학술대회논문집
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• 대한전기학회 2007년도 심포지엄 논문집 정보 및 제어부문
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• pp.471-472
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• 2007

The scalp is skin tissue for skull-protection and roots for hair growth. Therefore continuous monitoring of scalp condition is essential for hair management. However, the equipments for existent are inconvenient to use because of focus tremor and external factors(Hair Gel, Wax, accessories and so on). Furthermore there is a problem to use an expensive optical devices like CCD (Charge Coupled Device) camera or lens of 200 - 1000 magnification. It causes a difficulty of using those equipment. We design the special electrode(length 5.65mm, diameter 0.8mm of needle shape) and the impedance system(1kHz, 78uA). Tn this paper, we can measure scalp impedance with our system. Moreover, we find the possibility of classifying scalp condition with measured impedance values. For the classification of scalp condition, we used ARAMO-TS as an imaging system. In conclusion, the problem of existent devices could be improved using these method. It also has a benefit of continuous monitoring of scalp condition.

• 대한의용생체공학회:의공학회지
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• 제32권3호
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• pp.198-206
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• 2011

Hearing devices like cochlear implant, vibrant soundbridge, etc. try to offer better sound for people. In hearing devices, several beamformers including conventional directional microphone are applicable to noise reduction. Each beamformer has different directional response and it could change sound intelligibility or quality for listeners. Therefore, we investigated the performance of three beamformers, which are first and second order directional microphone, and broadband beamformer(BBF) with a computer simulation assuming hearing device microphone configuration. We also calculated objective measurements which have been used to evaluate speech enhancement algorithms. In the simulation, a single speech and a single babble noisewere propagated from the front and $135^{\circ}$ azimuth degrees respectively. Microphones were configured in an end-fire array and the spacing was varied in comparison. With 3 cm spacing, BBF had about 3 dB higher enhanced SNR than that of directional microphones. However, enhancement of segmental SNR and frequency weighted segmental SNR were similar between the first order directional microphone and broadband beamformer. In addition when steady state noise was used, broadband beamformer showed the increased performance and had the highest enhanced SNR, and segmental SNR.

• 대한전기학회:학술대회논문집
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• 대한전기학회 2008년도 학술대회 논문집 정보 및 제어부문
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• pp.151-152
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• 2008

Laser has been applied in various diagnostic and therapeutic medical fields. For last few decades, medical low-level laser devices have been introduced in market, but they have limitations which cannot convey enough energy to deep layer of tissues for diagnostic or therapeutic purposes. To address the issue, there have been many studies of using physical and chemical methods; it is one of ways to apply negative or positive pressure to tissue. However, it is hard to apply desired pressure on tissues continuously when practical laser devices arc used. In this study, we introduce a low-level laser probe which allows maintain pressure on skin tissue. Consequently, we are confident that the pressure probe for low-level laser treatment should be a useful tool in order to deliver sufficient energy for practical uses.

• 대한의용생체공학회:의공학회지
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• 제40권1호
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• pp.15-19
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• 2019

In this study, Theta Gamma Coupling (TGC) analysis was carried out after performing simple and repeated upper limb exercise and comparative experiment to observe changes in the motor cortex of the brain through TGC and to see if mobile rehabilitation therapy is actually effective. As a result, exercise using mobile devices showed higher TGC values in motor cortex as compared with simple repeat upper limb exercise. In addition, paired t-test using SPSS showed statistically significant difference between exercise using mobile devices and simple repeat exercise at P3(t=3.390, df(degree of freedom)=12, p value=0.005). Exercise using mobile devices is effective for rehabilitation because it increases the Theta-Gamma Coupling and activates the motor cortex. Also, since the mobile game contents required the subject to detailed athletic ability adjustment with immersion in the task, it may be thought that brain activation is stronger than simple rehabilitation.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.19-24
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• 2023

Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

• 융합보안논문지
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• 제21권1호
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• pp.63-72
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• 2021

병원의 Biomedical engineering team은 의료기기가 안전하고 신뢰할 수 있도록 의료기기 관리 프로그램(MEMP, Medical Equipment Management Program)을 수립하고 규제할 책임이 있다. 기술의 발전으로 인공지능, 정밀의료 등 의료기기는 언제 어디서나 사물들 간 연결이 가능한 형태로 발전하고 있으며 다양한 기술의 융합에 따라 내외·부 보안위협이 지속적으로 증가하고 있다. 본 논문에서는 기술의 발전으로 지속적으로 증가하는 의료기기의 보안위협을 고려하여 안전한 의료기기 관리 프로그램(Secure-MEMP) 방법을 연구 제시한다.