• Journal of Biomedical Engineering Research
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• v.38 no.3
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• pp.111-115
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• 2017

Blood pressure is one of the important vital signs for monitoring the medical condition of a patient. Automated NIBP(non-invasive blood pressure) monitoring devices calculate systolic and diastolic blood pressures from the oscillation in cuff pressure caused by a pulsation of an artery. To validate the NIBP devices, we developed a simulator to supply the oscillometric waveforms obtained from human subjects. The simulator provided pressure pulses to device-under-test and device readings were compared to the auscultatory references. Fully automated simulation system including OCR(optical character recognition) were developed and used for NIBP monitoring devices. The validation results using the simulator agreed well with previous clinical validation. More validation studies using the standardized oscillometric waveforms would be required for the replacement of clinical trials to validate a new automated NIBP monitoring device.

• Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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• 2002.11a
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• pp.59-62
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• 2002

Wavelength selection and prediction algorithm for determining hematocrit are investigated. A model based on the difference in optical density induced by the pulsation of heart beat is developed by taking approximation of Twersky's theory on the assumption that the variation of blood vessel size is small during arterial pulsing[1]. A device is constructed with a five-wavelength LED array as light source. The selected wavelengths are two isobestic points and three in compensation for tissue scattering. Data are collected from 549 out-patients who are randomly grouped as calibration and prediction sets. The range of percent hematocrit was 19.3∼51.8. The ratio of the variations of optical density between systole and diastole at two different wavelengths is used as a variable. We selected several such variables that show high reproducibility among all variables. Multiple linear regression analysis is made. The relative percent error is 8% and the standard deviation is 3.67 for the calibration set. The relative % error and standard deviation of the prediction set are 8.2% and 3.69 respectively. We successfully demonstrate the possibility of non-invasive hematocrit measurement, particularly, using the wavelengths below 1000nm.

• Journal of Satellite, Information and Communications
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• v.11 no.3
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• pp.18-23
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• 2016

Internet of things (IoT) is revolutionizing in the patient-Centered medical monitoring and management by authorizing the Smartphone application and data analysis with medical centers. The network connectivity is basic requirement to collect the observed human beings' health information from Smartphone to monitor the health from IoT medical devices in personal healthcare. The IoT environment built in Smartphone is very effective and does not demand infrastructure. This paper presents the smart phone deployed personal IoT architecture for Non-Invasive ECG Capturing. The adaptable IoT medical device cum Gateway is used for personal healthcare with big data storage on cloud configuration. In this approach, the Smartphone camera based imaging technique used to extract the personal ECG waveform and forward it to the cloud based big data storage connectivity using IoT architecture. Elaborated algorithm allows for efficient ECG registration directly from face image captured from Smartphone or Tablet camera. The profound technique may have an exceptional value in monitoring personal healthcare after adequate enhancements are introduced.

• International Journal of Contents
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• v.9 no.1
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• pp.38-41
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• 2013

The clamp meter maintains electric safety as a non-invasive method while measuring the absolute value of tube current with it has been recently developed for an X-ray high-tension cable. Especially this can show high accuracy at short X-ray exposure time. Considering such a condition, this study is to evaluate the feasibility of a clamp meter in measuring X-ray tube current by taking the measurements and comparing with those of the Dynalyzer III which has been considered as a standard measuring device. From measuring the tube current accuracy depending on changes in tube voltage and exposure time, the clamp meter showed higher accuracy rate which was -1.3~4.2% difference. Thus clamp meter can be used for clinical radiologists who are not familiar electric circuit to manage X-ray devices easily and correctly in the future.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• Journal of Sensor Science and Technology
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• v.22 no.4
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• pp.281-285
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• 2013

In this study a biosensor was developed by using Drosophila cells expressing a gustatory receptor Gr5a and an ion sensitive field effect transistors (ISFETs) sensor device, which demonstrated significant compatibility with the Drosophila cells expressing Gr5a and their response to sugar. These results suggested that the newly developed cell based biosensor has a potential as a simple and easy screening device for Alzheimer's disease in the future.

• Progress in Medical Physics
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• v.10 no.1
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• pp.9-15
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• 1999

The oxygen saturation of blood can be measured by the difference absorption in optical spectra of Hb and Hb0$_2$, as the well known previous study. In this study we developed the non-invasive oxygen measurement device for diagnosis of peripheral vascular disease in lower extremity using infrared and red LED which produce a peak spectral emission at a wavelength of 660 nm, and 940 nm. To evaluate the clinical application of the oxygen measurement device, we performed lower extremity study to measure the oxygen changes in response to physiological changes within biological tissue. The results showed that oxygen saturation of blood in biological tissue can be monitored from the separation arrangement light source and detector.

• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.235-241
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• 2019

The purpose of this study was to investigate the effect of the body temperature peripheral circulation with vibration shoes in healthy 10 adults. The magnetic vibration device with non-electric power was mounted in the midsole of the vibration shoes. The experiment was divided into two groups: vibration shoes and no vibration shoes. Subjects were randomly selected and measured body surface temperature by digital infrared thermal imaging (DITI) and non-invasive capillaries change by nailfold microscope (NFM). After walking in a treadmill for 15 minutes at 4.0 km/h speed wearing normal shoes or vibration shoes, DITI and NFM were measured. The walking with vibration shoes showed the body surface temperature shift from the proximal to the distal. In addition, the diameter of the nailfold capillary in the vibration shoes group was thicker and clearer due to the increased blood flow than that of the no vibration shoes group. The vibration shoes are easy to apply to anyone who can walk because it can give vibration stimulation by walking without additional time, cost, and effort in daily life. Further studies are needed to explain the physiological effects of vibration frequency and intensity on the long-term perspective of target subjects resulting from vascular dysfunction.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• Journal of Biomedical Engineering Research
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• v.31 no.5
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• pp.351-358
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• 2010

In the automatic non-invasive blood pressure measurement device, the oscillometric method iswidely used. In the oscillometric method, the step-wise deflation has the advantage of the robustness for the motion artifacts than the linear deflation method. But it has the disadvantage of its longer measurement time because we need to detect two or more pulses in a certain cuff pressure step. In this study, we suggest the modified step-wise deflation method to overcome this limitation while maintaining the general concept of step-wise deflation. Using one valid pulse in each step and the deflating valve control during the diastolic period, the measurement time could be reduced. In order to verify the accuracy of the proposed algorithm, we compared the blood pressure values from the suggested method and the blood pressure values from the conventional auscultation method. The mean and standard deviation were -0.50${\pm}$5.3mmHg and 2.08${\pm}$4.75mmHg, for systolic and diastolic blood pressure respectively. The measurement time can be reduced up to the half of conventional step-wise deflation method.