• The Journal of the Society of Korean Medicine Diagnostics
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• v.18 no.1
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• pp.11-24
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• 2014

Objectives The aim of this study is to contribute to the establishment of the Traditional Korean Medicine (TKM) policies in future, which is through the assessment to predict the realization by diagnostic subjects. Methods First, we evaluated 8 subjects that were deduced by professionals in 1996 regarding whether or not to be realized in 2013. Second, the governmental and private research projects, reports, articles, domestic patents and products were reviewed and investigated. Third, the Subjects in domestic fields of TKM were investigated on the followings: importance, time of realization, domestic Research and Development level, principal agents and methods for the realization, and hindrance factor on the realization. Results Of the 8 forecasting subjects, one subject was realized, two subjects were partly realized and five subjects were unrealized. Thus, their realization rate was 12.5%. The realized subject is the 'Standard naming of the TKM diagnosis'. Conclusion Continuous researches are necessary to realize the TKM subjects and moreover, professionals should predict new feasible TKM subjects, based on this study.

• Journal of Acupuncture Research
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• v.26 no.6
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• pp.101-110
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• 2009

Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

• The Journal of Korean Medicine
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• v.44 no.1
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• pp.128-128
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• 2023

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.17 no.1
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• pp.63-76
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• 2013

The aims of this study are to investigate a logisitic regression equation of the vacuous pulse and the replete pulse for efficacy evaluation of clip-type pulsimeter by using magnetic Hall device. To evaluate the efficacy of clip-type pulsimeter by using magnetic Hall device as sensing the minute movement of a radial artery, one research clinical trial have been performed. The number of subject was 120, the clinical data of patients did treated with a normal statistical method. The systolic peak amplitude, the reflective peak amplitude and time, and the notch peak amplitude and time are analyzed major efficacy parameters to discern the vacuous pulse and the replete pulse. The equations included of five parameters such as systolic peak amplitude, the reflective peak amplitude and time, and the notch peak amplitude and notch amplitude time for determination of the vacuous pulse and the replete pulse were deducted by statistical logistic regression method. It suggests that the logistic regression equations are possible to develop the oriental algorithm for pulse diagnosis.

• Journal of the Korean Magnetics Society
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• v.22 no.4
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• pp.136-141
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• 2012

In the this research, two simultaneous peaks of radial artery pulse wave and ECG pulse wave measured by using clip-type pulsimeter and ECG were investigated in order to analyze pulse wave velocity. The measured value of a pulse wave velocity is about 5~7 m/s, it is proved one new method to measure an exact value of pulse wave velocity more than the typical biomedical signal monitoring system. This result implies that data measured by the oriental medical diagnosis apparatus as pulsimeter is clinically used in future.

• Journal of the Korean Magnetics Society
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• v.16 no.4
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• pp.216-220
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• 2006

The electric signals for the voltage as a function of distance between Hall devices and permanent magnets over the radial artery were investigated. The electric sgnals, that means signals of arterial pulse wave, were differentiated by the hardware of circuits and then were changed to differential signals as magnetic field. The 3-D images simulated by the software as function fo the intensity of differential signals were achieved. It shows that these system can apply to pulse diagnostic apparatus of porthble type medical instrument.

• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.125-153
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• 2023

The Supreme Court's en banc decision on December 12, 2022 (docket number 2016Do21314) presented a new standard for determining whether the use of diagnostic medical devices by Korean medical doctors constitutes oriental medical doctors constitutes unlicensed medical practice. Based on this standard, it was determined that the use of ultrasound by Korean medical doctors was not an unlicensed medical practice. Supreme Court's Decision 2016Du51405 on August 18, 2023, is the first case in which a new standard was applied to determine that an Korean medical doctor's use of electroencephalography to diagnose Parkinson's disease and dementia was not an unlicensed medical practice. The Supreme Court abolished the previous standard that Western medical knowledge and technology should not be required for Korean medical doctors to use medical devices. However, it was unclear whether Western medical diagnosis of Korean medical doctors using diagnostic medical devices would be viewed as an an auxiliary method of diagnosis. Parkinson's disease and dementia are Western medical diagnoses. The Supreme Court judged that the Western medical diagnosis of Korean medical doctors was not an unlicensed medical practice. This clearly explains what an auxiliary method of diagnosis means. In addition, the Supreme Court excluded the principles of development and production of electroencephalography from its judgment criteria. Automatic extraction and automatic reading of test results were also excluded. The criminal court's view that the meaning of oriental medical practice should be clearly and strictly interpreted from the perspective of an oriental doctor, and it was clarified that diagnostic medical devices were excluded from criminal punishment unless it was clear that they were not related to the principle of oriental medical practice. As a result, the Supreme Court made it clear that the use of diagnostic medical devices is excluded from criminal punishment unless it is clear that they are not related to the principles of Korean medicine.

• Journal of Biomedical Engineering Research
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• v.28 no.6
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• pp.721-726
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• 2007

The study relates to achievement and analysis of 3-dimensional spatial pulse wave archived by a spatially arterial pulse diagnostic apparatus (SAPDA), wherein a pulse sensing part array consists of multiple hall devices and is located over a skin contacting part which consists of a magnetic material. When a radially arterial pulse is transferred to the magnetic material, which is contacted skin that results in changes in a magnetic field of the lower part of the pulse sensing part array, the changes in a magnetic field can be detected by the commercial Hall semiconductor device of the pulse sensing part array. Finally, according to development of SAPDA, the 3-dimensionally arterial pulse waveform can be measured noninvasively by detecting the changes of the magnetic field.

• Journal of the Korean Magnetics Society
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• v.24 no.3
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• pp.90-96
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• 2014

The magnetic field variation by the permanent magnet fluctuation positioned on a "Chwan" of wrist according to the movement of radial artery was generated. The clip-type pulsimeter equipped with a Hall device sensing magnetic field pulse movement analyzed the characteristics of pulse wave as output signals. The magnetic field curve and pulse waveform simulated by the finite element method were compared and analyzed with each other. Also, the variation of magnetic field distribution one permanent magnet investigated by the fabrication of clip-type pulsimeter simulator. This result suggests that the clip-type pulsimeter can be used the reproducible and efficacious oriental diagnostic medical instrument.

• Journal of the Korean Magnetics Society
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• v.24 no.5
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• pp.146-151
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• 2014

The pulse waveforms of a carotid artery in the neck and a radial artery in the hand wrist were individually measured by using clip-type pulsimeter equipped with a permanent and Hall device. The pulse transit time and the pulse wave velocity obtained through comparison of two pulse waveforms were analyzed each other. A value of the pulse wave velocity was about 8.5 m/s similar to one measured by a conservative method. This result suggests that the clip-type pulsimeter as the reproducible and reliable one oriental diagnostic medical device can be predicted to any atherosclerosis state in the cardiac circulatory system.