• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.6
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• pp.2453-2459
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• 2014

Ginsenoside Rg1 is one effective anticancer and antioxidant constituent of total saponins of Panax ginseng (TSPG), which has been shown to have various pharmacological effects. Our previous study demonstrated that Rg1 had anti-tumor activity in K562 leukemia cells. The aim of this study was designed to investigate whether Rg1 could induce apoptosis in TF-1/Epo cells and further to explore the underlying molecular mechanisms. Here we found that Rg1 could inhibit TF-1/Epo cell proliferation and induce cell apoptosis in vitro in a concentration and time dependent manner. It also suppressed the expression of EpoR on the surface membrane and inhibited JAK2/STAT5 pathway activity. Rg1 induced up-regulation of Bax, cleaved caspase-3 and C-PAPR protein and down-regulation of Bcl-2 and AG490, a JAK2 specific inhibitor, could enhance the effects of Rg1. Our studies showed that EpoR-mediated JAK2/STAT5 signaling played a key role in Rg1-induced apoptosis in TF-1/Epo cells. These results may provide new insights of Rg1 protective roles in the prevention a nd treatment of leukemia.

• The Journal of the Convergence on Culture Technology
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• v.10 no.2
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• pp.35-42
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• 2024

Biomedical engineering is a discipline that diagnoses and treats human diseases using engineering techniques based on medical and biological understanding. Proper biomedical engineering education requires education on medical terminology, human anatomy, and human physiology, but students have a preconceived notion that these basic medical subjects are subjects to be memorized. In order to eliminate these students' preconceptions, various educational methods must be developed so that students can easily access basic medical subjects. In this paper, we present a method to increase learning effectiveness by introducing observation practice of a human anatomical model to the medical terminology subject. The half-body model of the human body is a form in which various organs are assembled and can be observed by disassembling them one by one. This observation exercise consisted of questions about the organs of the head, neck, chest, and abdomen, with students working in groups to find answers. After the practice, students evaluated that this practice motivated them to learn and made it easier to understand the lecture.

• Journal of Biomedical Engineering Research
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• v.14 no.2
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• pp.147-153
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• 1993

In this paper, we studied about the micro pressure transmission system using fluid. For the investigation of feasibility of microhydraulic system, the hydraulic characteristics were examined by using the capillary tube system and the micro cylinder system that consists of a rod and a micro capillary tube. A new hydraulic micro actuator using magnetic fluid and an external magnetic field was also investigated. The results showed that our microhydraulic system has the possibility of power transmission in arbitrary directions.

• Quality Improvement in Health Care
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• v.5 no.2
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• pp.190-201
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• 1998

Background : Medical equipments take a very important role in diagnosis and treatment of disease in modern medicine and effective maintenance of the equipments is a necessary to provide a good health care to the public. After developing a new QC program for effective maintenance of medical equipments and practicing it for a year, we report the results of the new program. Methods : The maintenance data of 9 equipments in 8 categories including a CT Scanner were analyzed with regard to the parts responsible for most frequent failure and cause of the failure. After learning the most frequent failure part and cause of the failure, we developed a new QC program that emphasizes preventive maintenance of the most frequent failure part. We compared the number of failure per year and active rate of each equipment before and after the adoption of the new QC program. Results : The average number of failure per year per equipment was 20.7 before and it decreased by 43% to 11.9 after adoption of the new QC program. The average active rate of the equipments was 92.6% before and it increased by 3.2% to 95.8% after adoption of the new program. Conclusions : The practice of the new QC program appears very useful as it decreased the failure rate and increased the active rate of the equipments.

• 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.

• Biomedical Engineering Letters
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• v.8 no.4
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• pp.337-344
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• 2018

Additive manufacturing (AM) is an alternative metal fabrication technology. The outstanding advantage of AM (3D-printing, direct manufacturing), is the ability to form shapes that cannot be formed with any other traditional technology. 3D-printing began as a new method of prototyping in plastics. Nowadays, AM in metals allows to realize not only net-shape geometry, but also high fatigue strength and corrosion resistant parts. This success of AM in metals enables new applications of the technology in important fields, such as production of medical implants. The 3D-printing of medical implants is an extremely rapidly developing application. The success of this development lies in the fact that patient-specific implants can promote patient recovery, as often it is the only alternative to amputation. The production of AM implants provides a relatively fast and effective solution for complex surgical cases. However, there are still numerous challenging open issues in medical 3D-printing. The goal of the current research review is to explain the whole technological and design chain of bio-medical bone implant production from the computed tomography that is performed by the surgeon, to conversion to a computer aided drawing file, to production of implants, including the necessary post-processing procedures and certification. The current work presents examples that were produced by joint work of Polygon Medical Engineering, Russia and by TechMed, the AM Center of Israel Institute of Metals. Polygon provided 3D-planning and 3D-modelling specifically for the implants production. TechMed were in charge of the optimization of models and they manufactured the implants by Electron-Beam Melting ($EBM^{(R)}$), using an Arcam $EBM^{(R)}$ A2X machine.

• Proceedings of the KOSOMBE Conference
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• v.1995 no.11
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• pp.141-141
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• 1995

• Proceedings of the Korean Society of Medical Physics Conference
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• 2006.08a
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• pp.137-137
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• 2006

• Journal of the Korean Society for Precision Engineering
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• v.17 no.9
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• pp.21-31
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• 2000