• Title/Summary/Keyword: 아산호

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A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

Estimation of Sediment Yield to Asan Bay Using the USLE and GIS (GIS와 USLE를 이용한 아산만 유입 유사량 추정)

  • Kim, Sang-Min;Park, Seung-Woo;Kang, Moon-Seong
    • Journal of Korea Water Resources Association
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    • v.36 no.6
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    • pp.1059-1068
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    • 2003
  • Geographic Information System (GIS) combined with Universal Soil Loss Equation (USLE) was used to estimate the soil erosion of Asan Bay experiment watershed in Korea. Spatial data for each USLE factors were obtained from the Landsat-5 TM remote sensing images and 1/25,000 scale digital contour maps. Sediment yield to Asan Bay was estimated by the sediment delivery ratio and trap efficiency. The estimated sediment yield was compared with observed on the Asan and Sapgyo estuary sub-watershed within Asan Bay experimental watershed for the period from 1981 to 2000. The calculated total annual sediment yields from Asan and Sapgyo estuary sub-watershed to Asan Bay were 5,665tonnes/yr and 6,766tonnes/yr, respectively. The measured sediment yields were 12,937tonnes/yr and 12,395tonnes/yr, respectively on an average.

Looking for an Adequate Methodology for the Korean Reservoir Using Canonical Correspondence Analysis (CCA를 통한 한국 호소 연구 방법론 탐색)

  • Chung, Sang-Ok;Jeon, Hyoung-Joo;Hong, Kwan-Eui;Kim, Jong-Hwa;Park, Young-Seuk
    • Korean Journal of Environment and Ecology
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    • v.20 no.4
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    • pp.365-373
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    • 2006
  • With a few exceptions, Korean lakes are artificially constructed for multi-purposes throughout the country. In the majority of cases, a lake is in a multiple series of reservoirs along a river or is an estuary Moreover, nutrient supplying activities (including sand extraction) and biomanipulation(esp., overfishing and fish introduction) are omnipresent in most cases. Furthermore, there is an Asian monsoon every year. In brief, europhication and algal blooms break out as a result of complicated causes. However limnological monitoring and scientific working programs are in the course of beginning. The question is what kind of strategy is desirable to establish a solid limnological database for the efficiency of the restoration process in each Korean reservoir We present light monitoring cases on the basis of algal and some physicochemical data in 2005. Do they give some useful informations despite their simplicity. Based on physicochemical factors and phytoplankton data using Utermohl method and Canonical Correspondence Analysis(CCA) were performed for Lake Cheongpyeong, Lake ASan, Lake Namyang, and Lake SapGyo. The results of CCA showed that Lake Cheongpyeong was different from the other three Lakes at estuary. Also each Lake at estuary was slightly different from one other. This result would encourage to initiate building an adequate Korean reservoir-ecosystem understanding and models for better ecological management despite the limited data. However, the results also indicate to sustain collecting ecological data and building database to interpret the Korean ecological reservoir model.

Seasonal Variations in Seawater Quality Due to Freshwater Discharge in Asan Bay (담수유입으로 인한 아산만 해양수질의 계절적인 변동)

  • Jeong, Yong Hoon;Cho, Min Kyun;Lee, Dong Gi;Doo, Sun Min;Choi, Hyun Soo;Yang, Jae Sam
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.22 no.5
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    • pp.454-467
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    • 2016
  • In order to understand the seasonal characteristics of seawater in Asan Bay, the quality of this water was observed over four seasons form December 2011 to February 2013, and correlations between seawater quality variations and freshwater input were analyzed by a statistical method. The results, based on factor analysis, indicate that the two most important factors in understanding variation are freshwater input (37.7 %) and seawater exchange (24.4 %). Asan-ho and Sapgyo-ho are two major freshwater sources that affect inner (eastern) Asan Bay. Discharged freshwater from the inner bay strongly affects the spatial and temporal distribution of seawater in the bay overall during the summer rainy season. On other hand, water re-suspended from the bottom of the bay overwhelmed the water quality during the dry winter season. In conclusion, seasonal freshwater discharge dominated the water quality of the bay, and, consequently, DIP limited the growth of phytoplankton in the bay.

A Study for Application of Standard and Performance Test According to Purpose and Subject of Respiratory Medical Device (호흡보조의료기기의 사용목적 및 대상에 따른 규격적용 방안 및 성능에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.215-221
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    • 2019
  • The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.