• 대한의용생체공학회:의공학회지
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• 제40권5호
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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.

• 한국건축시공학회지
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• 제11권3호
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• pp.229-237
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• 2011

인발법은 콘크리트 강도를 비파괴적으로 측정하는 방법으로 매우 신뢰할 만한 실험결과를 보여주고 구미에서는 규격화되고 표준화가 이루어져 있다. 하지만 시험방법이 복잡하고 시험기기가 고가이어서 국내에서는 사용이 전무한 실정이다. 이에 본 연구에서는 인발법이 현장에서 사용하기 쉽도록 시험방법을 간단히 하고 저렴하게 할 수 있도록 후매입 파단형 인발볼트를 이용한 인발시험법을 제안하였으며, 시험법에 필요한 후매입 파단형 인발볼트와 매입인발너트 고정방법, 인발시험기를 개발하였다. 특히 매입인발너트 고정방법으로는 임시고정용 볼트를 이용한 방법, 플라스틱 고정판을 이용한 방법, 고정막대를 이용한 고정방법을 제안하였다. 인발시험기는 유압실린더와 로드셀 등이 필요 없도록 기어를 이용하여 손잡이를 통한 회전력으로 인발시험이 가능하도록 고안하였다. 이 개발된 각각의 항목들은 직접 제작하고 현장에서 그 편리성과 정확성을 검토해 보았으며 검증실험도 실시하였다. 결과적으로 개발된 항목들은 추가적인 수정만 거치면 현장에서 유용하게 사용할 수 있으리라 판단된다.

• 한국산업보건학회지
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• 제24권3호
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• pp.310-320
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• 2014

Backgrounds: Endotoxin, which found in the outer membrane of the gram-negative bacteria cell wall, makes up almost all of the lipopolysaccharide(LPS). When people are exposed to endotoxin,it can result in diverse health effects such as an airway irritation and inflammation, fever, malaise, bronchitis, allergic asthma, toxic pneumonitis, hypersensitivity lung disease. Cases among the elderly, children or pregnant can occur more frequently than a healthy adult if they are repeatedly exposed to the existing endotoxin. Therefore, we investigated and assessed the environmental characteristics associated with the airborne endotoxin concentration level in six hospital lobbies. Method: Endotoxin from indoor air in six hospital lobbies was measured by an area sampling method and analyzed according to American Society for Testing and Materials International(ASTM international) E2144-01. Total suspended particulate(TSP), carbon dioxide($CO_2$), temperature and humidity were also measured by using direct reading measurements or airborne sampling equipment at the same time. Environmental characteristics were appropriately divided into two or three groups for a statistics analysis. One-way analysis variable(one-way ANOVA) was used to examine a difference of the endotoxin concentration, depending on the environmental characteristics. In addition, only variables with p-value(p<0.25) were eventually designed to the best model by using multiple regression analysis. Results: The correlation analysis result indicated that TSP(p=0.003) and $CO_2$(p<0.0001) levels were significantly associated with endotoxin concentration levels. In contrast, temperature(p<0.068) and humidity(p<0.365) were not associated with endotoxin concentration. Levels of endotoxin concentration were statistically different among the environmental characteristics of Service time(p=0.01), Establishment of hospital(p<0.001), Scale of hospital(p=0.01), Day average people using hospital(p=0.03), Cleaning time of lobby(p=0.05), Season(p<0.001), and Cleaning of ventilation system(p<0.001) according to ANOVA. Finally, the best model(Adjusted R-square=72%) that we designed through a multiple regression test included environmental characteristics related to Service time, Area of lobby, Season, Cleaning of ventilation system, and Temperature. Conclusions: According to this study, our result showed a normal level of endotoxin concentration in the hospital lobbies and found environmental management methods to reduce the level of endotoxin concentration to a minimum. Consequently, this study recognized to be requirement for the management of ventilation systems and an indoor temperature in order to reduce the level of endotoxin concentration in the hospital lobbies.