• 대한의용생체공학회:의공학회지
• /
• 제40권5호
• /
• pp.197-205
• /
• 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.

• 재활복지공학회논문지
• /
• 제4권1호
• /
• pp.9-14
• /
• 2010

인구의 고령화와 국민의 소득증대에 따라 정보통신기술을 활용한 새로운 형태의 보건의료서비스인 유헬스케어에 대한 관심과 보급이 증가되어 가고 있어 이러한 용도의 유헬스 의료기기의 안전성 확보를 위한 사용환경을 고려한 안전성 및 성능 평가방법이 필요하다. 본 연구에서는 유헬스의료기기와 관련된 국제규격(IEC)과 국내규격(KS)을 참고하여 유헬스케어의료기기의 사용환경에 대한 안전성을 평가할 수 있는 기준 및 방법과 전원문제등을 고려한 필수성능을 평가할 수 있는 기준 및 방법을 개발하였다.

• 대한의용생체공학회:의공학회지
• /
• 제31권4호
• /
• pp.280-284
• /
• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• 한국연소학회지
• /
• 제22권2호
• /
• pp.50-56
• /
• 2017

This study was conducted an experiment for the thermal flow mechanism of the surrounding butane gas can and pressure change in butane can with oversized cookware. And numerical analysis was performed to analyze the process of heat transfer around butane can. Effect of radiant heat from small size cookware is very small. Thus small size cookware does not have a significant impact on the butane gas range safety. But radiant heat of oversized cookware is larger than small size cookware. Therefore it gives an adverse effect on the butane can. And when internal pressure of butane can is greater than about 406.8~447.2 kPa, a safety device of portable butane gas range were working. The causes of safety device working is because of trivet height. Trivet height is lowered, the radiant heat is increased. This radiant heat is to raise pressure of inside butane can. Experimental and numerical analysis results, the lower thermal conductivity of the cookware is greater the effects of radiant heat.

• 정보과학회 컴퓨팅의 실제 논문지
• /
• 제20권10호
• /
• pp.561-566
• /
• 2014

통신기능과 상호연동가능성을 통해 의료기기들을 통합 제어함으로써 의료서비스의 효율과 환자의 안전성을 높이려는 요구가 증가하고 있다. 그러나, 네트워크와 제어컴퓨터를 통한 의료기기의 통합이 체계적이지 못할 경우 시스템의 복잡도를 크게 높이게 되며, 이는 안전사고의 위험성을 높일 가능성이 있다. 본 논문에서는 의료기기간의 안전한 상호작용 형태를 패턴으로 분류하였으며, 이를 이용하여 네트워크 통합형 의료기기의 제어 구조를 계층적으로 설계하고 안전성을 검사하는 방법을 제시한다. 제안된 기법은 Architecture Analysis and Description Language (AADL)의 플러그인으로써 구현되었다. AADL환경에서 의료기기들을 가상으로 통합하고, 이들의 구조적인 안전성 여부를 검사할 수 있게 함으로써, 실제 개발에 앞서 안전성을 검증할 수 있게 된다.

• 한국임상수의학회지
• /
• 제37권1호
• /
• pp.15-22
• /
• 2020

This study investigated the effectiveness of radiation safety rules in animal hospital and the awareness and behavior of veterinary radiation workers. With the questionnaires, the data was collected from randomly selected veterinarians in animal hospitals and animal medical imaging centers. Collected data were about radiation device, shielding device, regulations, safety management, education, knowledge, behavior and awareness. Frequency, correlation and multiple regression analysis were performed. The medical devices related with radiation in animal hospital were X-ray (59%), CT (15%), fluoroscopy (12%), mobile X-ray (12%) and others (2%). The number of people using radiation shielding device is high. The answers were low on knowing radiation related regulation and receiving radiation protection education. The group with higher knowledge and awareness shows positive correlation with safety behavior. The increase of use of the radiation related medical devices in veterinary hospital causes the increase of radiation exposure risk. This study suggests that radiation safety management system and policies need to be developed to protect radiation workers and give them correct information and consciousness.

• International Journal of Safety
• /
• 제7권2호
• /
• pp.27-30
• /
• 2008

In the 21st century, safety issues in the strained silicon industry, such as dislocation injection, should be carefully considered. This is because a microelectronic device usually contains sharp features (e.g., edges and corners) that may intensify stresses, inject dislocations into silicon, and ultimately cause the failure of the device. In this paper, critical residual stresses in various strained structures are calculated. It is confirmed that this model correctly predicts trends and the order of magnitude of critical residual stresses.

• 한국통신학회논문지
• /
• 제41권11호
• /
• pp.1440-1442
• /
• 2016

LTE (Long Term Evolution) 네트워크를 기반으로 하는 공공안전 및 재난통신 관련 연구가 활발히 진행되고 있으며, 기지국의 도움 없이 직접통신이 가능한 D2D (Device-to-Device) 통신 기술은 차세대 공공안전 및 재난통신망의 기반 기술로 각광받고 있다. 본 논문에서는 재난 지역의 기지국이 붕괴되었거나 통신 폭주로 인해 자원 할당이 지연되는 경우에 D2D 단말 탐색을 활용하여 재난 지역 단말들의 통신을 위한 신속하고도 정확한 주파수 자원 확보 기술을 제안한다.

• 방사성폐기물학회지
• /
• 제12권4호
• /
• pp.299-314
• /
• 2014

인양장비는 원자력발전소에서 발생하는 사용후핵연료를 운반하는 운반용기를 인양하기 위해 사용된다. 본 연구는 원자력 안전위원회고시 제2013-27호와 미국 10CFR Part 71 ${\S}71.45$에서 규정하는 기술수준에 따라 이론적인 방법과 유한요소방법으로 인양장비의 구조적안전성을 평가하였다. 이론적으로 평가한 결과 모든 구성 요소에서의 응력이 응력제한치 내에 있어 운영상 발생하는 구조적 안전성을 확보하고 있는 것으로 판단하였다. 또한 유한요소해석을 통한 평가결과, 항복과 극한조건 모두에서 설계기준을 만족하는 것으로 평가되었다. 모든 구성요소에서 충분한 안전여유도(항복조건에서 3 이상의 안전율, 극한조건에서 5 이상의 안전율)를 갖는 것으로 나타나 구조적으로 안전하다고 판단하였다.

• 식품보건융합연구
• /
• 제6권5호
• /
• pp.19-25
• /
• 2020

The purpose of this study was to research and develop a step-type chemical liquid deodorizer including a liquid catalyst that can prevent civil complaints due to odor due to its excellent deodorizing performance. The main composition of chemical liquid deodorizer including liquid catalyst is cleaning deodorization, catalyst deodorization, chemical deodorization, water film plate, deodorization water circulation device, deodorization water injection device, catalyst management system, gas-liquid separation device, chemical supply device, deodorizer control panel, etc. It consists of a device. The air flow of the step-type liquid catalyst chemical liquid deodorizer is a technology that firstly removes basic odor substances, and the liquid catalyst installed in the subsequent process stably removes sulfur compounds, which are acidic odor substances, to discharge clean air. The efficiency of treating the complex odor of the prototype was 98.5% for the first and 99.6% for the second, achieving the target of 95%. The hydrogen sulfide treatment efficiency of the prototype was 100% for the first and 99.9% for the second, which achieved 95%, which was the target of the project. As a result, ammonia was removed by the reaction of ammonia and hydrogen sulfide.