• 한국건설순환자원학회논문집
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• 제7권3호
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• pp.224-234
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• 2019

토목구조물의 교면은 토목구조물 상부에 방수층이 존재하고 방수층 상부에 아스콘이나 콘크리트로 포장층을 마무리하여 교면의 시공을 완성하고 있다. 그러나 아스팔트계열은 뛰어난 감온성으로 고온에서 용융되는 취약한 특성을 지녔고, 이는 아스콘 포설시 고온으로 인하여 방수재가 용융되어 두께저하로 인한 하자 발생률이 증가하게 된다. 본 연구에서는 교면에 적용되는 MMA(Methyl Methacrylate)의 경질 Type과 연질 Type에 대하여 동시 사용시 배합에 따른 경화상태를 확인하고 각각의 인장강도와 신장률이 관련 품질기준에 대한 성능 만족 여부와 적정 배합비율을 확인해 보고자 한다. 그 결과 MMA 경질 수지 또는 연질 수지를 단독으로 사용하게 될 경우 경질 수지는 인장특성을 연질 수지는 신장특성이 명확하게 나타나기 때문에 수지의 단독 사용으로는 KS F 4932의 인장성능 품질기준을 만족시키지 못하는 것으로 나타났고, 파우더 양이 총 배합량 중 56.25%를 초과하게 될 경우에는 경화 후 표면에 공극이 발생되고 셀프 레벨링이 불가능하여 불균질한 표면을 형성하는 것으로 확인되었다. 또한, 경질 수지: 연질 수지: 파우더 비율을 15g: 85g: 150g으로 설정한 시험편은 인장강도 $1.5N/mm^2$, 신장률 133%가 나타남에 따라 KS F 4932의 인장성능을 만족하는 것으로 확인되었다.

• 대한의용생체공학회:의공학회지
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• 제22권1호
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• pp.69-80
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• 2001

본 연구에서는 환자의 골다공증 유무에 따른 내고정 장치 시술 직후 및 융합 후의 안정성을 평가하기 위해 다양한 하중 모드에서 C5-C6 운동분절의 생체역학적 거동을 분석하였다. 이러한 목적으로 먼저, C5-C6 경추부의 유한요소 모델을 구현하여 검증하였다. 모델의 결과는 기존 실험치와 유사하여 신뢰성이 부여되었다. 검증된 모델은 Smith-Robinson 방식으로 골이식물을 삽입한 후 전방 내고정 장치를 적용한 시술 상황을 재현하기 위해 수정되었다. 수정된 모델은 두 종류로 구현되었다. (1) 첫 번째 모델에서는, 시술 직후의 상황을 재현하기 위해 골이식물과 종판의 경계면에 접촉요소를 사용하였다. (2)두 번째 모델에서는 완전히 융합된 상황을 나타내기 위해 골이식물을 종판에 고정하였다. 골다공증의 효과를 예측하기 위하여 두 모델의 해면골에 대한 탄성계수를 변화시켰다(정상: 100MPa, 골다공증: 40MPa). 각 모델의 C5 주체의 상위면에 73.6N의 압축 하중을 가한 후에 108Nm의 굴곡/신전, 굽힘, 비틀림 하중을 가하였으며, C6 추체의 하단면은 모든 방향에 대하여 구속하였다. 전체적인 결과에 있어서 상대적 회전운동, 미끄럼운동, 골이식물 내에서의 von Mises 응력의 경우 정상 모델에 비해 골다공증 모델에서 증가함을 보였으며, 특히 시술 직후의 모델에서 비틀림 하중이 가해진 경우, 상대적 회전운동 및 미끄럼 운동이 가장 높게 예측되었다. 이는 골다공증환자에게 전방 내고정 장치를 시술한 경우 골이식물의 파단 및 유합의 실패가 비틀림 하중에서 발생할 수 있음을 나타낸다. 해면골의 von Mises 응력은 시술 직후에 골다공증 모델의 모든 하중 모드에서, 유합 후에는 굽힘 하중 외의 모든 하중에서 ultimate strength를 초과하는 것으로 나타나 골다공증 환자에게 screw의 해리가 발생할 가능성이 높은 것으로 예측되었다. 따라서 골다공증 환자에게 과도한 운동이 발생하지 않도록 하기 위해서 시술 후 세심한 주의와 halo 같은 견고한 정형술이 필요할 것으로 사료된다.

• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.143-150
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• 2019

To evaluate the toxicity of ophthalmic drug, the Draize test and Bovine Corneal Opacity and Permeability (BCOP) test commonly used. In Draize test, experimental animals were under stress and pain due to long-term exposure of drug. In addition, regarding physiological functions, animal model is not perfectly reflected a human eye condition. Although some models such as $EpiOcular^{TM}$, HCE model, LabCyte Cornea-Model, and MCTT $HCE^{TM}$ were already presented advanced cornea ex-vivo model to replace animal test. In this sense, cornea tissue structure mimicked ex-vivo toxicity model was fabricated in this study. The corneal epithelial cells (CECs) and keratocytes (CKs) isolated from rabbit eyeball were seeded on non-patterned silk film (n-pSF) and patterned silk film (pSF) at $32,500cells/cm^2$ and $6,500cells/cm^2$. Sequentially, n-pSF and pSF were stacked to mimic a multi-layered stroma structure. The thickness of films was about $15.63{\mu}m$ and the distance of patterns was about $3{\mu}m$. H&E stain was performed to confirm the cell proliferation on silk film. F-actin of CKs was also stained with Phalloidin to observe the cytoskeletal alignment along with patterns of the pSF. In the results, CECs and CKs were shown the good cell attachment on the n-pSF and pSFs. Proliferated cells expressed the specific phenotype of cornea epithelium and stroma. In conclusion, we successfully established the ex-vivo cornea toxicity model to replace the eye irritation tests. In further study, we will set up the human ex-vivo cornea toxicity model and then will evaluate the drug screening efficacy.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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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.

• 대한의용생체공학회:의공학회지
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• 제43권6호
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• pp.424-433
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• 2022

As the proportion of non-contact telemedicine increases and the number of electrocardiogram (ECG) data measured using portable ECG monitors increases, the demand for automatic algorithms that can precisely analyze vast amounts of ECG is increasing. Since the P, QRS, and T waves of the ECG have different shapes depending on the location of electrodes or individual characteristics and often have similar frequency components or amplitudes, it is difficult to distinguish P, QRS and T waves and measure each parameter. In order to measure the widths, intervals and areas of P, QRS, and T waves, a new algorithm that recognizes the start and end points of each wave and automatically measures the time differences and amplitudes between each point is required. In this study, the start and end points of the P, QRS, and T waves were measured using six Deep Neural Networks (DNN) that recognize the start and end points of each wave. Then, by synthesizing the results of all DNNs, 12 parameters for ECG characteristics for each heartbeat were obtained. In the ECG waveform of 10 subjects provided by Physionet, 12 parameters were measured for each of 660 heartbeats, and the 12 parameters measured for each heartbeat well represented the characteristics of the ECG, so it was possible to distinguish them from other subjects' parameters. When the ECG data of 10 subjects were combined into one file and analyzed with the suggested algorithm, 10 types of ECG waveform were observed, and two types of ECG waveform were simultaneously observed in 5 subjects, however, it was not observed that one person had more than two types.

• 대한의용생체공학회:의공학회지
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• 제44권2호
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• pp.125-138
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• 2023

The development of AI systems for radiation therapy is important to improve the accuracy, effectiveness, and safety of cancer treatment. The current system has the disadvantage of monitoring patients using CCTV, which can cause errors and mistakes in the treatment process, which can lead to misalignment of radiation. Developed the PMRP system, an AI automation system that uses depth cameras to measure patient's fine movements, segment patient's body into parts, align Z values of depth cameras with Z values, and transmit measured feedback to positioning devices in real time, monitoring errors and treatments. The need for such a system began because the CCTV visual monitoring system could not detect fine movements, Z-direction movements, and body part movements, hindering improvement of radiation therapy performance and increasing the risk of side effects in normal tissues. This study could provide the development of a field of radiotherapy that lags in many parts of the world, along with the economic and social importance of developing an independent platform for radiotherapy devices. This study verified its effectiveness and efficiency with data through phantom experiments, and future studies aim to help improve treatment performance by improving the posture correction mechanism and correcting left and right up and down movements in real time.

• 대한의용생체공학회:의공학회지
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• 제44권4호
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• pp.225-241
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• 2023

The study empirically analyzed the differences in industry distribution and innovation activity performance in the metropolitan and non-metropolitan areas of Korea's bio companies, which are highlighted as future growth engines. The main innovation activities of the bio industry, which are focused on science and technology and expressed with high uncertainty, were analyzed, centering on human resources, technology cooperation, and investment promotion. As a result of the analysis, the biomedical industry in the metropolitan area was found to have a high proportion, and bio foods, bio-based chemicals, and energy industries in the non-metropolitan area, respectively. Moreover, the innovation activity performances differed between the two regions. In particular, the notable characteristics included human resources, investment promotion, and technical cooperation with medical institutions in the metropolitan area with a high proportion of biomedical industries, and technology personnel exchange and cooperation with private research institutions in the non-metropolitan area, which has a high proportion of bio foods, bio-based chemicals, and energy industries. This study is significant in that it is the first study to compare and analyze the performance of innovative activities based on the distribution of industries in the bio-industry, focusing on human resources, technology cooperation, and investment promotion. In addition, after investigating the distribution status and competitiveness of the domestic bio-industry by region, it will analyze the status and characteristics of the domestic bio-industry and present policy implications to implement relevant promotion policy more efficiently.

• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.211-217
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• 2023

Recently, many studies have introduced artificial intelligence systems in the surgical process to reduce the incidence and mortality of complications in patients. Bleeding is a major cause of operative mortality and complications. However, there have been few studies conducted on detecting bleeding in surgical videos. To advance the development of deep learning models for detecting intraoperative hemorrhage, three models have been trained and compared; such as, YOLOv5, RetinaNet50, and RetinaNet101. We collected 1,016 bleeding images extracted from five surgical videos. The ground truths were labeled based on agreement from two specialists. To train and evaluate models, we divided the datasets into training data, validation data, and test data. For training, 812 images (80%) were selected from the dataset. Another 102 images (10%) were used for evaluation and the remaining 102 images (10%) were used as the evaluation data. The three main metrics used to evaluate performance are precision, recall, and false positive per image (FPPI). Based on the evaluation metrics, RetinaNet101 achieved the best detection results out of the three models (Precision rate of 0.99±0.01, Recall rate of 0.93±0.02, and FPPI of 0.01±0.01). The information on the bleeding detected in surgical videos can be quickly transmitted to the operating room, improving patient outcomes.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.19-24
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• 2023

Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

• 대한의용생체공학회:의공학회지
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• 제43권4호
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.