• Journal of the Korea Safety Management & Science
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• v.6 no.4
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• pp.155-170
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• 2004

Among the semiconductor If-chips, unlike memory chips, a majority of Application Specific IC(ASIC) products are produced by customer orders, and meeting the customer specified due date is a critical issue for the case. However, to the one who understands the nature of semiconductor manufacturing, it does not take much effort to realize the difficulty of meeting the given specific production due dates. Due to its multi-layered feature of products, to be completed, a semiconductor product(called device) enters into the fabrication manufacturing process(FAB) repeatedly as many times as the number of the product specified layers, and fabrication processes of individual layers are composed with similar but not identical unit processes. The unit process called photo-lithography is the only process where every layer must pass through. This re-entrant feature of FAB makes predicting and planning of due date of an ordered batch of devices difficult. Parallel machines problem in the photo process, which is bottleneck process, is solved with restricted roll out algorithm. Roll out algorithm is a method of solving the problem by embedding it within a dynamic programming framework. Restricted roll out algorithm Is roll out algorithm that restricted alternative states to decrease the solving time and improve the result. Results of simulation test in condition as same as real FAB facilities show the effectiveness of the developed algorithm.

• Journal of the Institute of Electronics Engineers of Korea SC
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• v.49 no.2
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• pp.55-62
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• 2012

Convergence of information technology (IT) and medical devices enables people to measure health-related information ubiquitously, such as measuring blood glucose at home and checking cardiac signals during exercise and it allows us to access to medical care anywhere and anytime. Nowadays, the market for U-healthcare medical devices is growing rapidly, but guidelines for the evaluation of safety and effectiveness of such devices remain to be formulated. We performed a study on the development of safety and performance evaluation method for portable, hand-held, U-healthcare medical devices. We reviewed current guidelines and standards for home-health devices from the Korea Food and Drug Administration (KFDA) and related international committees such as the ISO/IEEE and CE. We summarized the test methods and items for the evaluation of safety and performance related to U-healthcare medical devices from the above guidelines and standards. We defined requirements for a U-healthcare medical device to demonstrate good performance. In conclusion, we propose an evaluation method for U-healthcare medical devices, which will help improve the safety and reliability of these devices.

• Journal of Biomedical Engineering Research
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• v.44 no.2
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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.

• Korean Journal of Radiology
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• v.25 no.6
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• pp.565-574
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• 2024

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

• Journal of the Korean Institute of Gas
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• v.21 no.1
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• pp.59-64
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• 2017

We implemented virtual reality training system for city gas virtual training platform using oculus $rift^{TM}$, gear $VR^{TM}$ and dome screen. And we carry out a survey targeting ordinary person using each device. The contents of survey are usability and reality about each training system and the goal of survey is a verification how to bring effectiveness using city gas governor safety training system. The survey method used each VR device for the ordinary person and investigated the difference. Based on the survey it was to find out the direction for the implementation of platform, could find out the possibility of a virtual training system.

• Journal of Acupuncture Research
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• v.32 no.4
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• pp.91-102
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• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• Journal of Information Technology Services
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• v.15 no.4
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• pp.73-83
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• 2016

Pedestrian safety was recently highlighted with a yellow carpet, a yellow-colored pavement material prepared for children waiting for signals for pedestrian crossing, without validation of its efficiency in practice. It was a promising device likely to assist highway safety by stimulating pedestrian to step on the yellow-colored area; it was generally called nudge effects. This paper delivers a study conducted to check the effectiveness of yellow carpet in three different aspects in vehicle driver's perspective by applying the newly introduced information technology (IT) service: Visual Attention Software (VAS). It was assumed that VAS developed by 3M in the United States should be able explain the Korean drivers' visual reaction behaviors since technology embedded in VAS was developed based on and proved by other various international countries and continents in the world. A set of pictures was taken at thirteen different field sites in seven school zone areas in the Seoul metropolitan area before and after the installation of a yellow carpet, respectively. Sets of those pictures were analyzed with VAS, and the results were compared based on the selective safety measures: the likely focusing on standing pedestrians (waiting for a pedestrian's green signal time) affected by its background (yellow-colored pavement) contrasting him or her. The test results from a set of before-and-after comparison analyses showed that the placement of yellow carpet would (1) increase 71% of driver's visual attention on pedestrian crossing areas and (2) change the sequential order of visual attention on that area 2.4 steps ahead. The findings would enhance deployment of such promising efficiency and thus increase children safety in pedestrian crossing. The result was promising to highlight the way to support the changes in conservative traffic safety engineering field by applying the advanced IT services, while much robust research was recommended to overcome the limitation of simplification of this study.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.24 no.10
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• pp.1294-1299
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• 2020

Recently, interest in safety education based on VR has been increasing, but it started rising doubts are growing over its effectiveness. Therefore, the purpose of this thesis project is to research the current status of safety education contents based on VR and present situations and future prospects for safety education based on VR. As a result of researching about safety education contents using VR, the movement or condition of characters in the contents in the VR environment was very unnatural. Especially, in simulations such as driving a VR device, the controller was skeptical about its efficiency because the operation was different from the actual environment. As a result, we would like to make suggestions and forecasts as follows: First, the production of real and twin environment in VR should be realized. Second, the natural movement of the character should be performed. Third, various controllers should be released in VR devices. Fourth, a realistic scenario should be developed.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• International Journal of Internet, Broadcasting and Communication
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• v.12 no.2
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• pp.1-7
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• 2020

The secure access the lighting, Heating, ventilation, and air conditioning (HVAC), fire safety, and security control boxes of building facilities is the primary objective of future smart buildings. This paper proposes an authorized user access to the electrical, lighting, fire safety, and security control boxes in the smart building, by using color grid coded optical camera communication (OCC) with face recognition Technologies. The existing CCTV subsystem can be used as the face recognition security subsystem for the proposed approach. At the same time a smart device attached camera can used as an OCC receiver of color grid code for user access authentication data sent by the control boxes to proceed authorization. This proposed approach allows increasing an authorization control reliability and highly secured authentication on accessing building facility infrastructure. The result of color grid code sequence received by the unauthorized person and his face identification allows getting good results in security and gaining effectiveness of accessing building facility infrastructure. The proposed concept uses the encoded user access authentication information through control box monitor and the smart device application which detect and decode the color grid coded informations combinations and then send user through the smart building network to building management system for authentication verification in combination with the facial features that gives a high protection level. The proposed concept is implemented on testbed model and experiment results verified for the secured user authentication in real-time.