• Journal of Biomedical Engineering Research
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• v.44 no.1
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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.

• Journal of the Korean Society of Manufacturing Technology Engineers
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• v.23 no.5
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• pp.413-420
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• 2014

Although the transfer forming process has various advantages, it is also inefficient for the use of multiple press machines, especially for small part sizes. In this study, a new forming process was proposed to use multiple tandem dies in a single press machine. A rotary transfer forming device was developed to combine the advantages of the progressive and transfer forming process. In this study, a detailed forming process using this device was analyzed, and the device was designed to perform four series of tandem forming processes in a single press. In order to analyze the feasibility of this forming process, simple forming dies were made. As a result, the position accuracy was 4 arcsec, and the forming speed reached up to 20 strokes per minute. It is thought that this rotary transfer forming device can help to save initial setup costs through the more efficient use of space in a press machine.

• Proceedings of the KIEE Conference
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• 2006.07b
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• pp.813-814
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• 2006

The squirrel case induction motor has widely used in the driving of the blowers but it is low efficiency and hard to control. So, the damper is used for the control of a flow and it cause to low the driving efficiency. Our laboratory has proposed the single-phase SRM(switched reluctance motor) for driving blowers. It has salient pole structure and can be reduced a number of semiconductors than three-phase SRM. But it can not be starting by itself and has heavier torque ripple than three-phase SRM. For self-starting the single-phase SRM is required the starting device which place the rotor at the rising inductance slope. On this paper, the electromagnet starting device is designed to generate the starting torque and to fix the rotating direction of the single-phase SRM which is fabricaed to use a blower.

• Korean Journal of Materials Research
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• v.34 no.2
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• pp.63-71
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• 2024

Slipchip offers advantages such as high-throughout, low cost, and simple operation, and therefore, it is one of the technologies with the greatest potential for high-throughput, single-cell, and single-molecule analyses. Slipchip devices have achieved remarkable advances over the past decades, with its simplified molecular diagnostics gaining particular attention, especially during the COVID-19 pandemic and in various infectious diseases scenarios. Medical testing based on nucleic acid amplification in the Slipchip has become a promising alternative simple and rapid diagnostic tool in field situations. Herein, we present a comprehensive review of Slipchip device advances in molecular diagnostics, highlighting its use in digital recombinase polymerase amplification (RPA), loop-mediated isothermal amplification (LAMP), and polymerase chain reaction (PCR). Slipchip technology allows users to conduct reliable droplet transfers with high-throughput potential for single-cell and molecule analyses. This review explores the device's versatility in miniaturized and rapid molecular diagnostics. A complete Slipchip device can be operated without special equipment or skilled handling, and provides high-throughput results in minimum settings. This review focuses on recent developments and Slipchip device challenges that need to be addressed for further advancements in microfluidics technology.

• Journal of KIISE:Information Networking
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• v.32 no.3
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• pp.291-300
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• 2005

The Ubiquitous computer environment is thing which invisible computer that is not shown linked mutually through network so that user may use computer always is been pervasive. Intend computing environment that can use easily as user wants and it is the smart environment that user provides context awareness that is wanting computing environment. This Ubiquitous computing contains much specially weak side in security. Masquerade attack of that crawl that is quoted to user or server among device that is around user by that discrete various computing devices exist everywhere among them become possible. Hereupon, in this paper, proposed method that have following characteristic. Present authentication model through transfer or device. Suggest two method that realize authentication through device in case of moved to method(MD: Multi Domain) and user ownself space(SD: Single Domain) that realize authentication through device in case of moved user's direct path who device differs.

• The Journal of Korean Medicine
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• v.27 no.3 s.67
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• pp.222-226
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• 2006

Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use. Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.

• Progress in Superconductivity and Cryogenics
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• v.19 no.4
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• pp.22-25
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• 2017

Superconducting nanowire single photon detectors (SNSPD) have become the most competent photon-counting devices in wide range of wavelengths. Especially in the communication wavelength (infrared), SNSPD has shown unbeatable superior performance compared to the state-of-art semiconductor single photon detectors. The technology has matured enough for the last decade so that several commercial systems are now almost ready for routine use in general optics experiments. Here we summarize briefly the recent progress in this research field, and hope to motivate further research on the improvement of the device and the system. We cover the basic key concepts, device and system performances, remaining issues and possible further research directions of SNSPD.

• ETRI Journal
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• v.30 no.3
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• pp.480-482
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• 2008

A novel InGaAsP/InP buried-ridge waveguide laser diode structure is proposed and demonstrated for use as a single-mode laser. The lateral mode of the proposed device can be controlled by adjusting the composition and thickness of the InGaAsP layer grown over the active region. Stable single-mode operation without kinks or beam-steering is achieved successfully with lateral and transverse in the junction plane even for the device with the ridge width of 9 ${\mu}m$ up to an injection current of 500 mA.

• International Journal of Computer Science & Network Security
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• v.21 no.2
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• pp.221-228
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• 2021

Recent improvements on the quality, fidelity and availability of biometric data have led to effective human physical activity detection (HPAD) in real time which adds significant value to applications such as human behavior identification, healthcare monitoring, and user authentication. Current approaches usually use machine-learning techniques for human physical activity recognition based on the data collected from wearable accelerometer sensor from a single wearable smart device on the user. However, collecting data from a single wearable smart device may not provide the complete user activity data as it is usually attached to only single part of the user's body. In addition, in case of the absence of the single sensor, then no data can be collected. Hence, in this paper, a continuous HPAD will be presented to effectively perform user activity detection with mobile service infrastructure using multiple wearable smart devices, namely smartphone and smartwatch placed in various locations on user's body for more accurate HPAD. A case study on a comprehensive dataset of classified human physical activities with our HAPD approach shows substantial improvement in HPAD accuracy.

• Journal of Sensor Science and Technology
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• v.32 no.3
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• pp.180-186
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• 2023

Test devices can perform various functions, such as research on detection targets, sensors that detect detection targets, combined products containing sensors, and certification for the launch of combined products. However, the scope of use of test devices is limited because they perform only a single role or could only serve a particular purpose in the past. Therefore, studies on test devices that can perform various functions, such as research on detection targets, sensors that detect detection targets, combined products containing sensors, and certification for the release of combined products are necessary. Accordingly, this study proposes a test device that can increase the scope of use in the technical field of electric fires. In addition, we examine various outcomes of the proposed test device.