• 제어로봇시스템학회논문지
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• 제22권8호
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• pp.603-609
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• 2016

This paper presents an optimally designed master device mechanism for teleoperated interventional robotic system. The interventional procedures using the teleoperated robotic system and the physicians' requirements are summarized. The master device should implement 5-DOF motion including 2-DOF translational motion for the entry position control, 2-DOF rotational motion for the orientation control, and 1- DOF translational motion for needle insertion. The handle assembly includes a 1-DOF translational mechanism for needle insertion and buttons for operation mode selection. The mechanisms for the 2-DOF translational motion and the 2-DOF rotational motion are designed using motors and brakes based on the various mechanisms to satisfy all the above requirements, respectively. Absolute position sensors are adopted to implement automatic initial positioning and orientation matching at the first step of needle insertion.

• 전자공학회논문지
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• 제52권1호
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• pp.140-147
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• 2015

본 연구는 의료기기법이 시행된 이래 의료기기 부작용등 안전성 정보관리를 위한 의료기기 안전성 정보 원내 보고 시스템 설계에 대한 연구이다. 본 연구는 현행 의료기기 부작용등 안전성정보 보고 관리에 대한 법적 규정 및 시스템에 대한 절차와 현황을 파악하고, MSF/CD(Microsoft Solution Framework/Component Design)설계방법론을 적용한 시스템 설계 방법을 적용하여 의료기기 안전성 정보 원내 보고 시스템 구축을 위한 설계를 하였다. 본 연구를 통해 우리나라의 부작용 등 안전성 정보 보고에 대한 식품의약품안전처 고시 규정을 포함한 의료기기 관리 제도를 파악하고, 좀 더 환자의 안전과 의료기기의 위험관리를 효과적으로 할 수 있는 의료기기 안전성 정보 원내 보고 시스템을 설계 및 구축함으로써 의료기기 부작용 등 안전성 정보 보고의 활성화에 이바지 할 수 있기를 기대한다.

• 한국정보통신학회:학술대회논문집
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• 한국정보통신학회 2013년도 춘계학술대회
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• pp.392-394
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• 2013

최근 u-Healthcare 서비스에서 다양한 생체정보를 간편하게 측정하는 개인건강기기(PHD)와 측정된 정보를 전송하고 수집하기 위한 표준의 필요성이 제품 간의 이식성, 확장성, 상호 운영성을 보장하기 위해 크게 대두되고 있다. 개인건강기기에서 측정된 생체정보(산소포화도, 몸무게, 심전도, 혈압 등)를 ISO/IEEE 11073 기반인 Bluetooth Health Device Profile을 이용해서 스마트폰으로 실시간 모니터링 할 수 있는 시스템을 설계한다.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• 대한의용생체공학회:의공학회지
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• 제27권4호
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• pp.143-153
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• 2006

The purpose of this work was to assess and quantify the beneficial effects of gas exchange, while testingto the various frequencies of the sinusoidal wave that was excited by the PZT actuator, for patients suffering from acute respiratory distress syndrome (ARDS) or chronic respiratory problems. Also, this paper considered a simulator to design a hollow type artificial lung, and a mathematical model was used to predict a behavior of blood. This simulation was carried out according to the Montecarno's simulation method, anda fourth order Runge-Kutta method was used to solve the equation. The experimental design and procedure are then applied to the construction of a new device to assess the effectiveness of the membrane vibrations. As a result, the vibration method is very effective in the increase of gas transport. The gas exchange efficiency for the vibrating intravascular lung assist device can be increased by emphasizing the following design features: consistent and reproducible fiber geometry, and most importantly, an active means of enhancing convective mixing of water around the hollow fiber membranes. The experimental results showed the effective performance of the vibrating intravascular lung assist device. Also, we concluded that important design parameters were blood flow rates, fiber outer diameter and oxygen pressure drop. Based on the present results, it was believed that the optimal level of blood flow rates was 200$cm^3$/min.

• Communications for Statistical Applications and Methods
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• 제24권6호
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Korean Journal of Acupuncture
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• 제24권4호
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• pp.37-45
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• 2007

Objectives : Temporomandibular joint (TMJ) balance is known to be intricately integrated with nervous system, cervical spine, and meridian system balance. This retrospective study with one-group pretest-posttest design reviewed cervical spine imaging data to provide evidence of spinal alignment improving effect of TMJ balance treatment. Methods : Cervical spine imaging data including computed tomography and simple x-ray of 25 cases with painful condition were reviewed to explore any change in cervical alignment on wearing the intraoral device for TMJ balance treatment of functional cerebrospinal therapy. Results : Cervical spine alignment significantly improved on wearing the intraoral device. Conclusions : TMJ balance treatment improves cervical spinal alignment, which may be a firm basis to proceed with further research of TMJ balance therapy as a way of balancing the whole-body meridian system.

• 한국디자인학회:학술대회논문집
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• 한국디자인학회 2004년도 추계 학술발표대회 논문집
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• pp.28-29
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• 2004

• 제어로봇시스템학회논문지
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• 제9권8호
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• pp.592-599
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• 2003

As one of the Principal modalities of human sensation, tactile feel is prerequisite for building wide variety of applications such as telemanipulation, virtual reality and medical engineering. A dynamic Braille display device based on a polymer actuator is presented. The actuator, often called artificial muscle actuator has advantageous features over the existing methods in terms of intrinsic softness, ease of fabrication, cost-effectiveness and miniaturization. The principles of actuation with dielectric elastomer is introduced, and necessary considerations on the design of a tactile display device are discussed. The design of the device is described in detail including the fabrication process and driving electronics. Also, preliminary results of experiments are given to evaluate its performance.

• International Journal of Precision Engineering and Manufacturing
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• 제7권4호
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• pp.40-46
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• 2006

The market of programmable implantable pumps has bound to a monopolistic situation, inducing high device costs, thus making them inaccessible to most patients. Micro-mechanical and medical innovations allow improved performances by reducing the dimensions. This affects the consumption and weight, and, by reducing the number of parts, the cost is also affected. This paper presents the procedure followed to design an innovative implantable drug delivery system. This drug delivery system consists of a low flow pump which shall be implanted in the human body to relieve pain. In comparison to classical known solutions, this pump presents many advantages of high interest in both medical and mechanical terms. The first section of the article describes the specifications which would characterize a perfect delivery system from every points of view. This concerns shape, medication, flow, autonomy, biocompatibility, security and sterilization ability. Afterwards, an overview of existing systems is proposed in a decisional tree. Positive displacement motorized pumps are classified into three main groups: the continuous movement group, the fractioned translation group and the alternative movement group. These systems are described and the different problems which are specific to these mechanisms are presented. Since none of them fully satisfy the specifications, an innovation is justified.. The decisional tree is therefore extended by adding new principles: fractioned refilling and fractioned injection within the fractioned translation movement group, spider guiding system within the alternative translation movement group, rotational bearing guided device and notch hinge guided device in the alternative rotation movement group.