• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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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.

• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Journal of Biomedical Engineering Research
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• v.44 no.6
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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.

• Progress in Medical Physics
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• v.27 no.3
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• pp.117-124
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• 2016

Intrafractional motion of patients, such as respiratory motion during radiation treatment, is an important issue in image-guided radiotherapy. The accuracy of the radiation treatment decreases as the motion range increases. We developed a control system for a robotic patient immobilization system that enables to reduce the range of tumor motion by compensating the tumor motion. Fusion technology, combining robotics and mechatronics, was developed and applied in this study. First, a small-sized prototype was established for use with an industrial miniature robot. The patient immobilization system consisted of an optical tracking system, a robotic couch, a robot controller, and a control program for managing the system components. A multi speed and position control mechanism with three degrees of freedom was designed. The parameters for operating the control system, such as the coordinate transformation parameters and calibration parameters, were measured and evaluated for a prototype device. After developing the control system using the prototype device, a feasibility test on a full-scale patient immobilization system was performed, using a large industrial robot and couch. The performances of both the prototype device and the realistic device were evaluated using a respiratory motion phantom, for several patterns of respiratory motion. For all patterns of motion, the root mean squared error of the corresponding detected motion trajectories were reduced by more than 40%. The proposed system improves the accuracy of the radiation dose delivered to the target and reduces the unwanted irradiation of normal tissue.

• Journal of Institute of Control, Robotics and Systems
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• v.22 no.8
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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.

• Journal of Biomedical Engineering Research
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• v.19 no.1
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• pp.39-46
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• 1998

In this paper, we present a neural network identification and a control of highly complicated nonlinear left ventricular assist device(LVAD) system with a pneumatically driven mock circulation system. Generally, the LVAD system needs to compensate for nonlinearities. It is necessary to apply high performance control techniques. Fortunately, the neural network can be applied to control of a nonlinear dynamic system by learning capability. In this study, we identify the LVAD system with neural network identification(NNI). Once the NNI has learned the dynamic model of the LVAD system, the other network, called neural network controller(NNC), is designed for a control of the LVAD system. The ability and effectiveness of identifying and controlling the LVAD system using the proposed algorithm will be demonstrated by computer simulation.

• Progress in Medical Physics
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• v.33 no.4
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• pp.136-141
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• 2022

Purpose: This study aimed to develop a breath control training system for breath-hold technique and respiratory-gated radiation therapy wherein the patients can learn breath-hold techniques in their convenient environment. Methods: The breath control training system comprises a sensor device and software. The sensor device uses a loadcell sensor and an adjustable strap around the chest to acquire respiratory signals. The device connects via Bluetooth to a computer where the software is installed. The software visualizes the respiratory signal in near real-time with a graph. The developed system can signal patients through visual (software), auditory (buzzer), and tactile (vibrator) stimulation when breath-holding starts. A motion phantom was used to test the basic functions of the developed breath control training system. The relative standard deviation of the maxima of the emulated free breathing data was calculated. Moreover, a relative standard deviation of a breath-holding region was calculated for the simulated breath-holding data. Results: The average force of the maxima was 487.71 N, and the relative standard deviation was 4.8%, while the average force of the breath hold region was 398.5 N, and the relative standard deviation was 1.8%. The data acquired through the sensor was consistent with the motion created by the motion phantom. Conclusions: We have developed a breath control training system comprising a sensor device and software that allow patients to learn breath-hold techniques in their convenient environment.

• The Journal of Korea Robotics Society
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• v.12 no.4
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• pp.395-401
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• 2017

In this paper, we introduce a robot-assisted medical diagnostic system that enables remote ultrasound (US) imaging to be applied to the conventional telemedicine, which has been possible only with interviewing or a visual exam. In particular, a master-slave robot system is developed that ultrasonic diagnosis specialist can control the position and orientation of US probe in the remote place. The slave robot is designed to be compact, lightweight, and hand-held so that it can easily transfer to the remote healthcare center. Moreover, 6-degree-of-freedom (DOF) probe motion is possible by the robot design based on Stewart platform. The master device is also based on a similar structure of the slave robot. To connect master and slave system in the wide area network (WAN) environment, a hardware CODEC was developed. In this paper, we introduce the detail of each component and the results of the recent experiments conducted in the remote sites by the developed robotic ultrasound imaging system.

• Proceedings of the KOSOMBE Conference
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• v.1996 no.11
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• pp.178-181
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• 1996

The Outflow facility of eye ball provides crucial informations in the diagnose of ophthalmological glaucoma. Tn this study an ophthalmic outflow facility measuring device is developed and experimentally tested. This system employs pressure sensors and linear positioning device to regulate solution reservoir height, the pressure of eye ball. The experimental result show that the system works well even in harsh environment so that it can be implemented in ophthalmic practice as well as in biomedical research.

• 제어로봇시스템학회:학술대회논문집
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• 2003.10a
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• pp.2535-2539
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• 2003

The haptic system becomes an essential device in the area of tele-operation, video entertainment and medical operation. To control a haptic device, impedance control method is widely used, but force sensor costs so much that open-loop control method is usually preferred for commercial purpose. In this case, modeled/un-modeled dynamics affects the performance of device. In this paper, we present a new 3DOF five-link type haptic device that we can reduce the effect of device dynamics and compensate its dynamics. We also evaluate its performance.