• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• Child Health Nursing Research
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• 제25권2호
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• pp.133-142
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• 2019

Purpose: This prospective study was conducted to determine the incidence and related characteristics of respiratory medical device-related pressure ulcers (MDRPU) in children admitted to a pediatric intensive care unit (PICU). Methods: The participants were 184 children who were admitted to the PICU of P University Hospital from April 2016 to January 2017. Data were collected on the occurrence of respiratory MDRPU and characteristics regarding the application of respiratory medical devices. Results: Respiratory MDRPU occurred in 11.9% of participants (58.3%: stage I ulcers, 37.5%: mucosal ulcers). The devices associated with respiratory MDRPU were endotracheal tubes (54.2%), high-flow nasal cannulas (37.5%), and oximetry probes (8.3%). Respiratory MDRPU associated with an endotracheal tube were significant differences according to the site and strength of fixation, the use of a bite block and adhesive tape, skin dryness, and edema. In high-flow nasal cannulas, significant differences were found according to the site of fixation, immobility after fixation, and skin dryness. Conclusion: The occurrence of respiratory MDRPU is significantly affected by the method and strength of fixation, as well as skin dryness and edema. Therefore, appropriate consideration of these factors in nursing care can help prevent respiratory MDRPU.

• 대한방사선치료학회지
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• 제23권2호
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• pp.83-90
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• 2011

목 적: 일정한 호흡주기의 유지가 필요한 방사선치료에서 치료 자세와 device의 사용에 따른 호흡주기의 차이를 통계적으로 분석하여, 그 경향과 device의 유용성에 관하여 알아보고자 한다. 대상 및 방법: 피험자 11명을 대상으로 바로 누운 자세와 엎드린 자세에서 각 20분씩 호흡주기를 유지한 호흡신호를 획득 및 분석하였다. 엎드린 자세에서 호흡주기의 유지가 양호하지 못한 7명에게 belly board를 사용한 후 호흡신호를 획득하여 device의 사용전후의 호흡변화와 안정성을 분석하였다(통계 분석에는 PASW 18.0을 이용). 결 과: 피험자의 특성에 따른 차이는 없었으며 자세에 따른 호흡주기유지 안정성은 바로 누운 자세 54.5%, 엎드린 자세 36.4%로 나타났다. Belly board를 사용한 7명 중 4명은 호흡주기유지 안정성이 유의하게 양호한 변화를 보였으며, 허리치수에 따라 바로 누운 자세에서 처음 10분간의 호흡주기유지에는 유의한 차이(P=0.022, Fisher's Exact Test)를 보였다. 시간의 흐름에 따른 호흡의 안정성은 7명(63%)이 엎드린 자세보다 바로 누운 자세에서 보다 안정적이었다. 결 론: 흉부 및 복부 심지어 골반의 방사선치료에서도 호흡에 의한 환자의 움직임은 중요한 고려사항 중 하나이다. 본 연구와 같이 호흡신호의 통계적 분석과 이의 적용을 통해 호흡유지에 최적의 자세, belly board와 같은 device 사용여부를 결정하면 호흡주기의 유지 및 호흡의 안정도 유지에 기여할 수 있을 것으로 사료된다.

• 한국의학물리학회지:의학물리
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• 제25권4호
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• pp.264-270
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• 2014

본 연구에서는 영상유도 로봇 정위방사선치료장비(Stereotactic Radiation Therapy, SRT) 사이버나이프의 Synchrony 호흡추적장치의 사용에 있어 중요한 요소 중에 하나인 호흡의 안정성을 향상 시키고자 휴대형 호흡연습장치(portable respiratory training device)를 개발하였다. 그래프와 막대 형식의 2가지 디스플레이 중 사용자가 원하는 방식을 선택할 수 있도록 인터페이스를 제작하고, 자신의 호흡주기에 대한 리듬감을 향상 시켜 다음 호흡을 예측할 수 있도록 도와주는 청각시스템을 지원하여 편안한 호흡유도를 제공하였다. 5명의 지원자를 대상으로 자체 프로그램을 통해 검출한 개인고유 호흡주기를 적용하여, '자유호흡(free respiration)'에서 획득한 신호데이터와 시청각시스템을 통해 호흡을 유도하는 '모니터호흡(guide respiration)'의 신호데이터를 획득하고, 호흡주기(period)와 호흡깊이(amplitude)의 편차 평균값을 비교하여 유용성을 평가하였다. 호흡주기의 경우 자유호흡에 비하여 $55.74{\pm}0.14%$로 감소하였고, 호흡깊이의 경우에도 자유호흡의 비해 $28.12{\pm}0.10%$ 감소함으로써 호흡의 규칙성과, 안정성이 향상됨을 확인하였다. 이러한 결과를 바탕으로 개발한 휴대형 호흡연습장치를 이용한 간암, 폐암 등의 체부정위방사선치료에 있어, 호흡 불안정에 의해 발생되는 치료시간의 지연을 줄이고 치료정확도 향상에 도움을 줄 수 있을 것으로 평가되며, 차후 안드로이드(Android)기반의 휴대용단말기를 대상으로 한 호흡연습 어플리케이션 개발에 적용한다면 사용 편의성과 더불어 경제적 효율까지 기대할 수 있을 것으로 판단된다.

• 보건행정학회지
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• 제28권4호
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• pp.402-410
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• 2018

Background: Monitoring appropriate medication categories can provide early warning of certain disease outbreaks. This study aimed to present a methodology for selecting and monitoring medications relevant to the surveillance of acute respiratory tract infections, such as influenza. Methods: To estimate correlations between acute febrile respiratory tract infection and some medication categories, the cross-correlation coefficient (CCC) was used and established. Two databases were used: real-time prescription trend of antivirals, anti-inflammatory drugs, antibiotics using Drug Utilization Review Program between 2012 and 2015 and physicians' number of encounters with acute febrile respiratory tract infections such as influenza outbreaks using the national level health insurance claims data. The seasonality was also evaluated using the CCC. Results: After selecting six candidate diseases that require extensive monitoring, influenza with highly specific medical treatment according to the health insurance claims data and its medications were chosen as final candidates based on a data-driven approach. Antiviral medications and influenza were significantly correlated. Conclusion: An annual correlation was observed between influenza and antiviral medications, anti-inflammatory drugs. Suitable models should be established for syndromic surveillance of influenza.

• 한국컴퓨터정보학회논문지
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• 제29권3호
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• pp.165-171
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• 2024

본 연구는 2급 응급구조사가 호흡부전 및 호흡정지 환자에게 백-밸브 마스크(BVM) 인공호흡 시 호흡량 측정기를 사용하여 적정량의 호흡량과 및 성공률을 알아보고자 한다. 연구는 2023년 12월 11일부터 12일까지 D 대학교에 재학 중인 2급 응급구조사를 대상으로 20명을 선정하여 10명은 호흡량 측정기를 이용하여 BVM 인공호흡을 교육한 실험군으로, 다른 10명은 호흡량 측정기 없이 BVM 인공호흡을 교육한 대조군으로 선정하여 2분간 인공호흡을 제공하는 실험을 하였다. 연구 결과, 대조군에서는 정확한 호흡량을 제공하지 못하였고(p=.025), 호흡 성공률 역시 실험군에서는 2분간 호흡 성공률이 높았으나 대조군에서는 유의한 차이를 보였으며(p=.001), 주관적 호흡량과 측정된 객관적 호흡량이 대조군에서 유의한 차이를 보였다(p=.010). 따라서 호흡량 측정기를 사용한 교육은 2급 응급구조사가 느끼는 주관적 호흡량을 객관적 호흡량과 일치시키고 호흡 성공률을 높여 호흡부전 및 호흡정지와 심폐소생술 시 심장정지 환자의 생존율을 높이는 데 도움이 될 것이다.

• 한국방사선학회논문지
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• 제5권4호
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• pp.179-187
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• 2011

방사선 치료에서 일정한 호흡주기의 유지가 필요한 흉부 및 복부를 치료할 때 환자의 자세와 belly board device의 사용 여부에 따라 다르게 나타나는 호흡신호의 차이를 통계적으로 분석하여 임상적용에 관한 유용성을 검정하였다. 호흡주기유지는 supine 자세에서 비교적 양호하게 나타났으며, prone 자세에서 호흡주기 유지가 양호하지 않은 경우에 belly board를 적용하여 85%가 유의하게 다른 패턴의 호흡주기를 보였고, 57%는 호흡주기 유지가 양호하게 변화한 것으로 나타났다. 각 피험자의 비만도와 체중에 따른 호흡주기유지 안정성의 차이는 보이지 않았으며, 안정성의 상대적 비교지수로 분석한 시간의 흐름에 따른 호흡의 안정성 유지는 supine 자세에서 비교적 안정적이었으며, 호흡주기 유지의 검정통계결과와 일치하였다(p=0.044, kappa=0.607). 흉부 및 복부 심지어 골반의 방사선치료에서도 호흡에 의한 환자의 움직임은 중요한 고려사항 중 하나이다. 환자의 치료부위와 target의 위치, 예상되는 plan의 beam arrangement에 따라, 환자의 자세 및 device의 여부가 결정되지만, 본 연구와 같이 호흡신호의 통계적 분석과 이의 적용을 통해, 호흡유지에 최적의 자세, belly board와 같은 device 사용여부를 결정하여, 호흡주기의 유지 및 호흡의 안정도 유지에 기여할 수 있을 것으로 사료된다.

• 대한의용생체공학회:의공학회지
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• 제26권3호
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• pp.163-169
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• 2005

Respiratory tubes with a length of 35mm and diameters of 10, 15, and 20mm were made for experimental purpose, and both the static$(P_s)\;and\;dynamic(P_D)$ pressures were simultaneously measured for steady flow rates ranging 1-12//sec. Least squares analysis resulted successful fitting of $P_s\;and\;P_D$ data with quadratic equations with correlation coefficients higher than 0.99(P<0.0001). The spirometric measurement standards of the American Thoracic Society(ATS) were applied to $P_s$ data, which demonstrated the smallest tube diameter of 15mm to satisfy the ATS standards. The maximum $P_D$ value of the velocity type transducer(the functional single use respiratory air flow tube) with the diameter of 15mm was estimated to be approximately $75cmH_2O$, implying more than 7 times larger sensitivity than the widely used pneumotachometers. These results showed that the velocity type respiratory air flow transducer is a unique device accomplishing miniaturization with the sensitivity increased, thus would be of great advantage to develop portable medical devices.

• 한국의학물리학회지:의학물리
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• 제27권3호
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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.

• 한국의학물리학회지:의학물리
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• 제33권4호
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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.