• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Current Optics and Photonics
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• v.4 no.1
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• pp.31-43
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• 2020

The feasibility of the application of terahertz electromagnetic waves in the diagnosis of prostate cancer was examined. Four samples of incomplete cancerous prostatic paraffin-embedded tissues were examined using terahertz spectral imaging (TPI) system and the results obtained by comparing the absorption coefficient and refractive index of prostate tumor, normal prostate tissue and smooth muscle from one of the paraffin tissue masses examined were reported. Three hundred and sixty cases of absorption coefficients from one of the paraffin tissues examined were used as raw data to classify these three tissues using the Principal Component Analysis (PCA) and Least Squares Support Vector Machine (LS-SVM). An excellent classification with an accuracy of 92.22% in the prediction set was achieved. Using the distribution information of THz reflection signal intensity from sample surface and absorption coefficient of the sample, an attempt was made to use the TPI system to identify the boundaries of the different tissues involved (prostate tumors, normal and smooth muscles). The location of three identified regions in the terahertz images (frequency domain slice absorption coefficient imaging, 1.2 THz) were compared with those obtained from the histopathologic examination. The tissue tumor region had a distinctively visible color and could well be distinguished from other tissue regions in terahertz images. Results indicate that a THz spectroscopy imaging system can be efficiently used in conjunction with the proposed advanced computer-based mathematical analysis method to identify tumor regions in the paraffin tissue mass of prostate cancer.

• International Journal of Oral Biology
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• v.38 no.1
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• pp.1-4
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• 2013

Staphylococcus species are one of prevalent pathogens found in hospitals. Microbes that are a primary cause of nosocomial infection were isolated from a dental and medical environment it may assist the reader to explain what this is and how it differs from the 'dental health care providers and ward health care providers'. To investigate the distribution of staphylococcus species in this environment, we used vitek II to measure drug sensitivity, and further performed biochemical testing. The isolation rate of staphylococcus species from the dental and medical environment was 100% but from dental health care providers and ward health care providers were 44.4% and 33.3%, respectively. In the analyses, staphylococcus species showed resistance to diffusion of cefoxitin and oxacillin discs. These staphylococci may be sufficiently positive for the mecA gene. Our results suggest that staphylococci might be an important cause of nosocomial infection in the dental clinic.

• Clinical and Experimental Pediatrics
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• v.58 no.10
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• pp.369-373
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• 2015

Purpose: In 2004, the American Heart Association (AHA) had published an algorithm for the diagnosis of incomplete Kawasaki disease (KD). The aim of the present study was to investigate characteristics of supplemental laboratory criteria in this algorithm. Methods: We retrospectively examined the medical records of 355 patients with KD who were treated with intravenous immunoglobulin (IVIG) during the acute phase of the disease. Laboratory data were obtained before the initial IVIG administration and up to 10 days after fever onset. In 106 patients, laboratory testing was performed more than twice. Results: The AHA supplemental laboratory criteria were fulfilled in 90 patients (25.4%), and the frequency of laboratory examination (odds ratio [OR], 1.981; 95% confidence interval [CI], 1.391-2.821; P<0.001) was a significant predictor of it. The fulfillment of AHA supplemental laboratory criteria was significantly associated with refractoriness to the initial IVIG administration (OR, 2.388; 95% CI, 1.182-4.826; P=0.013) and dilatation of coronary arteries (OR, 2.776; 95% CI, 1.519-5.074; P=0.001). Conclusion: Repeated laboratory testing increased the rate of fulfillment of the AHA supplemental laboratory criteria in children with KD.

• Journal of Biomedical Engineering Research
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• v.40 no.1
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• pp.20-31
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• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• International Journal of Internet, Broadcasting and Communication
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• v.15 no.3
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• pp.32-42
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• 2023

There are serious problems worldwide, such as a pandemic due to an unprecedented infection caused by COVID-19. On previous approaches, they invented medical vaccines and preemptive testing tools for medical engineering. However, it is difficult to access poor medical systems and medical institutions due to disparities between countries and regions. In advanced nations, the damage was even greater due to high medical and examination costs because they did not go to the hospital. Therefore, from a software engineering-based perspective, we propose a learning model for determining coronavirus infection through symptom data-based software prediction models and tools. After a comparative analysis of various models (decision tree, Naive Bayes, KNN, multi-perceptron neural network), we decide to choose an appropriate decision tree model. Due to a lack of data, additional survey data and overseas symptom data are applied and built into the judgment model. To protect from thiswe also adapt human normalization approach with traditional Korean medicin approach. We expect to be possible to determine coronavirus, flu, allergy, and cold without medical examination and diagnosis tools through data collection and analysis by applying decision trees.

• Safety and Health at Work
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• v.8 no.4
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• pp.364-370
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• 2017

Background: Labeled noise reduction (NR) data presented by manufacturers are considered one of the main challenging issues for occupational experts in employing hearing protection devices (HPDs). This study aimed to determine the actual NR data of typical HPDs using the objective fit testing method with a microphone in real ear (MIRE) method. Methods: Five available commercially earmuff protectors were investigated in 30 workers exposed to reference noise source according to the standard method, ISO 11904-1. Personal attenuation rating (PAR) of the earmuffs was measured based on the MIRE method using a noise dosimeter (SVANTEK, model SV102). Results: The results showed that means of PAR of the earmuffs are from 49% to 86% of the nominal NR rating. The PAR values of earmuffs when a typical eyewear was worn differed statistically (p < 0.05). It is revealed that a typical safety eyewear can reduce the mean of the PAR value by approximately 2.5 dB. The results also showed that measurements based on the MIRE method resulted in low variability. The variability in NR values between individuals, within individuals, and within earmuffs was not the statistically significant (p > 0.05). Conclusion: This study could provide local individual fit data. Ergonomic aspects of the earmuffs and different levels of users experience and awareness can be considered the main factors affecting individual fitting compared with the laboratory condition for acquiring the labeled NR data. Based on the obtained fit testing results, the field application of MIRE can be employed for complementary studies in real workstations while workers perform their regular work duties.

• ETRI Journal
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• v.37 no.2
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• pp.204-211
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• 2015

For this study, we designed an implantable rectangular spiral antenna for medical biotelemetry in the Medical Implant Communications Service band (402 MHz to 405 MHz). The designed antenna has a U-shaped loop for impedance matching. The antenna impedance is easily adjusted by controlling the shape and length of the U-shaped loop. Significant design parameters were studied to understand their effects on the antenna performance. To verify the potential of the antenna for the desired applications, we fabricated a prototype and measured its performance in terms of the resonant characteristics and gain radiation patterns of the antenna. In the testing phase, the prototype antenna was embedded in human skin tissue-emulating gel, which was developed to simulate a real operation environment. The measured resonant characteristics show good agreement with the simulations, and the -10 dB frequency band is within the range of 398 MHz to 420 MHz. The antenna exhibits a maximum gain of -22.26 dBi and an antenna efficiency of 0.215%.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.2
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• pp.143-150
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• 2021

The recent spread of novel and highly variant pathogenic viruses, including the coronavirus (SARS-CoV-2), has increased the demand for diagnostic testing for rapid confirmation. This has resulted in investigating the functional capability of each space, and preparing facility guidelines to secure the safety of medical technologists. During viral evaluations, there is a requirement of negative pressure facilities along with thread separation, during pre-treatment of samples and before nucleic acid amplification. Space composition therefore needs to be planned by considering unidirectional air flow. This classification of safety management facilities is designated as biosafety level 2, and personal protective equipment is placed accordingly. In case of handling dangerous materials, they need to be carried out of the biosafety cabinet, and sterilizers are required for suitable disposal of infectious agents. A common feature of domestic laboratories is maintenance of the sample pre-treatment space at a negative pressure of -2.5 Pa or less, and arranging separate pre-treatment and reagent preparation spaces during the test process. We believe that the data generated in this study is meaningful, and offers an efficient direction and detailed flow for separation of the inspection process and space functions. Moreover, this study introduces construction of the laboratory by applying the safety management standards.

• Laboratory Medicine and Quality Assurance
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• v.40 no.2
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• pp.51-69
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• 2018

As part of the immunoserology program of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of hepatitis viral markers in 2016 and 2017. The hepatitis viral antigens and antibodies program consisted of 10 test items. We delivered two and three types of pooled sera specimens to 965 and 965 institutions for the first and second trials of external proficiency testing in 2016, respectively. The number of participating laboratories was 915 (94.8%) and 913 (95.0%) in the first and second trials in 2016, respectively. We also delivered three kinds of pooled sera specimens to 936 and 1,015 institutions for the first and second trials of external proficiency testing in 2017, respectively. The number of participating laboratories was 920 (98.3%) and 996 (98.1%) in the first and second trials in 2017, respectively. The most commonly tested items were hepatitis B surface antigen, followed by the antibodies to hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus and antibodies to hepatitis B core antigen. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay and the electrochemiluminescence immunoassay, but they yielded a few-false positive results due to the matrix effect. The immunochromatographic assay yielded false-negative results for anti-hepatitis A virus due to low sensitivity. Continuous improvement in the quality of viral hepatitis testing through participation in the survey seems necessary.