• The Journal of Korean Obstetrics and Gynecology
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• v.29 no.3
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• pp.23-34
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• 2016

Objectives: The purpose of this study was to survey the status of clinical use of a pulse tonometric device (PTD).Methods: We searched domestic and international articles using the PTD from online medical databases including OASIS, RISS, DBpia and PubMed. We selected articles on clinical application of PTD but excluded articles on mechanical design or software programming for developing a new PTD. Finally we found 13 articles and classified the articles according to the disease of clinical study.Results: Out of the 13 articles, 5 were focused on the dysmenorrhea. Three articles were focused on the infertility, two article were focused on the post mastectomy. According to the results, the pulse energy has been widely used in research as the primary outcome.Conclusions: We found out that until now the researches on clinical application of PTD mainly had been performed for producing a variety of PTDs. This results of this study will be used as a useful information during perform a clinical study and clinics. We suggest that the standard operating procedure for PTD will be developed, and researches for development and its application of various new contents will be performed.

• Journal of Korean Neurosurgical Society
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• v.59 no.5
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• pp.521-524
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• 2016

Use of the Pipeline embolization device (PED) has increased based on studies about its safety and effectiveness, and new reports that describe perior postprocedural complications are now emerging. We report a rare periprocedural device-related complication that occurred during endovascular treatment with the pipeline embolization device for a dissecting aneurysm on the vertebral artery. A 55-year old woman was admitted due to left medullary infarction, and angiography showed a fusiform dilatation in the left vertebral artery that was suspicious for dissecting aneurysm. Endovascular treatment with PED was planned. Under general anesthesia, the procedure was performed without significant problems and a PED was deployed in an appropriate position. However, in the final step of the procedure, the distal tip of the PED delivery wire became engaged within a small branch of the posterior cerebral artery and fractured. Fortunately, imaging studies after the procedure revealed neither hemorrhagic nor ischemic stroke, and the patient recovered without neurological morbidities except initial symptoms.

• Journal of Korean Medicine Rehabilitation
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• v.20 no.3
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• pp.131-137
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• 2010

This study was designed to evaluate clinical effects of device for correcting bowleg and Chuna to patients with genu varum. The clinical study was carried out 4 cases with genu varum, who had been treated from April, 2009 to May, 2010 in the department of oriental rehabilitation medicine, Sang-ji university oriental medical hospital. After treating device for correcting bowleg and Chuna, we find out that genu varum was improved after treatment. So these results suggest that device for correcting bowleg and Chuna was effective to patients with genu varum.

• Journal of the Korean Society of Radiology
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• v.16 no.5
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• pp.505-512
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• 2022

In this study, a 3D printed assistive device was applied to X-ray examinations to diagnose human diseases. Based on the results of evaluating the device, statistical and regression analyses were conducted to evaluate its clinical utility and purchase intention, respectively. In the experiment, 90 radiologists performed X-ray examinations on patients who agreed with the use of the assistive device in oblique view X-rays of the lumbar spine, and then statistical analyses were undertaken with a traditional aid and factor analysis. The non-standardized coefficient values of the multiple regression analysis performed by setting the purchase intention of the 3D printed device as the dependent variable and the 3D printed device and traditional aid calculated by factor analysis as independent variables were 0.893 (p<0.001) and 0.269 (p<0.001), indicating statistically significant results. The results show that the 3D printed assistive device proposed in this study has higher clinical utility than traditional aids used in oblique view X-rays of the lumbar spine.

• Korean Circulation Journal
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• v.53 no.7
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• pp.483-496
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• 2023

Background and Objectives: Atrial fibrillation (AF) is associated with decreased cardiac resynchronization therapy (CRT) benefits compared to sinus rhythm (SR). Effective biventricular (BiV) pacing is a determinant of CRT success, but AF can interfere with adequate BiV pacing and affect clinical outcomes. We investigated the effect of device-detected AF on clinical outcomes and optimal BiV pacing in patients with heart failure (HF) treated with CRT. Methods: We retrospectively analyzed 174 patients who underwent CRT implantation between 2012 and 2019 at a tertiary center. The optimal BiV pacing percentage was defined as ≥98%. Device-detected AF was defined as an atrial high-rate episode ≥180 beats per minute lasting more than 6 minutes during the follow-up period. We stratified the patients without preexisting AF at pre-implantation into device-detected AF and no-AF groups. Results: A total of 120 patients did not show preexisting AF at pre-implantation, and 54 had AF. Among these 120 patients, 19 (15.8%) showed device-detected AF during a median follow-up of 25.1 months. The proportion of optimal BiV pacing was significantly lower in the device-detected AF group than in the no-AF group (42.1% vs. 75.2%, p=0.009). The devicedetected AF group had a higher incidence of HF hospitalization, cardiovascular death, and all-cause death than the no-AF group. The device-detected AF and previous AF groups showed no significant differences regarding the percentage of BiV pacing and clinical outcomes. Conclusions: For HF patients implanted with CRT, device-detected AF was associated with lower optimal BiV pacing and worse clinical outcomes than no-AF.

• Journal of Veterinary Science
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• v.22 no.1
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• pp.14.1-14.11
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• 2021

Background: Quantitation of urine protein is important in dogs with chronic kidney disease. Various analyzers are used to measure urine protein-to-creatinine ratios (UPCR). Objectives: This study aimed to compare the UPCR obtained by three types of analyzers (automated wet chemistry analyzer, in-house dry chemistry analyzer, and dipstick reading device) and investigate whether the differences could affect clinical decision process. Methods: Urine samples were collected from 115 dogs. UPCR values were obtained using three analyzers. Bland-Altman and Passing Bablok tests were used to analyze agreement between the UPCR values. Urine samples were classified as normal or proteinuria based on the UPCR values obtained by each analyzer and concordance in the classification evaluated with Cohen's kappa coefficient. Results: Passing and Bablok regression showed that there were proportional as well as constant difference between UPCR values obtained by a dipstick reading device and those obtained by the other analyzers. The concordance in the classification of proteinuria was very high (κ = 0.82) between the automated wet chemistry analyzer and in-house dry chemistry analyzer, while the dipstick reading device showed moderate concordance with the automated wet chemistry analyzer (κ = 0.52) and in-house dry chemistry analyzer (κ = 0.53). Conclusions: Although the urine dipstick test is simple and a widely used point-of-care test, our results indicate that UPCR values obtained by the dipstick test are not appropriate for clinical use. Inter-instrumental variability may affect clinical decision process based on UPCR values and should be emphasized in veterinary practice.

• Korean Journal of Clinical Pharmacy
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• v.19 no.1
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• pp.65-68
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• 2009

Disposal infusion device is known to be useful for chemotherapy. Anti-cancer drug can be released by the force of carbon dioxide or balloon. In this study, we compared the$Anapa^{(R)}$ (LC0020) with B Company (LV2 ml) in terms of infusion rate and stability. Infusion rate was determined every six minute using software, MSI08IH. Stability of 5-fluorouracil was examined periodically using a High Performance Liquid Chromatography. Infusion rates of gas-derived $Anapa^{(R)}$ device were 2.29, 1.86, 1.98 ml/hr and those of balloon-derived B Company device were 1.71, 1.58, 1.37 ml/min. There were no significant differences in stability of 5-fluorouracil between $Anapa^{(R)}$ and B Company devices. In summary, gas-derived $Anapa^{(R)}$ device is thought to be comparable or superior to balloon-derived B Company device as far as infusion rate and stability are concerned. We expect that $Anapa^{(R)}$ as a home infusion device can be employed to improve a quality of life and compliance of cancer patients.

• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• The Journal of Internal Korean Medicine
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• v.36 no.2
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• pp.85-92
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• 2015

Objectives: The liver fibroscan has been developed as a noninvasive and convenient method to assess hepatic fibrosis. This study aimed to review this device in terms of its technological concept and clinical application in traditional Korean medicine (TKM). Methods: The technological background, diagnostic evaluation, and clinical usefulness of fibroscan were reviewed using various literature and clinical studies. One clinical example-a patient with hepatofibrosis who had been treated with TKM-is presented. Results: The liver fibroscan was approved as a medical device for noninvasive measurement of the hepatic fibrosis level by the Korean Food and Drug Administration (KFDA). Numerous clinical studies have confirmed that its sensitivity and specificity allow it to serve as a substitute for liver biopsy, the present gold standard diagnostic method. The accuracy and reproducibility and lack of technical risks are strong points of the fibroscan; however, it has some limitations for application, especially in patients with obesity or severe hepatitis. One clinical example showed the applicability of the liver fibroscan in herbal medicine-based treatments. Conclusions: The requirement for diagnostic medical devices is an important issue in TKM; therefore, this study provides valuable information for practitioners of TKM.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.135-140
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• 2013

Objectives : The purpose of this study is to investigate the repeatability and reproducibility of the Ryodoraku acupuncture device. For such device to be accepted as a good apparatus for clinical diagnosis, the score it provides should be stable no matter who measure it or when it is measured, assuming all other conditions equal. Materials and Methods : Three oriental medical doctors who were well trained and fully aware of the usage of the Ryodoraku acupuncture device examined ten randomly selected patients three times. Each doctor measured the Ryodoraku scores three times from each of the 10 selected patients. Three doctors were involved in this experiment to investigate the reproducibility and each of them measured the Ryodoraku scores three times from each patient to investigate the repeatability. Data was analyzed with Friedman test, Spearman correlation test, and intra-class correlation coefficient(ICC) in SPSS ver. 18. Results : 1. The Friedman test showed that there is no statistically significant difference between the 1st, 2nd and 3rd Ryodoraku scores measured by the same examiner. It indicates that the Ryodoraku acupuncture device provides the repeatability. 2. Spearman correlation test confirmed the results obtained by the Fiedman test by showing that there exists a strong positive correlation between the three Ryodoraku scores measured by the same examiner. 3. A very high ICC among the three examiner assured that the Ryodoraku acupuncture device achieves the reproducibility. Conclusions : The Ryodoraku acupuncture device achieves the repeatability and reproducibility. However, we still recommend that a doctor trained to a certain level use the Device to carry out the diagnosis. Also, to improve the device in terms of Reproducibility even more, it should be considered to provide a manual for the exact usage.