• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.2
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• pp.164-177
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• 2022

Medical device usability evaluation refers to the evaluation of medical devices through actual users before the final prototype production is completed. IEC 62366, one of the international safety standards for electronic medical devices, is a standard that must be applied to obtain medical device licenses in major advanced countries such as Europe and the United States. In Korea, through the Ministry of Food and Drug Safety's notice, from January 2021, sequential application by grade has been implemented. In this study, 15 participant specialists were recruited through the Incheon G University Hospital Medical Device Convergence Center for formative evaluation during user suitability evaluation of the focused ultrasound stimulation system being developed by Icleo Co., Ltd., and the test was conducted through joint scenario development. . In the result of task performance, the performance rate was 90.67%, and after the completion of the performance, 86.67% of 'Easy user interface' and 94% of 'Identification/Readability/Understanding of information' questions in the participant survey results analysis by question. The response rate was above average.

• Journal of the Korean Orthopaedic Association
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• v.54 no.4
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• pp.293-301
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• 2019

Soft tissue masses of the extremities and torso are a common problem encountered by orthopaedic surgeons. Although these soft tissue masses are often benign, orthopaedic surgeons need to recognize the key features differentiating benign and malignant masses. An understanding of the epidemiology and clinical presentation of soft tissue masses is needed to develop a practical approach for evaluation and surgical management. Size and depth are the two most important factors on which triage decisions should be based. In a differential diagnosis of a tumor, it is important to know the characteristics of the soft tissue mass through detailed history taking and physical examinations before the diagnostic procedures. A variety of imaging studies, such as simple radiography, ultrasound, magnetic resonance imaging, positron emission tomography, computed tomography, bone scan, and angiography can be used to diagnose tumors. Know the ledge of advantages and disadvantages of each imaging study is essential for confirming the characteristics of the tumor that can be observed in the image. In particular, ultrasonography is convenient because it can be performed easily in an outpatient clinic and its cost is lower than other image studies. On the other hand, the accuracy of the test is affected by the skill of the examiner. A biopsy should be performed to confirm the tumor and be performed after all imaging studies have been done but before the final treatment of soft tissue tumors. When a biopsy is to be performed, careful attention to detail with respect to multidisciplinary coordination beforehand, cautious execution of the procedure to minimize complications, and expedient follow-up and referral to a musculoskeletal oncologist when appropriate, are essential.

• Journal of Korean Society of Water and Wastewater
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• v.37 no.4
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• pp.215-229
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• 2023

In this study, non-destructive technologies that can be applied to evaluate the integrity of valve materials, safety against internal pressure caused by corrosion, and the blocking function of large-diameter water valves during operation without requiring specimen collection or manpower entering the inside of the valve were tested to assess the reliability of the technologies and their suitability for field application. The results showed that the condition of the graphite structure inside the valve body can be evaluated directly through the optical microscope in the field without specimen collection for large-diameter water butterfly valves, and the depth of corrosion inside the valve body can be determined by array ultrasound and the tensile strength can be measured by instrumented indentation test. The reliability of each of these non-destructive techniques is high, and they can be widely used to evaluate the condition of steel or cast iron pipes that are significantly smaller in thickness than valves. Evaluation of blocking function of the valves with mixed gas showed that it can be detected even when a very low flow rate of mixed gas passes through the disk along with the water flow. Finally, as a result of evaluating the field applicability of non-destructive technologies for three old butterfly valves installed in the US industrial water pipeline, it was found that it is possible to check the material and determine the suitability of large-diameter water valves without taking samples, and to determine the corrosion state and mechanical strength. In addition, it was possible to evaluate safety through the measurement results, and it is judged that the evaluation of the blocking function using mixed gas will help strengthen preventive response in the event of an accident.

• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.125-153
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• 2023

The Supreme Court's en banc decision on December 12, 2022 (docket number 2016Do21314) presented a new standard for determining whether the use of diagnostic medical devices by Korean medical doctors constitutes oriental medical doctors constitutes unlicensed medical practice. Based on this standard, it was determined that the use of ultrasound by Korean medical doctors was not an unlicensed medical practice. Supreme Court's Decision 2016Du51405 on August 18, 2023, is the first case in which a new standard was applied to determine that an Korean medical doctor's use of electroencephalography to diagnose Parkinson's disease and dementia was not an unlicensed medical practice. The Supreme Court abolished the previous standard that Western medical knowledge and technology should not be required for Korean medical doctors to use medical devices. However, it was unclear whether Western medical diagnosis of Korean medical doctors using diagnostic medical devices would be viewed as an an auxiliary method of diagnosis. Parkinson's disease and dementia are Western medical diagnoses. The Supreme Court judged that the Western medical diagnosis of Korean medical doctors was not an unlicensed medical practice. This clearly explains what an auxiliary method of diagnosis means. In addition, the Supreme Court excluded the principles of development and production of electroencephalography from its judgment criteria. Automatic extraction and automatic reading of test results were also excluded. The criminal court's view that the meaning of oriental medical practice should be clearly and strictly interpreted from the perspective of an oriental doctor, and it was clarified that diagnostic medical devices were excluded from criminal punishment unless it was clear that they were not related to the principle of oriental medical practice. As a result, the Supreme Court made it clear that the use of diagnostic medical devices is excluded from criminal punishment unless it is clear that they are not related to the principles of Korean medicine.

• Clinics in Shoulder and Elbow
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• v.15 no.2
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• pp.99-108
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• 2012

Purpose: To evaluate the clinical results of arthroscopic repair with UU-Tension Band suture for full thickness rotator cuff tear above 4 cm sized. Materials and Methods: From January 2006 to October 2011, in 71 full thickness tears above 4 cm sized which is possible to arthroscopic repair to medial margin of greater tuberosity. The group I is 71 patients which is arthroscopic repair with UU-Tension Band suture, and the group II is 20 cases which is arthroscopic repair with simple suture. Both groups were compared with a VAS score for pain, Activity of Daily Living, UCLA score, KSS score in pre operation, 7 months, 1 year and last follow-up. Statistical analysis was performed by student t test and paired t est. Mean age was 63.2 (52~80) year old, mean follow-up was 38.4 (13~62) months. Results: The VAS scores for pain decreased from 8.1 at preoperative period to 1.6 at postoperative last follow-up period in group I (p<0.05), the score decreased from 7.6 at preoperative period to 1.8 postoperative last follow-up period in group II (p<0.05). The significant difference was not noted between two groups (p<0.05). Mean ADL scores increased from 12.5 at preoperative period to 29.0 post operative last follow-up period in group I (p<0.05), the score increased from 11.3 in pre op to 27.5 post-operative last follow-up in group II (p<0.05). The significant difference was not noted between two groups (p<0.05). The UCLA score increased from 12.9 at preoperative period to 28.7 postoperative last follow-up period in group I (p<0.05), the score increased from 13.8 at preoperative period to 30.1 postoperative last follow-up period in group II (p<0.05). The significant difference was not noted between two groups (p<0.05). In comparing of retear which was checked by MRI and ultrasound evaluated at postoperative period 7 months (mean: 27.5 weeks), the retears were 28% in the group I, and 11 shoulders out of 20 shoulders in the group II. The significant differences were noted between two groups (p<0.05). Conclusion: Arthroscopic repair with UU-Tension Band suture and simple suture for full thickness rotator cuff tear above 4 cm sized were not different clinical result between both groups. However, the significant differences were noted in point of failure rate between both groups.

• The Journal of Korean society of community based occupational therapy
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• v.10 no.1
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• pp.31-38
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• 2020

Objective : The purpose of this study is to investigate the effects of bilateral chewing exercise applied for 6 weeks on occlusion force and masseter muscle thickness in the elderly living in the community. Methods : This study recruited 25 community residents. All participants performed bilateral chewing exercise using equipment developed for the purpose of oral chewing exercise. The chewing exercise was divided into isometric and isotonic type and applied for about 20 minutes a day, five times a week for six weeks. For the evaluation, the masseter muscle thickness and the maximum occlusion force were measured three times at three week intervals using a portable ultrasound instrument and an occlusion force gauge. Results : As a result of the change in masseter muscle thickness, baseline, 3 weeks later, and 6 weeks later referred to 7.51±0.43, 7.63±0.44, and 7.83±0.46, respectively (F=3.819, p<.05). The post hoc test resulted in a significance between baseline and 6 weeks later (p=0.023). Similarly, as a result of the change in occlusion force, baseline, 3 weeks later, and 6 weeks later referred to 265±9.22, 268±9.57, and 271.59±10.16, respectively (F=3.031, p<.05). The post hoc test resulted in a significance between baseline and 6 weeks later (p=0.048). Conclusion : This study confirmed that bilateral chewing exercise was effective for increasing masseter muscle thickness and occlusion force in the elderly. Therefore, bilateral chewing exercise can be applied as a therapeutic exercise method for improving oral function.

• Journal of The Korean Society of Inherited Metabolic disease
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• v.20 no.2
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• pp.55-62
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• 2020

A 22-month-old girl who had taken iron supplements due to iron deficiency anemia, presented bloody mucoid stool for one month. She had a bruise at the right periorbital area due to minor trauma and hepatosplenomegaly. Laboratory studies showed anemia, thrombocytopenia, elevated alkaline phosphatase (ALP), hypophosphatemia, decreased haptoglobin, hypocomplementemia, negative direct/indirect Coomb's test, normal vitamin D3 level and high PTHi. Wrist x-ray showed no signs of rickets. The abdominal ultrasound showed only accessory spleen. Tandem mass spectrometry was normal. During follow up, bloody stool regressed after seven days of withdrawal of iron supplement and cow milk, and the total CO2 level had been within 15-20 mEq/L with normal anion gap. NGS (next generation sequencing) panel test for evaluation of renal tubular acidosis showed negative results. After low dose steroid and vitamin D supplements under the impression of hypocomplementemic vasculitis, thrombocytopenia, C3/C4, decreased haptoglobin, and elevated ALP level became normal. At 57 months of age, laboratory findings showed elevated liver enzyme, ALP and gamma-glutamyl transferase again. And liver cirrhosis with splenomegaly and diffuse renal disease were reported with abdomen CT scan. Liver biopsy reported macro- and micronodular cirrhosis. Urine organic acid profile showed elevated succinylacetone level. Whole exome sequencing revealed novel compound heterozygous mutations (NM_00137.2:c.107T>C, NM_00137, 2:c.614T>C) in FAH gene and confirmed by Sanger sequencing. Consequently, the patient was diagnosed as chronic hereditary tyrosinemia type I. She started low phenylalanine/tyrosine diet and nitisinone treatment. Our case had presented symptoms very slowly, which is the first case of chronic tyrosinemia type I in South Korea.

• Transactions of the Korean Society for Noise and Vibration Engineering
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• v.25 no.1
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• pp.48-57
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• 2015

In a sodium-cooled fast reactor, which is a Generation-IV reactor, refueling is conducted by rotating, but not opening, the reactor head to prevent a reaction between the sodium, water and air. Therefore, an inspection technique that checks for the presence of any obstacles between the reactor core and the upper internal structure, which could disturb the rotation of the reactor head, is essential prior to the refueling of a sodium-cooled fast reactor. To this end, an ultrasound-based inspection technique should be employed because the opacity of the sodium prevents conventional optical inspection techniques from being applied to the monitoring of obstacles. In this study, a ranging inspection technique using a plate-type ultrasonic waveguide sensor was developed to monitor the presence of any obstacles between the reactor core and the upper internal structure in the opaque sodium. Because the waveguide sensor installs an ultrasonic transducer in a relatively cold region and transmits the ultrasonic waves into the hot radioactive liquid sodium through a long waveguide, it offers better reliability and is less susceptible to thermal or radiation damage. A 10 m horizontal beam waveguide sensor capable of radiating an ultrasonic wave horizontally was developed, and beam profile measurements and basic experiments were carried out to investigate the characteristics of the developed sensor. The beam width and propagation distance of the ultrasonic wave radiated from the sensor were assessed based on the experimental results. Finally, a feasibility test using cylindrical targets (corresponding to the shape of possible obstacles) was also conducted to evaluate the applicability of the developed ranging inspection technique to actual applications.

• Journal of Genetic Medicine
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• v.6 no.2
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• pp.175-178
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• 2009

The 22q11.2 duplication syndrome is an extremely variable disorder with a phenotype ranging from normal to congenital defects and learning disabilities. Recently, the detection rate of 22q11.2 duplication has been increased by molecular techniques, such as array CGH. In this study, we report a familial case of 22q11.2 duplication detected prenatally. Her first pregnancy was terminated because of 22q11.2 duplication detected incidentally by BAC array CGH. The case was referred due to second pregnancy with same 22q11.2 duplication. We perfomed repeat amniocentesis for karyotype and FISH analysis. Karyotype analysis from amniocytes and parental lymphocytes were normal, while FISH analysis of interphase cells presented a duplication of 22q11.2 in the fetus and phenotypically normal mother. The fetal ultrasound showed grossly normal finding. After genetic counseling about variable phenotype with intrafamilial variability with 50% recurrence rate, the couple decided to continue the pregnancy. The newborn had no apparent congenital abnormalities until 2 weeks after birth. We recommend that family members of patients with a 22q11.2 duplication be tested by the interphase FISH analysis. Also, we point out the importance of genetic counseling and an evaluation of the clinical relevance of diagnostic test results.

• Journal of the Korean Society of Radiology
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• v.8 no.5
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• pp.241-248
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• 2014

The purpose of this study were to analyze the clinical correlation between the thyroid autoimmune antibodies (anti-TPO Ab, anti-TG Ab, and TSH) and the maximum standardized uptake value ($SUV_{max}$) base on the Hashimoto's thyroiditis and the Graves' disease in diffusely $^{18}F-FDG$ uptake of the thyroid gland to the PET/CT image. To achieve this, we was performed the PET/CT examination for the 1,097 subjects from May 2010 to April 2013 in the health screening, and was detected the diffused FDG thyroid uptake, and was additionally performed the thyroid function test (TFT) and the ultrasound (US). As a results, the autoimmune thyroid disease with the diffused FDG thyroid uptake were discovered 39 patients (3.9%), of this, the Hashimoto's thyroiditis was 43.6% and the Graves' disease was 23.1%. Hashimoto's thyroiditis was shown the positive reaction of high titer between the anti-TPO Ab and the anti-TG Ab level, and the correlation coefficient between the $SUV_{max}$ and the anti-TPO Ab was a statistically significant (r>04, p<0.05). Also, Graves' disease was shown the positive reaction of high titer most of the thyroid autoimmune antibodies, and the correlation coefficient between the $SUV_{max}$ and the anti-TPO Ab was a statistically significant (r>05, p<0.01). Therefor, when have a high standard of the $SUV_{max}$ due to the diffusely $^{18}F-FDG$ uptake of the thyroid gland, Hashimoto's thyroiditis and Graves' disease were proportionally increased the anti-TPO Ab and TSH level, respectively. The correlation coefficient between the $SUV_{max}$ and the thyroid autoimmune antibodies will be the most influential criterion that was a standard of judgment for the epihpenomenon of the autoimmune thyroid disease, and it will be available for the clinical application.