• Title/Summary/Keyword: biomedical

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A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

A Study for Application of Standard and Performance Test According to Purpose and Subject of Respiratory Medical Device (호흡보조의료기기의 사용목적 및 대상에 따른 규격적용 방안 및 성능에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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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.

Enzyme-processed Korean Red Ginseng extracts protects against skin damage induced by UVB irradiation in hairless mice

  • Hwang, Eunson;Sun, Zheng-Wang;Lee, Taek Hwan;Shin, Heon-Sub;Park, Sang-Yong;Lee, Don-Gil;Cho, Byung-Goo;Sohn, Hyunjoo;Kwon, Oh Wook;Kim, Sun Yeou;Yi, Tae Hoo
    • Journal of Ginseng Research
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    • v.37 no.4
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    • pp.425-434
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    • 2013
  • UV irradiation is the main factor contributing to skin damages that are associated with an excessive production of matrix-degrading metalloproteinase (MMP)-1 and a deficient expression of collagens. To date, red ginseng has been revealed to possess many biomedical effects, such as anti-aging, anti-oxidation, and anti-inflammatory. In this study, we prepared the Korean Red Ginseng extracts treated with enzyme (KRGE) and investigated the effects of dietary KRGE on the formation of wrinkles generated by UVB irradiation in hairless mice. It was found that KRGE inhibited the UVB-induced formation of wrinkles, epidermal thickness, and skin dryness in hairless mice. Further results also showed that KRGE attenuated UVB-induced MMP-${\beta}$1 level, while accelerated procollagen type I, transforming growth factor-${\beta}$1 secretion. Interestingly, the expression of profilaggrin and filaggrin in both the epidermis and dermis were decreased due to UVB exposure and reversed by KRGE. The KRGE 0.06% was prior to KRGE 0.24%. In view of these results, which indicated that KRGE protected skin from UVB-induced photodamages, which may not only mediated by regulating of MMP-1 and procollagen type I, but also by increasing the production of profilaggrin and filaggrin. In conclusion, our results suggest that KRGE may be a promising agent for the treatment of skin photodamages. The challenge of KRGE will be expected as cosmeceuticals and nutraceuticals in order to intervene in aging-related degenerative skin changes.

The Low and Static Magnetic Field Effects on the Motion of Biomolecule Sanals Inside the Primo Vascular System (낮은 정자기장 하에서 프리모 시스템 산알의 운동특성 연구)

  • Lee, Sang-Suk;Soh, Kwang-Sup
    • Journal of the Korean Magnetics Society
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    • v.21 no.6
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    • pp.219-224
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    • 2011
  • The motion features of sanals inside of the primo vascular system (PVS), that is so-called the Kyungrak system, are investigated under a low static magnetic field by using the anatomy technology and optical microscope. The sanals with a size of about 1 selected and separated from the primo vessel and node of the real PVS inside of the surface of the internal organs are observed from rabbits' abdominal wall and dipped with PBS liquid inside of petri dish. The sanal's moving velocity along the direction of magnetic field (xdirection) and perpendicular to the direction of magnetic field (y-direction) under the low magnetic field of 0 Oe, 20 Oe, 40 Oe, 60 Oe, and 80 Oe, respectively, is observed below a internal temperature of $38^{\circ}C$. Ten sanals' moving velocities versus magnetic field are shown two differently dominant tendencies with an average velocity of 0.9 pixel/s and a random velocity according to the x-direction and y-direction, respectively. This experimental results imply that the rotating motion of sanal with nuclei DNA composed of many inorganic magnetic materials of Mn and Co is monotonically weakened by the increase of applied magnetic field.

Preparation of Sulfobetaine Chitosan, Silk Blended Films, and Their Properties (설포베타인 키토산의 실크 블렌드 필름의 제조 및 그들의 성질)

  • Koo, Ja-Sung;Cha, Jae-Ryung;Oh, Se-Heang;Gong, Myoung-Seon
    • Polymer(Korea)
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    • v.38 no.1
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    • pp.54-61
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    • 2014
  • Water-soluble sulfobetaine chitosan (SCs) was prepared for a blending film with Bombyx mori silk fibroin (SF) by reacting chitosan with 1,3-propanesultone. A series of SF/SCs blended films were successfully prepared by mixing aqueous solutions of B. mori SF and SCs. The SF/SCs blended films were examined through spectroscopic and thermal analysis to determine the morphological changes of SF in the SCs. The effects of the SF/SCs blend ratios on physical and mechanical properties were investigated to discover the feasibility of using these films as biomedical materials such as artificial skin and wound dressing. X-ray analysis showed good compatibility between the two biopolymers. The in vitro degradation behavior of the SF/SCs blended films was systematically investigated for up to 8 weeks in phosphate buffered saline solution at $37^{\circ}C$ and showed a mass loss of 46.4% after 8 weeks. All films showed no cytotoxicity by MC3T3-E1 assay. After 3 days of culture, the relative cell number on all the SF/SCs films was slightly lower than that of an optimized tissue culture plastic.

The Effect of Squat Exercise According to Ankle Angle-Toe 0°, Toe In 10°, Toe Out 10°-on Muscle Thickness and Ground Reaction Force of Vastus Medialis Oblique and Vastus Lateralis Oblique Muscles (발목각도 Toe 0°, Toe in 10°, Toe out 10°에 따른 스쿼트 운동이 안쪽넓은근과 가쪽넓은근의 근두께와 지면반발력에 미치는 영향)

  • Ahn, Su-Hong;Lee, Su-Kyong
    • PNF and Movement
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    • v.18 no.1
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    • pp.65-75
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    • 2020
  • Purpose: The purpose of this study was to investigate the differences in muscle thickness and ground reaction force of the vastus medialis oblique and vastus lateral oblique muscles during squats at ankle angles of toe 0°, toe in 10°, and toe out 10°. Methods: In this study, 9 male and 17 female students in their 20s participated in a randomized controlled trial and were compared according to the ankle angles of toe 0°, toe in 10°, and toe out 10°. To determine the reliability and measurement of muscle thickness according to ankle angle using ultrasound equipment and muscle thickness, the participants' ankle angles-toe 0°, toe in 10°, and toe out 10°-were measured three times at the vastus medialis oblique and vastus lateralis oblique muscles during squats. At the same time, the maximum vertical ground reaction force was measured with a force plate. A total of three measurements were taken and averaged, and two minutes of squat movements were assessed between ankle angles to prevent target action. Results: The results of this study illustrated that the reliability of the vastus medialis oblique muscles and vastus lateralis oblique muscles in ankle angle was high. The difference in muscle thickness was significantly greater in comparing the toe out 10° angle with the toe 0° angle than between toe in 10° and toe out 10° in vastus medialis oblique and vastus lateralis oblique (p < 0.05). There was no statistically significant difference between the ankle angle of toe 0° and toe in 10° (p > 0.05). The maximum vertical ground reaction force was significantly greater at toe out 10° than at the ankle angle of toe 0° and toe out 10° and between toe in 10° and toe out 10° (p < 0.05). There was no statistically significant difference in the comparison between toe 0° and toe in 10° (p > 0.05). Conclusion: Squatting at an ankle angle of toe out 10° increases the dorsi flexion; thus, the stability of the ankle and the thickness of both oblique muscles increased to perform more effective squats. In addition, as the base of support widens, it is thought that the stability of the posture increases so that squat training can be performed safely.

Inhibitory Effects of Ethanol Extract from Angelica tenuissima Root on Oxidative Stress and Melanogenesis

  • Koo, Hyun Jung;Lee, Sung Ryul;Park, Yuna;Lee, Jin Woo;So, Gyeongseop;Kim, Sung Hyeok;Ha, Chang Woo;Lee, Sang Eun;Bak, Jong Phil;Ham, Su Ryeon;Lim, Hyosun;Kim, Youn Kyu;Sohn, Eun-Hwa
    • Korean Journal of Plant Resources
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    • v.31 no.4
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    • pp.312-321
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    • 2018
  • Angelica tenuissima, also known as Ligusticum tenuissimum, is classified as a food-related plant and has been used as traditional medicines treating headache and anemia in Asia. However, its anti-melanogenic effect has not been reported in detail. When the extract of Angelica tenuissima (ATE) was prepared by the extraction with 70% EtOH at $80^{\circ}C$ (final yield = 22%), the contents of decursin and Z-ligustilide in ATE were determined 0.06% and 8.43%, respectively. Total flavonoid and phenolic content in mg ATE were $5.52{\pm}0.07{\mu}g$ quercetin equivalents and $237.27{\pm}13.24{\mu}g$ gallic acid equivalents, respectively. Antioxidant capacity of ATE determined by DPPH and ABTS assay was increased with a dose dependent manner up to $1000{\mu}g/m{\ell}$. The amount of melanin synthesis followed by ${\alpha}-melanocyte$ stimulating hormone on B16F10 cells were significantly reduced in the presence of ATE (250 to $1000{\mu}g/m{\ell}$, p<0.05). ATE (125 to $1000{\mu}g/m{\ell}$, p<0.05) suppressed the tyrosinase activity but did not show any significant effect on ${\alpha}-glucosidase$ activity at the same condition. Taken together, ATE possesses tyrosinase inhibitory potential with significant antioxidant capacities. These effects of ATE might be involved in suppression of melanin synthesis, at least, in B16F10 cells. The anti-melanogenic potential of ATE will provide an insight into developing a new skin whitening product.

Manufacture and Characterization of Silkworm Gland Hydrolysate (누에 실샘 가수분해물의 제조 및 특성 규명)

  • Hwang, Jung Wook;Lee, Heui Sam;Kim, Hojin;Kim, Kyu-Oh;Choi, Yong-Soo
    • Journal of Sericultural and Entomological Science
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    • v.50 no.2
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    • pp.76-81
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    • 2012
  • Silk protein has been explored to be used for biomedical applications for several decades. However, it has not been used in this field cause to their irreversible crystallization after dissolving in water. The existing methods of silk protein hydrolysis using silkworm cocoon were used with harmful solvents and through a very complicated process. Therefore, we have developed novel methods for the production of water-soluble hydrolysate using silkworm gland. We manufactured two types of silkworm gland-derived hydrolysate (water-soluble SGH, SSGH; total SGH, TSGH) and compared the characteristics with commercial cocoon-derived sericin hydrolysate (CSH). The molecular weight of SGH ranged from 7 to 50 kDa (SSGH) and 5 to 15 kDa (TSGH) within glycine, alanine, and aspartic acid as a main amino acid composition. In contrast, CSH ranged from 15 to 50 kDa within serine and aspartic acid. The results of FTIR implied that SGH was more soluble form than CSH, as shown by the decrease in the ${\beta}$-sheet structure at $1630cm^{-1}$ on amide I peak. In comparison with 10% fetal bovine serum, 0.1% (1 mg/ml) SSGH had equivalent effect on the proliferation of human dermal fibroblasts and mesenchymal stem cells. All results of the SSGH made by novel manufacturing process indicate the SSGH is more preferable as a culture medium supplement than cocoon-derived sericin.

The Necessity of Redefining the Radiological Technologist Independent Law (방사선사법 제정의 필요성)

  • Lim, Woo-Taek;Lim, Cheong-Hwan;Joo, Young-Cheol;Hong, Dong-Hee;Jung, Hong-Ryang;Jung, Young-Jin;Choi, Ji-Won;Yoon, Yong-Su;Kim, Eun-Hye;Yoo, Se-Jong;Park, Myeong-Hwan;Yang, Oh-Nam;Jeong, Bong-Jae
    • Journal of radiological science and technology
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    • v.44 no.5
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    • pp.545-554
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    • 2021
  • According to the changes of the medical environment of the times, it is necessary to discuss the issues of the doctor's medical guidance and to conduct continuous research so that alternatives can be prepared systematically. Furthermore, in order to enhance the professionalism of radiological technologists and to develop the medical technician system, the new Radiological Technologist Independent Act has been established, which contains the overall contents of the scope of work, professional qualifications, and specialized education of radiological technologists, and provides quality medical services to patients through professional procedures and treatment. In order to increase the level of medical care, the purpose, definition, mission, role, and scope of work specified in the Medical Act, Medical Service Technologists, etc. Act, the Enforcement Decree, and the Enforcement Rules were variously analyzed and new directions were presented. First, the definition of a medical technician should use a generic term so that the factors of conflict and prejudice could be resolved. Second, change the doctor's guide to doctor's prescription; and then legislate the authority to sign and write medical records after examination by radiological technologists, thereby prohibiting unlicensed technicians that seriously endanger patient safety. Third, an accurate definition of radiological technologists' roles should be established; not only selection and management of radiological technologists' work but also procedures and treatment for each radiology field should be specified to suit the current medical system. Fourth, a professional radiological technologists' qualification system and a specialized education system should be established in order to secure human resources that could provide patients trust in procedures and treatment based on professional knowledge and experience in the field of radiology. Fifth, the Education and Evaluation Institute should be operated in Korea education system to educate the professional knowledge and competency for students. In addition, it is necessary to in-depth analysis of foreign cases could be applied to the medical system and education system in Korea; it could strive to nurture systematic human resources.

Analysis of the Necessity of Medical Records Related to Radiological Examination (방사선검사의 의무기록에 관한 요구도 분석)

  • Hong, Dong-Hee;Lim, Cheong-Hwan;Lim, Woo-Taek;Joo, Young-Cheol;Jung, Hong-Ryang;Kim, Eun-Hye;Yoon, Yong-Su;Jung, Young-Jin;Choi, Ji-Won;Jeong, Sung-Hun;Park, Myeong-Hwan;Yang, Oh-Nam;Jeong, Bong-Jae
    • Journal of radiological science and technology
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    • v.44 no.5
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    • pp.513-523
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    • 2021
  • The purpose of this study was to discuss the required items and feasibility of medical records of radiological examinations performed by radiological technologists at medical institutions. An online survey was conducted to a total of 10,000 radiation-related workers, of which 1,026 (10.3%) responded. As a research method, self-made questionnaires were used. The online survey was conducted from September 10 to September 20, 2021 for the survey period. For response data, a Chi-square test was performed according to demographic characteristics using SPSS 27.0 version (IBM Inc., Chicago, Ill, USA), and it was judged to be significant when the P value was less than 0.05. The reliability of the questionnaire response was found to be Chronbach α=0.933. More than 90% of the medical records related to radiological examinations are necessary, and they answered that a curriculum, remuneration curriculum, and legal system for medical records should be prepared. More than 90% of the respondents agreed with the proposal of the Radiological Technologist Independent Act for legal preparation, and most of the information required for medical records is currently recorded in DICOM images. According to the demographic characteristics, the medical record requirement for radiological examination, curriculum, continuing education, and legislation were found to be higher with higher education and higher with longer working experience. In addition, most of the radiology departments showed a high demand for medical records, so most of them responded positively to the medical records requirements for radiological examinations. This study analyzed the medical record requirements for radiological examinations, and as shown in the results, medical record requirements for radiological examinations was found that most radiological technologists felt need for the new law and supported it. In addition, if the information recorded in the DICOM image is used, it is considered that medical records could be easily prepared without additional work by the radiological technologists.