• Title/Summary/Keyword: External quality control

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Progress of Composite Fabrication Technologies with the Use of Machinery

  • Choi, Byung-Keun;Kim, Yun-Hae;Ha, Jin-Cheol;Lee, Jin-Woo;Park, Jun-Mu;Park, Soo-Jeong;Moon, Kyung-Man;Chung, Won-Jee;Kim, Man-Soo
    • International Journal of Ocean System Engineering
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    • v.2 no.3
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    • pp.185-194
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    • 2012
  • A Macroscopic combination of two or more distinct materials is commonly referred to as a "Composite Material", having been designed mechanically and chemically superior in function and characteristic than its individual constituent materials. Composite materials are used not only for aerospace and military, but also heavily used in boat/ship building and general composite industries which we are seeing increasingly more. Regardless of the various applications for composite materials, the industry is still limited and requires better fabrication technology and methodology in order to expand and grow. An example of this is that the majority of fabrication facilities nearby still use an antiquated wet lay-up process where fabrication still requires manual hand labor in a 3D environment impeding productivity of composite product design advancement. As an expert in the advanced composites field, I have developed fabrication skills with the use of machinery based on my past composite experience. In autumn 2011, the Korea government confirmed to fund my project. It is the development of a composite sanding machine. I began development of this semi-robotic prototype beginning in 2009. It has possibilities of replacing or augmenting the exhaustive and difficult jobs performed by human hands, such as sanding, grinding, blasting, and polishing in most often, very awkward conditions, and is also will boost productivity, improve surface quality, cut abrasive costs, eliminate vibration injuries, and protect workers from exposure to dust and airborne contamination. Ease of control and operation of the equipment in or outside of the sanding room is a key benefit to end-users. It will prove to be much more economical than normal robotics and minimize errors that commonly occur in factories. The key components and their technologies are a 360 degree rotational shoulder and a wrist that is controlled under PLC controller and joystick manual mode. Development on both of the key modules is complete and are now operational. The Korean government fund boosted my development and I expect to complete full scale development no later than 3rd quarter 2012. Even with the advantages of composite materials, there is still the need to repair or to maintain composite products with a higher level of technology. I have learned many composite repair skills on composite airframe since many composite fabrication skills including repair, requires training for non aerospace applications. The wind energy market is now requiring much larger blades in order to generate more electrical energy for wind farms. One single blade is commonly 50 meters or longer now. When a wind blade becomes damaged from external forces, on-site repair is required on the columns even under strong wind and freezing temperature conditions. In order to correctly obtain polymerization, the repair must be performed on the damaged area within a very limited time. The use of pre-impregnated glass fabric and heating silicone pad and a hot bonder acting precise heating control are surely required.

Analysis of Residual Solvents of [F-18]FDG Using Gas Chromatography (기체크로마토그래프법을 이용한 [F-18]FDG의 잔류용매 분석)

  • Kim, Dong-Il;Lee, Il-Jung;Kim, Shi-Hwal;Chi, Yong-Gi;Seok, Jae-Dong
    • The Korean Journal of Nuclear Medicine Technology
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    • v.15 no.2
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    • pp.26-29
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    • 2011
  • Purpose: The general test method of the Korean Pharmacopeia specifies the test method on the clauses of quality control after manufacturing. According to KFDA Guidance for Medicines, standards of residual solvents regulates the maximum permissible dose of acetonitrile as 400 ppm, ethanol as 5,000 ppm, and acetic acid as 5,000 ppm. This study aims at identifying the type of resiual solvents in the final [F-18]FDG vial of an automatic synthesizer and measure its residual quantity. Materials and Methods: The center carried out residual solvents test of [F-18]FDG injection using Agilent Technologies 7890A with a Flame Ionization Detector. The column of Agilent Technologies 7890A used in measuring of residual solvents was CP WAX column ($30m{\times}0.53mm{\times}1.0{\mu}m$) and analysis condition was split mode 1:1 at the initial temperature $70^{\circ}C$ which was increased $20^{\circ}C/minute$ after two minutes and maintained at the final $140^{\circ}C$ for two minutes. The analysis method was as following: Firstly, ethanol-acetonitrile-acetic acid mixture was classified into four types of concentration (250-25-250 ppm, 1,000-100-1,000 ppm, 3,000-300-3,000 ppm, and 6,000-600-6,000 ppm), and $1.0{\mu}L$ of each type of concentration was injected into gas chromatography followed by an analysis of its peak domain. Then, a calibration-curve by the external standard method was drawn based on the analysis result. Results: While ethanol and acetonitrile were detected in TRACERlab MX, FASTlab had additional acetic acid. The residual quantity of the ethanol-acetonitrile-acetic acid mixture evaluated using the calibration-curve was average 72 ppm ethanol, 54 ppm acetonitrile, and 1030 ppm acetic acid for FASTlab, whereas average 439 ppm ethanol and 79 ppm acetonitrile for TRACERlab MX. This indicated that both of them were within the maximum permissible dose. Conclusion: Solvent residues in the [F-18]FDG injection were all within maximum permissible doses and proper to be used to examine a patient. The result indicated that types and quantities of solvent resides of radioactive pharmaceuticals vary depending on the automatic synthesizer.

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A Hybrid Forecasting Framework based on Case-based Reasoning and Artificial Neural Network (사례기반 추론기법과 인공신경망을 이용한 서비스 수요예측 프레임워크)

  • Hwang, Yousub
    • Journal of Intelligence and Information Systems
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    • v.18 no.4
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    • pp.43-57
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    • 2012
  • To enhance the competitive advantage in a constantly changing business environment, an enterprise management must make the right decision in many business activities based on both internal and external information. Thus, providing accurate information plays a prominent role in management's decision making. Intuitively, historical data can provide a feasible estimate through the forecasting models. Therefore, if the service department can estimate the service quantity for the next period, the service department can then effectively control the inventory of service related resources such as human, parts, and other facilities. In addition, the production department can make load map for improving its product quality. Therefore, obtaining an accurate service forecast most likely appears to be critical to manufacturing companies. Numerous investigations addressing this problem have generally employed statistical methods, such as regression or autoregressive and moving average simulation. However, these methods are only efficient for data with are seasonal or cyclical. If the data are influenced by the special characteristics of product, they are not feasible. In our research, we propose a forecasting framework that predicts service demand of manufacturing organization by combining Case-based reasoning (CBR) and leveraging an unsupervised artificial neural network based clustering analysis (i.e., Self-Organizing Maps; SOM). We believe that this is one of the first attempts at applying unsupervised artificial neural network-based machine-learning techniques in the service forecasting domain. Our proposed approach has several appealing features : (1) We applied CBR and SOM in a new forecasting domain such as service demand forecasting. (2) We proposed our combined approach between CBR and SOM in order to overcome limitations of traditional statistical forecasting methods and We have developed a service forecasting tool based on the proposed approach using an unsupervised artificial neural network and Case-based reasoning. In this research, we conducted an empirical study on a real digital TV manufacturer (i.e., Company A). In addition, we have empirically evaluated the proposed approach and tool using real sales and service related data from digital TV manufacturer. In our empirical experiments, we intend to explore the performance of our proposed service forecasting framework when compared to the performances predicted by other two service forecasting methods; one is traditional CBR based forecasting model and the other is the existing service forecasting model used by Company A. We ran each service forecasting 144 times; each time, input data were randomly sampled for each service forecasting framework. To evaluate accuracy of forecasting results, we used Mean Absolute Percentage Error (MAPE) as primary performance measure in our experiments. We conducted one-way ANOVA test with the 144 measurements of MAPE for three different service forecasting approaches. For example, the F-ratio of MAPE for three different service forecasting approaches is 67.25 and the p-value is 0.000. This means that the difference between the MAPE of the three different service forecasting approaches is significant at the level of 0.000. Since there is a significant difference among the different service forecasting approaches, we conducted Tukey's HSD post hoc test to determine exactly which means of MAPE are significantly different from which other ones. In terms of MAPE, Tukey's HSD post hoc test grouped the three different service forecasting approaches into three different subsets in the following order: our proposed approach > traditional CBR-based service forecasting approach > the existing forecasting approach used by Company A. Consequently, our empirical experiments show that our proposed approach outperformed the traditional CBR based forecasting model and the existing service forecasting model used by Company A. The rest of this paper is organized as follows. Section 2 provides some research background information such as summary of CBR and SOM. Section 3 presents a hybrid service forecasting framework based on Case-based Reasoning and Self-Organizing Maps, while the empirical evaluation results are summarized in Section 4. Conclusion and future research directions are finally discussed in Section 5.

THE CURRENT STATUS OF BIOMEDICAL ENGINEERING IN THE USA

  • Webster, John G.
    • Proceedings of the KOSOMBE Conference
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    • v.1992 no.05
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    • pp.27-47
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    • 1992
  • Engineers have developed new instruments that aid in diagnosis and therapy Ultrasonic imaging has provided a nondamaging method of imaging internal organs. A complex transducer emits ultrasonic waves at many angles and reconstructs a map of internal anatomy and also velocities of blood in vessels. Fast computed tomography permits reconstruction of the 3-dimensional anatomy and perfusion of the heart at 20-Hz rates. Positron emission tomography uses certain isotopes that produce positrons that react with electrons to simultaneously emit two gamma rays in opposite directions. It locates the region of origin by using a ring of discrete scintillation detectors, each in electronic coincidence with an opposing detector. In magnetic resonance imaging, the patient is placed in a very strong magnetic field. The precessing of the hydrogen atoms is perturbed by an interrogating field to yield two-dimensional images of soft tissue having exceptional clarity. As an alternative to radiology image processing, film archiving, and retrieval, picture archiving and communication systems (PACS) are being implemented. Images from computed radiography, magnetic resonance imaging (MRI), nuclear medicine, and ultrasound are digitized, transmitted, and stored in computers for retrieval at distributed work stations. In electrical impedance tomography, electrodes are placed around the thorax. 50-kHz current is injected between two electrodes and voltages are measured on all other electrodes. A computer processes the data to yield an image of the resistivity of a 2-dimensional slice of the thorax. During fetal monitoring, a corkscrew electrode is screwed into the fetal scalp to measure the fetal electrocardiogram. Correlations with uterine contractions yield information on the status of the fetus during delivery To measure cardiac output by thermodilution, cold saline is injected into the right atrium. A thermistor in the right pulmonary artery yields temperature measurements, from which we can calculate cardiac output. In impedance cardiography, we measure the changes in electrical impedance as the heart ejects blood into the arteries. Motion artifacts are large, so signal averaging is useful during monitoring. An intraarterial blood gas monitoring system permits monitoring in real time. Light is sent down optical fibers inserted into the radial artery, where it is absorbed by dyes, which reemit the light at a different wavelength. The emitted light travels up optical fibers where an external instrument determines O2, CO2, and pH. Therapeutic devices include the electrosurgical unit. A high-frequency electric arc is drawn between the knife and the tissue. The arc cuts and the heat coagulates, thus preventing blood loss. Hyperthermia has demonstrated antitumor effects in patients in whom all conventional modes of therapy have failed. Methods of raising tumor temperature include focused ultrasound, radio-frequency power through needles, or microwaves. When the heart stops pumping, we use the defibrillator to restore normal pumping. A brief, high-current pulse through the heart synchronizes all cardiac fibers to restore normal rhythm. When the cardiac rhythm is too slow, we implant the cardiac pacemaker. An electrode within the heart stimulates the cardiac muscle to contract at the normal rate. When the cardiac valves are narrowed or leak, we implant an artificial valve. Silicone rubber and Teflon are used for biocompatibility. Artificial hearts powered by pneumatic hoses have been implanted in humans. However, the quality of life gradually degrades, and death ensues. When kidney stones develop, lithotripsy is used. A spark creates a pressure wave, which is focused on the stone and fragments it. The pieces pass out normally. When kidneys fail, the blood is cleansed during hemodialysis. Urea passes through a porous membrane to a dialysate bath to lower its concentration in the blood. The blind are able to read by scanning the Optacon with their fingertips. A camera scans letters and converts them to an array of vibrating pins. The deaf are able to hear using a cochlear implant. A microphone detects sound and divides it into frequency bands. 22 electrodes within the cochlea stimulate the acoustic the acoustic nerve to provide sound patterns. For those who have lost muscle function in the limbs, researchers are implanting electrodes to stimulate the muscle. Sensors in the legs and arms feed back signals to a computer that coordinates the stimulators to provide limb motion. For those with high spinal cord injury, a puff and sip switch can control a computer and permit the disabled person operate the computer and communicate with the outside world.

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Radiotherapy Incidents Analysis Based on ROSIS: Tendency and Frequency (ROSIS 자료 기반 방사선 사고 사례 분석 : 경향과 빈도)

  • Koo, Jihye;Yoon, MyongGeun;Chung, Won Kuu;Kim, Dong Wook
    • Progress in Medical Physics
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    • v.25 no.4
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    • pp.298-303
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    • 2014
  • In this study, we examine the trends and types of incidents frequently occur during radiation therapy by using the data from the radiation oncology safety information system (ROSIS), according to discovery method explores the development direction of future research accident cause factor control method. This study was carried out analysis of incident data in ROSIS nearly 1163 cases in last 11 years from 2003 to 2013. We categorized into treatment methods, found the time, discoverer of occupations and finding ways to analyze the data. Then, we calculate the percentage and the classification for each item. About 1163 cases of incident cases including the near miss cases, external radiation therapy, brachytherapy and other were 97%, 2% and 1%. In the case was improperly planned dose delivery was 44% (497 cases) which 429 cases (86%) was found before 3 fractions and 13 cases were found after 11 fractions. The investigation was found to be distributed in various a found times. Approximately 42% of found time was during treatment and 29% of patients were found the problem during inspection chart. Occupation to discover the most radiation accidents was the radiation therapist (53%) who works in treatment room. Among 1163 incidence cases, 24% cases were found the accident before the treatment, therefore most of accident were found after of during the treatment (70%, 813 cases). This trend is acquired through ROSIS analysis, is expected to be not significantly different in the case of Korea, so it is necessary more diverse and systematic research for the prevention and early detection by using the ROSIS data.

Development of Digital Transceiver Unit for 5G Optical Repeater (5G 광중계기 구동을 위한 디지털 송수신 유닛 설계)

  • Min, Kyoung-Ok;Lee, Seung-Ho
    • Journal of IKEEE
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    • v.25 no.1
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    • pp.156-167
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    • 2021
  • In this paper, we propose a digital transceiver unit design for in-building of 5G optical repeaters that extends the coverage of 5G mobile communication network services and connects to a stable wireless network in a building. The digital transceiver unit for driving the proposed 5G optical repeater is composed of 4 blocks: a signal processing unit, an RF transceiver unit, an optical input/output unit, and a clock generation unit. The signal processing unit plays an important role, such as a combination of a basic operation of the CPRI interface, a 4-channel antenna signal, and response to external control commands. It also transmits and receives high-quality IQ data through the JESD204B interface. CFR and DPD blocks operate to protect the power amplifier. The RF transmitter/receiver converts the RF signal received from the antenna to AD, is transmitted to the signal processing unit through the JESD204B interface, and DA converts the digital signal transmitted from the signal processing unit to the JESD204B interface and transmits the RF signal to the antenna. The optical input/output unit converts an electric signal into an optical signal and transmits it, and converts the optical signal into an electric signal and receives it. The clock generator suppresses jitter of the synchronous clock supplied from the CPRI interface of the optical input/output unit, and supplies a stable synchronous clock to the signal processing unit and the RF transceiver. Before CPRI connection, a local clock is supplied to operate in a CPRI connection ready state. XCZU9CG-2FFVC900I of Xilinx's MPSoC series was used to evaluate the accuracy of the digital transceiver unit for driving the 5G optical repeater proposed in this paper, and Vivado 2018.3 was used as the design tool. The 5G optical repeater digital transceiver unit proposed in this paper converts the 5G RF signal input to the ADC into digital and transmits it to the JIG through CPRI and outputs the downlink data signal received from the JIG through the CPRI to the DAC. And evaluated the performance. The experimental results showed that flatness, Return Loss, Channel Power, ACLR, EVM, Frequency Error, etc. exceeded the target set value.

Radioimmunoassay Reagent Survey and Evaluation (검사별 radioimmunoassay시약 조사 및 비교실험)

  • Kim, Ji-Na;An, Jae-seok;Jeon, Young-woo;Yoon, Sang-hyuk;Kim, Yoon-cheol
    • The Korean Journal of Nuclear Medicine Technology
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    • v.25 no.1
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    • pp.34-40
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    • 2021
  • Purpose If a new test is introduced or reagents are changed in the laboratory of a medical institution, the characteristics of the test should be analyzed according to the procedure and the assessment of reagents should be made. However, several necessary conditions must be met to perform all required comparative evaluations, first enough samples should be prepared for each test, and secondly, various reagents applicable to the comparative evaluations must be supplied. Even if enough comparative evaluations have been done, there is a limit to the fact that the data variation for the new reagent represents the overall patient data variation, The fact puts a burden on the laboratory to the change the reagent. Due to these various difficulties, reagent changes in the laboratory are limited. In order to introduce a competitive bid, the institute conducted a full investigation of Radioimmunoassay(RIA) reagents for each test and established the range of reagents available in the laboratory through comparative evaluations. We wanted to share this process. Materials and Methods There are 20 items of tests conducted in our laboratory except for consignment tests. For each test, RIA reagents that can be used were fully investigated with the reference to external quality control report. and the manuals for each reagent were obtained. Each reagent was checked for the manual to check the test method, Incubation time, sample volume needed for the test. After that, the primary selection was made according to whether it was available in this laboratory. The primary selected reagents were supplied with 2kits based on 100tests, and the data correlation test, sensitivity measurement, recovery rate measurement, and dilution test were conducted. The secondary selection was performed according to the results of the comparative evaluation. The reagents that passed the primary and secondary selections were submitted to the competitive bidding list. In the case of reagent is designated as a singular, we submitted a explanatory statement with the data obtained during the primary and secondary selection processes. Results Excluded from the primary selection was the case where TAT was expected to be delayed at the moment, and it was impossible to apply to our equipment due to the large volume of reagents used during the test. In the primary selection, there were five items which only one reagent was available.(squamous cell carcinoma Ag(SCC Ag), β-human chorionic gonadotropin(β-HCG), vitamin B12, folate, free testosterone), two reagents were available(CA19-9, CA125, CA72-4, ferritin, thyroglobulin antibody(TG Ab), microsomal antibody(Mic Ab), thyroid stimulating hormone-receptor-antibody(TSH-R-Ab), calcitonin), three reagents were available (triiodothyronine(T3), Tree T3, Free T4, TSH, intact parathyroid hormone(intact PTH)) and four reagents were available are carcinoembryonic antigen(CEA), TG. In the secondary selection, there were eight items which only one reagent was available.(ferritin, TG, CA19-9, SCC, β-HCG, vitaminB12, folate, free testosterone), two reagents were available(TG Ab, Mic Ab, TSH-R-Ab, CA125, CA72-4, intact PTH, calcitonin), three reagents were available(T3, Tree T3, Free T4, TSH, CEA). Reasons excluded from the secondary selection were the lack of reagent supply for comparative evaluations, the problems with data reproducibility, and the inability to accept data variations. The most problematic part of comparative evaluations was sample collection. It didn't matter if the number of samples requested was large and the capacity needed for the test was small. It was difficult to collect various concentration samples in the case of a small number of tests(100 cases per month or less), and it was difficult to conduct a recovery rate test in the case of a relatively large volume of samples required for a single test(more than 100 uL). In addition, the lack of dilution solution or standard zero material for sensitivity measurement or dilution tests was one of the problems. Conclusion Comparative evaluation for changing test reagents require appropriate preparation time to collect diverse and sufficient samples. In addition, setting the total sample volume and reagent volume range required for comparative evaluations, depending on the sample volume and reagent volume required for one test, will reduce the burden of sample collection and planning for each comparative evaluation.