Search results for: limit cycle behavior

Authors: Abraham V. M., I. Sahul Hamid

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A decomposition of a graph G is a collection ψ of graphs H1,H2, . . . , Hr of G such that every edge of G belongs to exactly one Hi. If each Hi is either an induced path in G, then ψ is called an induced acyclic path decomposition of G and if each Hi is a (induced) cycle in G then ψ is called a (induced) cycle decomposition of G. The minimum cardinality of an induced acyclic path decomposition of G is called the induced acyclic path decomposition number of G and is denoted by ¤Çia(G). Similarly the cyclic decomposition number ¤Çc(G) is defined. In this paper we begin an investigation of these parameters.

Keywords: Cycle decomposition, Induced acyclic path decomposition, Induced acyclic path decomposition number.

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Authors: M. Stoklasa, H. Starzyczna, P. Sykorova

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This paper presents partial results of primary research on consumer purchasing behavior in times of crisis. It starts with brief theoretical debate on purchasing behavior and short secondary research related to the issues, which is used for the comparison of results. For purpose of collecting data, questionnaire survey was given to 355 respondents in Moravian-Silesian region. Hypotheses deal with the relationship of the financial situation of the respondents and their purchasing behavior. The research analysis disclosed that consumers change their behavior during crisis and MS region has some specifics compared to other regions.

Keywords: Crisis, financial situation, consumer behavior, postponement of purchases, consumer credit.

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Authors: Masimuddin Mohd Khaled

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This paper subsidizes to the discussion of Six Sigma in the Aerospace Industry. The main aim of this report is to study the literature review of Six Sigma emphasizing on the aerospace industry. The implementation of Six Sigma stages are studied and how the improvement cycle ‘Define, Measure, Analyze, Improve and Control cycle’ (DMAIC) and the design process is ‘Define, Measure, Analyze, Design and Verify cycle’ (DMADV) is used. The focus is also done by studying how the implementation of Six Sigma on an aerospace company has brought a positive effect to the company.

Keywords: Six Sigma, DMAIC, DMADV, aerospace.

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Authors: Heyam Daod

Abstract:

Soils are normally dried in either a convection oven or stove. Laboratory moisture content testing indicated that the typical drying durations for a convection oven were, 24 hours. The purpose of this study was to determine the accuracy and soil drying duration of both, moisture content and liquid limit using microwave radiation. The soils were tested with both, convection and microwave ovens. The convection oven was considered to produce the true values for both, natural moisture content and liquid limit of soils; it was, therefore, used as a basis for comparison for the results of the microwave ovens. The samples used in this study were obtained from different projects of Consulting Engineering Bureau of College of Engineering of Sulaimani University. These samples were collected from different locations and at the different depths and consist mostly of brown and light brown clay and silty clay. A total of 102 samples were prepared. 26 of them were tested for natural moisture determination, while the other 76 were used for liquid limits determination

Keywords: Fine-grained soils, liquid limit, microwave drying,

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Authors: Ismail Gerzeli, Cemal Baykara, Osman Akin Kutlar

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Skip cycle is a working strategy for spark ignition engines, which allows changing the effective stroke of an engine through skipping some of the four stroke cycles. This study proposes a new mechanism to achieve the desired skip-cycle strategy for internal combustion engines. The air and fuel leakage, which occurs through the gas exchange, negatively affects the efficiency of the engine at high speeds and loads. An absolute sealing is assured by direct use of poppet valves, which are kept in fully closed position during the skipped mode. All the components of the mechanism were designed according to the real dimensions of the Anadolu Motor's gasoline engine and modeled in 3D by means of CAD software. As the mechanism operates in two modes, two dynamically equivalent models are established to obtain the force and strength analysis for critical components.

Keywords: Dynamic Model, Mechanical Design, Skip Cycle System (SCS), Valve Disabling Mechanism

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Authors: R. Anitha, R. S. Lekshmi

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Graph decompositions are vital in the study of combinatorial design theory. Given two graphs G and H, an H-decomposition of G is a partition of the edge set of G into disjoint isomorphic copies of H. An n-sun is a cycle Cn with an edge terminating in a vertex of degree one attached to each vertex. In this paper we have proved that the complete graph of order 2n, K2n can be decomposed into n-2 n-suns, a Hamilton cycle and a perfect matching, when n is even and for odd case, the decomposition is n-1 n-suns and a perfect matching. For an odd order complete graph K2n+1, delete the star subgraph K1, 2n and the resultant graph K2n is decomposed as in the case of even order. The method of building n-suns uses Walecki's construction for the Hamilton decomposition of complete graphs. A spanning tree decomposition of even order complete graphs is also discussed using the labeling scheme of n-sun decomposition. A complete bipartite graph Kn, n can be decomposed into n/2 n-suns when n/2 is even. When n/2 is odd, Kn, n can be decomposed into (n-2)/2 n-suns and a Hamilton cycle.

Keywords: Hamilton cycle, n-sun decomposition, perfectmatching, spanning tree.

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Authors: Vaishali P. Joshi, Pallav Joshi

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The objective of this study is to examine the differences fashion innovators and non-fashion innovators in their fashion consumption behavior in terms of their pre-purchase behavior, purchase behavior and post purchase behavior. The questionnaire was distributed to a female college student for data collection for achieving the objective of the first part of the study. Question-related to fashion innovativeness and fashion consumption behavior was asked. The sample was comprised of 81 college females ages 18 through 30 who were attending Business Management degree. A series of attitude questions was used to categorize respondents on the Innovativeness Scale. 32 respondents with a score of 21 and above were designated as Fashion innovators and the remainder (49) as Non-fashion innovators. Findings showed that there exist significant differences between innovators and non-innovators in their fashion consumption behavior. Data was analyzed through frequency distribution table. Many differences were found in the behavior of innovators and non-innovators in terms of their pre-purchase, actual purchase, and post-purchase behavior.

Keywords: Consumption behavior, fashion, innovativeness, frequency distribution table.

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Authors: Chris K. Y. Lo, Andy C. L. Yeung, T. C. Edwin Cheng

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ISO 9000 is the most popular and widely adopted meta-standard for quality and operational improvements. However, only limited empirical research has been conducted to examine the impact of ISO 9000 on operational performance based on objective and longitudinal data. To reveal any causal relationship between the adoption of ISO 9000 and operational performance, we examined the timing and magnitude of change in time-based performance as a result of ISO 9000 adoption. We analyzed the changes in operating cycle, inventory days, and account receivable days prior and after the implementation of ISO 9000 in 695 publicly listed manufacturing firms. We found that ISO 9000 certified firms shortened their operating cycle time by 5.28 days one year after the implementation of ISO 9000. In the long-run (3 years after certification), certified firms showed continuous improvement in time-based efficiency, and experienced a shorter operating cycle time of 11 days than that of non-certified firms. There was an average of 6.5% improvement in operating cycle time for ISO 9000 certified firms. Both inventory days and account receivable days showed similar significant improvements after the implementation of ISO 9000, too.

Keywords: ISO 9000, Operating Cycle, Time-based efficiency.

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Authors: S. Sabzchi Asl, N. Tahouni, M. H. Panjeshahi

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Benchmarking of a process with respect to energy consumption, without accomplishing a full retrofit study, can save both engineering time and money. In order to achieve this goal, the first step is to develop a conceptual-mathematical model that can easily be applied to a group of similar processes. In this research, we have aimed to identify a set of key parameters for the model which is supposed to be used for benchmarking of combined cycle power plants. For this purpose, three similar combined cycle power plants were studied. The results showed that ambient temperature, pressure and relative humidity, number of HRSG evaporator pressure levels and relative power in part load operation are the main key parameters. Also, the relationships between these parameters and produced power (by gas/ steam turbine), gas turbine and plant efficiency, temperature and mass flow rate of the stack flue gas were investigated.

Keywords: Combined cycle power plant, energy benchmarking, modelling, Retrofit.

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Authors: Ya Hong Dong, Conrad T.C. Wong, S. Thomas Ng, James M.W. Wong

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Precast concrete has been widely adopted in public housing construction of Hong Kong since the mid-1980s. While pre-casting is considered an environmental friendly solution, there is lack of study to investigate the life cycle performance of precast concrete units. This study aims to bridge the knowledge gap by providing a comprehensive life cycle assessment (LCA) study for two precast elements namely façade and bathroom. The results show that raw material is the most significant contributor of environmental impact accounting for about 90% to the total impact. Furthermore, human health is more affected by the production of precast concrete than the ecosystems.

Keywords: Environment, green, LCA, LCIA, precast.

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Authors: Ching-Feng Chen, Ching-Chih Tsai

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With the size of the transistor gradually approaching the physical limit, it challenges the persistence of Moore’s Law due to such issues of the short channel effect and the development of the high numerical aperture (NA) lithography equipment. In the context of the ever-increasing technical requirements of portable devices and high-performance computing (HPC), relying on the law continuation to enhance the chip density will no longer support the prospects of the electronics industry. Weighing the chip’s power consumption-performance-area-cost-cycle time to market (PPACC) is an updated benchmark to drive the evolution of the advanced wafer nanometer (nm). The advent of two and half- and three-dimensional (2.5 and 3D)- Very-Large-Scale Integration (VLSI) packaging based on Through Silicon Via (TSV) technology has updated the traditional die assembly methods and provided the solution. This overview investigates the up-to-date and cutting-edge packaging technologies for 2.5D and 3D integrated circuits (IC) based on the updated transistor structure and technology nodes. We conclude that multi-chip solutions for 2.5D and 3D IC packaging can prolong Moore’s Law.

Keywords: Moore’s Law, High Numerical Aperture, Power Consumption-Performance-Area-Cost-Cycle Time to Market, PPACC, 2.5 and 3D-Very-Large-Scale Integration Packaging, Through Silicon Vi.

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Authors: P. Pongsumpun, I.M. Tang

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Plasmodium vivax malaria differs from P. falciparum malaria in that a person suffering from P. vivax infection can suffer relapses of the disease. This is due the parasite being able to remain dormant in the liver of the patients where it is able to re-infect the patient after a passage of time. During this stage, the patient is classified as being in the dormant class. The model to describe the transmission of P. vivax malaria consists of a human population divided into four classes, the susceptible, the infected, the dormant and the recovered. The effect of a time delay on the transmission of this disease is studied. The time delay is the period in which the P. vivax parasite develops inside the mosquito (vector) before the vector becomes infectious (i.e., pass on the infection). We analyze our model by using standard dynamic modeling method. Two stable equilibrium states, a disease free state E0 and an endemic state E1, are found to be possible. It is found that the E0 state is stable when a newly defined basic reproduction number G is less than one. If G is greater than one the endemic state E1 is stable. The conditions for the endemic equilibrium state E1 to be a stable spiral node are established. For realistic values of the parameters in the model, it is found that solutions in phase space are trajectories spiraling into the endemic state. It is shown that the limit cycle and chaotic behaviors can only be achieved with unrealistic parameter values.

Keywords: Equilibrium states, Hopf bifurcation, limit cyclebehavior, local stability, Plasmodium Vivax, time delay.

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Authors: Sayali Vyas, Atharva Desai, Shreyas Badave, Apurv Kulkarni, B. Rajiv

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The Failure Modes and Effect Analysis (FMEA) is an efficient evaluation technique to identify potential failures in products, processes, and services. FMEA is designed to identify and prioritize failure modes. It proves to be a useful method for identifying and correcting possible failures at its earliest possible level so that one can avoid consequences of poor performance. In this paper, FMEA tool is used in detection of failures of various components of heat exchanger cycle and to identify critical failures of the components which may hamper the system’s performance. Further, a detailed Pareto analysis is done to find out the most critical components of the cycle, the causes of its failures, and possible recommended actions. This paper can be used as a checklist which will help in maintainability of the system.

Keywords: FMEA, heat exchanger cycle, Ishikawa diagram, Pareto analysis, risk priority number.

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Authors: Chih-Hsiang Chang

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This study aims to explore the relationship between the disposition effect and herding behavior of investors trading Taiwanese information technology stocks. This study differs from previous literature in two aspects. First, in contrast with the earlier studies that focused on investigating investors’ herding behavior, this study explores the possibility that the disposition effect drives investors’ herding behavior. Additionally, it takes an in-depth look at the interdependence between the disposition effect and herding behavior of investors, including lead-lag relationship and volatility transmission effect. Empirical results show that investors trading Taiwan’s information technology stocks exhibit pronounced herding behavior and that the disposition effect has a great impact on their herding behavior.

Keywords: Herding behavior, Disposition effect, Behavioral finance.

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Authors: Jung-Ho Moon, Tae Kwon Ha

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Continually increasing working temperature and growing need for greater efficiency and reliability of automotive exhaust require systematic investigation into the thermal fatigue properties especially of high temperature stainless steels. In this study, thermal fatigue properties of 300 series austenitic stainless steels have been evaluated in the temperature ranges of 200-800^oC and 200-900^oC. Systematic methods for control of temperatures within the predetermined range and measurement of load applied to specimens as a function of temperature during thermal cycles have been established. Thermal fatigue tests were conducted under fully constrained condition, where both ends of specimens were completely fixed. Load relaxation behavior at the temperatures of thermal cycle was closely related with the thermal fatigue property.

Keywords: Austenitic stainless steel, automotive exhaust, thermal fatigue, microstructure, load relaxation.

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Authors: Amaraja Taur, Pankaj Doshi, Hak Koon Yeoh

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The dripping modes for a Newtonian liquid of viscosity µ emanating from an inclined nozzle at flow rate Q is investigated experimentally. As the liquid flow rate Q increases, starting with period-1 with satellite drops, the system transitions to period-1 dripping without satellite, then to limit cycle before showing chaotic responses. Phase diagrams showing the changes in the transitions between the different dripping modes for different nozzle inclination angle q is constructed in the dimensionless (Q, µ) space.

Keywords: Dripping, inclined nozzle, phase diagram.

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Authors: Marina Franulovic, Robert Basan, Bozidar Krizan

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Constitutive modeling of material behavior is becoming increasingly important in prediction of possible failures in highly loaded engineering components, and consequently, optimization of their design. In order to account for large number of phenomena that occur in the material during operation, such as kinematic hardening effect in low cycle fatigue behavior of steels, complex nonlinear material models are used ever more frequently, despite of the complexity of determination of their parameters. As a method for the determination of these parameters, genetic algorithm is good choice because of its capability to provide very good approximation of the solution in systems with large number of unknown variables. For the application of genetic algorithm to parameter identification, inverse analysis must be primarily defined. It is used as a tool to fine-tune calculated stress-strain values with experimental ones. In order to choose proper objective function for inverse analysis among already existent and newly developed functions, the research is performed to investigate its influence on material behavior modeling.

Keywords: Genetic algorithm, kinematic hardening, material model, objective function

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Authors: Saria Abed, Tahar Khir, Ammar Ben Brahim

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A thermo-exergy optimization of a gas turbine cycle with two different regenerator designs is established. A comparison was made between the performance of the two regenerators and their roles in improving the cycle efficiencies. The effect of operational parameters (the pressure ratio of the compressor, the ambient temperature, excess of air, geometric parameters of the regenerators, etc.) on thermal efficiencies, the exergy efficiencies, and irreversibilities were studied using thermal balances and quantitative exegetic equilibrium for each component and for the whole system. The results are given graphically by using the EES software, and an appropriate discussion and conclusion was made.

Keywords: Exergy efficiency, gas turbine, heat transfer, irreversibility, optimization, regenerator, thermal efficiency.

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Authors: J.-Y. Lee, H.-S. Lim, S.-E. Kim

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Recently, the use of high-strength materials is increasing as the construction of large structures and high-rise structures increases. This paper presents an analysis of the shear behavior of prestressed concrete members with various types of materials by simulating a finite element (FE) analysis. The analytical results indicated that the shear strength and shear failure mode were strongly influenced by not only the shear reinforcement ratio but also the yield strength of shear reinforcement and the compressive strength of concrete. Though the yield strength of shear reinforcement increased the shear strength of prestressed concrete members, there was a limit to the increase in strength because of the change of shear failure modes. According to the results of FE analysis on various parameters, the maximum yield strength of the steel stirrup that can be applied to prestressed concrete members was about 860 MPa.

Keywords: PSC members, shear failure mode, high strength stirrups, high strength concrete, shear behavior.

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Authors: Djamal Atlaoui, Youcef Bouafia

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This work deals with the experimental study of the mechanical behavior, by shear tests (fracture shear), elements of concrete beams reinforced with fibers in chips. These fibers come from the machining waste of the steel parts. The shear tests are carried out on prismatic specimens of dimensions 10 x 20 x 120 cm³. The fibers are characterized by mechanical resistance and tearing. The optimal composition of the concrete was determined by the workability test. Two fiber contents are selected for this study (W = 0.6% and W = 0.8%) and a BT control concrete (W = 0%) of the same composition as the matrix is developed to serve as a reference with a sand-to-gravel ratio (S/G) of concrete matrix equal to 1. The comparison of the different results obtained shows that the chips fibers confer a significant ductility to the material after cracking of the concrete. Also, the fibers used limit diagonal cracks in shear and improve strength and rigidity.

Keywords: Characterization, chips fibers, cracking mode, ductility, undulation, shear.

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Authors: E. S. Fraser, G. P. A. G. van Zijl

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In many buildings we rely on large footings to offer structural stability. Designers often compensate for the lack of knowledge available with regard to foundation-soil interaction by furnishing structures with overly large footings. This may lead to a significant increase in building expenditures if many large foundations are present. This paper describes the interface material law that governs the behavior along the contact surface of adjacent materials, and the behavior of a large foundation under ultimate limit loading. A case study is chosen that represents a common foundation-soil system frequently used in general practice and therefore relevant to other structures. Investigations include compressing versus uplifting wind forces, alterations to the foundation size and subgrade compositions, the role of the slab stiffness and presence and the effect of commonly used structural joints and connections. These investigations aim to provide the reader with an objective design approach, efficiently preventing structural instability.

Keywords: Computational investigation of footing rotation.

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Authors: E. Elgendy

Abstract:

There are several ways of improving the performance of a vapor compression refrigeration cycle. Use of an ejector as expansion device is one of the alternative ways. The present paper aims at evaluate the performance improvement of a vapor compression refrigeration cycle under a wide range of operating conditions. A numerical model is developed and a parametric study of important parameters such as condensation (30-50°C) and evaporation temperatures (-20-5°C), nozzle and diffuser efficiencies (0.75-0.95), subcooling and superheating degrees (0-15K) are investigated. The model verification gives a good agreement with the literature data. The simulation results revealed that condensation temperature has the highest effect (129%) on the performance improvement ratio while superheating has the lowest one (6.2%). Among ejector efficiencies, the diffuser efficiency has a significant effect on the COP of ejector expansion refrigeration cycle. The COP improvement percentage decreases from 10.9% to 4.6% as subcooling degrees increases by 15K.

Keywords: Numerical modeling, R134a, Two phase ejector, Vapor compression refrigeration system.

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Authors: Constantia Achilleos, Diofantos G. Hadjimitsis

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Road industry has challenged the prospect of ecoconstruction. Pavements may fit within the framework of sustainable development. Hence, research implements assessments of conventional pavements impacts on environment in use of life cycle approach. To meet global, and often national, targets on pollution control, newly introduced pavement designs are under study. This is the case of Cyprus demonstration, which occurred within EcoLanes project work. This alternative pavement differs on concrete layer reinforced with tire recycling product. Processing of post-consumer tires produces steel fibers improving strength capacity against cracking. Thus maintenance works are relevantly limited in comparison to flexible pavement. This enables to be more ecofriendly, referenced to current study outputs. More specific, proposed concrete pavement life cycle processes emits 15 % less air pollutants and consumes 28 % less embodied energy than those of the asphalt pavement. In addition there is also a reduction on costs by 0.06 %.

Keywords: Environmental impact assessment, life cycle, tirerecycling, transportation pavement.

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Authors: W. Wu, S. Utili

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Based on the kinematic approach of limit analysis, a full set of upper bound solutions for the stability of homogeneous rock slopes subjected to tension cracks are obtained. The generalized Hoek-Brown failure criterion is employed to describe the non-linear strength envelope of rocks. In this paper, critical failure mechanisms are determined for cracks of known depth but unspecified location, cracks of known location but unknown depth, and cracks of unspecified location and depth. It is shown that there is a nearly up to 50% drop in terms of the stability factors for the rock slopes intersected by a tension crack compared with intact ones. Tables and charts of solutions in dimensionless forms are presented for ease of use by practitioners.

Keywords: Hoek-Brown failure criterion, limit analysis, rock slope, tension cracks.

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Authors: Mohd Azrul Hisham Mohd Adib, Nur Hazreen Mohd Hasni

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A three-dimensional and pulsatile blood flow in the left ventricle of heart model has been studied numerically. The geometry was derived from a simple approximation of the left ventricle model and the numerical simulations were obtained using a formulation of the Navier-Stokes equations. In this study, simulation was used to investigate the pattern of flow velocity in 3D model of heart with consider the left ventricle based on critical parameter of blood under steady condition. Our results demonstrate that flow velocity focused from mitral valve channel and continuous linearly to left ventricle wall but this skewness progresses into outside wall in atrium through aortic valve with random distribution that is irregular due to force subtract from ventricle wall during cardiac cycle. The findings are the prediction of the behavior of the blood flow velocity pattern in steady flow condition which can assist the medical practitioners in their decision on the patients- treatments.

Keywords: Mitral Valve, Aortic Valve, Cardiac Cycle, Leaflet, Biomechanics, Left Ventricle

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Authors: R.R. Saraf, S.S.Thipse, P.K.Saxena

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This paper presents comparative emission study of newly introduced gasoline/LPG bifuel automotive engine in Indian market. Emissions were tested as per LPG-Bharat stage III driving cycle. Emission tests were carried out for urban cycle and extra urban cycle. Total time for urban and extra urban cycle was 1180 sec. Engine was run in LPG mode by using conversion system. Emissions were tested as per standard procedure and were compared. Corrected emissions were computed by deducting ambient reading from sample reading. Paper describes detail emission test procedure and results obtained. CO emissions were in the range of38.9 to 111.3 ppm. HC emissions were in the range of 18.2 to 62.6 ppm. Nox emissions were 08 to 3.9 ppm and CO2 emissions were from 6719.2 to 8051 ppm. Paper throws light on emission results of LPG vehicles recently introduced in Indian automobile market. Objectives of this experimental study were to measure emissions of engines in gasoline & LPG mode and compare them.

Keywords: Gasoline, LPG, Emission, Bifuel, Engine.

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Authors: Aedah A. Rahman, Nurdatillah Hasim

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Software quality issues require special attention especially in view of the demands of quality software product to meet customer satisfaction. Software development projects in most organisations need proper defect management process in order to produce high quality software product and reduce the number of defects. The research question of this study is how to produce high quality software and reducing the number of defects. Therefore, the objective of this paper is to provide a framework for managing software defects by following defined life cycle processes. The methodology starts by reviewing defects, defect models, best practices, and standards. A framework for defect management life cycle is proposed. The major contribution of this study is to define a defect management roadmap in software development. The adoption of an effective defect management process helps to achieve the ultimate goal of producing high quality software products and contributes towards continuous software process improvement.

Keywords: Defects, defect management, life cycle process, software quality.

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Authors: Ayedh Alqahtani, Andrew Whyte

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Life Cycle Cost (LCC) is one of the goals and key pillars of the construction management science because it comprises many of the functions and processes necessary, which assist organisations and agencies to achieve their goals. It has therefore become important to design and control assets during their whole life cycle, from the design and planning phase through to disposal phase. LCCA is aimed to improve the decision making system in the ownership of assets by taking into account all the cost elements including to the asset throughout its life. Current application of LCC approach is impractical during misunderstanding of the advantages of LCC. This main objective of this research is to show a different relationship between capital cost and long-term running costs. One hundred and thirty eight actual building projects in United Kingdom (UK) were used in order to achieve and measure the above-mentioned objective of the study. The result shown that LCC is one of the most significant tools should be considered on the decision making process.

Keywords: Building projects, Capital cost, Life cycle cost, Maintenance costs, Operation costs.

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Authors: J. Mbihi

Abstract:

This paper presents a dynamic architecture of digital duty-cycle modulation control drivers. Compared to most oversampling digital modulation schemes encountered in industrial electronics, its novelty is founded on a number of relevant merits including; embedded positive and negative feedback loops, internal modulation clock, structural simplicity, elementary building operators, no explicit need of samples of the nonlinear duty-cycle function when computing the switching modulated signal, and minimum number of design parameters. A prototyping digital control driver is synthesized and well tested within MATLAB/Simulink workspace. Then, the virtual simulation results and performance obtained under a sample of relevant instrumentation and control systems are presented, in order to show the feasibility, the reliability, and the versatility of target applications, of the proposed class of low cost and high quality digital control drivers in industrial electronics.

Keywords: Dynamic architecture, virtual simulation, duty-cycle modulation, digital control drivers, industrial electronics.

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Authors: Takashi Kaminagayoshi, Shigeyuki Haruyama

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To improve the manufacturing efficiency of biologics, such as antibody drugs, a quality engineering framework was designed. Within this framework, critical steps and parameters in the manufacturing process were studied. Identification of these critical steps and critical parameters allows a deeper understanding of manufacturing capabilities, and suggests to process development department process control standards based on actual manufacturing capabilities as part of a PDCA (plan-do-check-act) cycle. This cycle can be applied to each manufacturing process so that it can be standardized, reducing the time needed to establish each new process.

Keywords: Antibody drugs, biologics, manufacturing efficiency, PDCA cycle, quality engineering.

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