Search results for: single-use medical device

Authors: Lucas B. Naves, Maria José Abreu

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Reprocessing single-use device has attracted interesting on the medical environment over the last decades. The reprocessing technique was sought in order to reduce the cost of purchasing the new medical device, which can achieve almost double of the price of the reprocessed product. In this manuscript, we have done a literature review, aiming the reuse of medical device that was firstly designed for single use only, but has become, more and more, effective on its reprocessing procedure. We also show the regulation, the countries which allows this procedure, the classification of these device and also the most important issue concerning the re-utilization of medical device, how to minimizing the risk of gram positive and negative bacteria, avoid cross-contamination, hepatitis B (HBV), and C (HCV) virus, and also human immunodeficiency virus (HIV).

Keywords: reusing, reprocessing, single-use medical device, HIV, hepatitis B and C

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Authors: Yoon Chung Kim

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In this coming aging society, medical device industry is expected to become one of the major industries. Since developing medical devices usually requires technology convergence, research collaboration is important, especially for some small and medium enterprises (SMEs) that do not have enough R&D resources in each related field. Collaboration in medical device development has some unique properties. Since it requires convergence technology, collaboration with different fields, and different types of people are often required. Since it requires clinical test, the development process usually takes longer and collaboration with hospitals is also required. However, despite these importance and uniqueness, collaboration in medical device development has not yet been widely studied. Thus, our research focuses on investigating collaborations in medical device development. For our research, we conducted surveys and interviews, especially with SMEs’ perspective in Korea. The result and discussion will be presented with a major impact factors for collaboration result, as well as future strategies that will improve and strengthen collaboration process in medical devices.

Keywords: medical device, SME, research collaboration, development, clinical

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Authors: Hao-Jun Hong, Jung-Tang Huang

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The world is gradually becoming an aging society, and with the lack of laboring forces, this phenomenon is affecting the nation’s economy growth. Although nursing centers are booming in recent years, the lack of medical resources are yet to be resolved, thus creating an innovative wearable medical device could be a vital solution. This research is focused on the design and development of a wearable device which obtains a more precise heart failure measurement than products on the market. The method used by the device is based on the sensor fusion and big data algorithm. From the test result, the modified structure of wearable device can significantly decrease the MA (Motion Artifact) and provide users a more cozy and accurate physical monitor experience.

Keywords: big data, heart failure, motion artifact, sensor fusion, wearable medical device

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Authors: Surafel Demissie, Frank Keenan, Fergal McCaffery

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Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. MDevSPICE^® has been developed to provide guidance to support such development. To increase the flexibility of this framework agile practices have been introduced. This paper outlines the challenges for embedded medical device software development and the structure of MDevSPICE^® and suggests a suitable combination of agile practices that will help to add flexibility and address corresponding challenges of embedded medical device software development.

Keywords: agile practices, challenges, embedded software, MDevSPICE®, medical device

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Authors: S. Botman, D. Borchevkin, V. Petrov, E. Bogdanov, M. Patrushev, N. Shusharina

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In this paper, we report the development of the device for diagnostics of cardiovascular system state and associated automated workstation for large-scale medical measurement data collection and analysis. It was shown that optimal design for the monitoring device is wristband as it represents engineering trade-off between accuracy and usability. The monitoring device is based on the infrared reflective photoplethysmographic sensor, which allows collecting multiple physiological parameters, such as heart rate and pulsing wave characteristics. Developed device use BLE interface for medical and supplementary data transmission to the coupled mobile phone, which process it and send it to the doctor's automated workstation. Results of this experimental model approbation confirmed the applicability of the proposed approach.

Keywords: cardiovascular diseases, health monitoring systems, photoplethysmography, pulse wave, remote diagnostics

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Authors: Nadir A. Carreon, Christa Sonderer, Aakarsh Rao, Roman Lysecky

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With the advent of complex software and increased connectivity, the security of life-critical medical devices is becoming an increasing concern, particularly with their direct impact on human safety. Security is essential, but it is impossible to develop completely secure and impenetrable systems at design time. Therefore, it is important to assess the potential impact on the security and safety of exploiting a vulnerability in such critical medical systems. The common vulnerability scoring system (CVSS) calculates the severity of exploitable vulnerabilities. However, for medical devices it does not consider the unique challenges of impacts to human health and privacy. Thus, the scoring of a medical device on which human life depends (e.g., pacemakers, insulin pumps) can score very low, while a system on which human life does not depend (e.g., hospital archiving systems) might score very high. In this paper, we propose a medical vulnerability scoring system (MVSS) that extends CVSS to address the health and privacy concerns of medical devices. We propose incorporating two new parameters, namely health impact, and sensitivity impact. Sensitivity refers to the type of information that can be stolen from the device, and health represents the impact on the safety of the patient if the vulnerability is exploited (e.g., potential harm, life-threatening). We evaluate fifteen different known vulnerabilities in medical devices and compare MVSS against two state-of-the-art medical device-oriented vulnerability scoring systems and the foundational CVSS.

Keywords: common vulnerability system, medical devices, medical device security, vulnerabilities

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Authors: Shigenori Togashi, Yukako Asano

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We developed an effective microfluidic device for photoreactions with low reflectance and good heat conductance. The performance of this microfluidic device was tested by carrying out a photoreactive synthesis of benzopinacol and acetone from benzophenone and 2-propanol. The yield reached 36% with an irradiation time of 469.2 s and was improved by more than 30% when compared to the values obtained by the batch method. Therefore, the microfluidic device was found to be effective for improving the yields of photoreactions.

Keywords: microfluidic device, photoreaction, black aluminum oxide, benzophenone, yield improvement

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Authors: Zeynep Sener, Mehtap Dursun

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Supplier evaluation and selection is one of the most important components of an effective supply chain management system. Due to the expanding competition in healthcare, selecting the right medical device suppliers offers great potential for increasing quality while decreasing costs. This paper proposes a fuzzy decision making approach for medical supplier selection. A real-world medical device supplier selection problem is presented to illustrate the application of the proposed decision methodology.

Keywords: fuzzy decision making, fuzzy multiple objective programming, medical supply chain, supplier selection

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Authors: Arash Sepehri bonab

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One of the regions of critical development in medical devices has been the part of the software - as an indispensable component of a therapeutic device, as a standalone device, and more as of late, as applications on portable gadgets. The chance related to a breakdown of the standalone computer program utilized inside healthcare is in itself not a model for its capability or not as a medical device. It is, subsequently, fundamental to clarify a few criteria for the capability of a stand-alone computer program as a medical device. The number of computer program items and therapeutic apps is persistently expanding and so as well is used in wellbeing education (e. g., in clinics and doctors' surgeries) for determination and treatment. Within the last decade, the use of information innovation in healthcare has taken a developing part. In reality, the appropriation of an expanding number of computer devices has driven several benefits related to the method of quiet care and permitted simpler get to social and health care assets. At the same time, this drift gave rise to modern challenges related to the usage of these modern innovations. The program utilized in healthcare can be classified as therapeutic gadgets depending on the way they are utilized and on their useful characteristics. In the event that they are classified as therapeutic gadgets, they must fulfill particular directions. The point of this work is to show a computer program improvement system that can permit the generation of secure and tall, quality restorative gadget computer programs and to highlight the correspondence between each program advancement stage and the fitting standard and/or regulation.

Keywords: medical devices, regulation, software, development, healthcare

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Authors: Shilpa Kulkarni, Sujata Patrikar

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A single-mode fiber directional coupler is modeled and simulated for its application in medical field. Various fiber devices based on evanescent field absorption, interferometry, couplers, resonators, tip coated fibers, etc, have been developed so far, suitable for medical application. This work focuses on the possibility of sensing by single mode fiber directional coupler. In the preset work, a fiber directional coupler is modeled to detect the changes taking place in the surrounding medium optoelectronically. In this work, waveguiding characteristics of the fiber are studied in depth. The sensor is modeled and simulated by finding photocurrent, sensitivity and detection limit by varying various parameters of the directional coupler. The device is optimized for the best possible output. It is found that the directional coupler shows measurable photocurrents and good sensitivity with coupling length in micrometers. It is thus a miniature device, hence, suitable for medical applications.

Keywords: single mode fiber directional coupler, modeling and simulation of fiber directional coupler sensor, biomolecular sensing, medical sensor device

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Authors: Wen Liang Chang

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In this study, the optimal replacement time and number of preventive maintenance (PM) actions were investigated for a second-hand device. Suppose that a user intends to use a second-hand device for manufacturing products, and that the device is replaced with a new one. Any device failure is rectified through minimal repair, thereby incurring a fixed repair cost to the user. If the new device fails within the FRW period, minimal repair is performed at no cost to the user. After the FRW expires, a failed device is repaired and the cost of repair is incurred by the user. In this study, two profit models were developed, and the optimal replacement time and number of PM actions were determined to maximize profits. Finally, the influence of the optimal replacement time and number of PM actions were elaborated on, using numerical examples.

Keywords: second-hand device, preventive maintenance, replacement time, device failure

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Authors: Mannan Mridha, Usama Gazay, Kosovare V. Aslani, Hugo Linder, Alice Ravizza, Carmelo de Maria

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In most developing countries, although the vast majority of the people are living in the rural areas, the qualified medical doctors are not available there. Health care workers and paramedics, called village doctors, informal healthcare providers, are largely responsible for the rural medical care. Mishaps due to wrong diagnosis and inappropriate medication have been causing serious suffering that is preventable. While innovators have created many devices, the vast majority of these technologies do not find applications to address the needs and conditions in low-resource settings. The primary motive is to address the acute lack of affordable medical technologies for the poor people in low-resource settings. A low cost smart medical device that is portable, battery operated and can be used at any point of care has been developed to detect breathing rate, electrocardiogram (ECG) and arterial pulse rate to improve diagnosis and monitoring of patients and thus improve care and safety. This simple and easy to use smart medical device can be used, managed and maintained effectively and safely by any health worker with some training. In order to empower the health workers and village doctors, our device is being further developed to integrate with ICT tools like smart phones and connect to the medical experts wherever available, to manage the serious health problems.

Keywords: e-health for low resources settings, health awareness education, improve patient care and safety, smart and affordable medical device

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Authors: Mustapha Aminu Bagiwa, Ainuddin Wahid Abdul Wahab, Mohd Yamani Idna Idris, Suleman Khan

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Video source device identification has become a problem of concern in numerous domains especially in multimedia security and digital investigation. This is because videos are now used as evidence in legal proceedings. Source device identification aim at identifying the source of digital devices using the content they produced. However, due to affordable processing tools and the influx in digital content generating devices, source device identification is still a major problem within the digital forensic community. In this paper, we discuss source device identification for digital videos by identifying techniques that were proposed in the literature for model or specific device identification. This is aimed at identifying salient open challenges for future research.

Keywords: video forgery, source camcorder, device identification, forgery detection

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Authors: Lv Shizeng, Han Xiao, Zhang Yi, Ding Wenjing

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The lunar sample storage device is mainly used for the preparation of the lunar samples, observation, physical analysis and other work. The lunar samples and operating equipment are placed directly inside the storage device. The inside of the storage device is a high purity nitrogen environment to ensure that the sample is not contaminated by the Earth's environment. In order to ensure that the water and oxygen indicators in the storage device meet the sample requirements, a dynamic gas cycle is required between the storage device and the external purification equipment. However, the internal gas disturbance in the storage device can affect the operation of the sample. In this paper, the storage device model is established, and the tetrahedral mesh is established by Tetra/Mixed method. The influence of different inlet position and gas flow on the internal flow field disturbance is calculated, and the disturbed flow area should be avoided during the sampling operation.

Keywords: lunar samples, gas disturbance, storage device, characteristic analysis

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Authors: Zahra Asgharpour, Eric Renteria, Sebastian De Boodt

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There is a growing trend towards personalization of medical care, as evidenced by the emphasis on outcomes based medicine, the latest developments in CT and MR imaging and personalized treatment in a variety of surgical disciplines. 3D Printing has been introduced and applied in the medical field since 2000. The first applications were in the field of dental implants and custom prosthetics. According to recent publications, 3D printing in the medical field has been used in a wide range of applications which can be organized into several categories including implants, prosthetics, anatomical models and tissue bioprinting. Some of these categories are still in their infancy stage of the concept of proof while others are in application phase such as the design and manufacturing of customized implants and prosthesis. The approach of 3D printing in this category has been successfully used in the health care sector to make both standard and complex implants within a reasonable amount of time. In this study, some of the clinical applications of 3D printing in design and manufacturing of a patient-specific hip implant would be explained. In cases where patients have complex bone geometries or are undergoing a complex revision on hip replacement, the traditional surgical methods are not efficient, and hence these patients require patient-specific approaches. There are major advantages in using this new technology for medical applications, however, in order to get this technology widely accepted in medical device industry, there is a need for gaining more acceptance from the medical device regulatory offices. This is a challenge that is moving onward and will help the technology find its way at the end as an accepted manufacturing method for medical device industry in an international scale. The discussion will conclude with some examples describing the future directions of 3D Medical Printing.

Keywords: CT/MRI, image processing, 3D printing, medical devices, patient specific implants

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Authors: Sagar R. Patil, Dinesh R. Gawade, Sudhir N. Divekar

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One of the medical devices we found when we visit a hospital care unit such device is ‘patient monitoring system’. This device (patient monitoring system) informs doctors and nurses about the patient’s physiological signals. However, this device (patient monitoring system) does not have a remote monitoring capability, which is necessitates constant onsite attendance by support personnel (doctors and nurses). Thus, we have developed a Remote Wireless Patient Monitoring System using some biomedical sensors and Android OS, which is a portable patient monitoring. This device(Remote Wireless Patient Monitoring System) monitors the biomedical signals of patients in real time and sends them to remote stations (doctors and nurse’s android Smartphone and web) for display and with alerts when necessary. Wireless Patient Monitoring System different from conventional device (Patient Monitoring system) in two aspects: First its wireless communication capability allows physiological signals to be monitored remotely and second, it is portable so patients can move while there biomedical signals are being monitor. Wireless Patient Monitoring is also notable because of its implementation. We are integrated four sensors such as pulse oximeter (SPO2), thermometer, respiration, blood pressure (BP), heart rate and electrocardiogram (ECG) in this device (Wireless Patient Monitoring System) and Monitoring and communication applications are implemented on the Android OS using threads, which facilitate the stable and timely manipulation of signals and the appropriate sharing of resources. The biomedical data will be display on android smart phone as well as on web Using web server and database system we can share these physiological signals with remote place medical personnel’s or with any where in the world medical personnel’s. We verified that the multitasking implementation used in the system was suitable for patient monitoring and for other Healthcare applications.

Keywords: patient monitoring, wireless patient monitoring, bio-medical signals, physiological signals, embedded system, Android OS, healthcare, pulse oximeter (SPO2), thermometer, respiration, blood pressure (BP), heart rate, electrocardiogram (ECG)

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Authors: Anirudh Bhaikhel

Abstract:

The exclusive objective of this paper is to develop a device which can pass on the interpreted result of the sensed information to the interfaced communicable devices to avoid or minimise accidents. This device may also be used in case of emergencies like kidnapping, robberies, medical emergencies etc. The present era has seen a rapid metamorphosis in the automobile industry with increasing use of technology and speed. The increase in purchasing power of customers and price war of automobile companies has made an easy access to the automobile users. The use of automobiles has increased tremendously in last 4-5 years thus causing traffic congestions and thus making vehicles more prone to accidents. This device can be an effective measure to counteract cases of abduction. Risks of accidents can be decreased tremendously through the notifications received by these alerts. It will help to detect the upcoming emergencies. This paper includes the simulation of the communication and sensing device required in automobiles using VHDL.

Keywords: automobiles, communication, component, cyclic redundancy check (CRC), modulo-2 arithmetic, parity bits, receiver, sensors, transmitter, turns, VHDL (VHSIC hardware descriptive language)

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Authors: Mohammad Reza Zamani Kouhpanji

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This paper presents a MEMS/NEMS device for fatigue and fracture characterization of nanomaterials. This device can apply static loads, cyclic loads, and their combinations in nanomechanical experiments. It is based on the electromagnetic force induced between paired parallel wires carrying electrical currents. Using this concept, the actuator and sensor parts of the device were designed and analyzed while considering the practical limitations. Since the PWCC device only uses two wires for actuation part and sensing part, its fabrication process is extremely easier than the available MEMS/NEMS devices. The total gain and phase shift of the MEMS/NEMS device were calculated and investigated. Furthermore, the maximum gain and sensitivity of the MEMS/NEMS device were studied to demonstrate the capability and usability of the device for wide range of nanomaterials samples. This device can be readily integrated into SEM/TEM instruments to provide real time study of the mechanical behaviors of nanomaterials as well as their fatigue and fracture properties, softening or hardening behaviors, and initiation and propagation of nanocracks.

Keywords: sensors and actuators, MEMS/NEMS devices, fatigue and fracture nanomechanical testing device, static and cyclic nanomechanical testing device

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Authors: M. McHugh, D. Lillis

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Mobile applications are being used to perform a wide variety of tasks in day-to-day life, ranging from checking email to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibility of facing a criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques, such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation.

Keywords: agile, applications, FDA, medical, mobile, regulations, software engineering, standards

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Authors: Dawei Cai

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In this paper, we present a new wearable device that provide an automatic guidance servie for visitors. By combining the position information from NFC and the orientation information from a 6 axis acceleration and terrestrial magnetism sensor, the head's direction can be calculated. We developed an algorithm to calculate the device orientation based on the data from acceleration and terrestrial magnetism sensor. If visitors want to know some explanation about an exhibit in front of him, what he has to do is just lift up his mobile device. The identification program will automatically identify the status based on the information from NFC and MEMS, and start playing explanation content for him. This service may be convenient for old people or disables or children.

Keywords: wearable device, ubiquitous computing, guide sysem, MEMS sensor, NFC

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Authors: Mahmood Alsaadi, Alexei Lisitsa

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Nowadays, medical devices rely completely on software whether as whole software or as embedded software, therefore, the organization that develops medical device software can benefit from adopting agile practices. Using agile practices in healthcare software development industries would bring benefits such as producing a product of a high-quality with low cost and in short period. However, medical device software development companies faced challenges in adopting agile practices. These due to the gaps that exist between agile practices and the requirements of healthcare regulations such as documentation, traceability, and formality. This research paper will conduct a study to investigate the adoption rate of agile practice in medical device software development, and they will extract and outline the requirements of healthcare regulations such as Food and Drug Administration (FDA), Health Insurance Portability and Accountability Act (HIPAA), and Medical Device Directive (MDD) that affect directly or indirectly on software development life cycle. Moreover, this research paper will evaluate the suitability of using agile practices in healthcare industries by analyzing the most popular agile practices such as eXtream Programming (XP), Scrum, and Feature-Driven Development (FDD) from healthcare industry point of view and in comparison with the requirements of healthcare regulations. Finally, the authors propose an agile mixture model that consists of different practices from different agile methods. As result, the adoption rate of agile practices in healthcare industries still low and agile practices should enhance with regard to requirements of the healthcare regulations in order to be used in healthcare software development organizations. Therefore, the proposed agile mixture model may assist in minimizing the gaps existing between healthcare regulations and agile practices and increase the adoption rate in the healthcare industry. As this research paper part of the ongoing project, an evaluation of agile mixture model will be conducted in the near future.

Keywords: adoption of agile, agile gaps, agile mixture model, agile practices, healthcare regulations

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Authors: Amin Hamrahi

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Near Field Communication (NFC) is one of the latest wireless communication technologies. NFC enables electronic devices to communicate in short range using the radio waves. NFC offers safe yet simple communication between electronic devices. This technology provides the fastest way to communicate two device with in a fraction of second. With NFC technology, communication occurs when an NFC-compatible device is brought within a few centimeters of another NFC device. NFC is an open-platform technology that is being standardized in the NFC Forum. NFC is based on and extends on RFID. It operates on 13.56 MHz frequency.

Keywords: near field communication, NFC technology, wireless communication technologies, NFC-compatible device, NFC, communication

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Authors: Ting-Ting Wen, H. C. Lin

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This paper reports a study for the light outcoupling efficiency of the PLED device. In use of a designed substrate combined with nano-line patterns in PLED device, the light outcoupling efficiency can be significantly enhanced. The designed substrate was made by UV imprinting technology, such as triangular microlens arrays on the front and periodic corrugated patterns on the back surface. The nano-line patterns in PLED device was fabricated by advanced microstamping and ink-jet printing techniques. For high angles of observation with respect to the substrate surface normal, the light out intensity of the developed PLED device is increased from 0.05 (a.u.) up to 0.69 (a.u.) at the view angle 85 degree. The designed integration leads to 64% increase of the light out intensity compared with the conventional PLED device.

Keywords: triangular microlens, corrugation patterns, nano-line patterns, PLED device, UV imprinting technology, microstamping

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Authors: Jeyeon Kim

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This paper describes the development of the automatic battery charging device for the rotor wings type unmanned aerial vehicle (UAV) and the positioning method that can be accurately landed on the charging device when landing. The developed automatic battery charging device is considered by simple maintenance, durability, cost and error of the positioning when landing. In order to for the UAV accurately land on the charging device, two kinds of markers (a color marker and a light marker) installed on the charging device is detected by the camera mounted on the UAV. And then, the UAV is controlled so that the detected marker becomes the center of the image and is landed on the device. We conduct the performance evaluation of the proposal positioning method by the outdoor experiments at day and night, and show the effectiveness of the system.

Keywords: unmanned aerial vehicle, automatic battery charging, positioning

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Authors: Bangwon Seo

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In this paper, we consider multicast device-to-device (D2D) direct communication systems in cellular networks. In multicast D2D communications, nearby mobile devices exchanges, their data directly without going through a base station and a D2D transmitter send its data to multiple D2D receivers that compose of D2D multicast group. We consider wiretap channel where there is an eavesdropper that attempts to overhear the transmitted data of the D2D transmitter. In this paper, we propose a secure transmission scheme in D2D multicast communications in cellular networks. In order to prevent the eavesdropper from overhearing the transmitted data of the D2D transmitter, a precoding vector is employed at the D2D transmitter in the proposed scheme. We perform computer simulations to evaluate the performance of the proposed scheme. Through the simulation, we show that the secrecy rate performance can be improved by selecting an appropriate precoding vector.

Keywords: device-to-device communications, wiretap channel, secure transmission, precoding

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Authors: Nuanwan Tuaycharoen, Wanarat Konisranukul

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The main aim of this research was to investigate the prototype of bamboo shading device. There were two objectives of this study. The first objective was to investigate the effect of non-chemical treatments on damage of bamboo shading device by powder-post beetle and fungi. The second aim of this study was to develop a prototype of bamboo shading device. The study of the effect of non-chemical treatments on damage of bamboo shading device by powder-post beetle in laboratory showed that, among seven treatments tested, wood vinegar treatment can protect powder-post beetle better than the original method up to 92.91%. It was also found that wood vinegar treatment can show the best performance in fungi protection and work better than the original method up to 40%. The second experiment was carried out by constructing four bamboo shading devices and installing them on a building for 28 days. All aspects of shading device were investigated in terms of their beauty, durability, and ease of construction and assembly. The final prototype was developed from the lessons drawn from these tested options. In conclusion this study showed the effectiveness of some natural preservatives against insect and fungi damage. It also illustrated the characteristics of the prototype of bamboo shading device that can constructed by rural workers within one week.

Keywords: bamboo, shading device, energy conservation, alternative material

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Authors: Ching-Sung Wang, Teng-Wei Wang, Zhen-Ting Zheng

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This study mainly concerns a safety device designed for child care. When children are out of sight or the caregivers cannot always pay attention to the situation, through the functions of this device, caregivers can immediately be informed to make sure that the children do not get lost or hurt, and thus, ensure their safety. Starting from this concept, a device is produced based on the relatively low-cost Bluetooth piconet system and a three-axis gyroscope sensor. This device can transmit data to a mobile phone app through Bluetooth, in order that the user can learn the situation at any time. By simply clipping the device in a pocket or on the waist, after switching on/starting the device, it will send data to the phone to detect the child’s fall and distance. Once the child is beyond the angle or distance set by the app, it will issue a warning to inform the phone owner.

Keywords: children care, piconet system, three-axis gyroscope, distance detection, falls detection

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Authors: Kathryn Rooney, Kaitlyn Eddy, Evan Landers, Weihui Li

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The international mortality rate for neonates and infants has been declining at a disproportionally low rate when compared to the overall decline in child mortality in recent decades. A significant portion of infant deaths could be prevented with the implementation of low-cost and easy to use physiological monitoring devices, by enabling early identification of symptoms before they progress into life-threatening illnesses. The oral diagnostic device discussed in this paper serves to continuously monitor the key vital signs of body temperature, respiratory rate, heart rate, and oxygen saturation. The device mimics an infant pacifier, designed to be easily tolerated by infants as well as orthodontically inert. The fundamental measurements are gathered via thermistors and a pulse oximeter, each encapsulated in medical-grade silicone and wired internally to a microcontroller chip. The chip then translates the raw measurements into physiological values via an internal algorithm, before outputting the data to a liquid crystal display screen and an Android application. Additionally, a biological sample collection chamber is incorporated into the internal portion of the device. The movement within the oral chamber created by sucking on the pacifier-like device pushes saliva through a small check valve in the distal end, where it is accumulated and stored. The collection chamber can be easily removed, making the sample readily available to be tested for various diseases and analytes. With the vital sign monitoring and sample collection offered by this device, abnormal fluctuations in physiological parameters can be identified and appropriate medical care can be sought. This device enables preventative diagnosis for infants who may otherwise have gone undiagnosed, due to the inaccessibility of healthcare that plagues vast numbers of underprivileged populations.

Keywords: neonate mortality, infant mortality, low-cost diagnostics, vital signs, saliva testing, preventative care

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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Authors: Sangeeta Singh, Pankaj Kumar, P. N. Kondekar

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In this paper, the transient device performance analysis of n-type Gate Inside Junctionless Transistor (GIJLT)has been evaluated. 3-D Bohm Quantum Potential (BQP)transport device simulation has been used to evaluate the delay and power dissipation performance. GI-JLT has a number of desirable device parameters such as reduced propagation delay, dynamic power dissipation, power and delay product, intrinsic gate delay and energy delay product as compared to Gate-all-around transistors GAA-JLT. In addition to this, various other device performance parameters namely, on/off current ratio, short channel effects (SCE), transconductance Generation Factor(TGF) and unity gain cut-off frequency (fT) and subthreshold slope (SS) of the GI-JLT and Gate-all-around junctionless transistor(GAA-JLT) have been analyzed and compared. GI-JLT shows better device performance characteristics than GAA-JLT for low power and high frequency applications, because of its larger gate electrostatic control on the device operation.

Keywords: gate-inside junctionless transistor GI-JLT, gate-all-around junctionless transistor GAA-JLT, propagation delay, power delay product

Procedia PDF Downloads 546