Bibliografias temáticas / Active implantable medical device (AMID)

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Literatura científica selecionada sobre o tema "Active implantable medical device (AMID)"

Autor: Grafiati

Publicado: 1 de fevereiro de 2025

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Artigos de revistas sobre o assunto "Active implantable medical device (AMID)"

Newaskar, Deepali, e B. P. Patil. "Rechargeable Active Implantable Medical Devices (AIMDs)". International Journal of Online and Biomedical Engineering (iJOE) 19, n.º 13 (18 de setembro de 2023): 108–19. http://dx.doi.org/10.3991/ijoe.v19i13.41197.

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Active Implantable Medical Devices (AIMDs) act as lifesaving devices. They provide electrical signals to tissues as well as perform data-logging operations. To perform these operations, they need power. The battery is the only source for such devices, as they are placed invasively inside the human body. Once the battery drains out, the patient wearing the device has to undergo medical surgery for the second time, where there are many chances of infections, and it could be life-threatening too. If the AIMDs, e.g., pacemakers are designed using rechargeable batteries, then the devices can be recharged regularly, which can increase the life of the device as well as reduce its size. Wireless charging of AIMDs such as ICDs or pacemakers is proposed in this paper using magnetic resonant coupling. The selection of frequency for power transfer is the most crucial part, as the basic restriction (BR) criteria proposed by ICNIRP guidelines and the IEEEC95.1 standard need to be followed, which ensures the safety of the patient. This is suggested by considering some basic restriction parameters, such as specific absorption rate (SAR) and current density, as suggested by guidelines. In this paper, experimentation using two frequencies is shown, i.e., 1.47 MHz (the high frequency) and 62 KHz (the low frequency). For experimentation, goat flesh and saline solution are used. Secondary coil and flesh are dipped in the saline solution. Battery recharging performed at a lower frequency took less time than with a frequency in the MHz range. All BR criteria are fulfilled for both frequencies, so the proposed methodology is safe to use.

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Jensen, Maria Lund, e Jayme Coates. "Planning Human Factors Engineering for Development of Implantable Medical Devices". Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 7, n.º 1 (junho de 2018): 156–60. http://dx.doi.org/10.1177/2327857918071037.

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Development of implantable medical devices is becoming increasingly interesting for manufacturers, but identifying the right Human Factors Engineering (HFE) approach to ensure safe use and effectiveness is challenging. Most active implantable devices are highly complex; they are built on extremely advanced, compact technology, often comprise systems of several device elements and accessories, and they span various types of user interfaces which must facilitate diverse interaction performed by several different user groups throughout the lifetime of the device. Furthermore, since treatment with implantable devices is often vital and by definition involves surgical procedures, potential risks related to use error can be severe. A systematic mapping of Product System Elements and Life Cycle Stages can help early identification of Use Cases, and for example user groups and high-level use risks, to be accounted for via HFE throughout development to optimize Human Factors processes and patient outcomes. This paper presents a concrete matrix tool which can facilitate an early systematic approach to planning and frontloading of Human Factors Engineering activities in complex medical device development.

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YOSHINO, Yuuki, e Masao TAKI. "Induced Voltage to an Active Implantable Medical Device by a Near-Field Intra-Body Communication Device". IEICE Transactions on Communications E94-B, n.º 9 (2011): 2473–79. http://dx.doi.org/10.1587/transcom.e94.b.2473.

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Wang, Zhichao, Jianfeng Zheng, Yu Wang, Wolfgang Kainz e Ji Chen. "On the Model Validation of Active Implantable Medical Device for MRI Safety Assessment". IEEE Transactions on Microwave Theory and Techniques 68, n.º 6 (junho de 2020): 2234–42. http://dx.doi.org/10.1109/tmtt.2019.2957766.

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Wang, Zhichao, Jianfeng Zheng, Yu Wang, Wolfgang Kainz e Ji Chen. "Erratum to “On the Model Validation of Active Implantable Medical Device for MRI Safety Assessment”". IEEE Transactions on Microwave Theory and Techniques 68, n.º 6 (junho de 2020): 2469. http://dx.doi.org/10.1109/tmtt.2020.2978595.

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Crisp, S. "The Medical Device Directives and Their Impact on the Development and Manufacturing of Medical Implants". Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 210, n.º 4 (dezembro de 1996): 233–39. http://dx.doi.org/10.1243/pime_proc_1996_210_419_02.

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The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. All implants must meet certain essential requirements to ensure that they do not harm the patient, clinician or any third party. For most implants this will be indicated on the product or its packaging by CE marking involving an independent organization called a Notified Body; the latter are appointed by the Competent Authority of the Member State. Devices are classified in proportion to the risk associated with them. The steps needed to be taken by manufacturers are outlined and the verification options discussed. The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.

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Hikage, Takashi, Toshio Nojima e Hiroshi Fujimoto. "Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands". Physics in Medicine and Biology 61, n.º 12 (25 de maio de 2016): 4522–36. http://dx.doi.org/10.1088/0031-9155/61/12/4522.

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Egitto, Frank D., Rabindra N. Das, Glen E. Thomas e Susan Bagen. "Miniaturization of Electronic Substrates for Medical Device Applications". International Symposium on Microelectronics 2012, n.º 1 (1 de janeiro de 2012): 000186–91. http://dx.doi.org/10.4071/isom-2012-ta57.

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The medical industry is clearly and urgently in need of development of advanced packaging that can meet the growing demand for miniaturization, high-speed performance, and flexibility for handheld, portable, in vivo, and implantable devices. To accomplish this, new packaging structures need to be able to integrate more dies with greater function, higher I/O counts, smaller die pad pitches, and high reliability, while being pushed into smaller and smaller footprints. As a result, the microelectronics industry is moving toward alternative, innovative approaches as solutions for squeezing more function into smaller packages. In the present report, key enablers for achieving reduction in size, weight, and power (SWaP) in electronic packaging for a variety of medical applications are discussed. These enablers include materials selection, embedded passives and active devices, System-in-Package (SiP) designs, and flex circuits. Manufacturing methods and materials for producing advanced organic substrates and flex along with ultra fine pitch assemblies are discussed. A case study detailing the fabrication of a flexible substrate for use in an intravascular ultrasound (IVUS) catheter demonstrates how the challenges of miniaturization are met. These challenges include use of ultra-thin polymer films, extreme fine-feature circuitization, and assembly processes to accommodate die having reduced die pad pitch.

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Mattei, Eugenio, Giovanni Calcagnini, Federica Censi, Iole Pinto, Andrea Bogi e Rosaria Falsaperla. "Workers with Active Implantable Medical Devices Exposed to EMF: In Vitro Test for the Risk Assessment". Environments 6, n.º 11 (15 de novembro de 2019): 119. http://dx.doi.org/10.3390/environments6110119.

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The occupational health and safety framework identifies workers with an active implantable medical device (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we describe the results of in vitro testing/measurements performed according to the EN50527-2-1:2016 standard, for the risk assessment of employees with a PM exposed to three EMF sources: (1) An electrosurgical unit (ESU); (2) a transcranial stimulator (TMS); and (3) an arc welder. The ESU did not affect the PM behavior in any of the configurations tested. For the TMS and the arc welder, interference phenomena were observed in limited experimental configurations, corresponding to the maximum magnetic field coupling between the EMF source and the implant. The in vitro measurements presented can be considered an example of how the specific risk assessment for a worker with a PM can be performed, according to one of the methodologies proposed in the EN50527-2-1:2016, and can be used as scientific evidence and literature data for future risk assessments on the same EMF sources.

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Wagner, Marcel Vila, e Thomas Schanze. "Challenges of Medical Device Regulation for Small and Medium sized Enterprises". Current Directions in Biomedical Engineering 4, n.º 1 (1 de setembro de 2018): 653–56. http://dx.doi.org/10.1515/cdbme-2018-0157.

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AbstractFor known reasons, the European Parliament was forced not only to revise the old Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), but to replace it with the extensive MDR. With the implementation of the Medical Device Regulation (MDR) in May 2017, manufacturers of medical devices will face new challenges for their products in the future, which also have to be implemented in a timely manner. Particularly small and medium-sized enterprises (SMEs) are concerned about whether a timely adaptation to the MDR and their requirements can be implemented. The conversion is associated with a huge effort for all producers of medical devices and certainly, produkt launchers. The purpose of this paper is to get an overview of the most relevant and emerging requirements that manufacturers need to adapt to sell their medical devices in compliance with the MDR regulations. It also explains the extent to which changes and innovations in the MDR are discusses and problems for SMEs.

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Mais fontes

Teses / dissertações sobre o assunto "Active implantable medical device (AMID)"

Indmeskine, Fatima-Ezahra. "Evaluation et qualification de la fiabilité des composants et des procédés d’assemblages électroniques pour applications médicales". Electronic Thesis or Diss., Angers, 2024. http://www.theses.fr/2024ANGE0029.

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L’électronique des DMIAs expose les patients à des risques en cas de défaillance d’un composant. Contrairement à l’aéronautique, où la redondance est courante, les dispositifs médicaux implantables actifs sont confrontés à des contraintes telles que la miniaturisation, qui entravent leur application. En outre, « le grade médical » des composants n’est pas normalisé, ce qui complique la qualification. L’absence de normes spécifiques et le nombre limité d’études sur les environnements des DMIAs rendent difficile l’élaboration de profils de mission. Pour y remédier, une étude de l’état de l’art a défini un profil de mission intégrant les contraintes environnementales critiques pour les essais de fiabilité, car elles influencent fortement les défaillances des composants. Une méthodologie basée sur le profil de mission, la FMMEA, les plans d’expériences et les essais accélérés a été développée pour qualifier les composants CMS, y compris les résistances, les condensateurs céramiques, les inductances et les circuits intégrés. Cette méthodologie résout deux problèmes majeurs : la conception d’essais accélérés efficaces pour détecter les défauts de qualité latents et la démonstration d’une fiabilité conforme au profil de la mission. Ce travail fait partie du projet de R&D « RECOME »
Electronics in AIMDs expose patients to risks in case of component failure. Unlike aeronautics, where redundancy is common, AIMDs face constraints like miniaturisation that hinder its application. Additionally, the "medical grade" of components lacks standardization, complicating qualification. The absence of specific standards and limited studies on AIMD environments makes mission profile development challenging. To address this, a state-of-the-art review defined a mission profile integrating environmental constraints critical for reliability tests, as these strongly influence component failures. A methodology based on the mission profile, FMMEA, experimental designs, and accelerated tests was developed to qualify SMD components, including resistors, ceramic capacitors, inductors, and integrated circuits. This solves two key issues: designing efficient accelerated tests to detect latent quality defects and demonstrating reliability aligned with the mission profile. This work is part of the R&D project "RECOME"

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Siegel, Alice. "Etude de l’interaction mécanique entre un dispositif médical implantable actif crânien et le crâne face à des sollicitations dynamiques". Thesis, Paris, ENSAM, 2019. http://www.theses.fr/2019ENAM0012.

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Dans le cadre du développement accru d’implants crâniens actifs, l’étude de la résistance du complexe crâne-implant face à des chocs modérés est nécessaire afin d’assurer la sécurité du patient. Le but de cette thèse est de quantifier l’interaction mécanique entre le crâne et l’implant afin de développer un modèle éléments finis prédictif utilisable pour la conception des futurs dispositifs. Dans un premier temps, des essais matériaux sur titane et silicone ont permis d’extraire les paramètres élastiques, plastiques et de viscosité de leurs lois de comportement. Ces paramètres ont ensuite été implémentés dans un modèle éléments finis de l’implant sous sollicitations dynamiques, validé par des essais de choc de 2,5 J. L’implant dissipe une partie de l’énergie du choc et le modèle obtenu permet d’optimiser la conception de l’implant afin qu’il reste fonctionnel et étanche après l’impact. La troisième partie porte sur l’élaboration d’un modèle éléments finis du complexe crâne-implant sous sollicitations dynamiques. Des essais sur têtes cadavériques ovines ont permis d’optimiser les paramètres d’endommagement du crâne. Le modèle complet du complexe crâne-implant, corrélé à des essais de choc, apporte des éléments de réponses sur le comportement du crâne implanté face un choc mécanique, permettant ainsi d’optimiser la conception de l’implant afin de garantir l’intégrité du crâne.Ce modèle représente un premier outil pour l’analyse de l’interaction mécanique entre crâne et implant actif, et permet de dimensionner ce dernier de sorte à garantir son fonctionnement et son étanchéité, tout en assurant l’intégrité du crâne
Active cranial implants are more and more developed to cure neurological diseases. In this context it is necessary to evaluate the mechanical resistance of the skull-implant complex under impact conditions as to ensure the patient’s security. The aim of this study is to quantify the mechanical interactions between the skull and the implant as to develop a finite element model for predictive purpose and for use in cranial implant design methodologies for future implants. First, material tests were necessary to identify the material law parameters of titanium and silicone. They were then used in a finite element model of the implant under dynamic loading, validated against 2.5 J-impact tests. The implant dissipates part of the impact energy and the model enables to optimize the design of implants for it to keep functional and hermetic after the impact. In the third part, a finite element model of the skull-implant complex is developed under dynamic loading. Impact tests on ovine cadaver heads are performed for model validation by enhancing the damage parameters of the three-layered skull and give insight into the behavior of the implanted skull under impact.This model is a primary tool for analyzing the mechanical interaction between the skull and an active implant and enables for an optimized design for functional and hermetic implants, while keeping the skull safe

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Livros sobre o assunto "Active implantable medical device (AMID)"

Schoenmakers, C. C. W. CE marking for medical devices: A handbook to the medical devices directives : Medical Device Directive 93/42/EEC : the Active Implantable Medical Device Directive 90/396/EEC. New York, NY: Standards Information Network/IEEE Press, 1997.

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AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. AAMI, 2018. http://dx.doi.org/10.2345/9781570206993.

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Capítulos de livros sobre o assunto "Active implantable medical device (AMID)"

Nahler, Gerhard. "active implantable medical device". In Dictionary of Pharmaceutical Medicine, 2. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_16.

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Brown, James E., Rui Qiang, Paul J. Stadnik, Larry J. Stotts e Jeffrey A. Von Arx. "RF-Induced Unintended Stimulation for Implantable Medical Devices in MRI". In Brain and Human Body Modeling 2020, 283–92. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-45623-8_17.

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AbstractHistorically, patients with implantable medical devices have been denied access to magnetic resonance imaging (MRI) due to several potentially hazardous interactions. There has been significant interest in recent years to provide access to MRI to patients with implantable medical devices, as it is the preferred imaging modality for soft tissue imaging. Among the potential hazards of MRI for patients with an active implantable medical device is radio frequency (RF)-induced unintended stimulation. RF energy incident on the device may be rectified by internal active components. Any rectified waveform present at the lead electrodes may stimulate nearby tissue. In order to assess the risk to the patient, device manufacturers use computational human models (CHMs) to quantify the incident RF on the device and perform in vitro testing to determine the likelihood of unintended stimulation. The use of CHMs enables the investigation of millions of scenarios of scan parameters, patient sizes and anatomies, and MR system technologies.

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Brown, James E., Paul J. Stadnik, Jeffrey A. Von Arx e Dirk Muessig. "RF-induced Heating Near Active Implanted Medical Devices in MRI: Impact of Tissue Simulating Medium". In Brain and Human Body Modelling 2021, 125–32. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-031-15451-5_8.

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AbstractRecent advances in the MR conditional safety assessment of active implantable medical devices (AIMDs) have begun providing guidelines in the development of transfer functions for evaluating risk to the patient due to RF-induced heating. This work introduces the complexity of the analysis of RF-induced heating and explores the impact of the computational human model (CHM) on the resulting analysis. Through historical analysis techniques, simplified structures, and real medical device geometries, the interaction of the AIMD lead with the tissue simulating medium (TSM) can be better understood. Finally, a general guiding principle for MR manufacturers is identified, whereby the thickness of the lead insulation can be used to determine the appropriate TSM for the most accurate in vivo predictions of RF-induced heating.

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"The Active Implantable Medical Device Directive (AIMDD)". In International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products, 273–84. CRC Press, 2003. http://dx.doi.org/10.1201/9780203488393-30.

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"The Active Implantable Medical Device Directive (AIMDD)". In International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products. Informa Healthcare, 2003. http://dx.doi.org/10.1201/9780203488393.ch16.

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"5: General requirements for non-implantable parts". In AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. AAMI, 2018. http://dx.doi.org/10.2345/9781570206993.ch5.

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Ren, Tingting, Meina Fang, Han Luo, Lingjian Zeng e Cheng Zeng. "Study on Calibration of Extracorporeal Pacemaker". In Studies in Health Technology and Informatics. IOS Press, 2023. http://dx.doi.org/10.3233/shti230869.

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Extracorporeal pacemaker is cardiac rhythm management device with non-implantable pulse generator and is widely used medical institutions. Parameters such as pulse duration, pulse amplitude, pulse rate, sensibility, and PVARP can directly decide the metrological performance of the instrument. However, at present, there is no relevant calibration specification for extracorporeal pacemaker in China to calibrate the important parameters. This article presents a novel calibration method for extracorporeal pacemaker by determining corresponding environmental conditions, calibration standards, and calculation equations. The calibration results of the important parameters can meet the requirements of GB 16174.2-2015 Implants for surgery – Active implantable medical devices – Part 2 Cardiac pacemakers, which shows that the calibration method is scientific and practical for metrological performance evaluation of extracorporeal pacemaker.

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"9: Protection from harm to the patient caused by gradient-induced device heating". In AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. AAMI, 2018. http://dx.doi.org/10.2345/9781570206993.ch9.

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"15: Protection from harm to the patient caused by RF-induced malfunction and RF rectification". In AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. AAMI, 2018. http://dx.doi.org/10.2345/9781570206993.ch15.

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"10: Protection from harm to the patient caused by gradient-induced vibration". In AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. AAMI, 2018. http://dx.doi.org/10.2345/9781570206993.ch10.

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Trabalhos de conferências sobre o assunto "Active implantable medical device (AMID)"

Nelson, Jody J., Wes Clement, Brian Martel, Richard Kautz e Katarina H. Nelson. "Assessment of active implantable medical device interaction in hybrid electric vehicles". In 2008 IEEE International Symposium on Electromagnetic Compatibility - EMC 2008. IEEE, 2008. http://dx.doi.org/10.1109/isemc.2008.4652064.

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Campi, Tommaso, Silvano Cruciani, Mauro Feliziani e Akimasa Hirata. "Wireless power transfer system applied to an active implantable medical device". In 2014 IEEE Wireless Power Transfer Conference (WPTC). IEEE, 2014. http://dx.doi.org/10.1109/wpt.2014.6839612.

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Gas, Piotr, e Arkadiusz Miaskowski. "A Heating from a Standard Active Implantable Medical Device under MRI Exposure". In 2019 15th Selected Issues of Electrical Engineering and Electronics (WZEE). IEEE, 2019. http://dx.doi.org/10.1109/wzee48932.2019.8979783.

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Chang, Jiajun, Qianlong Lan, Ran Guo, Jianfeng Zheng, Ji Chen e Wolfgang Kainz. "Prediction of Active Implantable Medical Device Electromagnetic Models Using a Neural Network". In 2021 IEEE International Symposium on Antennas and Propagation and USNC-URSI Radio Science Meeting (APS/URSI). IEEE, 2021. http://dx.doi.org/10.1109/aps/ursi47566.2021.9704511.

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Long, Tiangang, Changqing Jiang e Luming Li. "Electrode Sensitivity for MRI-RF Induced Heating Evaluation of Active Implantable Medical Device". In 2023 IEEE MTT-S International Microwave Biomedical Conference (IMBioC). IEEE, 2023. http://dx.doi.org/10.1109/imbioc56839.2023.10305093.

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Hikage, T., Y. Kawamura, T. Nojima, B. Koike, H. Fujimoto e T. Toyoshima. "Active implantable medical device EMI assessments for electromagnetic emitters operating in various RF bands". In 2011 IEEE MTT-S International Microwave Workshop Series on Innovative Wireless Power Transmission: Technologies, Systems, and Applications (IMWS 2011). IEEE, 2011. http://dx.doi.org/10.1109/imws.2011.5877102.

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Guo, Ran, Jianfeng Zheng, Zhichao Wang, Rui Yang, Ji Chen e Thomas Hoegh. "Reducing the Radiofrequency-Induced Heating of Active Implantable Medical Device with Load Impedance Modification". In 2020 IEEE International Symposium on Antennas and Propagation and North American Radio Science Meeting. IEEE, 2020. http://dx.doi.org/10.1109/ieeeconf35879.2020.9329822.

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Hikage, Takashi, Yoshifumi Kawamura e Toshio Nojima. "Numerical estimation methodology for RFID/Active Implantable Medical Device-EMI based upon FDTD analysis". In 2011 XXXth URSI General Assembly and Scientific Symposium. IEEE, 2011. http://dx.doi.org/10.1109/ursigass.2011.6051331.

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Zhao, Y. X., J. Chen, J. Y. Zhang, L. H. Li e C. Lin. "Testing based on cyclomatic complexity analysis in software development of active implantable medical device". In International Conference on Automation, Mechanical and Electrical Engineering. Southampton, UK: WIT Press, 2014. http://dx.doi.org/10.2495/amee141042.

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Hu, Wei, Yu Wang, Qingyan Wang, Md Zahidul Islam, Jeffrey Tsang, Wolfgang Kainz e Ji Chen. "RF-Induced Heating for Active Implantable Medical Device with Dual Parallel Leads under MRI". In 2021 IEEE International Symposium on Antennas and Propagation and USNC-URSI Radio Science Meeting (APS/URSI). IEEE, 2021. http://dx.doi.org/10.1109/aps/ursi47566.2021.9704099.

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