Equipment Failure Analysis

设备故障分析
  • 文章类型: Journal Article
    背景:皮肤神经纤维瘤(cNFs)是1型神经纤维瘤病(NF1)患者毁容的主要原因。然而,研究cNF治疗的临床试验缺乏标准化的结局指标来客观评估cNF大小和外观的变化.3D成像已经被提出作为客观的标准化结果度量,然而存在具有影响临床设置中的可用性的不同特征的各种系统。这项研究的目的是比较准确性,精度,可行性,三个成像系统的可靠性和可访问性。
    方法:我们比较了Vectra-H1、LifeViz-Micro和Cherry-Imaging系统。选择来自13名NF1参与者的58个cNFs进行成像和分析。主要终点是通过比较成像系统之间的测量值来测量的准确性。次要终点包括两个运营商之间的可靠性,用平均变异系数测量的精度,由时间确定的可行性,以捕获和分析图像和由成本确定的可访问性。
    结果:对于长度或表面积测量,三种设备之间的准确性没有显着差异(p>0.05),可靠性和精度相似。与其他测量相比,体积测量显示出最大的变异性;LifeViz-Micro显示出表面积的最小测量变异性,而LifeViz-Micro的图像捕获和分析最快。LifeViz-Micro对于成像数量较少的cNF(1-3)更好,Vectra-H1更好的面积和樱桃不平坦的表面。
    结论:所有系统均表现出良好的可靠性,但具有明显的优势和局限性。表面积是临床试验中测量cNF大小的最一致和可靠的参数。
    BACKGROUND: Cutaneous neurofibromas (cNFs) are a major cause of disfigurement in patients with Neurofibromatosis Type 1 (NF1). However, clinical trials investigating cNF treatments lack standardised outcome measures to objectively evaluate changes in cNF size and appearance. 3D imaging has been proposed as an objective standardised outcome measure however various systems exist with different features that affect useability in clinical settings. The aim of this study was to compare the accuracy, precision, feasibility, reliability and accessibility of three imaging systems.
    METHODS: We compared the Vectra-H1, LifeViz-Micro and Cherry-Imaging systems. A total of 58 cNFs from 13 participants with NF1 were selected for imaging and analysis. The primary endpoint was accuracy as measured by comparison of measurements between imaging systems. Secondary endpoints included reliability between two operators, precision as measured with the average coefficient of variation, feasibility as determined by time to capture and analyse an image and accessibility as determined by cost.
    RESULTS: There was no significant difference in accuracy between the three devices for length or surface area measurements (p > 0.05), and reliability and precision were similar. Volume measurements demonstrated the most variability compared to other measurements; LifeViz-Micro demonstrated the least measurement variability for surface area and image capture and analysis were fastest with LifeViz-Micro. LifeViz-Micro was better for imaging smaller number of cNFs (1-3), Vectra-H1 better for larger areas and Cherry for uneven surfaces.
    CONCLUSIONS: All systems demonstrated excellent reliability but possess distinct advantages and limitations. Surface area is the most consistent and reliable parameter for measuring cNF size in clinical trials.
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  • 文章类型: Journal Article
    更准确地预测寿命对于姑息治疗团队及其陪伴的家庭很重要。然而,医生估计生存时间的方式与实际情况之间存在差距。这是第一项使用无意义的可穿戴传感器收集临终关怀患者的心电图,并通过分析心率变异性来探索患者生命的最后时刻的研究。
    Predicting lifespan much more accurately is important for the palliative care team and the families they accompany. However, the way physicians estimate survival time has a gap between the real conditions. This is the first study to use a senseless wearable sensor to collect electrocardiograms from hospice care patients and explore the final moments of patients\' lives by analyzing heart rate variability.
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  • 文章类型: English Abstract
    UNASSIGNED: The purpose of this study is to compare the wear properties of UHMWPE acetabular liners after undergoing 3 million (3 Mc) and 5 million (5 Mc) cycles of in-vitro wear testing. The results will serve as a reference for the design of in-vitro testing for hip prostheses and as a control for clinical revision removals.
    UNASSIGNED: Wear tests were conducted on three different sizes of acetabular liners (28 mm, 32 mm, and 36 mm internal diameters) using a hip simulator to determine the amount of wear after 3 and 5 million cycles. The analysis included the number, size, and shape of abrasive particles.
    UNASSIGNED: After 3 and 5 million cycles of wear, the amount of wear on the acetabular liner increased as the inner diameter increased. The abrasive particles had an average equivalent circular area diameter (ECD) of 0.27 μm and 0.29 μm, and 94.4% and 90.1% of the aspect ratio (AR) less than 4.
    UNASSIGNED: The amount of wear on the acetabular liner after 3 Mc wear can indicate the wear performance of the product. The number of particles increased and the percentage of fibrous particles was higher after 5 Mc wear compared to 3 Mc wear.
    UNASSIGNED: 分析超高分子量聚乙烯髋臼内衬经历300万次(3 Mc)和500万次(5 Mc)体外磨损测试后磨损性能的差异,为髋关节假体体外测试试验设计作参考,并为临床翻修取出物作对照。.
    UNASSIGNED: 使用髋关节模拟机,对内径为28 mm、32 mm、36 mm三种规格的髋臼内衬进行磨损测试,计算3 Mc和5 Mc磨损后的磨损量;分析磨屑颗粒的数量、大小和形状。.
    UNASSIGNED: 经历3 Mc、5 Mc磨损后,髋臼内衬磨损量随内径的增大而增多;磨屑颗粒的等效圆面积直径(equivalent circular diameter, ECD)平均值为0.27 μm、0.29 μm,体态比(AR)小于4的占比为94.4%、90.1%。.
    UNASSIGNED: 髋臼内衬经历3 Mc磨损后的磨损量可以反映出产品的磨损性能趋势;相比于3 Mc磨损,经历5 Mc磨损后颗粒数量增多、纤维状颗粒占比升高。.
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  • 文章类型: Journal Article
    In modern ophthalmic surgery, an intraocular lens (IOL) is commonly implanted into the patient\'s eye with an IOL injector. Many injectors are available, showing various technological differences, from the early manually loaded injector systems to the modern preloaded injectors. This review aims to give a concise overview of the defining characteristics of injector models and draws attention to complications that may occur during IOL implantation. One can differentiate injectors according to their preoperative preparation (manually loaded or preloaded), their implantation mechanism (push-type or screw-type or combined or automated), the size of the nozzle tip, the presence of an insertion depth control feature, and the injector\'s reusability. Potential complications are IOL misconfigurations such as a haptic-optic adhesion, adherence of the IOL to the injector plunger, an overriding plunger, uncontrolled IOL rotation, a trapped trailing haptic, or damage to the IOL. Additionally, during IOL implantation, the nozzle can become damaged with scratches, extensions, cracks, or bursts to the tip. While these complications rarely produce long-term consequences, manufacturers should try to prevent them by further improving their devices. Similarly, surgeons should evaluate new injectors carefully to ensure the highest possible surgical safety.
    In der modernen Augenchirurgie wird eine Intraokularlinse (IOL) i. d. R. mithilfe eines IOL-Injektors in das Auge implantiert. Es gibt eine Vielzahl von Injektoren, die sich technologisch unterscheiden, von den frühen manuell zu ladenden Injektorsystemen bis hin zu den moderneren vorgeladenen IOL-Injektoren. Dieser Übersichtsartikel soll einen prägnanten Überblick über die charakteristischen Merkmale der unterschiedlichen Injektormodelle geben und auf Komplikationen aufmerksam machen, die während der IOL-Implantation auftreten können. Die Injektoren lassen sich nach ihrer präoperativen Vorbereitung (manuell geladen oder vorgeladen), ihrem Implantationsmechanismus (Druck- oder Schraubmechanismus, eine Kombination von beidem oder ein Automatismus), der Größe der Injektorspitze, dem Vorhandensein einer Funktion zur Kontrolle der Einführtiefe und der Wiederverwendbarkeit des Injektors unterscheiden. Zu den potenziellen Komplikationen gehören Fehlkonfigurationen der IOL, wie z. B. eine Haptik-Optik-Adhäsion, ein Anhaften der IOL am Kolben des Injektors, ein vorbeischiebender Injektorkolben, eine unkontrollierte IOL-Rotation, eine eingeklemmte Haptik oder eine Beschädigung der IOL. Darüber hinaus kann die Injektorspitze während der IOL-Implantation durch Kratzer, Ausdehnungen, Risse oder Aufplatzen der Spitze beschädigt werden. Obwohl diese Komplikationen selten langfristige Folgen haben, sollten die Hersteller versuchen, das Auftreten von Komplikationen durch weitere Verbesserungen der Injektoren zu verhindern. In der Zwischenzeit sollten Chirurgen vor der IOL-Implantation die IOL-Injektor-Systeme genaustens begutachten, um eine größtmögliche chirurgische Sicherheit zu gewährleisten.
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  • 文章类型: Journal Article
    微型传感器,如压力和流量传感器,通常用于获取游泳仿生机器鱼周围的实际流体信息,以进行流体动力学分析和控制。然而,大多数报道的微传感器都离散地安装在机器鱼的身体表面上,不可能分析尾鳍和流体之间的流体动力学。在这项工作中,利用激光加工的导电碳纤维复合材料,设计并制造了一种集成有电阻压力传感器的仿生尾鳍。为了分析水下振荡过程中施加在尾鳍上的压力,在不同的振荡频率和角度下测量尾鳍上的压力。然后,从伯努利方程建立的模型表明,最大压差与振荡频率和最大振荡角的二次功率成线性关系。尾鳍振荡产生的流体扰动随振荡频率的增加而增加。导致尾鳍振荡的动能转化为尾鳍两侧的压力差的效率降低。然而,也许是由于受干扰流体的稳定时间较长,这种转换效率随着最大振荡角的增加而增加。此外,尾鳍以连续不同的振荡角度振荡的压力变化也被证明是有效检测的。建议将尾鳍与压力传感器集成在一起,可用于实时感测原位流场并分析仿生机器鱼的流体动力学。
    Micro-sensors, such as pressure and flow sensors, are usually adopted to attain actual fluid information around swimming biomimetic robotic fish for hydrodynamic analysis and control. However, most of the reported micro-sensors are mounted discretely on body surfaces of robotic fish and it is impossible to analyzed the hydrodynamics between the caudal fin and the fluid. In this work, a biomimetic caudal fin integrated with a resistive pressure sensor is designed and fabricated by laser machined conductive carbon fibre composites. To analyze the pressure exerted on the caudal fin during underwater oscillation, the pressure on the caudal fin is measured under different oscillating frequencies and angles. Then a model developed from Bernoulli equation indicates that the maximum pressure difference is linear to the quadratic power of the oscillating frequency and the maximum oscillating angle. The fluid disturbance generated by caudal fin oscillating increases with an increase of oscillating frequency, resulting in the decrease of the efficiency of converting the kinetic energy of the caudal fin oscillation into the pressure difference on both sides of the caudal fin. However, perhaps due to the longer stability time of the disturbed fluid, this conversion efficiency increases with the increase of the maximum oscillating angle. Additionally, the pressure variation of the caudal fin oscillating with continuous different oscillating angles is also demonstrated to be detected effectively. It is suggested that the caudal fin integrated with the pressure sensor could be used for sensing thein situflow field in real time and analyzing the hydrodynamics of biomimetic robotic fish.
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  • 文章类型: Journal Article
    目的:皮下植入式心律转复除颤器(S-ICD)已在预防心源性猝死中确立,与经静脉除颤器系统相比有一些优势,包括较低的引线故障发生率。尽管技术进步,S-ICD携带者可能患有严重的并发症,例如电池过早耗尽(PBD),这导致了近4万名患者的咨询。这项多中心研究评估了大量S-ICD患者中PBD的发生率。
    结果:回顾了2012年10月至2023年7月在欧洲和美国的9个中心植入S-ICD模型A209和A219的患者的数据。PBD的发生率和影响,定义为临床观察到的电池寿命突然下降,进行了分析,并与60个月内电池耗尽的定义的PBD进行了比较。前瞻性收集的临床数据从病历中获得,设备遥测,和制造商报告。该注册表列在ClinicalTrials.gov(NCT05713708)上。在分析的1112台S-ICD装置中,547(49.2%)配备了与PBD事件相关的潜在受影响的电容器,目前在食品和药物管理局的咨询。所有患者的中位随访时间为46[四分位距(IQR)24-63]个月。在159例(29.1%)中观察到临床怀疑的PBD,去除或更换发电机的中位时间为65个月(IQR55-72),表明与预期电池寿命有显著偏差。在91.7%的返回用于分析的设备中,制造商确认了PBD。未在未咨询的装置中观察到PBD病例。
    结论:这项独立于制造商的分析强调了在咨询下配备S-ICD模型的患者中PBD的显著发生率,本研究中PBD的比率与制造商目前估计的比率相对应。据我们所知,本研究提供了当代最大的同行评审研究队列,调查了S-ICD患者中PBD的实际发病率.这些发现强调了上市后注册在临床医生和制造商之间合作以优化S-ICD治疗的安全性和有效性的重要性。
    OBJECTIVE: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.
    RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.
    CONCLUSIONS: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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  • 文章类型: Journal Article
    目的:对描述基于规则的临床决策支持(CDS)故障的研究进行范围审查。
    方法:2022年4月,我们检索了三个书目数据库(MEDLINE,CINAHL,和Embase)引用CDS故障的文献。我们根据现有的CDS故障分类对识别出的故障进行了编码,并为尚未捕获的因素添加了新的类别。我们还提取和总结了与CDS系统相关的信息,比如建筑,数据源,和数据格式。
    结果:28篇文章符合纳入标准,捕获130个故障。使用的架构包括独立系统(例如,基于网络的计算器),集成系统(例如,最佳实践警报),和面向服务的体系结构(例如,分布式系统,如SMART或CDSHooks)。没有发现基于标准的CDS故障。原始分类法的“原因”类别包括三种新类型(组织策略、硬件错误,和数据源)和两个现有的原因被扩展到包括额外的层。只有29个故障(22%)描述了故障对患者护理的潜在影响。
    结论:虽然存在大量关于CDS的研究,我们的审查表明,对CDS故障的关注有限,对与SMART和CDSHooks等现代交付架构相关的故障的关注甚至更少。
    结论:CDS故障可以并且确实发生在几种不同的护理交付架构中。考虑到卫生信息技术的进步,CDS故障的现有分类必须不断更新。这对于面向服务的体系结构尤其重要,连接几个不同的系统,并且正在增加使用。
    OBJECTIVE: Conduct a scoping review of research studies that describe rule-based clinical decision support (CDS) malfunctions.
    METHODS: In April 2022, we searched three bibliographic databases (MEDLINE, CINAHL, and Embase) for literature referencing CDS malfunctions. We coded the identified malfunctions according to an existing CDS malfunction taxonomy and added new categories for factors not already captured. We also extracted and summarized information related to the CDS system, such as architecture, data source, and data format.
    RESULTS: Twenty-eight articles met inclusion criteria, capturing 130 malfunctions. Architectures used included stand-alone systems (eg, web-based calculator), integrated systems (eg, best practices alerts), and service-oriented architectures (eg, distributed systems like SMART or CDS Hooks). No standards-based CDS malfunctions were identified. The \"Cause\" category of the original taxonomy includes three new types (organizational policy, hardware error, and data source) and two existing causes were expanded to include additional layers. Only 29 malfunctions (22%) described the potential impact of the malfunction on patient care.
    CONCLUSIONS: While a substantial amount of research on CDS exists, our review indicates there is a limited focus on CDS malfunctions, with even less attention on malfunctions associated with modern delivery architectures such as SMART and CDS Hooks.
    CONCLUSIONS: CDS malfunctions can and do occur across several different care delivery architectures. To account for advances in health information technology, existing taxonomies of CDS malfunctions must be continually updated. This will be especially important for service-oriented architectures, which connect several disparate systems, and are increasing in use.
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  • 文章类型: Journal Article
    在二十一世纪初,随着显微镜技术的进步,壁虎爬垂直墙壁的能力已经进行了广泛的研究。前所未有的研究和发展集中在粘附机理上,结构设计,制备方法,和生物启发干粘合剂的应用。值得注意的是,已发现并提出了坚持接触分裂和应力均匀分布原则的强粘附力。柔性电子皮肤的日益普及,柔软的爬行机器人,和智能组装系统已经使可切换的粘合性能对于智能粘合剂至关重要。这些粘合剂被设计为可编程的和可切换的,以响应外部刺激,如磁场,热变化,电信号,曝光以及机械过程。本文全面回顾了生物启发干粘合剂从实现强粘合到实现可转换粘合的发展历史。 .
    In the early twenty-first century, extensive research has been conducted on geckos\' ability to climb vertical walls with the advancement of microscopy technology. Unprecedented studies and developments have focused on the adhesion mechanism, structural design, preparation methods, and applications of bioinspired dry adhesives. Notably, strong adhesion that adheres to both the principles of contact splitting and stress uniform distribution has been discovered and proposed. The increasing popularity of flexible electronic skins, soft crawling robots, and smart assembly systems has made switchable adhesion properties essential for smart adhesives. These adhesives are designed to be programmable and switchable in response to external stimuli such as magnetic fields, thermal changes, electrical signals, light exposure as well as mechanical processes. This paper provides a comprehensive review of the development history of bioinspired dry adhesives from achieving strong adhesion to realizing switchable adhesion.
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  • 文章类型: Journal Article
    这项工作研究了人工鞭毛微型游泳者(AFMS)的声学驱动运动,并将这些微型游泳者的运动性与基于校正阻力理论(CRFT)和我们先前工作中提出的杠关节模型的预测进行了比较。该理论的关键要素是引入校正因子Kin阻力系数以校正常规阻力理论,从而可以准确地对具有矩形横截面的声学致动AFMS的动力学进行建模。实验上,这样的AFMS可以基于UV可固化树脂的数字光处理(DLP)容易地制造。我们首先通过动态力学分析(DMA)确定了UV固化树脂的粘弹性。特别是,基于时间-温度叠加(TTS)的假设,获得了高频储能模量和损耗因子,然后应用于理论计算中。尽管基于TTS的外推法暗示了高频材料响应的不确定性,并且确定磁头振荡幅度的准确性有限,AFMS的测量终端速度与预测终端速度之间的差异小于50%,which,对我们来说,是可以接受的。这些结果表明,声学AFMS的运动可以预测,因此,设计,这为他们期待已久的靶向治疗应用铺平了道路。
    This work examines the acoustically actuated motions of artificial flagellated micro-swimmers (AFMSs) and compares the motility of these micro-swimmers with the predictions based on the corrected resistive force theory (RFT) and the bar-joint model proposed in our previous work. The key ingredient in the theory is the introduction of a correction factorKin drag coefficients to correct the conventional RFT so that the dynamics of an acoustically actuated AFMS with rectangular cross-sections can be accurately modeled. Experimentally, such AFMSs can be easily manufactured based on digital light processing of ultra-violet (UV)-curable resins. We first determined the viscoelastic properties of a UV-cured resin through dynamic mechanical analysis. In particular, the high-frequency storage moduli and loss factors were obtained based on the assumption of time-temperature superposition (TTS), which were then applied in theoretical calculations. Though the extrapolation based on the TTS implied the uncertainty of high-frequency material response and there is limited accuracy in determining head oscillation amplitude, the differences between the measured terminal velocities of the AFMSs and the predicted ones are less than 50%, which, to us, is well acceptable. These results indicate that the motions of acoustic AFMS can be predicted, and thus, designed, which pave the way for their long-awaited applications in targeted therapy.
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  • 文章类型: Journal Article
    目的:微皮质图(μECoG)阵列能够记录皮质表面的神经活动,不需要穿透大脑实质.部分由于小的电极尺寸,先前的研究表明,可以从皮质表面检测到单个单位的尖峰,可能来自新皮层的第一层神经元。在这里,我们测试了使用μECoG阵列解码的能力,在老鼠身上,在野外导航期间的身体位置,通过孤立的单一单位活动。

方法:将μECoG阵列长期植入Wistar大鼠的初级运动皮层(M1),神经记录是在清醒时进行的,在露天围栏中表现出老鼠的行为。在300至3000Hz之间对信号进行带通滤波。根据定义的标准,包括波形形态和不应期,确定了阈值交叉尖峰,并将其分为不同的单位。身体位置来自视频记录。我们使用梯度增强机来根据之前100毫秒的尖峰数据预测身体位置,和相关分析,以阐明位置和尖峰模式之间的关系。

主要结果:在长期记录过程中可以从μECoG中提取单单位尖峰,和空间位置可以从这些尖峰中解码,在x和y维度(归一化范围从0到1)中预测的平均绝对误差为0.135和0.090,皮尔逊的r分别为0.607和0.571。

意义:μECoG可以检测可能来自皮质浅层神经元的单单位活动,是皮质内阵列的有希望的替代方案,具有可扩展性的额外好处,以最小的增量风险覆盖大皮质表面。应该在人类中进行更多与其用作脑机接口有关的研究。
    Objective.Micro-electrocorticographic (μECoG) arrays are able to record neural activities from the cortical surface, without the need to penetrate the brain parenchyma. Owing in part to small electrode sizes, previous studies have demonstrated that single-unit spikes could be detected from the cortical surface, and likely from Layer I neurons of the neocortex. Here we tested the ability to useμECoG arrays to decode, in rats, body position during open field navigation, through isolated single-unit activities.Approach. μECoG arrays were chronically implanted onto primary motor cortex (M1) of Wistar rats, and neural recording was performed in awake, behaving rats in an open-field enclosure. The signals were band-pass filtered between 300-3000 Hz. Threshold-crossing spikes were identified and sorted into distinct units based on defined criteria including waveform morphology and refractory period. Body positions were derived from video recordings. We used gradient-boosting machine to predict body position based on previous 100 ms of spike data, and correlation analyses to elucidate the relationship between position and spike patterns.Main results.Single-unit spikes could be extracted during chronic recording fromμECoG, and spatial position could be decoded from these spikes with a mean absolute error of prediction of 0.135 and 0.090 in the x- and y- dimensions (of a normalized range from 0 to 1), and Pearson\'s r of 0.607 and 0.571, respectively.Significance. μECoG can detect single-unit activities that likely arise from superficial neurons in the cortex and is a promising alternative to intracortical arrays, with the added benefit of scalability to cover large cortical surface with minimal incremental risks. More studies should be performed in human related to its use as brain-machine interface.
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