21 CFR 26.0 - General.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General. 26.0 Section 26.0 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

Analysis of the Transfer of Training, Substitution, and Fidelity of Simulation of Training Equipment. TAEG Report 2.

ERIC Educational Resources Information Center

Naval Training Equipment Center, Orlando, FL. Training Analysis and Evaluation Group.

This report summarizes, evaluates, and synthesizes the data on the training value of training devices. The report discusses the issues of substitution of some operational training time by training devices and the relationship between training effectiveness and cost (fidelity of simulation). These general conclusions were made: 1) Experiments…

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 26.63 - General coverage of this part.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General coverage of this part. 26.63 Section 26.63 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

Characterization of Greater-Than-Class C sealed sources. Volume 3, Sealed sources held by general licensees

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harris, G.

1994-09-01

This is the third volume in a series of three volumes characterizing the population of sealed sources that may become greater-than-Class C low-level radioactive waste (GTCC LLW). In this volume, those sources possessed by general licensees are discussed. General-licensed devices may contain sealed sources with significant amounts of radioactive material. However, the devices are designed to be safe to use without special knowledge of radiological safety practices. Devices containing Am-241 or Cm-244 sources are most likely to become GTCC LLW after concentration averaging. This study estimates that there are about 16,000 GTCC devices held by general licensees; 15,000 of thesemore » contain Am-241 sources and 1,000 contain Cm-244 sources. Additionally, this study estimates that there are 1,600 GTCC devices sold to general licensees each year. However, due to a lack of available information on general licensees in Agreement States, these estimates are uncertain. This uncertainty is quantified in the low and high case estimates given in this report, which span approximately an order of magnitude.« less

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the insulin pens. Findings from four studies assessing preference and satisfaction were not consistent. This systematic review identified evidence that injection safety devices are generally perceived as easy to use, safe, and tolerated by patients. There were few reports of technical problems while using the devices and some discomfort by nurses using the insulin pens.

Cost and Information Effectiveness Analysis (CIEA): A Methodology for Evaluating a Training Device Operational Readiness Assessment Capability (DORAC).

DTIC Science & Technology

1981-02-01

Report 528 COST AIND I*FO•?JidTH ?i EFFECT•• ES1BS ANALYSIS (CDEA): A METiBLOBU Y FOR EVALUATIN1G A TRAINING DEMCE OPERATMDN1AL MAEA3 ],SE 3SSESS$ iElT ...8217, N. Within a military setting, the uses of training devices in performance evaluation have generally mirrored civilian uses and primarily...Technical Report 528 COST AND INFORMATION EFFECTIVENESS ANALYSIS (CIEA): A METHODOLOGY FOR EVALUATING A TRAINING DEVICE OPERATIONAL READINESS

A serial digital data communications device. [for real time flight simulation

NASA Technical Reports Server (NTRS)

Fetter, J. L.

1977-01-01

A general purpose computer peripheral device which is used to provide a full-duplex, serial, digital data transmission link between a Xerox Sigma computer and a wide variety of external equipment, including computers, terminals, and special purpose devices is reported. The interface has an extensive set of user defined options to assist the user in establishing the necessary data links. This report describes those options and other features of the serial communications interface and its performance by discussing its application to a particular problem.

Biofouling detection monitoring devices: status assessment. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hillman, R.E.; Anson, D.; Corliss, J.M.

1985-03-01

An inventory of devices to detect and monitor biofouling in power plant condenser systems was prepared. The inventory was developed through a review of manufacturers' product information brochures, a general literature review, and limited personal contact with users and manufacturers. Two macrofouling and seventeen microfouling detection devices were reviewed. A summary analysis of the principal features of each device was prepared. Macrofouling devices are generally simple devices located at or near cooling water intakes. They monitor the growth of larger organisms such as mussels, barnacles, and large seaweeds. Microfouling detectors are usually located in or near the condenser tubes. Theymore » detect and monitor the growth of slime films on the tubes. Some of the devices measure changes in heat transfer or pressure drop in the condenser tubes. Other types include condenser simulators, biofilm samplers, or devices that measure the acoustic properties of the fouling films. Most devices are still in the development stage. Of the few available for general use, the type that measures heat transfer and/or pressure drop are developed to a greater degree than the other types. Recommendations for further research into development of a biofouling detection and monitoring devices include a side-by-side field comparison of selected devices, and the continued development of an effective acoustic device.« less

40 CFR 98.352 - GHGs to report.

Code of Federal Regulations, 2011 CFR

2011-07-01

... digester. (c) You must report CH4 emissions and CH4 destruction resulting from each biogas collection and biogas destruction device. (d) You must report under subpart C of this part (General Stationary Fuel...

Thermoelectric efficiency of nanoscale devices in the linear regime

NASA Astrophysics Data System (ADS)

Bevilacqua, G.; Grosso, G.; Menichetti, G.; Pastori Parravicini, G.

2016-12-01

We study quantum transport through two-terminal nanoscale devices in contact with two particle reservoirs at different temperatures and chemical potentials. We discuss the general expressions controlling the electric charge current, heat currents, and the efficiency of energy transmutation in steady conditions in the linear regime. With focus in the parameter domain where the electron system acts as a power generator, we elaborate workable expressions for optimal efficiency and thermoelectric parameters of nanoscale devices. The general concepts are set at work in the paradigmatic cases of Lorentzian resonances and antiresonances, and the encompassing Fano transmission function: the treatments are fully analytic, in terms of the trigamma functions and Bernoulli numbers. From the general curves here reported describing transport through the above model transmission functions, useful guidelines for optimal efficiency and thermopower can be inferred for engineering nanoscale devices in energy regions where they show similar transmission functions.

Computer Augmented Learning; A Survey.

ERIC Educational Resources Information Center

Kindred, J.

The report contains a description and summary of computer augmented learning devices and systems. The devices are of two general types programed instruction systems based on the teaching machines pioneered by Pressey and developed by Skinner, and the so-called "docile" systems that permit greater user-direction with the computer under student…

Experimental Measurement-Device-Independent Entanglement Detection

NASA Astrophysics Data System (ADS)

Nawareg, Mohamed; Muhammad, Sadiq; Amselem, Elias; Bourennane, Mohamed

2015-02-01

Entanglement is one of the most puzzling features of quantum theory and of great importance for the new field of quantum information. The determination whether a given state is entangled or not is one of the most challenging open problems of the field. Here we report on the experimental demonstration of measurement-device-independent (MDI) entanglement detection using witness method for general two qubits photon polarization systems. In the MDI settings, there is no requirement to assume perfect implementations or neither to trust the measurement devices. This experimental demonstration can be generalized for the investigation of properties of quantum systems and for the realization of cryptography and communication protocols.

Experimental Measurement-Device-Independent Entanglement Detection

PubMed Central

Nawareg, Mohamed; Muhammad, Sadiq; Amselem, Elias; Bourennane, Mohamed

2015-01-01

Entanglement is one of the most puzzling features of quantum theory and of great importance for the new field of quantum information. The determination whether a given state is entangled or not is one of the most challenging open problems of the field. Here we report on the experimental demonstration of measurement-device-independent (MDI) entanglement detection using witness method for general two qubits photon polarization systems. In the MDI settings, there is no requirement to assume perfect implementations or neither to trust the measurement devices. This experimental demonstration can be generalized for the investigation of properties of quantum systems and for the realization of cryptography and communication protocols. PMID:25649664

40 CFR 1068.501 - How do I report emission-related defects?

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Electronic control units, aftertreatment devices, fuel-metering components, EGR-system components, crankcase...) AIR POLLUTION CONTROLS GENERAL COMPLIANCE PROVISIONS FOR HIGHWAY, STATIONARY, AND NONROAD PROGRAMS Reporting Defects and Recalling Engines/Equipment § 1068.501 How do I report emission-related defects? This...

40 CFR 1068.501 - How do I report emission-related defects?

Code of Federal Regulations, 2014 CFR

2014-07-01

...) Electronic control units, aftertreatment devices, fuel-metering components, EGR-system components, crankcase...) AIR POLLUTION CONTROLS GENERAL COMPLIANCE PROVISIONS FOR HIGHWAY, STATIONARY, AND NONROAD PROGRAMS Reporting Defects and Recalling Engines/Equipment § 1068.501 How do I report emission-related defects? This...

40 CFR 1068.501 - How do I report emission-related defects?

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Electronic control units, aftertreatment devices, fuel-metering components, EGR-system components, crankcase...) AIR POLLUTION CONTROLS GENERAL COMPLIANCE PROVISIONS FOR HIGHWAY, STATIONARY, AND NONROAD PROGRAMS Reporting Defects and Recalling Engines/Equipment § 1068.501 How do I report emission-related defects? This...

Visual performance with changes in eccentricity in PROSE device: a case report.

PubMed

Jagadeesh, Divya; Mahadevan, Rajeswari

2014-01-01

This case report describes the variations in visual performance of a subject with moderate keratoconus with changes in front surface eccentricities (FSEs) of PROSE (Prosthetic Replacement of Ocular Surface Ecosystem). PROSE device of 0.6 FSE provided maximum visual improvement and reduction in Higher Order Aberrations (HOAs) compared to 0, 0.3 and 0.8 FSEs in this clinical condition. Copyright © 2013 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Apollo experience report: Electrical wiring subsystem

NASA Technical Reports Server (NTRS)

White, L. D.

1975-01-01

The general requirements of the electrical wiring subsystems and the problem areas and solutions that occurred during the major part of the Apollo Program are detailed in this report. The concepts and definitions of specific requirements for electrical wiring; wire-connecting devices; and wire-harness fabrication, checkout, and installation techniques are discussed. The design and development of electrical wiring and wire-connecting devices are described. Mission performance is discussed, and conclusions and recommendations for future programs are presented.

Separation of density and viscosity influence on liquid-loaded surface acoustic wave devices

NASA Astrophysics Data System (ADS)

Herrmann, F.; Hahn, D.; Büttgenbach, S.

1999-05-01

Love-mode sensors are reported for separate measurement of liquid density and viscosity. They combine the general merits of Love-mode devices, e.g., ease of sensitivity adjustment and robustness, with a highly effective procedure of separate determination of liquid density and viscosity. A model is proposed to describe the frequency response of the devices to liquid loading. Moreover, design rules are given for further optimization and sensitivity enhancement.

Gender Differences in the Use and Effectiveness of Personal Response Devices

ERIC Educational Resources Information Center

King, Daniel B.; Joshi, Shivani

2008-01-01

The use of personal response devices (or "clickers") in the classroom has increased in recent years. While few quantitative studies on the effectiveness of clickers have been published, it is generally reported that clickers have been well-received by the students who use them. Two separate populations (Winter 2006 and Spring 2006) of engineering…

Beyond "fire temperatures": calibrating thermocouple probes and modeling their response to surface fires in hardwood fuels

Treesearch

Anthony S. Bova; Matthew B. Dickinson

2008-01-01

The maximum temperatures of thermocouples, temperature-sensitive paints, and calorimeters exposed to flames in wildland fires are often called "fire temperatures" but are determined as much by the properties and deployment of the measurement devices as by the fires themselves. Rather than report device temperatures that are not generally comparable among...

21 CFR 26.76 - Confidentiality.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Confidentiality. 26.76 Section 26.76 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

A General Approach for Fluid Patterning and Application in Fabricating Microdevices.

PubMed

Huang, Zhandong; Yang, Qiang; Su, Meng; Li, Zheng; Hu, Xiaotian; Li, Yifan; Pan, Qi; Ren, Wanjie; Li, Fengyu; Song, Yanlin

2018-06-19

Engineering the fluid interface such as the gas-liquid interface is of great significance for solvent processing applications including functional material assembly, inkjet printing, and high-performance device fabrication. However, precisely controlling the fluid interface remains a great challenge owing to its flexibility and fluidity. Here, a general method to manipulate the fluid interface for fluid patterning using micropillars in the microchannel is reported. The principle of fluid patterning for immiscible fluid pairs including air, water, and oils is proposed. This understanding enables the preparation of programmable multiphase fluid patterns and assembly of multilayer functional materials to fabricate micro-optoelectronic devices. This general strategy of fluid patterning provides a promising platform to study the fundamental processes occurring on the fluid interface, and benefits applications in many subjects, such as microfluidics, microbiology, chemical analysis and detection, material synthesis and assembly, device fabrication, etc. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Efficiency limits for photoelectrochemical water-splitting

DOE PAGES

Fountaine, Katherine T.; Lewerenz, Hans Joachim; Atwater, Harry A.

2016-12-02

Theoretical limiting efficiencies have a critical role in determining technological viability and expectations for device prototypes, as evidenced by the photovoltaics community’s focus on detailed balance. However, due to their multicomponent nature, photoelectrochemical devices do not have an equivalent analogue to detailed balance, and reported theoretical efficiency limits vary depending on the assumptions made. Here we introduce a unified framework for photoelectrochemical device performance through which all previous limiting efficiencies can be understood and contextualized. Ideal and experimentally realistic limiting efficiencies are presented, and then generalized using five representative parameters—semiconductor absorption fraction, external radiative efficiency, series resistance, shunt resistance andmore » catalytic exchange current density—to account for imperfect light absorption, charge transport and catalysis. Finally, we discuss the origin of deviations between the limits discussed herein and reported water-splitting efficiencies. This analysis provides insight into the primary factors that determine device performance and a powerful handle to improve device efficiency.« less

iPhone in the Management of the Berlin Heart EXCOR Ventricular Assist Device.

PubMed

Badheka, Aditya; Allareddy, Veerajalandhar

Berlin Heart Inc. EXCOR is an extracorporeal pneumatically pulsatile ventricular assist device approved for use in pediatric age group since 2011 in the United States. It is a well-established life-saving therapy for the bridge to heart transplant or to provide circulatory support in a transplanted patient. The most commonly reported problem was "membrane defect" in a postmarketing major device reporting. In general, the filling and emptying of the pump can be easily visualized, but the interobserver variability exist. In this first novel report, we used the iPhone slow motion video to quantify and compare the differences in filling and emptying that positively impacted the management of the Berlin Heart. This is an initial exploratory concept that will need further studies to validate this bedside tool.

21 CFR 26.49 - Regulatory cooperation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory cooperation. 26.49 Section 26.49 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.21 - Safeguard clause.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Safeguard clause. 26.21 Section 26.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.18 - Regulatory collaboration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.16 - Suspension.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Suspension. 26.16 Section 26.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.77 - Fees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees. 26.77 Section 26.77 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.73 - Joint Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Joint Committee. 26.73 Section 26.73 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.60 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Definitions. 26.60 Section 26.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.79 - Territorial application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Territorial application. 26.79 Section 26.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.65 - Designating authorities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Designating authorities. 26.65 Section 26.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.3 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 26.3 Section 26.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.34 - Regulatory authorities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory authorities. 26.34 Section 26.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.64 - Transitional arrangements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Transitional arrangements. 26.64 Section 26.64 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.48 - Harmonization.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Harmonization. 26.48 Section 26.48 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.81 - Final provisions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Final provisions. 26.81 Section 26.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 803.3 - How does FDA define the terms used in this part?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How does FDA define the terms used in this part... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA..., for an estimated period of time. FDA, we, or us means the Food and Drug Administration. Five-day...

21 CFR 803.3 - How does FDA define the terms used in this part?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false How does FDA define the terms used in this part... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA..., for an estimated period of time. FDA, we, or us means the Food and Drug Administration. Five-day...

21 CFR 803.3 - How does FDA define the terms used in this part?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false How does FDA define the terms used in this part... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA..., for an estimated period of time. FDA, we, or us means the Food and Drug Administration. Five-day...

21 CFR 803.3 - How does FDA define the terms used in this part?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false How does FDA define the terms used in this part... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA..., for an estimated period of time. FDA, we, or us means the Food and Drug Administration. Five-day...

21 CFR 26.36 - Listing of CAB's.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Listing of CAB's. 26.36 Section 26.36 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.71 - Exchange of information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exchange of information. 26.71 Section 26.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.70 - Conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Conformity assessment bodies. 26.70 Section 26.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.8 - Other transition activities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Other transition activities. 26.8 Section 26.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.72 - Sectoral contact points.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Sectoral contact points. 26.72 Section 26.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

A General Method for the Chemical Synthesis of Large-Scale, Seamless Transition Metal Dichalcogenide Electronics.

PubMed

Li, Li; Guo, Yichuan; Sun, Yuping; Yang, Long; Qin, Liang; Guan, Shouliang; Wang, Jinfen; Qiu, Xiaohui; Li, Hongbian; Shang, Yuanyuan; Fang, Ying

2018-03-01

The capability to directly build atomically thin transition metal dichalcogenide (TMD) devices by chemical synthesis offers important opportunities to achieve large-scale electronics and optoelectronics with seamless interfaces. Here, a general approach for the chemical synthesis of a variety of TMD (e.g., MoS 2 , WS 2 , and MoSe 2 ) device arrays over large areas is reported. During chemical vapor deposition, semiconducting TMD channels and metallic TMD/carbon nanotube (CNT) hybrid electrodes are simultaneously formed on CNT-patterned substrate, and then coalesce into seamless devices. Chemically synthesized TMD devices exhibit attractive electrical and mechanical properties. It is demonstrated that chemically synthesized MoS 2 -MoS 2 /CNT devices have Ohmic contacts between MoS 2 /CNT hybrid electrodes and MoS 2 channels. In addition, MoS 2 -MoS 2 /CNT devices show greatly enhanced mechanical stability and photoresponsivity compared with conventional gold-contacted devices, which makes them suitable for flexible optoelectronics. Accordingly, a highly flexible pixel array based on chemically synthesized MoS 2 -MoS 2 /CNT photodetectors is applied for image sensing. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

21 CFR 26.5 - Length of transition period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Length of transition period. 26.5 Section 26.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.61 - Purpose of this part.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Purpose of this part. 26.61 Section 26.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.11 - Start of operational period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Start of operational period. 26.11 Section 26.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

Epilepsy in Adults with TSC

MedlinePlus

... brain. Devices to treat epilepsy include vagus nerve stimulation and responsive neurostimulation. Who Treats Epilepsy? A general ... Many men with epilepsy will experience changes in sexual drive and performance. For example, many men report ...

Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

PubMed

Fadlallah, Racha; Nas, Hala; Naamani, Dana; El-Jardali, Fadi; Hammoura, Ihsan; Al-Khaled, Lina; Brax, Hneine; Kahale, Lara; Akl, Elie A

2016-01-01

To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and more acceptance of surgeon-device industry interactions relative to physician-pharmaceutical industry interactions. We discuss the implications of the findings at the patient, provider, organizational, and systems level.

Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review

PubMed Central

Fadlallah, Racha; Nas, Hala; Naamani, Dana; El-Jardali, Fadi; Hammoura, Ihsan; Al-Khaled, Lina; Brax, Hneine; Kahale, Lara; Akl, Elie A.

2016-01-01

Objective To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. Methods We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Results Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians’ disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. Conclusion The awareness of participants was low for physicians’ receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and more acceptance of surgeon-device industry interactions relative to physician-pharmaceutical industry interactions. We discuss the implications of the findings at the patient, provider, organizational, and systems level. PMID:27556929

Recommendations for measuring non-image-forming effects of light: A practical method to apply on cognitive impaired and unaffected participants.

PubMed

van Duijnhoven, J; Aarts, M P J; Aries, M B C; Böhmer, M N; Rosemann, A L P

2017-01-01

The non-image-forming effects of luminous radiation on people with intellectual disabilities or dementia received attention from researchers. Such studies, however, have generally been conducted using disparate methodologies which precludes generalization and reproducibility. The aim of this study was to determine the practical applicability of measurement devices for studies investigating non-image-forming effects of luminous radiation, specifically for people with intellectual disabilities or dementia. In three experiments, ten cognitive impaired people and thirty-nine unaffected subjects participated by wearing one or more portable devices. Six devices were assessed in total. Measurement data was accompanied with user experiences obtained from questionnaires, interviews and observations in order to assess the devices on practical and comfort issues. On average, the devices worn by the cognitive impaired subjects were not experienced as annoying or irritating. No significant differences are found between genders and for one of the portable devices significantly less annoyance was reported by the cognitive impaired participants compared to the unaffected group of participants. The three phases of the research process in towards measuring personal luminous exposures are: selection of the most suitable portable device, application of the assessment method, and the application of the device in the (pilot) study. However, the findings of this study suggest that inaccuracies potentially caused by practical and comfort issues associated with the portable devices need to be considered.

Implementation of a Peltier-based cooling device for localized deep cortical deactivation during in vivo object recognition testing

NASA Astrophysics Data System (ADS)

Marra, Kyle; Graham, Brett; Carouso, Samantha; Cox, David

2012-02-01

While the application of local cortical cooling has recently become a focus of neurological research, extended localized deactivation deep within brain structures is still unexplored. Using a wirelessly controlled thermoelectric (Peltier) device and water-based heat sink, we have achieved inactivating temperatures (<20 C) at greater depths (>8 mm) than previously reported. After implanting the device into Long Evans rats' basolateral amygdala (BLA), an inhibitory brain center that controls anxiety and fear, we ran an open field test during which anxiety-driven behavioral tendencies were observed to decrease during cooling, thus confirming the device's effect on behavior. Our device will next be implanted in the rats' temporal association cortex (TeA) and recordings from our signal-tracing multichannel microelectrodes will measure and compare activated and deactivated neuronal activity so as to isolate and study the TeA signals responsible for object recognition. Having already achieved a top performing computational face-recognition system, the lab will utilize this TeA activity data to generalize its computational efforts of face recognition to achieve general object recognition.

78 FR 19510 - Privacy Act of 1974; Republication To Delete and Update Privacy Act System of Records...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

... reported under that notice. FOR FURTHER INFORMATION CONTACT: The Chief Privacy Officer, 451 Seventh Street...). (This is not a toll-free number.) A telecommunication device for hearing- and speech-impaired... of General Routine Uses inadvertently reported repeated information that HUD proposes to exclude from...

Psychiatrists’ Comfort Using Computers and Other Electronic Devices in Clinical Practice

PubMed Central

Fochtmann, Laura J.; Clarke, Diana E.; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K.; Plovnick, Robert M.

2015-01-01

This report highlights findings from the Study of Psychiatrists’ Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists’ comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted. PMID:26667248

Psychiatrists' Comfort Using Computers and Other Electronic Devices in Clinical Practice.

PubMed

Duffy, Farifteh F; Fochtmann, Laura J; Clarke, Diana E; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K; Plovnick, Robert M

2016-09-01

This report highlights findings from the Study of Psychiatrists' Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists' comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted.

The constitutionality and effectiveness of legislation requiring child passenger restraints.

DOT National Transportation Integrated Search

1982-01-01

This report was prepared in anticipation of the Virginia General Assembly's consideration of proposals to require motorists to properly restrain their child passengers in safety devices. Three questions are discussed. First, are child restraint laws ...

Guide for preparing annual reports on radiation-safety testing of electronic products (general)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

For manufacturers of electronic products other than those for which a specific guide has been issued, the guide replaces the Guide for the Filing of Annual Reports (21 CFR Subchapter J, Section 1002.11), HHS Publication FDA 82-8127. The electronic product (general) annual reporting guide is applicable to the following products: products intended to produce x radiation (accelerators, analytical devices, therapy x-ray machines); microwave diathermy machines; cold-cathode discharge tubes; and vacuum switches and tubes operating at or above 15,000 volts. To carry out its responsibilities under Public Law 90-602, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH)more » has issued a series of regulations contained in Title 21 of the Code of Federal Regulations (CFR). Part 1002 of 21 CFR deals with records and reports. Section 1002.61 categorizes electronic products into Groups A through C. Section 1002.30 requires manufacturers of products in Groups B and C to establish and maintain certain records, while Section 1002.11 requires such manufacturers to submit an Annual Report summarizing the contents of the required records. Section 1002.7 requires that reports conform to reporting guides issued by CDRH unless an acceptable justification for an alternate format is provided.« less

Silicon Nanowire-Based Devices for Gas-Phase Sensing

PubMed Central

Cao, Anping; Sudhölter, Ernst J.R.; de Smet, Louis C.P.M.

2014-01-01

Since their introduction in 2001, SiNW-based sensor devices have attracted considerable interest as a general platform for ultra-sensitive, electrical detection of biological and chemical species. Most studies focus on detecting, sensing and monitoring analytes in aqueous solution, but the number of studies on sensing gases and vapors using SiNW-based devices is increasing. This review gives an overview of selected research papers related to the application of electrical SiNW-based devices in the gas phase that have been reported over the past 10 years. Special attention is given to surface modification strategies and the sensing principles involved. In addition, future steps and technological challenges in this field are addressed. PMID:24368699

Infrastructure-Less Communication Platform for Off-The-Shelf Android Smartphones

PubMed Central

2018-01-01

As smartphones and other small portable devices become more sophisticated and popular, opportunities for communication and information sharing among such device users have increased. In particular, since it is known that infrastructure-less device-to-device (D2D) communication platforms consisting only of such devices are excellent in terms of, for example, bandwidth efficiency, efforts are being made to merge their information sharing capabilities with conventional infrastructure. However, efficient multi-hop communication is difficult with the D2D communication protocol, and many conventional D2D communication platforms require modifications of the protocol and terminal operating systems (OSs). In response to these issues, this paper reports on a proposed tree-structured D2D communication platform for Android devices that combines Wi-Fi Direct and Wi-Fi functions. The proposed platform, which is expected to be used with general Android 4.0 (or higher) OS equipped terminals, makes it possible to construct an ad hoc network instantaneously without sharing prior knowledge among participating devices. We will show the feasibility of our proposed platform through its design and demonstrate the implementation of a prototype using real devices. In addition, we will report on our investigation into communication delays and stability based on the number of hops and on terminal performance through experimental confirmation experiments. PMID:29510536

Infrastructure-Less Communication Platform for Off-The-Shelf Android Smartphones.

PubMed

Oide, Takuma; Abe, Toru; Suganuma, Takuo

2018-03-04

As smartphones and other small portable devices become more sophisticated and popular, opportunities for communication and information sharing among such device users have increased. In particular, since it is known that infrastructure-less device-to-device (D2D) communication platforms consisting only of such devices are excellent in terms of, for example, bandwidth efficiency, efforts are being made to merge their information sharing capabilities with conventional infrastructure. However, efficient multi-hop communication is difficult with the D2D communication protocol, and many conventional D2D communication platforms require modifications of the protocol and terminal operating systems (OSs). In response to these issues, this paper reports on a proposed tree-structured D2D communication platform for Android devices that combines Wi-Fi Direct and Wi-Fi functions. The proposed platform, which is expected to be used with general Android 4.0 (or higher) OS equipped terminals, makes it possible to construct an ad hoc network instantaneously without sharing prior knowledge among participating devices. We will show the feasibility of our proposed platform through its design and demonstrate the implementation of a prototype using real devices. In addition, we will report on our investigation into communication delays and stability based on the number of hops and on terminal performance through experimental confirmation experiments.

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

Preliminary study of the reliability of imaging charge coupled devices

NASA Technical Reports Server (NTRS)

Beall, J. R.; Borenstein, M. D.; Homan, R. A.; Johnson, D. L.; Wilson, D. D.; Young, V. F.

1978-01-01

Imaging CCDs are capable of low light level response and high signal-to-noise ratios. In space applications they offer the user the ability to achieve extremely high resolution imaging with minimum circuitry in the photo sensor array. This work relates the CCD121H Fairchild device to the fundamentals of CCDs and the representative technologies. Several failure modes are described, construction is analyzed and test results are reported. In addition, the relationship of the device reliability to packaging principles is analyzed and test data presented. Finally, a test program is defined for more general reliability evaluation of CCDs.

Single-Event Effect Report for EPC Series eGaN FETs: EPC1001, EPC1010, EPC1014, EPC1012

NASA Technical Reports Server (NTRS)

Scheick, Leif

2013-01-01

Heavy ion testing of newly available GaN FETs from EPC were tested in March of 2012 at TAM. The EPC1010, EPC1001, EPC1012, and EPC1014 were tested for general radiation response from gold and xenon ions. Overall the devices showed radiation degradation commensurate with breakdown in isolation oxides, and similar testing by EPC and Microsemi agrees with these data. These devices were the first generation production of the device called Gen1. Gen2 parts are scheduled for later in the third quarter of FY2012

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

How Long Can Students Pay Attention in Class? A Study of Student Attention Decline Using Clickers

ERIC Educational Resources Information Center

Bunce, Diane M.; Flens, Elizabeth A.; Neiles, Kelly Y.

2010-01-01

Students enrolled in three levels of general chemistry self-reported their attention decline during both lecture and other teaching approaches via personal response devices (clickers). Students report attention declines of 1 min or less more often than longer attention lapses. The data suggest that student engagement alternates between attention…

40 CFR 167.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...

40 CFR 167.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...

40 CFR 167.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., active ingredient, or device is produced, regardless of whether such site is independently owned or... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual...

40 CFR 167.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual..., active ingredient, or device is produced, regardless of whether such site is independently owned or...

40 CFR 167.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS General Provisions... active ingredients or gallons for liquid pesticides and active ingredients, or number of individual..., active ingredient, or device is produced, regardless of whether such site is independently owned or...

49 CFR 220.303 - General use of electronic devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would... 49 Transportation 4 2010-10-01 2010-10-01 false General use of electronic devices. 220.303 Section...

49 CFR 220.303 - General use of electronic devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false General use of electronic devices. 220.303 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would...

49 CFR 220.303 - General use of electronic devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false General use of electronic devices. 220.303 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would...

True double bifurcation lesions: new application of the self-expandable Axxess stent and review of literature with dedicated bifurcation devices.

PubMed

Borgia, Francesco; Niglio, Tullio; De Luca, Nicola; Di Serafino, Luigi; Esposito, Giovanni; Trimarco, Bruno; Cirillo, Plinio

2018-04-21

Complex coronary artery bifurcation lesions occurred in hard clinical scenarios, such as acute coronary syndromes, may represent a challenge for interventional cardiologists, with not-defined general consensus on treatment. Even if provisional stenting is the most common option used to restore rapidly the coronary branches flow, improvements in industrial technologies and design of new dedicated bifurcation devices might open new modalities of treatment in these complex cases. The Axxess stent (Biosensors Europe SA, Morges, Switzerland) is a self-expanding biolimus-eluting conical V-shape stent, specifically designed to treat "easily" coronary artery bifurcation lesions, with reported favorable long-term clinical results in stable patients compared to a provisional technique. We report for the first time the feasibility to use this device in a case of "true double coronary bifurcation lesion" occurred in the context of acute coronary syndrome. Moreover, we reviewed studies with bifurcation dedicated devices and available cases of "true double bifurcation lesions", underlying advantages/disadvantages of using one device over the others during acute coronary syndrome. Copyright © 2018 Elsevier Inc. All rights reserved.

QUS devices for assessment of osteoporosis

NASA Astrophysics Data System (ADS)

Langton, Christian

2002-05-01

The acronym QUS (Quantitative Ultrasound) is now widely used to describe ultrasound assessment of osteoporosis, a disease primarily manifested by fragility fractures of the wrist and hip along with shortening of the spine. There is currently available a plethora of commercial QUS devices, measuring various anatomic sites including the heel, finger, and tibia. Largely through commercial rather than scientific drivers, the parameters reported often differ significantly from the two fundamental parameters of velocity and attenuation. Attenuation at the heel is generally reported as BUA (broadband ultrasound attenuation, the linearly regressed increase in attenuation between 200 and 600 kHz). Velocity derivatives include bone, heel, TOF, and AdV. Further, velocity and BUA parameters may be mathematically combined to provide proprietary parameters including ``stiffness'' and ``QUI.'' In terms of clinical utility, the situation is further complicated by ultrasound being inherently dependent upon ``bone quality'' (e.g., structure) in addition to ``bone quantity'' (generally expressed as BMD, bone mineral density). Hence the BMD derived WHO criteria for osteoporosis and osteopenia may not be directly applied to QUS. There is therefore an urgent need to understand the fundamental dependence of QUS parameters, to perform calibration and cross-correlation studies of QUS devices, and to define its clinical utility.

HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES IN EUROPE: PROCESSES, PRACTICES, AND METHODS.

PubMed

Fuchs, Sabine; Olberg, Britta; Panteli, Dimitra; Busse, Reinhard

2016-01-01

To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution. Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit. Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.

Interactive lectures: Clickers or personal devices?

PubMed

Morrell, Lesley J; Joyce, Domino A

2015-01-01

Audience response systems ('clickers') are frequently used to promote participation in large lecture classes, and evidence suggests that they convey a number of benefits to students, including improved academic performance and student satisfaction. The limitations of these systems (such as limited access and cost) can be overcome using students' personal electronic devices, such as mobile phones, tablets and laptops together with text message, web- or app-based polling systems. Using questionnaires, we compare student perceptions of clicker and smartphone based polling systems. We find that students prefer interactive lectures generally, but those that used their own device preferred those lectures over lectures using clickers. However, device users were more likely to report using their devices for other purposes (checking email, social media etc.) when they were available to answer polling questions. These students did not feel that this distracted them from the lecture, instead, concerns over the use of smartphones centred around increased battery usage and inclusivity for students without access to suitable technology. Our results suggest that students generally preferred to use their own devices over clickers, and that this may be a sensible way to overcome some of the limitations associated with clickers, although issues surrounding levels of distraction and the implications for retention and recall of information need further investigation.

Interactive lectures: Clickers or personal devices?

PubMed Central

Morrell, Lesley J.; Joyce, Domino A.

2015-01-01

Audience response systems (‘clickers’) are frequently used to promote participation in large lecture classes, and evidence suggests that they convey a number of benefits to students, including improved academic performance and student satisfaction. The limitations of these systems (such as limited access and cost) can be overcome using students’ personal electronic devices, such as mobile phones, tablets and laptops together with text message, web- or app-based polling systems. Using questionnaires, we compare student perceptions of clicker and smartphone based polling systems. We find that students prefer interactive lectures generally, but those that used their own device preferred those lectures over lectures using clickers. However, device users were more likely to report using their devices for other purposes (checking email, social media etc.) when they were available to answer polling questions. These students did not feel that this distracted them from the lecture, instead, concerns over the use of smartphones centred around increased battery usage and inclusivity for students without access to suitable technology. Our results suggest that students generally preferred to use their own devices over clickers, and that this may be a sensible way to overcome some of the limitations associated with clickers, although issues surrounding levels of distraction and the implications for retention and recall of information need further investigation. PMID:26594327

Shuttle mission simulator baseline definition report, volume 2

NASA Technical Reports Server (NTRS)

Dahlberg, A. W.; Small, D. E.

1973-01-01

The baseline definition report for the space shuttle mission simulator is presented. The subjects discussed are: (1) the general configurations, (2) motion base crew station, (3) instructor operator station complex, (4) display devices, (5) electromagnetic compatibility, (6) external interface equipment, (7) data conversion equipment, (8) fixed base crew station equipment, and (9) computer complex. Block diagrams of the supporting subsystems are provided.

Attracting Attention for the Cause. The Reporting of Three Indices in the UK National Press

ERIC Educational Resources Information Center

Morse, Stephen

2011-01-01

Indicators and indices (a collection of indicators into a single value) have been promoted for some time as convenient devices for the presentation of complex datasets to a more general audience. Examples of indices are the corruption perception index (CPI), human development index (HDI) and ecological footprint (EF). The research reported in this…

Young drivers' responses to anti-speeding advertisements: Comparison of self-report and objective measures of persuasive processing and outcomes.

PubMed

Kaye, Sherrie-Anne; Lewis, Ioni; Algie, Jennifer; White, Melanie J

2016-05-18

Self-report measures are typically used to assess the effectiveness of road safety advertisements. However, psychophysiological measures of persuasive processing (i.e., skin conductance response [SCR]) and objective driving measures of persuasive outcomes (i.e., in-vehicle Global Positioning System [GPS] devices) may provide further insights into the effectiveness of these advertisements. This study aimed to explore the persuasive processing and outcomes of 2 anti-speeding advertisements by incorporating both self-report and objective measures of speeding behavior. In addition, this study aimed to compare the findings derived from these different measurement approaches. Young drivers (N = 20, M age = 21.01 years) viewed either a positive or negative emotion-based anti-speeding television advertisement. While viewing the advertisement, SCR activity was measured to assess ad-evoked arousal responses. The RoadScout GPS device was then installed in participants' vehicles for 1 week to measure on-road speed-related driving behavior. Self-report measures assessed persuasive processing (emotional and arousal responses) and actual driving behavior. There was general correspondence between the self-report measures of arousal and the SCR and between the self-report measure of actual driving behavior and the objective driving data (as assessed via the GPS devices). This study provides insights into how psychophysiological and GPS devices could be used as objective measures in conjunction with self-report measures to further understand the persuasive processes and outcomes of emotion-based anti-speeding advertisements.

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

47 CFR 18.207 - Technical report.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT... the application. (c) The full name and mailing address of the manufacturer of the device and/or applicant filing for the equipment authorization. (d) The FCC Identifier, trade name(s), and/or model number...

47 CFR 18.207 - Technical report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT... the application. (c) The full name and mailing address of the manufacturer of the device and/or applicant filing for the equipment authorization. (d) The FCC Identifier, trade name(s), and/or model number...

Evolution of general surgical problems in patients with left ventricular assist devices.

PubMed

McKellar, Stephen H; Morris, David S; Mauermann, William J; Park, Soon J; Zietlow, Scott P

2012-11-01

Left ventricular assist devices (LVADs) are increasingly used to treat patients with end-stage heart failure. These patients may develop acute noncardiac surgical problems around the time of LVAD implantation or, as survival continues to improve, chronic surgical problems as ambulatory patients remote from the LVAD implant. Previous reports of noncardiac surgical problems in LVAD patients included patients with older, first-generation devices and do not address newer, second-generation devices. We describe the frequency and management of noncardiac surgical problems encountered during LVAD support with these newer-generation devices to assist noncardiac surgeons involved in the care of patients with LVADs. We retrospectively reviewed the medical records of consecutive patients receiving LVADs at our institution. We collected data for any consultation by noncardiac surgeons within the scope of general surgery during LVAD support and subsequent treatment. Ninety-nine patients received implantable LVADs between 2003 and 2009 (first-generation, n = 19; second-generation, n = 80). Excluding intestinal hemorrhage, general surgical opinions were rendered for 34 patients with 49 problems, mostly in the acute recovery phase after LVAD implantation. Of those, 27 patients underwent 28 operations. Respiratory failure and intra-abdominal pathologies were the most common problems addressed, and LVAD rarely precluded operation. Patients with second-generation LVADs were more likely to survive hospitalization (P = .04) and develop chronic, rather than emergent, surgical problems. Patients with LVADs frequently require consultation from noncardiac surgeons within the scope of general surgeons and often require operation. Patients with second-generation LVADs are more likely to become outpatients and develop more elective surgical problems. Noncardiac surgeons will be increasingly involved in caring for patients with LVADs and should anticipate the problems unique to this patient population. Copyright © 2012 Mosby, Inc. All rights reserved.

A diagnostic expert system for aircraft generator control unit (GCU)

NASA Astrophysics Data System (ADS)

Ho, Ting-Long; Bayles, Robert A.; Havlicsek, Bruce L.

The modular VSCF (variable-speed constant-frequency) generator families are described as using standard modules to reduce the maintenance cost and to improve the product's testability. A general diagnostic expert system shell that guides troubleshooting of modules or line replaceable units (LRUs) is introduced. An application of the diagnostic system to a particular LRU, the generator control unit (GCU) is reported. The approach to building the diagnostic expert system is first to capture general diagnostic strategy in an expert system shell. This shell can be easily applied to different devices or LRUs by writing rules to capture only additional device-specific diagnostic information from expert repair personnel. The diagnostic system has the necessary knowledge embedded in its programs and exhibits expertise to troubleshoot the GCU.

Light-Stimulated Synaptic Devices Utilizing Interfacial Effect of Organic Field-Effect Transistors.

PubMed

Dai, Shilei; Wu, Xiaohan; Liu, Dapeng; Chu, Yingli; Wang, Kai; Yang, Ben; Huang, Jia

2018-06-14

Synaptic transistors stimulated by light waves or photons may offer advantages to the devices, such as wide bandwidth, ultrafast signal transmission, and robustness. However, previously reported light-stimulated synaptic devices generally require special photoelectric properties from the semiconductors and sophisticated device's architectures. In this work, a simple and effective strategy for fabricating light-stimulated synaptic transistors is provided by utilizing interface charge trapping effect of organic field-effect transistors (OFETs). Significantly, our devices exhibited highly synapselike behaviors, such as excitatory postsynaptic current (EPSC) and pair-pulse facilitation (PPF), and presented memory and learning ability. The EPSC decay, PPF curves, and forgetting behavior can be well expressed by mathematical equations for synaptic devices, indicating that interfacial charge trapping effect of OFETs can be utilized as a reliable strategy to realize organic light-stimulated synapses. Therefore, this work provides a simple and effective strategy for fabricating light-stimulated synaptic transistors with both memory and learning ability, which enlightens a new direction for developing neuromorphic devices.

Study of the properties of new SPM detectors

NASA Astrophysics Data System (ADS)

Stewart, A. G.; Greene-O'Sullivan, E.; Herbert, D. J.; Saveliev, V.; Quinlan, F.; Wall, L.; Hughes, P. J.; Mathewson, A.; Jackson, J. C.

2006-02-01

The operation and performance of multi-pixel, Geiger-mode APD structures referred to as Silicon Photomultiplier (SPM) are reported. The SPM is a solid state device that has emerged over the last decade as a promising alternative to vacuum PMTs. This is due to their comparable performance in addition to their lower bias operation and power consumption, insensitivity to magnetic fields and ambient light, smaller size and ruggedness. Applications for these detectors are numerous and include life sciences, nuclear medicine, particle physics, microscopy and general instrumentation. With SPM devices, many geometrical and device parameters can be adjusted to optimize their performance for a particular application. In this paper, Monte Carlo simulations and experimental results for 1mm2 SPM structures are reported. In addition, trade-offs involved in optimizing the SPM in terms of the number and size of pixels for a given light intensity, and its affect on the dynamic range are discussed.

Electronic medical devices: a primer for pathologists.

PubMed

Weitzman, James B

2003-07-01

Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.

A general strategy for hybrid thin film fabrication and transfer onto arbitrary substrates.

PubMed

Zhang, Yong; Magan, John J; Blau, Werner J

2014-04-28

The development of thin film-based structures/devices often requires thin films to be transferred onto arbitrary substrates/surfaces. Controllable and non-destructive transfer method, although highly desired, remains quite challenging. Here we report a general method for fabrication and transfer of hybrid (ultra)thin films. The proposed solution-based in-situ transfer method shows not only its robust ability for thin film transfer onto arbitrary substrates but also its highly controlled and non-destructive characteristic. With a hole structure as the support, fully-stretched free-standing thin film is prepared. The successful transfer to a curved surface demonstrates the possibility for production of thin film-coated complex optical components. Ultrathin (35 nm) hybrid film transferred onto PET (50 μm thick) shows high transparency (>90% in visible range), conductivity (1.54 × 10(4) S/m), and flexibility (radius of curvature down to mm scale). The reported transfer method would provide a powerful route towards complex thin film-based structures/devices.

A General Strategy for Hybrid Thin Film Fabrication and Transfer onto Arbitrary Substrates

PubMed Central

Zhang, Yong; Magan, John J.; Blau, Werner J.

2014-01-01

The development of thin film-based structures/devices often requires thin films to be transferred onto arbitrary substrates/surfaces. Controllable and non-destructive transfer method, although highly desired, remains quite challenging. Here we report a general method for fabrication and transfer of hybrid (ultra)thin films. The proposed solution-based in-situ transfer method shows not only its robust ability for thin film transfer onto arbitrary substrates but also its highly controlled and non-destructive characteristic. With a hole structure as the support, fully-stretched free-standing thin film is prepared. The successful transfer to a curved surface demonstrates the possibility for production of thin film-coated complex optical components. Ultrathin (35 nm) hybrid film transferred onto PET (50 μm thick) shows high transparency (>90% in visible range), conductivity (1.54 × 104 S/m), and flexibility (radius of curvature down to mm scale). The reported transfer method would provide a powerful route towards complex thin film-based structures/devices. PMID:24769689

Novel Sternal Protection Device for Cardiac Surgery Via Median Sternotomy Incision

PubMed Central

Marasco, Silvana F.; McGiffin, David C.; Zimmet, Adam D.; Solis, Pablo C.; Bingham, Judy M.; Moshinsky, Randall A.

2017-01-01

Objective Sternal bleeding during cardiac surgery is currently controlled using bone wax or other chemical substances that may result in adverse effects and affect wound healing and recovery. The purpose of this study was to identify a safe, cost-effective, and easy-to-use technique to reduce sternal bleeding and sternal trauma during cardiac surgery. Methods After sternotomy, a sternal protection device was placed over each hemisternal section before insertion of the retractor and remained in situ until the end of surgery. Sternal bleeding and ease of use were assessed and recorded during surgery. Sternal trauma was assessed and recorded within 5 minutes of removal of the device, and overall satisfaction (Global Impression) and any intraoperative adverse events or device malfunction were reported at surgery completion. Patients were followed up 24 hours and 4 weeks after surgery. Results Twelve patients completed the study. Adverse events reported were not considered related to the device. No sternal trauma was identified in any patient. In 9 of 11 patients, sternal bleeding was reduced after insertion of the device. The device was generally considered easy to use, although some difficulty was encountered when used with the Internal Mammary Artery retractor. Conclusions Our data suggest that the device is safe and able to reduce sternal bleeding during surgery using sternal retractors. We recommend further studies in a larger population of patients with a control group to evaluate the device's ability to reduce the morbidity associated with sternal bleeding and sternal trauma. PMID:29023352

Novel Sternal Protection Device for Cardiac Surgery Via Median Sternotomy Incision.

PubMed

Marasco, Silvana F; McGiffin, David C; Zimmet, Adam D; Solis, Pablo C; Bingham, Judy M; Moshinsky, Randall A

Sternal bleeding during cardiac surgery is currently controlled using bone wax or other chemical substances that may result in adverse effects and affect wound healing and recovery. The purpose of this study was to identify a safe, cost-effective, and easy-to-use technique to reduce sternal bleeding and sternal trauma during cardiac surgery. After sternotomy, a sternal protection device was placed over each hemisternal section before insertion of the retractor and remained in situ until the end of surgery. Sternal bleeding and ease of use were assessed and recorded during surgery. Sternal trauma was assessed and recorded within 5 minutes of removal of the device, and overall satisfaction (Global Impression) and any intraoperative adverse events or device malfunction were reported at surgery completion. Patients were followed up 24 hours and 4 weeks after surgery. Twelve patients completed the study. Adverse events reported were not considered related to the device. No sternal trauma was identified in any patient. In 9 of 11 patients, sternal bleeding was reduced after insertion of the device. The device was generally considered easy to use, although some difficulty was encountered when used with the Internal Mammary Artery retractor. Our data suggest that the device is safe and able to reduce sternal bleeding during surgery using sternal retractors. We recommend further studies in a larger population of patients with a control group to evaluate the device's ability to reduce the morbidity associated with sternal bleeding and sternal trauma.

First-principles quantum transport method for disordered nanoelectronics: Disorder-averaged transmission, shot noise, and device-to-device variability

NASA Astrophysics Data System (ADS)

Yan, Jiawei; Wang, Shizhuo; Xia, Ke; Ke, Youqi

2017-03-01

Because disorders are inevitable in realistic nanodevices, the capability to quantitatively simulate the disorder effects on electron transport is indispensable for quantum transport theory. Here, we report a unified and effective first-principles quantum transport method for analyzing effects of chemical or substitutional disorder on transport properties of nanoelectronics, including averaged transmission coefficient, shot noise, and disorder-induced device-to-device variability. All our theoretical formulations and numerical implementations are worked out within the framework of the tight-binding linear muffin tin orbital method. In this method, we carry out the electronic structure calculation with the density functional theory, treat the nonequilibrium statistics by the nonequilbrium Green's function method, and include the effects of multiple impurity scattering with the generalized nonequilibrium vertex correction (NVC) method in coherent potential approximation (CPA). The generalized NVC equations are solved from first principles to obtain various disorder-averaged two-Green's-function correlators. This method provides a unified way to obtain different disorder-averaged transport properties of disordered nanoelectronics from first principles. To test our implementation, we apply the method to investigate the shot noise in the disordered copper conductor, and find all our results for different disorder concentrations approach a universal Fano factor 1 /3 . As the second test, we calculate the device-to-device variability in the spin-dependent transport through the disordered Cu/Co interface and find the conductance fluctuation is very large in the minority spin channel and negligible in the majority spin channel. Our results agree well with experimental measurements and other theories. In both applications, we show the generalized nonequilibrium vertex corrections play a determinant role in electron transport simulation. Our results demonstrate the effectiveness of the first-principles generalized CPA-NVC for atomistic analysis of disordered nanoelectronics, extending the capability of quantum transport simulation.

Review on microfluidic paper-based analytical devices towards commercialisation.

PubMed

Akyazi, Tugce; Basabe-Desmonts, Lourdes; Benito-Lopez, Fernando

2018-02-25

Paper-based analytical devices introduce an innovative platform technology for fluid handling and analysis, with wide range of applications, promoting low cost, ease of fabrication/operation and equipment independence. This review gives a general overview on the fabrication techniques reported to date, revealing and discussing their weak points as well as the newest approaches in order to overtake current mass production limitations and therefore commercialisation. Moreover, this review aims especially to highlight novel technologies appearing in literature for the effective handling and controlling of fluids. The lack of flow control is the main problem of paper-based analytical devices, which generates obstacles for marketing and slows down the transition of paper devices from the laboratory into the consumers' hands. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 26.7 - Participation in the equivalence assessment and determination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... determination. 26.7 Section 26.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.7...

A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility.

PubMed

Pavelec, Vaclav; Rotenberg, Brian W; Maurer, Joachim T; Gillis, Edward; Verse, Thomas

2016-01-01

Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans. A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period. Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report. Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.

[Development of a massage device based on microcontroller in the field of alimentary tract].

PubMed

Huang, Rong; Peng, Chenglin; He, Hongmei; Zhu, Jing

2007-12-01

In this artical is first reported a survey of the progress in research of MEMS technology. Then, the basic structure, features and the principles of a massage device based on microcontroller in the field of alimentary tract are introduced. Special emphasis is laid on the utilization of MSP430F123 microprocessor for producing a kind of period pulse to control the power of massage capsule. In general, the research and development of the massage device in the field of alimentary tract have active support and deep significance to therapy in the clinical and business settings as well as in the development of biomedical engineering and MEMS.

Equal Telecommunications Access for Deaf and Hard of Hearing Virginians (TDD/Message Relay Programs). Report to the Governor and the General Assembly of Virginia. House Document No. 9.

ERIC Educational Resources Information Center

Virginia State Dept. for the Deaf and Hard of Hearing, Richmond.

The report addresses issues of telecommunications access for hearing and speech impaired persons in Virginia. Six analyses were performed: (1) Accessibility of service organizations--over 89% of sample organizations were not accessible by a telecommunications device for the deaf and existing TDDs were underutilized; (2) Telephone use by persons…

Electrochemical energy storage devices for wearable technology: a rationale for materials selection and cell design.

PubMed

Sumboja, Afriyanti; Liu, Jiawei; Zheng, Wesley Guangyuan; Zong, Yun; Zhang, Hua; Liu, Zhaolin

2018-06-27

Compatible energy storage devices that are able to withstand various mechanical deformations, while delivering their intended functions, are required in wearable technologies. This imposes constraints on the structural designs, materials selection, and miniaturization of the cells. To date, extensive efforts have been dedicated towards developing electrochemical energy storage devices for wearables, with a focus on incorporation of shape-conformable materials into mechanically robust designs that can be worn on the human body. In this review, we highlight the quantified performances of reported wearable electrochemical energy storage devices, as well as their micro-sized counterparts under specific mechanical deformations, which can be used as the benchmark for future studies in this field. A general introduction to the wearable technology, the development of the selection and synthesis of active materials, cell design approaches and device fabrications are discussed. It is followed by challenges and outlook toward the practical use of electrochemical energy storage devices for wearable applications.

21 CFR 878.4800 - Manual surgical instrument for general use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual surgical instrument for general use. 878.4800 Section 878.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4800 Manual surgical instrument for general use. (a)...

10 CFR 31.10 - General license for strontium 90 in ice detection devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

10 CFR 31.10 - General license for strontium 90 in ice detection devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

10 CFR 31.10 - General license for strontium 90 in ice detection devices.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

10 CFR 31.10 - General license for strontium 90 in ice detection devices.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

10 CFR 31.10 - General license for strontium 90 in ice detection devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false General license for strontium 90 in ice detection devices... MATERIAL § 31.10 General license for strontium 90 in ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection...

Performance comparison of the MOXY and PortaMon near-infrared spectroscopy muscle oximeters at rest and during exercise

NASA Astrophysics Data System (ADS)

McManus, Chris J.; Collison, Jay; Cooper, Chris E.

2018-01-01

The purpose of the study was to compare muscle oxygenation as measured by two portable, wireless near-infrared spectroscopy (NIRS) devices under resting and dynamic conditions. A recently developed low-cost NIRS device (MOXY) was compared against an established PortaMon system that makes use of the spatially resolved spectroscopy algorithm. The influence of increasing external pressure on tissue oxygen saturation index (TSI) indicated that both devices are stable between 2 and 20 mmHg. However, above this pressure, MOXY reports declining TSI values. Analysis of adipose tissue thickness (ATT) and TSI shows a significant, nonlinear difference between devices at rest. The devices report similar TSI (%) values at a low ATT (<7 mm) (PortaMon minus MOXY difference is +1.1±2.8%) with the major subsequent change between the devices occurring between 7 and 10 mm at ATT values >10 mm the difference remains constant (-14.7±2.8%). The most likely explanation for this difference is the small source-detector separation (2.5 cm) in the MOXY resulting in lower tissue penetration into muscle in subjects with higher ATT. Interday test-retest reliability of resting TSI was evaluated on five separate occasions, with the PortaMon reporting a lower coefficient of variation (1.8% to 2.5% versus 5.7% to 6.2%). In studies on male subjects with low ATT, decreases in the TSI were strongly correlated during isometric exercise, arterial occlusion, and incremental arm crank exercise. However, the MOXY reports a greater dynamic range, particularly during ischemia induced by isometric contraction or occlusion (Δ74.3% versus Δ43.7% hyperemia MAX-occlusion MIN). This study shows that in this subject group both MOXY and PortaMon produce physiologically credible TSI measures during rest and exercise. However, the absolute values obtained during exercise are generally not comparable between devices unless corrected by physiological calibration following an arterial occlusion.

Contact engineering for efficient charge injection in organic transistors with low-cost metal electrodes

NASA Astrophysics Data System (ADS)

Panigrahi, D.; Kumar, S.; Dhar, A.

2017-10-01

Controlling charge injection at the metal-semiconductor interface is very crucial for organic electronic devices in general as it can significantly influence the overall device performance. Herein, we report a facile, yet efficient contact modification approach, to enhance the hole injection efficiency through the incorporation of a high vacuum deposited TPD [N,N'-Bis(3-methylphenyl)-N,N'-diphenylbenzidine] interlayer between the electrodes and the active semiconducting layer. The device performance parameters such as mobility and on/off ratio improved significantly after the inclusion of the TPD buffer layer, and more interestingly, the devices with cost effective Ag and Cu electrodes were able to exhibit a superior device performance than the typically used Au source-drain devices. We have also observed that this contact modification technique can be even more effective than commonly used metal oxide interface modifying layers. Our investigations demonstrate the efficacy of the TPD interlayer in effectively reducing the interfacial contact resistance through the modification of pentacene energy levels, which consequently results in the substantial improvement in the device performances.

47 CFR 2.801 - Radiofrequency device defined.

Code of Federal Regulations, 2011 CFR

2011-10-01

....801 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES AND REGULATIONS Marketing of Radio-frequency Devices § 2.801 Radiofrequency device..., but are not limited to: (a) The various types of radio communication transmitting devices described...

Use of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum: an integrative review.

PubMed

Strandell-Laine, Camilla; Stolt, Minna; Leino-Kilpi, Helena; Saarikoski, Mikko

2015-03-01

To identify and appraise study findings on the use of mobile devices, in particular for what purposes and how, in nursing student-nurse teacher cooperation during the clinical practicum. A systematic literature search was conducted using the PubMed/Medline, CINAHL, PsycINFO and ERIC for primary empirical studies published in English. An integrative literature review was undertaken. Quality appraisal of the included studies was conducted using design-specific standardized checklists. Studies were thematically analyzed. Based on the inclusion and exclusion criteria, eleven studies were included in the review. Weaknesses in designs, samples, questionnaires and results, compromised comparison and/or generalization of the findings of the studies. Three main themes were identified: (1) features of mobile devices (2) utility of mobile devices and (3) barriers to the use of mobile devices. Problems of connectivity were the main challenges reported in the use of mobile devices. Participants used mobile devices primarily as reference tools, but less frequently as tools for reflection, assessment or cooperation during the clinical practicum. Interest in mobile device use during the clinical practicum was reported, but training and ongoing support are needed. As only a small number of eligible primary empirical studies were found, it is not possible to draw firm conclusions on the results. In the future, rigorous primary empirical studies are needed to explore the potential of mobile devices in providing a supplementary pedagogical method in nursing student-nurse teacher cooperation during the clinical practicum. Robust study designs, including experimental ones, are clearly needed to assess the effectiveness of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum. Copyright © 2014 Elsevier Ltd. All rights reserved.

21 CFR 880.2460 - Electrically powered spinal fluid pressure monitor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and... electrical signal. The device includes signal amplification, conditioning, and display equipment. (b...

21 CFR 880.2460 - Electrically powered spinal fluid pressure monitor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and... electrical signal. The device includes signal amplification, conditioning, and display equipment. (b...

21 CFR 880.2460 - Electrically powered spinal fluid pressure monitor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and... electrical signal. The device includes signal amplification, conditioning, and display equipment. (b...

Retrievable Inferior vena cava filters in pregnancy: Risk versus benefit?

PubMed

Crosby, David A; Ryan, Kevin; McEniff, Niall; Dicker, Patrick; Regan, Carmen; Lynch, Caoimhe; Byrne, Bridgette

2018-03-01

Venous thromboembolism remains one of the leading causes of maternal mortality in the developed world. Retrievable inferior vena cava (IVC) filters have a role in the prevention of lethal pulmonary emboli when anticoagulation is contraindicated or has failed [1]. It is unclear whether or not the physiological changes in pregnancy influence efficacy and complications of these devices. The decision to place an IVC filter in pregnancy is complex and there is limited information in terms of benefit and risk to the mother. The objective of this study was to determine the efficacy and safety of these devices in pregnancy and to compare these with rates reported in the general population. The aim of this study was report three recent cases of retrievable IVC filter use in pregnant women in our department and to perform a systematic review of the literature to identify published cases of filters in pregnancy. The efficacy and complication rates of these devices in pregnancy were estimated and compared to rates reported in the general population in a recent review [2]. Fisher's exact test was used for statistical analysis. In addition to our three cases, 16 publications were identified with retrievable IVC filter use in 40 pregnant women resulting in a total of 43 cases. There was no pulmonary embolus in the pregnant group (0/43) compared to 57/6291 (0.9%) in the general population. Thrombosis of the filter (2.3% vs. 0.9%, p = 0.33) and perforation of the IVC (7.0% vs 4.4%, p = 0.44) were more common in pregnancy compared to the general population but the difference was not statistically significant. Failure to retrieve the filter is more likely to occur in pregnancy (26% vs. 11%, p = 0.006) but this did not correlate with the type of device (p = 0.61), duration of insertion (p = 0.58) or mode of delivery (p = 0.37). Data for retrievable IVC filters in pregnancy is limited and there may be a publication bias towards complicated cases. This study shows that the filter appears to protect against PE in pregnancy but the numbers are small. Complications such as filter thrombosis and IVC penetration appear to be higher in pregnancy but this difference is not statistically significant. It is not possible to retrieve the device in one out of every four pregnant women. This has implications in terms of long term risk of lower limb thrombosis and post thrombotic syndrome. The decision to use an IVC filter in pregnancy needs careful consideration by a multidisciplinary team. The benefit and risk assessment should be individualised and clearly outlined to the patient. Copyright © 2017 Elsevier B.V. All rights reserved.

An ingested mobile phone in the stomach may not be amenable to safe endoscopic removal using current therapeutic devices: A case report.

PubMed

Obinwa, Obinna; Cooper, David; O'Riordan, James M

2016-01-01

This case report is intended to inform clinicians, endoscopists, policy makers and industry of our experience in the management of a rare case of mobile phone ingestion. A 29-year-old prisoner presented to the Emergency Department with vomiting, ten hours after he claimed to have swallowed a mobile phone. Clinical examination was unremarkable. Both initial and repeat abdominal radiographs eight hours later confirmed that the foreign body remained in situ in the stomach and had not progressed along the gastrointestinal tract. Based on these findings, upper endoscopy was performed under general anaesthesia. The object could not be aligned correctly to accommodate endoscopic removal using current retrieval devices. Following unsuccessful endoscopy, an upper midline laparotomy was performed and the phone was delivered through an anterior gastrotomy, away from the pylorus. The patient made an uneventful recovery and underwent psychological counselling prior to discharge. In this case report, the use of endoscopy in the management when a conservative approach fails is questioned. Can the current endoscopic retrieval devices be improved to limit the need for surgical interventions in future cases? An ingested mobile phone in the stomach may not be amenable for removal using the current endoscopic retrieval devices. Improvements in overtubes or additional modifications of existing retrieval devices to ensure adequate alignment for removal without injuring the oesophagus are needed. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Liquid crystal cells with built-in CdSe nanotubes for chromogenic smart emission devices.

PubMed

Lin, Tsung Ju; Chen, Chin-Chang; Cheng, Soofin; Chen, Yang Fang

2008-01-21

A simple and general approach for controlling optical anisotropy of nanostructured semiconductors is reported. Our design involves the fabrication of liquid crystal devices with built-in semiconductor nanotubes. Quite interestingly, it is found that semiconductor nanotubes can be well aligned along the orientation of liquid crystals molecules automatically, resulting in a very large emission anisotropy with the degree of polarization up to 72%. This intriguing result manifests a way to obtain well aligned semiconductor nanotubes and the emission anisotropy can be easily manipulated by an external bias. The ability to well control the emission anisotropy should open up new opportunities for nanostructured semiconductors, including optical filters, polarized light emitting diodes, flat panel displays, and many other chromogenic smart devices.

21 CFR 880.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HOSPITAL AND PERSONAL USE DEVICES General Provisions § 880.1 Scope. (a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial... duplicative listings, a general hospital and personal use device that has two or more types of uses (e.g...

21 CFR 878.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...

21 CFR 878.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...

21 CFR 878.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...

21 CFR 878.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...

21 CFR 878.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...

Do You Hear Me? Information for Persons with a Hearing Impairment.

ERIC Educational Resources Information Center

Brook, Emily

1990-01-01

This compendium of general information for individuals with hearing impairments reports on: the incidence of hearing impairments; methods of communication between hearing and nonhearing persons (fingerspelling, lip reading, cued speech, signing, and telephone devices); 13 titles of books and tapes available; 4 sources of hearing ear dogs; 42…

Prospects and Challenges for Using Microcomputers in School. Technical Report No. 7.

ERIC Educational Resources Information Center

Pea, Roy D.

Prepared as an address for educator groups, this paper provides a theoretical perspective for thinking about problems and prospects for integrating microcomputer uses in school activities. Six major aspects of the perspective are defined: (1) the computer as general-purpose symbolic device; (2) the importance of developmental studies of children's…

List processing software for the LeCroy 1821 Segment Manager Interface

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dorries, T.; Moore, C.; Pordes, R.

1987-05-01

Many experiments at Fermilab now include some FASTBUS electronics in their data readout. The software reported in this paper provides general support for the LeCroy 1821 interface. The list processing device drivers allow FASTBUS data to be read out efficiently into the Fermilab Computing Department supported data acquisition systems.

21 CFR 880.6025 - Absorbent tipped applicator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... stick. The device is used to apply medications to, or to take specimens from, a patient. (b...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6025 Absorbent tipped applicator. (a) Identification. An absorbent tipped applicator is a...

Doctors' experience with handheld computers in clinical practice: qualitative study.

PubMed

McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

2004-05-15

To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. 54 doctors who did or did not use handheld computers. Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care.

Predicate calculus for an architecture of multiple neural networks

NASA Astrophysics Data System (ADS)

Consoli, Robert H.

1990-08-01

Future projects with neural networks will require multiple individual network components. Current efforts along these lines are ad hoc. This paper relates the neural network to a classical device and derives a multi-part architecture from that model. Further it provides a Predicate Calculus variant for describing the location and nature of the trainings and suggests Resolution Refutation as a method for determining the performance of the system as well as the location of needed trainings for specific proofs. 2. THE NEURAL NETWORK AND A CLASSICAL DEVICE Recently investigators have been making reports about architectures of multiple neural networksL234. These efforts are appearing at an early stage in neural network investigations they are characterized by architectures suggested directly by the problem space. Touretzky and Hinton suggest an architecture for processing logical statements1 the design of this architecture arises from the syntax of a restricted class of logical expressions and exhibits syntactic limitations. In similar fashion a multiple neural netword arises out of a control problem2 from the sequence learning problem3 and from the domain of machine learning. 4 But a general theory of multiple neural devices is missing. More general attempts to relate single or multiple neural networks to classical computing devices are not common although an attempt is made to relate single neural devices to a Turing machines and Sun et a!. develop a multiple neural architecture that performs pattern classification.

21 CFR 880.6060 - Medical disposable bedding.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical disposable bedding. 880.6060 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6060 Medical disposable bedding. (a) Identification. Medical disposable bedding is a device...

21 CFR 880.6060 - Medical disposable bedding.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical disposable bedding. 880.6060 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6060 Medical disposable bedding. (a) Identification. Medical disposable bedding is a device...

21 CFR 880.6775 - Powered patient transfer device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use... band stretched over long rollers that can advance itself under a patient and transfer the patient with...

21 CFR 878.4800 - Manual surgical instrument for general use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual surgical instrument for general use. 878.4800 Section 878.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4800 Manual...

21 CFR 878.4800 - Manual surgical instrument for general use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual surgical instrument for general use. 878.4800 Section 878.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4800 Manual...

21 CFR 878.4800 - Manual surgical instrument for general use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual surgical instrument for general use. 878.4800 Section 878.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4800 Manual...

21 CFR 878.4800 - Manual surgical instrument for general use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual surgical instrument for general use. 878.4800 Section 878.4800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4800 Manual...

An assessment of memristor intrinsic fluctuations: a measurement of single atomic motion

NASA Astrophysics Data System (ADS)

Borghetti, Julien; Yang, J. Joshua; Medeiros-Ribeiro, Gilberto; Williams, R. Stanley

2010-03-01

Memristors provides electrically tunable resistance for upcoming non-volatile memory and future neuromorphic computing. One of the key benefits of such a device is its scalability, which can be demonstrated from an architectural perspective as well as from a fundamental physics limit. 4D addressing schemes utilizing cross bar structures that can be stacked several layers high above the chip embodies unlimited addressing space. On the other limit, the basic operating principles of memristive devices allow one to reach storage of information in a single atom. In this report of nanoscale (sub 50nm) devices, we detect single atom fluctuations, which would then represent the ultimate limit for noise sources thus delineating the boundary conditions for circuit design. We show that electrically induced individual atom migrations do not affect the overall device atomic configuration until a critical bias where a single local fluctuation triggers a general atomic reconfiguration. This instability illustrates the robustness of the device non-volatility upon small electrical stress.

Program for the exploitation of unused NASA patents

NASA Technical Reports Server (NTRS)

Fay, R. J.

1972-01-01

The program to exploit unused NASA patents through the use of a multidisciplinary approach involving faculty students, and research staff is reported. NASA patents were screened for their applicability outside the space program, specific applications were identified, and the technical and commercial feasibility of these applications was established. Also application of this technology by governmental agencies outside the space program was sought. The program was specifically interested in energy absorbing devices such as those developed for lunar soft landings. These energy absorbing devices absorb large amounts of mechanical energy but are, in general, not reusable. Some of these devices can also operate as structural elements until their structural load capacity is exceeded and they become activated as energy absorbers. The capability of these devices to operate as structural elements and as energy absorbing devices makes them candidates for many applications in the fields of transportation and materials handling safety where accidents take a large toll in human injury and property damage.

Plastic-Syringe Induced Silicone Contamination in Organic Photvoltaic Fabrication: Implications for Small-Volume Additives

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carr, John A.; Nalwa, Kanwar S.; Mahadevapuram, Rakesh

Herein, the implications of silicone contamination found in solution-processed conjugated polymer solar cells are explored. Similar to a previous work based on molecular cells, we find this contamination as a result of the use of plastic syringes during fabrication. However, in contrast to the molecular case, we find that glass-syringe fabricated devices give superior performance than plastic-syringe fabricated devices in poly(3-hexylthiophene)-based cells. We find that the unintentional silicone addition alters the solution’s wettability, which translates to a thinner, less absorbent film on spinning. With many groups studying the effects of small-volume additives, this work should be closely considered as manymore » of these additives may also directly alter the solutions’ wettability, or the amount of silicone dissolved off the plastic syringes, or both. Thereby, film thickness, which generally is not reported in detail, can vary significantly from device to device.« less

Electromyography tests in patients with implanted cardiac devices are safe regardless of magnet placement.

PubMed

Ohira, Masayuki; Silcox, Jade; Haygood, Deavin; Harper-King, Valerie; Alsharabati, Mohammad; Lu, Liang; Morgan, Marla B; Young, Angela M; Claussen, Gwen C; King, Peter H; Oh, Shin J

2013-01-01

We compared the problems or complications associated with electrodiagnostic testing in 77 patients with implanted cardiac devices. Thirty tests were performed after magnet placement, and 47 were performed without magnet application. All electrodiagnostic tests were performed safely in all patients without any serious effect on the implanted cardiac devices with or without magnet placement. A significantly higher number of patient symptoms and procedure changes were reported in the magnet group (P < 0.013). No statistical difference was found in the testing difficulty or ECG changes. The magnet group patients had an approximately 11-fold greater risk of symptoms than those in the control group. Our data do not support a recommendation that magnet placement is necessary for routine electrodiagnostic testing in patients with implanted cardiac devices, as long as our general and specific guidelines are followed. Copyright © 2012 Wiley Periodicals, Inc.

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical absorbent fiber. 880.5300 Section 880.5300...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5300 Medical absorbent fiber. (a) Identification. A medical absorbent fiber is a device...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical absorbent fiber. 880.5300 Section 880.5300...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5300 Medical absorbent fiber. (a) Identification. A medical absorbent fiber is a device...

Thermoplastic nanofluidic devices for biomedical applications.

PubMed

Weerakoon-Ratnayake, Kumuditha M; O'Neil, Colleen E; Uba, Franklin I; Soper, Steven A

2017-01-31

Microfluidics is now moving into a developmental stage where basic discoveries are being transitioned into the commercial sector so that these discoveries can affect, for example, healthcare. Thus, high production rate microfabrication technologies, such as thermal embossing and/or injection molding, are being used to produce low-cost consumables appropriate for commercial applications. Based on recent reports, it is clear that nanofluidics offers some attractive process capabilities that may provide unique venues for biomolecular analyses that cannot be realized at the microscale. Thus, it would be attractive to consider early in the developmental cycle of nanofluidics production pipelines that can generate devices possessing sub-150 nm dimensions in a high production mode and at low-cost to accommodate the commercialization of this exciting technology. Recently, functional sub-150 nm thermoplastic nanofluidic devices have been reported that can provide high process yield rates, which can enable commercial translation of nanofluidics. This review presents an overview of recent advancements in the fabrication, assembly, surface modification and the characterization of thermoplastic nanofluidic devices. Also, several examples in which nanoscale phenomena have been exploited for the analysis of biomolecules are highlighted. Lastly, some general conclusions and future outlooks are presented.

Improved low-level radioactive waste management practices for hospitals and research institutions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1983-07-01

This report provides a general overview and a compendium of source material on low-level radioactive waste management practices in the institutional sector. Institutional sector refers to hospitals, universities, clinics, and research facilities that use radioactive materials in scientific research and the practice of medicine, and the manufacturers of radiopharmaceuticals and radiography devices. This report provides information on effective waste management practices for institutional waste to state policymakers, regulatory agency officials, and waste generators. It is not intended to be a handbook for actual waste management, but rather a sourcebook of general information, as well as a survey of the moremore » detailed analysis.« less

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2013 CFR

2013-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2012 CFR

2012-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2014 CFR

2014-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2011 CFR

2011-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2010 CFR

2010-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

30 CFR 75.1103-3 - Automatic fire sensor and warning device systems; minimum requirements; general.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic fire sensor and warning device...-UNDERGROUND COAL MINES Fire Protection § 75.1103-3 Automatic fire sensor and warning device systems; minimum requirements; general. Automatic fire sensor and warning device systems installed in belt haulageways of...

30 CFR 75.1103-3 - Automatic fire sensor and warning device systems; minimum requirements; general.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Automatic fire sensor and warning device...-UNDERGROUND COAL MINES Fire Protection § 75.1103-3 Automatic fire sensor and warning device systems; minimum requirements; general. Automatic fire sensor and warning device systems installed in belt haulageways of...

30 CFR 75.1103-3 - Automatic fire sensor and warning device systems; minimum requirements; general.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Automatic fire sensor and warning device...-UNDERGROUND COAL MINES Fire Protection § 75.1103-3 Automatic fire sensor and warning device systems; minimum requirements; general. Automatic fire sensor and warning device systems installed in belt haulageways of...

30 CFR 75.1103-3 - Automatic fire sensor and warning device systems; minimum requirements; general.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Automatic fire sensor and warning device...-UNDERGROUND COAL MINES Fire Protection § 75.1103-3 Automatic fire sensor and warning device systems; minimum requirements; general. Automatic fire sensor and warning device systems installed in belt haulageways of...

21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General... and medications and the sampling of blood. The device consists of a portal body with a resealable... device is available in various profiles and sizes and can be of a single or multiple lumen design. (b...

21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General... and medications and the sampling of blood. The device consists of a portal body with a resealable... device is available in various profiles and sizes and can be of a single or multiple lumen design. (b...

21 CFR 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General... and medications and the sampling of blood. The device consists of a portal body with a resealable... device is available in various profiles and sizes and can be of a single or multiple lumen design. (b...

21 CFR 880.6140 - Medical chair and table.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical chair and table. 880.6140 Section 880.6140...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6140 Medical chair and table. (a) Identification. A medical chair or table is a device...

10 CFR 32.61 - Ice detection devices containing strontium-90; requirements for license to manufacture or...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Ice detection devices containing strontium-90... Generally Licensed Items § 32.61 Ice detection devices containing strontium-90; requirements for license to... ice detection devices containing strontium-90 for distribution to persons generally licensed under...

10 CFR 32.61 - Ice detection devices containing strontium-90; requirements for license to manufacture or...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Ice detection devices containing strontium-90... Generally Licensed Items § 32.61 Ice detection devices containing strontium-90; requirements for license to... ice detection devices containing strontium-90 for distribution to persons generally licensed under...

10 CFR 32.61 - Ice detection devices containing strontium-90; requirements for license to manufacture or...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Ice detection devices containing strontium-90... Generally Licensed Items § 32.61 Ice detection devices containing strontium-90; requirements for license to... ice detection devices containing strontium-90 for distribution to persons generally licensed under...

10 CFR 32.61 - Ice detection devices containing strontium-90; requirements for license to manufacture or...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Ice detection devices containing strontium-90... Generally Licensed Items § 32.61 Ice detection devices containing strontium-90; requirements for license to... ice detection devices containing strontium-90 for distribution to persons generally licensed under...

Development of an Undergraduate Course in the Use of Digital Computers With Chemistry Instrumentation.

ERIC Educational Resources Information Center

Wilkins, Charles L.

Computer-assisted instruction (CAI) has proven useful in teaching chemistry instrumentation techniques to undergraduate students. The work completed at the time of this interim report has clearly shown that a general purpose laboratory computer system, equipped with suitable devices to allow direct data input from experiments, can be an effective…

77 FR 37720 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-22

... ``devices'' and/or ``UserIDs.'' \\4\\ OPRA defines a ``Subscriber,'' in general, as an entity or person that... Exchanges on an Unlisted Trading Privilege Basis'' (``Nasdaq/UTP Plan''). CTA and the Nasdaq/UTP Plan define... capacity.\\9\\ Second, because the definition of the term ``associated person'' is defined differently in the...

Proceedings of the International Conference on Sensory Devices for the Blind (London, England, June, 1966).

ERIC Educational Resources Information Center

Dufton, Richard, Ed.

The conference proceedings include papers on sensory aids for visually handicapped mobility and reading. Two papers each treat mobility as a general problem, sociocultural surveys on mobility and reading, and echolocation in man and bats. Five papers concern reports and evaluations of practical trials of the sonic monaural aid; one deals with…

The Debreather: A Report on Euthanasia and Suicide Assistance Using Adapted Scuba Technology

ERIC Educational Resources Information Center

Ogden, Russel D.

2010-01-01

In response to the general prohibition of euthanasia and assisted suicide, some right-to-die activists have developed non-medical methods to covertly hasten death. One such method is a "debreather," a closed system breathing device that laypersons can use to induce hypoxia for persons seeking euthanasia or assisted suicide. This article presents…

Transistor step stress program for JANTX2N4150

NASA Technical Reports Server (NTRS)

1979-01-01

Reliability analysis of the transistor JANTX2N4150 manufactured by General Semiconductor and Transitron is reported. The discrete devices were subjected to power and temperature step stress tests and then to electrical tests after completing the power/temperature step stress point. Control sample units were maintained for verification of the electrical parametric testing. Results are presented.

A Field Test of Electronic Telecommunication Terminals for the Deaf. Final Report, 1973-1974.

ERIC Educational Resources Information Center

Wyman, Raymond; Eachus, Todd

Telecommunications devices for the deaf were evaluated in social communications, business uses, and educational and general data systems uses. Approximately 80 TV Phones placed in the homes of deaf adults were evaluated in such areas as equipment utility and reliability, and user reaction, through collection instruments such as user questionnaires…

Electrokinetic Supercapacitor for Simultaneous Harvesting and Storage of Mechanical Energy.

PubMed

Yang, Peihua; Qu, Xiaopeng; Liu, Kang; Duan, Jiangjiang; Li, Jia; Chen, Qian; Xue, Guobin; Xie, Wenke; Xu, Zhimou; Zhou, Jun

2018-03-07

Energy harvesting and storage are two distinct processes that are generally achieved using two separated parts based on different physical and chemical principles. Here we report a self-charging electrokinetic supercapacitor that directly couples the energy harvesting and storage processes into one device. The device consists of two identical carbon nanotube/titanium electrodes, separated by a piece of anodic aluminum oxide nanochannels membrane. Pressure-driven electrolyte flow through the nanochannels generates streaming potential, which can be used to charge the capacitive electrodes, accomplishing simultaneous energy generation and storage. The device stores electric charge density of 0.4 mC cm -2 after fully charging under pressure of 2.5 bar. This work may offer a train of thought for the development of a new type of energy unit for self-powered systems.

How people with serious mental illness use smartphones, mobile apps, and social media.

PubMed

Naslund, John A; Aschbrenner, Kelly A; Bartels, Stephen J

2016-12-01

Research shows that people with serious mental illness are increasingly using mobile devices. Less is known about how these individuals use their mobile devices or whether they access social media. We surveyed individuals with serious mental illness to explore their use of these technologies. Individuals with serious mental illness engaged in lifestyle interventions through community mental health centers completed a survey about their use of mobile and online technologies. Responses were compared with data from the general population. Among respondents (n = 70), 93% owned cellphones, 78% used text messaging, 50% owned smartphones, and 71% used social media such as Facebook. Most respondents reported daily use of text messaging, mobile apps, and social media. Technology use was comparable to the general population, though smartphone ownership was lower. These findings can inform future interventions that fully leverage this group's use of popular digital technologies. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

How People with Serious Mental Illness Use Smartphones, Mobile Apps, and Social Media

PubMed Central

Naslund, John A.; Aschbrenner, Kelly A.; Bartels, Stephen J.

2016-01-01

Objective Research shows that people with serious mental illness are increasingly using mobile devices. Less is known about how these individuals use their mobile devices or whether they access social media. We surveyed individuals with serious mental illness to explore their use of these technologies. Methods Individuals with serious mental illness engaged in lifestyle interventions through community mental health centers completed a survey about their use of mobile and online technologies. Responses were compared to data from the general population. Results Among respondents (n=70), 93% owned cellphones, 78% used text messaging, 50% owned smartphones, and 71% used social media such as Facebook. Most respondents reported daily use of text messaging, mobile apps, and social media. Technology use was comparable to the general population, though smartphone ownership was lower. Conclusions and Implications for Practice These findings can inform future interventions that fully leverage this group’s use of popular digital technologies. PMID:27845533

Use of Vagus Nerve Stimulator on Children With Primary Generalized Epilepsy.

PubMed

Welch, William P; Sitwat, Bilal; Sogawa, Yoshimi

2018-06-01

To describe the response to vagus nerve stimulator (VNS) in otherwise neurotypical children with medically intractable primary generalized epilepsy. Retrospective chart review of patients who underwent vagus nerve stimulator surgery between January 2011 and December 2015. Eleven patients were identified. Median follow-up duration was 2.5 years (1.2-8.4 years). Prior to vagus nerve stimulator surgery, all patients had at least 1 seizure per week, and 7/11 (64%) had daily seizures. At 1-year follow-up after vagus nerve stimulator, 7/11 (64%) reported improved seizure frequency and 6/11 (55%) reported fewer than 1 seizure per month. Three patients (27%) reported complications related to vagus nerve stimulator surgery, and no patients required device removal. In children with medically intractable primary generalized epilepsy, vagus nerve stimulator is well tolerated and appears to lead to improvement in seizure frequency. Improvement was not attributable to epilepsy classification, age at vagus nerve stimulator implantation, output current, duty cycle, or follow-up duration.

Independent Auditors Report on the Air Force General Fund FY 2015 and FY 2014 Basic Financial Statements for United States Air Force Agency Financial Report 2015

DTIC Science & Technology

2015-11-09

and intelligence warfighting support. AFSPC operates sensors that provide direct attack warning and assessment to U.S. Strategic Command and North...combinations. AFRL conducted low-speed wind tunnel tests of 9%-scale model completed at NASA Langley Research Center (LaRC); data validated analytical...by $2M across JTAC platforms and expanding mobile device operation usage by 95 hours. The BATMAN-II team also delivered a new wireless mobile

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Henschke, Cornelia; Panteli, Dimitra; Perleth, Matthias; Busse, Reinhard

2015-01-01

The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

21 CFR 800.55 - Administrative detention.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GENERAL Administrative Practices and Procedures § 800.55 Administrative detention. (a) General. This section sets forth the procedures for detention of medical devices intended for human use... preventing distribution or use of devices encountered during inspections that may be adulterated or...

Phenyl substitution of cationic bis-cyclometalated iridium(iii) complexes for iTMC-LEECs.

PubMed

Suhr, Kristin J; Bastatas, Lyndon D; Shen, Yulong; Mitchell, Lauren A; Frazier, Gary A; Taylor, David W; Slinker, Jason D; Holliday, Bradley J

2016-11-28

A series of seven cationic bis-cyclometalated iridium(iii) complexes of the form [(C^N) 2 (N^N)Ir][PF 6 ] has been designed in order to examine the effect of bulky, hydrophobic phenyl substituents on the structure-property relationship of these ionic transition metal complexes (iTMCs) in light-emitting electrochemical cells (LEECs). Capping phenyl substituents on the cyclometalating and ancillary ligands allows for individual tuning of the HOMO and LUMO energy levels, respectively, yielding an emission range from yellow to red. The complexes in this series exhibit increased quantum yields, up to 70% higher than the unoptimized, archetypal [(2-phenylpyridine) 2 (2,2'-bipyridine)Ir][PF 6 ]. Among these, one complex, C3, was recently reported to produce devices with superior luminance and efficiency. Simultaneous measure of the series of complexes enabled the clear discernment of trends in device performance connected to fundamental structure-property relationships that elucidate the origin of enhanced luminance. In general, phenyl substitution of the 2-phenylpyridine ligands of the parent complex produced higher luminance and faster device response than phenyl substitution of the 2,2'-bipyridine ligand. Overall, complex design and device engineering produce competitive LEECs from simple, single-layer architectures. The synthesis, crystallographic, photophysical, and electrochemical properties of the iTMCs, along with the electroluminescence properties of the LEEC devices are reported herein.

Doctors' experience with handheld computers in clinical practice: qualitative study

PubMed Central

McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

2004-01-01

Objective To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Design Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Setting Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. Participants 54 doctors who did or did not use handheld computers. Results Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Conclusions Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care. PMID:15142920

Personal Communication Device Use by Nurses Providing In-Patient Care: Survey of Prevalence, Patterns, and Distraction Potential.

PubMed

McBride, Deborah L; LeVasseur, Sandra A

2017-04-13

Coincident with the proliferation of employer-provided mobile communication devices, personal communication devices, including basic and enhanced mobile phones (smartphones) and tablet computers that are owned by the user, have become ubiquitous among registered nurses working in hospitals. While there are numerous benefits of personal communication device use by nurses at work, little is known about the impact of these devices on in-patient care. Our aim was to examine how hospital-registered nurses use their personal communication devices while doing both work-related and non‒work-related activities and to assess the impact of these devices on in-patient care. A previously validated survey was emailed to 14,797 members of two national nursing organizations. Participants were asked about personal communication device use and their opinions about the impact of these devices on their own and their colleagues' work. Of the 1268 respondents (8.57% response rate), only 5.65% (70/1237) never used their personal communication device at work (excluding lunch and breaks). Respondents self-reported using their personal communication devices at work for work-related activities including checking or sending text messages or emails to health care team members (29.02%, 363/1251), as a calculator (25.34%, 316/1247), and to access work-related medical information (20.13%, 251/1247). Fewer nurses reported using their devices for non‒work-related activities including checking or sending text messages or emails to friends and family (18.75%, 235/1253), shopping (5.14%, 64/1244), or playing games (2.73%, 34/1249). A minority of respondents believe that their personal device use at work had a positive effect on their work including reducing stress (29.88%, 369/1235), benefiting patient care (28.74%, 357/1242), improving coordination of patient care among the health care team (25.34%, 315/1243), or increasing unit teamwork (17.70%, 220/1243). A majority (69.06%, 848/1228) of respondents believe that on average personal communication devices have a more negative than positive impact on patient care and 39.07% (481/1231) reported that personal communication devices were always or often a distraction while working. Respondents acknowledged their own device use negatively affected their work performance (7.56%, 94/1243), or caused them to miss important clinical information (3.83%, 47/1225) or make a medical error (0.90%, 11/1218). Respondents reported witnessing another nurse's use of devices negatively affect their work performance (69.41%, 860/1239), or cause them to miss important clinical information (30.61%, 378/1235) or make a medical error (12.51%, 155/1239). Younger respondents reported greater device use while at work than older respondents and generally had more positive opinions about the impact of personal communication devices on their work. The majority of registered nurses believe that the use of personal communication devices on hospital units raises significant safety issues. The high rate of respondents who saw colleagues distracted by their devices compared to the rate who acknowledged their own distraction may be an indication that nurses are unaware of their own attention deficits while using their devices. There were clear generational differences in personal communication device use at work and opinions about the impact of these devices on patient care. Professional codes of conduct for personal communication device use by hospital nurses need to be developed that maximize the benefits of personal communication device use, while reducing the potential for distraction and adverse outcomes. ©Deborah L McBride, Sandra A LeVasseur. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 13.04.2017.

E-SMART system for in-situ detection of environmental contaminants. Quarterly technical progress report, July--September 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-10-01

General Atomics (GA) leads a team of industrial, academic, and government organizations to develop the Environmental Systems Management, Analysis and Reporting neTwork (E-SMART) for the Defense Advanced Research Project Agency (DARPA), by way of this Technology Reinvestment Project (TRP). E-SMART defines a standard by which networks of smart sensing, sampling, and control devices can interoperate. E-SMART is intended to be an open standard, available to any equipment manufacturer. The user will be provided a standard platform on which a site-specific monitoring plan can be implemented using sensors and actuators from various manufacturers and upgraded as new monitoring devices become commerciallymore » available. This project will further develop and advance the E-SMART standardized network protocol to include new sensors, sampling systems, and graphical user interfaces.« less

Design and Construction of a Dense Plasma Focus Device

DTIC Science & Technology

1976-10-01

This paper deals with the design of a dense plasma focus device as an engineering project. Essentially this approach can be summarized as follows...First, an introduction dealing with a general discussion of plasma devices focusing on the role of a dense plasma focus device as a useful tool in...future research; second, an explanation of the operation of the dense plasma focus ; third, a general design discussion of the dense plasma focus device

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).

PubMed

Zeitler, Emily P; Al-Khatib, Sana M; Drozda, Joseph P; Kessler, Larry G; Kirtane, Ajay J; Kong, David F; Laschinger, John; Marinac-Dabic, Danica; Morice, Marie-Claude; Reed, Terrie; Sedrakyan, Art; Stein, Kenneth M; Tcheng, James; Krucoff, Mitchell W

2016-01-01

The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program. Copyright © 2015 Elsevier Inc. All rights reserved.

40 CFR 610.20 - General.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false General. 610.20 Section 610.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY RETROFIT... representations made with respect to retrofit devices: (a) Device functional category; (b) Device integrity; (c...

Application and Design Characteristics of Generalized Training Devices.

ERIC Educational Resources Information Center

Parker, Edward L.

This program identified applications and developed design characteristics for generalized training devices. The first of three sequential phases reviewed in detail new developments in Naval equipment technology that influence the design of maintenance training devices: solid-state circuitry, modularization, digital technology, standardization,…

Burns resulting from spontaneous combustion of electronic cigarettes: a case series.

PubMed

Sheckter, Clifford; Chattopadhyay, Arhana; Paro, John; Karanas, Yvonne

2016-01-01

Electronic cigarette (e-cigarette) sales have grown rapidly in recent years, coinciding with a public perception that they are a safer alternative to traditional cigarettes. However, there have been numerous media reports of fires associated with e-cigarette spontaneous combustion. Three severe burns caused by spontaneous combustion of e-cigarettes within a 6-month period were treated at the Santa Clara Valley Medical Center Burn Unit. Patients sustained partial and full-thickness burns. Two required hospitalization and surgical treatment. E-cigarettes are dangerous devices and have the potential to cause significant burns. Consumers and the general public should be made aware of these life-threatening devices.

Handling the procurement of prostheses for total hip replacement: description of an original value based approach and application to a real-life dataset reported in the UK

PubMed Central

Messori, Andrea; Trippoli, Sabrina; Marinai, Claudio

2017-01-01

Objectives In most European countries, innovative medical devices are not managed according to cost–utility methods, the reason being that national agencies do not generally evaluate these products. The objective of our study was to investigate the cost-utility profile of prostheses for hip replacement and to calculate a value-based score to be used in the process of procurement and tendering for these devices. Methods The first phase of our study was aimed at retrieving the studies reporting the values of QALYs, direct cost, and net monetary benefit (NMB) from patients undergoing total hip arthroplasty (THA) with different brands of hip prosthesis. The second phase was aimed at calculating, on the basis of the results of cost–utility analysis, a tender score for each device (defined according to standard tendering equations and adapted to a 0–100 scale). This allowed us to determine the ranking of each device in the simulated tender. Results We identified a single study as the source of information for our analysis. Nine device brands (cemented, cementless, or hybrid) were evaluated. The cemented prosthesis Exeter V40/Elite Plus Ogee, the cementless device Taperloc/Exceed, and the hybrid device Exeter V40/Trident had the highest NMB (£152 877, £156 356, and £156 210, respectively) and the best value-based tender score. Conclusions The incorporation of value-based criteria in the procurement process can contribute to optimising the value for money for THA devices. According to the approach described herein, the acquisition of these devices does not necessarily converge on the product with the lowest cost; in fact, more costly devices should be preferred when their increased cost is offset by the monetary value of the increased clinical benefit. PMID:29259062

Y stenting assisted coiling using a new low profile visible intraluminal support device for wide necked basilar tip aneurysms: a technical report.

PubMed

Conrad, Marcelo D; Brasiliense, Leonardo B C; Richie, Alexa N; Hanel, Ricardo A

2014-05-01

Many endovascular techniques have been described in recent years for the management of wide necked aneurysms. The Y stent assisted technique has been generally used for coil embolization of wide necked bifurcation aneurysms. This technique was first described for the treatment of basilar tip aneurysms in combination with several different devices, demonstrating encouraging results. We report the results of the first two cases of wide necked basilar tip aneurysms treated with Y stent assisted coil embolization using a new low profile visible intraluminal stent (LVIS Jr; MicroVention, Tustin, California, USA) delivered through a 0.017 inch microcatheter. We also reviewed the literature comparing other endovascular techniques (coiling alone, stent assisted coiling, and Y stent assisted coiling) for wide necked aneurysms. The LVIS Jr device offers a new option for the treatment of these challenging lesions, with clear advantages over currently available intracranial stents. Larger series and long term results are needed to confirm the applicability and durability of this technique/technology.

Computer Lab Tools for Science: An Analysis of Commercially Available Science Interfacing Software for Microcomputers. A Quarterly Report.

ERIC Educational Resources Information Center

Weaver, Dave

Science interfacing packages (also known as microcomputer-based laboratories or probeware) generally consist of a set of programs on disks, a user's manual, and hardware which includes one or more sensory devices. Together with a microcomputer they combine to make a powerful data acquisition and analysis tool. Packages are available for accurately…

40 CFR Table 1 to Subpart Hhhhhh... - Applicability of General Provisions to Subpart HHHHHH of Part 63

Code of Federal Regulations, 2012 CFR

2012-07-01

.../Reporting Waiver Yes § 63.11 Control Device Requirements/Flares No Subpart HHHHHH does not require the use... Control Agencies and EPA Regional Offices Yes § 63.14 Incorporation by Reference Yes Test methods for measuring paint booth filter efficiency and spray gun transfer efficiency in § 63.11173(e)(2) and (3) are...

40 CFR Table 1 to Subpart Hhhhhh... - Applicability of General Provisions to Subpart HHHHHH of Part 63

Code of Federal Regulations, 2011 CFR

2011-07-01

.../Reporting Waiver Yes § 63.11 Control Device Requirements/Flares No Subpart HHHHHH does not require the use... Control Agencies and EPA Regional Offices Yes § 63.14 Incorporation by Reference Yes Test methods for measuring paint booth filter efficiency and spray gun transfer efficiency in § 63.11173(e)(2) and (3) are...

40 CFR Table 1 to Subpart Hhhhhh... - Applicability of General Provisions to Subpart HHHHHH of Part 63

Code of Federal Regulations, 2014 CFR

2014-07-01

.../Reporting Waiver Yes § 63.11 Control Device Requirements/Flares No Subpart HHHHHH does not require the use... Control Agencies and EPA Regional Offices Yes § 63.14 Incorporation by Reference Yes Test methods for measuring paint booth filter efficiency and spray gun transfer efficiency in § 63.11173(e)(2) and (3) are...

40 CFR Table 1 to Subpart Hhhhhh... - Applicability of General Provisions to Subpart HHHHHH of Part 63

Code of Federal Regulations, 2013 CFR

2013-07-01

.../Reporting Waiver Yes § 63.11 Control Device Requirements/Flares No Subpart HHHHHH does not require the use... Control Agencies and EPA Regional Offices Yes § 63.14 Incorporation by Reference Yes Test methods for measuring paint booth filter efficiency and spray gun transfer efficiency in § 63.11173(e)(2) and (3) are...

Integrated Multiscale Modeling of Molecular Computing Devices. Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tim Schulze

2012-11-01

The general theme of this research has been to expand the capabilities of a simulation technique, Kinetic Monte Carlo (KMC) and apply it to study self-assembled nano-structures on epitaxial thin films. KMC simulates thin film growth and evolution by replacing the detailed dynamics of the system's evolution, which might otherwise be studied using molecular dynamics, with an appropriate stochastic process.

Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device.

PubMed

Boterhoven de Haan, Katrina L; Hafekost, Jennifer; Lawrence, David; Sawyer, Michael G; Zubrick, Stephen R

2015-03-01

The General Functioning 12-item subscale (GF12) of The McMaster Family Assessment Device (FAD) has been validated as a single index measure to assess family functioning. This study reports on the reliability and validity of using only the six positive items from the General Functioning subscale (GF6+). Existing data from two Western Australian studies, the Raine Study (RS) and the Western Australian Child Health Survey (WACHS), was used to analyze the psychometric properties of the GF6+ subscale. The results demonstrated that the GF6+ subscale had virtually equivalent psychometric properties and was able to identify almost all of the same families who had healthy or unhealthy levels of functioning as the full GF12 subscale. In consideration of the constraints faced by large-scale population-based surveys, the findings of this study support the use of a GF6+ subscale from the FAD, as a quick and effective tool to assess the overall functioning of families. © 2014 Family Process Institute.

Laparoscopic hernia repair and bladder injury.

PubMed

Dalessandri, K M; Bhoyrul, S; Mulvihill, S J

2001-01-01

Bladder injury is a complication of laparoscopic surgery with a reported incidence in the general surgery literature of 0.5% and in the gynecology literature of 2%. We describe how to recognize and treat the injury and how to avoid the problem. We report two cases of bladder injury repaired with a General Surgical Interventions (GSI) trocar and a balloon device used for laparoscopic extraperitoneal inguinal hernia repair. One patient had a prior appendectomy; the other had a prior midline incision from a suprapubic prostatectomy. We repaired the bladder injury, and the patients made a good recovery. When using the obturator and balloon device, it is important to stay anterior to the preperitoneal space and bladder. Prior lower abdominal surgery can be considered a relative contraindication to extraperitoneal laparoscopic hernia repair. Signs of gas in the Foley bag or hematuria should alert the surgeon to a bladder injury. A one- or two-layer repair of the bladder injury can be performed either laparoscopically or openly and is recommended for a visible injury. Mesh repair of the hernia can be completed provided no evidence exists of urinary tract infection. A Foley catheter is placed until healing occurs.

21 CFR 806.10 - Reports of corrections and removals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.10 Reports of corrections and removals. (a) Each device manufacturer or importer shall submit a written... injuries that have occurred with use of the device. If applicable, include the medical device report...

21 CFR 806.10 - Reports of corrections and removals.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.10 Reports of corrections and removals. (a) Each device manufacturer or importer shall submit a written... injuries that have occurred with use of the device. If applicable, include the medical device report...

21 CFR 880.6820 - Medical disposable scissors.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical disposable scissors. 880.6820 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6820 Medical disposable scissors. (a) Identification. Medical disposable scissors are...

21 CFR 880.6820 - Medical disposable scissors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical disposable scissors. 880.6820 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6820 Medical disposable scissors. (a) Identification. Medical disposable scissors are...

Manufacturer evaluations of endograft modifications.

PubMed

Waninger, Matthew S; Whirley, Robert G; Smith, Louis J; Wolf, Ben S

2013-03-01

The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1). Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

47 CFR 15.23 - Home-built devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Home-built devices. 15.23 Section 15.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.23 Home-built... that the individual builder of home-built equipment may not possess the means to perform the...

47 CFR 15.23 - Home-built devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Home-built devices. 15.23 Section 15.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.23 Home-built... that the individual builder of home-built equipment may not possess the means to perform the...

47 CFR 15.23 - Home-built devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Home-built devices. 15.23 Section 15.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.23 Home-built... that the individual builder of home-built equipment may not possess the means to perform the...

47 CFR 15.23 - Home-built devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Home-built devices. 15.23 Section 15.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.23 Home-built... that the individual builder of home-built equipment may not possess the means to perform the...

47 CFR 15.23 - Home-built devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Home-built devices. 15.23 Section 15.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.23 Home-built... that the individual builder of home-built equipment may not possess the means to perform the...

47 CFR 15.25 - Kits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Kits. 15.25 Section 15.25 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.25 Kits. A TV interface device, including a cable system terminal device, which is marketed as a kit shall comply with the...

47 CFR 15.25 - Kits.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Kits. 15.25 Section 15.25 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.25 Kits. A TV interface device, including a cable system terminal device, which is marketed as a kit shall comply with the...

47 CFR 15.25 - Kits.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Kits. 15.25 Section 15.25 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.25 Kits. A TV interface device, including a cable system terminal device, which is marketed as a kit shall comply with the...

47 CFR 15.25 - Kits.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Kits. 15.25 Section 15.25 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.25 Kits. A TV interface device, including a cable system terminal device, which is marketed as a kit shall comply with the...

47 CFR 15.25 - Kits.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Kits. 15.25 Section 15.25 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.25 Kits. A TV interface device, including a cable system terminal device, which is marketed as a kit shall comply with the...

21 CFR 880.5160 - Therapeutic medical binder.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Therapeutic medical binder. 880.5160 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5160 Therapeutic medical binder. (a) Identification. A therapeutic medical binder is a...

21 CFR 880.5160 - Therapeutic medical binder.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Therapeutic medical binder. 880.5160 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5160 Therapeutic medical binder. (a) Identification. A therapeutic medical binder is a...

21 CFR 880.6980 - Vein stabilizer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Vein stabilizer. 880.6980 Section 880.6980 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices...

21 CFR 880.6980 - Vein stabilizer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Vein stabilizer. 880.6980 Section 880.6980 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices...

21 CFR 880.6980 - Vein stabilizer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Vein stabilizer. 880.6980 Section 880.6980 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices...

A scoping review on smart mobile devices and physical strain.

PubMed

Tegtmeier, Patricia

2018-01-01

Smart mobile devices gain increasing importance at work. Integrating these smart mobile devices into the workplace creates new opportunities and challenges for occupational health and safety. Therefore the aim of the following scoping review was to identify ergonomic challenges with the use of smart mobile devices at work with respect to physical problems. A review of 36 papers based on literature including January 2016 was conducted. Biomechanical measures in the reviewed studies demonstrated i.e., head flexion angles exceeding 20° in 20 out of 26 different conditions described. Furthermore, laterally deviated wrists were frequently noted and thumb and finger flexor muscle activities generally greater than 5% MVC were reported. The reviewed literature indicated an elevated biomechanical risk, especially for the neck, the wrists and thumb. This was due to poor posture, ongoing and intermitted muscle tension, and/or repetitive movements. Papers addressing specific risks for smartphone and tablet use in different work environments are scarce. As the technology, as well as the use of smart mobile devices is rapidly changing, further research, especially for prolonged periods in the workplace is needed.

Fast Printing and In-Situ Morphology Observation of Organic Photovoltaics using Slot-Die Coating

NASA Astrophysics Data System (ADS)

Liu, Feng; Ferdous, Sunzida; Wang, Cheng; Hexamer, Alexander; Russell, Thomas; Cheng Wang Collaboration; Thomas Russell Team

2014-03-01

The solvent-processibility of polymer semiconductors is a key advantage for the fabrication of large area, organic bulk-heterojunction (BHJ) photovoltaic devices. Most reported power conversion efficiencies (PCE) are based on small active areas, fabricated by spin-coating technique. In general, this does not reflect device fabrication in an industrial setting. To realize commercial viability, devices need to be fabricated in a roll-to-roll fashion. The evolution of the morphology associated with different processing parameters, like solvent choice, concentration and temperature, needs to be understood and controlled. We developed a mini slot-die coater, to fabricate BHJ devices using various low band gap polymers mixed with phenyl-C71-butyric acid methyl ester (PCBM). Solvent choice, processing additives, coating rate and coating temperatures were used to control the final morphology. Efficiencies comparable to lab-setting spin-coated devices are obtained. The evolution of the morphology was monitored by in situ scattering measurements, detecting the onset of the polymer chain packing in solution that led to the formation of a fibrillar network in the film.

Generalized optical angular momentum sorter and its application to high-dimensional quantum cryptography.

PubMed

Larocque, Hugo; Gagnon-Bischoff, Jérémie; Mortimer, Dominic; Zhang, Yingwen; Bouchard, Frédéric; Upham, Jeremy; Grillo, Vincenzo; Boyd, Robert W; Karimi, Ebrahim

2017-08-21

The orbital angular momentum (OAM) carried by optical beams is a useful quantity for encoding information. This form of encoding has been incorporated into various works ranging from telecommunications to quantum cryptography, most of which require methods that can rapidly process the OAM content of a beam. Among current state-of-the-art schemes that can readily acquire this information are so-called OAM sorters, which consist of devices that spatially separate the OAM components of a beam. Such devices have found numerous applications in optical communications, a field that is in constant demand for additional degrees of freedom, such as polarization and wavelength, into which information can also be encoded. Here, we report the implementation of a device capable of sorting a beam based on its OAM and polarization content, which could be of use in works employing both of these degrees of freedom as information channels. After characterizing our fabricated device, we demonstrate how it can be used for quantum communications via a quantum key distribution protocol.

Copper indium gallium selenide (CIGS) photovoltaic devices made using multistep selenization of nanocrystal films.

PubMed

Harvey, Taylor B; Mori, Isao; Stolle, C Jackson; Bogart, Timothy D; Ostrowski, David P; Glaz, Micah S; Du, Jiang; Pernik, Douglas R; Akhavan, Vahid A; Kesrouani, Hady; Vanden Bout, David A; Korgel, Brian A

2013-09-25

The power conversion efficiency of photovoltaic devices made with ink-deposited Cu(InxGa1-x)Se2 (CIGS) nanocrystal layers can be enhanced by sintering the nanocrystals with a high temperature selenization process. This process, however, can be challenging to control. Here, we report that ink deposition followed by annealing under inert gas and then selenization can provide better control over CIGS nanocrystal sintering and yield generally improved device efficiency. Annealing under argon at 525 °C removes organic ligands and diffuses sodium from the underlying soda lime glass into the Mo back contact to improve the rate and quality of nanocrystal sintering during selenization at 500 °C. Shorter selenization time alleviates excessive MoSe2 formation at the Mo back contact that leads to film delamination, which in turn enables multiple cycles of nanocrystal deposition and selenization to create thicker, more uniform absorber films. Devices with power conversion efficiency greater than 7% are fabricated using the multiple step nanocrystal deposition and sintering process.

Single-Layer Halide Perovskite Light-Emitting Diodes with Sub-Band Gap Turn-On Voltage and High Brightness.

PubMed

Li, Junqiang; Shan, Xin; Bade, Sri Ganesh R; Geske, Thomas; Jiang, Qinglong; Yang, Xin; Yu, Zhibin

2016-10-03

Charge-carrier injection into an emissive semiconductor thin film can result in electroluminescence and is generally achieved by using a multilayer device structure, which requires an electron-injection layer (EIL) between the cathode and the emissive layer and a hole-injection layer (HIL) between the anode and the emissive layer. The recent advancement of halide perovskite semiconductors opens up a new path to electroluminescent devices with a greatly simplified device structure. We report cesium lead tribromide light-emitting diodes (LEDs) without the aid of an EIL or HIL. These so-called single-layer LEDs have exhibited a sub-band gap turn-on voltage. The devices obtained a brightness of 591 197 cd m -2 at 4.8 V, with an external quantum efficiency of 5.7% and a power efficiency of 14.1 lm W -1 . Such an advancement demonstrates that very high efficiency of electron and hole injection can be obtained in perovskite LEDs even without using an EIL or HIL.

Increasing the density of passive photonic-integrated circuits via nanophotonic cloaking

NASA Astrophysics Data System (ADS)

Shen, Bing; Polson, Randy; Menon, Rajesh

2016-11-01

Photonic-integrated devices need to be adequately spaced apart to prevent signal cross-talk. This fundamentally limits their packing density. Here we report the use of nanophotonic cloaking to render neighbouring devices invisible to one another, which allows them to be placed closer together than is otherwise feasible. Specifically, we experimentally demonstrated waveguides that are spaced by a distance of ~λ0/2 and designed waveguides with centre-to-centre spacing as small as 600 nm (<λ0/2.5). Our experiments show a transmission efficiency >-2 dB and an extinction ratio >15 dB over a bandwidth larger than 60 nm. This performance can be improved with better design algorithms and industry-standard lithography. The nanophotonic cloak relies on multiple guided-mode resonances, which render such devices very robust to fabrication errors. Our devices are broadly complimentary-metal-oxide-semiconductor compatible, have a minimum pitch of 200 nm and can be fabricated with a single lithography step. The nanophotonic cloaks can be generally applied to all passive integrated photonics.

21 CFR 880.5100 - AC-powered adjustable hospital bed.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false AC-powered adjustable hospital bed. 880.5100... (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5100 AC-powered adjustable hospital bed. (a) Identification. An AC-powered...

21 CFR 880.5100 - AC-powered adjustable hospital bed.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false AC-powered adjustable hospital bed. 880.5100... (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5100 AC-powered adjustable hospital bed. (a) Identification. An AC-powered...

21 CFR 880.5100 - AC-powered adjustable hospital bed.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false AC-powered adjustable hospital bed. 880.5100... (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5100 AC-powered adjustable hospital bed. (a) Identification. An AC-powered...

21 CFR 880.5100 - AC-powered adjustable hospital bed.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false AC-powered adjustable hospital bed. 880.5100... (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5100 AC-powered adjustable hospital bed. (a) Identification. An AC-powered...

37 CFR 201.28 - Statements of Account for digital audio recording devices or media.

Code of Federal Regulations, 2011 CFR

2011-07-01

... digital audio recording devices or media. 201.28 Section 201.28 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.28 Statements of Account for digital audio recording devices or media. (a) General. This section prescribes rules...

37 CFR 201.28 - Statements of Account for digital audio recording devices or media.

Code of Federal Regulations, 2012 CFR

2012-07-01

... digital audio recording devices or media. 201.28 Section 201.28 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.28 Statements of Account for digital audio recording devices or media. (a) General. This section prescribes rules...

37 CFR 201.28 - Statements of Account for digital audio recording devices or media.

Code of Federal Regulations, 2013 CFR

2013-07-01

... digital audio recording devices or media. 201.28 Section 201.28 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.28 Statements of Account for digital audio recording devices or media. (a) General. This section prescribes rules...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

21 CFR 882.1560 - Skin potential measurement device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

PubMed

Mehta, Rashi I; Mehta, Rupal I

2018-03-19

Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.

Rapid Prototyping of Nanofluidic Slits in a Silicone Bilayer

PubMed Central

Kole, Thomas P.; Liao, Kuo-Tang; Schiffels, Daniel; Ilic, B. Robert; Strychalski, Elizabeth A.; Kralj, Jason G.; Liddle, J. Alexander; Dritschilo, Anatoly; Stavis, Samuel M.

2015-01-01

This article reports a process for rapidly prototyping nanofluidic devices, particularly those comprising slits with microscale widths and nanoscale depths, in silicone. This process consists of designing a nanofluidic device, fabricating a photomask, fabricating a device mold in epoxy photoresist, molding a device in silicone, cutting and punching a molded silicone device, bonding a silicone device to a glass substrate, and filling the device with aqueous solution. By using a bilayer of hard and soft silicone, we have formed and filled nanofluidic slits with depths of less than 400 nm and aspect ratios of width to depth exceeding 250 without collapse of the slits. An important attribute of this article is that the description of this rapid prototyping process is very comprehensive, presenting context and details which are highly relevant to the rational implementation and reliable repetition of the process. Moreover, this process makes use of equipment commonly found in nanofabrication facilities and research laboratories, facilitating the broad adaptation and application of the process. Therefore, while this article specifically informs users of the Center for Nanoscale Science and Technology (CNST) at the National Institute of Standards and Technology (NIST), we anticipate that this information will be generally useful for the nanofabrication and nanofluidics research communities at large, and particularly useful for neophyte nanofabricators and nanofluidicists. PMID:26958449

Wireless augmented reality communication system

NASA Technical Reports Server (NTRS)

Devereaux, Ann (Inventor); Agan, Martin (Inventor); Jedrey, Thomas (Inventor)

2006-01-01

The system of the present invention is a highly integrated radio communication system with a multimedia co-processor which allows true two-way multimedia (video, audio, data) access as well as real-time biomedical monitoring in a pager-sized portable access unit. The system is integrated in a network structure including one or more general purpose nodes for providing a wireless-to-wired interface. The network architecture allows video, audio and data (including biomedical data) streams to be connected directly to external users and devices. The portable access units may also be mated to various non-personal devices such as cameras or environmental sensors for providing a method for setting up wireless sensor nets from which reported data may be accessed through the portable access unit. The reported data may alternatively be automatically logged at a remote computer for access and viewing through a portable access unit, including the user's own.

Wireless Augmented Reality Communication System

NASA Technical Reports Server (NTRS)

Jedrey, Thomas (Inventor); Agan, Martin (Inventor); Devereaux, Ann (Inventor)

2014-01-01

The system of the present invention is a highly integrated radio communication system with a multimedia co-processor which allows true two-way multimedia (video, audio, data) access as well as real-time biomedical monitoring in a pager-sized portable access unit. The system is integrated in a network structure including one or more general purpose nodes for providing a wireless-to-wired interface. The network architecture allows video, audio and data (including biomedical data) streams to be connected directly to external users and devices. The portable access units may also be mated to various non-personal devices such as cameras or environmental sensors for providing a method for setting up wireless sensor nets from which reported data may be accessed through the portable access unit. The reported data may alternatively be automatically logged at a remote computer for access and viewing through a portable access unit, including the user's own.

Wireless Augmented Reality Communication System

NASA Technical Reports Server (NTRS)

Agan, Martin (Inventor); Devereaux, Ann (Inventor); Jedrey, Thomas (Inventor)

2016-01-01

The system of the present invention is a highly integrated radio communication system with a multimedia co-processor which allows true two-way multimedia (video, audio, data) access as well as real-time biomedical monitoring in a pager-sized portable access unit. The system is integrated in a network structure including one or more general purpose nodes for providing a wireless-to-wired interface. The network architecture allows video, audio and data (including biomedical data) streams to be connected directly to external users and devices. The portable access units may also be mated to various non-personal devices such as cameras or environmental sensors for providing a method for setting up wireless sensor nets from which reported data may be accessed through the portable access unit. The reported data may alternatively be automatically logged at a remote computer for access and viewing through a portable access unit, including the user's own.

V/STOL Concepts and Developed Aircraft. Volume 1. A Historical Report (1940-1986)

DTIC Science & Technology

1986-06-26

in this - direction. Generally, the propellants considered for use create logistic, safety and operational cost problems. Further, the very high...been expanded into multiplace transpcrt devices. The operational use of the individual lift systems creates an important distinction between them in...two separate, alternate thrust vectoring means tc control horizontal translational flight with attitude stabilization being created by the flier’s

Investigation of the diaphragm-type pressure cell

NASA Technical Reports Server (NTRS)

Theodorsen, Theodore

1932-01-01

This report relates to various improvements in the process of manufacture of the NACA standard pressure cell. Like most pressure recording devices employing thin diaphragms, they would in general show considerable change in calibration with temperature and also some change of calibration with time or aging effect. The required diaphragm thickness and the desirable rate of mechanical magnification have been determined on the basis of several hundred tests.

21 CFR 880.6890 - General purpose disinfectants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...

Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the health economics committee of the European Heart Rhythm Association.

PubMed

Mairesse, Georges H; Braunschweig, Frieder; Klersy, Katherine; Cowie, Martin R; Leyva, Francisco

2015-05-01

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias, device, and lead failure and may also be useful in risk-predicting patient-related outcomes. Financial benefits for patients and healthcare organizations have also been shown. We sought to assess the implementation and funding of RM of CIEDs, including conventional pacemakers (PMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in Europe. Electronic survey from 43 centres in 15 European countries. In the study sample, RM was available in 22% of PM patients, 74% of ICD patients, and 69% of CRT patients. The most significant perceived benefits were the early detection of atrial arrhythmias in pacemaker patients, lead failure in ICD patients, and worsening heart failure in CRT patients. Remote monitoring was reported to lead a reduction of in-office follow-ups for all devices. The most important reported barrier to the implementation of RM for all CIEDs was lack of reimbursement (80% of centres). Physicians regard RM of CIEDs as a clinically useful technology that affords significant benefits for patients and healthcare organizations. Remote monitoring, however, is perceived as increasing workload. Reimbursement for RM is generally perceived as a major barrier to implementation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Evaluation of Home Health Care Devices: Remote Usability Assessment.

PubMed

Kortum, Philip; Peres, S Camille

2015-06-05

An increasing amount of health care is now performed in a home setting, away from the hospital. While there is growing anecdotal evidence about the difficulty patients and caregivers have using increasingly complex health care devices in the home, there has been little systematic scientific study to quantify the global nature of home health care device usability in the field. Research has tended to focus on a handful of devices, making it difficult to gain a broad view of the usability of home-care devices in general. The objective of this paper is to describe a remote usability assessment method using the System Usability Scale (SUS), and to report on the usability of a broad range of health care devices using this metric. A total of 271 participants selected and rated up to 10 home health care devices of their choice using the SUS, which scores usability from 0 (unusable) to 100 (highly usable). Participants rated a total of 455 devices in their own home without an experimenter present. Usability scores ranged from 98 (oxygen masks) to 59 (home hormone test kits). An analysis conducted on devices that had at least 10 ratings showed that the effect of device on SUS scores was significant (P<.001), and that the usability of these devices was on the low end when compared with other commonly used items in the home, such as microwave ovens and telephones. A large database of usability scores for home health care devices collected using this remote methodology would be beneficial for physicians, patients, and their caregivers.

General purpose programmable accelerator board

DOEpatents

Robertson, Perry J.; Witzke, Edward L.

2001-01-01

A general purpose accelerator board and acceleration method comprising use of: one or more programmable logic devices; a plurality of memory blocks; bus interface for communicating data between the memory blocks and devices external to the board; and dynamic programming capabilities for providing logic to the programmable logic device to be executed on data in the memory blocks.

37 CFR 201.27 - Initial notice of distribution of digital audio recording devices or media.

Code of Federal Regulations, 2013 CFR

2013-07-01

... distribution of digital audio recording devices or media. 201.27 Section 201.27 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.27 Initial notice of distribution of digital audio recording devices or media. (a) General. This section...

37 CFR 201.27 - Initial notice of distribution of digital audio recording devices or media.

Code of Federal Regulations, 2014 CFR

2014-07-01

... distribution of digital audio recording devices or media. 201.27 Section 201.27 Patents, Trademarks, and Copyrights U.S. COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.27 Initial notice of distribution of digital audio recording devices or media. (a) General. This...

37 CFR 201.28 - Statements of Account for digital audio recording devices or media.

Code of Federal Regulations, 2014 CFR

2014-07-01

... digital audio recording devices or media. 201.28 Section 201.28 Patents, Trademarks, and Copyrights U.S. COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.28 Statements of Account for digital audio recording devices or media. (a) General. This section prescribes rules...

37 CFR 201.27 - Initial notice of distribution of digital audio recording devices or media.

Code of Federal Regulations, 2012 CFR

2012-07-01

... distribution of digital audio recording devices or media. 201.27 Section 201.27 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.27 Initial notice of distribution of digital audio recording devices or media. (a) General. This section...

37 CFR 201.27 - Initial notice of distribution of digital audio recording devices or media.

Code of Federal Regulations, 2011 CFR

2011-07-01

... distribution of digital audio recording devices or media. 201.27 Section 201.27 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.27 Initial notice of distribution of digital audio recording devices or media. (a) General. This section...

37 CFR 201.27 - Initial notice of distribution of digital audio recording devices or media.

Code of Federal Regulations, 2010 CFR

2010-07-01

... distribution of digital audio recording devices or media. 201.27 Section 201.27 Patents, Trademarks, and Copyrights COPYRIGHT OFFICE, LIBRARY OF CONGRESS COPYRIGHT OFFICE AND PROCEDURES GENERAL PROVISIONS § 201.27 Initial notice of distribution of digital audio recording devices or media. (a) General. This section...

21 CFR 814.80 - General.

Code of Federal Regulations, 2010 CFR

2010-04-01

... APPROVAL OF MEDICAL DEVICES Postapproval Requirements § 814.80 General. A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions...

Legislation to regulate medical devices.

PubMed

Harris, M

1975-01-01

The history of medical device regulation began with the need to rid the marketplace of bogus inventions which were either harmful in themselves or harmful because they delayed meaningful treatment of illness. Since World War II, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to cure and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance or scientific review, those for which standards could be established to protect the public, and those which are generally recognized as safe and for which nor standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975.

Predictable And SuStainable Implementation Of National Cardiovascular Registries Infrastructure: A Think Tank Report from MDEpiNet

PubMed Central

Zeitler, Emily P.; Al-Khatib, Sana M.; Drozda, Joseph P.; Kessler, Larry G.; Kirtane, Ajay J.; Kong, David F.; Laschinger, John; Marinac-Dabic, Danica; Morice, Marie-Claude; Reed, Terrie; Sedrakyan, Art; Stein, Kenneth M.; Tcheng, James; Krucoff, Mitchell W.

2015-01-01

The Medical Device Epidemiological Network Initiative (MDEpiNet) is a public-private partnership between the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and participating partners. The Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) program is an MDEpiNet-sponsored program which aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle (TPLC). To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included four areas of cardiovascular medicine intended to cultivate interest in four MDEpiNet Disease Specific/Device Specific Working Groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the Working Groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program. PMID:26699602

21 CFR 803.33 - If I am a user facility, what must I include when I submit an annual report?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User Facility... medical device reports, or the number assigned by us for reporting purposes in accordance with § 803.3; (2...) Date of the annual report and report numbers identifying the range of medical device reports that you...

21 CFR 803.33 - If I am a user facility, what must I include when I submit an annual report?

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User Facility... medical device reports, or the number assigned by us for reporting purposes in accordance with § 803.3; (2...) Date of the annual report and report numbers identifying the range of medical device reports that you...

Radial Shock Wave Devices Generate Cavitation

PubMed Central

Császár, Nikolaus B. M.; Angstman, Nicholas B.; Milz, Stefan; Sprecher, Christoph M.; Kobel, Philippe; Farhat, Mohamed; Furia, John P.; Schmitz, Christoph

2015-01-01

Background Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues. Methods and Findings We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms. Results FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device. Conclusions The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices. Clinical Relevance Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that “kick-starts” the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice. PMID:26509573

Radial Shock Wave Devices Generate Cavitation.

PubMed

Császár, Nikolaus B M; Angstman, Nicholas B; Milz, Stefan; Sprecher, Christoph M; Kobel, Philippe; Farhat, Mohamed; Furia, John P; Schmitz, Christoph

2015-01-01

Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues. We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms. FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device. The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices. Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that "kick-starts" the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice.

Custom large scale integrated circuits for spaceborne SAR processors

NASA Technical Reports Server (NTRS)

Tyree, V. C.

1978-01-01

The application of modern LSI technology to the development of a time-domain azimuth correlator for SAR processing is discussed. General design requirements for azimuth correlators for missions such as SEASAT-A, Venus orbital imaging radar (VOIR), and shuttle imaging radar (SIR) are summarized. Several azimuth correlator architectures that are suitable for implementation using custom LSI devices are described. Technical factors pertaining to selection of appropriate LSI technologies are discussed, and the maturity of alternative technologies for spacecraft applications are reported in the context of expected space mission launch dates. The preliminary design of a custom LSI time-domain azimuth correlator device (ACD) being developed for use in future SAR processors is detailed.

Wind-tunnel research comparing lateral control devices, particularly at high angles of attack XII : upper-surface ailerons on wings with split flaps

NASA Technical Reports Server (NTRS)

Weick, Fred E; Wenzinger, Carl J

1935-01-01

This report covers the twelfth of a series of tests conducted to compare different lateral control devices with particular reference to their effectiveness at high angles of attack. The present wind tunnel tests were made with two sizes of upper-surface ailerons on rectangular Clark Y wing models equipped with full span split flaps. The tests showed the effect of the upper-surface ailerons and of the split flaps on the general performance characteristics of the wings, and on the lateral controllability and stability characteristics. The results are compared with those for plain wings with ordinary ailerons of similar sizes.

Controlled dehydration improves the diffraction quality of two RNA crystals.

PubMed

Park, HaJeung; Tran, Tuan; Lee, Jun Hyuck; Park, Hyun; Disney, Matthew D

2016-11-03

Post-crystallization dehydration methods, applying either vapor diffusion or humidity control devices, have been widely used to improve the diffraction quality of protein crystals. Despite the fact that RNA crystals tend to diffract poorly, there is a dearth of reports on the application of dehydration methods to improve the diffraction quality of RNA crystals. We use dehydration techniques with a Free Mounting System (FMS, a humidity control device) to recover the poor diffraction quality of RNA crystals. These approaches were applied to RNA constructs that model various RNA-mediated repeat expansion disorders. The method we describe herein could serve as a general tool to improve diffraction quality of RNA crystals to facilitate structure determinations.

21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... preexisting medical conditions. (c) Device information (Form 3500A, Block D). You must submit the following... device code (refer to FDA MEDWATCH Medical Device Reporting Code Instructions); (11) Whether a report was...

21 CFR 803.42 - If I am an importer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... preexisting medical conditions. (c) Device information (Form 3500A, Block D). You must submit the following... device code (refer to FDA MEDWATCH Medical Device Reporting Code Instructions); (11) Whether a report was...

21 CFR 864.4010 - General purpose reagent.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false General purpose reagent. 864.4010 Section 864.4010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Specimen Preparation Reagents § 864.4010 General purpose...

21 CFR 864.4010 - General purpose reagent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false General purpose reagent. 864.4010 Section 864.4010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Specimen Preparation Reagents § 864.4010 General purpose...

21 CFR 864.4010 - General purpose reagent.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false General purpose reagent. 864.4010 Section 864.4010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Specimen Preparation Reagents § 864.4010 General purpose...

Use of home blood-pressure monitoring in the detection, treatment and surveillance of hypertension.

PubMed

Manning, Gillian; Donnelly, Richard

2005-11-01

Use of home blood-pressure monitoring is increasing but the technique and the equipment have limitations. We provide an overview of recent evidence in this rapidly evolving field. Home blood-pressure monitoring is an acceptable method for screening patients for hypertension. There is increasing evidence supporting the predictive power of home blood pressure for stroke risk even in the general population. The identification of white-coat and masked hypertension remains an important role for home blood-pressure monitoring. Unvalidated equipment and poor patient technique are major concerns. The purchase of devices needs to be linked to a simple patient-education programme, which is perhaps an opportunity for collaboration between healthcare providers and commercial companies. Devices that store the blood-pressure measurements in the memory are preferred to ensure accuracy of reporting. Data-transmission systems providing automatic storage, transmission and reporting of blood pressure, direct involvement of the patient and potentially a reduced number of hospital/general practitioner visits, offer significant advantages. To reduce patient anxiety, overuse of home blood-pressure monitoring should be avoided but there is the potential for self-modification of treatment, subject to certain safeguards. Self-monitoring of blood pressure is developing rapidly, linked to increasing awareness of the impact of reducing high blood pressure on public health and the marketing/advertising strategies used to sell automatic devices. Home blood-pressure monitoring has a role in the detection and management of blood pressure, but not at the expense of careful blood-pressure measurement in the office and adherence to national guidelines.

Pathogen Distribution and Antimicrobial Resistance Among Pediatric Healthcare-Associated Infections Reported to the National Healthcare Safety Network, 2011-2014.

PubMed

Lake, Jason G; Weiner, Lindsey M; Milstone, Aaron M; Saiman, Lisa; Magill, Shelley S; See, Isaac

2018-01-01

OBJECTIVE To describe pathogen distribution and antimicrobial resistance patterns for healthcare-associated infections (HAIs) reported to the National Healthcare Safety Network (NHSN) from pediatric locations during 2011-2014. METHODS Device-associated infection data were analyzed for central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infections (CAUTI), ventilator-associated pneumonia (VAP), and surgical site infection (SSI). Pooled mean percentage resistance was calculated for a variety of pathogen-antimicrobial resistance pattern combinations and was stratified by location for device-associated infections (neonatal intensive care units [NICUs], pediatric intensive care units [PICUs], pediatric oncology and pediatric wards) and by surgery type for SSIs. RESULTS From 2011 to 2014, 1,003 hospitals reported 20,390 pediatric HAIs and 22,323 associated pathogens to the NHSN. Among all HAIs, the following pathogens accounted for more than 60% of those reported: Staphylococcus aureus (17%), coagulase-negative staphylococci (17%), Escherichia coli (11%), Klebsiella pneumoniae and/or oxytoca (9%), and Enterococcus faecalis (8%). Among device-associated infections, resistance was generally lower in NICUs than in other locations. For several pathogens, resistance was greater in pediatric wards than in PICUs. The proportion of organisms resistant to carbapenems was low overall but reached approximately 20% for Pseudomonas aeruginosa from CLABSIs and CAUTIs in some locations. Among SSIs, antimicrobial resistance patterns were similar across surgical procedure types for most pathogens. CONCLUSION This report is the first pediatric-specific description of antimicrobial resistance data reported to the NHSN. Reporting of pediatric-specific HAIs and antimicrobial resistance data will help identify priority targets for infection control and antimicrobial stewardship activities in facilities that provide care for children. Infect Control Hosp Epidemiol 2018;39:1-11.

Laboratory demonstration model: Active cleaning technique device. [for removal of contaminants from an optical surface

NASA Technical Reports Server (NTRS)

Shannon, R. L.; Gillette, R. B.

1974-01-01

The technique which utilizes exposure to a plasma to remove contaminants from a surface was incorporated into a laboratory model which demonstrates active cleaning by both plasma cleaning and ion sputtering modes of operation. The development phase is reported and includes discussion of the plasma tube configuration, device design, and performance tests. A general description of the active cleaning device is provided which includes information on the main power/plasma discharge sensors, and the power, gas supply, and ion accelerator systems. Development of the active cleaning species at high vacuum conditions is described and results indicate that plasma cleaning occurs in the region of a visible plume which extends from the end of the plasma tube. Recommendations are made for research to determine the plasma cleaning mechanism and the plasma species responsible for the cleaning, as well limitations on the type of contaminants that can be removed.

Information Security due to Electromagnetic Environments

NASA Astrophysics Data System (ADS)

Sekiguchi, Hidenori; Seto, Shinji

Generally, active electronic devices emit slightly unintentional electromagnetic noise. From long ago, electromagnetic emission levels have been regulated from the aspect of electromagnetic compatibility (EMC). Also, it has been known the electromagnetic emissions have been generated from the ON/OFF of signals in the device. Recently, it becomes a topic of conversation on the information security that the ON/OFF on a desired signal in the device can be reproduced or guessed by receiving the electromagnetic emission. For an example, a display image on a personal computer (PC) can be reconstructed by receiving and analyzing the electromagnetic emission. In sum, this fact makes known information leakage due to electromagnetic emission. “TEMPEST" that has been known as a code name originated in the U. S. Department of Defense is to prevent the information leakage caused by electromagnetic emissions. This paper reports the brief summary of the information security due to electromagnetic emissions from information technology equipments.

Tulip deformity with Cera atrial septal defect devices: a report of 3 cases.

PubMed

Kohli, Vikas

2015-02-01

Device closure of secundum atrial septal defect (ASD) is the treatment of choice when anatomy is favourable. Amplatzer device has remained the gold standard for closure of ASD. Cobra deformity is a well-reported problem with devices. Recently, Tulip deformity has been reported in a single case. We report a series of cases where we noted Tulip deformity along with inability to retract the device in the sheath in Cera Lifetech devices. This resulted in prolongation of procedure, excessive fluoroscopic exposure and additional interventional procedures not usually anticipated in ASD device closure. We believe that the problem is due to the stiffness of the device resulting in its inability to be retracted into the sheath. We also report a unique way of retrieving the device.

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 201.2 - Drugs and devices; National Drug Code numbers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs and devices; National Drug Code numbers. 201.2 Section 201.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.2 Drugs and devices; National Drug Code...

21 CFR 880.2460 - Electrically powered spinal fluid pressure monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrically powered spinal fluid pressure monitor. 880.2460 Section 880.2460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2460...

30 CFR 75.1103-3 - Automatic fire sensor and warning device systems; minimum requirements; general.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Automatic fire sensor and warning device systems; minimum requirements; general. 75.1103-3 Section 75.1103-3 Mineral Resources MINE SAFETY AND...-UNDERGROUND COAL MINES Fire Protection § 75.1103-3 Automatic fire sensor and warning device systems; minimum...

21 CFR 880.5475 - Jet lavage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5475..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b...

21 CFR 880.5680 - Pediatric position holder.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic... requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69682-69737, Oct. 21...

21 CFR 880.5680 - Pediatric position holder.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic... requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69682-69737, Oct. 21...

Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children.

PubMed

Vinney, Lisa A; Grade, John D; Connor, Nadine P

2012-01-01

The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus, we used a cross-over design to compare responses to a pediatric health quality of life instrument (PedsQL 4.0) delivered using a handheld electronic device to those from a traditional paper form. Respondents were children with (n=9) and without (n=10) a speech or voice disorder. For paper versus the electronic format, we examined time to completion, number of incomplete or inaccurate question responses, intra-rater reliability, ease of use, and child and parent preference. There were no significant differences between children's scores, time to complete the measure, or ratings related to ease of answering questions. The percentage of children who made answering errors or omissions with paper and pencil was significantly greater than the percentage of children who made such errors using the device. This preliminary study demonstrated that use of an electronic device to collect QOL or patient-reported outcomes (PRO) data from children is more efficient than and just as feasible, reliable, and acceptable as using paper forms. The development of hardware and software applications for the collection of QOL and/or PRO data in children with speech disorders is likely warranted. The reader will be able to understand: (1) The potential benefits of using electronic data capture via handheld devices for collecting pediatric patient reported outcomes; (2) The Pediatric Quality of Life Inventory 4.0 is a measure of the perception of general health quality that has distinguished between healthy children and those with chronic health conditions; (3) Past research in communication disorders indicates that voice and speech disorders may impact quality of life in children; (4) Based on preliminary data, electronic collection of patient reported outcomes in children with and without speech/voice disorders is more efficient and equally feasible, reliable, and acceptable when compared to paper forms. Copyright © 2011 Elsevier Inc. All rights reserved.

21 CFR 880.5700 - Neonatal phototherapy unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic... of one or more lamps that emit a specific spectral band of light, under which an infant is placed for...

21 CFR 880.2930 - Apgar timer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2930... requirements concerning records, and § 820.198 of this chapter, with respect to complaint files. [63 FR 59718...

21 CFR 880.2930 - Apgar timer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2930... requirements concerning records, and § 820.198 of this chapter, with respect to complaint files. [63 FR 59718...

21 CFR 880.5025 - I.V. container.

Code of Federal Regulations, 2010 CFR

2010-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices § 880.5025 I.V. container. (a) Identification. An I.V. container is a container made of plastic or glass used...

JPRS Report, Arms Control

DTIC Science & Technology

1989-10-04

General Trading , Sharjah, which, in turn, apparently sold the chemical to M/s Rhcinscn chemical products GnbH, Düsseldorf, West Germany. He said Transpek...Situation 30 Sep-2 Oct [Prague Radio 29 Sep] 2 Tank Dismantling Begins in North Moravia [CTK 28 Sep] 2 Jackson Hole Meetings ’Very Productive ’ [J...13 Missile Project Consortium [THE TELEGRAPH 10 Jim] 14 Production of Missile Devices [S. Srinivasan; THE TELEGRAPH 14 Jim] 15

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

Infrared transmission of electronic information via LAN in the operating room.

PubMed

Hagihira, S; Takashina, M; Mori, T; Taenaka, N; Mashimo, T; Yoshiya, I

2000-01-01

Recent advances in technology have brought many kinds of monitoring devices into the operating room (OR). The information gathered by monitors can be channeled to the operating ward information system via a local area network (LAN). Connecting patients to monitors and monitors to the LAN, however, requires a large number of cables. This wiring is generally inconvenient and particularly troublesome if the layout of the OR is rearranged. From this point of view, wireless transmission seems ideally suited to clinical settings. Currently, two modes of wireless connectivity are available: radio-frequency (RF) waves or infrared (IR) waves. Some reports suggest that RF transmission is likely to cause electromagnetic interference (EMI) in medical devices such as cardiac pacemakers or infusion pumps. The risk of malfunctioning life-sustaining devices and the catastrophic consequences this would have on seriously ill patients rules out the use of RF. Here, we report an IR system using IR modems for LAN connectivity in the OR. In this study, we focused on the possible detrimental effects of EMI during wireless connectivity. In our trial, we found no evidence of EMI of IR modems with any of the medical devices we tested. Furthermore, IR modems showed similar performance to a wired system even in an electrically noisy environment. We conclude that IR wireless connectivity can be safely and effectively used in ORs.

An In-home Advanced Robotic System to Manage Elderly Home-care Patients' Medications: A Pilot Safety and Usability Study.

PubMed

Rantanen, Pekka; Parkkari, Timo; Leikola, Saija; Airaksinen, Marja; Lyles, Alan

2017-05-01

We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic malfunctions would hinder the device's safe use. Phase II involved home-care patients from 3 sites (n = 27) who were on long-term medication. On-time dispensing and missed doses were recorded by the robotic system. Patients' and nurses' experiences were assessed with structured interviews. The 17 nursing home patients had 457 total days using the device (Phase I; mean, 26.9 per patient). On-time sachet retrieval occurred with 97.7% of the alerts, and no medication doses were missed. At baseline, Phase II home-dwelling patients reported difficulty remembering to take their medicines (23%), and 18% missed at least 2 doses per week. Most Phase II patients (78%) lived alone. The device delivered and patients retrieved medicine sachets for 99% of the alerts. All patients and 96% of nurses reported the device was easy to use. This trial demonstrated the safety profile and usability of an in-home advanced robotic device and telecare system and its acceptability to patients and nurses. It supports individualized patient dosing schedules, patient-provider communications, and on-time, in-home medication delivery to promote adherence. Real time dose-by-dose monitoring and communication with providers if a dose is missed provide oversight generally not seen in home care. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... and 11, 2012, the committee will discuss general issues related to medical devices intended for obese...

78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...

A randomized trial of standardized nursing patient assessment using wireless devices.

PubMed

Dykes, Patricia C; Carroll, Diane L; Benoit, Angela; Coakley, Amanda; Chang, Frank; Empoliti, Joanne; Gallagher, Joan; Lasala, Cynthia; O'Malley, Rosemary; Rath, Greg; Silva, Judy; Li, Qi

2007-10-11

A complete and accurate patient assessment database is essential for effective communication, problem identification, planning and evaluation of patient status. When employed consistently for point-of-care documentation, information systems are associated with completeness and quality of documentation. The purpose of this paper is to report on the findings of a randomized, cross-over study conducted to evaluate the adequacy of a standard patient assessment module to support problem identification, care planning and tracking of nursing sensitive patient outcomes. The feasibility of wireless devices to support patient assessment data collection at the point-of-care was evaluated using wireless PDAs and tablet PCs. Seventy-nine (79) nurses from two patient care units at Massachusetts General Hospital (Boston, MA) were recruited into the study and randomized to complete patient assessment using wireless or paper devices. At the end of six weeks, nurses who where randomized to the paper assessment module were assigned to a device and those who used a device were assigned to paper for an additional six weeks. Impact was evaluated with regard to data capture, workflow implications and nurse satisfaction. Findings suggest that a standard patient assessment set promotes patient sensitive and quality data capture, which is augmented by the use of wireless devices.

A Randomized Trial of Standardized Nursing Patient Assessment Using Wireless Devices

PubMed Central

Dykes, Patricia C.; Carroll, Diane L.; Benoit, Angela; Coakley, Amanda; Chang, Frank; Empoliti, Joanne; Gallagher, Joan; Lasala, Cynthia; O’Malley, Rosemary; Rath, Greg; Silva, Judy; Li, Qi

2007-01-01

A complete and accurate patient assessment database is essential for effective communication, problem identification, planning and evaluation of patient status. When employed consistently for point-of-care documentation, information systems are associated with completeness and quality of documentation. The purpose of this paper is to report on the findings of a randomized, cross-over study conducted to evaluate the adequacy of a standard patient assessment module to support problem identification, care planning and tracking of nursing sensitive patient outcomes. The feasibility of wireless devices to support patient assessment data collection at the point-of-care was evaluated using wireless PDAs and tablet PCs. Seventy-nine (79) nurses from two patient care units at Massachusetts General Hospital (Boston, MA) were recruited into the study and randomized to complete patient assessment using wireless or paper devices. At the end of six weeks, nurses who where randomized to the paper assessment module were assigned to a device and those who used a device were assigned to paper for an additional six weeks. Impact was evaluated with regard to data capture, workflow implications and nurse satisfaction. Findings suggest that a standard patient assessment set promotes patient sensitive and quality data capture, which is augmented by the use of wireless devices. PMID:18693827

Automated Long-Term Monitoring of Parallel Microfluidic Operations Applying a Machine Vision-Assisted Positioning Method

PubMed Central

Yip, Hon Ming; Li, John C. S.; Cui, Xin; Gao, Qiannan; Leung, Chi Chiu

2014-01-01

As microfluidics has been applied extensively in many cell and biochemical applications, monitoring the related processes is an important requirement. In this work, we design and fabricate a high-throughput microfluidic device which contains 32 microchambers to perform automated parallel microfluidic operations and monitoring on an automated stage of a microscope. Images are captured at multiple spots on the device during the operations for monitoring samples in microchambers in parallel; yet the device positions may vary at different time points throughout operations as the device moves back and forth on a motorized microscopic stage. Here, we report an image-based positioning strategy to realign the chamber position before every recording of microscopic image. We fabricate alignment marks at defined locations next to the chambers in the microfluidic device as reference positions. We also develop image processing algorithms to recognize the chamber positions in real-time, followed by realigning the chambers to their preset positions in the captured images. We perform experiments to validate and characterize the device functionality and the automated realignment operation. Together, this microfluidic realignment strategy can be a platform technology to achieve precise positioning of multiple chambers for general microfluidic applications requiring long-term parallel monitoring of cell and biochemical activities. PMID:25133248

What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review.

PubMed

Caro, Mario A; Rosenthal, Julie L; Kendall, Kay; Pozuelo, Leopoldo; Funk, Margo C

2016-01-01

The number of patients with end-stage heart failure using mechanical circulatory support has dramatically increased over the past decade. Left ventricular assist devices, the most common type of mechanical circulatory support, can be used as a bridge to transplant, destination therapy, and as a bridge to recovery. As this patient population continues to grow, consultation-liaison psychiatrists will become increasingly involved in their care. A thorough biopsychosocial assessment is required to ensure adequate recognition and management of medical, psychiatric, social, and ethical challenges posed by this population. We performed a literature review to identify key issues relevant to the practice of consultation-liaison psychiatrists. General functioning of left ventricular assist devices, device types, system components, life with a left ventricular assist device, preoperative evaluation, treatment of psychiatric comorbidities, and end-of-life decision-making are discussed. Consultation-liaison psychiatrists need to be familiar with the high prevalence of psychopathology in patients implanted with left ventricular assist devices. A detailed biopsychosocial formulation is required to adequately identify and, if possible, resolve a myriad of medical, psychiatric, social, and ethical challenges presented by this population. Future efforts should accurately identify and report specific psychiatric disorders and adverse events within this cohort. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

The Dangers of Dental Devices as reported in the FDA MAUDE Database

PubMed Central

Hebballi, Nutan B; Ramoni, Rachel; Kalenderian, Elsbeth; Delattre, Veronique F.; Stewart, Denice C.L.; Kent, Karla; White, Joel M; Vaderhobli, Ram; Walji, Muhammad F

2014-01-01

Objectives To determine the frequency and type of adverse events (AEs) associated with dental devices reported to Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods We downloaded and thoroughly reviewed the dental device-related AEs reported to MAUDE from January 01, 1996 – December 31, 2011. Results MAUDE received a total of 1,978,056 reports between January 01, 1996 and December 31, 2011. Among these reports, 28,046 (1.4 percent) AEs reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 actually reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. 53.5 percent of the dental device associated AEs pertained to endosseous implants. Conclusion There is a plethora of devices used in dental care, and to achieve Element 1 of AHRQ’s Patient Safety Initiative, we must be able to monitor the safety of dental devices. While MAUDE is essentially the single source of this valuable information, our investigations led us to conclude that it currently has major limitations that prevent it from being the broad-based patient safety sentinel the profession requires. Practical Implications As potential contributors to MAUDE, dental care teams play a key role in improving the profession’s access to information about the safety of dental devices. PMID:25637208

Three upper limb robotic devices for stroke rehabilitation: a review and clinical perspective.

PubMed

Bishop, Lauri; Stein, Joel

2013-01-01

Stroke is a leading cause of disability worldwide. Many survivors of stroke remain with residual disabilities, even years later. Advances in technology have led to the development of a variety of robotic devices for use in rehabilitation. The integration of robotics in the delivery of neurorehabilitation is promising, but still not widely used in clinical settings. The aim of this review is to discuss the general design of three typical upper limb robotic devices, and examine the practical considerations for their use in a clinical environment. Each device is described, the available clinical literature is reviewed and a clinical perspective is given on the usefulness of these robotic devices in rehabilitation of this population. Current literature supports the use of robotics in the clinical environment. However, claims that robotic therapy is more effective than traditional treatment is not substantially supported. The majority of clinical trials reported are small, and lack the use of a control group for comparison treatment. The use of robotics in stroke rehabilitation is still a relatively new treatment platform, and still evolving. As technological advances are made, there is much potential for growth in this field.

Statistical inference for the within-device precision of quantitative measurements in assay validation.

PubMed

Liu, Jen-Pei; Lu, Li-Tien; Liao, C T

2009-09-01

Intermediate precision is one of the most important characteristics for evaluation of precision in assay validation. The current methods for evaluation of within-device precision recommended by the Clinical Laboratory Standard Institute (CLSI) guideline EP5-A2 are based on the point estimator. On the other hand, in addition to point estimators, confidence intervals can provide a range for the within-device precision with a probability statement. Therefore, we suggest a confidence interval approach for assessment of the within-device precision. Furthermore, under the two-stage nested random-effects model recommended by the approved CLSI guideline EP5-A2, in addition to the current Satterthwaite's approximation and the modified large sample (MLS) methods, we apply the technique of generalized pivotal quantities (GPQ) to derive the confidence interval for the within-device precision. The data from the approved CLSI guideline EP5-A2 illustrate the applications of the confidence interval approach and comparison of results between the three methods. Results of a simulation study on the coverage probability and expected length of the three methods are reported. The proposed method of the GPQ-based confidence intervals is also extended to consider the between-laboratories variation for precision assessment.

Increasing cell-device adherence using cultured insect cells for receptor-based biosensors

NASA Astrophysics Data System (ADS)

Terutsuki, Daigo; Mitsuno, Hidefumi; Sakurai, Takeshi; Okamoto, Yuki; Tixier-Mita, Agnès; Toshiyoshi, Hiroshi; Mita, Yoshio; Kanzaki, Ryohei

2018-03-01

Field-effect transistor (FET)-based biosensors have a wide range of applications, and a bio-FET odorant sensor, based on insect (Sf21) cells expressing insect odorant receptors (ORs) with sensitivity and selectivity, has emerged. To fully realize the practical application of bio-FET odorant sensors, knowledge of the cell-device interface for efficient signal transfer, and a reliable and low-cost measurement system using the commercial complementary metal-oxide semiconductor (CMOS) foundry process, will be indispensable. However, the interfaces between Sf21 cells and sensor devices are largely unknown, and electrode materials used in the commercial CMOS foundry process are generally limited to aluminium, which is reportedly toxic to cells. In this study, we investigated Sf21 cell-device interfaces by developing cross-sectional specimens. Calcium imaging of Sf21 cells expressing insect ORs was used to verify the functions of Sf21 cells as odorant sensor elements on the electrode materials. We found that the cell-device interface was approximately 10 nm wide on average, suggesting that the adhesion mechanism of Sf21 cells may differ from that of other cells. These results will help to construct accurate signal detection from expressed insect ORs using FETs.

Increasing cell–device adherence using cultured insect cells for receptor-based biosensors

PubMed Central

Mitsuno, Hidefumi; Sakurai, Takeshi; Okamoto, Yuki; Tixier-Mita, Agnès; Toshiyoshi, Hiroshi; Mita, Yoshio; Kanzaki, Ryohei

2018-01-01

Field-effect transistor (FET)-based biosensors have a wide range of applications, and a bio-FET odorant sensor, based on insect (Sf21) cells expressing insect odorant receptors (ORs) with sensitivity and selectivity, has emerged. To fully realize the practical application of bio-FET odorant sensors, knowledge of the cell–device interface for efficient signal transfer, and a reliable and low-cost measurement system using the commercial complementary metal-oxide semiconductor (CMOS) foundry process, will be indispensable. However, the interfaces between Sf21 cells and sensor devices are largely unknown, and electrode materials used in the commercial CMOS foundry process are generally limited to aluminium, which is reportedly toxic to cells. In this study, we investigated Sf21 cell–device interfaces by developing cross-sectional specimens. Calcium imaging of Sf21 cells expressing insect ORs was used to verify the functions of Sf21 cells as odorant sensor elements on the electrode materials. We found that the cell–device interface was approximately 10 nm wide on average, suggesting that the adhesion mechanism of Sf21 cells may differ from that of other cells. These results will help to construct accurate signal detection from expressed insect ORs using FETs. PMID:29657822

An Integrated Device View on Photo-Electrochemical Solar-Hydrogen Generation.

PubMed

Modestino, Miguel A; Haussener, Sophia

2015-01-01

Devices that directly capture and store solar energy have the potential to significantly increase the share of energy from intermittent renewable sources. Photo-electrochemical solar-hydrogen generators could become an important contributor, as these devices can convert solar energy into fuels that can be used throughout all sectors of energy. Rather than focusing on scientific achievement on the component level, this article reviews aspects of overall component integration in photo-electrochemical water-splitting devices that ultimately can lead to deployable devices. Throughout the article, three generalized categories of devices are considered with different levels of integration and spanning the range of complete integration by one-material photo-electrochemical approaches to complete decoupling by photovoltaics and electrolyzer devices. By using this generalized framework, we describe the physical aspects, device requirements, and practical implications involved with developing practical photo-electrochemical water-splitting devices. Aspects reviewed include macroscopic coupled multiphysics device models, physical device demonstrations, and economic and life cycle assessments, providing the grounds to draw conclusions on the overall technological outlook.

Portable Diagnostics Technology Assessment for Space Missions. Part 1; General Technology Capabilities for NASA Exploration Missions

NASA Technical Reports Server (NTRS)

Nelson, Emily S.; Chait, Arnon

2010-01-01

The changes in the scope of NASA s mission in the coming decade are profound and demand nimble, yet insightful, responses. On-board clinical and environmental diagnostics must be available for both mid-term lunar and long-term Mars exploration missions in an environment marked by scarce resources. Miniaturization has become an obvious focus. Despite solid achievements in lab-based devices, broad-based, robust tools for application in the field are not yet on the market. The confluence of rapid, wide-ranging technology evolution and internal planning needs are the impetus behind this work. This report presents an analytical tool for the ongoing evaluation of promising technology platforms based on mission- and application-specific attributes. It is not meant to assess specific devices, but rather to provide objective guidelines for a rational down-select of general categories of technology platforms. In this study, we have employed our expertise in the microgravity operation of fluidic devices, laboratory diagnostics for space applications, and terrestrial research in biochip development. A rating of the current state of technology development is presented using the present tool. Two mission scenarios are also investigated: a 30-day lunar mission using proven, tested technology in 5 years; and a 2- to 3-year mission to Mars in 10 to 15 years.

Need and availability of assistive devices to compensate for impaired hand function of individuals with tetraplegia.

PubMed

Wäckerlin, Stephanie; Gemperli, Armin; Sigrist-Nix, Diana; Arnet, Ursina

2018-06-04

Context/Objective To evaluate the availability and self-declared unmet need of assistive devices to compensate for impaired hand function of individuals with tetraplegia in Switzerland. Design Cross-sectional survey. Setting Community. Participants Individuals with tetraplegia, aged 16 years or older, living in Switzerland. Interventions not applicable. Outcome Measures The self-report availability and unmet need of 18 assistive devices for impaired hand function was analyzed descriptively. The availability of devices was further evaluated stratified by sex, age, SCI severity, independence in grooming, time since injury, living situation, working status, and income. Associations between availability of devices and person characteristics were investigated using logistic regression analysis. Results Overall 32.7% of participants had any assistive device for impaired hand function at their disposal. The most frequent devices were adapted cutlery (14.8%), type supports (14.1%), environmental control systems (11.4%), and writing orthosis (10.6%). In the bivariate analysis several factors showed significant associations with at least one assistive device. Nevertheless, when controlling for potential confounding in multivariate analysis only independence in grooming (adapted cutlery, environmental control systems, type support, speech recognition software), SCI severity (writing orthosis, type support), and sex (adapted kitchenware) remained significantly associated with the availability of the mentioned assistive devices. The self-declared unmet need was generally low (0.7% - 4.3%), except for adapted kitchenware with a moderate unmet need (8.9%). Conclusion This study indicates that most individuals with tetraplegia in Switzerland are adequately supplied with assistive devices to compensate for impaired hand function. The availability depends mainly on SCI severity and independence in grooming.

47 CFR 2.801 - Radiofrequency device defined.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Radiofrequency device defined. 2.801 Section 2... MATTERS; GENERAL RULES AND REGULATIONS Marketing of Radio-frequency Devices § 2.801 Radiofrequency device defined. As used in this part, a radiofrequency device is any device which in its operation is capable of...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

Initial Asian experience in hysteroscopic sterilisation using the Essure permanent birth control device.

PubMed

Chern, Bernard; Siow, Anthony

2005-09-01

To present our initial experience in the use of the Essure permanent birth control device in a predominately Asian population. A retrospective study. Minimally Invasive Surgery Unit, KK Women's and Children's Hospital, Singapore. Eighty women seeking permanent birth control. From 22 June 2001, women who sought sterilisation were counselled with regards to the various options of permanent birth control. Informed consent for hysteroscopic sterilisation was obtained only after the woman met the criteria for Essure permanent birth control. The sterilisation procedure was carried out without the need for general anaesthesia in a day surgery centre using the Essure permanent birth control device. The surgical details and post procedure follow up were analysed. Feasibility and safety of the Essure permanent birth control device in Asians and its non-placement rate. No serious adverse events or complications were encountered in using the Essure device. No pregnancies have been reported in our series to date. A significant reduction in the Essure device non-placement rate (20.0%vs 4.0%, P= 0.021) and mean operation time (27.3 vs 19.6 minutes, P= 0.006) were seen when patients were pre-medicated with spasmolytic agent and analgesia. The Essure permanent birth control device is safe and suitable for Asians. Its non-placement rate may be improved with pre-medication of spasmolytic agent and analgesia.

Analysis of quantum information processors using quantum metrology

NASA Astrophysics Data System (ADS)

Kandula, Mark J.; Kok, Pieter

2018-06-01

Physical implementations of quantum information processing devices are generally not unique, and we are faced with the problem of choosing the best implementation. Here, we consider the sensitivity of quantum devices to variations in their different components. To measure this, we adopt a quantum metrological approach and find that the sensitivity of a device to variations in a component has a particularly simple general form. We use the concept of cost functions to establish a general practical criterion to decide between two different physical implementations of the same quantum device consisting of a variety of components. We give two practical examples of sensitivities of quantum devices to variations in beam splitter transmittivities: the Knill-Laflamme-Milburn (KLM) and reverse nonlinear sign gates for linear optical quantum computing with photonic qubits, and the enhanced optical Bell detectors by Grice and Ewert and van Loock. We briefly compare the sensitivity to the diamond distance and find that the latter is less suited for studying the behavior of components embedded within the larger quantum device.

21 CFR 886.1700 - Pupillometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... eye. (b) Classification. Class I (general controls). The AC-powered device and the manual device are... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1700 Pupillometer. (a) Identification. A pupillometer is an AC...

77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-05

... Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency... utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative...

75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

Increasing the density of passive photonic-integrated circuits via nanophotonic cloaking

PubMed Central

Shen, Bing; Polson, Randy; Menon, Rajesh

2016-01-01

Photonic-integrated devices need to be adequately spaced apart to prevent signal cross-talk. This fundamentally limits their packing density. Here we report the use of nanophotonic cloaking to render neighbouring devices invisible to one another, which allows them to be placed closer together than is otherwise feasible. Specifically, we experimentally demonstrated waveguides that are spaced by a distance of ∼λ0/2 and designed waveguides with centre-to-centre spacing as small as 600 nm (<λ0/2.5). Our experiments show a transmission efficiency >−2 dB and an extinction ratio >15 dB over a bandwidth larger than 60 nm. This performance can be improved with better design algorithms and industry-standard lithography. The nanophotonic cloak relies on multiple guided-mode resonances, which render such devices very robust to fabrication errors. Our devices are broadly complimentary-metal-oxide-semiconductor compatible, have a minimum pitch of 200 nm and can be fabricated with a single lithography step. The nanophotonic cloaks can be generally applied to all passive integrated photonics. PMID:27827391

Increasing the density of passive photonic-integrated circuits via nanophotonic cloaking

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shen, Bing; Polson, Randy; Menon, Rajesh

Photonic-integrated devices need to be adequately spaced apart to prevent signal cross-talk. This fundamentally limits their packing density. Here we report the use of nanophotonic cloaking to render neighbouring devices invisible to one another, which allows them to be placed closer together than is otherwise feasible. Specifically, we experimentally demonstrated waveguides that are spaced by a distance of ~λ 0/2 and designed waveguides with centre-to-centre spacing as small as 600 nm (0/2.5). Our experiments show a transmission efficiency >–2 dB and an extinction ratio >15 dB over a bandwidth larger than 60 nm. This performance can be improved with bettermore » design algorithms and industry-standard lithography. The nanophotonic cloak relies on multiple guided-mode resonances, which render such devices very robust to fabrication errors. Our devices are broadly complimentary-metal-oxide-semiconductor compatible, have a minimum pitch of 200 nm and can be fabricated with a single lithography step. In conclusion, the nanophotonic cloaks can be generally applied to all passive integrated photonics.« less

Increasing the density of passive photonic-integrated circuits via nanophotonic cloaking

DOE PAGES

Shen, Bing; Polson, Randy; Menon, Rajesh

2016-11-09

Photonic-integrated devices need to be adequately spaced apart to prevent signal cross-talk. This fundamentally limits their packing density. Here we report the use of nanophotonic cloaking to render neighbouring devices invisible to one another, which allows them to be placed closer together than is otherwise feasible. Specifically, we experimentally demonstrated waveguides that are spaced by a distance of ~λ 0/2 and designed waveguides with centre-to-centre spacing as small as 600 nm (0/2.5). Our experiments show a transmission efficiency >–2 dB and an extinction ratio >15 dB over a bandwidth larger than 60 nm. This performance can be improved with bettermore » design algorithms and industry-standard lithography. The nanophotonic cloak relies on multiple guided-mode resonances, which render such devices very robust to fabrication errors. Our devices are broadly complimentary-metal-oxide-semiconductor compatible, have a minimum pitch of 200 nm and can be fabricated with a single lithography step. In conclusion, the nanophotonic cloaks can be generally applied to all passive integrated photonics.« less

Prospective intra-patient evaluation of a shoulder retraction device for radiotherapy in head and neck cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Newbold, Katie L., E-mail: kate.newbold@rmh.nhs.uk; Bhide, Shreerang; The Institute of Cancer Research, London

Irradiation of tumors in the larynx and pharynx is often technically challenging in patients with a short neck or high shoulders. Shoulder retraction devices can sometimes resolve this problem and allow irradiation via lateral beam directions. This study aimed to measure the proportion of patients who would benefit from such an approach and to quantify the magnitude of the benefit obtained. Twenty patients were studied. Simulator images were obtained before and after intervention. The additional exposure of the cervical spine was measured. Patient comfort and acceptability were assessed with a questionnaire. Improvement of exposure of the cervical spine was observedmore » in 80% of patients. In 20%, there was either no difference or the position was worse. Shoulder retraction exposed a mean of 8.4-10.2 mm more of the cervical spine. Patients in general reported the device as comfortable. The use of a shoulder retraction device produced clinically significant improvements in exposure of the tissues of the cervical spine and neck and should be considered in patients being irradiated for tumors arising in the larynx or hypopharynx.« less

A Qualitative Assessment of Beliefs, Attitudes, and Behaviors Related to Diarrhea and Water Filtration in Rural Kenya

PubMed Central

Apondi, Rose; Lugada, Eric; Kahn, James G.; Sandiford-Day, Mary Ann; DasBanerjee, Tania

2011-01-01

Objectives. We qualitatively assessed beliefs, attitudes, and behaviors related to diarrhea and water filtration in rural Kenya. Methods. A public health campaign was conducted in rural western Kenya to give community members a comprehensive prevention package of goods and services, including a personal water filter or a household water filter (or both). Two months after the campaign, we conducted qualitative interviews with 34 campaign attendees to assess their beliefs, attitudes, and behaviors related to diarrhea and use of the filtration devices. Results. Participants held generally correct perceptions of diarrhea causation. Participants provided positive reports of their experiences with using filters and of their success with obtaining clean water, reducing disease, and reducing consumption of resources otherwise needed to produce clean water. Several participants offered technical suggestions for device improvements, and most participants were still using the devices at the time of the assessment. Conclusions. Novel water filtration devices distributed as part of a comprehensive public health campaign rapidly proved acceptable to community members and were consistent with community practices and beliefs. PMID:21680914

Increasing the density of passive photonic-integrated circuits via nanophotonic cloaking.

PubMed

Shen, Bing; Polson, Randy; Menon, Rajesh

2016-11-09

Photonic-integrated devices need to be adequately spaced apart to prevent signal cross-talk. This fundamentally limits their packing density. Here we report the use of nanophotonic cloaking to render neighbouring devices invisible to one another, which allows them to be placed closer together than is otherwise feasible. Specifically, we experimentally demonstrated waveguides that are spaced by a distance of ∼λ 0 /2 and designed waveguides with centre-to-centre spacing as small as 600 nm (<λ 0 /2.5). Our experiments show a transmission efficiency >-2 dB and an extinction ratio >15 dB over a bandwidth larger than 60 nm. This performance can be improved with better design algorithms and industry-standard lithography. The nanophotonic cloak relies on multiple guided-mode resonances, which render such devices very robust to fabrication errors. Our devices are broadly complimentary-metal-oxide-semiconductor compatible, have a minimum pitch of 200 nm and can be fabricated with a single lithography step. The nanophotonic cloaks can be generally applied to all passive integrated photonics.

A qualitative assessment of beliefs, attitudes, and behaviors related to diarrhea and water filtration in rural Kenya.

PubMed

De Ver Dye, Timothy; Apondi, Rose; Lugada, Eric; Kahn, James G; Sandiford-Day, Mary Ann; Dasbanerjee, Tania

2011-08-01

We qualitatively assessed beliefs, attitudes, and behaviors related to diarrhea and water filtration in rural Kenya. A public health campaign was conducted in rural western Kenya to give community members a comprehensive prevention package of goods and services, including a personal water filter or a household water filter (or both). Two months after the campaign, we conducted qualitative interviews with 34 campaign attendees to assess their beliefs, attitudes, and behaviors related to diarrhea and use of the filtration devices. Participants held generally correct perceptions of diarrhea causation. Participants provided positive reports of their experiences with using filters and of their success with obtaining clean water, reducing disease, and reducing consumption of resources otherwise needed to produce clean water. Several participants offered technical suggestions for device improvements, and most participants were still using the devices at the time of the assessment. Novel water filtration devices distributed as part of a comprehensive public health campaign rapidly proved acceptable to community members and were consistent with community practices and beliefs.

An emerging network storage management standard: Media error monitoring and reporting information (MEMRI) - to determine optical tape data integrity

NASA Technical Reports Server (NTRS)

Podio, Fernando; Vollrath, William; Williams, Joel; Kobler, Ben; Crouse, Don

1998-01-01

Sophisticated network storage management applications are rapidly evolving to satisfy a market demand for highly reliable data storage systems with large data storage capacities and performance requirements. To preserve a high degree of data integrity, these applications must rely on intelligent data storage devices that can provide reliable indicators of data degradation. Error correction activity generally occurs within storage devices without notification to the host. Early indicators of degradation and media error monitoring 333 and reporting (MEMR) techniques implemented in data storage devices allow network storage management applications to notify system administrators of these events and to take appropriate corrective actions before catastrophic errors occur. Although MEMR techniques have been implemented in data storage devices for many years, until 1996 no MEMR standards existed. In 1996 the American National Standards Institute (ANSI) approved the only known (world-wide) industry standard specifying MEMR techniques to verify stored data on optical disks. This industry standard was developed under the auspices of the Association for Information and Image Management (AIIM). A recently formed AIIM Optical Tape Subcommittee initiated the development of another data integrity standard specifying a set of media error monitoring tools and media error monitoring information (MEMRI) to verify stored data on optical tape media. This paper discusses the need for intelligent storage devices that can provide data integrity metadata, the content of the existing data integrity standard for optical disks, and the content of the MEMRI standard being developed by the AIIM Optical Tape Subcommittee.

Risk of Essure microinsert abdominal migration: case report and review of literature

PubMed Central

Ricci, Giuseppe; Restaino, Stefano; Di Lorenzo, Giovanni; Fanfani, Francesco; Scrimin, Federica; Mangino, Francesco P

2014-01-01

Purpose To report a case of Essure microinsert abdominal migration and literature review. Methods A 41-year-old woman was counseled to undergo Essure sterilization. The procedure was hampered by the presence of endometrial cavity adhesions, obscuring left tubal ostium. By using microscissors the adhesions were progressively lysed. Since the procedure had become very painful, the patient required general anesthesia. Once adhesion lysis was completed, the tubal ostium was well visible. Both devices were then easily introduced into the fallopian tubes. At the end of the procedure, five coils were visible on the right side and five coils on the left side, as recommended. Results The 3-month hysterosalpingogram follow-up suspected abdominal migration of the left device. Laparoscopy confirmed the device displacement in the left lower abdominal quadrant. Both fallopian tubes and the uterus appeared normal. No signs of perforation were detected. The device was embedded into the omentum, but it was easily removed. Bilateral tubal sterilization was performed by bipolar coagulation. Conclusion There are only 13 cases, including the present, of Essure abdominal migration in the literature. In most cases, abdominal displacement of the microinsert is asymptomatic and does not induce tissue damage. However, in some cases, it may cause a severe adverse event, requiring major surgery. Therefore, removal of the migrated device should be performed as soon as possible. Moreover, during presterilization counseling, the patient should also be correctly informed about the risk of this rare but relevant complication, as well as about the surgical interventions that could be required to solve it. PMID:25484591

Differences between Mothers' and Fathers' Ratings of Family Functioning with the Family Assessment Device: The Validity of Combined Parent Scores

ERIC Educational Resources Information Center

Cooke, Dawson; Marais, Ida; Cavanagh, Robert; Kendall, Garth; Priddis, Lynn

2015-01-01

The psychometric properties of the General Functioning subscale of the McMaster Family Assessment Device were examined using the Rasch Model (N = 237 couples). Mothers' and fathers' ratings of the General Functioning subscale of the McMaster Family Assessment Device are recommended, provided these are analyzed separately. More than a quarter of…

Automated touch screen device for recording complex rodent behaviors

PubMed Central

Mabrouk, O.S.; Dripps, I.J.; Ramani, S.; Chang, C.; Han, J.L.; Rice, KC; Jutkiewicz, E.M.

2016-01-01

Background Monitoring mouse behavior is a critical step in the development of modern pharmacotherapies. New Method Here we describe the application of a novel method that utilizes a touch display computer (tablet) and software to detect, record, and report fine motor behaviors. A consumer-grade tablet device is placed in the bottom of a specially made acrylic cage allowing the animal to walk on the device (MouseTrapp). We describe its application in open field (for general locomotor studies) which measures step lengths and velocity. The device can perform light-dark (anxiety) tests by illuminating half of the screen and keeping the other half darkened. A divider is built into the lid of the device allowing the animal free access to either side. Results Treating mice with amphetamine and the delta opioid peptide receptor agonist SNC80 stimulated locomotor activity on the device. Amphetamine increased step velocity but not step length during its peak effect (40–70 min after treatment), thus indicating detection of subtle amphetamine-induced effects. Animals showed a preference (74% of time spent) for the darkened half compared to the illuminated side. Comparison with Existing Method Animals were videotaped within the chamber to compare quadrant crosses to detected motion on the device. The slope, duration and magnitude of quadrant crosses tightly correlated with overall locomotor activity as detected by Mousetrapp. Conclusions We suggest that modern touch display devices such as MouseTrapp will be an important step toward automation of behavioral analyses for characterizing phenotypes and drug effects. PMID:24952323

Type I allergic hypersensitivity reactions due to ethylene oxide sterilised leucocyte filters in patients with thalassaemia: report of four cases.

PubMed

Belen, Burcu; Polat, Meltem

2015-02-27

Ethylene oxide (EO) is a highly reactive gas used in sterilisation of heat sensitive medical devices, such as infusion sets, cannulae, intubation materials, ventriculoperitoneal shunts, dialysis catheters and stents. Allergic reactions due to EO have been reported in haemodialysis patients, patients undergoing extracorporeal photopheresis and donors of plasmapheresis. Clinical manifestations vary considerably and generally do not allow differentiation between IgE-mediated anaphylaxis and anaphylactoid reactions. We report four patients with thalassaemia who experienced anaphylaxis during transfusion due to ethylene oxide sterilised leucocyte filters. The aim of this report is to highlight the fact that frequently transfused patients can have allergic reactions due to EO particles left in leucocyte filters. 2015 BMJ Publishing Group Ltd.

Observation of Frenkel and charge transfer excitons in pentacene single crystals using spectroscopic generalized ellipsometry

NASA Astrophysics Data System (ADS)

Qi, Dongchen; Su, Haibin; Bastjan, M.; Jurchescu, O. D.; Palstra, T. M.; Wee, Andrew T. S.; Rübhausen, M.; Rusydi, A.

2013-09-01

We report on the emerging and admixture of Frenkel and charge transfer (CT) excitons near the absorption onset in pentacene single crystals. Using high energy-resolution spectroscopic generalized ellipsometry with in-plane polarization dependence, the excitonic nature of three lowest lying excitations is discussed. Their distinct polarization dependence strongly indicates the presence of both Frenkel and CT types of excitons near the excitation onset. In particular, the peculiar polarization behavior of the second excitation can only be rationalized by taking into account the inherent CT transition dipole moment. This observation has important implications for the pentacene-based optoelectronic devices.

21 CFR 886.1380 - Diagnostic condensing lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...

21 CFR 892.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.1 Scope. (a) This part sets forth the classification of radiology devices... devices, as required by § 807.87. (c) To avoid duplicative listings, a radiology device that has two or...

Expanding stroke telerehabilitation services to rural veterans: a qualitative study on patient experiences using the robotic stroke therapy delivery and monitoring system program.

PubMed

Cherry, Colleen O'Brien; Chumbler, Neale R; Richards, Kimberly; Huff, Amber; Wu, David; Tilghman, Laura M; Butler, Andrew

2017-01-01

The present study reports on a robotic stroke therapy delivery and monitoring system intervention. The aims of this pilot implementation project were to determine participants' general impressions about the benefits and barriers of using robotic therapy devices for in-home rehabilitation. We used a qualitative study design employing ethnographic-based anthropological methods including direct observation of the in-home environment and in-depth semi-structured interviews with 10 users of the hand or foot robotic devices. Thematic analysis was conducted using an inductive approach. Participants reported positive experiences with the robotic stroke therapy delivery and monitoring system. Benefits included convenience, self-reported increased mobility, improved mood and an outlet for physical and mental tension and anxiety. Barriers to use were few and included difficulties with placing the device on the body, bulkiness of the monitor and modem connection problems. Telerehabilitation robotic devices can be used as a tool to extend effective, evidence-based and specialized rehabilitation services for upper and lower limb rehabilitation to rural Veterans with poor access to care. Implications for Rehabilitation Participants whose formal therapy services had ended either because they had exhausted their benefits or because traveling to outpatient therapy was too cumbersome due to distance were able to perform therapeutic activities in the home daily (or at least multiple times per week). Participants who were still receiving formal therapy services either in-home or in the clinic were able to perform therapeutic activities in the home on the days they were not attending/receiving formal therapy. Based on the feedback from these veterans and their caregivers, the manufacturing company is working on modifying the devices to be less cumbersome and more user-friendly (lighter-weight, more mobile, changing software, etc.), as well as more adaptable to participants' homes. Removing these specific barriers will potentially allow participants to utilize the device more easily and more frequently. Since participants expressed that they wished they could have the device in their homes longer than the 3-month usage period required for this pilot project, the project team is working on a proposal to extend this project to a wider area and the new paradigm would extend the usage period until the patient reaches a plateau in progress or no longer wants to use the device.

Progress of OLED devices with high efficiency at high luminance

NASA Astrophysics Data System (ADS)

Nguyen, Carmen; Ingram, Grayson; Lu, Zhenghong

2014-03-01

Organic light emitting diodes (OLEDs) have progressed significantly over the last two decades. For years, OLEDs have been promoted as the next generation technology for flat panel displays and solid-state lighting due to their potential for high energy efficiency and dynamic range of colors. Although high efficiency can readily be obtained at low brightness levels, a significant decline at high brightness is commonly observed. In this report, we will review various strategies for achieving highly efficient phosphorescent OLED devices at high luminance. Specifically, we will provide details regarding the performance and general working principles behind each strategy. We will conclude by looking at how some of these strategies can be combined to produce high efficiency white OLEDs at high brightness.

Optical Electronic Bragg Reflection Sensor System with Hydrodynamic Flow Applications

NASA Technical Reports Server (NTRS)

Lyons, D. R.

2003-01-01

This project, as described in the following report, involved design and fabrication of fiber optic sensors for the detection and measurement of dynamic fluid density variations. These devices are created using UV (ultraviolet) ablation and generally modified transverse holographic fiber grating techniques. The resulting phase gratings created on or immediately underneath the flat portion of D-shaped optical waveguides are characterized as evanescent field sensing devices. The primary applications include the sensor portion of a real-time localized or distributed measurement system for hydrodynamic flow, fluid density measurements, and phase change phenomena. Several design modifications were implemented in an attempt to accomplish the tasks specified in our original proposal. In addition, we have established key collaborative relationships with numerous people and institutions.

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General... also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus...

77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General..., introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. FDA intends to...

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

Can EDA Combat the Rise of Electronic Counterfeiting?

DTIC Science & Technology

2012-06-01

Categories and Subject Descriptors B .7 [Hardware]: Integrated Circuits General Terms Design, Security Keywords Counterfeiting; Reliability; Device and...1199-1/12/06 ...$10.00. SIA at $7.5 B . Very recently, EE Times estimated that IC counterfeiting losses are as high as $ 169 B annually. There- fore, the...PERSON a. REPORT unclassified b . ABSTRACT unclassified c. THIS PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18

Human-Agent Teaming for Multi-Robot Control: A Literature Review

DTIC Science & Technology

2013-02-01

neurophysiological devices are becoming more cost effective and less invasive, future systems will most likely take advantage of this technology to monitor...Parasuraman et al., 1993). It has also been reported that both the cost of automation errors and the cost of verification affect humans’ reliance on...decision aids, and the effects are also moderated by age (Ezer et al., 2008). Generally, reliance is reduced as the cost of error increases and it

Dispersion, Mixing, and Combustion in Uniform- and Variable-Density Air-Breathing High-Speed Propulsion Flows

DTIC Science & Technology

2013-08-28

and dispersion whose behavior is relevant to fuel-injection in propulsion devices. The latter investigations were conducted in water that allows...initially sharp scalar gradients in this high Schmidt-number fluid medium ( water : ⁄ ). Generally, such scalar plumes re reported to exhibit... Flowmetering : The Characteristics of Cylindrical Nozzles with Sharp Upstream Edges. Int. J. Heat and Fluid Flow 1(3):123-132. 3. Research personnel

Development of concepts for satellite retrieval devices

NASA Technical Reports Server (NTRS)

Pruett, E. C.; Robertson, K. B., III; Loughead, T. E.

1979-01-01

The teleoperator being developed to augment the Space Transportation System (STS) for satellite placement, retrieval, or servicing at altitudes or orbital planes where it would be impractical to use the shuttle is primarily a general purpose propulsion stage that can be fitted with manipulator arms, automated servicers and satellite retrieval devices for particular missions. Design concepts for a general purpose retrieval device for docking with a satellite to which a grappling fixture has been attached, and for a retrieval device for docking with the Solar Maximum Mission (SMM) spacecraft were defined. The mechanical aspects of these two devices are discussed as well as the crew operations involved and problems created by the requirement for remote control. Drawings for the two retrieval device concepts are included.

21 CFR 872.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

21 CFR 872.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

21 CFR 872.6570 - Impression tube.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 886.1770 - Manual refractor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

Estimation of the two-dimensional presampled modulation transfer function of digital radiography devices using one-dimensional test objects

PubMed Central

Wells, Jered R.; Dobbins, James T.

2012-01-01

Purpose: The modulation transfer function (MTF) of medical imaging devices is commonly reported in the form of orthogonal one-dimensional (1D) measurements made near the vertical and horizontal axes with a slit or edge test device. A more complete description is found by measuring the two-dimensional (2D) MTF. Some 2D test devices have been proposed, but there are some issues associated with their use: (1) they are not generally available; (2) they may require many images; (3) the results may have diminished accuracy; and (4) their implementation may be particularly cumbersome. This current work proposes the application of commonly available 1D test devices for practical and accurate estimation of the 2D presampled MTF of digital imaging systems. Methods: Theory was developed and applied to ensure adequate fine sampling of the system line spread function for 1D test devices at orientations other than approximately vertical and horizontal. Methods were also derived and tested for slit nonuniformity correction at arbitrary angle. Techniques were validated with experimental measurements at ten angles using an edge test object and three angles using a slit test device on an indirect-detection flat-panel system [GE Revolution XQ/i (GE Healthcare, Waukesha, WI)]. The 2D MTF was estimated through a simple surface fit with interpolation based on Delaunay triangulation of the 1D edge-based MTF measurements. Validation by synthesis was also performed with simulated images from a hypothetical direct-detection flat-panel device. Results: The 2D MTF derived from physical measurements yielded an average relative precision error of 0.26% for frequencies below the cutoff (2.5 mm−1) and approximate circular symmetry at frequencies below 4 mm−1. While slit analysis generally agreed with the results of edge analysis, the two showed subtle differences at frequencies above 4 mm−1. Slit measurement near 45° revealed radial asymmetry in the MTF resulting from the square pixel aperture (0.2 mm × 0.2 mm), a characteristic which was not necessarily appreciated with the orthogonal 1D MTF measurements. In simulation experiments, both slit- and edge-based measurements resolved the radial asymmetries in the 2D MTF. The average absolute relative accuracy error in the 2D MTF between the DC and cutoff (2.5 mm−1) frequencies was 0.13% with average relative precision error of 0.11%. Other simulation results were similar to those derived from physical data. Conclusions: Overall, the general availability, acceptance, accuracy, and ease of implementation of 1D test devices for MTF assessment make this a valuable technique for 2D MTF estimation. PMID:23039654

Estimation of the two-dimensional presampled modulation transfer function of digital radiography devices using one-dimensional test objects

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wells, Jered R.; Dobbins, James T. III; Carl E. Ravin Advanced Imaging Laboratories, Duke University Medical Center, Durham, North Carolina 27705

2012-10-15

Purpose: The modulation transfer function (MTF) of medical imaging devices is commonly reported in the form of orthogonal one-dimensional (1D) measurements made near the vertical and horizontal axes with a slit or edge test device. A more complete description is found by measuring the two-dimensional (2D) MTF. Some 2D test devices have been proposed, but there are some issues associated with their use: (1) they are not generally available; (2) they may require many images; (3) the results may have diminished accuracy; and (4) their implementation may be particularly cumbersome. This current work proposes the application of commonly available 1Dmore » test devices for practical and accurate estimation of the 2D presampled MTF of digital imaging systems. Methods: Theory was developed and applied to ensure adequate fine sampling of the system line spread function for 1D test devices at orientations other than approximately vertical and horizontal. Methods were also derived and tested for slit nonuniformity correction at arbitrary angle. Techniques were validated with experimental measurements at ten angles using an edge test object and three angles using a slit test device on an indirect-detection flat-panel system [GE Revolution XQ/i (GE Healthcare, Waukesha, WI)]. The 2D MTF was estimated through a simple surface fit with interpolation based on Delaunay triangulation of the 1D edge-based MTF measurements. Validation by synthesis was also performed with simulated images from a hypothetical direct-detection flat-panel device. Results: The 2D MTF derived from physical measurements yielded an average relative precision error of 0.26% for frequencies below the cutoff (2.5 mm{sup -1}) and approximate circular symmetry at frequencies below 4 mm{sup -1}. While slit analysis generally agreed with the results of edge analysis, the two showed subtle differences at frequencies above 4 mm{sup -1}. Slit measurement near 45 Degree-Sign revealed radial asymmetry in the MTF resulting from the square pixel aperture (0.2 mm Multiplication-Sign 0.2 mm), a characteristic which was not necessarily appreciated with the orthogonal 1D MTF measurements. In simulation experiments, both slit- and edge-based measurements resolved the radial asymmetries in the 2D MTF. The average absolute relative accuracy error in the 2D MTF between the DC and cutoff (2.5 mm{sup -1}) frequencies was 0.13% with average relative precision error of 0.11%. Other simulation results were similar to those derived from physical data. Conclusions: Overall, the general availability, acceptance, accuracy, and ease of implementation of 1D test devices for MTF assessment make this a valuable technique for 2D MTF estimation.« less

Estimation of the two-dimensional presampled modulation transfer function of digital radiography devices using one-dimensional test objects.

PubMed

Wells, Jered R; Dobbins, James T

2012-10-01

The modulation transfer function (MTF) of medical imaging devices is commonly reported in the form of orthogonal one-dimensional (1D) measurements made near the vertical and horizontal axes with a slit or edge test device. A more complete description is found by measuring the two-dimensional (2D) MTF. Some 2D test devices have been proposed, but there are some issues associated with their use: (1) they are not generally available; (2) they may require many images; (3) the results may have diminished accuracy; and (4) their implementation may be particularly cumbersome. This current work proposes the application of commonly available 1D test devices for practical and accurate estimation of the 2D presampled MTF of digital imaging systems. Theory was developed and applied to ensure adequate fine sampling of the system line spread function for 1D test devices at orientations other than approximately vertical and horizontal. Methods were also derived and tested for slit nonuniformity correction at arbitrary angle. Techniques were validated with experimental measurements at ten angles using an edge test object and three angles using a slit test device on an indirect-detection flat-panel system [GE Revolution XQ∕i (GE Healthcare, Waukesha, WI)]. The 2D MTF was estimated through a simple surface fit with interpolation based on Delaunay triangulation of the 1D edge-based MTF measurements. Validation by synthesis was also performed with simulated images from a hypothetical direct-detection flat-panel device. The 2D MTF derived from physical measurements yielded an average relative precision error of 0.26% for frequencies below the cutoff (2.5 mm(-1)) and approximate circular symmetry at frequencies below 4 mm(-1). While slit analysis generally agreed with the results of edge analysis, the two showed subtle differences at frequencies above 4 mm(-1). Slit measurement near 45° revealed radial asymmetry in the MTF resulting from the square pixel aperture (0.2 mm × 0.2 mm), a characteristic which was not necessarily appreciated with the orthogonal 1D MTF measurements. In simulation experiments, both slit- and edge-based measurements resolved the radial asymmetries in the 2D MTF. The average absolute relative accuracy error in the 2D MTF between the DC and cutoff (2.5 mm(-1)) frequencies was 0.13% with average relative precision error of 0.11%. Other simulation results were similar to those derived from physical data. Overall, the general availability, acceptance, accuracy, and ease of implementation of 1D test devices for MTF assessment make this a valuable technique for 2D MTF estimation.

76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0097] Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS... compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food...

Editorial Conference Comments by the General Chairman

NASA Astrophysics Data System (ADS)

Hopkins, M. A.

2009-12-01

This paper tells about the comments given by the general chairman in the 2009 conference at Quebec City's Hilton and convection centre in the province of Quebec, canada. NSREC is recoginized as one of the premier international conference on radiation effects in electronic materials, devices and systems. Also the radiation effects in microelectronic devices and materials are discussed. Reliability effects in electronic device is also given in the conference.

77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

...] Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public...), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on Medical Device Reporting, Complaint Files, and Recalls...

Plasmonic Photovoltaic Cells with Dual-Functional Gold, Silver, and Copper Half-Shell Arrays.

PubMed

Wu, Ling; Kim, Gyu Min; Nishi, Hiroyasu; Tatsuma, Tetsu

2017-09-12

Solid-state photovoltaic cells based on plasmon-induced charge separation (PICS) have attracted growing attention during the past decade. However, the power conversion efficiency (PCE) of the previously reported devices, which are generally loaded with dispersed metal nanoparticles as light absorbers, has not been sufficiently high. Here we report simpler plasmonic photovoltaic cells with interconnected Au, Ag, and Cu half-shell arrays deposited on SiO 2 @TiO 2 colloidal crystals, which serve both as a plasmonic light absorber and as a current collector. The well-controlled and easily prepared plasmonic structure allows precise comparison of the PICS efficiency between different plasmonic metal species. The cell with the Ag half-shell array has higher photovoltaic performance than the cells with Au and Cu half-shell arrays because of the high population of photogenerated energetic electrons, which gives a high electron injection efficiency and suppressed charge recombination probability, achieving the highest PCE among the solid-state PICS devices even without a hole transport layer.

Tuning pentacene based dye-sensitized solar cells.

PubMed

Kunzmann, Andreas; Gruber, Marco; Casillas, Rubén; Tykwinski, Rik R; Costa, Rubén D; Guldi, Dirk M

2018-05-10

We report on the synthesis, as well as photophysical and electrochemical characterization of a new family of pentacene derivatives, which are applied in n-type dye-sensitized solar cells (DSSCs). As far as the molecular structure of the pentacene is concerned, the synthetic design focuses on cyano acrylic tethered at the 13-position of the pentacene chromophore. The electrolyte composition features increasing amounts of Li+ ions as an additive. In general, the increase of Li+ concentrations extrinsically reduces the quasi Fermi level of the photoanode and as such facilitates the electron injection process. We demonstrate that pentacene derivatives give rise to a unique charge injection process, which is controlled by the positioning of the quasi Fermi level energies as a function of the Li+ concentration. As a result of the enhanced charge injection, device efficiencies as high as 1.5% are achieved, representing a 3-fold increase from previously reported efficiencies in pentacene-based DSSCs. These findings are supported by device analysis in combination with transient absorption and electrochemical impedance spectroscopy assays.

21 CFR 862.1795 - Vanilmandelic acid test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.1335 - Glucagon test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... mellitus, hypoglycemia, and hyperglycemia. (b) Classification. Class I (general controls). The device is...

46 CFR 197.342 - Buoyancy-changing devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... STANDARDS GENERAL PROVISIONS Commercial Diving Operations Equipment § 197.342 Buoyancy-changing devices. (a...-changing device must have an inflation source separate from the breathing gas supply. ...

21 CFR 878.5910 - Pneumatic tourniquet.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...

21 CFR 878.5910 - Pneumatic tourniquet.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...

21 CFR 878.5910 - Pneumatic tourniquet.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...

21 CFR 878.5910 - Pneumatic tourniquet.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...

21 CFR 878.5910 - Pneumatic tourniquet.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...

21 CFR 821.4 - Imported devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Imported devices. 821.4 Section 821.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE TRACKING REQUIREMENTS General Provisions § 821.4 Imported devices. For purposes of this...

21 CFR 821.4 - Imported devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Imported devices. 821.4 Section 821.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE TRACKING REQUIREMENTS General Provisions § 821.4 Imported devices. For purposes of this...

21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 886.1500 - Headband mirror.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

21 CFR 803.16 - When I submit a report, does the information in my report constitute an admission that the device...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? 803.16 Section 803.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...

21 CFR 803.16 - When I submit a report, does the information in my report constitute an admission that the device...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? 803.16 Section 803.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...

21 CFR 803.16 - When I submit a report, does the information in my report constitute an admission that the device...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? 803.16 Section 803.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...

21 CFR 803.16 - When I submit a report, does the information in my report constitute an admission that the device...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? 803.16 Section 803.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...

21 CFR 803.16 - When I submit a report, does the information in my report constitute an admission that the device...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? 803.16 Section 803.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...

Are physical activity studies in Hispanics meeting reporting guidelines for continuous monitoring technology? A systematic review.

PubMed

Layne, Charles S; Parker, Nathan H; Soltero, Erica G; Rosales Chavez, José; O'Connor, Daniel P; Gallagher, Martina R; Lee, Rebecca E

2015-09-18

Continuous monitoring technologies such as accelerometers and pedometers are the gold standard for physical activity (PA) measurement. However, inconsistencies in use, analysis, and reporting limit the understanding of dose-response relationships involving PA and the ability to make comparisons across studies and population subgroups. These issues are particularly detrimental to the study of PA across different ethnicities with different PA habits. This systematic review examined the inclusion of published guidelines involving data collection, processing, and reporting among articles using accelerometers or pedometers in Hispanic or Latino populations. English (PubMed; EbscoHost) and Spanish (SCIELO; Biblioteca Virtual en Salud) articles published between 2000 and 2013 using accelerometers or pedometers to measure PA among Hispanics or Latinos were identified through systematic literature searches. Of the 253 abstracts which were initially reviewed, 57 met eligibility criteria (44 accelerometer, 13 pedometer). Articles were coded and reviewed to evaluate compliance with recommended guidelines (N = 20), and the percentage of accelerometer and pedometer articles following each guideline were computed and reported. On average, 57.1 % of accelerometer and 62.2 % of pedometer articles reported each recommended guideline for data collection. Device manufacturer and model were reported most frequently, and provision of instructions for device wear in Spanish was reported least frequently. On average, 29.6 % of accelerometer articles reported each guideline for data processing. Definitions of an acceptable day for inclusion in analyses were reported most frequently, and definitions of an acceptable hour for inclusion in analyses were reported least frequently. On average, 18.8 % of accelerometer and 85.7 % of pedometer articles included each guideline for data reporting. Accelerometer articles most frequently included average number of valid days and least frequently included percentage of wear time. Inclusion of standard collection and reporting procedures in studies using continuous monitoring devices in Hispanic or Latino population is generally low. Lack of reporting consistency in continuous monitoring studies limits researchers' ability to compare studies or draw meaningful conclusions concerning amounts, quality, and benefits of PA among Hispanic or Latino populations. Reporting data collection, computation, and decision-making standards should be required. Improved interpretability would allow practitioners and researchers to apply scientific findings to promote PA.

Da Vinci robot error and failure rates: single institution experience on a single three-arm robot unit of more than 700 consecutive robot-assisted laparoscopic radical prostatectomies.

PubMed

Zorn, Kevin C; Gofrit, Ofer N; Orvieto, Marcelo A; Mikhail, Albert A; Galocy, R Matthew; Shalhav, Arieh L; Zagaja, Gregory P

2007-11-01

Previous reports have suggested that a 2% to 5% device failure rate (FR) be quoted when counseling patients about robot-assisted laparoscopic radical prostatectomy (RLRP). We sought to evaluate our FR on the da Vinci system. Since February 2003, more than 800 RLRPs have been performed at our institution using a single three-armed robotic unit. A prospective database was analyzed to determine the device FR and whether it resulted in case abortion or open conversion. Intuitive Surgical Systems provided data concerning the system's performance, including its fault rate. Error messages were classified as recoverable and non-recoverable faults. Between February 2003 and November 2006, 725 RLRP cases were available for evaluation. There were no intraoperative device failures that resulted in a case conversion. Technical errors resulting in surgeon handicap occurred in 3 cases (0.4%). Four patients (0.5%) had their procedures aborted secondary to system failure at initial set-up prior to patient entrance to the operating room. Data analysis retrieved from the da Vinci console reported on a total of 807 procedures since 2003. Only 4 cases (0.4%) were reported from the Intuitive Surgical database to result in either an aborted or a converted case, which compares favorably with our results. Since the last computer system upgrade (September 2005), the mean recoverable and non-recoverable fault rates per procedure were 0.21 and 0.05, respectively. For all the advanced features the da Vinci system offers, it is surprisingly reliable. Throughout our RLRP experience, device failure resulted in case conversion, procedure abortion, and surgeon handicap in 0, 0.5%, and 0.4% of procedures, respectively. As such, a lowered device FR of 0.5% should be used when counseling patients undergoing RLRP. To avoid futile general anesthesia, a policy should be enforced to ensure that the da Vinci system is completely set up before the patient enters the operating room.

Novel centrifugal technology for measuring sperm concentration in the home.

PubMed

Schaff, Ulrich Y; Fredriksen, Laura L; Epperson, Jon G; Quebral, Tiffany R; Naab, Sara; Sarno, Mark J; Eisenberg, Michael L; Sommer, Greg J

2017-02-01

To evaluate the analytical performance and usability of the Trak Male Fertility Testing System, a semiquantitative (categorical) device recently US Food and Drug Administration (FDA)-cleared for measuring sperm concentration in the home by untrained users. A three-site clinical trial comparing self-reported lay user results versus reference results obtained by computer-aided semen analysis (CASA). Simulated home use environments at fertility centers and urologist offices. A total of 239 untrained users. None. Sperm concentration results reported from self-testing lay users and laboratory reference method by CASA were evaluated semiquantitatively against the device's clinical cutoffs of 15 M/mL (current World Health Organization cutoff) and 55 M/mL (associated with faster time to pregnancy). Additional reported metrics include assay linearity, precision, limit of detection, and ease-of-use ratings from lay users. Lay users achieved an accuracy (versus the reference) of 93.3% (95% confidence interval [CI] 84.1%-97.4%) for results categorized as ≤15 M/mL, 82.4% (95% CI 73.3%-88.9%) for results categorized as 15-55 M/mL, and 95.5% (95% CI 88.9%-98.2%) for results categorized as >55 M/mL. When measured quantitatively, Trak results had a strong linear correlation with CASA measurements (r = 0.99). The precision and limit of detection studies show that the device has adequate reproducibility and detection range for home use. Subjects generally rated the device as easy to use. The Trak System is an accurate tool for semiquantitatively measuring sperm concentration in the home. The system may enable screening and longitudinal assessment of sperm concentration at home. ClinicalTrials.gov identifier: NCT02475395. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

21 CFR 862.1490 - Lysozyme (muramidase) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1430 - 17-Ketosteroids test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... hypertension, diabetes, and hypothyroidism. (b) Classification. Class I (general controls). The device is...

21 CFR 862.1500 - Malic dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

16 CFR 1750.4 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION REFRIGERATOR SAFETY ACT REGULATIONS STANDARD FOR DEVICES TO PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE § 1750.4 General requirements. Household refrigerators shall be equipped with a device enabling the doors thereof to be opened...

78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

47 CFR 15.13 - Incidental radiators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Incidental radiators. 15.13 Section 15.13 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.13 Incidental radiators. Manufacturers of these devices shall employ good engineering practices to minimize the risk of...

Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review.

PubMed

Polisena, Julie; Gagliardi, Anna; Urbach, David; Clifford, Tammy; Fiander, Michelle

2015-03-29

Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents. We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion. Thirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error. The available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence gaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to solicit information about their experiences with medical devices and suggested strategies for device surveillance improvement in a hospital context. Further research also should investigate the impact of human, system, organizational and education factors on the development and implementation of local medical device surveillance systems.

Generalized reciprocity theorem for semiconductor devices

NASA Technical Reports Server (NTRS)

Misiakos, K.; Lindholm, F. A.

1985-01-01

A reciprocity theorem is presented that relates the short-circuit current of a device, induced by a carrier generation source, to the minority-carrier Fermi level in the dark. The basic relation is general under low injection. It holds for three-dimensional devices with position dependent parameters (energy gap, electron affinity, mobility, etc.), and for transient or steady-state conditions. This theorem allows calculation of the internal quantum efficiency of a solar cell by using the analysis of the device in the dark. Other applications could involve measurements of various device parameters, interfacial surface recombination velocity at a polcrystalline silicon emitter contact, for rexample, by using steady-state or transient photon or mass-particle radiation.

21 CFR 862.1380 - Hydroxybutyric dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1330 - Globulin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... other disorders of blood globulins. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1470 - Lipid (total) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1805 - Vitamin A test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1605 - Pregnanediol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 862.1610 - Pregnanetriol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (congenital enlargement of the adrenal gland). (b) Classification. Class I (general controls). The device is...

21 CFR 862.1395 - 17-Hydroxyprogesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... adrenal glands or the ovaries. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 864.2360 - Mycoplasma detection media and components.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products... microbial contaminant in cell cultures. (b) Classification. Class I (general controls). These devices are...

Sudden visual loss after cardiac resynchronization therapy device implantation.

PubMed

De Vitis, Luigi A; Marchese, Alessandro; Giuffrè, Chiara; Carnevali, Adriano; Querques, Lea; Tomasso, Livia; Baldin, Giovanni; Maestranzi, Gisella; Lattanzio, Rosangela; Querques, Giuseppe; Bandello, Francesco

2017-03-10

To report a case of sudden decrease in visual acuity possibly due to a cardiogenic embolism in a patient who underwent cardiac resynchronization therapy (CRT) device implantation. A 62-year-old man with severe left ventricular systolic dysfunction and a left bundle branch block was referred to our department because of a sudden decrease in visual acuity. Nine days earlier, he had undergone cardiac transapical implantation of a CRT device, which was followed, 2 days later, by an inflammatory reaction. The patient underwent several general and ophthalmologic examinations, including multimodal imaging. At presentation, right eye (RE) best-corrected visual acuity (BCVA) was counting fingers and RE pupil was hyporeactive. Fundus examination revealed white-centered hemorrhagic dots suggestive of Roth spots. Fluorescein angiography showed delay in vascular perfusion during early stage, late hyperfluorescence of the macula and optic disk, and peripheral perivascular leakage. The first visual field test showed complete loss of vision RE and a normal left eye. Due to suspected giant cell arteritis, temporal artery biopsy was performed. Thirty minutes after the procedure, an ischemic stroke with right hemisyndrome and aphasia occurred. The RE BCVA worsened to hands motion. Four months later, RE BCVA did not improve, despite improvement in fluorescein angiography inflammatory sign. We report a possible cardiogenic embolism secondary to undiagnosed infective endocarditis causing monocular visual loss after CRT device implantation. It remains unclear how the embolus caused severe functional damage without altering the retinal anatomical structure.

21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING..., result, and conclusion codes) (refer to FDA MEDWATCH Medical Device Reporting Code Instructions); (7... the device was involved, nature of the problem, patient followup or required treatment, and any...

21 CFR 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING..., result, and conclusion codes) (refer to FDA MEDWATCH Medical Device Reporting Code Instructions); (7... the device was involved, nature of the problem, patient followup or required treatment, and any...

21 CFR 803.50 - If I am a manufacturer, what reporting requirements apply to me?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Manufacturer Reporting... become aware of information, from any source, that reasonably suggests that a device that you market: (1) May have caused or contributed to a death or serious injury; or (2) Has malfunctioned and this device...

Electrocautery device does not provide adequate pulmonary vessel sealing in transumbilical anatomic pulmonary lobectomy.

PubMed

Liu, Hung-Ping; Chu, Yen; Wu, Yi-Cheng; Hsieh, Ming-Ju; Liu, Chieng-Ying; Chen, Tzu-Ping; Chao, Yin-Kai; Wu, Ching-Yang; Yeh, Chi-Ju; Ko, Po-Jen; Liu, Yun-Hen

2016-05-01

Safe pulmonary vessel sealing device plays a crucial role in anatomic lung resection. In 2014, we reported high rates of massive bleeding complications during transumbilical lobectomy in a canine model due to difficulty in managing the pulmonary vessel with an endostapler. In this animal survival series, we aimed to evaluate the outcome of pulmonary vessel sealing with an electrocautery device to simplify the transumbilical thoracic surgery. Under general anesthesia, a 3-cm longitudinal incision was made over the umbilicus. Under video guidance, a bronchoscope was inserted through the incision for exploration. The diaphragmatic wound was created with an electrocautery knife and used as the entrance into the thoracic cavity. Using the transumbilical technique, anatomic lobectomy was performed with electrosurgical devices and endoscopic vascular staplers in 15 canines. Transumbilical endoscopic anatomic lobectomy was successfully completed in 12 of the 15 animals. Intraoperative bleeding developed in three animals during pulmonary hilum dissection, where one animal was killed due to hemodynamic instability and the other two animals required thoracotomy to complete the operation. There were five delayed bleeding and surgical mortality cases caused by inadequate vessel sealing by electrosurgical devices. Postmortem examination confirmed correct transumbilical lobectomy in the twelve animals that survived the operations. Transumbilical anatomic lobectomy is technically feasible in a canine model; however, the electrosurgical devices were not effective in sealing the pulmonary vessel in the current canine model.

Seeing with sound? exploring different characteristics of a visual-to-auditory sensory substitution device.

PubMed

Brown, David; Macpherson, Tom; Ward, Jamie

2011-01-01

Sensory substitution devices convert live visual images into auditory signals, for example with a web camera (to record the images), a computer (to perform the conversion) and headphones (to listen to the sounds). In a series of three experiments, the performance of one such device ('The vOICe') was assessed under various conditions on blindfolded sighted participants. The main task that we used involved identifying and locating objects placed on a table by holding a webcam (like a flashlight) or wearing it on the head (like a miner's light). Identifying objects on a table was easier with a hand-held device, but locating the objects was easier with a head-mounted device. Brightness converted into loudness was less effective than the reverse contrast (dark being loud), suggesting that performance under these conditions (natural indoor lighting, novice users) is related more to the properties of the auditory signal (ie the amount of noise in it) than the cross-modal association between loudness and brightness. Individual differences in musical memory (detecting pitch changes in two sequences of notes) was related to the time taken to identify or recognise objects, but individual differences in self-reported vividness of visual imagery did not reliably predict performance across the experiments. In general, the results suggest that the auditory characteristics of the device may be more important for initial learning than visual associations.

21 CFR 862.1590 - Porphobilinogen test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1790 - Uroporphyrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1595 - Porphyrins test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 862.1325 - Gastrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas). (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.1620 - Progesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

40 CFR 63.743 - Standards: General.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.743 Standards: General. (a... of the device or equipment, test data verifying the performance of the device or equipment in... chemical milling maskants, as determined in accordance with the applicable procedures set forth in § 63.750...

40 CFR 63.743 - Standards: General.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.743 Standards: General. (a... of the device or equipment, test data verifying the performance of the device or equipment in... chemical milling maskants, as determined in accordance with the applicable procedures set forth in § 63.750...

40 CFR 63.743 - Standards: General.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.743 Standards: General. (a... of the device or equipment, test data verifying the performance of the device or equipment in... chemical milling maskants, as determined in accordance with the applicable procedures set forth in § 63.750...

40 CFR 63.743 - Standards: General.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.743 Standards: General. (a... of the device or equipment, test data verifying the performance of the device or equipment in... chemical milling maskants, as determined in accordance with the applicable procedures set forth in § 63.750...

40 CFR 63.743 - Standards: General.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.743 Standards: General. (a... of the device or equipment, test data verifying the performance of the device or equipment in... chemical milling maskants, as determined in accordance with the applicable procedures set forth in § 63.750...

21 CFR 880.5200 - Intravascular catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intravascular catheter. 880.5200 Section 880.5200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic...

21 CFR 880.5200 - Intravascular catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intravascular catheter. 880.5200 Section 880.5200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic...

21 CFR 880.5200 - Intravascular catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Intravascular catheter. 880.5200 Section 880.5200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic...

21 CFR 880.5200 - Intravascular catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intravascular catheter. 880.5200 Section 880.5200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic...

Reconfigurable Carbon Nanotube Multiplexed Sensing Devices.

PubMed

Xu, Xinzhao; Clément, Pierrick; Eklöf-Österberg, Johnas; Kelley-Loughnane, Nancy; Moth-Poulsen, Kasper; Chávez, Jorge L; Palma, Matteo

2018-06-26

Here we report on the fabrication of reconfigurable and solution processable nanoscale biosensors with multisensing capability, based on single-walled carbon nanotubes (SWCNTs). Distinct DNA-wrapped (hence water-soluble) CNTs were immobilized from solution onto different prepatterned electrodes on the same chip, via a low-cost dielectrophoresis (DEP) methodology. The CNTs were functionalized with specific, and different, aptamer sequences that were employed as selective recognition elements for biomarkers indicative of stress and neuro-trauma conditions. Multiplexed detection of three different biomarkers was successfully performed, and real-time detection was achieved in serum down to physiologically relevant concentrations of 50 nM, 10 nM, and 500 pM for cortisol, dehydroepiandrosterone-sulfate (DHEAS), and neuropeptide Y (NPY), respectively. Additionally, the fabricated nanoscale devices were shown to be reconfigurable and reusable via a simple cleaning procedure. The general applicability of the strategy presented, and the facile device fabrication from aqueous solution, hold great potential for the development of the next generation of low power consumption portable diagnostic assays for the simultaneous monitoring of different health parameters.

All-inkjet-printed thin-film transistors: manufacturing process reliability by root cause analysis.

PubMed

Sowade, Enrico; Ramon, Eloi; Mitra, Kalyan Yoti; Martínez-Domingo, Carme; Pedró, Marta; Pallarès, Jofre; Loffredo, Fausta; Villani, Fulvia; Gomes, Henrique L; Terés, Lluís; Baumann, Reinhard R

2016-09-21

We report on the detailed electrical investigation of all-inkjet-printed thin-film transistor (TFT) arrays focusing on TFT failures and their origins. The TFT arrays were manufactured on flexible polymer substrates in ambient condition without the need for cleanroom environment or inert atmosphere and at a maximum temperature of 150 °C. Alternative manufacturing processes for electronic devices such as inkjet printing suffer from lower accuracy compared to traditional microelectronic manufacturing methods. Furthermore, usually printing methods do not allow the manufacturing of electronic devices with high yield (high number of functional devices). In general, the manufacturing yield is much lower compared to the established conventional manufacturing methods based on lithography. Thus, the focus of this contribution is set on a comprehensive analysis of defective TFTs printed by inkjet technology. Based on root cause analysis, we present the defects by developing failure categories and discuss the reasons for the defects. This procedure identifies failure origins and allows the optimization of the manufacturing resulting finally to a yield improvement.

Colorless polyimide/organoclay nanocomposite substrates for flexible organic light-emitting devices.

PubMed

Kim, Jin-Hoe; Choi, Myeon-Chon; Kim, Hwajeong; Kim, Youngkyoo; Chang, Jin-Hae; Han, Mijeong; Kim, Il; Ha, Chang-Sik

2010-01-01

We report the preparation and application of indium tin oxide (ITO) coated fluorine-containing polyimide/organoclay nanocomposite substrate. Fluorine-containing polyimide/organoclay nanocomposite films were prepared through thermal imidization of poly(amic acid)/organoclay mixture films, whilst on which ITO thin films were coated on the films using a radio-frequency planar magnetron sputtering by varying the substrate temperature and the ITO thickness. Finally the ITO coated fluorine-containing polyimide/organoclay nanocomposite substrate was employed to make flexible organic light-emitting devices (OLED). Results showed that the lower sheet resistance was achieved when the substrate temperature was high and the ITO film was thick even though the optical transmittance was slightly lowered as the thickness increased. approximately 10 nm width ITO nanorods were found for all samples but the size of clusters with the nanorods was generally increased with the substrate temperature and the thickness. The flexible OLED made using the present substrate was quite stable even when the device was extremely bended.

Comparative Efficacy of the Air-Q Intubating Laryngeal Airway during General Anesthesia in Pediatric Patients: A Systematic Review and Meta-Analysis.

PubMed

Ahn, Eun Jin; Choi, Geun Joo; Kang, Hyun; Baek, Chong Wha; Jung, Yong Hun; Woo, Young Cheol; Bang, Si Ra

2016-01-01

Air-Q® (air-Q) is a supraglottic airway device which can be used as a guidance of intubation in pediatric as well as in adult patients. We evaluated the efficacy and safety of air-Q compared to other airway devices during general anesthesia in pediatric patients by conducting a systematic review and meta-analysis. A total of 10 studies including 789 patients were included in the final analysis. Compared with other supraglottic airway devices, air-Q showed no evidence for a difference in leakage pressure and insertion time. The ease of insertion was significantly lower than other supraglottic airway devices. The success rate of intubation was significantly lower than other airway devices. However, fiberoptic view was better through the air-Q than other supraglottic airway devices. Therefore, air-Q could be a safe substitute for other airway devices and may provide better fiberoptic bronchoscopic view.

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 886.1760 - Ophthalmic refractometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls...

19 CFR 12.112 - Notice of arrival of pesticides and devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 19 Customs Duties 1 2012-04-01 2012-04-01 false Notice of arrival of pesticides and devices. 12...; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Pesticides and Devices § 12.112 Notice of arrival of pesticides and devices. (a) General. An importer desiring to import pesticides or devices into the...

19 CFR 12.112 - Notice of arrival of pesticides and devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 1 2014-04-01 2014-04-01 false Notice of arrival of pesticides and devices. 12...; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Pesticides and Devices § 12.112 Notice of arrival of pesticides and devices. (a) General. An importer desiring to import pesticides or devices into the...

19 CFR 12.112 - Notice of arrival of pesticides and devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 1 2013-04-01 2013-04-01 false Notice of arrival of pesticides and devices. 12...; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Pesticides and Devices § 12.112 Notice of arrival of pesticides and devices. (a) General. An importer desiring to import pesticides or devices into the...

19 CFR 12.112 - Notice of arrival of pesticides and devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 1 2011-04-01 2011-04-01 false Notice of arrival of pesticides and devices. 12...; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Pesticides and Devices § 12.112 Notice of arrival of pesticides and devices. (a) General. An importer desiring to import pesticides or devices into the...

19 CFR 12.112 - Notice of arrival of pesticides and devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 1 2010-04-01 2010-04-01 false Notice of arrival of pesticides and devices. 12...; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Pesticides and Devices § 12.112 Notice of arrival of pesticides and devices. (a) General. An importer desiring to import pesticides or devices into the...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual blood cell counting device. 864.6160... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

Standardizing intensive care device data to enable secondary usages.

PubMed

Ingenerf, Josef; Kock, Ann-Kristin; Poelker, Marcel; Seidl, Konrad; Zeplin, Georg; Mersmann, Stefan; Handels, Heinz

2012-01-01

To represent medical device observations in a format that is consumable by clinical software, standards like HL7v3 and ISO/IEEE 11073 should be used jointly. This is demonstrated in a project with Dräger Medical GmbH focusing on their Patient Data Management System (PDMS) in intensive care, called Integrated Care Manager (ICM). Patient and device data of interest should be mapped to suitable formats to enable data exchange and decision support. Instead of mapping device data to target formats bilaterally we use a generic HL7v3 Refined Message Information Model (RMIM) with device specific parts adapted to ISO/IEEE 11073 DIM. The generality of the underlying model (based on Yuksel et al. [1]) allows the flexible inclusion of IEEE 11073 conformant device models of interest on the one hand and the generation of needed artifacts for secondary usages on the other hand, e.g. HL7 V2 messages, HL7 CDA documents like the Personal Health Monitoring Report (PHMR) or web services. Hence, once the medical device data are obtained in the RMIM format, it can quite easily be transformed into HL7-based standard interfaces through XSL transformations because these interfaces all have their building blocks from the same RIM. From there data can be accessed uniformly, e.g. as needed by Dräger´s decision support system SmartCare [2] for automated control and optimization of weaning from mechanical ventilation.

Integrated Graphene-Based Optoelectronic Devices Used for Ultrafast Optical-THz Photodetectors, Modulators and Emitters

DTIC Science & Technology

2015-04-03

08 and AFRL/ CA policy clarification memorandum dated 16 Jan 09. This report is available to the general public, including foreign nationals. Copies... doped graphene micro-ribbon array and a quantum-well electron gas sitting at an interface between a half-space of air and another half-space of a... doped semiconductor substrate which supports a surface-plasmon mode in our system. The coupling between a spatially-modulated total electromagnetic

Torsional vibration of aircraft engines

NASA Technical Reports Server (NTRS)

Lurenbaum, Karl

1932-01-01

Exhaustive torsional-vibration investigations are required to determine the reliability of aircraft engines. A general outline of the methods used for such investigations and of the theoretical and mechanical means now available for this purpose is given, illustrated by example. True vibration diagrams are usually obtained from vibration measurements on the completed engine. Two devices for this purpose and supplementing each other, the D.V.L. torsiograph and the D.V.L. torsion recorder, are described in this report.

Research studies on advanced optical module/head designs for optical devices

NASA Technical Reports Server (NTRS)

Burke, James J.

1991-01-01

A summary is presented of research in optical data storage materials and of research at the center. The first section contains summary reports under the general headings of: (1) Magnetooptic media: modeling, design, fabrication, characterization, and testing; (2) Optical heads: holographic optical elements; and (3) Optical heads: integrated optics. The second section consist of a proposal entitled, Signal Processing Techniques for Optical Data Storage. And section three presents various publications prepared by the center.

Synergistic High Charge-Storage Capacity for Multi-level Flexible Organic Flash Memory

NASA Astrophysics Data System (ADS)

Kang, Minji; Khim, Dongyoon; Park, Won-Tae; Kim, Jihong; Kim, Juhwan; Noh, Yong-Young; Baeg, Kang-Jun; Kim, Dong-Yu

2015-07-01

Electret and organic floating-gate memories are next-generation flash storage mediums for printed organic complementary circuits. While each flash memory can be easily fabricated using solution processes on flexible plastic substrates, promising their potential for on-chip memory organization is limited by unreliable bit operation and high write loads. We here report that new architecture could improve the overall performance of organic memory, and especially meet high storage for multi-level operation. Our concept depends on synergistic effect of electrical characterization in combination with a polymer electret (poly(2-vinyl naphthalene) (PVN)) and metal nanoparticles (Copper). It is distinguished from mostly organic nano-floating-gate memories by using the electret dielectric instead of general tunneling dielectric for additional charge storage. The uniform stacking of organic layers including various dielectrics and poly(3-hexylthiophene) (P3HT) as an organic semiconductor, followed by thin-film coating using orthogonal solvents, greatly improve device precision despite easy and fast manufacture. Poly(vinylidene fluoride-trifluoroethylene) [P(VDF-TrFE)] as high-k blocking dielectric also allows reduction of programming voltage. The reported synergistic organic memory devices represent low power consumption, high cycle endurance, high thermal stability and suitable retention time, compared to electret and organic nano-floating-gate memory devices.

Graded recombination layers for multijunction photovoltaics.

PubMed

Koleilat, Ghada I; Wang, Xihua; Sargent, Edward H

2012-06-13

Multijunction devices consist of a stack of semiconductor junctions having bandgaps tuned across a broad spectrum. In solar cells this concept is used to increase the efficiency of photovoltaic harvesting, while light emitters and detectors use it to achieve multicolor and spectrally tunable behavior. In series-connected current-matched multijunction devices, the recombination layers must allow the hole current from one cell to recombine, with high efficiency and low voltage loss, with the electron current from the next cell. We recently reported a tandem solar cell in which the recombination layer was implemented using a progression of n-type oxides whose doping densities and work functions serve to connect, with negligible resistive loss at solar current densities, the constituent cells. Here we present the generalized conditions for design of efficient graded recombination layer solar devices. We report the number of interlayers and the requirements on work function and doping of each interlayer, to bridge an work function difference as high as 1.6 eV. We also find solutions that minimize the doping required of the interlayers in order to minimize optical absorption due to free carriers in the graded recombination layer (GRL). We demonstrate a family of new GRL designs experimentally and highlight the benefits of the progression of dopings and work functions in the interlayers.

Screening of inorganic wide-bandgap p-type semiconductors for high performance hole transport layers in organic photovoltaic devices

NASA Astrophysics Data System (ADS)

Ginley, David; Zakutayev, Andriy; Garcia, Andreas; Widjonarko, Nicodemus; Ndione, Paul; Sigdel, Ajaya; Parilla, Phillip; Olson, Dana; Perkins, John; Berry, Joseph

2011-03-01

We will report on the development of novel inorganic hole transport layers (HTL) for organic photovoltaics (OPV). All the studied materials belong to the general class of wide-bandgap p-type oxide semiconductors. Potential candidates suitable for HTL applications include SnO, NiO, Cu2O (and related CuAlO2, CuCrO2, SrCu2O4 etc) and Co3O4 (and related ZnCo2O4, NiCo2O4, MgCo2O4 etc.). Materials have been optimized by high-throughput combinatorial approaches. The thin films were deposited by RF sputtering and pulsed laser deposition at ambient and elevated temperatures. Performance of the inorganic HTLs and that of the reference organic PEDOT:PSS HTL were compared by measuring the power conversion efficiencies and spectral responses of the P3HT/PCBM- and PCDTBT/PCBM-based OPV devices. Preliminary results indicate that Co3O4-based HTLs have performance comparable to that of our previously reported NiOs and PEDOT:PSS HTLs, leading to a power conversion efficiency of about 4 percent. The effect of composition and work function of the ternary materials on their performance in OPV devices is under investigation.

Synergistic High Charge-Storage Capacity for Multi-level Flexible Organic Flash Memory.

PubMed

Kang, Minji; Khim, Dongyoon; Park, Won-Tae; Kim, Jihong; Kim, Juhwan; Noh, Yong-Young; Baeg, Kang-Jun; Kim, Dong-Yu

2015-07-23

Electret and organic floating-gate memories are next-generation flash storage mediums for printed organic complementary circuits. While each flash memory can be easily fabricated using solution processes on flexible plastic substrates, promising their potential for on-chip memory organization is limited by unreliable bit operation and high write loads. We here report that new architecture could improve the overall performance of organic memory, and especially meet high storage for multi-level operation. Our concept depends on synergistic effect of electrical characterization in combination with a polymer electret (poly(2-vinyl naphthalene) (PVN)) and metal nanoparticles (Copper). It is distinguished from mostly organic nano-floating-gate memories by using the electret dielectric instead of general tunneling dielectric for additional charge storage. The uniform stacking of organic layers including various dielectrics and poly(3-hexylthiophene) (P3HT) as an organic semiconductor, followed by thin-film coating using orthogonal solvents, greatly improve device precision despite easy and fast manufacture. Poly(vinylidene fluoride-trifluoroethylene) [P(VDF-TrFE)] as high-k blocking dielectric also allows reduction of programming voltage. The reported synergistic organic memory devices represent low power consumption, high cycle endurance, high thermal stability and suitable retention time, compared to electret and organic nano-floating-gate memory devices.

OLEDs for lighting

NASA Astrophysics Data System (ADS)

Boerner, Herbert

2006-04-01

Today, organic light emitting diodes are used in small to medium displays in portable electronic equipment like MP3 players and mobile phones. Their thin form factor, together with good readability due to low angular dependence of the emission makes them attractive for these applications. The rapid progress in the last years has lifted the performance of OLEDs to a level where one can seriously start to consider applications in lighting markets. Whereas it is obvious that first applications will be in less demanding niche markets, clearly the most interesting target is the general illumination market. In this report, first applications requirements will be described, followed by a brief review of state of the art monochrome OLEDs. The main part deals with the various ways in which monochrome devices can be combined into white ones, giving examples of existing solutions. The conclusion is that for the white OLED design, there no clear winner yet. Given the rapid progress in material and device development, one can expect that within a few years white OLEDs will be available which can start to penetrate the general lighting market.

ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests.

PubMed

Coates, Allan L; Wanger, Jack; Cockcroft, Donald W; Culver, Bruce H; Diamant, Zuzana; Gauvreau, Gail; Hall, Graham L; Hallstrand, Teal S; Horvath, Ildiko; de Jongh, Frans H C; Joos, Guy; Kaminsky, David A; Laube, Beth L; Leuppi, Joerg D; Sterk, Peter J

2017-05-01

This international task force report updates general considerations for bronchial challenge testing and the performance of the methacholine challenge test. There are notable changes from prior recommendations in order to accommodate newer delivery devices. Rather than basing the test result upon a methacholine concentration (provocative concentration (PC 20 ) causing a 20% fall in forced expiratory volume in 1 s (FEV 1 )), the new recommendations base the result upon the delivered dose of methacholine causing a 20% fall in FEV 1 (provocative dose (PD 20 )). This end-point allows comparable results from different devices or protocols, thus any suitable nebuliser or dosimeter may be used, so long as the delivery characteristics are known. Inhalation may be by tidal breathing using a breath-actuated or continuous nebuliser for 1 min (or more), or by a dosimeter with a suitable breath count. Tests requiring maximal inhalations to total lung capacity are not recommended because the bronchoprotective effect of a deep breath reduces the sensitivity of the test. Copyright ©ERS 2017.

Evaluation of commercial ADC radiation tolerance for accelerator experiments

DOE PAGES

Chen, K.; Chen, H.; Kierstead, J.; ...

2015-08-17

Electronic components used in high energy physics experiments are subjected to a radiation background composed of high energy hadrons, mesons and photons. These particles can induce permanent and transient effects that affect the normal device operation. Ionizing dose and displacement damage can cause chronic damage which disable the device permanently. Transient effects or single event effects are in general recoverable with time intervals that depend on the nature of the failure. The magnitude of these effects is technology dependent with feature size being one of the key parameters. Analog to digital converters are components that are frequently used in detectormore » front end electronics, generally placed as close as possible to the sensing elements to maximize signal fidelity. We report on radiation effects tests conducted on 17 commercially available analog to digital converters and extensive single event effect measurements on specific twelve and fourteen bit ADCs that presented high tolerance to ionizing dose. We discuss mitigation strategies for single event effects (SEE) for their use in the large hadron collider environment.« less

Matched-filtering generalized phase contrast using LCoS pico-projectors for beam-forming.

PubMed

Bañas, Andrew; Palima, Darwin; Glückstad, Jesper

2012-04-23

We report on a new beam-forming system for generating high intensity programmable optical spikes using so-called matched-filtering Generalized Phase Contrast (mGPC) applying two consumer handheld pico-projectors. Such a system presents a low-cost alternative for optical trapping and manipulation, optical lattices and other beam-shaping applications usually implemented with high-end spatial light modulators. Portable pico-projectors based on liquid crystal on silicon (LCoS) devices are used as binary phase-only spatial light modulators by carefully setting the appropriate polarization of the laser illumination. The devices are subsequently placed into the object and Fourier plane of a standard 4f-setup according to the mGPC spatial filtering configuration. Having a reconfigurable spatial phase filter, instead of a fixed and fabricated one, allows the beam shaper to adapt to different input phase patterns suited for different requirements. Despite imperfections in these consumer pico-projectors, the mGPC approach tolerates phase aberrations that would have otherwise been hard to overcome by standard phase projection. © 2012 Optical Society of America

Piezoelectric-based hybrid reserve power sources for munitions

NASA Astrophysics Data System (ADS)

Rastegar, J.; Kwok, P.

2017-04-01

Reserve power sources are used extensively in munitions and other devices, such as emergency devices or remote sensors that need to be powered only once and for a relatively short duration. Current chemical reserve power sources, including thermal batteries and liquid reserve batteries sometimes require more than 100 msec to become fully activated. In many applications, however, electrical energy is required in a few msec following the launch event. In such applications, other power sources are needed to provide power until the reserve battery is fully activated. The amount of electrical energy that is required by most munitions before chemical reserve batteries are fully activated is generally small and can be provided by properly designed piezoelectric-based energy harvesting devices. In this paper, the development of a hybrid reserve power source that is constructed by integration of a piezoelectric-based energy harvesting device with a reserve battery to provide power almost instantaneously upon munitions firing or other similar events is being reported. A review of the state of the art in piezoelectric-based electrical energy harvesting methods and devices and their charge collection electronics for use in the developed hybrid power sources is provided together with the results of testing of the piezoelectric component of the power source and its electronic safety and charge collection electronics.

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

PubMed

Deyo, Richard A

2004-01-01

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

MRI-conditional pacemakers: current perspectives.

PubMed

Ferreira, António M; Costa, Francisco; Tralhão, António; Marques, Hugo; Cardim, Nuno; Adragão, Pedro

2014-01-01

Use of both magnetic resonance imaging (MRI) and pacing devices has undergone remarkable growth in recent years, and it is estimated that the majority of patients with pacemakers will need an MRI during their lifetime. These investigations will generally be denied due to the potentially dangerous interactions between cardiac devices and the magnetic fields and radio frequency energy used in MRI. Despite the increasing reports of uneventful scanning in selected patients with conventional pacemakers under close surveillance, MRI is still contraindicated in those circumstances and cannot be considered a routine procedure. These limitations prompted a series of modifications in generator and lead engineering, designed to minimize interactions that could compromise device function and patient safety. The resulting MRI-conditional pacemakers were first introduced in 2008 and the clinical experience gathered so far supports their safety in the MRI environment if certain conditions are fulfilled. With this technology, new questions and controversies arise regarding patient selection, clinical impact, and cost-effectiveness. In this review, we discuss the potential risks of MRI in patients with electronic cardiac devices and present updated information regarding the features of MRI-conditional pacemakers and the clinical experience with currently available models. Finally, we provide some guidance on how to scan patients who have these devices and discuss future directions in the field.

Controllable Growth of Perovskite Films by Room-Temperature Air Exposure for Efficient Planar Heterojunction Photovoltaic Cells

DOE PAGES

Yang, Bin; Dyck, Ondrej; Poplawsky, Jonathan; ...

2015-12-01

A two-step-solution-processing approach has been established to grow void-free perovskite films for low-cost and high-performance planar heterojunction photovoltaic devices. We generally applied a high-temperature thermal annealing treatment in order to drive the diffusion of CH 3NH 3I precursor molecules into the compact PbI 2 layer to form perovskite films. But, thermal annealing for extended periods would lead to degraded device performance due to the defects generated by decomposition of perovskite into PbI 2. In this work, we explored a controllable layer-by-layer spin-coating method to grow bilayer CH 3NH 3I/PbI 2 films, and then drive the interdiffusion between PbI 2 andmore » CH 3NH 3I layers by a simple room-temperature-air-exposure for making well-oriented, highly-crystalline perovskite films without thermal annealing. This high degree of crystallinity resulted in a carrier diffusion length of ~ 800 nm and high device efficiency of 15.6%, which is comparable to the reported values from thermally-annealed perovskite films based counterparts. Finally, the simplicity and high device performance of this processing approach is highly promising for direct integration into industrial-scale device manufacture.« less

Evaluation of selected information on splitting devices for water samples

USGS Publications Warehouse

Capel, P.D.; Larson, S.J.

1996-01-01

Four devices for splitting water samples into representative aliquots are used by the U.S. Geological Survey's Water Resources Division. A thorough evaluation of these devices (14-liter churn, 8-liter churn, plastic cone, and Teflon cone) encompasses a wide variety of concerns, based on both chemical and physical considerations. This report surveys the existing data (as of April 1994) on cleaning efficiency and splitting capability of these devices and presents the data in a systematic framework for evaluation. From the existing data, some of these concerns are adequately or partially addressed, but the majority of concerns could not be addressed because of the lack of data. In general, the existing cleaning and transport protocols are adequate at the milligram per liter level, but the adequacy is largely unknown for trace elements and organic chemicals at lower concen- trations. The existing data indicate that better results are obtained when the splitters are cleaned in the laboratory rather than in the field. Two conclusions that can be reached on the splitting capability of solids are that more work must be done with all four devices to characterize and quantify their limitations and range of usefulness, and that the 14-liter churn (and by association, the 8-liter churn) is not useful in obtaining representative splits of sand-sized particles.

Self-Aligned van der Waals Heterojunction Diodes and Transistors.

PubMed

Sangwan, Vinod K; Beck, Megan E; Henning, Alex; Luo, Jiajia; Bergeron, Hadallia; Kang, Junmo; Balla, Itamar; Inbar, Hadass; Lauhon, Lincoln J; Hersam, Mark C

2018-02-14

A general self-aligned fabrication scheme is reported here for a diverse class of electronic devices based on van der Waals materials and heterojunctions. In particular, self-alignment enables the fabrication of source-gated transistors in monolayer MoS 2 with near-ideal current saturation characteristics and channel lengths down to 135 nm. Furthermore, self-alignment of van der Waals p-n heterojunction diodes achieves complete electrostatic control of both the p-type and n-type constituent semiconductors in a dual-gated geometry, resulting in gate-tunable mean and variance of antiambipolar Gaussian characteristics. Through finite-element device simulations, the operating principles of source-gated transistors and dual-gated antiambipolar devices are elucidated, thus providing design rules for additional devices that employ self-aligned geometries. For example, the versatility of this scheme is demonstrated via contact-doped MoS 2 homojunction diodes and mixed-dimensional heterojunctions based on organic semiconductors. The scalability of this approach is also shown by fabricating self-aligned short-channel transistors with subdiffraction channel lengths in the range of 150-800 nm using photolithography on large-area MoS 2 films grown by chemical vapor deposition. Overall, this self-aligned fabrication method represents an important step toward the scalable integration of van der Waals heterojunction devices into more sophisticated circuits and systems.

Combined atomic force microscopy and photoluminescence imaging to select single InAs/GaAs quantum dots for quantum photonic devices.

PubMed

Sapienza, Luca; Liu, Jin; Song, Jin Dong; Fält, Stefan; Wegscheider, Werner; Badolato, Antonio; Srinivasan, Kartik

2017-07-24

We report on a combined photoluminescence imaging and atomic force microscopy study of single, isolated self-assembled InAs quantum dots. The motivation of this work is to determine an approach that allows to assess single quantum dots as candidates for quantum nanophotonic devices. By combining optical and scanning probe characterization techniques, we find that single quantum dots often appear in the vicinity of comparatively large topographic features. Despite this, the quantum dots generally do not exhibit significant differences in their non-resonantly pumped emission spectra in comparison to quantum dots appearing in defect-free regions, and this behavior is observed across multiple wafers produced in different growth chambers. Such large surface features are nevertheless a detriment to applications in which single quantum dots are embedded within nanofabricated photonic devices: they are likely to cause large spectral shifts in the wavelength of cavity modes designed to resonantly enhance the quantum dot emission, thereby resulting in a nominally perfectly-fabricated single quantum dot device failing to behave in accordance with design. We anticipate that the approach of screening quantum dots not only based on their optical properties, but also their surrounding surface topographies, will be necessary to improve the yield of single quantum dot nanophotonic devices.

Substrate effects in high gain, low operating voltage SnSe2 photoconductor

NASA Astrophysics Data System (ADS)

Krishna, Murali; Kallatt, Sangeeth; Majumdar, Kausik

2018-01-01

High gain photoconductive devices find wide spread applications in low intensity light detection. Ultra-thin layered materials have recently drawn a lot of attention from researchers in this regard. However, in general, a large operating voltage is required to obtain large responsivity in these devices. In addition, the characteristics are often confounded by substrate induced trap effects. Here we report multi-layer SnSe2 based photoconductive devices using two different structures: (1) SiO2 substrate supported inter-digitated electrode (IDE), and (2) suspended channel. The IDE device exhibits a responsivity of ≈ {10}3 A W-1 and ≈ 8.66× {10}4 A W-1 at operating voltages of 1 mV and 100 mV, respectively—a superior low voltage performance over existing literature on planar 2D structures. However, the responsivity reduces by more than two orders of magnitude, while the transient response improves for the suspended device—providing insights into the critical role played by the channel-substrate interface in the gain mechanism. The results, on one hand, are promising for highly sensitive photoconductive applications consuming ultra-low power, and on the other hand, show a generic methodology that could be applied to other layered material based photoconductive devices as well for extracting the intrinsic behavior.

Performance of point-of-use devices to remove manganese from drinking water.

PubMed

Carrière, Annie; Brouillon, Manon; Sauvé, Sébastien; Bouchard, Maryse F; Barbeau, Benoit

2011-01-01

A recent epidemiological study reported significant cognitive deficits among children in relation with consumption of water with manganese concentrations in the order of 50-100 ug/L. Concerns for neurotoxic effects of manganese raises the need for evaluating the efficiency of domestic water treatment systems for removal of this metal. The objective of the present study was to determine whether POU devices are efficient at reducing dissolved manganese concentration in drinking water. Various devices were tested according to the NSF 53 protocol for general metals for high pH test water. Based on these assays, the pour-through filters were identified as the most promising POU devices, with dissolved manganese removal greater than 60% at 100% rated capacity, and greater than 45% at 200% rated capacity (influent Mn ≈1,000 μg/L). Under-the-sink filters using cationic exchange resins (i.e., water softeners) were also efficient at removing dissolved manganese but over a shorter operating life. Manganese leaching was also observed beyond their rated capacity, making them less robust treatments. The activated carbon block filters and other proprietary technologies were found to be inappropriate for dissolved manganese removal. Further evaluation of POU devices performance should evaluate the impact of hardness on process performance. The impact of particulate Mn should also be evaluated.

21 CFR 806.20 - Records of corrections and removals not required to be reported.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND... known, and the intended use of the device. (2) The model, catalog, or code number of the device and the...) Each device manufacturer or importer who initiates a correction or removal of a device that is not...

21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User... device; (10) Event problem codes—patient code and device code (refer to the “MEDWATCH Medical Device... device was involved, nature of the problem, patient followup or required treatment, and any environmental...

21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User... device; (10) Event problem codes—patient code and device code (refer to the “MEDWATCH Medical Device... device was involved, nature of the problem, patient followup or required treatment, and any environmental...

21 CFR 806.20 - Records of corrections and removals not required to be reported.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND... known, and the intended use of the device. (2) The model, catalog, or code number of the device and the...) Each device manufacturer or importer who initiates a correction or removal of a device that is not...

21 CFR 862.1615 - Pregnenolone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... diseases of the adrenal cortex or the gonads. (b) Classification. Class I (general controls). The device is...

21 CFR 878.4700 - Surgical microscope and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...

21 CFR 878.4700 - Surgical microscope and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...

21 CFR 878.4700 - Surgical microscope and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...

21 CFR 878.4700 - Surgical microscope and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...