Initiation devices, initiation systems including initiation devices and related methods

Energy Technology Data Exchange (ETDEWEB)

Daniels, Michael A.; Condit, Reston A.; Rasmussen, Nikki; Wallace, Ronald S.

2018-04-10

Initiation devices may include at least one substrate, an initiation element positioned on a first side of the at least one substrate, and a spark gap electrically coupled to the initiation element and positioned on a second side of the at least one substrate. Initiation devices may include a plurality of substrates where at least one substrate of the plurality of substrates is electrically connected to at least one adjacent substrate of the plurality of substrates with at least one via extending through the at least one substrate. Initiation systems may include such initiation devices. Methods of igniting energetic materials include passing a current through a spark gap formed on at least one substrate of the initiation device, passing the current through at least one via formed through the at least one substrate, and passing the current through an explosive bridge wire of the initiation device.

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

Factors affecting the utilization of safety devices by commercial ...

African Journals Online (AJOL)

Background: Motorcycle crashes are common causes of morbidity and mortality for both riders and passengers. To prevent and reduce the severity of injuries sustained through road traffic accidents (RTA) many countries enforce the use of safety devices while riding. Certain factors including non-enforcement of the existing ...

Monitoring Device Safety in Interventional Cardiology

OpenAIRE

Matheny, Michael E.; Ohno-Machado, Lucila; Resnic, Frederic S.

2006-01-01

Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.

Safety considerations in the design of the fusion engineering device

International Nuclear Information System (INIS)

Barrett, R.J.

1983-01-01

Safety considerations play a significant role in the design of a near-term Fusion Engineering Device (FED). For the safety of the general public and the plant workers, the radiation environment caused by the reacting plasma and the potential release of tritium fuel are the dominant considerations. The U.S. Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris. The highly activated device components make it necessary to design many of the maintenance activities in the reactor building for totally remote operation. The hot cell facility has evolved as a totally remote maintenance facility due to the high radiation levels of the device components. Safety considerations have had substantial impacts on the design of FED. Several examples of safety-related design impacts are discussed in the paper. Feasible solutions have been identified for all outstanding safety-related items, and additional optimization of these solutions is anticipated in future design studies

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

Science.gov (United States)

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters

Drug delivery device including electrolytic pump

KAUST Repository

Foulds, Ian G.; Buttner, Ulrich; Yi, Ying

2016-01-01

Systems and methods are provided for a drug delivery device and use of the device for drug delivery. In various aspects, the drug delivery device combines a “solid drug in reservoir” (SDR) system with an electrolytic pump. In various aspects an improved electrolytic pump is provided including, in particular, an improved electrolytic pump for use with a drug delivery device, for example an implantable drug delivery device. A catalytic reformer can be incorporated in a periodically pulsed electrolytic pump to provide stable pumping performance and reduced actuation cycle.

Drug delivery device including electrolytic pump

KAUST Repository

Foulds, Ian G.

2016-03-31

Systems and methods are provided for a drug delivery device and use of the device for drug delivery. In various aspects, the drug delivery device combines a “solid drug in reservoir” (SDR) system with an electrolytic pump. In various aspects an improved electrolytic pump is provided including, in particular, an improved electrolytic pump for use with a drug delivery device, for example an implantable drug delivery device. A catalytic reformer can be incorporated in a periodically pulsed electrolytic pump to provide stable pumping performance and reduced actuation cycle.

Push Off 2000 : new oilfield safety device catching on

Energy Technology Data Exchange (ETDEWEB)

Mowers, J.

2006-12-15

Fuel gas scrubbers use production gas to operate oil batteries, well separators, dehydrators, compressors, and pneumatic and pressure controls. Once an internal float gets stuck, production is stopped. The Push Off 2000 is a new safety device for fuel gas scrubbers which allows operators to easily dislodge a stuck internal float by activating the tool, which is mounted on top of the vessel. The device was developed after an operator suffered burns from a flash explosion that occurred after using a hammer to strike the fuel gas scrubber. The hammer method is the usual method of dealing with stuck internal floats, and can also jeopardize the integrity of the vessel, releasing gas or liquid hydrocarbons into the environment. The Push Off 2000 is expected to reduce costly facility downtime and increase revenue generating production time. Over 50 oil and gas companies have the Push Off 2000 device installed on fuel gas scrubber units at their facilities, and have recognized the safety and economic merits of the tool. The patented device has been approved by the Alberta Boilers Safety Association, the British Columbia Boiler and Elevator Safety Branch, and the Saskatchewan Boiler and Pressure Vessel Safety Unit. 1 fig.

Functionality of road safety devices – identification and analysis of factors

Directory of Open Access Journals (Sweden)

Jeliński Łukasz

2017-01-01

Full Text Available Road safety devices are designed to protect road users from the risk of injury or death. The principal type of restraint is the safety barrier. Deployed on sites with the highest risk of run-off-road accidents, safety barriers are mostly found on bridges, flyovers, central reservations, and on road edges which have fixed obstacles next to them. If properly designed and installed, safety barriers just as other road safety devices, should meet a number of functional features. This report analyses factors which may deteriorate functionality, ways to prevent this from happening and the thresholds for loss of road safety device functionality.

Safety evaluation in the development of medical devices and combination products

CERN Document Server

Gad, Shayne C

2008-01-01

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

Risk assessment of medical devices: evaluation of microbiological and toxicological safety

International Nuclear Information System (INIS)

Dorpema, J.W.

1995-01-01

Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)

78 FR 34669 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Science.gov (United States)

2013-06-10

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... importing wireless communication devices, portable music and data processing devices, and tablet computers... certain electronic devices, including wireless communication devices, portable music and data processing...

Materials for electrochemical device safety

Science.gov (United States)

Vissers, Daniel R.; Amine, Khalil; Thackeray, Michael M.; Kahaian, Arthur J.; Johnson, Christopher S.

2015-04-07

An electrochemical device includes a thermally-triggered intumescent material or a gas-triggered intumescent material. Such devices prevent or minimize short circuits in a device that could lead to thermal run-away. Such devices may include batteries or supercapacitors.

78 FR 16865 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Science.gov (United States)

2013-03-19

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... certain electronic devices, including wireless communication devices, portable music and data processing...

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Science.gov (United States)

2005-01-01

323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices

CFD Analysis of the Safety Injection Tank and Fluidic Device

Energy Technology Data Exchange (ETDEWEB)

Cho, Jai Oan; Nietiadi, Yohanes Setiawan; Lee, Jeong Ik [KAIST, Daejeon (Korea, Republic of); Addad, Yacine [KUSTAR, Abu Dhabi (United Arab Emirates)

2016-05-15

One of the most important components in the ECCS is the safety injection tank (SIT). Inside the SIT, a fluidic device is installed, which passively controls the mass flow of the safety injection and eliminates the need for low pressure safety injection pumps. As more passive safety mechanisms are being pursued, it has become more important to understand flow structure and the loss mechanism within the fluidic device. Current computational fluid dynamics (CFD) calculations have had limited success in predicting the fluid flow accurately. This study proposes to find a more exact result using CFD and more realistic modeling to predict the performance during accident scenarios more accurately. The safety injection tank with fluidic device was analyzed thoroughly using CFD. The preliminary calculation used 60,000 meshes for the initial test calculation. The results fit the experimental results surprisingly despite its coarse grid. Nonetheless, the mesh resolution was increased to capture the vortex in the fluidic device precisely. Once a detailed CFD computation is finished, a small-scale experiment will be conducted for the given conditions. Using the experimental results and the CFD model, physical models can be improved to fit the results more accurately.

Safety and feasibility research of CIPT-Ⅱ irradiation device

International Nuclear Information System (INIS)

Zhang Zhihua; Mi Xiangmiao; Li Rundong

2014-01-01

CITP-Ⅱ irradiation device, which is specially designed for fusion tritium breeder research, works in a thermal neutron reactor. With lithium orthosilicate as the breeder, the safety analysis was done to work out the device's influence on physical parameters of the reactor and get the breeder's temperature distribution and thermo-technical features in the n-γ field. The stiffness and strength were checked, and also the safety characters of the device were assessed. The feasibility of gap gas regulating the temperature and gas refueling the breeder was demonstrated. The calculation and analysis results provide data for comprehensive performance assessment. (authors)

Research Devices Maintenance Programs and Safety Network Infrastructures in Nuclear Malaysia

International Nuclear Information System (INIS)

Zainudin Jaafar; Muhammad Zahidee Taat; Ishak Mansor

2015-01-01

Instrumentation and Automation Center (PIA) is responsible in carrying out maintenance work for building safety infrastructure and area for nuclear scientific and research work. Care cycle and nuclear scientific tools starting from the preparation of specifications until devices disposal- to get the maximum output from devices therefore PIA has introduced Effective and Comprehensive Maintenance Plan under Management/ Trust/ Development/ Science Fund budgets and also user, Asset Management, caring and handling of the devices. This paper also discussed more on case study related to using and handling so that it can be guidance and standard when its involving mishandling, improper maintenance, inadequacy of supervision and others including improvement suggestion programs. (author)

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.

Science.gov (United States)

Sackner-Bernstein, Jonathan

2017-03-01

The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

78 FR 1247 - Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media...

Science.gov (United States)

2013-01-08

... Wireless Communication Devices, Tablet Computers, Media Players, and Televisions, and Components Thereof... devices, including wireless communication devices, tablet computers, media players, and televisions, and... wireless communication devices, tablet computers, media players, and televisions, and components thereof...

A safety control device for detecting undesirable conditions

Energy Technology Data Exchange (ETDEWEB)

1974-09-26

The invention relates to safety control devices. It deals with a device adapted to transmit a warning signal and to the detection of an undesirable condition in an associated apparatus, said device comprising switching means comprising transistors mounted in a reaction path, feeding means for opening the switching means whenever an undesirable condition has been detected by sensors, whereby an oscillator is caused to stop oscillating, and an outlet device controlled by the oscillator stoppage. This can be applied to the supervision of nuclear reactor.

Stakeholder challenges in purchasing medical devices for patient safety.

Science.gov (United States)

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

76 FR 45860 - In the Matter of Certain Electronic Devices, Including Wireless Communication Devices, Portable...

Science.gov (United States)

2011-08-01

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... electronic devices, including wireless communication devices, portable music and data processing devices, and...''). The complaint further alleges that an industry in the United States exists or is in the process of...

77 FR 70464 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Science.gov (United States)

2012-11-26

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... wireless communication devices, portable music and data processing devices, and tablet computers, by reason...

77 FR 60720 - Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data...

Science.gov (United States)

2012-10-04

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data Processing Devices, and Tablet Computers... communication devices, portable music and data processing devices, and tablet computers, imported by Apple Inc...

Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…

Effect of electronic device use on pedestrian safety : a literature review.

Science.gov (United States)

2016-04-01

This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Science.gov (United States)

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied on for Safety AGENCY: Nuclear Regulatory Commission. ACTION... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital...

Analytic device including nanostructures

KAUST Repository

Di Fabrizio, Enzo M.; Fratalocchi, Andrea; Totero Gongora, Juan Sebastian; Coluccio, Maria Laura; Candeloro, Patrizio; Cuda, Gianni

2015-01-01

A device for detecting an analyte in a sample comprising: an array including a plurality of pixels, each pixel including a nanochain comprising: a first nanostructure, a second nanostructure, and a third nanostructure, wherein size of the first nanostructure is larger than that of the second nanostructure, and size of the second nanostructure is larger than that of the third nanostructure, and wherein the first nanostructure, the second nanostructure, and the third nanostructure are positioned on a substrate such that when the nanochain is excited by an energy, an optical field between the second nanostructure and the third nanostructure is stronger than an optical field between the first nanostructure and the second nanostructure, wherein the array is configured to receive a sample; and a detector arranged to collect spectral data from a plurality of pixels of the array.

Autonomous booster device of a safety valve

International Nuclear Information System (INIS)

Namand, H.

1983-01-01

The invention concerns an autonomous booster device of a protection safety valve of a pressure vessel. The valve comprises a hollow structure, a seat connected with a mobile flap forming one piece with a stem and a calibration spring bearing on the stem and on the valve structure to maintain the flap bearing on the seat. The stem of the flap is prolongated in a box forming one piece with the valve structure and receives an added push of a spring. The box acts as a pressure device of which the piston can exercise on the stem a push opposite to and larger than the spring one. The feeding device of the pressure box is finally described in detail [fr

Launch Lock Assemblies Including Axial Gap Amplification Devices and Spacecraft Isolation Systems Including the Same

Science.gov (United States)

Barber, Tim Daniel (Inventor); Hindle, Timothy (Inventor); Young, Ken (Inventor); Davis, Torey (Inventor)

2014-01-01

Embodiments of a launch lock assembly are provided, as are embodiments of a spacecraft isolation system including one or more launch lock assemblies. In one embodiment, the launch lock assembly includes first and second mount pieces, a releasable clamp device, and an axial gap amplification device. The releasable clamp device normally maintains the first and second mount pieces in clamped engagement; and, when actuated, releases the first and second mount pieces from clamped engagement to allow relative axial motion there between. The axial gap amplification device normally residing in a blocking position wherein the gap amplification device obstructs relative axial motion between the first and second mount pieces. The axial gap amplification device moves into a non-blocking position when the first and second mount pieces are released from clamped engagement to increase the range of axial motion between the first and second mount pieces.

Product-based Safety Certification for Medical Devices Embedded Software.

Science.gov (United States)

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.

Science.gov (United States)

Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis

2013-11-25

Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction

Safety device for nuclear reactors

International Nuclear Information System (INIS)

Gruhl, H.

1974-01-01

The safety device is used to capture fragments of the lid of a pressure vessel when this vessel ruptures. It consists of a catcher structure attached to the concrete vessel, which is open at the top, and surrounding the pressure vessel. The catcher structure in this case may be designed as a ring installed very close to the concrete vessel, as a closure plate or may be made of transverse beams arranged parallel to each other. It is anchored either rigidly or elastically to the concrete vessel by means of springs or to the foundation by means of steel stretching members. (DG) [de

Electric drive systems including smoothing capacitor cooling devices and systems

Energy Technology Data Exchange (ETDEWEB)

Dede, Ercan Mehmet; Zhou, Feng

2017-02-28

An electric drive system includes a smoothing capacitor including at least one terminal, a bus bar electrically coupled to the at least one terminal, a thermoelectric device including a first side and a second side positioned opposite the first side, where the first side is thermally coupled to at least one of the at least one terminal and the bus bar, and a cooling element thermally coupled to the second side of the thermoelectric device, where the cooling element dissipates heat from the thermoelectric device.

MRI with cardiac pacing devices – Safety in clinical practice

Energy Technology Data Exchange (ETDEWEB)

Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)

2014-08-15

Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.

An examination of safety reports involving electronic flight bags and portable electronic devices

Science.gov (United States)

2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

The Role of Patient Safety in the Device Purchasing Process

National Research Council Canada - National Science Library

Johnson, Todd R; Zhang, Jiajie; Patel, Vimla L; Keselman, Alla; Tang, Xiaozhou; Brixey, Juliana J; Paige, Danielle; Turley, James P

2005-01-01

To examine how patient safety considerations are incorporated into medical device purchase decisions, individuals involved in recent infusion pump purchasing decisions at three different health care...

Safety considerations in the design of the Fusion Engineering Device

International Nuclear Information System (INIS)

Barrett, R.J.

1983-01-01

The US Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris

Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology

DEFF Research Database (Denmark)

Town, Graham; Ash, C; Dierickx, C

2012-01-01

. These guidelines provide a definition of light-based home-use technology, to inform healthcare professionals about home-use light-based technology and encourage manufacturers wishing to sell in Europe to adopt 'best practice'. The review presents the current status on standards and regulation issues and considers...... home-use safety issues, encompassing human, device and electrical safety, given risks to the eyes and skin from optical radiation both to the consumer and persons in the vicinity. Proposed technical measurement methodology is considered with focus on recognized critical parameters for the safe use...... of light-based hair removal technology including recording the technical performance and safety claims of a range of home-use hair removal devices. The literature review emphasizes potential adverse incidents and safety aspects of treating cosmetic conditions, such as unwanted hair growth. Although some...

Motorcycle safety device investigation: A case study on airbags

Indian Academy of Sciences (India)

analysis methods for research evaluation of rider crash protective devices fitted to ... The safety evaluation is then based on simulation of the 200 impact types. ... with recording of ISO 13232 car-front impact tests to evaluate the qualitative.

Energy storage device including a redox-enhanced electrolyte

Science.gov (United States)

Stucky, Galen; Evanko, Brian; Parker, Nicholas; Vonlanthen, David; Auston, David; Boettcher, Shannon; Chun, Sang-Eun; Ji, Xiulei; Wang, Bao; Wang, Xingfeng; Chandrabose, Raghu Subash

2017-08-08

An electrical double layer capacitor (EDLC) energy storage device is provided that includes at least two electrodes and a redox-enhanced electrolyte including two redox couples such that there is a different one of the redox couples for each of the electrodes. When charged, the charge is stored in Faradaic reactions with the at least two redox couples in the electrolyte and in a double-layer capacitance of a porous carbon material that comprises at least one of the electrodes, and a self-discharge of the energy storage device is mitigated by at least one of electrostatic attraction, adsorption, physisorption, and chemisorption of a redox couple onto the porous carbon material.

Universal Safety Distance Alert Device for Road Vehicles

Directory of Open Access Journals (Sweden)

Matic Virant

2016-04-01

Full Text Available Driving with too short of a safety distance is a common problem in road traffic, often with traffic accidents as a consequence. Research has identified a lack of vehicle-mountable devices for alerting the drivers of trailing vehicles about keeping a sufficient safe distance. The principal requirements for such a device were defined. A conceptual study was performed in order to select the components for the integration of the device. Based on the results of this study, a working prototype of a flexible, self-contained device was designed, built and tested. The device is intended to be mounted on the rear of a vehicle. It uses radar as the primary distance sensor, assisted with a GPS receiver for velocity measurement. A Raspberry Pi single-board computer is used for data acquisition and processing. The alerts are shown on an LED-matrix display mounted on the rear of the host vehicle. The device software is written in Python and provides automatic operation without requiring any user intervention. The tests have shown that the device is usable on almost any motor vehicle and performs reliably in simulated and real traffic. The open issues and possibilities for future improvements are presented in the Discussion.

Model for safety reports including descriptive examples

International Nuclear Information System (INIS)

1995-12-01

Several safety reports will be produced in the process of planning and constructing the system for disposal of high-level radioactive waste in Sweden. The present report gives a model, with detailed examples, of how these reports should be organized and what steps they should include. In the near future safety reports will deal with the encapsulation plant and the repository. Later reports will treat operation of the handling systems and the repository

Condition Monitoring and Fault Diagnosis for an Antifalling Safety Device

Directory of Open Access Journals (Sweden)

Guangxiang Yang

2015-01-01

Full Text Available There is a constant need for the safe operation and reliability of antifalling safety device (AFSD of an elevator. This paper reports an experimental study on rotation speed and catching torque monitoring and fault diagnosis of an antifalling safety device in a construction elevator. Denoising the signal using wavelet transform is presented in this paper. Based on the denoising effects for several types of wavelets, the sym8 wavelet basis, which introduces the high order approximation and an adaptive threshold, is employed for denoising the signal. The experimental result shows a maximum data error reduction of 7.5% is obtained and SNRs (signal-to-noise ratio of rotation speed and catching torque are improved for 3.9% and 6.4%, respectively.

The safety of non-incineration waste disposal devices in four hospitals of Tehran.

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

The safe management of hospital waste is a challenge in many developing countries. The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries.

Thermal-Responsive Polymers for Enhancing Safety of Electrochemical Storage Devices.

Science.gov (United States)

Yang, Hui; Leow, Wan Ru; Chen, Xiaodong

2018-03-01

Thermal runway constitutes the most pressing safety issue in lithium-ion batteries and supercapacitors of large-scale and high-power density due to risks of fire or explosion. However, traditional strategies for averting thermal runaway do not enable the charging-discharging rate to change according to temperature or the original performance to resume when the device is cooled to room temperature. To efficiently control thermal runaway, thermal-responsive polymers provide a feasible and reversible strategy due to their ability to sense and subsequently act according to a predetermined sequence when triggered by heat. Herein, recent research progress on the use of thermal-responsive polymers to enhance the thermal safety of electrochemical storage devices is reviewed. First, a brief discussion is provided on the methods of preventing thermal runaway in electrochemical storage devices. Subsequently, a short review is provided on the different types of thermal-responsive polymers that can efficiently avoid thermal runaway, such as phase change polymers, polymers with sol-gel transitions, and polymers with positive temperature coefficients. The results represent the important development of thermal-responsive polymers toward the prevention of thermal runaway in next-generation smart electrochemical storage devices. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The design study of the JT-60SU device. No.8. Nuclear shielding and safety design

Energy Technology Data Exchange (ETDEWEB)

Miya, Naoyuki; Kikuchi, Mitsuru; Ushigusa, Kenkichi [Japan Atomic Energy Research Inst., Naka, Ibaraki (Japan). Naka Fusion Research Establishment] [and others

1998-03-01

Results of nuclear shielding design study and safety analysis for the steady-state tokamak device JT-60SU are described. D-T operation (option) for two years is adopted in addition to ten years operation using deuterium. Design work has been done in accordance with general laws for radioisotopes handling in Japan as a guideline of safety evaluation, which is applied to the operation of present JT-60U device. Optimization of the shielding design for the device structure including vacuum vessel has been presented to meet with allowable limits of biological shielding determined in advance. It is shown that JT-60SU can be operated safely in the present JT-60 experimental building. It is planed to use 100g/year of tritium in D-T operation phase. A concept of multiple -barrier system is applied to the facility design to prevent propagation of tritium, in which the torus hall and the tritium removal room provide the tertiary confinement. From the design of atmosphere detritiation system for accidental tritium release, it is shown that tritium concentration level can be reduced to the allowable level after two weeks with reasonable compact size components. Safety assessment related to activation of coolant/air, and atmospheric tritium effluents are discussed. (author)

Software used to size the safety devices

CERN Multimedia

CERN. Geneva

2016-01-01

To avoid mistakes during the calculation, CEA/SBT has decided to write a software that take into account all the situations it is possible to encountered (subcritical state, supercritical state, …). The goal is to permit to the engineer in charge of a cryostat manufacturing to perform this calculation; he is the only person able to do the accidental analysis which is fundamental for the sizing of the safety device. The software performed will be presented.

Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

DEFF Research Database (Denmark)

Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

2017-01-01

Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

Development of a safety case for the use of current limiting devices to manage short circuit currents on electrical distribution networks. Final report

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

The original objective of this study was to review the safety issues associated with the use of current limiting devices and to write a risk assessment in accordance with good practice. But, when legislative procedures became apparent, the scope was changed to include involvement with the HSE, the DTI and Ofgem. It turned out that it would have been very difficult to write a safety case that would satisfy all of the agencies, or a risk assessment that would cover all applications. The scope of the study was therefore changed to focus on how the existing barriers should be tackled and the implications of the existing legislation. The approach to the study is described; it included reviews of background information and literature, questionnaires to manufacturers, a review of the reliability and hazards of the devices, and a review of UK safety legislation. The Final Report describes all this and includes discussion on the consequences of failure of fault current limiting devices, control measures which could be used to minimise risk, and recommendations for a way forward.

75 FR 10502 - In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices...

Science.gov (United States)

2010-03-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-667; Investigation No. 337-TA-673] In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices; Notice of... Entirety AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that...

Design and construction of safety devices utilizing methods of measurement and control engineering

Energy Technology Data Exchange (ETDEWEB)

Greiner, B; Weidlich, S

1982-08-01

This article considers a proposed concept for the design and construction of measurement and control devices for the safety of chemical plants with the aim of preventing danger to persons and the environment and damage. Such measurement and control devices are generally employed when primary measures adopted for plant safety, such as safety valves, collection vessels, etc. are not applicable or insufficient by themselves. The concept regards the new sheet no. 3 of the VDI/VDE code draft 2180 ''Safety of chemical engineering plant'' and proposes a further subdivision of class A into safety classes A0, A1, and A2. Overall, it is possible, on the basis of the measures for raising the availability of measurement and control equipment which are presented in this article, to make selection appropriate to the potential danger involved. The proposed procedure should not, however, be regarded as a rigid scheme but rather as leading to a systematic view and supporting decisions resting on sound operating experience.

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

Science.gov (United States)

Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

2011-06-01

Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

The safety of non-incineration waste disposal devices in four hospitals of Tehran

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

Background: The safe management of hospital waste is a challenge in many developing countries. Objectives: The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. Methods: VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. Results: There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. Conclusions: There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries. PMID:25000113

Microfluidic devices and methods including porous polymer monoliths

Science.gov (United States)

Hatch, Anson V; Sommer, Gregory J; Singh, Anup K; Wang, Ying-Chih; Abhyankar, Vinay V

2014-04-22

Microfluidic devices and methods including porous polymer monoliths are described. Polymerization techniques may be used to generate porous polymer monoliths having pores defined by a liquid component of a fluid mixture. The fluid mixture may contain iniferters and the resulting porous polymer monolith may include surfaces terminated with iniferter species. Capture molecules may then be grafted to the monolith pores.

10 CFR 32.101 - Schedule B-prototype tests for luminous safety devices for use in aircraft.

Science.gov (United States)

2010-01-01

....101 Schedule B—prototype tests for luminous safety devices for use in aircraft. An applicant for a... 10 Energy 1 2010-01-01 2010-01-01 false Schedule B-prototype tests for luminous safety devices for use in aircraft. 32.101 Section 32.101 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES...

Medical Device Safety

Science.gov (United States)

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

International Nuclear Information System (INIS)

Bang, Young Seok; Yoo, Seung Hun

2016-01-01

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

Energy Technology Data Exchange (ETDEWEB)

Bang, Young Seok; Yoo, Seung Hun [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level.

A systematic review of light-based home-use devices for hair removal and considerations on human safety

DEFF Research Database (Denmark)

Thaysen-Petersen, D; Bjerring, P; Dierickx, C

2012-01-01

To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. Methods A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled......, uncontrolled or randomized and with a sample size of at least 10 individuals. Results We identified a total of seven studies: one controlled (CT) and six uncontrolled trials (UCTs). No randomized controlled trials (RCT) were recognized. The best evidence was found for IPL (intense pulsed light) (three devices...

Regulatory Experience of the Embedded Digital Devices for Safety I and C Systems on Nuclear Power Plants

Energy Technology Data Exchange (ETDEWEB)

Kim, Y. M.; Lee, H. K.; Park, H. S. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Conventional I and C(Instrumentation and Control) systems are tend to becoming unavailable and being replaced by smart equipment. These smart equipment is usually called embedded digital devices (EDDs) or industrial digital devices of limited functionality. Usually, some of these devices are found embedded in plant equipment such as sensing instrumentation, motors, pumps, actuators and breakers. They typically have a micro-processor, RAM, communication interface, a power source, etc. The U.S. Nuclear Regulatory Commission (US NRC) is concerning that these EDDs might exist in procured equipment used in safety systems without the devices having been explicitly identified in procurement documentation. This paper addresses the regulatory experiences of KINS of the EDDs for safety I and C systems and the future works for them. In this paper, we showed regulatory experiences of EDDs which used for safety grade equipment. EDDs might exist in safety grade procured equipment without explicit identification. Undetected defects of EDDs might be the potential safety concerns. EDDs should meet certain specific requirements in order to be selected and used in safety I and C system. We have plan to develop technical positions for identification and qualifying them. The technical position will address, but may not be limited to, quality and reliability, CCFs via software errors, EMC, and CGID for EDDs.

Recommended safety procedures for the selection and use of demonstration-type gas discharge devices in schools

International Nuclear Information System (INIS)

1979-01-01

A 1972 survey of 30 Ottawa secondary schools revealed a total of 347 actual or potential X-ray sources available in these schools. More than half of these sources were gas discharge tubes. Some gas discharge tubes, in particular the cold cathode type, can emit X-rays at significantly high levels. Unless such tubes are used carefully, and with regard for good radiation safety practices, they can result in exposures to students that are in excess of the maximum levels recommended by the International Commission on Radiological Protection. Several cases of the recommended dose being exceeded were found in the classes surveyed. This document has been prepared to assist science teachers and others using demonstration-type gas discharge devices to select and use such devices so as to present negligible risk to themselves and students. Useful information on safety procedures to be followed when performing demonstrations or experiments is included. (J.T.A.)

78 FR 47410 - Certain Wireless Devices, Including Mobile Phones and Tablets Institution of Investigation

Science.gov (United States)

2013-08-05

... sale within the United States after importation of certain wireless devices, including mobile phones... importation of certain wireless devices, including mobile phones and tablets by reason of infringement of... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-889] Certain Wireless Devices, Including...

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Utilization of ocular safety devices among Sawmill workers in Nigeria

African Journals Online (AJOL)

Objective: The study was carried out to assess the use of eye safety devices in sawmill workers in Nigeria. Methods: A cross-sectional study of sawmill workers was carried out using pretested questionnaires. Ocular examination was done on site with a pen torch, portable hand-held slit lamp bio-microscope and direct ...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2012-10-04

... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-06-12

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-06-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

Passive safety device and internal short tested method for energy storage cells and systems

Science.gov (United States)

Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad

2015-09-22

A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.

Electrolyte solutions including a phosphoranimine compound, and energy storage devices including same

Science.gov (United States)

Klaehn, John R.; Dufek, Eric J.; Rollins, Harry W.; Harrup, Mason K.; Gering, Kevin L.

2017-09-12

An electrolyte solution comprising at least one phosphoranimine compound and a metal salt. The at least one phosphoranimine compound comprises a compound of the chemical structure ##STR00001## where X is an organosilyl group or a tert-butyl group and each of R.sup.1, R.sup.2, and R.sup.3 is independently selected from the group consisting of an alkyl group, an aryl group, an alkoxy group, or an aryloxy group. An energy storage device including the electrolyte solution is also disclosed.

78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-03-21

... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

41 CFR 102-34.250 - Do Federal employees in Government motor vehicles have to use all safety devices and follow all...

Science.gov (United States)

2010-07-01

... safety devices and follow all safety guidelines? Yes, Federal employees in Government motor vehicles have... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section...

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Science.gov (United States)

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

Predistortion control device and method, assembly including a predistortion control device

NARCIS (Netherlands)

Kokkeler, Andre B.J.

2003-01-01

A predistortion control device (1). The device has a first predistortion control input connectable to a power amplifier output (21); a second predistortion control input (11) connectable to a signal contact of a predistortion device; and a predistortion control output (12) connectable to a control

78 FR 34132 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Science.gov (United States)

2013-06-06

... INTERNATIONAL TRADE COMMISSION [Docket No 2958] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Correction to Notice of Receipt of Complaint; Solicitation... of complaint entitled Certain Portable Electronic Communications Devices, Including Mobile Phones and...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

Science.gov (United States)

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Safety catching device for pipes in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1976-01-01

The safety catching device consists of a steel wire passed in U-shape around the pipe to be caught and supported by two anchor ties embedded in the concrete of the missile shielding cylinder. This flexible catching device is to cause the energy released in case of a pipe rupture to be absorbed and no dangerous bending shesses to be transferred to the walls of the missile shielding cylinder. (UWI) [de

Safety evaluation of stamp type digital microneedle devices in hairless mice.

Science.gov (United States)

Park, Kui Young; Jang, Woo Sun; Lim, Yun Young; Ahn, Joo Hee; Lee, Sang Jin; Kim, Chan Woong; Kim, Sung Eun; Kim, Beom Joon; Kim, Myeung Nam

2013-02-01

Microneedles provide a minimally invasive means to transport molecules into the skin. A number of specific strategies have been employed to use microneedles for transdermal delivery. The purpose of this study was to investigate the safety of two new digital microneedle devices (Digital Hand® and Digital Pro®; Bomtech Electronics Co., Ltd., Seoul, Korea) for the perforation of skin in skin-hairless-1 mice. This device replaces conventional needles and is designed specifically for intradermal delivery. We used two newly developed digital microneedle devices to perforate the skin of skin-hairless-1 mice. We conducted a comparative study of the two digital microneedle devices and DTS® (Disk type-microneedle Therapy System; DTS lab., Seoul, Korea). To evaluate skin stability, we performed visual and dermatoscopic inspections, measurements of transepidermal water loss, and biopsies. The two novel digital microneedle devices did not induce significant abnormalities of the skin on visual or dermatoscopic inspection, regardless of needle size (0.25~2.0 mm). No significant histopathological changes, such as inflammatory cell infiltration, desquamation of the stratum corneum, or disruption of the basal layer, were observed. The digital microneedle devices and microneedle therapy system produced similar results on measures of skin stability. These two novel digital microneedle devices are safe transdermal drug delivery systems.

30 CFR 285.810 - What must I include in my Safety Management System?

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What must I include in my Safety Management System? 285.810 Section 285.810 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR..., COPs and GAPs Safety Management Systems § 285.810 What must I include in my Safety Management System...

The Challenges of Balancing Safety and Security in Implantable Medical Devices.

Science.gov (United States)

Katzis, Konstantinos; Jones, Richard W; Despotou, George

2016-01-01

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

ACCIDENT WITH NEEDLESTICK: KNOWLEDGE AND USE OF SAFETY DEVICE

Directory of Open Access Journals (Sweden)

Sandra Maria Souza da Silva

2016-07-01

Full Text Available Health workers engaged in labour activities in environments surrounded the occupational hazards. Identify knowledge and use of safety devide for preventing accidents with sharp objects between nurses and nurse technicians, workers of the Intensive Care Unit, Emergency and Surgical Block, during the month of may 2015. Exploratory study, quantitative, developed in a teaching hospital in in Recife-PE. The data collection was conducted using a questionnaire prepared by the research authors. The results were submitted to descriptive statistical analysis, being evidenced that, although data indicate high rate of respondents know and use products with referencing safety devices to prevent accidents, cite gloves and masks as representatives of those materials, which requires clarification in discussion of the study. It is necessary to guide and clarify as to such mechanisms, through the permanent education, and training among workers.

Ionic liquids, electrolyte solutions including the ionic liquids, and energy storage devices including the ionic liquids

Science.gov (United States)

Gering, Kevin L.; Harrup, Mason K.; Rollins, Harry W.

2015-12-08

An ionic liquid including a phosphazene compound that has a plurality of phosphorus-nitrogen units and at least one pendant group bonded to each phosphorus atom of the plurality of phosphorus-nitrogen units. One pendant group of the at least one pendant group comprises a positively charged pendant group. Additional embodiments of ionic liquids are disclosed, as are electrolyte solutions and energy storage devices including the embodiments of the ionic liquid.

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

Science.gov (United States)

Ho, Anita; Quick, Oliver

2018-03-06

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

78 FR 40171 - Certain Wireless Devices, Including Mobile Phones and Tablets; Notice Of Receipt of Complaint...

Science.gov (United States)

2013-07-03

... INTERNATIONAL TRADE COMMISSION [Docket No. 2964] Certain Wireless Devices, Including Mobile Phones.... International Trade Commission has received a complaint entitled Certain Wireless Devices, Including Mobile... importation, and the sale within the United States after importation of certain wireless devices, including...

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

Science.gov (United States)

2011-07-20

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...

TH-C-18C-01: MRI Safety

Energy Technology Data Exchange (ETDEWEB)

Pooley, R [Mayo Clinic, Jacksonville, FL (United States); Bernstein, M; Shu, Y; Gorny, K; Felmlee, J [Mayo Clinic, Rochester, MN (United States); Panda, A [Mayo Clinic, Arizona, Scottsdale, AZ (United States)

2014-06-15

Clinical diagnostic medical physicists may be responsible for implementing and maintaining a comprehensive MR safety program. Accrediting bodies including the ACR, IAC, Radsite and The Joint Commission each include aspects of MR Safety into their imaging accreditation programs; MIPPA regulations further raise the significance of non-compliance. In addition, The Joint Commission recently announced New and Revised Diagnostic Imaging Standards for accredited health care organizations which include aspects of MR Safety. Hospitals and clinics look to the physicist to understand guidelines, regulations and accreditation requirements related to MR safety. The clinical medical physicist plays a significant role in a clinical practice by understanding the physical basis for the risks and acting as a facilitator to successfully implement a safety program that provides well-planned siting, allows for the safe scanning of certain implanted devices, and helps radiologists manage specific patient exams. The MRI scanning of specific devices will be discussed including cardiac pacemakers and neurostimulators such as deep brain stimulators. Furthermore for sites involved in MR guided interventional procedures, the MR physicist plays an essential role to establish safe practices. Creating a framework for a safe MRI practice includes the review of actual safety incidents or close calls to determine methods for prevention in the future. Learning Objectives: Understand the requirements and recommendations related to MR safety from accrediting bodies and federal regulations. Understand the Medical Physicist's roles to ensure MR Safety. Identify best practices for dealing with implanted devices, including pacemakers and deep brain stimulators. Review aspects of MR safety involved in an MR guided interventional environment. Understand the important MR safety aspects in actual safety incidents or near misses.

Meta-structure and tunable optical device including the same

Science.gov (United States)

Han, Seunghoon; Papadakis, Georgia Theano; Atwater, Harry

2017-12-26

A meta-structure and a tunable optical device including the same are provided. The meta-structure includes a plurality of metal layers spaced apart from one another, an active layer spaced apart from the plurality of metal layers and having a carrier concentration that is tuned according to an electric signal applied to the active layer and the plurality of metal layers, and a plurality of dielectric layers spaced apart from one another and each having one surface contacting a metal layer among the plurality of metal layers and another surface contacting the active layer.

Integrated model of port oil piping transportation system safety including operating environment threats

Directory of Open Access Journals (Sweden)

Kołowrocki Krzysztof

2017-06-01

Full Text Available The paper presents an integrated general model of complex technical system, linking its multistate safety model and the model of its operation process including operating environment threats and considering variable at different operation states its safety structures and its components safety parameters. Under the assumption that the system has exponential safety function, the safety characteristics of the port oil piping transportation system are determined.

Integrated model of port oil piping transportation system safety including operating environment threats

OpenAIRE

Kołowrocki, Krzysztof; Kuligowska, Ewa; Soszyńska-Budny, Joanna

2017-01-01

The paper presents an integrated general model of complex technical system, linking its multistate safety model and the model of its operation process including operating environment threats and considering variable at different operation states its safety structures and its components safety parameters. Under the assumption that the system has exponential safety function, the safety characteristics of the port oil piping transportation system are determined.

The Physics of Semiconductors An Introduction Including Devices and Nanophysics

CERN Document Server

Grundmann, Marius

2006-01-01

The Physics of Semiconductors provides material for a comprehensive upper-level-undergrauate and graduate course on the subject, guiding readers to the point where they can choose a special topic and begin supervised research. The textbook provides a balance between essential aspects of solid-state and semiconductor physics, on the one hand, and the principles of various semiconductor devices and their applications in electronic and photonic devices, on the other. It highlights many practical aspects of semiconductors such as alloys, strain, heterostructures, nanostructures, that are necessary in modern semiconductor research but typically omitted in textbooks. For the interested reader some additional advanced topics are included, such as Bragg mirrors, resonators, polarized and magnetic semiconductors are included. Also supplied are explicit formulas for many results, to support better understanding. The Physics of Semiconductors requires little or no prior knowledge of solid-state physics and evolved from ...

IAEA safety glossary. Terminology used in nuclear safety and radiation protection, multilingual 2007 edition, including the IAEA safety fundamentals [no. SF-1

International Nuclear Information System (INIS)

2008-10-01

The IAEA Safety Glossary defines and explains technical terms used in the IAEA Safety Standards and other safety related IAEA publications, and provides information on their usage.The publication is multilingual and covers the six official IAEA languages,, Arabic, Chinese, English, French, Russian and Spanish. It has been in use since April 2000. The 2007 Edition is a revised and updated version. The primary purpose of the publication is to harmonize terminology and usage in the IAEA Safety Standards. It is a source of information for users of the IAEA Safety Standards and other safety related IAEA publications and provides guidance for the drafters and reviewers of publications, including IAEA technical officers and consultants, and members of technical committees, advisory groups, working groups and bodies for the endorsement of safety standards

The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

Energy Technology Data Exchange (ETDEWEB)

Yuan, Yongguang; Zong, Yao; Zheng, Qishan [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Qian, Garrett [University of New South Wales (Australia); Qian, Xiaobin; Li, Yujie; Shao, Wanwen [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Gao, Qianying, E-mail: gaoqy@mail.sysu.edu.cn [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China)

2016-05-01

Purpose: To evaluate the efficacy and safety of posterior scleral reinforcement (PSR) device for myopia suppression in rabbits' eyes. Methods: PSR surgery was performed on the normal 12 8-week-old New Zealand white rabbits' right eyes. To determine efficacy of the device, ophthalmic examination would be taken at pre-operation and post-operation (1 week, 1 month, 3 months, 6 months, and 1 year), such as A-ultrasound, diopter and B-ultrasound. Evaluation of safety were based on the following indicators: intraocular pressure (IOP), slit lamp, fundus photography, fundus fluorescein angiography and pathological examination after surgery. The efficacy and safety of PSR device were evaluated by comparison (treated eyes and contralateral eyes) of pre and post-operation. Results: The novel PSR device could significantly shorten axial length (preoperative axial length: 16.36 ± 0.14 mm, postoperative 1 week, 1 month, 3 months, 6 months and 1 year axial lengths: 15.03 ± 0.28 mm, 15.23 ± 0.32 mm, 15.39 ± 0.31 mm, 15.45 ± 0.22 mm and 15.45 ± 0.22 mm; P = 0.00037 < 0.001) in the treated eyes (right eyes) after surgery. At different postoperative time points, the B-ultrasound images showed that the PSR located in appropriate position and supported the posterior sclera very well. At the same time, IOP of treated eyes kept a relatively stable level (preoperative IOP: 12.56 ± 2.01 mmHg, postoperative IOP: ranging from 11.33 ± 1.23 mmHg to 13.44 ± 2.19 mmHg, P > 0.05) post-operation 1 year. During observation period, there was no significant inflammatory reaction and complications such as anterior chamber flare, empyema, endophthalmitis, vitreous hemorrhage, retina detachment and retinal choroid neovascularization by slit lamp, fundus photography and fundus fluorescein angiography. In addition, there were no pathologic changes be found by comparison treated eyes group and contralateral group eyes based on pathological examinations. Conclusions: In vivo study

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

Science.gov (United States)

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States.

Science.gov (United States)

Frost, Karen L; van Roosmalen, Linda; Bertocci, Gina; Cross, Douglas J

2012-01-01

An overview of the current status of wheelchair transportation safety in fixed route and demand-responsive, non-rail, public transportation vehicles within the US is presented. A description of each mode of transportation is provided, followed by a discussion of the primary issues affecting safety, accessibility, and usability. Technologies such as lifts, ramps, securement systems, and occupant restraint systems, along with regulations and voluntary industry standards have been implemented with the intent of improving safety and accessibility for individuals who travel while seated in their wheeled mobility device (e.g., wheelchair or scooter). However, across both fixed route and demand-responsive transit systems a myriad of factors such as nonuse and misuse of safety systems, oversized wheeled mobility devices, vehicle space constraints, and inadequate vehicle operator training may place wheeled mobility device (WhMD) users at risk of injury even under non-impact driving conditions. Since WhMD-related incidents also often occur during the boarding and alighting process, the frequency of these events, along with factors associated with these events are described for each transit mode. Recommendations for improving WhMD transportation are discussed given the current state of

77 FR 27078 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Science.gov (United States)

2012-05-08

... Phones and Tablet Computers, and Components Thereof; Notice of Receipt of Complaint; Solicitation of... entitled Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... the United States after importation of certain electronic devices, including mobile phones and tablet...

Developments of radiation safety requirements for the management of radiation devices

International Nuclear Information System (INIS)

Lee, Hee Seock; Choi, Jin Ho; Cheong, Yuon Young

2002-03-01

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research

Developments of radiation safety requirements for the management of radiation devices

Energy Technology Data Exchange (ETDEWEB)

Lee, Hee Seock [Pohang Accelerator Lab, Pohang (Korea, Republic of); Choi, Jin Ho [Gachun University of Medicine and science, Incheon (Korea, Republic of); Cheong, Yuon Young [Asan Medical Center, Seoul (Korea, Republic of)] (and others)

2002-03-15

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research.

Components for containment enclosures. Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices

International Nuclear Information System (INIS)

2001-01-01

ISO 11933 consists of the following parts, under the general title Components for containment enclosures: Part 1: Glove/bag ports, bungs for glove/bag ports, enclosure rings and interchangeable units; Part 2: Gloves, welded bags, gaiters for remote-handling tongs and for manipulators; Part 3: Transfer systems such as plain doors, airlock chambers, double door transfer systems, leaktight connections for waste drums; Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices; Part 5: Penetrations for electrical and fluid circuits. This part of ISO 11933 specifies the design criteria and the characteristics of various components used for ventilation and gas-cleaning in containment enclosures. These components are either directly fixed to the containment enclosure wall, or used in the environment of a shielded or unshielded containment enclosure or line of such enclosures. They can be used alone or in conjunction with other mechanical components, including those specified in ISO 11933-1 and ISO 11933-3. This part of ISO 11933 is applicable to: filtering devices, including high-efficiency particulate air (HEPA) filters and iodine traps; safety valves and pressure regulators; systems ensuring the mechanical protection of containment enclosures; control and pressure-measurement devices

Design and construction of engineering test device of a multi-purpose radwaste incineration system

International Nuclear Information System (INIS)

Wang Peiyi; Zhou Lianquan; Ma Mingxie; Qiu Mingcai; Yang Liguo; Li Xiaohai; Zhang Xiaobin; Lu Xiaowu; Dong Jingling; Wang Xujin; Li Chuanlian; Yang Baomin

2002-01-01

The author describes designs of main un-standard devices, monitoring system and safety system, as well as construction of the engineering system devices for a multi-purpose radwaste incineration system. Un-standard devices include waste crusher, pyrolysis furnace, incinerator furnace, cool stream dilution device and bag filter, etc. The monitoring system mainly includes industrial controlled computer, supported by conventional electrical equipment and instruments. Designs of system safety takes account of containment of radioactive materials fire-prevention, explosion prevention, anti-corrosion, redundance and reservation, emergency system, controlling and electric safety system, etc. Results show that main technological system remains good airtight with leakage ratio at 0.67%

76 FR 23255 - Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and Associated Equipment

Science.gov (United States)

2011-04-26

... petitions for reconsideration from Harley-Davidson Motor Company (January 18, 2008) and Ford Motor Company... [Docket No. NHTSA-2007-28322] Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and... part, the petitions for reconsideration of the December 4, 2007, final rule reorganizing Federal Motor...

Safety motion increase of trains by improvement diagnostics process devices of railway automation

Directory of Open Access Journals (Sweden)

B.M.Bondarenko

2012-12-01

Full Text Available The complex use of methods of nondestructive check for the automated diagnostics electromagnetic relays of railway automation the first class reliability is offered. The methods determination of their mechanical parameters are resulted, that allows to exclude a human factor from the control, promote reliability of devices railway automation and safety motion of railway transport.

The risk of a safety-critical event associated with mobile device use in specific driving contexts.

Science.gov (United States)

Fitch, Gregory M; Hanowski, Richard J; Guo, Feng

2015-01-01

We explored drivers' mobile device use and its associated risk of a safety-critical event (SCE) in specific driving contexts. Our premise was that the SCE risk associated with mobile device use increases when the driving task becomes demanding. Data from naturalistic driving studies involving commercial motor vehicle drivers and light vehicle drivers were partitioned into subsets representative of specific driving contexts. The subsets were generated using data set attributes that included level of service and relation to junction. These attributes were selected based on exogenous factors known to alter driving task demands. The subsets were analyzed using a case-cohort approach, which was selected to complement previous investigations of mobile device SCE risk using naturalistic driving data. Both commercial motor vehicle and light vehicle drivers varied as to how much they conversed on a mobile device but did not vary their engagement in visual-manual subtasks. Furthermore, commercial motor vehicle drivers conversed less frequently as the driving task demands increased, whereas light vehicle drivers did not. The risk of an SCE associated with mobile device use was dependent on the subtask performed and the driving context. Only visual-manual subtasks were associated with an increased SCE risk, whereas conversing was associated with a decreased risk in some driving contexts. Drivers' engagement in mobile device subtasks varies by driving context. The SCE risk associated with mobile device use is dependent on the types of subtasks performed and the driving context. The findings of this exploratory study can be applied to the design of driver-vehicle interfaces that mitigate distraction by preventing visual-manual subtasks while driving.

Electronic cigarette devices and oro-facial trauma (Literature review)

Science.gov (United States)

Ghazali, A. F.; Ismail, A. F.; Daud, A.

2017-08-01

Detrimental effects of cigarette smoking have been well described and recognized globally. With recent advancement of technology, electronic cigarette has been introduced and gained its popularity and became a global trend, especially among young adults. However, the safety of the electronic devices remains debatable. This paper aimed to compile and review the reported cases of oro-facial trauma related to the usage of electronic cigarette devices. A literature search was conducted using PubMed/Medline in December 2016. The search terms used were a combination of “oral trauma”, “dental trauma”, “oral injury” and “electronic cigarette”. The search included all abstract published from the inception of the database until December 2016. Abstract that was written in English, case report, letter to editors, clinical and human studies were included for analysis. All selected abstract were searched for full articles. A total of 8 articles were included for review. All of the articles were published in 2016 with mostly case reports. The sample size of the studies ranged from 1 to 15 patients. Seven of the included articles are from United States of America and one from Mexico. Our review concluded that the use of electronic cigarette devices posed not only a safety concern but also that the devices were mostly unregulated. There should be a recognized authority body to regulate the safety and standard of the electronic devices.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-15

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

An overview of review guidelines for HDL programmable devices in nuclear safety systems

International Nuclear Information System (INIS)

Komanduri, Raghavan; Srivani, L.; Thirugnana Murthy, D.

2013-01-01

HDL programmable devices viz. CPLDs and FPGAs are increasingly being used to implement digital designs in the I and C systems performing safety functions of nuclear power plants. Synthesizable RTL descriptions manually written in HDLs are the first step in developing industry standard large scale digital designs. The reliability of the implementation is determined by the methodologies followed by the designer during development. Very few guidelines on HPD design practices, specific to nuclear industry are available. This paper presents an overview of the existing guidelines such as IEC 62566 and U.S. NRC's 'Review guidelines for FPGAs in nuclear power plant safety systems'. (author)

Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages

Science.gov (United States)

... Food Resources for You Consumers FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages ... addition, the flavorings and nutrients added to these beverages must comply with all applicable FDA safety requirements and they must be identified in the ...

78 FR 29156 - Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems...

Science.gov (United States)

2013-05-17

..., and the sale within the United States after importation of certain digital media devices, including... INTERNATIONAL TRADE COMMISSION [Docket No 2954] Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems, Tablets and Mobile Phones, Components Thereof and...

Consumers' Use of Personal Electronic Devices in the Kitchen.

Science.gov (United States)

Lando, Amy M; Bazaco, Michael C; Chen, Yi

2018-02-23

Smartphones, tablets, and other personal electronic devices have become ubiquitous in Americans' daily lives. These devices are used by people throughout the day, including while preparing food. For example, a device may be used to look at recipes and therefore be touched multiple times during food preparation. Previous research has indicated that cell phones can harbor bacteria, including opportunistic human pathogens such as Staphylococcus and Klebsiella spp. This investigation was conducted with data from the 2016 Food Safety Survey (FSS) and from subsequent focus groups to determine the frequency with which consumers use personal electronic devices in the kitchen while preparing food, the types of devices used, and hand washing behaviors after handling these devices. The 2016 FSS is the seventh wave of a repeated cross-sectional survey conducted by the U.S. Food and Drug Administration in collaboration with the U.S. Department of Agriculture. The goal of the FSS is to evaluate U.S. adult consumer attitudes, behaviors, and knowledge about food safety. The FSS included 4,169 adults that were contacted using a dual-frame (land line and cell phone interviews) random-digit-dial sampling process. The personal electronics module was the first of three food safety topics discussed by each of eight consumer focus groups, which were convened in four U.S. cities in fall 2016. Results from the 2016 FSS revealed that of those individuals who use personal electronic devices while cooking, only about one third reported washing hands after touching the device and before continuing cooking. This proportion is significantly lower than that for self-reported hand washing behaviors after touching risky food products such as raw eggs, meat, chicken, or fish. Results from the focus groups highlight the varied usage of these devices during food preparation and the related strategies consumers are using to incorporate personal electric devices into their cooking routines.

Radiation Safety in Industrial Radiography. Specific Safety Guide

International Nuclear Information System (INIS)

2011-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

78 FR 48468 - Delphi Corporation, Electronics and Safety Division, Including On-Site Leased Workers From...

Science.gov (United States)

2013-08-08

..., Electronics and Safety Division, Including On-Site Leased Workers From Securitas, Bartech, Flint Janitorial... Adjustment Assistance on May 20, 2013, applicable to workers of Delphi Corporation, Electronics and Safety... on- site at the Flint, Michigan location of Delphi Corporation, Electronics and Safety Division. The...

RF radiation safety handbook

International Nuclear Information System (INIS)

Kitchen, Ronald.

1993-01-01

Radio frequency radiation can be dangerous in a number of ways. Hazards include electromagnetic compatibility and interference, electro-explosive vapours and devices, and direct effects on the human body. This book is a general introduction to the sources and nature of RF radiation. It describes the ways in which our current knowledge, based on relevant safety standards, can be used to safeguard people from any harmful effects of RF radiation. The book is designed for people responsible for, or concerned with, safety. This target audience will primarily be radio engineers, but includes those skilled in other disciplines including medicine, chemistry or mechanical engineering. The book covers the problems of RF safety management, including the use of measuring instruments and methods, and a review of current safety standards. The implications for RF design engineers are also examined. (Author)

Innovative safety ideas for fusion experimental machines

International Nuclear Information System (INIS)

Brereton, S.J.; Gouge, M.; Piet, S.J.; Merrill, B.J.; Holland, D.F.; Sze, D.K.

1990-01-01

Throughout the early stages of design of fusion experimental devices, such as ITER, safety experts have worked with designers to incorporate safety features into the design. Recent efforts have focused on passive safety features. Although designs of near-term fusion machines may appear consistent with expected regulatory requirements, the safety characteristics can potentially be more attractive. Here, a variety of suggestions that appear promising in terms of improving safety are given. These include new concepts, innovative technologies, further support of past concepts, and possible modification to operating scenarios. Some technical discussion on the feasibility of the proposals is provided. The ideas are generally conceptual at this stage and require further assessment and development work. However, each has the potential for enhancing the safety of experimental devices. 33 refs., 6 figs., 9 tabs

A novel safety device with metal counter meshing gears discriminator directly driven by axial flux permanent magnet micromotors based on MEMS technology

Science.gov (United States)

Zhang, Weiping; Chen, Wenyuan; Zhao, Xiaolin; Li, Shengyong; Jiang, Yong

2005-08-01

In a novel safety device based on MEMS technology for high consequence systems, the discriminator consists of two groups of metal counter meshing gears and two pawl/ratchet wheel mechanisms. Each group of counter meshing gears is onepiece and driven directly by an axial flux permanent magnet micromotor respectively. The energy-coupling element is an optical shutter with two collimators and a coupler wheel. The safety device's probability is less than 1/106. It is fabricated by combination of an LiGA-like process and precision mechanical engineering. The device has simple structure, few dynamic problems, high strength and strong reliability.

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

Directory of Open Access Journals (Sweden)

Anna R Gagliardi

Full Text Available Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI is a concern and how it is managed.A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.Twenty-two physicians (10 cardiovascular, 12 orthopedic were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how

Device for removing hydrogen gas from the safety containment vessel of a nuclear reactor

International Nuclear Information System (INIS)

Stiefel, M.

1983-01-01

The safe processing of all concentrations of gas mixtures should be possible with such a device using a thermal recombiner of compact construction. A recombiner consisting of a metal case and diverter sheets situated in it is heated by induction. The incoming pipe for the gas mixture enriched with hydrogen and the outgoing pipe for the gas mixture with low hydrogen content are connected together by a three way valve. The third connection to the safety valve takes the larger port of the gas mixture with low hydrogen content back to the safety containment vessel. Sufficient amount of the gas mixture with low hydrogen content is taken via the three way valve to the safety containment vessel to ensure that the hydrogen content of the gas mixture taken to the recombiner remains below the 4% by volume limit. (orig./PW)

Guide On Safety Tests

Energy Technology Data Exchange (ETDEWEB)

NONE

1987-05-15

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Guide On Safety Tests

International Nuclear Information System (INIS)

1987-05-01

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study

NARCIS (Netherlands)

Eekeren, R. van; Boersma, D.; Elias, S.; Holewijn, S.; Werson, D.A.; Vries, J.P. de; Reijnen, M.M.P.J.

2011-01-01

PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the

76 FR 31983 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and...

Science.gov (United States)

2011-06-02

... Devices, Including Mobile Phones, Portable Music Players, and Computers; Notice of Commission... States after importation of certain electronic devices, including mobile phones, portable music players... rendered asserted claim 5 invalid. The ALJ concluded that an industry exists within the United States that...

76 FR 40930 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and...

Science.gov (United States)

2011-07-12

... Devices, Including Mobile Phones, Portable Music Players, and Computers; Notice of Commission....S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic devices, including mobile phones, portable...

Reactor safety device

International Nuclear Information System (INIS)

Okada, Yasumasa.

1987-01-01

Purpose: To scram control rods by processing signals from a plurality of temperature detectors and generating abnormal temperature warning upon occurrence of abnormal temperature in a nuclear reactor. Constitution: A temperature sensor comprising a plurality of reactors each having a magnetic body as the magnetic core having a curie point different from each other and corresponding to the abnormal temperature against which reactor core fuels have to be protected is disposed in an identical instrumentation well near the reactor core fuel outlet/inlet of a reactor. A temperature detection device actuated upon detection of an abnormal temperature by the abrupt reduction of the reactance of each of the reactors is disposed. An OR circuit and an AND circuit for conducting OR and AND operations for each of the abnormal temperature detection signals from the temperature detection device are disposed. The output from the OR circuit is used as the abnormal temperature warning signal, while the output from the AND circuit is utilized as a signal for actuating the scram operation of control rod drive mechanisms. Accordingly, it is possible to improve the reliability of the reactor scram system, particularly, improve the reliability under a high temperature atmosphere. (Kamimura, M.)

78 FR 49684 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-08-15

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

78 FR 17099 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Science.gov (United States)

2013-03-20

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including...

78 FR 65874 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-11-04

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including...

77 FR 65478 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Science.gov (United States)

2012-10-29

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

77 FR 60044 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2012-10-02

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy.

Science.gov (United States)

Hieb, Robert A; Neisen, Melissa J; Hohenwalter, Eric J; Molnar, Jim A; Rilling, William S

2008-12-01

To retrospectively evaluate the safety and effectiveness of the use of the AngioSeal device for repeat arterial closure in patients with hepatic malignancy. A retrospective analysis of patients with hepatic malignancy who had undergone repeated arterial closure with the AngioSeal device was performed. All charts for patients undergoing transarterial chemoembolization or TheraSphere radioembolization were reviewed for the method of hemostasis and the number of arterial closures. A total of 53 patients (58.5% men, 41.5% women; mean age, 58.7 years) had repeat AngioSeal arterial puncture closure after chemoembolization or TheraSphere treatment. Percutaneous closure of the common femoral artery with the AngioSeal device was performed in accordance with the manufacturer's recommendations. The patients were examined for complications on follow-up. Effectiveness was defined by the ability to obtain satisfactory hemostasis. Safety was assessed by the absence of groin complications and by vessel patency on follow-up angiograms of the puncture site obtained at subsequent liver-directed therapy sessions. Fifty-three patients in this study group had a total of 203 common femoral artery punctures. There were a total of 161 closures with the AngioSeal device (79.3%): 58 (36%) single closures and 103 (64.0%) repeat closures. Of the 161 attempts at AngioSeal closure, there was one closure failure in the single-puncture group, yielding a success rate of 98.3%; and one closure failure in the repeat-puncture group, yielding a success rate of 99%. In these two patients, hemostasis was achieved with traditional manual compression without the need for any other device, and no complications were noted. The overall success rate of AngioSeal device closure was 98.7%. The repeat use of the AngioSeal closure device is safe and effective in patients with hepatic malignancy undergoing regional oncologic interventional procedures.

Tritium radioluminescent devices, Health and Safety Manual

Energy Technology Data Exchange (ETDEWEB)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information.

Tritium radioluminescent devices, Health and Safety Manual

International Nuclear Information System (INIS)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information

Review of Wearable Device Technology and Its Applications to the Mining Industry

Directory of Open Access Journals (Sweden)

Mokhinabonu Mardonova

2018-03-01

Full Text Available This paper reviews current trends in wearable device technology, and provides an overview of its prevalent and potential deployments in the mining industry. This review includes the classification of wearable devices with some examples of their utilization in various industrial fields as well as the features of sensors used in wearable devices. Existing applications of wearable device technology to the mining industry are reviewed. In addition, a wearable safety management system for miners and other possible applications are proposed. The findings of this review show that by introducing wearable device technology to mining sites, the safety of mining operations can be enhanced. Therefore, wearable devices should be further used in the mining industry.

Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices.

Science.gov (United States)

Elder, Alexander; Paterson, Caron

2006-12-01

To review the literature on sharps injuries and occupational bloodborne virus transmission in health care in the UK and the worldwide evidence for injury prevention of sharps safety devices. Literature review by online database and Internet resource search. Twenty-four relevant publications were identified regarding UK reported sharps injury rates. UK studies showed as much as a 10-fold difference between injuries reported through standard reporting systems (0.78-5.15 per 100 person-years) and rates estimated from retrospective questionnaires of clinical populations (30-284 per 100 person-years). National surveillance data from England, Wales and Northern Ireland gives a rate of 1.43 known hepatitis C virus or human immunodeficiency virus (HIV) transmissions to health care workers per annum. When extrapolated, this suggests an approximate rate of 0.009 such viral transmissions per 1000 hospital beds per annum. Risk of infection from sources with no risk factors is extremely small (less than one in one million for HIV transmission based on Scottish data). Thirty-one studies on the efficacy of sharps safety devices showed evidence of a reduction in injuries, with the greatest reductions achieved by blunt suture needles and safety cannulae. Although injuries remain common, confirmed viral transmission in the UK has been relatively rare. The degree of under-reporting of sharps injuries may be as much as 10-fold. Safety-engineered devices are likely to be effective at injury reduction.

Radiation Safety in Industrial Radiography. Specific Safety Guide (Spanish Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (French Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in … shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

78 FR 36573 - Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems...

Science.gov (United States)

2013-06-18

... importation, and the sale within the United States after importation of certain digital media devices... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-882] Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems, Tablets and Mobile Phones, Components...

Activity of safety review for the facilities using nuclear material (2). Safety review results and maintenance experiences for hot laboratories

International Nuclear Information System (INIS)

Amagai, Tomio; Fujishima, Tadatsune; Mizukoshi, Yasutaka; Sakamoto, Naoki; Ohmori, Tsuyoshi

2009-01-01

In the site of O-arai Research and Development Center of Japan Atomic Energy Agency (JAEA), five hot laboratories for post-irradiation examination and development of plutonium fuels are operated more than 30 years. A safety review method for preventive maintenance on these hot laboratories includes test facilities and devices are established in 2003. After that, the safety review of these facilities and devices are done and taken the necessary maintenance based on the results in each year. In 2008, 372 test facilities and devices in these hot laboratories were checked and reviewed by this method. As a results of the safety review, repair issues of 38 facilities of above 372 facilities were resolved. This report shows the review results and maintenance experiences based on the results. (author)

Model for safety reports including descriptive examples; Mall foer saekerhetsrapporter med beskrivande exempel

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-12-01

Several safety reports will be produced in the process of planning and constructing the system for disposal of high-level radioactive waste in Sweden. The present report gives a model, with detailed examples, of how these reports should be organized and what steps they should include. In the near future safety reports will deal with the encapsulation plant and the repository. Later reports will treat operation of the handling systems and the repository.

Clinician-Driven Design of VitalPAD–An Intelligent Monitoring and Communication Device to Improve Patient Safety in the Intensive Care Unit

Science.gov (United States)

Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter

2018-01-01

The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425

Upgraded safety analysis document including operations policies, operational safety limits and policy changes. Revision 2

International Nuclear Information System (INIS)

Batchelor, K.

1996-03-01

The National Synchrotron Light Source Safety Analysis Reports (1), (2), (3), BNL reports number-sign 51584, number-sign 52205 and number-sign 52205 (addendum) describe the basic Environmental Safety and Health issues associated with the department's operations. They include the operating envelope for the Storage Rings and also the rest of the facility. These documents contain the operational limits as perceived prior or during construction of the facility, much of which still are appropriate for current operations. However, as the machine has matured, the experimental program has grown in size, requiring more supervision in that area. Also, machine studies have either verified or modified knowledge of beam loss modes and/or radiation loss patterns around the facility. This document is written to allow for these changes in procedure or standards resulting from their current mode of operation and shall be used in conjunction with the above reports. These changes have been reviewed by NSLS and BNL ES and H committee and approved by BNL management

78 FR 56737 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Science.gov (United States)

2013-09-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-885] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Commission Determination Not To Review an... on the Commission's electronic docket (EDIS) at http://edis.usitc.gov . Hearing-impaired persons are...

78 FR 49764 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Science.gov (United States)

2013-08-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-885] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Commission Determination Not To Review n... for this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc...

78 FR 72712 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Science.gov (United States)

2013-12-03

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-885] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Commission Determination Not To Review an... this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov...

EC6 safety enhancement - including impact of Fukushima lessons learned

Energy Technology Data Exchange (ETDEWEB)

Yu, S.; Zemdegs, R.; Boyle, S.; Soulard, M., E-mail: stephen.yu@candu.com [Candu Energy Inc., Mississauga, Ontario (Canada)

2012-09-15

The Enhanced CANDU 6 (EC6) is the new Generation III CANDU reactor design that meets the most up to date regulatory requirements and customer expectations. EC6 builds on the proven high performance design inch as the Qinshan CANDU 6 units and has made improvements to safety and operational performance, and has incorporated extensive operational feedback including Fukushima. The Fukushima Dai-ichi March 11, 2011 event has demonstrated the importance of defence-in-depth considerations for beyond-design basis events, including severe accidents. The EC6 design is based on the defence-in-depth principles and provides further design features that address the lessons learned from Fukushima. (author)

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

Science.gov (United States)

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Modelling of safety barriers including human and organisational factors to improve process safety

DEFF Research Database (Denmark)

Markert, Frank; Duijm, Nijs Jan; Thommesen, Jacob

2013-01-01

It is believed that traditional safety management needs to be improved on the aspect of preparedness for coping with expected and unexpected deviations, avoiding an overly optimistic reliance on safety systems. Remembering recent major accidents, such as the Deep Water Horizon, the Texas City....... A valuable approach is the inclusion of human and organisational factors into the simulation of the reliability of the technical system using event trees and fault trees and the concept of safety barriers. This has been demonstrated e.g. in the former European research project ARAMIS (Accidental Risk...

The enhancement of Ignalina NPP in design and operational safety

International Nuclear Information System (INIS)

Negrivoda, G.

1999-01-01

Enhancement of Ignalina NPP design include: core design improvements; fuel channel integrity (multiple pressure tube rupture); improvements of shutdown systems; improvements of instrumentation and control devices; containment strength and tightness; design basis accident analysis; improvements of safety and support systems; seismic safety enhancement; Year 2000 project; cracks in pipes. Enhancement of operational safety includes: quality assurance; configuration management; safety management and safety culture; emergency operating procedures; training and full scope simulator; in-service inspection; fire protection and ageing monitoring and management

76 FR 35106 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2011-06-16

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago..., DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent safety zone from Brandon... Safety Zones; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary...

An optoelectronic integrated device including a laser and its driving circuit

Energy Technology Data Exchange (ETDEWEB)

Matsueda, H.; Nakano, H.; Tanaka, T.P.

1984-10-01

A monolithic optoelectronic integrated circuit (OEIC) including a laser diode, photomonitor and driving and detecting circuits has been fabricated on a semi-insulating GaAs substrate. The OEIC has a horizontal integrating structure which is suitable for realising high-density multifunctional devices. The fabricating process and the static and dynamic characteristics of the optical and electronic elements are described. The preliminary results of the co-operative operation of the laser and its driving circuit are also presented.

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

30 CFR 77.808 - Disconnecting devices.

Science.gov (United States)

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Surface High-Voltage Distribution § 77.808 Disconnecting devices. Disconnecting devices shall be installed at the...

78 FR 4071 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-01-18

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

Nuclear reactor safety protection device

International Nuclear Information System (INIS)

Okido, Fumiyasu; Noguchi, Atomi; Matsumiya, Shoichi; Furusato, Ken-ichiro; Arita, Setsuo.

1994-01-01

The device of the present invention extremely reduces a probability of causing unnecessary scram of a nuclear reactor. That is, four control devices receive signals from each of four sensors and output four trip signals respectively in a quardruplicated control device. Each of the trip signals and each of trip signals via a delay circuit are inputted to a logical sum element. The output of the logical sum circuit is inputted to a decision of majority circuit. The decision of majority circuit controls a scram pilot valve which conducts scram of the reactor by way of a solenoid coils. With such procedures, even if surge noises of a short pulse width are mixed to the sensor signals and short trip signals are outputted, there is no worry that the scram pilot valve is actuated. Accordingly, factors of lowering nuclear plant operation efficiency due to erroneous reactor scram can be reduced. (I.S.)

Estimating Safety Effects of Green-Man Countdown Devices at Signalized Pedestrian Crosswalk Based on Cellular Automata

Directory of Open Access Journals (Sweden)

Chen Chai

2017-01-01

Full Text Available Safety effects of Green-Man Countdown Device (GMCD at signalized pedestrian crosswalks are evaluated. Pedestrian behavior at GMCD and non-GMCD crosswalks is observed and analyzed. A microsimulation model is developed based on field observations to estimate safety performance. Simulation outputs allow analysts to assess the impacts of GMCD at various conditions with different geometric layout, traffic and pedestrian volumes, and the green time. According to simulation results, it is found that the safety impact of GMCD is affected by traffic condition as well as different time duration within green-man signal phase. In general, GMCD increases average walking velocity, especially during the last few seconds. The installation of GMCD improves safety performance generally, especially at more crowded crossings. Conflict severity is increased during last 10 s after GMCD installation. Findings from this study suggest that the current practice, which is to install GMCD at more crowded crosswalks or near the school zone, is effective. Moreover, at crosswalks with GMCD, longer all red signal phase is suggested to improve pedestrian safety during intergreen period.

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

Science.gov (United States)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

A Wii-controlled safety device for electric chainsaws

Directory of Open Access Journals (Sweden)

R. Gubiani

2013-09-01

Full Text Available Forestry continues to represent one of the most hazardous economic sectors of human activity, and historically, the operation of chainsaws has mainly been restricted to professional lumberjacks. In recent years, because of low cost, chainsaws have become popular among unprofessionals, e.g. for cutting firewood and trimming trees. Serious or lethal lesions due to the use of chainsaws or electric chainsaws are often observed by traumatologists or forensic pathologists. Such serious accidents often occur during occupational activities and are essentially due to kickback or uncorrected use of the tool, or when the operator falls down losing the control of the implement. A new device in order to stop a cutting chain was developed and adapted to an electric chainsaw. The device is based on a Wiimote controller (Nintendo™, including two accelerometers and two gyroscopes for detecting rotation and inclination. A Bluetooth wireless technology is used to transfer data to a portable computer. The data collected about linear and angular acceleration are filtered by an algorithm, based on the Euclid norm, capable to distinguishing between normal movements and dangerous chainsaw movements. The result show a good answer to device and when happen a dangerous situation an alarm signal is sent back to the implement in order to stop the cutting chain. The device show a correct behavior in tested dangerous situations and is envisaged to extend to combustion engine chainsaws, as well as to other portable equipment used in agriculture and forestry operations and for this objectives were patented.

Extraglottic airway devices: technology update

Directory of Open Access Journals (Sweden)

Sharma B

2017-08-01

Full Text Available Bimla Sharma, Chand Sahai, Jayashree Sood Department of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India Abstract: Extraglottic airway devices (EADs have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS formed the Airway Device Evaluation Project Team (ADEPT to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues. Keywords: extraglottic airway devices, laryngeal mask airway, other extraglottic airway devices, safety, technology update

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

Directory of Open Access Journals (Sweden)

Faunce Thomas

2006-03-01

Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

Safety analysis of an irradiation device for 99Mo production in RA-3 reactor

International Nuclear Information System (INIS)

Lerner, Ana Maria; Madariaga, Marcelo; Waldman, Ricardo

2000-01-01

The Argentine RA-3 research reactor (5 MW) has been converted to LEU fuel more than nine years ago. Since then, it has been operating with LEU fuel, which has been designed and fabricated at the National Atomic Energy Commission (CNEA). The Nuclear Regulatory Authority (ARN) is the institution in charge of the installation safety control. It is under this framework that the ARN has elaborated a neutronic calculation model for the RA-3 core, paying special attention to the device presently used for the irradiation of (HEU) 235 U targets required to obtain 9 '9Mo as a fission product. A regulatory analysis of results is carried out in the framework of ARN standards for fixed experiments. For such purpose, calculated reactivity values associated with such device are compared with recently measured values at the installation. Finally, and according to guidelines established in the first part of this work, a calculation model for a new device proposed by CNEA for the irradiation of metallic (LEU) uranium targets and still at its design stage, is here analysed. (author)

Evaluation of the Safety of the Taraklamp Male Circumcision Device ...

African Journals Online (AJOL)

SITWALA COMPUTERS

an effective additional means of preventing transmission of the HIV virus from ... country and include: cultural tradition, pain, and safety, as ... effective. Thus, the World Health Organization (WHO) has ..... systematic review and meta-analysis.

An experimental study of the flow characteristics of fluidic device in a passive safety injection tank

International Nuclear Information System (INIS)

Cho, Seok; Song, Chul Hwa; Won, Suon Yeon; Min, Kyong Ho; Chung, Moon Ki

1998-01-01

It is considered to adopt passive safety injection tank (SIT) as a enhanced safety feature in KNGR. Passive SIT employs a vortex chamber as a fluidic device, which control injection flow rate passively by the variation of flow resistance produced by vortex intensity within the vortex chamber. To investigate the flow characteristics of the vortex chamber many tests have been carried out by using small-scale test facility. In this report the effects of geometric parameters of vortex chamber on discharge flow characteristics and the velocity measurement result of flow field, measured by PIV, are presented and discussed. (author). 25 refs., 11 tabs., 31 figs

Loss and thermal model for power semiconductors including device rating information

DEFF Research Database (Denmark)

Ma, Ke; Bahman, Amir Sajjad; Beczkowski, Szymon

2014-01-01

The electrical loading and device rating are both important factors that determine the loss and thermal behaviors of power semiconductor devices. In the existing loss and thermal models, only the electrical loadings are focused and treated as design variables, while the device rating is normally...

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Science.gov (United States)

2010-10-01

... output terminal(s) of the device terminated by a resistance equal to the rated output impedance. The...: (1) At any RF output terminal, the maximum measured RMS voltage, in microvolts, corresponding to the peak envelope power of the modulated signal during maximum amplitude peaks across a resistance (R in...

75 FR 26094 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Science.gov (United States)

2010-05-11

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... establishing a temporary safety zone from Brandon Road Lock and Dam to Lake Michigan. This temporary safety...

75 FR 64673 - Safety Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2010-10-20

... Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and... Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Ship and...: The Coast Guard will enforce Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des...

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

Directory of Open Access Journals (Sweden)

Paul J Feldblum

Full Text Available To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC in routine service delivery in Kenya.We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs and time to complete healing, and interviewed men about acceptability and pain.Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%, all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%. Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58, and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.ClinicalTrials.gov NCT01711411.

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

Science.gov (United States)

Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

2017-12-01

To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

APR1400 Fluidic Device Sensitivity Test

International Nuclear Information System (INIS)

Choi, Nam Hyun; Chu, In Cheol; Min, Kyong Ho; Song, Chul Hwa

2005-12-01

In the safety injection tank at the emergency core cooling system of APR1400, a new safety design feature, passive fluidic device is equipped which includes no active driving system. It is essential to evaluate the new design feature with various experiments. For this reason, three categories of sensitivity tests have been performed in the present study. As the first sensitivity experiment, the effect of the height of the stand pipe was investigated. The second sensitivity test was conducted with removing the insert plate gasket to examine its effect. The effect of the expansion of the control nozzle width was ascertained from the third sensitivity test. The results of each test showed that the passive fluidic device which will be equipped in the SIT tank of APR1400 has great integrity and repeatability

Practice of Regulatory Science (Development of Medical Devices).

Science.gov (United States)

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

Digital Device Architecture and the Safe Use of Flash Devices in Munitions

Science.gov (United States)

Katz, Richard B.; Flowers, David; Bergevin, Keith

2017-01-01

Flash technology is being utilized in fuzed munition applications and, based on the development of digital logic devices in the commercial world, usage of flash technology will increase. Digital devices of interest to designers include flash-based microcontrollers and field programmable gate arrays (FPGAs). Almost a decade ago, a study was undertaken to determine if flash-based microcontrollers could be safely used in fuzes and, if so, how should such devices be applied. The results were documented in the Technical Manual for the Use of Logic Devices in Safety Features. This paper will first review the Technical Manual and discuss the rationale behind the suggested architectures for microcontrollers and a brief review of the concern about data retention in flash cells. An architectural feature in the microcontroller under study will be discussed and its use will show how to screen for weak or failed cells during manufacture, storage, or immediately prior to use. As was done for microcontrollers a decade ago, architectures for a flash-based FPGA will be discussed, showing how it can be safely used in fuzes. Additionally, architectures for using non-volatile (including flash-based) storage will be discussed for SRAM-based FPGAs.

Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

Science.gov (United States)

2013-03-04

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

76 FR 23524 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2011-04-27

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... safety zone from Brandon Road Lock and Dam to Lake Michigan. This proposed safety zone will cover 77.... This TIR established a 77 mile long safety zone from Brandon Road Lock to Lake Michigan in Chicago, IL...

Reactor safety

International Nuclear Information System (INIS)

Butz, H.P.; Heuser, F.W.; May, H.

1985-01-01

The paper comprises an introduction into nuclear physics bases, the safety concept generally speaking, safety devices of pwr type reactors, accident analysis, external influences, probabilistic safety assessment and risk studies. It further describes operational experience, licensing procedures under the Atomic Energy Law, research in reactor safety and the nuclear fuel cycle. (DG) [de

Development of several data bases related to reactor safety research including probabilistic safety assessment and incident analysis at JAERI

International Nuclear Information System (INIS)

Kobayashi, Kensuke; Oikawa, Tetsukuni; Watanabe, Norio; Izumi, Fumio; Higuchi, Suminori

1986-01-01

Presented are several databases developed at JAERI for reactor safety research including probabilistic safety assessment and incident analysis. First described are the recent developments of the databases such as 1) the component failure rate database, 2) the OECD/NEA/IRS information retrieval system, 3) the nuclear power plant database and so on. Then several issues are discussed referring mostly to the operation of the database (data input and transcoding) and to the retrieval and utilization of the information. Finally, emphasis is given to the increasing role which artifitial intelligence techniques such as natural language treatment and expert systems may play in improving the future capabilities of the databases. (author)

Analysis of quantum ballistic electron transport in ultrasmall silicon devices including space-charge and geometric effects

Science.gov (United States)

Laux, S. E.; Kumar, A.; Fischetti, M. V.

2004-05-01

A two-dimensional device simulation program which self consistently solves the Schrödinger and Poisson equations with current flow is described in detail. Significant approximations adopted in this work are the absence of scattering and a simple six-valley, parabolic band structure for silicon. A modified version of the quantum transmitting boundary method is used to describe open boundary conditions permitting current flow in device solutions far from equilibrium. The continuous energy spectrum of the system is discretized by temporarily imposing two different forms of closed boundary conditions, resulting in energies which sample the density-of-states and establish the wave function normalization conditions. These standing wave solutions ("normal modes") are decomposed into their traveling wave constituents, each of which represents injection from only one of the open boundary contacts ("traveling eigencomponents"). These current-carrying states are occupied by a drifted Fermi distribution associated with their injecting contact and summed to form the electron density in the device. Holes are neglected in this calculation. The Poisson equation is solved on the same finite element computational mesh as the Schrödinger equation; devices of arbitrary geometry can be modeled. Computational performance of the program including characterization of a "Broyden+Newton" algorithm employed in the iteration for self consistency is described. Device results are presented for a narrow silicon resonant tunneling diode (RTD) and many variants of idealized silicon double-gate field effect transistors (DGFETs). The RTD results show two resonant conduction peaks, each of which demonstrates hysteresis. Three 7.5 nm channel length DGFET structures with identical intrinsic device configurations but differing access geometries (straight, taper and "dog bone") are studied and found to have differing current flows owing to quantum-mechanical reflection in their access regions

Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

Science.gov (United States)

2015-11-20

The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

International Nuclear Information System (INIS)

Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

2015-01-01

Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

DESIGN PACKAGE 1E SYSTEM SAFETY ANALYSIS

Energy Technology Data Exchange (ETDEWEB)

M. Salem

1995-06-23

The purpose of this analysis is to systematically identify and evaluate hazards related to the Yucca Mountain Project Exploratory Studies Facility (ESF) Design Package 1E, Surface Facilities, (for a list of design items included in the package 1E system safety analysis see section 3). This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the Design Package 1E structures/systems/components(S/S/Cs) in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the structure/system/component design, (2) add safety devices and capabilities to the designs that reduce risk, (3) provide devices that detect and warn personnel of hazardous conditions, and (4) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions.

Reactor protecting device

International Nuclear Information System (INIS)

Ono, Hiroshi; Kasuga, Hajime; Kasuga, Hiroshi.

1984-01-01

Purpose: To reduce the recycling flowrate thereby decrease the neutron flux level before the reactor shutdown upon generation of abnormality such as increase in the neutron flux, by setting the safety level lower than the value for generating the reaction scram signal. Constitution: A netron flux safety level setter and an instruction signal generator are disposed between a neutron flux detector and a recycling flowrate control device. A neutron flux safety level lower than the level for generating a reactor scram signal and higher that the level for the ordinary operation is set and, if the detection level for the neutron flux in the reactor core arrives at the safety level, a neutron flux decreasing instruction signal is outputted from the instruction signal generator to the recycling flowrate control device to thereby decrease the recycling flowrate and decrease the neutron flux without reaching the reactor shutdown, whereby the thermal safety of the fuel rod can be maintained and the reactor operation performance can be improved. (Moriyama, K.)

Safety analysis and evaluation of the next fusion device

International Nuclear Information System (INIS)

Kobayashi, Shigetada; Honda, Tsutomu; Ohmura, Hiroshi; Kawai, Masayoshi; Shimizu, Takeshi; Yamaoka, Mitsuaki; Nakahara, Katsuhiko; Seki, Yasushi.

1988-12-01

As a part of safety evaluation, a probabilistic risk assessment (PRA) has been attempted for the Next Fusion Device system. Among the various events related to safety, a number of representative events have been selected for assessment, from the events in normal operation state, repair and maintenance state and accidental state. In the first chapter, in order to conduct the probabilistic risk assessment of the whole Fusion Experimental Reactor (FER), the data base required for the analysis was investigated in 1.1, the results on the failure mode and effects analysis (FMEA), accident sequence, radioactive inventory leakage flow path, event tree analysis (ETA) and fault tree analysis (FTA) were summarized in 1.2 to 1.5, respectively. Based on these results, accident initiating events were evaluated in 1.6, and overall risk was assessed in 1.7 and the tasks for the future were summarized in 1.8. It is important to analyze and evaluate various events during normal operations, repair and maintenance and accidents. However, due to the large uncertainties in the modeling of phenomena or the data base, there are many events for which realistic analyses are difficult. Three such events were selected and studied in chapter two. In 2.1, the temperature rise in the reactor structure after the Loss-of-Coolant-Accident caused by the decay heat under various heat removal conditions were investigated. In 2.2, the radiation dose of personnel during repair and maintenance period caused by the release of activated dust were estimated. Lastly, in 2.3 tritium behavior in the stainless steel first wall and graphite armour were studied. (author)

Operating room fire prevention: creating an electrosurgical unit fire safety device.

Science.gov (United States)

Culp, William C; Kimbrough, Bradly A; Luna, Sarah; Maguddayao, Aris J

2014-08-01

To reduce the incidence of surgical fires. Operating room fires represent a potentially life-threatening hazard and are triggered by the electrosurgical unit (ESU) pencil. Carbon dioxide is a fire suppressant and is a routinely used medical gas. We hypothesize that a shroud of protective carbon dioxide covering the tip of the ESU pencil displaces oxygen, thereby preventing fire ignition. Using 3-dimensional modeling techniques, a polymer sleeve was created and attached to an ESU pencil. This sleeve was connected to a carbon dioxide source and directed the gas through multiple precisely angled ports, generating a cone of fire-suppressive carbon dioxide surrounding the active pencil tip. This device was evaluated in a flammability test chamber containing 21%, 50%, and 100% oxygen with sustained ESU activation. The sleeve was tested with and without carbon dioxide (control) until a fuel was ignited or 30 seconds elapsed. Time to ignition was measured by high-speed videography. Fires were ignited with each control trial (15/15 trials). The control group median ± SD ignition time in 21% oxygen was 3.0 ± 2.4 seconds, in 50% oxygen was 0.1 ± 1.8 seconds, and in 100% oxygen was 0.03 ± 0.1 seconds. No fire was observed when the fire safety device was used in all concentrations of oxygen (0/15 trials; P fire ignition was 76% to 100%. A sleeve creating a cone of protective carbon dioxide gas enshrouding the sparks from an ESU pencil effectively prevents fire in a high-flammability model. Clinical application of this device may reduce the incidence of operating room fires.

33 CFR 159.95 - Safety.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety. 159.95 Section 159.95... SANITATION DEVICES Design, Construction, and Testing § 159.95 Safety. (a) Each device must— (1) Be free of... explosion or over pressurization as a result of an accumulation of gases; and (3) Meet all other safety...

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

Science.gov (United States)

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

Science.gov (United States)

2010-07-01

... Analysis Checklists are included in API RP 14C you must utilize the analysis technique and documentation... device requirements for pipelines are under § 250.1004. (c) Specification for surface safety valves (SSV..., Recommended Practice for Installation, Maintenance, and Repair of Surface Safety Valves and Underwater Safety...

76 FR 24051 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Science.gov (United States)

2011-04-29

..., Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components Thereof... certain electronic devices, including mobile phones, mobile tablets, portable music players, and computers...''). The complaint further alleges that an industry in the United States exists or is in the process of...

Organizational Culture and Safety

Science.gov (United States)

Adams, Catherine A.

2003-01-01

'..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

'The Closer'-percutaneous vascular suture device: evaluation of safety and performance in neuroangiography

International Nuclear Information System (INIS)

Henk, Christine B.; Grampp, Stephan; Heimberger, Karl; Czerny, Christian; Schindler, Erwin; Mostbeck, Gerhard H.

2003-01-01

Objective: To evaluate the use of the suture mediated vascular closure device concerning practicability and safety in clinical angiography practice. Material and methods: One hundred and seventeen patients (59 female, 58 male, mean age 40.9±13.4) underwent percutaneous closure of common femoral arterial puncture sites following diagnostic neuroangiography using the suture device 'the Closer' (Perclose Inc., Redwood City, CA, USA). Primary success, early problems (within 24 h) and late complications were evaluated. Complications were graded as minor and severe with or without need of surgical intervention and categorized by type. Parameters such as age, gender, sheath size and number of previous arterial punctures were evaluated with respect to complications. Results: Percutaneous closure was primary successful in 85% (100/117). The overall complication rate was 32% (28% mild n=35, 4% severe n=6, which needed surgical intervention). All but one problem occurred within the first 24 h after the suture. Additional manual compression was necessary in 32 cases (25%). There was no significant difference in age and gender between the groups with and without complications. Sheath size was significantly larger (P<0.01) and numbers of preceding angiograms were significantly higher (P<0.01) in the complications group compared with uncomplicated cases. Conclusion: The evaluated percutaneous vascular suture device is useful in clinical practice but limitations concerning patient selection seem to emerge in order to avoid complications

Nuclear criticality safety and time reactivity enhancement aspects of energy amplifier system devices

Energy Technology Data Exchange (ETDEWEB)

Siciliano, F [ENEA, Centro Ricerche Trisaia, Rotondelle, Matera (Italy). Direzione INFO

1995-12-01

As far as the Rubbia`s and colleagues proposal of innovating Energy Amplifier system (E.A.s.) device driven by a particle beam accelerator is concerned, four basic topics are comprised in the present paper: (1) A short outline of the nuclear aspects of Th-U and U-Pu fuel cycles regarding their general breeding and efficiency features. (2) The needed nuclear criticality control requirements have been studied in terms of safety regulating parameters on the basis of the ThO2 mixed oxides selected as fuel kind for the E.A.s. device technology development. Particular attention is devoted to time evolution of neutron multiplication factor since delayed development of the 233U buildup and so system reactivity are expected in the Th-U cycle. (3) Code E.A.s. device irradiation and post-irradiation modelling for determining higher actinides buildup, fission products formation and fuel consumption trends as function of time, system enrichment degree and flux level parameters. (4) The confirmation, on the basis of the same specific power irradiation, of expected actinides waste obtainment cleaner than the one deriving from the U-Pu cycle utilization. For this end, a model comparison of equivalent enriched fissile nuclides in both cycles has been devised as having, within the range of 0-700 days, ten irradiation periods of about 53 MW/ton specific power and equivalent cooling time post-irradiation periods.

75 FR 4583 - In the Matter of: Certain Electronic Devices, Including Mobile Phones, Portable Music Players...

Science.gov (United States)

2010-01-28

..., Including Mobile Phones, Portable Music Players, and Computers; Notice of Investigation AGENCY: U.S... music players, and computers, by reason of infringement of certain claims of U.S. Patent Nos. 6,714,091... importation of certain electronic devices, including mobile phones, portable music players, or computers that...

Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

Radiation Safety in Industrial Radiography. Specific Safety Guide (French Edition); Surete radiologique en radiographie industrielle

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-05-15

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in Horizontal-Ellipsis shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

78 FR 63492 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Science.gov (United States)

2013-10-24

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-847] Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is...

Safety work with MRI devices in medicine

International Nuclear Information System (INIS)

Zivkovic, D.; Hrnjak, M.

1999-01-01

This paper gives the basis of biological effects of physical factors which could affect personnel working on MRI devices and patients, and corresponding protection measures. Medical personnel working with MRI devices and patients could be exposed to static magnetic field, time varying fields and radiofrequency radiation, danger from electric current and chemical matters, and there is a high risk from moving metal objects which could wound the persons near-by. The protection from static magnetic field could be ensured by increasing the distance from the source. If MRI device is put in Faradays cage it could be corresponding protection of radiofrequency radiation. (author)

Model-based engineering for medical-device software.

Science.gov (United States)

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

Tornadoes: Nature's Most Violent Storms. A Preparedness Guide Including Safety Information for Schools.

Science.gov (United States)

American National Red Cross, Washington, DC.

This preparedness guide explains and describes tornadoes, and includes safety information for schools. A tornado is defined as a violently rotating column of air extending from a thunderstorm to the ground. The guide explains the cause of tornadoes, provides diagrams of how they form, describes variations of tornadoes, and classifies tornadoes by…

Complete Loss and Thermal Model of Power Semiconductors Including Device Rating Information

DEFF Research Database (Denmark)

Ma, Ke; Bahman, Amir Sajjad; Beczkowski, Szymon

2015-01-01

Thermal loading of power devices are closely related to the reliability performance of the whole converter system. The electrical loading and device rating are both important factors that determine the loss and thermal behaviors of power semiconductor devices. In the existing loss and thermal...

I. Reactor safety (including comments on criticisms of WASH-1400)

International Nuclear Information System (INIS)

1976-01-01

A major concern in any nuclear power programme is a reactor accident resulting in a large release of radioactivity to the environment. Serious reactor accidents are possible and the risk of such accidents cannot be reduced to zero i.e. absolute safety cannot be assured. All that can be expected is that the measures used to ensure safety in the design and operation of a reactor are such that the risk of accident is reduced to acceptably low levels. No member of the general public is known to have died or been injured as a result of an accident in over 1000 commercial nuclear power reactor-years. Some accidents in power reactors in operation today have come close enough to an environmental release of radioactivity to cause serious public concern about future safety. Apparent inadequacies in safety practices disclosed by former members of the nuclear power industry have added to this concern. To obtain an objective appraisal of the reactor safety issue this report examines the measures taken in the design and operation of nuclear reactors to reduce the probability of accident to acceptably low levels

Preventing medical device recalls

CERN Document Server

Raheja, Dev

2014-01-01

Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety     Overview of FDA Quality System Regulation     Overview of Risk Management Standard ISO 14971     Overview of FDA Device Approval Process     Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and

Safety of mechanical chest compression devices AutoPulse and LUCAS in cardiac arrest: a randomized clinical trial for non-inferiority

NARCIS (Netherlands)

Koster, Rudolph W.; Beenen, Ludo F.; van der Boom, Esther B.; Spijkerboer, Anje M.; Tepaske, Robert; van der Wal, Allart C.; Beesems, Stefanie G.; Tijssen, Jan G.

2017-01-01

Aims Mechanical chest compression (CC) during cardiopulmonary resuscitation (CPR) with AutoPulse or LUCAS devices has not improved survival from cardiac arrest. Cohort studies suggest risk of excess damage. We studied safety of mechanical CC and determined possible excess damage compared with manual

Energy star compliant voice over internet protocol (VoIP) telecommunications network including energy star compliant VoIP devices

Science.gov (United States)

Kouchri, Farrokh Mohammadzadeh

2012-11-06

A Voice over Internet Protocol (VoIP) communications system, a method of managing a communications network in such a system and a program product therefore. The system/network includes an ENERGY STAR (E-star) aware softswitch and E-star compliant communications devices at system endpoints. The E-star aware softswitch allows E-star compliant communications devices to enter and remain in power saving mode. The E-star aware softswitch spools messages and forwards only selected messages (e.g., calls) to the devices in power saving mode. When the E-star compliant communications devices exit power saving mode, the E-star aware softswitch forwards spooled messages.

Thermodynamic Analysis of TEG-TEC Device Including Influence of Thomson Effect

Science.gov (United States)

Feng, Yuanli; Chen, Lingen; Meng, Fankai; Sun, Fengrui

2018-01-01

A thermodynamic model of a thermoelectric cooler driven by thermoelectric generator (TEG-TEC) device is established considering Thomson effect. The performance is analyzed and optimized using numerical calculation based on non-equilibrium thermodynamic theory. The influence characteristics of Thomson effect on the optimal performance and variable selection are investigated by comparing the condition with and without Thomson effect. The results show that Thomson effect degrades the performance of TEG-TEC device, it decreases the cooling capacity by 27 %, decreases the coefficient of performance (COP) by 19 %, decreases the maximum cooling temperature difference by 11 % when the ratio of thermoelectric elements number is 0.6, the cold junction temperature of thermoelectric cooler (TEC) is 285 K and the hot junction temperature of thermoelectric generator (TEG) is 450 K. Thomson effect degrades the optimal performance of TEG-TEC device, it decreases the maximum cooling capacity by 28 % and decreases the maximum COP by 28 % under the same junction temperatures. Thomson effect narrows the optimal variable range and optimal working range. In the design of the devices, limited-number thermoelectric elements should be more allocated appropriately to TEG when consider Thomson effect. The results may provide some guidelines for the design of TEG-TEC devices.

Radiation emitting devices act

International Nuclear Information System (INIS)

1970-01-01

This Act, entitled the Radiation Emitting Devices Act, is concerned with the sale and importation of radiation emitting devices. Laws relating to the sale, lease or import, labelling, advertising, packaging, safety standards and inspection of these devices are listed as well as penalties for any person who is convicted of breaking these laws

Can we use IEC 61850 for safety related functions?

Directory of Open Access Journals (Sweden)

Luca Rocca

2016-08-01

Full Text Available Safety is an essential issue for processes that present high risk for human beings and environment. An acceptable level of risk is obtained both with actions on the process itself (risk reduction and with the use of special safety systems that switch the process into safe mode when a fault or an abnormal operation mode happens. These safety systems are today based on digital devices that communicate through digital networks. The IEC 61508 series specifies the safety requirements of all the devices that are involved in a safety function, including the communication network. Also electrical generation and distribution systems are processes that may have a significant level of risk, so the criteria stated by the IEC 61508 applies. Starting from this consideration, the paper analyzes the safety requirement for the communication network and compare them with the services of the communication protocol IEC 61850 that represents the most used protocol for automation of electrical plants. The goal of this job is to demonstrate that, from the technical point of view, IEC 61850 can be used for implementing safety-related functions, even if a formal safety certification is still missing.

Safety catching device for pipe lines in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1975-01-01

The safety catching device for pipes in the missile shielding cylinders consists of a flexible steel cable surrounding the pipe in a distance in U-shape. The arrester cable - which works as a spring and is freely movable in all directions - is attached to the cylinder wall. For this, the ends of the cable are primarily fastened to anchor boxes which are then inserted in a stay tube with the same axis as the cable ends. The anchor boxes are fastened to the outer wall of the missile shielding cylinder by anchor bolts and holding plates. (DG/AK) [de

CERN safety system monitoring - SSM

International Nuclear Information System (INIS)

Hakulinen, T.; Ninin, P.; Valentini, F.; Gonzalez, J.; Salatko-Petryszcze, C.

2012-01-01

CERN SSM (Safety System Monitoring) is a system for monitoring state-of-health of the various access and safety systems of the CERN site and accelerator infrastructure. The emphasis of SSM is on the needs of maintenance and system operation with the aim of providing an independent and reliable verification path of the basic operational parameters of each system. Included are all network-connected devices, such as PLCs (local purpose control unit), servers, panel displays, operator posts, etc. The basic monitoring engine of SSM is a freely available system-monitoring framework Zabbix, on top of which a simplified traffic-light-type web-interface has been built. The web-interface of SSM is designed to be ultra-light to facilitate access from hand-held devices over slow connections. The underlying Zabbix system offers history and notification mechanisms typical of advanced monitoring systems. (authors)

Radiation Safety in Industrial Radiography. Specific Safety Guide (Spanish Edition); Seguridad radiologica en la radiografia industrial

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-12-15

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

CIRSE Vascular Closure Device Registry

NARCIS (Netherlands)

Reekers, Jim A.; Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2011-01-01

Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. The CIRSE registry of closure devices

Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices.

Science.gov (United States)

Sezdi, Mana

2016-01-01

A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices.

77 FR 34063 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Science.gov (United States)

2012-06-08

... Phones and Tablet Computers, and Components Thereof Institution of Investigation AGENCY: U.S... the United States after importation of certain electronic devices, including mobile phones and tablet... mobile phones and tablet computers, and components thereof that infringe one or more of claims 1-3 and 5...

Recommended safety guides for industrial laboratories and shops

Science.gov (United States)

Allison, W. W.

1971-01-01

Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.

Fuel cladding tube leak detection device

International Nuclear Information System (INIS)

Naito, Makoto.

1992-01-01

The device of the present invention can detect even a minute leakage or a continuous leakage during reactor operation. That is, the device of the present invention comprises a detector for analyzing nuclides of gases incorporated in a gas waste processing system, and a calculation device connected to the detector and detecting leakage from a fuel cladding tube by calculation for variation coefficient of long-life nuclides. By using theses devices, radioactivity contained in gases incorporated in the gas waste processing system is analyzed for the nuclides. Among the analized nuclides, if the amount of the long-life nuclides exceeds a predetermined value, it is judged as leakage of the fuel cladding tube. For example, the long-life nuclides include Xe-133. The device of the present invention can certainly detect occurrence of leakage even when it is minute or continues leakage. Accordingly, countermeasures can be taken in an early stage, thereby enabling to contribute improvement for the safety of a nuclear power plant. (I.S.)

Fast reactor recharging device

International Nuclear Information System (INIS)

Artemiev, L.N.; Kurilkin, V.V.

1979-01-01

Disclosure is made of a device for recharging a fast-neutron reactor, intended for the transfer of fuel assemblies and rods of the control and safety system, having profiled heads to be gripped on the outside. The device comprises storage drums whose compartments for rods of the control and safety system are identical to compartments for fuel assemblies. In order to store and transport rods of the control and safety system from the storage drums to the recharging mechanism provision is made for sleeve-type holders. When placed in such a holder, the dimensions of a rod of the control and safety system are equal to those of a fuel assembly. To join a holder to a rod of the control and safety system, on the open end of each holder there is mounted a collet, whereas on the surface of each rod of the control and safety system, close to its head, there is provided an encircling groove to interact with the collet. The grip of the recharging mechanism is provided with a stop interacting with the collet in order to open the latter and withdraw the safety and control system rod from its holder

Traffic sounds and cycling safety : the use of electronic devices by cyclists and the quietness of hybrid and electric cars.

NARCIS (Netherlands)

Stelling-Konczak, A. Hagenzieker, M.P. & Wee, B. van

2015-01-01

The growing popularity of electric devices and the increasing number of hybrid and electric cars have recently raised concerns about the use of auditory signals by vulnerable road users. This paper consolidates current knowledge about the two trends in relation to cycling safety. Both a literature

Safety-related control air systems

International Nuclear Information System (INIS)

Anon.

1977-01-01

This Standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This Standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this Standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

Augmented reality for improved safety

CERN Multimedia

Stefania Pandolfi

2016-01-01

Sometimes, CERN experts have to operate in low visibility conditions or in the presence of possible hazards. Minimising the duration of the operation and reducing the risk of errors is therefore crucial to ensuring the safety of personnel. The EDUSAFE project integrates different technologies to create a wearable personnel safety system based on augmented reality.    The EDUSAFE integrated safety system uses a camera mounted on the helmet to monitor the working area.  In its everyday operation of machines and facilities, CERN adopts a whole set of measures and safety equipment to ensure the safety of its personnel, including personal wearable safety devices and access control systems. However, sometimes, scheduled and emergency maintenance work needs to be done in zones with potential cryogenic hazards, in the presence of radioactive equipment or simply in demanding conditions where visibility is low and moving around is difficult. The EDUSAFE Marie Curie Innovative&...

OPG waterways public safety program

Energy Technology Data Exchange (ETDEWEB)

Bennett, T [Ontario Power Generation Inc., Niagara Falls, ON (Canada)

2009-07-01

Ontario Power Generation (OPG) has 64 hydroelectric generating stations, 241 dams, and 109 dams in Ontario's registry with the International Commission on Large Dams (ICOLD). In 1986, it launched a formal dam safety program. This presentation addressed the importance of public safety around dams. The safety measures are timely because of increasing public interaction around dams; the public's unawareness of hazards; public interest in extreme sports; easier access by recreational vehicles; the perceived right of public to access sites; and the remote operation of hydroelectric stations. The presentation outlined the OPG managed system approach, with particular reference to governance; principles; standards and procedures; and aspects of implementation. Specific guidelines and governing documents for public safety around dams were identified, including guidelines for public safety of waterways; booms and buoys; audible warning devices and lights; public safety signage; fencing and barricades; and risk assessment for public safety around waterways. The presentation concluded with a discussion of audits and management reviews to determine if safety objectives and targets have been met. figs.

76 FR 12358 - Common Formats for Patient Safety Data Collection and Event Reporting

Science.gov (United States)

2011-03-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats... information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b...: Device or Supply, including Health Information Technology; Fall; Healthcare-Associated Infection...

Construction safety and waste management an economic analysis

CERN Document Server

Li, Rita Yi Man

2015-01-01

This monograph presents an analysis of construction safety problems and on-site safety measures from an economist’s point of view. The book includes examples from both emerging countries, e.g. China and India, and developed countries, e.g. Australia and Hong Kong. Moreover, the author covers an analysis on construction safety knowledge sharing by means of updatable mobile technology such as apps in Androids and iOS platform mobile devices. The target audience comprises primarily researchers and experts in the field but the book may also be beneficial for graduate students.

[Industry regulation and its relationship to the rapid marketing of medical devices].

Science.gov (United States)

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Science.gov (United States)

2011-04-15

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...

78 FR 56736 - Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems...

Science.gov (United States)

2013-09-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-882] Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems, Tablets and Mobile Phones, Components... (``section 337''), in the importation into the United States, the sale for importation, and the sale within...

Monitoring readiness of safety relevant devices in nuclear power plants by means of CRT-colour displays

International Nuclear Information System (INIS)

Haubert, R.; Stokke, R.

1980-01-01

The development of an information system for monitoring readiness of safety relevant devices is encouraged by the requirements of KTA-rule 3501 (DIN 25434), which states in section 4.9.1.1. 'A display shall be provided for giving a survey of the condition of the components of the reactor protection system and the active engineered safeguards including their energy and auxiliary media supplies'. In the first stage of the development which was reported at the Enlarged Halden Programme Group Meeting in Loen, Norway, 5th-9th June, 1978, only the components of parts of a BWR-protection system were considered and no display was provided. This paper outlines the next step in the development which comprises implementation of the active engineered safeguards into the system and development of a display system based on a colour CRT-screen. A prototype of this computer-based system for monitoring of protection systems has been established, and it is planned to demonstrate this prototype system using the computer equipment at GRS, Garching (orig./HP)

Medical instruments and devices principles and practices

CERN Document Server

Schreiner, Steven; Peterson, Donald R

2015-01-01

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...

Radiation safety

International Nuclear Information System (INIS)

Jain, Priyanka

2014-01-01

The use of radiation sources is a privilege; in order to retain the privilege, all persons who use sources of radiation must follow policies and procedures for their safe and legal use. The purpose of this poster is to describe the policies and procedures of the Radiation Protection Program. Specific conditions of radiation safety require the establishment of peer committees to evaluate proposals for the use of radionuclides, the appointment of a radiation safety officer, and the implementation of a radiation safety program. In addition, the University and Medical Centre administrations have determined that the use of radiation producing machines and non-ionizing radiation sources shall be included in the radiation safety program. These Radiation Safety policies are intended to ensure that such use is in accordance with applicable State and Federal regulations and accepted standards as directed towards the protection of health and the minimization of hazard to life or property. It is the policy that all activities involving ionizing radiation or radiation emitting devices be conducted so as to keep hazards from radiation to a minimum. Persons involved in these activities are expected to comply fully with the Canadian Nuclear Safety Act and all it. The risk of prosecution by the Department of Health and Community Services exists if compliance with all applicable legislation is not fulfilled. (author)

A novel mechanical design of broken rope protection device for enhancing the safety performances of overhead manned equipment in coal mine

Directory of Open Access Journals (Sweden)

Xiaoguang Zhang

2015-08-01

Full Text Available A novel mechanical design of the broken rope protection device is proposed to enhance the safety performances of the overhead manned equipment. According to the operating characteristics and functional requirements of the overhead manned equipment, a three-dimensional mechanical model of the broken rope protection device was redesigned. Based on the known parameters of the mechanical model, the stress and strength of the main components are readjusted using the statics characteristics of finite element analysis. To ensure the reliability of the control system of the broken rope protection device, the process of people’s falling, the response performance of the tension sensor, and the signal extraction of the broken rope are analyzed under different loading and unloading speeds. The working principle of the broken rope protection device is expounded in detail. The experimental results showed that better effect is obtained by the new broken rope protection device, which is characterized by good durability, low investment, and high reliability.

30 CFR 75.208 - Warning devices.

Science.gov (United States)

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Roof Support § 75.208 Warning devices. Except during the..., or a physical barrier shall be installed to impede travel beyond permanent support. ...

ALARP considerations in criticality safety assessments

International Nuclear Information System (INIS)

Bowden, Russell L.; Barnes, Andrew; Thorne, Peter R.; Venner, Jack

2003-01-01

Demonstrating that the risk to the public and workers is As Low As Reasonably Practicable (ALARP) is a fundamental requirement of safety cases for nuclear facilities in the United Kingdom. This is embodied in the Safety Assessment Principles (SAPs) published by the Regulator, the essence of which is incorporated within the safety assessment processes of the various nuclear site licensees. The concept of ALARP within criticality safety assessments has taken some time to establish in the United Kingdom. In principle, the licensee is obliged to search for a deterministic criticality safety solution, such as safe geometry vessels and passive control features, rather than placing reliance on active measurement devices and plant administrative controls. This paper presents a consideration of some ALARP issues in relation to the development of criticality safety cases. The paper utilises some idealised examples covering a range of issues facing the criticality safety assessor, including new plant design, operational plant and decommissioning activities. These examples are used to outline the elements of the criticality safety cases and present a discussion of ALARP in the context of criticality safety assessments. (author)

76 FR 41522 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Science.gov (United States)

2011-07-14

... Devices, Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components.... 1337, in the importation, sale for importation and sale within the United States after importation of certain mobile phones, mobile tablets, portable music players, and computers. 76 FR 24051 (Apr. 29, 2011...

Transcatheter Device Closure of Patent Ductus Arteriosus

International Nuclear Information System (INIS)

Sultan, M.; Ullah, M.; Sadiq, N.; Akhtar, K.; Akbar, H.

2014-01-01

Objective: To determine the efficacy, safety and immediate complications encountered during percutaneous device closure of patent ductus arteriosus (PDA). Study Design: Case series. Place and Duration of Study: Department of Paediatric Cardiology, AFIC/NIHD, Rawalpindi, from January 2005 to December 2010. Methodology: Consecutive 500 patients who underwent attempted transcatheter PDA device closure were included in the study. Device type position, success of closure and complications were described as frequency percentage. Results: In 491 cases (98.2%), PDA was successfully occluded including 4 cases (0.8%) where devices were dislodged but retrieved and redeployed in Cath laboratory. PDA occluder devices used in 448 cases (91%) while coils (single or multiple) were used in 42 cases (8.5%) and in one case (0.2%) ASD occluder device was used to occlude the PDA. There were 09 (1.8%) unsuccessful cases, 06 (1.2%) were abandoned as ducts were considered unsuitable for device closure, 02 (0.4%) devices dislodged and needed surgical retrieval and one case (0.2%) was abandoned due to faulty equipment. The narrowest PDA diameter ranged from 0.5 - 14 mm with mean of 4.5 +- 2.4 mm. There was a single (0.2%) mortality. Conclusion: Transcatheter occlusion of PDA by coil or occluder device is an effective therapeutic option with high success rate. Complication rate is low in the hands of skilled operators yet paediatric cardiac surgical back-up cover is mandatory. (author)

Access safety systems - New concepts from the LHC experience

International Nuclear Information System (INIS)

Ladzinski, T.; Delamare, C.; Luca, S. di; Hakulinen, T.; Hammouti, L.; Havart, F.; Juget, J.F.; Ninin, P.; Nunes, R.; Riesco, T.; Sanchez-Corral Mena, E.; Valentini, F.

2012-01-01

The LHC Access Safety System has introduced a number of new concepts into the domain of personnel protection at CERN. These can be grouped into several categories: organisational, architectural and concerning the end-user experience. By anchoring the project on the solid foundations of the IEC 61508/61511 methodology, the CERN team and its contractors managed to design, develop, test and commission on time a SIL3 safety system. The system uses a successful combination of the latest Siemens redundant safety programmable logic controllers with a traditional relay logic hard wired loop. The external envelope barriers used in the LHC include personnel and material access devices, which are interlocked door-booths introducing increased automation of individual access control, thus removing the strain from the operators. These devices ensure the inviolability of the controlled zones by users not holding the required credentials. To this end they are equipped with personnel presence detectors and the access control includes a state of the art bio-metry check. Building on the LHC experience, new projects targeting the refurbishment of the existing access safety infrastructure in the injector chain have started. This paper summarises the new concepts introduced in the LHC access control and safety systems, discusses the return of experience and outlines the main guiding principles for the renewal stage of the personnel protection systems in the LHC injector chain in a homogeneous manner. (authors)

Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

Science.gov (United States)

Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

2017-12-15

Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

Health and safety manual

International Nuclear Information System (INIS)

1980-02-01

The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices

Device for increasing the safety in the environment of nuclear facilities in case of containment failure

International Nuclear Information System (INIS)

Morlock, G.; Wiesemes, J.; Bachner, D.

1978-01-01

In order to increase the safety in the environment of nuclear facilities, e.g. in case of containment failure, with respect to released radioactive material new or existing facilities are covered with ground. The ground material has got a consistency very much reducing the permeability for liquids and gases. In addition irrigation devices for keeping the ground wet and/or intermediate layers of films pervious to water, e.g. perforated sheets, may be provided. Additionally the ground is protected against frost. Especially suited for ground material is clay. (DG) [de

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

Science.gov (United States)

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Licensing of simple digital devices

International Nuclear Information System (INIS)

Jackson, T. W.

2008-01-01

The inability to guarantee error-free software gave rise to the potential for common-cause failure of digital safety systems in nuclear power plants. To address this vulnerability, the U. S. Nuclear Regulatory Commission (NRC) required a quality software development process and a defense-in-depth and diversity analysis for digital safety systems. As a result of recent interim [NRC] staff guidance in the digital instrumentation and control (I and C) area, licensing of simple digital devices decreases some regulatory burden with respect to demonstrating a quality software development process and defense-in-depth and diversity analysis. This paper defines simple digital devices and addresses the interim staff guidance that applies to such devices. The paper also highlights the technical aspects that affect the licensing of such devices and incorporates licensing experience in the U.S. to date. (authors)

A Detection Device for the Signs of Human Life in Accident

Science.gov (United States)

Ning, Li; Ruilan, Zhang; Jian, Liu; Ruirui, Cheng; Yuhong, Diao

2017-12-01

A detection device for the signs of human life in accidents is a device used in emergency situations, such as the crash site. the scene of natural disasters, the battlefield ruins. it designed to detect the life signs of the distress under the injured ambulance vital signs devices. The device can on human vital signs, including pulse, respiration physiological signals to make rapid and accurate response. After some calculations, and after contrast to normal human physiological parameters given warning signals, in order for them to make timely ambulance judgment. In this case the device is required to do gymnastics convenience, ease of movement, power and detection of small flexible easy realization. This device has the maximum protection of the wounded safety significance.

Do Undergraduate Engineering Faculty Include Occupational and Public Health and Safety in the Engineering Curriculum?

Science.gov (United States)

Farwell, Dianna; And Others

1995-01-01

The purpose of this study was to determine whether and, if so, why engineering faculty include occupational and public health and safety in their undergraduate engineering courses. Data were collected from 157 undergraduate engineering faculty from 65 colleges of engineering in the United States. (LZ)

CIRSE Vascular Closure Device Registry

International Nuclear Information System (INIS)

Reekers, Jim A.; Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2011-01-01

Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only 5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.

Rumble devices for road traffic safety

CSIR Research Space (South Africa)

Jobson, AJ

1973-01-01

Full Text Available on the approaches to hazardous curves or intersections. City and town engineers had little to report on rumble installations but showed a keen interest in their potential usefulness. Each type of rumble device has certain merits and these are discussed...

30 CFR 57.9311 - Anchoring stationary sizing devices.

Science.gov (United States)

2010-07-01

... NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and Loading and...

Eat-by-light fiber-optic and micro-optic devices for food quality and safety assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Grimaldi, M. F.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-06-01

A selection is presented of fiber-optic and micro-optic devices that have been designed and tested for guaranteeing the quality and safety of typical foods, such as extra virgin olive oil, beer, and milk. Scattered colorimetry is used to authenticate various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids, which are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma that is capable of distinguishing different ageing levels of extra virgin olive oil is also presented. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer for the rapid monitoring of the carcinogenic M1 aflatoxin in milk, is experimented.

Eat-by-light: fiber-optic and micro-optic devices for food safety and quality assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-07-01

A selection of fiber-optic and micro-optic devices is presented designed and tested for monitoring the quality and safety of typical foods, namely the extra virgin olive oil, the beer, and the milk. Scattered colorimetry is used for the authentication of various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids that are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma is presented. It is capable of distinguishing different ageing levels of extra virgin olive oil. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer is experimented for the rapid monitoring of the carcinogenic M1 aflatoxin in milk.

Safety review and approval process for the TFTR

International Nuclear Information System (INIS)

Levine, J.D.; Howe, H.J.; Howe, K.E.

1983-01-01

The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices

Safety device and machine system of nuclear power plant

International Nuclear Information System (INIS)

1978-10-01

It introduces principle and kinds of heat power including heat balance and nuclear power. It explains a lot of technical terms about the nuclear power system, which are primary loop, reactor, steam generator, primary coolant pump and pressurizer in PWR, chemical and volume control system, component cooling system, safety injection system, and spent fuel cooling and storage system in auxiliary system, liquid solid and gaseous waste disposal system in radwaste disposal, gland sealing system, turbine instrumentation, turning gear, hydrogen cooling system, condenser, feedwater heater, degenerate heater, auxiliary heat exchanger, centrifugal pump, rotary reciprocating and tank and pressure vessel.

The development of neural stimulators: a review of preclinical safety and efficacy studies.

Science.gov (United States)

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

International Nuclear Information System (INIS)

2016-01-01

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

CONSIDERATIONS FOR THE DEVELOPMENT OF A DEVICE FOR THE DECOMMISSIONING OF THE HORIZONTAL FUEL CHANNELS IN THE CANDU 6 NUCLEAR REACTOR. PART 6 - PRESENTATION OF THE DECOMMISSIONING DEVICE

Directory of Open Access Journals (Sweden)

Gabi ROSCA FARTAT

2015-05-01

Full Text Available The objective of this paper is to present a possible solution for the designing of a device for the decommissioning of the horizontal fuel channels in the CANDU 6 nuclear reactor. The decommissioning activities are dismantling, demolition, controlled removal of equipment, components, conventional or hazardous waste (radioactive, toxic in compliance with the international basic safety standards on radiation protection. One as the most important operation in the final phase of the nuclear reactor dismantling is the decommissioning of fuel channels. For the fuel channels decommissioning should be taken into account the detailed description of the fuel channel and its components, the installation documents history, adequate radiological criteria for decommissioning guidance, safety and environmental impact assessment, including radiological and non-radiological analysis of the risks that can occur for workers, public and environment, the description of the proposed program for decommissioning the fuel channel and its components, the description of the quality assurance program and of the monitoring program, the equipments and methods used to verify the compliance with the decommissioning criteria, the planning of performing the final radiological assessment at the end of the fuel channel decommissioning. These will include also, a description of the proposed radiation protection procedures to be used during decommissioning. The dismantling of the fuel channel is performed by one device which shall provide radiation protection during the stages of decommissioning, ensuring radiation protection of the workers. The device shall be designed according to the radiation protection procedures. The decommissioning device assembly of the fuel channel components is composed of the device itself and moving platform support for coupling of the selected channel to be dismantled. The fuel channel decommissioning device is an autonomous device designed for

Development of Pneumatic Aerodynamic Devices to Improve the Performance, Economics, and Safety of Heavy Vehicles

International Nuclear Information System (INIS)

Robert J. Englar

2000-01-01

Under contract to the DOE Office of Heavy Vehicle Technologies, the Georgia Tech Research Institute (GTRI) is developing and evaluating pneumatic (blown) aerodynamic devices to improve the performance, economics, stability and safety of operation of Heavy Vehicles. The objective of this program is to apply the pneumatic aerodynamic aircraft technology previously developed and flight-tested by GTRI personnel to the design of an efficient blown tractor-trailer configuration. Recent experimental results obtained by GTRI using blowing have shown drag reductions of 35% on a streamlined automobile wind-tunnel model. Also measured were lift or down-load increases of 100-150% and the ability to control aerodynamic moments about all 3 axes without any moving control surfaces. Similar drag reductions yielded by blowing on bluff afterbody trailers in current US trucking fleet operations are anticipated to reduce yearly fuel consumption by more than 1.2 billion gallons, while even further reduction is possible using pneumatic lift to reduce tire rolling resistance. Conversely, increased drag and down force generated instantaneously by blowing can greatly increase braking characteristics and control in wet/icy weather due to effective ''weight'' increases on the tires. Safety is also enhanced by controlling side loads and moments caused on these Heavy Vehicles by winds, gusts and other vehicles passing. This may also help to eliminate the jack-knifing problem if caused by extreme wind side loads on the trailer. Lastly, reduction of the turbulent wake behind the trailer can reduce splash and spray patterns and rough air being experienced by following vehicles. To be presented by GTRI in this paper will be results developed during the early portion of this effort, including a preliminary systems study, CFD prediction of the blown flowfields, and design of the baseline conventional tractor-trailer model and the pneumatic wind-tunnel model

Development of Pneumatic Aerodynamic Devices to Improve the Performance, Economics, and Safety of Heavy Vehicles

Energy Technology Data Exchange (ETDEWEB)

Robert J. Englar

2000-06-19

Under contract to the DOE Office of Heavy Vehicle Technologies, the Georgia Tech Research Institute (GTRI) is developing and evaluating pneumatic (blown) aerodynamic devices to improve the performance, economics, stability and safety of operation of Heavy Vehicles. The objective of this program is to apply the pneumatic aerodynamic aircraft technology previously developed and flight-tested by GTRI personnel to the design of an efficient blown tractor-trailer configuration. Recent experimental results obtained by GTRI using blowing have shown drag reductions of 35% on a streamlined automobile wind-tunnel model. Also measured were lift or down-load increases of 100-150% and the ability to control aerodynamic moments about all 3 axes without any moving control surfaces. Similar drag reductions yielded by blowing on bluff afterbody trailers in current US trucking fleet operations are anticipated to reduce yearly fuel consumption by more than 1.2 billion gallons, while even further reduction is possible using pneumatic lift to reduce tire rolling resistance. Conversely, increased drag and down force generated instantaneously by blowing can greatly increase braking characteristics and control in wet/icy weather due to effective ''weight'' increases on the tires. Safety is also enhanced by controlling side loads and moments caused on these Heavy Vehicles by winds, gusts and other vehicles passing. This may also help to eliminate the jack-knifing problem if caused by extreme wind side loads on the trailer. Lastly, reduction of the turbulent wake behind the trailer can reduce splash and spray patterns and rough air being experienced by following vehicles. To be presented by GTRI in this paper will be results developed during the early portion of this effort, including a preliminary systems study, CFD prediction of the blown flowfields, and design of the baseline conventional tractor-trailer model and the pneumatic wind-tunnel model.

Long-term efficacy of an ergonomics program that includes patient-handling devices on reducing musculoskeletal injuries to nursing personnel.

Science.gov (United States)

Garg, Arun; Kapellusch, Jay M

2012-08-01

The aim of this study was to evaluate long-term efficacy of an ergonomics program that included patient-handling devices in six long-term care facilities (LTC) and one chronic care hospital (CCH). Patient handling is recognized as a major source of musculoskeletal disorders (MSDs) among nursing personnel, and several studies have demonstrated effectiveness of patient-handling devices in reducing those MSDs. However, most studies have been conducted in a single facility, for a short period, and/or without a comprehensive ergonomics program. Patient-handling devices along with a comprehensive ergonomics program was implemented in six LTC facilities and one CCH. Pre- and postintervention injury data were collected for 38.9 months (range = 29 to 54 months) and 51.2 months (range = 36 to 60 months), respectively. Postintervention patient-handling injuries decreased by 59.8% (rate ratio [RR] = 0.36, 95% confidence interval [CI] [0.28, 0.49], p nursing staff were fairly low. A vast majority of patients found the devices comfortable and safe. Longer transfer times with the use of devices was not an issue. Implementation of patient-handling devices along with a comprehensive program can be effective in reducing MSDs among nursing personnel. Strategies to expand usage of patient-handling devices in most health care settings should be explored.

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

Science.gov (United States)

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Laser safety in design of near-infrared scanning LIDARs

Science.gov (United States)

Zhu, X.; Elgin, D.

2015-05-01

3D LIDARs (Light Detection and Ranging) with 1.5μm nanosecond pulse lasers have been increasingly used in different applications. The main reason for their popularity is that these LIDARs have high performance while at the same time can be made eye-safe. Because the laser hazard effect on eyes or skin at this wavelength region (industrial mining applications. We have incorporated the laser safety requirements in the LIDAR design and conducted laser safety analysis for different operational scenarios. While 1.5μm is normally said to be the eye-safe wavelength, in reality a high performance 3D LIDAR needs high pulse energy, small beam size and high pulse repetition frequency (PRF) to achieve long range, high resolution and high density images. The resulting radiant exposure of its stationary beam could be many times higher than the limit for a Class 1 laser device. Without carefully choosing laser and scanning parameters, including field-of-view, scan speed and pattern, a scanning LIDAR can't be eye- or skin-safe based only on its wavelength. This paper discusses the laser safety considerations in the design of eye-safe scanning LIDARs, including laser pulse energy, PRF, beam size and scanning parameters in two basic designs of scanning mechanisms, i.e. galvanometer based scanner and Risley prism based scanner. The laser safety is discussed in terms of device classification, nominal ocular hazard distance (NOHD) and safety glasses optical density (OD).

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

Science.gov (United States)

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

30 CFR 57.9306 - Warning devices for restricted clearances.

Science.gov (United States)

2010-07-01

... AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and...

Safety-related control air systems - approved 1977

International Nuclear Information System (INIS)

Anon.

1978-01-01

This standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

78 FR 36091 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-06-17

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

CIRSE Vascular Closure Device Registry

Science.gov (United States)

Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2010-01-01

Purpose Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only 5.9 cm, and two vessel occlusions. Conclusion The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters. PMID:20981425

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

Directory of Open Access Journals (Sweden)

Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

Some safety considerations in laser-controlled thermonuclear reactors. Final report

International Nuclear Information System (INIS)

Botts, T.E.; Breton, D.; Chan, C.K.; Levy, S.I.; Sehnert, M.; Ullman, A.Z.

1978-07-01

A major objective of this study was to identify potential safety questions for laser controlled thermonuclear reactors. From the safety viewpoint, it does not appear that the actual laser controlled thermonuclear reactor conceptual designs present hazards very different than those of magnetically confined fusion reactors. Some aspects seem beneficial, such as small lithium inventories, and the absence of cryogenic devices, while other aspects are new, for example the explosion of pressure vessels and laser hazards themselves. Major aspects considered in this report include: (a) general safety considerations, (b) tritium inventories, (c) system behavior during loss of flow accidents, and (d) safety considerations of laser related penetrations

Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.

Science.gov (United States)

2014-07-08

The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

OpenAIRE

A. Yu. Galkin; A. G. Komar; A. A. Grigorenko

2015-01-01

In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO...

77 FR 20295 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Science.gov (United States)

2012-04-04

... Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 73966 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2010-11-30

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

77 FR 35854 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2012-06-15

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

76 FR 2829 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2011-01-18

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 52462 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2010-08-26

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.

Science.gov (United States)

Ross, Sue; Robert, Magali; Harvey, Marie-Andrée; Farrell, Scott; Schulz, Jane; Wilkie, David; Lovatsis, Danny; Epp, Annette; Easton, Bill; McMillan, Barry; Schachter, Joyce; Gupta, Chander; Weijer, Charles

2008-06-01

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health

77 FR 25595 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2012-05-01

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Safety Zone; Brandon Road Lock and [[Page 25596

Safety Evakuation Of Triga-2000 Reactor Operation Viewed From Safety Culture

International Nuclear Information System (INIS)

Karliana, Itjeu

2001-01-01

The safety evaluation activities of TRIGA-2000 operation viewed from safety culture performed by questioners data collected from the operators and supervisor site of TRIGA-2000 P3TN, Bandung. There are 9 activity aspects surveyed, for instant to avail the policy of safety from their chairman, safety management, education and training, emergency aids planning, safety consultancy, accident information, safety analysis, safety devices, safety and occupational health. The surveying undertaken by filling the questioner that containing of 9 activity aspects and 20 samples of employees. The safety evaluation results' of the operation personnel in TRIGA-2000 P3TN are good implemented by both the operators and supervisors should be improve and attention need to provide the equipment's. The education and training especially for safety refreshment must be performing

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

Science.gov (United States)

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Features and selection of vascular access devices.

Science.gov (United States)

Sansivero, Gail Egan

2010-05-01

To review venous anatomy and physiology, discuss assessment parameters before vascular access device (VAD) placement, and review VAD options. Journal articles, personal experience. A number of VAD options are available in clinical practice. Access planning should include comprehensive assessment, with attention to patient participation in the planning and selection process. Careful consideration should be given to long-term access needs and preservation of access sites. Oncology nurses are uniquely suited to perform a key role in VAD planning and placement. With knowledge of infusion therapy, anatomy and physiology, device options, and community resources, nurses can be key leaders in preserving vascular access and improving the safety and comfort of infusion therapy. Copyright 2010 Elsevier Inc. All rights reserved.

Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill.

Science.gov (United States)

Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

2016-09-01

Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty.

Flexible barrier film, method of forming same, and organic electronic device including same

Science.gov (United States)

Blizzard, John; Tonge, James Steven; Weidner, William Kenneth

2013-03-26

A flexible barrier film has a thickness of from greater than zero to less than 5,000 nanometers and a water vapor transmission rate of no more than 1.times.10.sup.-2 g/m.sup.2/day at 22.degree. C. and 47% relative humidity. The flexible barrier film is formed from a composition, which comprises a multi-functional acrylate. The composition further comprises the reaction product of an alkoxy-functional organometallic compound and an alkoxy-functional organosilicon compound. A method of forming the flexible barrier film includes the steps of disposing the composition on a substrate and curing the composition to form the flexible barrier film. The flexible barrier film may be utilized in organic electronic devices.

The Development of Computer Code for Safety Injection Tank (SIT) with Fluidic Device(FD) Blowdown Test

International Nuclear Information System (INIS)

Lee, Joo Hee; Kim, Tae Han; Choi, Hae Yun; Lee, Kwang Won; Chung, Chang Kyu

2007-01-01

Safety Injection Tanks (SITs) with the Fluidic Device (FD) of APR1400 provides a means of rapid reflooding of the core following a large break Loss Of Coolant Accident (LOCA), and keeping it covered until flow from the Safety Injection Pump (SIP) becomes available. A passive FD can provide two operation stages of a safety water injection into the RCS and allow more effective use of borated water in case of LOCA. Once a large break LOCA occurs, the system will deliver a high flow rate of cooling water for a certain period of time, and thereafter, the flow rate is reduced to a lower flow rate. The conventional computer code 'TURTLE' used to simulate the blowdown of OPR1000 SIT can not be directly applied to simulate a blowdown process of the SIT with FD. A new computer code is needed to be developed for the blowdown test evaluation of the APR1400 SIT with FD. Korea Power Engineering Company (KOPEC) has developed a new computer code to analyze the characteristics of the SIT with FD and validated the code through the comparison of the calculation results with the test results obtained by Ulchin 5 and 6 units pre-operational test and VAlve Performance Evaluation Rig (VAPER) tests performed by The Korea Atomic Energy Research Institute (KAERI)

The inverted cup device for blood transfer on malaria RDTs: ease of use, acceptability and safety in routine use by health workers in Nigeria.

Science.gov (United States)

Incardona, Sandra; Mwancha-Kwasa, Magoma; Rees-Channer, Roxanne R; Albertini, Audrey; Havumaki, Joshua; Chiodini, Peter; Oyibo, Wellington; Gonzalez, Iveth J

2018-01-15

Malaria rapid diagnostic tests (RDTs) are becoming widely adopted for case management at community level. However, reports and anecdotal observations indicate that the blood transfer step poses a significant challenge to many users. This study sought to evaluate the inverted cup device in the hands of health workers in everyday clinical practice, in comparison with the plastic pipette, and to determine the volume accuracy of the device made of a lower-cost plastic. The volume accuracy of inverted cup devices made of two plastics, PMMA and SBC, was compared by transferring blood 150 times onto filter paper and comparing the blood spot areas with those produced by 20 reference transfers with a calibrated micropipette. The ease of use, safety and acceptability of the inverted cup device and the pipette were evaluated by 50 health workers in Nigeria. Observations were recorded on pre-designed questionnaires, by the health workers themselves and by trained observers. Focus group discussions were also conducted. The volume accuracy assessment showed that the device made from the low-cost material (SBC) delivered a more accurate volume (mean 5.4 μL, SD 0.48 μL, range 4.5-7.0 μL) than the PMMA device (mean 5.9 μL, SD 0.48 μL, range 4.9-7.2 μL). The observational evaluation demonstrated that the inverted cup device performed better than the pipette in all aspects, e.g. higher proportions of health workers achieved successful blood collection (96%, vs. 66%), transfer of the required blood volume (90%, vs. 58%), and blood deposit without any loss (95%, vs. 50%). Majority of health workers also considered it' very easy' to use (81%),'very appropriate' for everyday use (78%), and 50% of them reported that it was their preferred BTD. The good volume accuracy and high acceptability of the inverted cup device shown in this study, along with observed ease of use and safety in hands of health workers, further strengthens prior findings which demonstrated its higher

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

Science.gov (United States)

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Expediting Clinician Adoption of Safety Practices: The UCSF Venous Access Patient Safety Interdisciplinary Education Project

National Research Council Canada - National Science Library

Donaldson, Nancy E; Plank, Rosemary K; Williamson, Ann; Pearl, Jeffrey; Kellogg, Jerry; Ryder, Marcia

2005-01-01

...) Venous Access Device (VAD) Patient Safety Interdisciplinary Education Project was to develop a 30-hour/one clinical academic unit VAD patient safety course with the aim of expediting clinician adoption of critical concepts...

Neutronic, thermal-hydraulics and safety calculations of a Miniplate Irradiation Device (MID) of dispersion type fuel elements

International Nuclear Information System (INIS)

Domingos, Douglas Borges

2010-01-01

Neutronic, thermal-hydraulics and accident analysis calculations were developed to estimate the safety of a Miniplate Irradiation Device (MID) to be placed in the IEA-R1 reactor core. The irradiation device is used to receive miniplates of U 3 O 8 -Al and U 3 Si 2 - Al dispersion fuels, LEU type (19.75 % 235 U) with uranium densities of, respectively, 3.2 gU/cm 3 and 4.8 gU/cm 3 . The fuel miniplates will be irradiated to nominal 235 U burnup levels of 50% and 80%, in order to qualify the above high-density dispersion fuels to be used in the Brazilian Multipurpose Reactor (RMB), now in the conception phase. For the neutronic calculation, the computer codes CITATION and 2DB were utilized. The computer code FLOW was used to calculate the coolant flow rate in the irradiation device, allowing the determination of the fuel miniplate temperatures with the computer model MTRCR-IEA-R1. A postulated Loss of Coolant Accident (LOCA) was analyzed with the computer codes LOSS and TEMPLOCA, allowing the calculation of the fuel miniplate temperatures after the reactor pool draining. The calculations showed that the irradiation should occur without adverse consequences in the IEA-R1 reactor. (author)

Development of Network Protocol for the Integrated Safety System

Energy Technology Data Exchange (ETDEWEB)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M. [Hannam Univ., Daejeon (Korea, Republic of)

2007-06-15

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants.

Development of Network Protocol for the Integrated Safety System

International Nuclear Information System (INIS)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M.

2007-06-01

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants

Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke

Directory of Open Access Journals (Sweden)

Christopher M. Loftus

2018-06-01

Full Text Available The United States Food and Drug Administration (FDA Center for Devices and Radiological Health (CDRH is charged with ensuring patients in the US have timely access to high-quality, safe, and effective medical devices of public health importance. Within CDRH, the Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the central and peripheral nervous system (neurotechnologies, including neurointerventional medical devices that are used in the treatment of stroke. Endovascular treatments have demonstrated recent advances in reaching the marketplace and providing more options for patients with acute ischemic stroke and intracranial aneurysms specifically. Depending upon the pathway chosen for regulatory approval, and the evidentiary standard for different regulatory pathways, neurotechnologies can have well-established safety and effectiveness profiles, varying degrees of scientific and clinical uncertainty regarding safety and effectiveness, or when a humanitarian use exists, need only demonstrate a probable benefit and safety to the patient so potentially life-saving treatments can reach the marketplace. Reperfusion therapies have had specific advances in the treatment of stroke patients that originally had limited or no treatment options and for preventative treatments in providing care to patients with intracranial aneurysms to avoid potentially more catastrophic outcomes. Collaboration in multiple forums and environments will be important to continue to foster the neurointerventional technology sector and positively impact clinical medicine, from diagnosing and treating a neurological disorder, to potentially altering the progression of disease, and in many ways, contemporary approved devices have brought a new sense of hope and optimism that serious and otherwise disabling neurological diseases can be treated and in many cases cured with modern therapy. We present here the scope of FDA�

Access Safety Systems – New Concepts from the LHC Experience

CERN Document Server

Ladzinski, T; di Luca, S; Hakulinen, T; Hammouti, L; Riesco, T; Nunes, R; Ninin, P; Juget, J-F; Havart, F; Valentini, F; Sanchez-Corral Mena, E

2011-01-01

The LHC Access Safety System has introduced a number of new concepts into the domain of personnel protection at CERN. These can be grouped into several categories: organisational, architectural and concerning the end-user experience. By anchoring the project on the solid foundations of the IEC 61508/61511 methodology, the CERN team and its contractors managed to design, develop, test and commission on time a SIL3 safety system. The system uses a successful combination of the latest Siemens redundant safety programmable logic controllers with a traditional relay logic hardwired loop. The external envelope barriers used in the LHC include personnel and material access devices, which are interlocked door-booths introducing increased automation of individual access control, thus removing the strain from the operators. These devices ensure the inviolability of the controlled zones by users not holding the required credentials. To this end they are equipped with personnel presence detectors and th...

30 CFR 75.320 - Air quality detectors and measurement devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Air quality detectors and measurement devices... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.320 Air quality detectors and measurement devices. (a) Tests for methane shall be made by a qualified person with...

Evolution of atherectomy devices.

Science.gov (United States)

Al Khoury, G; Chaer, R

2011-08-01

Percutaneous atherectomy provides an alternative approach to the endovascular treatment of peripheral atherosclerotic occlusive disease beyond angioplasty and stenting, and has the theoretical advantage of lesion debulking and minimizing barotrauma to the vessel wall. Atherectomy has evolved greatly during the last decade, with currently four FDA approved devices for the treatment of peripheral arterial disease. Several reports have focused on the initial technical success rates, and demonstrated the safety and short as well as mid-term efficacy of atherectomy devices. This article will review the evolution of current atherectomy devices and the associated literature.

Graphene device and method of using graphene device

Science.gov (United States)

Bouchiat, Vincent; Girit, Caglar; Kessler, Brian; Zettl, Alexander K.

2015-08-11

An embodiment of a graphene device includes a layered structure, first and second electrodes, and a dopant island. The layered structure includes a conductive layer, an insulating layer, and a graphene layer. The electrodes are coupled to the graphene layer. The dopant island is coupled to an exposed surface of the graphene layer between the electrodes. An embodiment of a method of using a graphene device includes providing the graphene device. A voltage is applied to the conductive layer of the graphene device. Another embodiment of a method of using a graphene device includes providing the graphene device without the dopant island. A dopant island is placed on an exposed surface of the graphene layer between the electrodes. A voltage is applied to the conductive layer of the graphene device. A response of the dopant island to the voltage is observed.

Feasibility and Safety of Endovascular Stripping of Totally Implantable Venous Access Devices

International Nuclear Information System (INIS)

Heye, Sam; Maleux, Geert; Goossens, G. A.; Vaninbroukx, Johan; Jerôme, M.; Stas, M.

2012-01-01

Purpose: To evaluate the safety and feasibility of percutaneous stripping of totally implantable venous access devices (TIVAD) in case of catheter-related sleeve and to report a technique to free the catheter tip from vessel wall adherence. Materials and Methods: A total of 37 stripping procedures in 35 patients (14 men, 40%, and 21 women, 60%, mean age 53 ± 14 years) were reviewed. Totally implantable venous access devices were implanted because of malignancy in most cases (85.7%). Catheter-related sleeve was confirmed as cause of persistent catheter dysfunction despite instillation of thrombolytics. A technique to mobilize the catheter tip from the vessel wall was used when stripping with the snare catheter was impossible. Technical success, complication rate, and outcome were noted. Results: A total of 55.9% (n = 19) of the 34 technically successful procedures (91.9%) could be done with the snare catheter. In 15 cases (44.1%), additional maneuvers to free the TIVAD’s tip from the vessel wall were needed. Success rate was not significantly lower before (72.4%) than after (96.7%) implementation of the new technique (P = 0.09). No complications were observed. Follow-up was available in 67.6% of cases. Recurrent catheter dysfunction was found in 17 TIVADs (78.3%) at a mean of 137.7 days and a median of 105 days. Conclusions: Stripping of TIVADs is technically feasible and safe, with an overall success rate of 91.9%. Additional endovascular techniques to mobilize the distal catheter tip from the wall of the superior vena cava or right atrium to allow encircling the TIVAD tip with the snare catheter may be needed in 44.1% of cases.

Healthcare Provider Attitudes of Safety of Intrauterine Devices in the Postpartum Period.

Science.gov (United States)

Rauh-Benoit, Lisa A; Tepper, Naomi K; Zapata, Lauren B; Whiteman, Maura K; Curtis, Kathryn M; Mandel, Michele G; Marchbanks, Polly A; Jamieson, Denise J

2017-07-01

Immediate postpartum intrauterine devices (IUDs) have been underutilized in the United States despite their known safety. Understanding how providers' attitudes contribute to underutilization is important in improving access. Our objective was to examine healthcare providers' perceptions of the safety of immediate postpartum IUDs before publication of United States contraceptive guidelines. We analyzed survey data collected from December 2009 to March 2010 from 635 office-based physicians and 1368 Title X clinic providers (overall response rate of 64.8%). Providers were asked how safe they thought copper and levonorgestrel (LNG) IUDs were in postpartum women (very safe, safe, unsafe, very unsafe, and unsure). Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for characteristics associated with considering immediate and delayed postpartum IUDs to be safe. Less than 40% of respondents considered immediate or delayed IUD insertion to be safe. Providers with postpartum IUD insertion to be safe compared with unsafe/unsure (aOR 0.18, 95% CI 0.04-0.84 for copper IUD and aOR 0.17, 95% CI 0.04-0.81 for LNG-IUD). Providers without training in postpartum or interval copper IUD insertion had decreased odds of considering immediate postpartum copper IUD insertion (aOR 0.40, 95% CI 0.16-0.79) and delayed postpartum insertion for both IUD types to be safe (aOR 0.34, 95% CI 0.18-0.66 for copper IUD and aOR 0.41, 95% CI 0.21-0.77 for LNG-IUD). Before United States contraceptive guidelines, a majority of providers perceived immediate postpartum IUDs to be unsafe.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

Science.gov (United States)

2017-12-19

The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

47 CFR 95.1125 - RF safety.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

Directory of Open Access Journals (Sweden)

A. Yu. Galkin

2015-04-01

Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.

76 FR 65609 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2011-10-24

... Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship Canal... Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal, Chicago... INFORMATION: The Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake...

75 FR 64147 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2010-10-19

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Ship and Sanitary Canal... . SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zone, Brandon Road Lock and Dam to Lake Michigan...

ACED devices and SECAF supports for the control of structure, pipe network and equipment behaviour at seismic movements in order to enhance the safety margin

International Nuclear Information System (INIS)

Serban, Viorel; Prisecaru, I.; Cretu, D.; Moldoveanu, T.

2002-01-01

In order to enhance the safety margin of structure, pipe networks and equipment associated to the existing NPPs, the classic consolidation solutions are very expensive and many times, impossible to be implemented. Structures, pipe networks, systems and equipment have geometries imposed by the basic construction requirements, operating and safety requirements and their modifications is not always possible. In order to enhance the strength capacity of (new or old) structures, systems and equipment mechanical devices with controlled elasticity and damping (ACED) have been designed, constructed and experimented. These devices are capable to support very large static loads over which dynamic loads (shock, vibration and seismic movements) overlap (which are damped). To increase the strength capacity of (new or existing) pipe networks and equipment connecting with pipes, SECAF supports that allow displacements from thermal expansions with low reaction force have been designed, constructed and experimented. SECAF supports are capable elastically to take permanent loads over which shocks, vibrations and seismic movements (which are damp) overlap. ACED devices and SECAF supports can be used to rehabilitate the existing NPPs with law financial costs and an increase of their strength capacity up to 100% under seismic movements, shocks and vibrations. ACED devices and SECAF supports do not require maintenance, are not affected by presence of a radiation field and their estimated service-life is similar to the NPPs

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

Science.gov (United States)

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Soft robotic devices for hand rehabilitation and assistance: a narrative review.

Science.gov (United States)

Chu, Chia-Ye; Patterson, Rita M

2018-02-17

The debilitating effects on hand function from a number of a neurologic disorders has given rise to the development of rehabilitative robotic devices aimed at restoring hand function in these patients. To combat the shortcomings of previous traditional robotics, soft robotics are rapidly emerging as an alternative due to their inherent safety, less complex designs, and increased potential for portability and efficacy. While several groups have begun designing devices, there are few devices that have progressed enough to provide clinical evidence of their design's therapeutic abilities. Therefore, a global review of devices that have been previously attempted could facilitate the development of new and improved devices in the next step towards obtaining clinical proof of the rehabilitative effects of soft robotics in hand dysfunction. A literature search was performed in SportDiscus, Pubmed, Scopus, and Web of Science for articles related to the design of soft robotic devices for hand rehabilitation. A framework of the key design elements of the devices was developed to ease the comparison of the various approaches to building them. This framework includes an analysis of the trends in portability, safety features, user intent detection methods, actuation systems, total DOF, number of independent actuators, device weight, evaluation metrics, and modes of rehabilitation. In this study, a total of 62 articles representing 44 unique devices were identified and summarized according to the framework we developed to compare different design aspects. By far, the most common type of device was that which used a pneumatic actuator to guide finger flexion/extension. However, the remainder of our framework elements yielded more heterogeneous results. Consequently, those results are summarized and the advantages and disadvantages of many design choices as well as their rationales were highlighted. The past 3 years has seen a rapid increase in the development of soft robotic

Safety implications of a graphite oxidation accident in the compact ignition tokamak device

International Nuclear Information System (INIS)

Merrill, B.J.; O'Brien, M.H.

1989-01-01

This paper addresses the possible safety consequences of an air ingress accident for the Compact Ignition Tokamak (CIT) device. An experimental program was undertaken to determine oxidation rates of four nuclear grade graphites in air at temperatures ranging from 800 to 1800 C and flow velocities from 3 to 7 m/s. On the basis of these test results, an analytic model was developed to assess the extent of first wall/divertor protective tile oxidation and the amount of energy released from this oxidation. For CIT, a significant restriction to vacuum vessel air inflow will be provided by the air seals and walls of the surrounding test cells. Under these conditions, the graphite oxidation reaction inside the vacuum vessel will become oxygen starved within minutes of the onset of this event. Since significant oxidation rates were not achieved, the heat release did not elevate structural temperatures to levels of concern with regard to activated material release. 7 refs., 9 figs

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

Science.gov (United States)

Bohnet-Joschko, Sabine; Zippel, Claus; Siebert, Hartmut

2015-01-01

The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment. Copyright © 2015. Published by Elsevier GmbH.

Safety in the Internet

Directory of Open Access Journals (Sweden)

Semenko T.V.

2016-11-01

Full Text Available the modern world is the world of computer technology, and the children living in this world feel comfortable in it, they master the computer, mobile devices, new-fangled gadgets easily and use them skillfully. However, their knowledge of the safety in the Internet lags behind their ability to develop new devices. The number of the Internet users is increased every year, so the problem of children safety in the Internet is very urgent. It is necessary for parents, educators and teachers to conduct explanatory conversations and activities for explanation and consolidation the rules of “The Safe Internet”.

Assisting the older driver : intersection design and in-car devices to improve the safety of the older driver. Proefschrift Rijksuniversiteit Groningen RUG, Groningen.

NARCIS (Netherlands)

Davidse, R.J.

2007-01-01

In this thesis, the main focus was on assistive devices that may improve and prolong the safe mobility of older drivers. Older drivers form a group of road users that is getting more and more attention in road safety research and policy. An important reason for this growing interest is the increase

76 FR 78161 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2011-12-16

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... INFORMATION: The Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake...

78 FR 40635 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-07-08

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

78 FR 36092 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Science.gov (United States)

2013-06-17

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

The nuclear fuel cycle including essential aspects of safety

International Nuclear Information System (INIS)

Warnemuende, R.; May, H.

1978-11-01

When judging nuclear energy not only the reactor but also the whole fuel cycle is of importance. The fuel cycle consists of the supply, i.e. the process from uranium ore to the insertion of fuel elements into the reactor and the waste management, the removal of fuel elements from the reactor and the final storage of radioactive waste. The different stages of the nuclear fuel cycle are well known with regard to their technical difficulties, their problems of industrial safety and pollution. Although it is possible to compare them qualitatively, they still differ partly to a considerable extent, from a quantitative point of view. However, the fact that technical solutions are available for all kinds of tasks can be stated. It is significant for the Federal Republic of Germany that all essential preparatory work for closing the nuclear fuel cycle has been carried out and that safety problems will no longer be in the way of the large-scale realization of uranium enrichment, reprocessing of nuclear fuels and final storage of radioactive waste. Further research and development activities will serve its technical and economic optimization. (orig.) [de

Overview of fusion reactor safety

International Nuclear Information System (INIS)

Cohen, S.; Crocker, J.G.

1981-01-01

Use of deuterium-tritium burning fusion reactors requires examination of several major safety and environmental issues: (1) tritium inventory control, (2) neutron activation of structural materials, fluid streams and reactor hall environment, (3) release of radioactivity from energy sources including lithium spill reactions, superconducting magnet stored energy release, and plasma disruptions, (4) high magnetic and electromagnetic fields associated with fusion reactor superconducting magnets and radio frequency heating devices, and (5) handling and disposal of radioactive waste. Early recognition of potential safety problems with fusion reactors provides the opportunity for improvement in design and materials to eliminate or greatly reduce these problems. With an early start in this endeavor, fusion should be among the lower risk technologies for generation of commercial electrical power

Detection of fecal contamination on beef meat surfaces using handheld fluorescence imaging device (HFID)

Science.gov (United States)

Current meat inspection in slaughter plants, for food safety and quality attributes including potential fecal contamination, is conducted through by visual examination human inspectors. A handheld fluorescence-based imaging device (HFID) was developed to be an assistive tool for human inspectors by ...

Using Mobile Devices in Nursing Education.

Science.gov (United States)

Day-Black, Crystal; Merrill, Earlene B

2015-01-01

The use of mobile device technology in nursing education is growing. These devices are becoming more important in the health care environment with an advantage of providing a compendium of drug, nursing procedures and treatments, and disease information to nursing students. Senior baccalaureate nursing students traditionally are prohibited from medication administration during psychiatric-mental health clinical rotations, but they are required to participate in simulated medication discussions and administration experiences. The incorporation of this mobile device technology to augment clinical learning experiences has advantages including potential reduction of medication errors, and improved patient safety during students' clinical rotation. The purpose of this project is to explain how the mobile device (iPod Touch, 4th generation wireless media player) may be used to enhance and augment comprehensive nursing care in a psychiatric-mental health clinical setting. Thirty-four (34) baccalaureate senior nursing students enrolled in a clinical psychiatric-mental nursing course at a mid-Atlantic public university school of nursing were used. Each student was provided a loaner mobile device with appropriate software and the necessary training. Data were collected on the student's ability to simulate medication administration to a psychiatric-mental health client. Surveys were administered before distribution, at mid-point and at the end of two (2) seven week semesters.

Texas curve margin of safety.

Science.gov (United States)

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

30 CFR 57.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 57.19006 Section 57.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 57.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

30 CFR 56.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 56.19006 Section 56.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 56.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

Overview of Robotic Devices for Nursing Care Project.

Science.gov (United States)

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

Science.gov (United States)

Doyle, Brendan J; Godfrey, Michael J; Lennon, Ryan J; Ryan, James L; Bresnahan, John F; Rihal, Charanjit S; Ting, Henry H

2007-02-01

The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications. (c) 2006 Wiley-Liss, Inc.

Cybersecurity for Connected Diabetes Devices.

Science.gov (United States)

Klonoff, David C

2015-04-16

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. © 2015 Diabetes Technology Society.

How can cardiothoracic and vascular medical devices stay in the market?

Science.gov (United States)

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Safety valve including a hydraulic brake and hydraulic brake that could be fitted into a valve

International Nuclear Information System (INIS)

Chabat-Courrede, Jean.

1981-01-01

Making of a safety valve that can be fitted to a containment vessel filled with a non compressible fluid, such as the water system of a nuclear power station. It includes a hydraulic brake located between the valve and the elastic means, close to the valve which completely suppresses the high frequency oscillations of the equipment [fr

The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand

International Nuclear Information System (INIS)

Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R.

2006-01-01

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines

Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

Science.gov (United States)

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Use of consumer wireless devices by South Africans with severe communication disability.

Science.gov (United States)

Bornman, Juan; Bryen, Diane Nelson; Moolman, Enid; Morris, John

2016-01-01

Advancements in wireless technology (e.g. cell phones and tablets) have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC) technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3%) needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends), for leisure activities (e.g. listening to music, watching videos, playing games), and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance). These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population.

Practical microwave electron devices

CERN Document Server

Meurant, Gerard

2013-01-01

Practical Microwave Electron Devices provides an understanding of microwave electron devices and their applications. All areas of microwave electron devices are covered. These include microwave solid-state devices, including popular microwave transistors and both passive and active diodes; quantum electron devices; thermionic devices (including relativistic thermionic devices); and ferrimagnetic electron devices. The design of each of these devices is discussed as well as their applications, including oscillation, amplification, switching, modulation, demodulation, and parametric interactions.

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Science.gov (United States)

2013-05-10

... DEPARTMENT OF LABOR Mine Safety and Health Administration Coal Mine Dust Sampling Devices; Correction AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: On April 30, 2013, Mine Safety and Health Administration (MSHA) published a notice in the Federal Register...

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

Science.gov (United States)

Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J

2015-05-01

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

Science.gov (United States)

Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore

2015-10-01

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal). © The Author(s) 2015.

Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

Science.gov (United States)

2014-07-03

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Assistive devices alter gait patterns in Parkinson disease: advantages of the four-wheeled walker.

Science.gov (United States)

Kegelmeyer, Deb A; Parthasarathy, Sowmya; Kostyk, Sandra K; White, Susan E; Kloos, Anne D

2013-05-01

Gait abnormalities are a hallmark of Parkinson's disease (PD) and contribute to fall risk. Therapy and exercise are often encouraged to increase mobility and decrease falls. As disease symptoms progress, assistive devices are often prescribed. There are no guidelines for choosing appropriate ambulatory devices. This unique study systematically examined the impact of a broad range of assistive devices on gait measures during walking in both a straight path and around obstacles in individuals with PD. Quantitative gait measures, including velocity, stride length, percent swing and double support time, and coefficients of variation were assessed in 27 individuals with PD with or without one of six different devices including canes, standard and wheeled walkers (two, four or U-Step). Data were collected using the GAITRite and on a figure-of-eight course. All devices, with the exception of four-wheeled and U-Step walkers significantly decreased gait velocity. The four-wheeled walker resulted in less variability in gait measures and had less impact on spontaneous unassisted gait patterns. The U-Step walker exhibited the highest variability across all parameters followed by the two-wheeled and standard walkers. Higher variability has been correlated with increased falls. Though subjects performed better on a figure-of-eight course using either the four-wheeled or the U-Step walker, the four-wheeled walker resulted in the most consistent improvement in overall gait variables. Laser light use on a U-Step walker did not improve gait measures or safety in figure-of-eight compared to other devices. Of the devices tested, the four-wheeled-walker offered the most consistent advantages for improving mobility and safety. Copyright © 2012 Elsevier B.V. All rights reserved.

Time temperature indicators as devices intelligent packaging

Directory of Open Access Journals (Sweden)

Adriana Pavelková

2013-01-01

Full Text Available Food packaging is an important part of food production. Temperature is a one of crucial factor which affecting the quality and safety of food products during distribution, transport and storage. The one way of control of food quality and safety is the application of new packaging systems, which also include the intelligent or smart packaging. Intelligent packaging is a packaging system using different indicators for monitoring the conditions of production, but in particular the conditions during transport and storage. Among these indicators include the time-temperature indicators to monitor changes in temperature, which is exposed the product and to inform consumers about the potential risks associated with consumption of these products. Time temperature indicators are devices that show an irreversible change in a physical characteristic, usually color or shape, in response to temperature history. Some are designed to monitor the evolution of temperature with time along the distribution chain and others are designed to be used in the consumer packages.

Safeguards of basic protection devices, high-protection devices, full-protection devices and school X-ray devices. Guideline for manufacturer and evaluating experts, rev. 1.0; Sicherheitsvorrichtungen von Basisschutzgeraeten, Hochschutzgeraeten, Vollschutzgeraeten und Schulroentgeneinrichtungen. Anforderungen fuer die Bauartpruefung nach der Roentgenverordnung. Leitfaden fuer Hersteller und Gutachter Rev. 1.0

Energy Technology Data Exchange (ETDEWEB)

Dombrowski, Harald; Grottker, Ulrich; Pullner, Bjoern; Roettger, Annette; Zwiener, Roland

2017-07-15

This report describes the PTB requirements for engineered safeguards of basic-protection devices, high-protection devices, full-protection devices and school X-ray devices within the framework of type tests according to the German X-ray Ordinance. It contains detailed requirements for the hard- and software to ensure the required safety level. Especially manufacturers and evaluators of such X-ray tube assemblies are addressed.

The Ex Hoc Infrastructure - Enhancing Traffic Safety through LIfe WArning Systems

DEFF Research Database (Denmark)

Hansen, Klaus Marius; Kristensen, Lars Michael; Eskildsen, Toke

2004-01-01

New pervasive computing technologies for sensing and communication open up novel possibilities for enhancing traffic safety. We are currently designing and implementing the Ex Hoc infrastructure framework for communication among mobile and stationary units including vehicles. The infrastructure...... will connect sensing devices on vehicles with sensing devices on other vehicles and with stationary communication units placed alongside roads. The current application of Ex Hoc is to enable the collection and dissemination of information on road condition through LIfe Warning Systems (LIWAS) units....

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Science.gov (United States)

Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

2016-12-01

Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

Fast-acting nuclear reactor control device

International Nuclear Information System (INIS)

Kotlyar, O.M.; West, P.B.

1993-01-01

A fast-acting nuclear reactor control device is described for controlling a safety control rod within the core of a nuclear reactor, the reactor controlled by a reactor control system, the device comprising: a safety control rod drive shaft and an electromagnetic clutch co-axial with the drive shaft operatively connected to the safety control rod for driving and positioning the safety control rod within or without the reactor core during reactor operation, the safety rod being oriented in a substantially vertical position to allow the rod to fall into the reactor core under the influence of gravity during shutdown of the reactor; the safety control rod drive shaft further operatively connected to a hydraulic pump such that operation of the drive shaft simultaneously drives and positions the safety control rod and operates the hydraulic pump such that a hydraulic fluid is forced into an accumulator, filling the accumulator with oil for the storage and supply of primary potential energy for safety control rod insertion such that the release of potential energy in the accumulator causes hydraulic fluid to flow through the hydraulic pump, converting the hydraulic pump to a hydraulic motor having speed and power capable of full length insertion and high speed driving of the safety control rod into the reactor core; a solenoid valve interposed between the hydraulic pump and the accumulator, said solenoid valve being a normally open valve, actuated to close when the safety control rod is out of the reactor during reactor operation; and further wherein said solenoid opens in response to a signal from the reactor control system calling for shutdown of the reactor and rapid insertion of the safety control rod into the reactor core, such that the opening of the solenoid releases the potential energy in the accumulator to place the safety control rod in a safe shutdown position

Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

NARCIS (Netherlands)

Dorr, H.G.; Zabransky, S.; Keller, E.; Otten, B.J.; Partsch, C.J.; Nyman, L.; Gillespie, B.K.; Lester, N.R.; Wilson, A.M.; Hyren, C.; Kuijck, M.A. van; Schuld, P.; Schoenfeld, S.L.

2003-01-01

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of

Ordinance on the Implementation of Atomic Safety and Radiation Protection

International Nuclear Information System (INIS)

1984-01-01

In execution of the new Atomic Energy Act the Ordinance on the Implementation of Atomic Safety and Radiation Protection was put into force on 1 February 1985. It takes into account all forms of peaceful nuclear energy and ionizing radiation uses in nuclear installations, irradiation facilities and devices in research, industries, and health services, and in radioactive isotope production and laboratories. It covers all aspects of safety and protection and defines atomic safety as nuclear safety and nuclear safeguards and physical protection of nuclear materials and facilities, whereas radiation protection includes the total of requirements, measures, means and methods necessary to protect man and the environment from the detrimental effects of ionizing radiation. It has been based on ICRP Recommendation No. 26 and the IAEA's Basic Safety Standards and supersedes the Radiation Protection Ordinance of 1969

Radiation safety in X-ray facilities

International Nuclear Information System (INIS)

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2

Radiation safety in X-ray facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2.

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review.

Science.gov (United States)

Bocan, Kara N; Sejdić, Ervin

2016-03-18

Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review

Directory of Open Access Journals (Sweden)

Kara N. Bocan

2016-03-01

Full Text Available Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters and variability (changes over time. Current strategies in adaptive (or tunable systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

Science.gov (United States)

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

Science.gov (United States)

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

A knee-mounted biomechanical energy harvester with enhanced efficiency and safety

Science.gov (United States)

Chen, Chao; Chau, Li Yin; Liao, Wei-Hsin

2017-06-01

Energy harvesting is becoming a major limiting issue for many portable devices. When undertaking any activity, the human body generates a significant amount of biomechanical energy, which can be collected by means of a portable energy harvester. This energy provides a method of powering portable devices such as prosthetic limbs. In this paper, a knee-mounted energy harvester with enhanced efficiency and safety is proposed and developed to convert mechanical energy into electricity during human motion. This device can change the bi-directional knee input into uni-directional rotation for an electromagnetic generator using a specially designed transmission system. Without the constraint of induced impact on the human body, this device can harvest biomechanical energy from both knee flexion and extension, improving the harvesting efficiency over previous single-direction energy harvesters. It can also provide protection from device malfunction, and increase the safety of current biomechanical energy harvesters. A highly compact and light prototype is developed taking into account human kinematics. The biomechanical energy harvesting system is also modeled and analyzed. The prototype is tested under different conditions including walking, running and climbing stairs, to evaluate the energy harvesting performance and effect on the human gait. The experimental results show that the prototype can harvest an average power of 3.6 W at 1.5 m s-1 walking speed, which is promising for portable electronic devices.

Medical device risk management and its economic impact

Directory of Open Access Journals (Sweden)

Katerina Krsteva Jakimovska

2013-10-01

Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

ALARA issues arising for safety and security of radiation sources and security screening devices - Summary and recommendations of the 12. European ALARA network workshop

International Nuclear Information System (INIS)

Shaw, P.; Crouail, P.; Drouet, F.

2010-01-01

The 12. European ALARA Network (EAN) workshop on 'ALARA issues arising for safety and security of radiation sources and security screening devices' took place in Vienna (Austria) in October 2009. The aim of that workshop was to consider how the implementation of ALARA3, in terms of planned and emergency situations, involving worker and public doses, is affected by the introduction of security-related measures. In the case of new equipment and procedures, there was also the question of whether exposures arising from security screening devices can be justified and optimised. This workshop consisted of invited oral presentations, which highlighted the main issues, and half of the programme was devoted to discussions within working groups on specific topics. During their discussions, the working groups identified recommendations dealing with the following topics: the implementation of the Code of Conduct and HASS4 - ensuring ALARA; balancing security and safety - how to achieve an optimum solution; the management of an emergency exposure situation from an ALARA perspective; the justification and optimisation of the use of security devices. The objective of this paper is to present the main conclusions and recommendations produced during the workshop. Individual presentations (papers and slides) as well as the reports from the working groups are available to download on the EAN web site (http://www.eu-alara.net). (authors)

Current challenges for clinical trials of cardiovascular medical devices.

Science.gov (United States)

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Safety and efficiency of emergency department interrogation of cardiac devices.

Science.gov (United States)

Neuenschwander, James F; Peacock, W Frank; Migeed, Madgy; Hunter, Sara A; Daughtery, John C; McCleese, Ian C; Hiestand, Brian C

2016-12-01

Patients with implanted cardiac devices may wait extended periods for interrogation in emergency departments (EDs). Our purpose was to determine if device interrogation could be done safely and faster by ED staff. Prospective randomized, standard therapy controlled, trial of ED staff device interrogation vs. standard process (SP), with 30-day follow-up. Eligibility criteria: ED presentation with a self-report of a potential device related complaint, with signed informed consent. SP interrogation was by company representative or hospital employee. Of 60 patients, 42 (70%) were male, all were white, with a median (interquartile range) age of 71 (64 to 82) years. No patient was lost to follow up. Of all patients, 32 (53%) were enrolled during business hours. The overall median (interquartile range) ED vs. SP time to interrogation was 98.5 (40 to 260) vs. 166.5 (64 to 412) minutes (P=0.013). While ED and SP interrogation times were similar during business hours, 102 (59 to 138) vs. 105 (64 to 172) minutes (P=0.62), ED interrogation times were shorter vs. SP during non-business hours; 97 (60 to 126) vs. 225 (144 to 412) minutes, P=0.002, respectively. There was no difference in ED length of stay between the ED and SP interrogation, 249 (153 to 390) vs. 246 (143 to 333) minutes (P=0.71), regardless of time of presentation. No patient in any cohort suffered an unplanned medical contact or post-discharge adverse device related event. ED staff cardiac device interrogations are faster, and with similar 30-day outcomes, as compared to SP.

Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.

Science.gov (United States)

Fistonić, Ivan; Sorta Bilajac Turina, Iva; Fistonić, Nikola; Marton, Ingrid

2016-03-01

To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity. This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS). An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction. © 2016 Wiley Periodicals, Inc.

Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine.

Science.gov (United States)

Kaplan, Aaron V; Harvey, Elisa D; Kuntz, Richard E; Shiran, Hadas; Robb, John F; Fitzgerald, Peter

2005-11-01

The Second Dartmouth Device Development Symposium held in October 2004 brought together leaders from the medical device community, including clinical investigators, senior representatives from the US Food and Drug Administration, large and small device manufacturers, and representatives from the financial community to examine difficult issues confronting device development. The role of the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in the development of new cardiovascular devices was discussed in this forum. The HUD/HDE pathway was created by Congress to facilitate the availability of medical devices for "orphan" indications, ie, those affecting HDEs have been granted (23 devices, 6 diagnostic tests). As the costs to gain regulatory approval for commonly used devices increase, companies often seek alternative ways to gain market access, including the HUD/HDE pathway. For a given device, there may be multiple legitimate and distinct indications, including indications that meet the HUD criteria. Companies must choose how and when to pursue each of these indications. The consensus of symposium participants was for the HUD/HDE pathway to be reserved for true orphan indications and not be viewed strategically as part of the clinical development plan to access a large market.

User interface design in safety parameter display systems

International Nuclear Information System (INIS)

Schultz, E.E. Jr.; Johnson, G.L.

1988-01-01

The extensive installation of computerized safety Parameter Display Systems (SPDSs) in nuclear power plants since the Three-Mile Island accident has enhanced plant safety. It has also raised new issues of how best to ensure an effective interface between human operators and the plant via computer systems. New developments in interface technologies since the current generation of SPDSs was installed can contribute to improving display interfaces. These technologies include new input devices, three-dimensional displays, delay indicators, and auditory displays. Examples of how they might be applied to improve current SPDSs are given. These examples illustrate how the new use interface technology could be applied to future nuclear plant displays

Use of consumer wireless devices by South Africans with severe communication disability

Directory of Open Access Journals (Sweden)

Juan Bornman

2016-02-01

Full Text Available Background: Advancements in wireless technology (e.g. cell phones and tablets have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. Objectives: To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Method: Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. Results: All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3% needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends, for leisure activities (e.g. listening to music, watching videos, playing games, and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance. Conclusion: These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population.

A History of the Sonocare CST-100: The First FDA-approved HIFU Device

Science.gov (United States)

Muratore, Robert

2006-05-01

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.

Science.gov (United States)

Gold, Michael H; Biron, Julie; Levi, Liora; Sensing, Whitney

2017-03-01

The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation. This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance. Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end. Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles. © 2016 Wiley Periodicals, Inc.

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up.

Science.gov (United States)

Kühn, Anna Luisa; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Rex, David E; Massari, Francesco; Tamura, Takamitsu; Howk, Mary; Brooks, Christopher; L'Heureux, Jenna; Gounis, Matthew J; Wakhloo, Ajay K; Puri, Ajit S

2017-12-01

Evaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs). Retrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months' follow-up and assessed intimal hyperplasia at follow-up. Twenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months' follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months' follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs. Treatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Safety Assessment of Wearing the AN/PVS-14 Monocular Night Vision Device (MNVD) and AN/AVS-6 Aviators' Night Vision Imaging System (ANVIS) During 5-Ton and HMMWV Night Driving

National Research Council Canada - National Science Library

Redden, Elizabeth

2002-01-01

.... The Communications-Electronics Command Directorate for Safety Risk Management, Fort Monmouth, New Jersey, will use the results of the assessment to determine the suitability of both devices for driving...

[Hygienic relevance of devices for indoor air treatment].

Science.gov (United States)

Wegner, J

1982-01-01

Shortcomings regarding design, construction, operation (including emissions), maintenance/repair and control of buildings with rooms for the accommodation of persons may be the reason to install air conditioning devices. According to manufacturers' data, such devices may be applied for various purposes, e.g. the creation of a defined air temperature or humidity, an increase of the supply of outdoor air, the cleaning and deodorization of indoor air or the alteration of the so-called electric climate of a room. The hygienic health evaluation of the different types of air conditioning devices should establish whether --there are aspects of health necessitating alterations of the microclimate of a room; --such alterations could be brought about in a more economic way by purely constructional or individual measures; --the function of individual apparatuses could be accomplished in a better way by replacing them by a larger device serving several rooms; --the operation of such devices may produce adverse health effects such as nuisance by noise, formation of undesirable gases (ozone), danger owing to non-adherence to electric safety rules; --there will be no damage to rooms and furniture, e.g. by water droplets. A look at a number of commercially available devices shows that they are generally dispensable. There are, however, special rare cases where the use of such devices may result in an improvement of the quality of indoor environments.

An Assessment of Hazards Caused by Electromagnetic Interaction on Humans Present near Short-Wave Physiotherapeutic Devices of Various Types Including Hazards for Users of Electronic Active Implantable Medical Devices (AIMD

Directory of Open Access Journals (Sweden)

Jolanta Karpowicz

2013-01-01

Full Text Available Leakage of electromagnetic fields (EMF from short-wave radiofrequency physiotherapeutic diathermies (SWDs may cause health and safety hazards affecting unintentionally exposed workers (W or general public (GP members (assisting patient exposed during treatment or presenting there for other reasons. Increasing use of electronic active implantable medical devices (AIMDs, by patients, attendants, and workers, needs attention because dysfunctions of these devices may be caused by electromagnetic interactions. EMF emitted by 12 SWDs (with capacitive or inductive applicators were assessed following international guidelines on protection against EMF exposure (International Commission on Nonionizing Radiation Protection for GP and W, new European directive 2013/35/EU for W, European Recommendation for GP, and European Standard EN 50527-1 for AIMD users. Direct EMF hazards for humans near inductive applicators were identified at a distance not exceeding 45 cm for W or 62 cm for GP, but for AIMD users up to 90 cm (twice longer than that for W and 50% longer than that for GP because EMF is pulsed modulated. Near capacitive applicators emitting continuous wave, the corresponding distances were: 120 cm for W or 150 cm for both—GP or AIMD users. This assessment does not cover patients who undergo SWD treatment (but it is usually recommended for AIMD users to be careful with EMF treatment.

Device including a contact detector

DEFF Research Database (Denmark)

2011-01-01

arms (12) may extend from the supporting body in co-planar relationship with the first surface. The plurality of cantilever arms (12) may extend substantially parallel to each other and each of the plurality of cantilever arms (12) may include an electrical conductive tip for contacting the area......The present invention relates to a probe for determining an electrical property of an area of a surface of a test sample, the probe is intended to be in a specific orientation relative to the test sample. The probe may comprise a supporting body defining a first surface. A plurality of cantilever...... of the test sample by movement of the probe relative to the surface of the test sample into the specific orientation.; The probe may further comprise a contact detector (14) extending from the supporting body arranged so as to contact the surface of the test sample prior to any one of the plurality...

Safety valve opening and closing operation monitor

International Nuclear Information System (INIS)

Kodama, Kunio; Takeshima, Ikuo; Takahashi, Kiyokazu.

1981-01-01

Purpose: To enable the detection of the closing of a safety valve when the internal pressure in a BWR type reactor is a value which will close the safety valve, by inputting signals from a pressure detecting device mounted directly at a reactor vessel and a safety valve discharge pressure detecting device to an AND logic circuit. Constitution: A safety valve monitor is formed of a pressure switch mounted at a reactor pressure vessel, a pressure switch mounted at the exhaust pipe of the escape safety valve and a logic circuit and the lide. When the input pressure of the safety valve is raised so that the valve and the pressure switch mounted at the exhaust pipe are operated, an alarm is indicated, and the operation of the pressure switch mounted at a pressure vessel is eliminated. If the safety valve is not reclosed when the vessel pressure is decreased lower than the pressure at which it is to be reclosed after the safety valve is operated, an alarm is generated by the logic circuit since both the pressure switches are operated. (Sekiya, K.)

Formalising Java safety -- An overview

NARCIS (Netherlands)

Hartel, Pieter H.; Domingo-Ferrer, J; Chan, D.; Watson, A.

We review the existing literature on Java safety, emphasizing formal approaches, and the impact of Java safety on small footprint devices such as smart cards. The conclusion is that while a lot of good work has been done, a more concerted effort is needed to build a coherent set of machine readable

Ageing study of the engineered safety features actuation system of the Loviisa NPP

International Nuclear Information System (INIS)

Simola, K.; Maskuniitty, M.

1995-06-01

An ageing study of the engineered safety features actuation system of the Loviisa nuclear power plant has been performed. The operating experience, including failure and maintenance histories of analog measuring devices, logics for safety signal formation and individual control electronics of pumps and valves, has been collected and analysed. The safety importance of system components has been studied with a fault tree analysis of a selected safety function. Based on the results of the analysis of operating experiences and the fault tree analysis, some components were selected for deeper analyses. According to the operating experience, the amount of failures in the Loviisa plant safety system has been low and no increasing trend in the failure history can yet be observed. Only a few failures had prohibited the propagation of the safety signal, mostly the failures have caused a false alarm. The failures reported have concerned mainly limit signal units, transmitters, and priority units. According to the fault tree analysis of one safety function, the most important components of this subsystem are individual control units and pulse/DC converters. Failure modes and effect analyses were performed for priority and individual control unit, limit signal unit and comparator and pulse/DC converter in order to identify the critical failure modes of these devices. (orig.) (15 refs., 26 figs., 9 tabs.)

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

Science.gov (United States)

Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

2017-12-01

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

Study of an automatized experimental device for the irradiation of a radioactive target

International Nuclear Information System (INIS)

Claverie, G.

1996-01-01

In order to solve the enigma of solar neutrinos, a team of physicians of the nuclear research center of Bordeaux-Gradignan and of the center of nuclear spectroscopy and mass spectroscopy of Orsay (France) decided to measure again the cross section of the beryllium-proton nuclear reaction at the lowest possible energies. This measurement requires the design of an automatized experimental device to irradiate in a specific way a beryllium target with an accelerated proton beam. The aim of this work is the study of such a device for an energy range of 800 to 300 KeV. This device comprises a particle multi-detector and a shutter for the irradiation of the target and the counting of the reaction products according to a programmable time sequence. The advantage of this setup is to allow an important bombardment of the target and to ensure its cooling. This device is automatically controlled thanks to a micro-controller, actuators (step motors and electrostatic deflector). It includes some beam diagnosis elements controlled by step motors and a target temperature monitoring system controlling a safety valve. The management of the experiment cell vacuum has led to the design of a vacuum monitor allowing the precise follow up of the vacuum and the control of the safety valves of the device. The nuclear instrumentation necessary to be implemented for this measurement is also presented. (J.S.)

Volume 8 No. 4 2008 December 2008 427 THE USE OF SAFETY ...

African Journals Online (AJOL)

the knowledge and use of safety devices and methods attached to the proper application of the ... farmers aware of the high risk due to inadequate education, training and safety devices in ..... delivery in Southwestern Nigeria. Ph. D Thesis.

Regulatory issues on using programmable logic device in nuclear power plants

International Nuclear Information System (INIS)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H.

2012-01-01

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards

Regulatory issues on using programmable logic device in nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-10-15

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards.

Locking device of a guiding ring on a plate including an aperture; application to guide tube of nuclear reactor

International Nuclear Information System (INIS)

Cauquelin, C.; Poitrenaud, P.

1987-01-01

To make easy to take to pieces a guide tube, by a simple tool, this device includes a guide ring. This guide ring aligned with an aperture in a plate has a tubular support fixed to the plate and coaxial with the aperture and lock the guide tube by rotation [fr

Radiation and nuclear safety included in the environmental health programme

International Nuclear Information System (INIS)

Salomaa, S.

1996-01-01

Finland is currently preparing a national environmental health programme, the objective of which is to chart the main environmental health problems in Finland, to identify means for securing a healthy environment, and to draw up a practical action programme for preventing and rectifying problems pertaining to environmental health. Radiation and nuclear safety form an essential part of preventive health care. The action programme is based on decisions and programmes approved at the WHO Conference on the Environment and Health, held in Helsinki in June 1994. In addition to the state of the Finnish environment and the health of the Finnish population, the programme addresses the relevant international issues, in particular in areas adjacent to Finland. The Committee on Environmental Health is expected to complete its work by the end of the year. A wide range of representatives from various branches of administration have contributed to the preparation of the programme. Besides physical, biological and chemical factors, the environmental factors affecting health also include the physical environment and the psychological, social and aesthetic features of the environment. Similarly, environmental factors that have an impact on the health of present or future generations, on the essential preconditions of life and on the quality of life are investigated. The serious risk to nature caused by human actions is also considered as a potential risk to human health. (orig.)

Dynamic 2D-barcodes for multi-device Web session migration including mobile phones

DEFF Research Database (Denmark)

Alapetite, Alexandre

2010-01-01

This article introduces a novel Web architecture that supports session migration in multi-device Web applications, particularly the case when a user starts a Web session on a computer and wishes to continue on a mobile phone. The proposed solution for transferring the needed session identifiers...... across devices is to dynamically generate pictures of 2D-barcodes containing a Web address and a session ID in an encoded form. 2D-barcodes are a cheap, fast and robust approach to the problem. They are widely known and used in Japan, and are spreading in other countries. Variations on the topic...

Oversight and Influencing of Licensee Leadership and Management for Safety, Including Safety Culture - Regulatory Approaches and Methods. Proceedings of an NEA/IAEA Workshop, Chester, United Kingdom, 26-28 September 2011

International Nuclear Information System (INIS)

2012-01-01

Both regulators and the nuclear industry recognise the need for licensees to develop a strong, positive safety culture to support successful and sustainable nuclear safety performance. A number of reports have been issued by the IAEA and the NEA on the role of the regulator in relation to oversight of safety culture (References 1 to 5). There has been less clarity on how this should be achieved - in particular, with regard to strategies and practical approaches for maintaining oversight of, and influencing, those facets of licensee leadership and management which have a profound influence on safety culture. In recognition of this, the CSNI Working Group on Human and Organisational Factors (WGHOF), together with the CNRA Working Group on Inspection Practices (WGIP) and the IAEA, organised a workshop in Chester, United Kingdom, in May 2007 to provide a forum for gathering and sharing international experience, including good practices and learning points. The results of the workshop are reported in Reference 6. Workshop participants agreed that, in view of the rapidly developing approaches in this area, it would be sensible to hold a further workshop ('Chester 2') in 3-5 years in order to discuss how regulatory approaches have moved on and to share lessons learned from their application. In 2010, the WGIP hosted a workshop which included regulatory approaches for the assessment of licensee safety culture as a discussion topic. The outputs of the workshop included a list of commendable practices for monitoring and evaluating licensee safety culture (Reference 7). The 'Chester 2' workshop took place in September 2011. This report sets out the findings of the workshop, organised by the UK Office for Nuclear Regulation (ONR) on behalf of the CSNI/WGHOF and the IAEA. The workshop was attended by over 40 representatives of nuclear regulatory bodies and licensees from 15 countries plus IAEA and NEA. The workshop featured keynote papers on learning from major events, and from

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Science.gov (United States)

2012-02-14

... premarket notification, prior to marketing the device, which contains information about the endovascular...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

Modulation Techniques for Biomedical Implanted Devices and Their Challenges

Directory of Open Access Journals (Sweden)

Salina A. Samad

2011-12-01

Full Text Available Implanted medical devices are very important electronic devices because of their usefulness in monitoring and diagnosis, safety and comfort for patients. Since 1950s, remarkable efforts have been undertaken for the development of bio-medical implanted and wireless telemetry bio-devices. Issues such as design of suitable modulation methods, use of power and monitoring devices, transfer energy from external to internal parts with high efficiency and high data rates and low power consumption all play an important role in the development of implantable devices. This paper provides a comprehensive survey on various modulation and demodulation techniques such as amplitude shift keying (ASK, frequency shift keying (FSK and phase shift keying (PSK of the existing wireless implanted devices. The details of specifications, including carrier frequency, CMOS size, data rate, power consumption and supply, chip area and application of the various modulation schemes of the implanted devices are investigated and summarized in the tables along with the corresponding key references. Current challenges and problems of the typical modulation applications of these technologies are illustrated with a brief suggestions and discussion for the progress of implanted device research in the future. It is observed that the prime requisites for the good quality of the implanted devices and their reliability are the energy transformation, data rate, CMOS size, power consumption and operation frequency. This review will hopefully lead to increasing efforts towards the development of low powered, high efficient, high data rate and reliable implanted devices.

Clinical efficacy and safety evaluation of a novel fractional unipolar radiofrequency device on facial tightening: A preliminary report.

Science.gov (United States)

Suh, Dong Hye; Byun, Eun Jung; Lee, Sang Jun; Song, Kye Yong; Kim, Hei Sung

2017-06-01

Previous studies have shown that radiofrequency (RF) energy is safe and effective for improving skin laxity. Unlike monopolar and bipolar devices, little has been studied with the unipolar hand piece. We sought to evaluate the safety and efficacy of a novel fractional unipolar RF device on facial tightening. This was a retrospective, single-center study of 14 subjects with age-related facial laxity who underwent five sessions of fractional unipolar RF at an interval of 2 weeks, and then followed-up for 3 months. Standardized photos were taken at baseline and at 3-months follow-up, and were assessed by two independent dermatologists using a 4-point scale (0=no improvement, 1=mild improvement, 2=moderate improvement, 3=significant improvement). Punch biopsies (2 mm) were performed and a questionnaire was used to evaluate the patient's satisfaction and the incidence of adverse reactions. Fourteen subjects with mild to moderate age-related facial laxity were included in the study. The mean age of the subjects was 49.7 years (range 32-80). 35.7% of the subjects showed significant improvement, 50% moderate improvement, and 14.3% slight improvement of facial laxity in their follow-up photos. About 85.7% of the patients replied that they were either greatly satisfied or satisfied with the results at 3-months follow-up. Skin biopsies revealed an increase in collagen in the dermis. None of the subjects experienced any serious adverse events during or after the procedure. Our findings suggest that fractional Unipolar RF can be safely performed on the face and is effective in skin tightening. It has a great advantage over other forms of RF by being entirely painless. © 2017 Wiley Periodicals, Inc.

Monitor for safety engineering facility

International Nuclear Information System (INIS)

Sato, Akira; Kaneda, Mitsunori.

1982-01-01

Purpose: To improve the reactor safety and decrease misoperation upon periodical inspection by instantly obtaining the judgement for the stand-by states in engineering safety facilities of a nuclear power plant. Constitution: Process inputs representing the states of valves, pumps, flowrates or the likes of the facility are gathered into an input device and inputted to a status monitor. The status of the facility inputted to the input device are judged for each of the inputs in a judging section and recognized as a present system stand-by pattern of the system (Valve) to be inspected. While on the other hand, a normal system stand-by pattern previously stored in a memory unit is read out by an instruction from an operator console and judged by comparison with the system stand-by pattern in a comparison section. The results are displayed on a display device. Upon periodical inspection, inspection procedures stored in the memory unit are displayed on the display device by the instruction from the operator console. (Seki, T.)

X-ray safety at the Los Alamos National Laboratory

International Nuclear Information System (INIS)

Gutierrez, J.A.

1986-11-01

An organized and structured safety program for x-ray generating devices was initiated in October, 1979. An X-ray Device Control Office was established to manage the program that currently oversees the activities of 201 x-ray generating devices and to provide SOP reviews, perform shielding calculations, and provide training for both the operators and health physics x-ray device surveyors. The new program also establishes controls for procurement of new equipment, requires the writing of Standard Operating Procedures, requires training for operators and provides routine and non-routine safety inspections of x-ray generating devices. Prior to this program going into effect, the Laboratory had recorded nine documented x-ray related exposure accidents. Since then, there have been none. Program elements and experiences of interest to other x-ray device users are discussed. 3 refs

Norms concerning the programmable automatic control devices

International Nuclear Information System (INIS)

Fourmentraux, G.

1995-01-01

This presentation is a report of the studies carried out by the Work Group on Functioning Safety of Programmable Automatic Control Devices and by the Group for Prevention Studies (GEP) from the CEA. The objective of these groups is to evaluate the methods which could be used to estimate the functioning safety of control and instrumentation systems involved in the Important Elements for Safety (EIS) of the Basic Nuclear Installations (INB) of the CEA, and also to carry out a qualification of automatic control devices. Norms, protocols and tools for the evaluation are presented. The problem comprises two aspects: the evaluation of fault avoidance techniques and the evaluation of fault control techniques used during the conceiving. For the fault avoidance techniques, the quality assurance organization, the environment tests, and the software quality plans are considered. For the fault control techniques, the different available tools and fault injection models are analysed. The results of an analysis carried out with the DEF.I tool from the National Institute for Research and Safety (INRS) are reported. (J.S.). 23 refs

Preliminary Safety Information Document for the Standard MHTGR. Volume 1, (includes latest Amendments)

Energy Technology Data Exchange (ETDEWEB)

None

1986-01-01

With NRC concurrence, the Licensing Plan for the Standard HTGR describes an application program consistent with 10CFR50, Appendix O to support a US Nuclear Regulatory Commission (NRC) review and design certification of an advanced Standard modular High Temperature Gas-Cooled Reactor (MHTGR) design. Consistent with the NRC's Advanced Reactor Policy, the Plan also outlines a series of preapplication activities which have as an objective the early issuance of an NRC Licensability Statement on the Standard MHTGR conceptual design. This Preliminary Safety Information Document (PSID) has been prepared as one of the submittals to the NRC by the US Department of Energy in support of preapplication activities on the Standard MHTGR. Other submittals to be provided include a Probabilistic Risk Assessment, a Regulatory Technology Development Plan, and an Emergency Planning Bases Report.

New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

Science.gov (United States)

Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2015-08-01

Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.

Reactor power control device

International Nuclear Information System (INIS)

Ishii, Yoshihiko; Arita, Setsuo; Miyamoto, Yoshiyuki; Fukazawa, Yukihisa; Ishii, Kazuhiko

1998-01-01

The present invention provides a reactor power control device capable of enhancing an operation efficiency while keeping high reliability and safety in a BWR type nuclear power plant. Namely, the device of the present invention comprises (1) a means for inputting a set value of a generator power and a set value of a reactor power, (2) a means for controlling the reactor power to either smaller one of the reactor power corresponding to the set value of the generator power and the set value of the reactor power. With such procedures, even if the nuclear power plant is set so as to operate it to make the reactor power 100%, when the generator power reaches the upper limit, the reactor power is controlled with a preference given to the upper limit value of the generator power. Accordingly, safety and reliability are not deteriorated. The operation efficiency of the plant can be improved. (I.S.)

Environmental safety issues for semiconductors (research on scarce materials recycling)

International Nuclear Information System (INIS)

Izumi, Shigekazu

2004-01-01

In the 21st century, in the fabrication of various industrial parts, particularly, current and future electronics devices in the semiconductor industry, environmental safety issues should be carefully considered. We coined a new term, environmental safety issues for semiconductors, considering our semiconductor research and technology which include environmental and ecological factors. The main object of this analysis is to address the present situation of environmental safety problems in the semiconductor industry; some of which are: (1) the generation and use of hazardous toxic gases in the crystal growth procedure such as molecular beam epitaxy (MBE) and metalorganic chemical vapor deposition (MOCVD), (2) the generation of industrial toxic wastes in the semiconductor process and (3) scarce materials recycling from wastes in the MBE and MOCVD growth procedure

Reliability evaluation programmable logic devices

International Nuclear Information System (INIS)

Srivani, L.; Murali, N.; Thirugnana Murthy, D.; Satya Murty, S.A.V.

2014-01-01

Programmable Logic Devices (PLD) are widely used as basic building modules in high integrity systems, considering their robust features such as gate density, performance, speed etc. PLDs are used to implement digital design such as bus interface logic, control logic, sequencing logic, glue logic etc. Due to semiconductor evolution, new PLDs with state-of-the-art features are arriving to the market. Since these devices are reliable as per the manufacturer's specification, they were used in the design of safety systems. But due to their reduced market life, the availability of performance data is limited. So evaluating the PLD before deploying in a safety system is very important. This paper presents a survey on the use of PLDs in the nuclear domain and the steps involved in the evaluation of PLD using Quantitative Accelerated Life Testing. (author)

Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

Science.gov (United States)

Ansel, Gary M; Hopkins, L Nelson; Jaff, Michael R; Rubino, Paolo; Bacharach, J Michael; Scheinert, Dierk; Myla, Subbarao; Das, Tony; Cremonesi, Alberto

2010-07-01

The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) 2010 Wiley-Liss, Inc.

Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.

Science.gov (United States)

Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E

2018-02-01

The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Science.gov (United States)

2011-04-14

... looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user...). The special control for this device is the FDA guidance document entitled ``Guidance for Industry and...

Safety balance: Analysis of safety systems

International Nuclear Information System (INIS)

Delage, M.; Giroux, C.

1990-12-01

Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

Development of Necessary Technology for localizing of Nuclear Safety Grade I and C System

International Nuclear Information System (INIS)

Kwon, Kee Choon; Jang, Tong Il; Kim, Jung Tack

2010-08-01

Through KNICS and Nu-Tech 2012, a MMIS(Man-Machine Interface System) package for nuclear plants was localized and is expected to be applied to SUN 1,2 plants. This study is aimed to support the application of the MMIS package including the following technologies that meet strengthened regulation requirements and enhanced utility's performance requirements to nuclear plants. - Dedication to safety-grade computers and real time operating systems - The broadband communication network for safety information - Application of the automatic test for safety systems - Application of programmable logic controllers to nuclear plants - Development strategy for an integrated SW development tool for control device

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

Cybersecurity and the Medical Device Product Development Lifecycle.

Science.gov (United States)

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

Use of computational fluid dynamics codes for safety analysis of nuclear reactor systems, including containment. Summary report of a technical meeting

International Nuclear Information System (INIS)

2003-11-01

Safety analysis is an important tool for justifying the safety of nuclear power plants. Typically, this type of analysis is performed by means of system computer codes with one dimensional approximation for modelling real plant systems. However, in the nuclear area there are issues for which traditional treatment using one dimensional system codes is considered inadequate for modelling local flow and heat transfer phenomena. There is therefore increasing interest in the application of three dimensional computational fluid dynamics (CFD) codes as a supplement to or in combination with system codes. There are a number of both commercial (general purpose) CFD codes as well as special codes for nuclear safety applications available. With further progress in safety analysis techniques, the increasing use of CFD codes for nuclear applications is expected. At present, the main objective with respect to CFD codes is generally to improve confidence in the available analysis tools and to achieve a more reliable approach to safety relevant issues. An exchange of views and experience can facilitate and speed up progress in the implementation of this objective. Both the International Atomic Energy Agency (IAEA) and the Nuclear Energy Agency of the Organisation for Economic Co-operation and Development (OECD/NEA) believed that it would be advantageous to provide a forum for such an exchange. Therefore, within the framework of the Working Group on the Analysis and Management of Accidents of the NEA's Committee on the Safety of Nuclear Installations, the IAEA and the NEA agreed to jointly organize the Technical Meeting on the Use of Computational Fluid Dynamics Codes for Safety Analysis of Reactor Systems, including Containment. The meeting was held in Pisa, Italy, from 11 to 14 November 2002. The publication constitutes the report of the Technical Meeting. It includes short summaries of the presentations that were made and of the discussions as well as conclusions and

ESRS guidelines for software safety reviews. Reference document for the organization and conduct of Engineering Safety Review Services (ESRS) on software important to safety in nuclear power plants

International Nuclear Information System (INIS)

2000-01-01

The IAEA provides safety review services to assist Member States in the application of safety standards and, in particular, to evaluate and facilitate improvements in nuclear power plant safety performance. Complementary to the Operational Safety Review Team (OSART) and the International Regulatory Review Team (IRRT) services are the Engineering Safety Review Services (ESRS), which include reviews of siting, external events and structural safety, design safety, fire safety, ageing management and software safety. Software is of increasing importance to safety in nuclear power plants as the use of computer based equipment and systems, controlled by software, is increasing in new and older plants. Computer based devices are used in both safety related applications (such as process control and monitoring) and safety critical applications (such as reactor protection). Their dependability can only be ensured if a systematic, fully documented and reviewable engineering process is used. The ESRS on software safety are designed to assist a nuclear power plant or a regulatory body of a Member State in the review of documentation relating to the development, application and safety assessment of software embedded in computer based systems important to safety in nuclear power plants. The software safety reviews can be tailored to the specific needs of the requesting organization. Examples of such reviews are: project planning reviews, reviews of specific issues and reviews prior final acceptance. This report gives information on the possible scope of ESRS software safety reviews and guidance on the organization and conduct of the reviews. It is aimed at Member States considering these reviews and IAEA staff and external experts performing the reviews. The ESRS software safety reviews evaluate the degree to which software documents show that the development process and the final product conform to international standards, guidelines and current practices. Recommendations are

Aceptación de los dispositivos de bioseguridad de material corto-punzante en personal de enfermería de un hospital terciario Acceptance of safety devices in nursing staff in general hospital

Directory of Open Access Journals (Sweden)

Lourdes Jiménez Bajo

2009-06-01

Full Text Available El objetivo de este estudio es evaluar la aceptación entre el personal de enfermería de los dispositivos de bioseguridad de material corto-punzante tras 20 meses de su implantación en un hospital terciario y su comparación con los resultados obtenidos en el estudio piloto previo a la implantación. Se realiza estudio descriptivo transversal en 5 servicios del hospital, Nefrología, Medicina Interna, Infecciosas, Unidad de Críticos y Cirugía General antes y tras 20 meses de implantación de los dispositivos. El cuestionario recoge variables como seguridad de usuario, comodidad y sencillez de uso, tiempo de maniobra y seguridad del paciente de cinco dispositivos, agujas intramusculares, agujas subcutáneas, jeringas de gasometría, catéter intravenoso y aguja de diálisis; valoración global de la importancia del uso generalizado de los dispositivos y necesidad de más información/ formación. El 62% considera importantísimo el uso generalizado de dispositivos de seguridad. Tras 20 meses de implantación, la aceptación de los dispositivos entre el personal de enfermería parece mayor, aunque estas diferencias no son estadísticamente significativas. Es necesario aumentar el período de estudio y reforzar las medidas de información-formación entre otras propuestas, ya que contribuyen a su mayor aceptación la frecuencia de utilización y la información/formación recibida.The purpose of this study is asses the acceptance of the safety devices in nursing staff after 20 months of implementation in general hospital and compare the results with pilot study before implementation. A descriptive study was conducted in 5 hospital services: Nephrology, Internal Medicine, Infectous Diseases Service, Intensive Care and General Surgery. The questionnaire includes following variables: user safety, comfort and ease of use, time to maneuver and patient safety of the five devices, intramuscular needle, needle subcutaneous, syringe of gas, intravenous

Industrial Personal Computer based Display for Nuclear Safety System

International Nuclear Information System (INIS)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min

2014-01-01

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view

Industrial Personal Computer based Display for Nuclear Safety System

Energy Technology Data Exchange (ETDEWEB)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min [KEPCO, Youngin (Korea, Republic of)

2014-08-15

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

Science.gov (United States)

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

International Nuclear Information System (INIS)

Green, Michael A.

2005-01-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

Energy Technology Data Exchange (ETDEWEB)

Green, Michael A.

2005-08-20

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Science.gov (United States)

2013-06-12

... necessary to assure the safety and effectiveness of the device. II. Regulatory History of the Device On... petitioner's own history of use, the petitioner's own preclinical testing, and the development of relevant... inclined planes (forward, backward, and lateral); [cir] Demonstration of the ability of the device to...

Home Healthcare Medical Devices: A Checklist

Science.gov (United States)

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

Surgical tools and medical devices

CERN Document Server

Jackson, Mark

2016-01-01

This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...

Microfluidic chip-capillary electrophoresis devices

CERN Document Server

Fung, Ying Sing; Du, Fuying; Guo, Wenpeng; Ma, Tongmei; Nie, Zhou; Sun, Hui; Wu, Ruige; Zhao, Wenfeng

2015-01-01

Capillary electrophoresis (CE) and microfluidic chip (MC) devices are relatively mature technologies, but this book demonstrates how they can be integrated into a single, revolutionary device that can provide on-site analysis of samples when laboratory services are unavailable. By introducing the combination of CE and MC technology, Microfluidic Chip-Capillary Electrophoresis Devices broadens the scope of chemical analysis, particularly in the biomedical, food, and environmental sciences. The book gives an overview of the development of MC and CE technology as well as technology that now allows for the fabrication of MC-CE devices. It describes the operating principles that make integration possible and illustrates some achievements already made by the application of MC-CE devices in hospitals, clinics, food safety, and environmental research. The authors envision further applications for private and public use once the proof-of-concept stage has been passed and obstacles to increased commercialization are ad...

Current Methods Applied to Biomaterials - Characterization Approaches, Safety Assessment and Biological International Standards.

Science.gov (United States)

Oliveira, Justine P R; Ortiz, H Ivan Melendez; Bucio, Emilio; Alves, Patricia Terra; Lima, Mayara Ingrid Sousa; Goulart, Luiz Ricardo; Mathor, Monica B; Varca, Gustavo H C; Lugao, Ademar B

2018-04-10

Safety and biocompatibility assessment of biomaterials are themes of constant concern as advanced materials enter the market as well as products manufactured by new techniques emerge. Within this context, this review provides an up-to-date approach on current methods for the characterization and safety assessment of biomaterials and biomedical devices from a physicalchemical to a biological perspective, including a description of the alternative methods in accordance with current and established international standards. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Vehicle Battery Safety Roadmap Guidance

Energy Technology Data Exchange (ETDEWEB)

Doughty, D. H.

2012-10-01

The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

Independent V and V for Safety Grade I and C System

International Nuclear Information System (INIS)

Lee, Jang Soo; Kwon, Kee Choon; Lee, Dong Young

2010-08-01

Through KNICS and Nu-Tech 2012, a MMIS(Man-Machine Interface System) package for nuclear plants was localized and is expected to be applied to SUN 1,2 plants. This study is aimed to support the application of the MMIS package including the following technologies that meet strengthened regulation requirements and enhanced utility's performance requirements to nuclear plants. - Dedication to real time operating system for safety-grade computers - V and V of the broadband communication network for safety information - Independent V and V for application of programmable logic controllers to nuclear plants - Development strategy for an integrated SW development tool for control devices

Neuro-oncology update: radiation safety and nursing care during interstitial brachytherapy

International Nuclear Information System (INIS)

Randall, T.M.; Drake, D.K.; Sewchand, W.

1987-01-01

Radiation control and safety are major considerations for nursing personnel during the care of patients receiving brachytherapy. Since the theory and practice of radiation applications are not part of the routine curriculum of nursing programs, the education of nurses and other health care professionals in radiation safety procedures is important. Regulatory agencies recommend that an annual safety course be given to all persons frequenting, using, or associated with patients containing radioactive materials. This article presents pertinent aspects of the principles and procedures of radiation safety, the role of personnel dose-monitoring devices, and the value of additional radiation control features, such as a lead cubicle, during interstitial brain implants. One institution's protocol and procedures for the care of high-intensity iridium-192 brain implants are discussed. Preoperative teaching guidelines and nursing interventions included in the protocol focus on radiation control principles

Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial.

Science.gov (United States)

Ross, Sue; Tang, Selphee; Schulz, Jane; Murphy, Magnus; Goncalves, Jose; Kaye, Stephen; Dederer, Lorel; Robert, Magali

2014-12-22

In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life. The sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880). Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research

Safety strategy and safety analysis of nuclear power plants

International Nuclear Information System (INIS)

Franzen, L.F.

1976-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the finding derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant, it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essentail for accident analyses, and the determination of the loads occurring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig.) [de

Medical devices, electronic health records and assuring patient safety : Future challenges?

NARCIS (Netherlands)

Kalkman, Cor J.

2015-01-01

The patient safety movement was triggered by publications showing that modern health care is more unsafe than road travel and that more patients are killed annually by avoidable adverse events than by breast cancer [1]. As a result, an urgent need to improve patient safety has dominated

A scoping review on smart mobile devices and physical strain.

Science.gov (United States)