21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

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

A static induction device manufactured by silicon direct bonding

NASA Astrophysics Data System (ADS)

Chen, Xin'an; Liu, Su; Huang, Qing'an

2004-07-01

It is always a key problem how to improve the gate-source breakdown voltage (VGK) of static induction devices during manufacturing. By using a silicon direct bonding process to replace the high resistivity epitaxy process, a bonding buried gate structure is formed, which is different from an epitaxy buried gate structure. The new structure can improve the gate-source breakdown voltage from the process and the structure. It is shown that the bonding buried gate structure is a promising structure, that can improve the VGK and other performances of devices, by manufacture of a static induction thyristor.

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

...] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility... experience or expertise with nanotechnology. There will be a limited number of round-table participants. FDA...

75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The...

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

PubMed Central

2011-01-01

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often

Reticle variation influence on manufacturing line and wafer device performance

NASA Astrophysics Data System (ADS)

Nistler, John L.; Spurlock, Kyle

1994-01-01

Cost effective manufacturing of devices at 0.5, 0.35 and 0.25μm geometries will be highly dependent on a companys' ability to obtain an economic return on investment. The high capital investment in equipment and facilities, not to mention the related chemical and wafer costs, for producing 200mm silicon wafers requires aspects of wafer processing to be tightly controlled. Reduction in errors and enhanced yield management requires early correction or avoidance of reticle problems. It is becoming increasingly important to recognize and track all pertinent factors impacting both the technical and financial viability of a wafer manufacturing fabrication area. Reticle related effects on wafer manufacturing can be costly and affect the total quality perceived by the device customer.

Patient views on financial relationships between surgeons and surgical device manufacturers

PubMed Central

Camp, Mark W.; Gross, Allan E.; McKneally, Martin F.

2015-01-01

Background Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients’ knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. Methods This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. Results We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. Conclusion This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry. PMID:26384147

Patient views on financial relationships between surgeons and surgical device manufacturers.

PubMed

Camp, Mark W; Gross, Allan E; McKneally, Martin F

2015-10-01

Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients' knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry.

RapidNAM: generative manufacturing approach of nasoalveolar molding devices for presurgical cleft lip and palate treatment.

PubMed

Bauer, Franz Xaver; Schönberger, Markus; Gattinger, Johannes; Eblenkamp, Markus; Wintermantel, Erich; Rau, Andrea; Güll, Florian Dieter; Wolff, Klaus-Dietrich; Loeffelbein, Denys J

2017-08-28

Nasoalveolar molding (NAM) is an accepted treatment strategy in presurgical cleft therapy. The major drawbacks of the treatment listed in the literature relate to the time of the treatment and the coordination of the required interdisciplinary team of therapists, parents, and patients. To overcome these limitations, we present the automated RapidNAM concept that facilitates the design and manufacturing process of NAM devices, and that allows the virtual modification and subsequent manufacture of the devices in advance, with a growth prediction factor adapted to the patient's natural growth. The RapidNAM concept involves (i) the prediction of three trajectories that envelope the fragmented alveolar segments with the goal to mimic a harmonic arch, (ii) the extrusion from the larger toward the smaller alveolar segment along the envelope curves toward the harmonic upper alveolar arch, and (iii) the generation of the NAM device with a ventilation hole, fixation pin, and fixation points for the nasal stents. A feasibility study for a vector-based approach was successfully conducted for unilateral and bilateral cleft lip and palate (CLP) patients. A comparison of the modified target models with the reference target models showed similar results. For further improvement, the number of landmarks used to modify the models was increased by a curve-based approach.

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

21 CFR 821.25 - Device tracking system and content requirements: manufacturer requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure... this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure: (1) Data...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

Device overlay method for high volume manufacturing

NASA Astrophysics Data System (ADS)

Lee, Honggoo; Han, Sangjun; Kim, Youngsik; Kim, Myoungsoo; Heo, Hoyoung; Jeon, Sanghuck; Choi, DongSub; Nabeth, Jeremy; Brinster, Irina; Pierson, Bill; Robinson, John C.

2016-03-01

Advancing technology nodes with smaller process margins require improved photolithography overlay control. Overlay control at develop inspection (DI) based on optical metrology targets is well established in semiconductor manufacturing. Advances in target design and metrology technology have enabled significant improvements in overlay precision and accuracy. One approach to represent in-die on-device as-etched overlay is to measure at final inspection (FI) with a scanning electron microscope (SEM). Disadvantages to this approach include inability to rework, limited layer coverage due to lack of transparency, and higher cost of ownership (CoO). A hybrid approach is investigated in this report whereby infrequent DI/FI bias is characterized and the results are used to compensate the frequent DI overlay results. The bias characterization is done on an infrequent basis, either based on time or triggered from change points. On a per-device and per-layer basis, the optical target overlay at DI is compared with SEM on-device overlay at FI. The bias characterization results are validated and tracked for use in compensating the DI APC controller. Results of the DI/FI bias characterization and sources of variation are presented, as well as the impact on the DI correctables feeding the APC system. Implementation details in a high volume manufacturing (HVM) wafer fab will be reviewed. Finally future directions of the investigation will be discussed.

47 CFR 15.124 - DTV transition notices by manufacturers of televisions and related devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false DTV transition notices by manufacturers of televisions and related devices. 15.124 Section 15.124 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES Unintentional Radiators § 15.124 DTV transition notices by manufacturers...

21 CFR 1301.33 - Application for bulk manufacture of Schedule I and II substances.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Application for bulk manufacture of Schedule I and... manufacture of Schedule I and II substances. (a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, the...

77 FR 6028 - Taxable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-07

... use by the purchaser for further manufacture, or for resale by the purchaser to a second purchaser for use by such second purchaser in further manufacture, and (ii) for export, or for resale by the... manufacture, prepare, propagate, compound, assemble, process, repackage, or relabel medical devices intended...

Fringe stabilizers and their application to telecommunication device manufacturing

NASA Astrophysics Data System (ADS)

Odhner, Jefferson E.

2000-10-01

The ability to create stable holographic grating is an important part of the production of many telecommunication products. The stability problem is increased by the need to use ultra-violet light for close fringe spacing and long exposure times on phot-resist - a relatively low sensitivity material. Active fringe locking increases the modulation depth and efficiency of these holographic gratings. A discussion of how fringe lockers work and how they can be incorporated into a manufacturing set-up is followed by results of using fringe lockers in the manufacturing of some telecommunication devices.

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Manufacture and distribution of sources or devices... SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Generally Licensed Items § 32.74 Manufacture and distribution of sources or devices containing byproduct material for...

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, S.P.; Chamberlin, R.

1997-10-07

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells. 13 figs.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, Scot P.; Chamberlin, Rhodes

1999-02-09

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, S.P.; Chamberlin, R.

1999-02-09

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells. 13 figs.

Thin film photovoltaic device and process of manufacture

DOEpatents

Albright, Scot P.; Chamberlin, Rhodes

1997-10-07

Provided is a thin film photovoltaic device and a method of manufacturing the device. The thin film photovoltaic device comprises a film layer having particles which are smaller than about 30 microns in size held in an electrically insulating matrix material to reduce the potential for electrical shorting through the film layer. The film layer may be provided by depositing preformed particles onto a surrogate substrate and binding the particles in a film-forming matrix material to form a flexible sheet with the film layer. The flexible sheet may be separated from the surrogate substrate and cut into flexible strips. A plurality of the flexible strips may be located adjacent to and supported by a common supporting substrate to form a photovoltaic module having a plurality of electrically interconnected photovoltaic cells.

21 CFR 1301.33 - Application for bulk manufacture of Schedule I and II substances.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Application for bulk manufacture of Schedule I and II substances. 1301.33 Section 1301.33 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF... manufacture of Schedule I and II substances. (a) In the case of an application for registration or...

Improved Method of Manufacturing SiC Devices

NASA Technical Reports Server (NTRS)

Okojie, Robert S.

2005-01-01

The phrase, "common-layered architecture for semiconductor silicon carbide" ("CLASSiC") denotes a method of batch fabrication of microelectromechanical and semiconductor devices from bulk silicon carbide. CLASSiC is the latest in a series of related methods developed in recent years in continuing efforts to standardize SiC-fabrication processes. CLASSiC encompasses both institutional and technological innovations that can be exploited separately or in combination to make the manufacture of SiC devices more economical. Examples of such devices are piezoresistive pressure sensors, strain gauges, vibration sensors, and turbulence-intensity sensors for use in harsh environments (e.g., high-temperature, high-pressure, corrosive atmospheres). The institutional innovation is to manufacture devices for different customers (individuals, companies, and/or other entities) simultaneously in the same batch. This innovation is based on utilization of the capability for fabrication, on the same substrate, of multiple SiC devices having different functionalities (see figure). Multiple customers can purchase shares of the area on the same substrate, each customer s share being apportioned according to the customer s production-volume requirement. This makes it possible for multiple customers to share costs in a common foundry, so that the capital equipment cost per customer in the inherently low-volume SiC-product market can be reduced significantly. One of the technological innovations is a five-mask process that is based on an established set of process design rules. The rules provide for standardization of the fabrication process, yet are flexible enough to enable multiple customers to lay out masks for their portions of the SiC substrate to provide for simultaneous batch fabrication of their various devices. In a related prior method, denoted multi-user fabrication in silicon carbide (MUSiC), the fabrication process is based largely on surface micromachining of poly Si

Fabrication of Thermoelectric Devices Using Additive-Subtractive Manufacturing Techniques: Application to Waste-Heat Energy Harvesting

NASA Astrophysics Data System (ADS)

Tewolde, Mahder

Thermoelectric generators (TEGs) are solid-state devices that convert heat directly into electricity. They are well suited for waste-heat energy harvesting applications as opposed to primary energy generation. Commercially available thermoelectric modules are flat, inflexible and have limited sizes available. State-of-art manufacturing of TEG devices relies on assembling prefabricated parts with soldering, epoxy bonding, and mechanical clamping. Furthermore, efforts to incorporate them onto curved surfaces such as exhaust pipes, pump housings, steam lines, mixing containers, reaction chambers, etc. require custom-built heat exchangers. This is costly and labor-intensive, in addition to presenting challenges in terms of space, thermal coupling, added weight and long-term reliability. Additive manufacturing technologies are beginning to address many of these issues by reducing part count in complex designs and the elimination of sub-assembly requirements. This work investigates the feasibility of utilizing such novel manufacturing routes for improving the manufacturing process of thermoelectric devices. Much of the research in thermoelectricity is primarily focused on improving thermoelectric material properties by developing of novel materials or finding ways to improve existing ones. Secondary to material development is improving the manufacturing process of TEGs to provide significant cost benefits. To improve the device fabrication process, this work explores additive manufacturing technologies to provide an integrated and scalable approach for TE device manufacturing directly onto engineering component surfaces. Additive manufacturing techniques like thermal spray and ink-dispenser printing are developed with the aim of improving the manufacturing process of TEGs. Subtractive manufacturing techniques like laser micromachining are also studied in detail. This includes the laser processing parameters for cutting the thermal spray materials efficiently by

Towards roll-to-roll manufacturing of polymer photonic devices

NASA Astrophysics Data System (ADS)

Subbaraman, Harish; Lin, Xiaohui; Ling, Tao; Guo, L. Jay; Chen, Ray T.

2014-03-01

Traditionally, polymer photonic devices are fabricated using clean-room processes such as photolithography, e-beam lithography, reactive ion etching (RIE) and lift-off methods etc, which leads to long fabrication time, low throughput and high cost. We have utilized a novel process for fabricating polymer photonic devices using a combination of imprinting and ink jet printing methods, which provides high throughput on a variety of rigid and flexible substrates with low cost. We discuss the manufacturing challenges that need to be overcome in order to realize true implementation of roll-to-roll manufacturing of flexible polymer photonic systems. Several metrology and instrumentation challenges involved such as availability of particulate-free high quality substrate, development and implementation of high-speed in-line and off-line inspection and diagnostic tools with adaptive control for patterned and unpatterned material films, development of reliable hardware, etc need to be addressed and overcome in order to realize a successful manufacturing process. Due to extreme resolution requirements compared to print media, the burden of software and hardware tools on the throughput also needs to be carefully determined. Moreover, the effect of web wander and variations in web speed need to accurately be determined in the design of the system hardware and software. In this paper, we show the realization of solutions for few challenges, and utilizing these solutions for developing a high-rate R2R dual stage ink-jet printer that can provide alignment accuracy of <10μm at a web speed of 5m/min. The development of a roll-to-roll manufacturing system for polymer photonic systems opens limitless possibilities for the deployment of high performance components in a variety of applications including communication, sensing, medicine, agriculture, energy, lighting etc.

21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... for Communicable Disease Agents § 610.42 Restrictions on use for further manufacture of medical...

Soft ionization device with characterization systems and methods of manufacture

NASA Technical Reports Server (NTRS)

Hartley, Frank T. (Inventor)

2004-01-01

Various configurations of characterization systems such as ion mobility spectrometers and mass spectrometers are disclosed that are coupled to an ionization device. The ionization device is formed of a membrane that houses electrodes therein that are located closer to one another than the mean free path of the gas being ionized. Small voltages across the electrodes generate large electric fields which act to ionize substantially all molecules passing therethrough without fracture. Methods to manufacture the mass spectrometer and ion mobility spectrometer systems are also described.

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

PubMed Central

Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

2015-01-01

Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2012-05-29

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture

DOEpatents

West, Phillip B [Idaho Falls, ID; Novascone, Stephen R [Idaho Falls, ID; Wright, Jerry P [Idaho Falls, ID

2011-09-27

Earth analysis methods, subsurface feature detection methods, earth analysis devices, and articles of manufacture are described. According to one embodiment, an earth analysis method includes engaging a device with the earth, analyzing the earth in a single substantially lineal direction using the device during the engaging, and providing information regarding a subsurface feature of the earth using the analysis.

Radiation analysis devices, radiation analysis methods, and articles of manufacture

DOEpatents

Roybal, Lyle Gene

2010-06-08

Radiation analysis devices include circuitry configured to determine respective radiation count data for a plurality of sections of an area of interest and combine the radiation count data of individual of sections to determine whether a selected radioactive material is present in the area of interest. An amount of the radiation count data for an individual section is insufficient to determine whether the selected radioactive material is present in the individual section. An article of manufacture includes media comprising programming configured to cause processing circuitry to perform processing comprising determining one or more correction factors based on a calibration of a radiation analysis device, measuring radiation received by the radiation analysis device using the one or more correction factors, and presenting information relating to an amount of radiation measured by the radiation analysis device having one of a plurality of specified radiation energy levels of a range of interest.

Manufacturing process and material selection in concurrent collaborative design of MEMS devices

NASA Astrophysics Data System (ADS)

Zha, Xuan F.; Du, H.

2003-09-01

In this paper we present knowledge of an intensive approach and system for selecting suitable manufacturing processes and materials for microelectromechanical systems (MEMS) devices in concurrent collaborative design environment. In the paper, fundamental issues on MEMS manufacturing process and material selection such as concurrent design framework, manufacturing process and material hierarchies, and selection strategy are first addressed. Then, a fuzzy decision support scheme for a multi-criteria decision-making problem is proposed for estimating, ranking and selecting possible manufacturing processes, materials and their combinations. A Web-based prototype advisory system for the MEMS manufacturing process and material selection, WebMEMS-MASS, is developed based on the client-knowledge server architecture and framework to help the designer find good processes and materials for MEMS devices. The system, as one of the important parts of an advanced simulation and modeling tool for MEMS design, is a concept level process and material selection tool, which can be used as a standalone application or a Java applet via the Web. The running sessions of the system are inter-linked with webpages of tutorials and reference pages to explain the facets, fabrication processes and material choices, and calculations and reasoning in selection are performed using process capability and material property data from a remote Web-based database and interactive knowledge base that can be maintained and updated via the Internet. The use of the developed system including operation scenario, use support, and integration with an MEMS collaborative design system is presented. Finally, an illustration example is provided.

Enhanced, rapid occlusion of carotid and vertebral arteries using the AMPLATZER Vascular Plug II device: the Duke Cerebrovascular Center experience in 8 patients with 22 AMPLATZER Vascular Plug II devices.

PubMed

Mihlon, Frank; Agrawal, Abishek; Nimjee, Shahid M; Ferrell, Andrew; Zomorodi, Ali R; Smith, Tony P; Britz, Gavin W

2015-01-01

Therapeutic embolization of the common carotid artery (CCA), internal carotid artery (ICA), and vertebral artery (VA) is necessary in the treatment of a subset of chronic arteriovenous fistulas (AVFs), hemorrhages, highly vascularized neoplasms before resection, and giant aneurysms. There are currently no reports of the use of the AMPLATZER Vascular Plug II (AVP II) device to occlude the CCA, ICA, or VA. The objective of this article is to present the Duke Cerebrovascular Center experience using the AVP II device in neurointerventional applications. This case series is a retrospective review of all of the cases at Duke University Hospital in which an AVP II device was used in the CCA, ICA, or VA up to September 2012. The AVP II device was often used in conjunction with embolization coils or as multiple AVP II devices deployed in tandem. During 2010-2012, 8 cases meeting criteria were performed. These included 2 chronic VA to internal jugular AVFs, 1 hemorrhagic CCA to internal jugular AVF secondary to invasive head and neck squamous cell carcinoma, 1 ICA hemorrhage secondary to invasive head and neck squamous cell carcinoma, 1 ICA hemorrhage secondary to trauma, 1 ruptured ICA aneurysm, 1 giant petrous ICA aneurysm, and 1 case of cervical vertebral sarcoma requiring preoperative VA embolization. Successful occlusion of the target vessel was achieved in all 8 cases. There was 1 major complication that consisted of a watershed distribution cerebral infarct; however, this was related to emergent occlusion of the ICA in the setting of intracranial hemorrhage and was not a problem intrinsic to the AVP II device. The AVP II device is relatively large, self-expanding vascular occlusion device that safely allows enhanced, rapid take-down of the CCA, ICA, and VA with low risk of distal migration. Copyright © 2015 Elsevier Inc. All rights reserved.

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2013 CFR

2013-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2010 CFR

2010-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2012 CFR

2012-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2014 CFR

2014-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2011 CFR

2011-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

3D printing for health & wealth: Fabrication of custom-made medical devices through additive manufacturing

NASA Astrophysics Data System (ADS)

Colpani, Alessandro; Fiorentino, Antonio; Ceretti, Elisabetta

2018-05-01

Additive Manufacturing (AM) differs from traditional manufacturing technologies by its ability to handle complex shapes with great design flexibility. These features make the technique suitable to fabricate customized components, particularly answering specific custom needs. Although AM mainly referred to prototyping, nowadays the interest in direct manufacturing of actual parts is growing. This article shows the application of AM within the project 3DP-4H&W (3D Printing for Health & Wealth) which involves engineers and physicians for developing pediatric custom-made medical devices to enhance the fulfilling of the patients specific needs. In the project, two types of devices made of a two-component biocompatible silicone are considered. The first application (dental field) consists in a device for cleft lip and palate. The second one (audiological field) consists in an acoustic prosthesis. The geometries of the devices are based on the anatomy of the patient that is obtained through a 3D body scan process. For both devices, two different approaches were planned, namely direct AM and indirect Rapid Tooling (RT). In particular, direct AM consists in the FDM processing of silicone, while RT consists in molds FDM fabrication followed by silicone casting. This paper presents the results of the RT method that is articulated in different phases: the acquisition of the geometry to be realized, the design of the molds taking into account the casting feasibility (as casting channel, vents, part extraction), the realization of molds produced through AM, molds surface chemical finishing, pouring and curing of the silicone. The fabricated devices were evaluated by the physicians team that confirmed the effectiveness of the proposed procedure in fabricating the desired devices. Moreover, the procedure can be used as a general method to extend the range of applications to any custom-made device for anatomic districts, especially where complex shapes are present (as tracheal or

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials.

PubMed

Zadpoor, Amir A

2017-07-25

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials

PubMed Central

Zadpoor, Amir A.

2017-01-01

Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes. PMID:28757572

Hypothesis analysis methods, hypothesis analysis devices, and articles of manufacture

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

Sanfilippo, Antonio P; Cowell, Andrew J; Gregory, Michelle L

Hypothesis analysis methods, hypothesis analysis devices, and articles of manufacture are described according to some aspects. In one aspect, a hypothesis analysis method includes providing a hypothesis, providing an indicator which at least one of supports and refutes the hypothesis, using the indicator, associating evidence with the hypothesis, weighting the association of the evidence with the hypothesis, and using the weighting, providing information regarding the accuracy of the hypothesis.

33 CFR 159.126 - Coliform test: Type II devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Coliform test: Type II devices. 159.126 Section 159.126 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.126 Coliform test...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2011 CFR

2011-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2012 CFR

2012-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

Code of Federal Regulations, 2010 CFR

2010-04-01

... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

Text analysis devices, articles of manufacture, and text analysis methods

DOEpatents

Turner, Alan E; Hetzler, Elizabeth G; Nakamura, Grant C

2013-05-28

Text analysis devices, articles of manufacture, and text analysis methods are described according to some aspects. In one aspect, a text analysis device includes processing circuitry configured to analyze initial text to generate a measurement basis usable in analysis of subsequent text, wherein the measurement basis comprises a plurality of measurement features from the initial text, a plurality of dimension anchors from the initial text and a plurality of associations of the measurement features with the dimension anchors, and wherein the processing circuitry is configured to access a viewpoint indicative of a perspective of interest of a user with respect to the analysis of the subsequent text, and wherein the processing circuitry is configured to use the viewpoint to generate the measurement basis.

Lasers in energy device manufacturing

NASA Astrophysics Data System (ADS)

Ostendorf, A.; Schoonderbeek, A.

2008-02-01

Global warming is a current topic all over the world. CO II emissions must be lowered to stop the already started climate change. Developing regenerative energy sources, like photovoltaics and fuel cells contributes to the solution of this problem. Innovative technologies and strategies need to be competitive with conventional energy sources. During the last years, the photovoltaic solar cell industry has experienced enormous growth. However, for solar cells to be competitive on the longer term, both an increase in efficiency as well as reduction in costs is necessary. An effective method to reduce costs of silicon solar cells is reducing the wafer thickness, because silicon makes up a large part of production costs. Consequently, contact free laser processing has a large advantage, because of the decrease in waste materials due to broken wafers as caused by other manufacturing processes. Additionally, many novel high efficiency solar cell concepts are only economically feasible with laser technology, e.g. for scribing silicon thin-film solar cells. This paper describes laser hole drilling, structuring and texturing of silicon wafer based solar cells and describes thin film solar cell scribing. Furthermore, different types of lasers are discussed with respect to processing quality and time.

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Standard for egress windows and... SAFETY STANDARDS Testing § 3280.404 Standard for egress windows and devices for use in manufactured homes..., construction, and installation of windows and approved devices intended to be used as an emergency exit during...

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

PubMed

Mehta, Rashi I; Mehta, Rupal I

2018-03-19

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

Digital capture, design, and manufacturing of an extraoral device for a clarinet player with Bell's palsy.

PubMed

Aita-Holmes, Cynthia; Liacouras, Peter; Wilson, William O; Grant, Gerald T

2015-08-01

An extraoral device was fabricated to assist a clarinet player with Bell's palsy. The device was fabricated by using stereophotogrammetry, digital design, and additive manufacturing technologies. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Text analysis devices, articles of manufacture, and text analysis methods

DOEpatents

Turner, Alan E; Hetzler, Elizabeth G; Nakamura, Grant C

2015-03-31

Text analysis devices, articles of manufacture, and text analysis methods are described according to some aspects. In one aspect, a text analysis device includes a display configured to depict visible images, and processing circuitry coupled with the display and wherein the processing circuitry is configured to access a first vector of a text item and which comprises a plurality of components, to access a second vector of the text item and which comprises a plurality of components, to weight the components of the first vector providing a plurality of weighted values, to weight the components of the second vector providing a plurality of weighted values, and to combine the weighted values of the first vector with the weighted values of the second vector to provide a third vector.

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture

DOEpatents

Steele, Kerry D [Kennewick, WA; Anderson, Gordon A [Benton City, WA; Gilbert, Ronald W [Morgan Hill, CA

2011-02-01

Communications device identification methods, communications methods, wireless communications readers, wireless communications systems, and articles of manufacture are described. In one aspect, a communications device identification method includes providing identification information regarding a group of wireless identification devices within a wireless communications range of a reader, using the provided identification information, selecting one of a plurality of different search procedures for identifying unidentified ones of the wireless identification devices within the wireless communications range, and identifying at least some of the unidentified ones of the wireless identification devices using the selected one of the search procedures.

Design and fabrication of a sleep apnea device using computer-aided design/additive manufacture technologies.

PubMed

Al Mortadi, Noor; Eggbeer, Dominic; Lewis, Jeffrey; Williams, Robert J

2013-04-01

The aim of this study was to analyze the latest innovations in additive manufacture techniques and uniquely apply them to dentistry, to build a sleep apnea device requiring rotating hinges. Laser scanning was used to capture the three-dimensional topography of an upper and lower dental cast. The data sets were imported into an appropriate computer-aided design software environment, which was used to design a sleep apnea device. This design was then exported as a stereolithography file and transferred for three-dimensional printing by an additive manufacture machine. The results not only revealed that the novel computer-based technique presented provides new design opportunities but also highlighted limitations that must be addressed before the techniques can become clinically viable.

33 CFR 159.126a - Suspended solids test: Type II devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Suspended solids test: Type II devices. 159.126a Section 159.126a Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.126a...

33 CFR 159.89 - Power interruption: Type I and II devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Power interruption: Type I and II devices. 159.89 Section 159.89 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.89 Power...

An overview of the regulatory aspects of medical devices from the viewpoint of research and device manufacturing.

PubMed

Patrick, J

1993-01-01

To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.

Numerical study of the Columbia high-beta device: Torus-II

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

Izzo, R.

1981-01-01

The ionization, heating and subsequent long-time-scale behavior of the helium plasma in the Columbia fusion device, Torus-II, is studied. The purpose of this work is to perform numerical simulations while maintaining a high level of interaction with experimentalists. The device is operated as a toroidal z-pinch to prepare the gas for heating. This ionization of helium is studied using a zero-dimensional, two-fluid code. It is essentially an energy balance calculation that follows the development of the various charge states of the helium and any impurities (primarily silicon and oxygen) that are present. The code is an atomic physics model ofmore » Torus-II. In addition to ionization, we include three-body and radiative recombination processes.« less

Manufacture of micro fluidic devices by laser welding using thermal transfer printing techniques

NASA Astrophysics Data System (ADS)

Klein, R.; Klein, K. F.; Tobisch, T.; Thoelken, D.; Belz, M.

2016-03-01

Micro-fluidic devices are widely used today in the areas of medical diagnostics and drug research, as well as for applications within the process, electronics and chemical industry. Microliters of fluids or single cell to cell interactions can be conveniently analyzed with such devices using fluorescence imaging, phase contrast microscopy or spectroscopic techniques. Typical micro-fluidic devices consist of a thermoplastic base component with chambers and channels covered by a hermetic fluid and gas tight sealed lid component. Both components are usually from the same or similar thermoplastic material. Different mechanical, adhesive or thermal joining processes can be used to assemble base component and lid. Today, laser beam welding shows the potential to become a novel manufacturing opportunity for midsize and large scale production of micro-fluidic devices resulting in excellent processing quality by localized heat input and low thermal stress to the device during processing. For laser welding, optical absorption of the resin and laser wavelength has to be matched for proper joining. This paper will focus on a new approach to prepare micro-fluidic channels in such devices using a thermal transfer printing process, where an optical absorbing layer absorbs the laser energy. Advantages of this process will be discussed in combination with laser welding of optical transparent micro-fluidic devices.

33 CFR 159.126a - Suspended solids test: Type II devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Suspended solids test: Type II... Suspended solids test: Type II devices. During the sewage processing test (§ 159.121) 40 effluent samples... suspended solids in accordance with 40 CFR part 136. The arithmetic mean of the total suspended solids in 38...

Additively Manufactured Device for Dynamic Culture of Large Arrays of 3D Tissue Engineered Constructs.

PubMed

Costa, Pedro F; Hutmacher, Dietmar W; Theodoropoulos, Christina; Gomes, Manuela E; Reis, Rui L; Vaquette, Cédryck

2015-04-22

The ability to test large arrays of cell and biomaterial combinations in 3D environments is still rather limited in the context of tissue engineering and regenerative medicine. This limitation can be generally addressed by employing highly automated and reproducible methodologies. This study reports on the development of a highly versatile and upscalable method based on additive manufacturing for the fabrication of arrays of scaffolds, which are enclosed into individualized perfusion chambers. Devices containing eight scaffolds and their corresponding bioreactor chambers are simultaneously fabricated utilizing a dual extrusion additive manufacturing system. To demonstrate the versatility of the concept, the scaffolds, while enclosed into the device, are subsequently surface-coated with a biomimetic calcium phosphate layer by perfusion with simulated body fluid solution. 96 scaffolds are simultaneously seeded and cultured with human osteoblasts under highly controlled bidirectional perfusion dynamic conditions over 4 weeks. Both coated and noncoated resulting scaffolds show homogeneous cell distribution and high cell viability throughout the 4 weeks culture period and CaP-coated scaffolds result in a significantly increased cell number. The methodology developed in this work exemplifies the applicability of additive manufacturing as a tool for further automation of studies in the field of tissue engineering and regenerative medicine. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

30 CFR 57.22227 - Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). 57.22227 Section 57.22227 Mineral Resources MINE SAFETY AND... Ventilation § 57.22227 Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). (a...

Status of TJ-II project

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

Alejaldre, C.; Blaumoser, M.; Almoguera, L.

1995-04-01

The flexible Heliac TJ-II is a medium six device (R=1.5m, [a]=0.2 m, B(0)=1.0 T) in an advanced stage of construction at Centro de Investigaciones Energeticas Medio Ambientales y Tecnologicas (CIEMAT), Madrid. The problems encountered during manufacturing so far have been solved satisfactorily. Nevertheless the narrow tolerances, which result from the compact machine design, create real challenges for all the component manufacturers. In this paper we present the present status of the project with a particular emphasis on the construction situation of the main components. 1 ref., 2 figs., 1 tab.

Simulating The Technological Movements Of The Equipment Used For Manufacturing Prosthetic Devices Using 3D Models

NASA Astrophysics Data System (ADS)

Chicea, Anca-Lucia

2015-09-01

The paper presents the process of building geometric and kinematic models of a technological equipment used in the process of manufacturing devices. First, the process of building the model for a six axes industrial robot is presented. In the second part of the paper, the process of building the model for a five-axis CNC milling machining center is also shown. Both models can be used for accurate cutting processes simulation of complex parts, such as prosthetic devices.

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... interior pressure tests for components and cladding must be conducted at the design wind loads required by... in high wind areas. For homes designed to be located in Wind Zones II and III, manufacturers shall... egress window openings. This method must be capable of resisting the design wind pressures specified in...

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... interior pressure tests for components and cladding must be conducted at the design wind loads required by... in high wind areas. For homes designed to be located in Wind Zones II and III, manufacturers shall... egress window openings. This method must be capable of resisting the design wind pressures specified in...

24 CFR 3280.404 - Standard for egress windows and devices for use in manufactured homes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... interior pressure tests for components and cladding must be conducted at the design wind loads required by... in high wind areas. For homes designed to be located in Wind Zones II and III, manufacturers shall... egress window openings. This method must be capable of resisting the design wind pressures specified in...

78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Additive Manufacture of Plasma Diagnostic Components Final Report Phase II

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

Woodruff, Simon; Romero-Talamas, Carlos; You, Setthivoine

There is now a well-established set of plasma diagnostics (see e.g. [3]), but these remain some of the mostexpensive assemblies in fusion systems since for every system they have to be custom built, and time fordiagnostic development can pace the project. Additive manufacturing (AM) has the potential to decreaseproduction cost and significantly lower design time of fusion diagnostic subsystems, which would realizesignificant cost reduction for standard diagnostics. In some cases, these basic components can be additivelymanufactured for less than 1/100th costs of conventional manufacturing.In our DOE Phase II SBIR, we examined the impact that AM can have on plasma diagnosticmore » cost bytaking 15 separate diagnostics through an engineering design using Conventional Manufacturing (CM) tech-niques, then optimizing the design to exploit the benefits of AM. The impact of AM techniques on cost isfound to be in several areas. First, the cost of materials falls because AM parts can be manufactured withlittle to no waste, and engineered to use less material than CM. Next, the cost of fabrication falls for AMparts relative to CM since the fabrication time can be computed exactly, and often no post-processing isrequired for the part to be functional. We find that AM techniques are well suited for plasma diagnosticssince typical diagnostic complexity comes at no additional cost. Cooling channels, for example, can be builtin to plasma-facing components at no extra cost. Fabrication costs associated with assembly are lower forAM parts because many components can be combined and printed as monoliths, thereby mitigating the needfor alignment or calibration. Finally, the cost of engineering is impacted by exploiting AM design tools thatallow standard components to be customized through web-interfaces. Furthermore, we find that conceptdesign costs can be impacted by scripting interfaces for online engineering design tools.« less

33 CFR 159.126 - Coliform test: Type II devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... follows: During each of the 10 test days, one sample must be taken at the beginning, middle and end of an 8-consecutive hour period with one additional sample taken immediately following the peak capacity...: Type II devices. (a) The arithmetic mean of the fecal coliform bacteria in 38 of 40 samples of effluent...

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

PubMed

Haber, Karina; Hawkins, Eleanor; Levie, Mark; Chudnoff, Scott

2015-01-01

To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events

TOPAZ II Anti-Criticality Device Rapid Prototype

NASA Astrophysics Data System (ADS)

Campbell, Donald R.; Otting, William D.

1994-07-01

The Ballistic Missile Defense Organization (BMDO) has been working on a Nuclear Electric Propulsion Space Test Project (NEPSTP) using an existing Russian Topaz II reactor system to power the NEPSTP satellite. Safety investigations have shown that it will be possible to safely launch the Topaz II system in the United States with some modification to preclude water flooded criticality. A ``fuel-out'' water subcriticality concept was selected by the Los Alamos National Laboratory (LANL) as the baseline concept. A fuel-out anti-criticality device (ACD) conceptual design was developed by Rockwell. The concept functions to hold the fuel from the four centermost thermionic fuel elements (TFEs) outside the reactor during launch and reliably inserts the fuel into the reactor once the operational orbit is achieved. A four-tenths scale ACD rapid prototype model, fabricated from the CATIA solids design model, clearly shows in three dimensions the relative size and spatial relationship of the ACD components.

Data graphing methods, articles of manufacture, and computing devices

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

Wong, Pak Chung; Mackey, Patrick S.; Cook, Kristin A.

Data graphing methods, articles of manufacture, and computing devices are described. In one aspect, a method includes accessing a data set, displaying a graphical representation including data of the data set which is arranged according to a first of different hierarchical levels, wherein the first hierarchical level represents the data at a first of a plurality of different resolutions which respectively correspond to respective ones of the hierarchical levels, selecting a portion of the graphical representation wherein the data of the portion is arranged according to the first hierarchical level at the first resolution, modifying the graphical representation by arrangingmore » the data of the portion according to a second of the hierarchal levels at a second of the resolutions, and after the modifying, displaying the graphical representation wherein the data of the portion is arranged according to the second hierarchal level at the second resolution.« less

Manufacturer evaluations of endograft modifications.

PubMed

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

2013-03-01

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

Corpuls cpr resuscitation device generates superior emulated flows and pressures than LUCAS II in a mechanical thorax model.

PubMed

Eichhorn, S; Mendoza Garcia, A; Polski, M; Spindler, J; Stroh, A; Heller, M; Lange, R; Krane, M

2017-06-01

The provision of sufficient chest compression is among the most important factors influencing patient survival during cardiopulmonary resuscitation (CPR). One approach to optimize the quality of chest compressions is to use mechanical-resuscitation devices. The aim of this study was to compare a new device for chest compression (corpuls cpr) with an established device (LUCAS II). We used a mechanical thorax model consisting of a chest with variable stiffness and an integrated heart chamber which generated blood flow dependent on the compression depth and waveform. The method of blood-flow generation could be changed between direct cardiac-compression mode and thoracic-pump mode. Different chest-stiffness settings and compression modes were tested to generate various blood-flow profiles. Additionally, an endurance test at high stiffness was performed to measure overall performance and compression consistency. Both resuscitation machines were able to compress the model thorax with a frequency of 100/min and a depth of 5 cm, independent of the chosen chest stiffness. Both devices passed the endurance test without difficulty. The corpuls cpr device was able to generate about 10-40% more blood flow than the LUCAS II device, depending on the model settings. In most scenarios, the corpuls cpr device also generated a higher blood pressure than the LUCAS II. The peak compression forces during CPR were about 30% higher using the corpuls cpr device than with the LUCAS II. In this study, the corpuls cpr device had improved blood flow and pressure outcomes than the LUCAS II device. Further examination in an animal model is required to prove the findings of this preliminary study.

A review of nanoimprint lithography for high-volume semiconductor device manufacturing

NASA Astrophysics Data System (ADS)

Resnick, Douglas J.; Choi, Jin

2017-06-01

Imprint lithography has been shown to be a promising technique for the replication of nanoscale features. Jet and flash imprint lithography (J-FIL) [jet and flash imprint lithography and J-FIL are trademarks of Molecular Imprints, Inc.] involves the field-by-field deposition and exposure of a low-viscosity resist deposited by jetting technology onto the substrate. The patterned mask is lowered into the fluid, which then quickly flows into the relief patterns in the mask by capillary action. After this filling step, the resist is cross-linked under UV radiation, and then the mask is removed, leaving a patterned resist on the substrate. There are many criteria that determine whether a particular technology is ready for wafer manufacturing. Included on the list are overlay, throughput, and defectivity. The most demanding devices now require an overlay of better than 4 nm, 3σ. Throughput for an imprint tool is generally targeted at 80 wafers/h. Defectivity and mask life play a significant role relative to meeting the cost of ownership (CoO) requirements in the production of semiconductor devices. The purpose of this paper is to report the status of throughput and defectivity work and to describe the progress made in addressing overlay for advanced devices. To address high-order corrections, a high-order distortion correction (HODC) system is introduced. The combination of applying magnification actuation to the mask and temperature correction to the wafer is described in detail. Examples are presented for the correction of K7, K11, and K17 distortions as well as distortions on actual device wafers.

The Latest Status of NSLS-II Insertion Devices

NASA Astrophysics Data System (ADS)

Tanabe, Toshi; Kitegi, Charles; He, Ping; Musardo, Marco; Rank, Oleg Chubar James; Cappadoro, Peter; Fernandes, Huston; Harder, David; Corwin, Todd

2014-03-01

The National Synchrotron Light Source-II (NSLS-II) project is now in the final stage of construction. The Linac, the Booster synchrotron, and the Storage Ring magnets girder assemblies have been installed. The first damping wiggler has been delivered and its field characteristics are carefully measured. A Three Pole Wiggler (3PW) and Apple-II type elliptically polarizing undulators (EPUs) have been fabricated by the vendors. Two 3.0m long in-vacuum undulators (IVUs) and one 1.5m long IVU are almost complete and waiting for factory acceptance tests. One 3.0m long IVU for Inelastic X-ray Scattering beamline is in fabrication by a different vendor. Recently two 2.8m long IVUs for long straight sections (LSSs) have been added to the project for "future beamlines". In addition, two 1.5m long IVUs and one 2.8m long IVU for LSSs have been procured for Advanced Beamlines for Biological Investigations with X-rays (ABBIX) project funded by National Institure of Health (NIH). Further, two 3.5m long EPUs for LSSs are being designed for NSLS-II Experimental Tools (NEXT) -Major Item of Equipment (MIE) project. To succeed these conventional IVUs, PrFeB based cryo-permanent magnet undulator (CPMU) is considered as next generation device of hard X-ray sources. An In-Vacuum Magnetic Measurement System (IVMMS) for cold in-situ Hall probe mapping of CPMUs up to 1.5m in length has been developed. Summary of the current status of each project and future plans for the NSLS-II ring will be discussed.

Lexicon generation methods, lexicon generation devices, and lexicon generation articles of manufacture

DOEpatents

Carter, Richard J [Richland, WA; McCall, Jonathon D [West Richland, WA; Whitney, Paul D [Richland, WA; Gregory, Michelle L [Richland, WA; Turner, Alan E [Kennewick, WA; Hetzler, Elizabeth G [Kennewick, WA; White, Amanda M [Kennewick, WA; Posse, Christian [Seattle, WA; Nakamura, Grant C [Kennewick, WA

2010-10-26

Lexicon generation methods, computer implemented lexicon editing methods, lexicon generation devices, lexicon editors, and articles of manufacture are described according to some aspects. In one aspect, a lexicon generation method includes providing a seed vector indicative of occurrences of a plurality of seed terms within a plurality of text items, providing a plurality of content vectors indicative of occurrences of respective ones of a plurality of content terms within the text items, comparing individual ones of the content vectors with respect to the seed vector, and responsive to the comparing, selecting at least one of the content terms as a term of a lexicon usable in sentiment analysis of text.

Development and Implementation of the X.25 Protocol for the Universal Network Interface Device (UNID) II. Volume 1.

DTIC Science & Technology

1985-12-01

development of an improved Universal Network Interface Device (UNID II). The UNID II’s architecture was based on a preliminary design project at...interface device, performing all functions required ,: the multi-ring LAN. The device depicted by RADC’s studies would connect a highly variable group of host...used the ISO Open Systems Ilterconnection (OSI) seven layer model as the basic structure for data flow and program development . In 1982 Cuomo

Electron heat transport comparison in the Large Helical Device and TJ-II

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

Garcia, J.; Dies, J.; Castejon, F.

2007-10-15

The electron heat transport in the Large Helical Device (LHD) [K. Ida, T. Shimozuma, H. Funaba et al., Phys. Rev. Lett. 91, 085003 (2003)] and TJ-II [F. Castejon, V. Tribaldos, I. Garcia-Cortes, E. de la Luna, J. Herranz, I. Pastor, T. Estrada, and TJ-II Team, Nucl. Fusion 42, 271 (2002)] is analyzed by means of the TOTAL [K. Yamazaki and T. Amano, Nucl. Fusion 32, 4 (1992)] and PRETOR-Stellarator [J. Dies, F. Castejon, J. M. Fontdecaba, J. Fontanet, J. Izquierdo, G. Cortes, and C. Alejaldre, Proceedings of the 29th European Physical Society Conference on Plasma Physics and Controlled Fusion, Montreux,more » 2002, Europhysics Conference Abstracts, 2004, Vol. 26B, P-5.027] plasma simulation codes and assuming a global transport model mixing GyroBohm-like drift wave model and other drift wave model with shorter wavelength. The stabilization of the GyroBohm-like model by the ExB shear has been also taken into account. Results show how such kind of electron heat transport can simulate experimental evidence in both devices, leading to the electron internal transport barrier (eITB) formation in the LHD and to the so-called 'enhanced heat confinement regimes' in TJ-II when electron density is low enough. Therefore, two sources for the anomalous electron heat transport can coexist in plasmas with eITB; however, for each device the relative importance of anomalous and neoclassical transport can be different.« less

Free-world microelectronic manufacturing equipment

NASA Astrophysics Data System (ADS)

Kilby, J. S.; Arnold, W. H.; Booth, W. T.; Cunningham, J. A.; Hutcheson, J. D.; Owen, R. W.; Runyan, W. R.; McKenney, Barbara L.; McGrain, Moira; Taub, Renee G.

1988-12-01

Equipment is examined and evaluated for the manufacture of microelectronic integrated circuit devices and sources for that equipment within the Free World. Equipment suitable for the following are examined: single-crystal silicon slice manufacturing and processing; required lithographic processes; wafer processing; device packaging; and test of digital integrated circuits. Availability of the equipment is also discussed, now and in the near future. Very adequate equipment for most stages of the integrated circuit manufacturing process is available from several sources, in different countries, although the best and most widely used versions of most manufacturing equipment are made in the United States or Japan. There is also an active market in used equipment, suitable for manufacture of capable integrated circuits with performance somewhat short of the present state of the art.

Manufacturing Math Classes: An Instructional Program Guide for Manufacturing Workers.

ERIC Educational Resources Information Center

McBride, Pamela G.; And Others

This program guide documents a manufacturing job family curriculum that develops competence in generic work force education skills through three courses: Reading Rulers, Charts, and Gauges and Math for Manufacturing Workers I and II. An annotated table of contents lists a brief description of the questions answered in each section. An introduction…

[Risk management for medical devices].

PubMed

Xie, Ying-jie; Xu, Xing-gang

2007-07-01

Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database.

PubMed

Naumann, R Wendel; Brown, Jubilee

2015-01-01

To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database. Retrospective analysis of an established database (Canadian Task Force classification III). A search of the MAUDE database for terms associated with commercially available electromechanical morcellation devices was undertaken for events leading to injury or death between 2004 and 2014. Data, including the types of injury, need for conversion to open surgery, type of open surgery, and clinical outcomes, were extracted from the records. Over a 10-year period, 9 events associated with death and 215 events associated with patient injury or significant delay of the surgical procedure were recorded. These involved 137 device failures, 51 organ injuries, and the morcellation of 27 previously undiagnosed malignancies. Of the 9 deaths, 1 was associated with organ injury, and the other 8 were associated with morcellation of cancer. Of the 27 undiagnosed cancers, 5 were reported by the manufacturer, 8 were reported by the patient or family, 9 were reported by medical or news reports, 2 were reported by medical professionals, and 3 were due to litigation. Morcellation of an undiagnosed malignancy was first reported to the database in December 2013. The MAUDE database appears to detect perioperative events, such as device failures and organ injury at the time of surgery, but appears to be poor at detecting late events after surgery, such as the potential spread of cancer. Outcome registries are likely a more efficient means of tracking potential long-term adverse events associated with surgical devices. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

Latest experiences and future plans on NSLS-II insertion devices

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

Tanabe, T.; Hidaka, Y.; Kitegi, C.

National Synchrotron Light Source-II (NSLS-II) is the latest storage ring of 3 GeV energy at the Brookhaven National Laboratory (BNL). The horizontal emittance of the electron beam with the currently installed six damping wigglers is 0.9 nm.rad, which could be further reduced to 0.5 nm.rad with more insertion devices (IDs). With only one RF cavity the beam current is restricted to 200 mA. Five hundred mA operation is envisaged for next year with an addition of the second cavity. Six (plus two branches) beamlines have been commissioned in the initial phase of the project. In July 2015, three NIH fundedmore » beamlines called “Advanced Beamlines for Biological Investigations with X-rays” (ABBIX) will be added for operation. This paper describes the experiences of ID development, installation, and commissioning for the NSLS-II project as well as our future plans to improve the performance of the facility in terms of source development.« less

CAD/CAM/AM applications in the manufacture of dental appliances.

PubMed

Al Mortadi, Noor; Eggbeer, Dominic; Lewis, Jeffrey; Williams, Robert J

2012-11-01

The purposes of this study were to apply the latest developments in additive manufacturing (AM) construction and to evaluate the effectiveness of these computer-aided design and computer-aided manufacturing (CAD/CAM) techniques in the production of dental appliances. In addition, a new method of incorporating wire into a single build was developed. A scanner was used to capture 3-dimensional images of Class II Division 1 dental models that were translated onto a 2-dimensional computer screen. Andresen and sleep-apnea devices were designed in 3 dimensions by using FreeForm software (version 11; Geo Magics SensAble Group, Wilmington, Mass) and a phantom arm. The design was then exported and transferred to an AM machine for building. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

NSLS-II storage ring insertion device and front-end commissioning and operation

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

Wang, G., E-mail: gwang@bnl.gov; Shaftan, T.; Amundsen, C.

The National Synchrotron Light Source II (NSLS-II) is a state of the art 3 GeV third generation light source at Brookhaven National Laboratory. During spring/ summer of 2014, the storage ring was commissioned up to 50 mA without insertion devices. In the fall of 2014, we began commissioning of the project beamlines, which included seven insertion devices on six ID ports. Beamlines IXS, HXN, CSX-1, CSX-2, CHX, SRX, and XPD-1 consist of elliptically polarized undulator (EPU), damping wigglers (DW) and in-vacuum undulators (IVU) covering from VUV to hard x-ray range. In this paper, experience with commissioning and operation is discussed.more » We focus on reaching storage ring performance with IDs, including injection, design emittance, compensation of orbit distortions caused by ID residual field, source point stability, beam alignment and tools for control, monitoring and protection of the ring chambers from ID radiation.« less

George E. Pake Prize: A Few Challenges in the Evolution of Semiconductor Device/Manufacturing Technology

NASA Astrophysics Data System (ADS)

Doering, Robert

In the early 1980s, the semiconductor industry faced the related challenges of ``scaling through the one-micron barrier'' and converting single-level-metal NMOS integrated circuits to multi-level-metal CMOS. Multiple advances in lithography technology and device materials/process integration led the way toward the deep-sub-micron transistors and interconnects that characterize today's electronic chips. In the 1990s, CMOS scaling advanced at an accelerated pace enabled by rapid advances in many aspects of optical lithography. However, the industry also needed to continue the progress in manufacturing on ever-larger silicon wafers to maintain economy-of-scale trends. Simultaneously, the increasing complexity and absolute-precision requirements of manufacturing compounded the necessity for new processes, tools, and control methodologies. This talk presents a personal perspective on some of the approaches that addressed the aforementioned challenges. In particular, early work on integrating silicides, lightly-doped-drain FETs, shallow recessed isolation, and double-level metal will be discussed. In addition, some pioneering efforts in deep-UV lithography and single-wafer processing will be covered. The latter will be mainly based on results from the MMST Program - a 100 M +, 5-year R&D effort, funded by DARPA, the U.S. Air Force, and Texas Instruments, that developed a wide range of new technologies for advanced semiconductor manufacturing. The major highlight of the program was the demonstration of sub-3-day cycle time for manufacturing 350-nm CMOS integrated circuits in 1993. This was principally enabled by the development of: (1) 100% single-wafer processing, including rapid-thermal processing (RTP), and (2) computer-integrated-manufacturing (CIM), including real-time, in-situ process control.

Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

PubMed

Al-Safi, Zain A; Shavell, Valerie I; Hobson, Deslyn T G; Berman, Jay M; Diamond, Michael P

2013-01-01

The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). Online retrospective review. Online reports of patients who underwent Essure tubal sterilization. Essure tubal sterilization. Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Identification and validation of nebulized aerosol devices for sputum induction

PubMed Central

Davidson, Warren J; Dennis, John; The, Stephanie; Litoski, Belinda; Pieron, Cora; Leigh, Richard

2014-01-01

Induced sputum cell count measurement has proven reliability for evaluating airway inflammation in patients with asthma and other airway diseases. Although the use of nebulizer devices for sputum induction is commonplace, they are generally labelled as single-patient devices by the manufacturer and, therefore, cannot be used for multiple patients in large clinical sputum induction programs due to infect ion-control requirements. Accordingly, this study investigated the aerosol characteristics of alternative devices that could be used in such programs. BACKGROUND: Induced sputum cell counts are a noninvasive and reliable method for evaluating the presence, type and degree of airway inflammation in patients with asthma. Currently, standard nebulizer devices used for sputum induction in multiple patients are labelled as single-patient devices by the manufacturer, which conflicts with infection prevention and control requirements. As such, these devices cannot feasibly be used in a clinical sputum induction program. Therefore, there is a need to identify alternative nebulizer devices that are either disposable or labelled for multi-patient use. OBJECTIVE: To apply validated rigorous, scientific testing methods to identify and validate commercially available nebulizer devices appropriate for use in a clinical sputum induction program. METHODS: Measurement of nebulized aerosol output and size for the selected nebulizer designs followed robust International Organization for Standardization methods. Sputum induction using two of these nebulizers was successfully performed on 10 healthy adult subjects. The cytotechnologist performing sputum cell counts was blinded to the type of nebulizer used. RESULTS: The studied nebulizers had variable aerosol outputs. The AeroNeb Solo (Aerogen, Ireland), Omron NE-U17 (Omron, Japan) and EASYneb II (Flaem Nuova, Italy) systems were found to have similar measurements of aerosol size. There was no significant difference in induced sputum

Flexible manufacturing for photonics device assembly

NASA Technical Reports Server (NTRS)

Lu, Shin-Yee; Pocha, Michael D.; Strand, Oliver T.; Young, K. David

1994-01-01

The assembly of photonics devices such as laser diodes, optical modulators, and opto-electronics multi-chip modules (OEMCM), usually requires the placement of micron size devices such as laser diodes, and sub-micron precision attachment between optical fibers and diodes or waveguide modulators (usually referred to as pigtailing). This is a very labor intensive process. Studies done by the opto-electronics (OE) industry have shown that 95 percent of the cost of a pigtailed photonic device is due to the use of manual alignment and bonding techniques, which is the current practice in industry. At Lawrence Livermore National Laboratory, we are working to reduce the cost of packaging OE devices through the use of automation. Our efforts are concentrated on several areas that are directly related to an automated process. This paper will focus on our progress in two of those areas, in particular, an automated fiber pigtailing machine and silicon micro-technology compatible with an automated process.

Redox active polymer devices and methods of using and manufacturing the same

DOEpatents

Johnson, Paul; Bautista-Martinez, Jose Antonio; Friesen, Cody; Switzer, Elise

2018-06-05

The disclosed technology relates generally to apparatus comprising conductive polymers and more particularly to tag and tag devices comprising a redox-active polymer film, and method of using and manufacturing the same. In one aspect, an apparatus includes a substrate and a conductive structure formed on the substrate which includes a layer of redox-active polymer film having mobile ions and electrons. The conductive structure further includes a first terminal and a second terminal configured to receive an electrical signal therebetween, where the layer of redox-active polymer is configured to conduct an electrical current generated by the mobile ions and the electrons in response to the electrical signal. The apparatus additionally includes a detection circuit operatively coupled to the conductive structure and configured to detect the electrical current flowing through the conductive structure.

Longevity of implantable cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer.

PubMed

Landolina, Maurizio; Curnis, Antonio; Morani, Giovanni; Vado, Antonello; Ammendola, Ernesto; D'onofrio, Antonio; Stabile, Giuseppe; Crosato, Martino; Petracci, Barbara; Ceriotti, Carlo; Bontempi, Luca; Morosato, Martina; Ballari, Gian Paolo; Gasparini, Maurizio

2015-08-01

Device replacement at the time of battery depletion of implantable cardioverter-defibrillators (ICDs) may carry a considerable risk of complications and engenders costs for healthcare systems. Therefore, ICD device longevity is extremely important both from a clinical and economic standpoint. Cardiac resynchronization therapy defibrillators (CRT-D) battery longevity is shorter than ICDs. We determined the rate of replacements for battery depletion and we identified possible determinants of early depletion in a series of patients who had undergone implantation of CRT-D devices. We retrieved data on 1726 consecutive CRT-D systems implanted from January 2008 to March 2010 in nine centres. Five years after a successful CRT-D implantation procedure, 46% of devices were replaced due to battery depletion. The time to device replacement for battery depletion differed considerably among currently available CRT-D systems from different manufacturers, with rates of batteries still in service at 5 years ranging from 52 to 88% (log-rank test, P < 0.001). Left ventricular lead output and unipolar pacing configuration were independent determinants of early depletion [hazard ratio (HR): 1.96; 95% 95% confidence interval (CI): 1.57-2.46; P < 0.001 and HR: 1.58, 95% CI: 1.25-2.01; P < 0.001, respectively]. The implantation of a recent-generation device (HR: 0.57; 95% CI: 0.45-0.72; P < 0.001), the battery chemistry and the CRT-D manufacturer (HR: 0.64; 95% CI: 0.47-0.89; P = 0.008) were additional factors associated with replacement for battery depletion. The device longevity at 5 years was 54%. High left ventricular lead output and unipolar pacing configuration were associated with early battery depletion, while recent-generation CRT-Ds displayed better longevity. Significant differences emerged among currently available CRT-D systems from different manufacturers. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

PubMed Central

Tu, Pei-Weng; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

PubMed

Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

Hearing Device Manufacturers Call for Interoperability and Standardization of Internet and Audiology.

PubMed

Laplante-Lévesque, Ariane; Abrams, Harvey; Bülow, Maja; Lunner, Thomas; Nelson, John; Riis, Søren Kamaric; Vanpoucke, Filiep

2016-10-01

This article describes the perspectives of hearing device manufacturers regarding the exciting developments that the Internet makes possible. Specifically, it proposes to join forces toward interoperability and standardization of Internet and audiology. A summary of why such a collaborative effort is required is provided from historical and scientific perspectives. A roadmap toward interoperability and standardization is proposed. Information and communication technologies improve the flow of health care data and pave the way to better health care. However, hearing-related products, features, and services are notoriously heterogeneous and incompatible with other health care systems (no interoperability). Standardization is the process of developing and implementing technical standards (e.g., Noah hearing database). All parties involved in interoperability and standardization realize mutual gains by making mutually consistent decisions. De jure (officially endorsed) standards can be developed in collaboration with large national health care systems as well as spokespeople for hearing care professionals and hearing device users. The roadmap covers mutual collaboration; data privacy, security, and ownership; compliance with current regulations; scalability and modularity; and the scope of interoperability and standards. We propose to join forces to pave the way to the interoperable Internet and audiology products, features, and services that the world needs.

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

21 CFR 820.184 - Device history record.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

Statistical study of EBR-II fuel elements manufactured by the cold line at Argonne-West and by Atomics International

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

Harkness, A. L.

1977-09-01

Nine elements from each batch of fuel elements manufactured for the EBR-II reactor have been analyzed for /sup 235/U content by NDA methods. These values, together with those of the manufacturer, are used to estimate the product variance and the variances of the two measuring methods. These variances are compared with the variances computed from the stipulations of the contract. A method is derived for resolving the several variances into their within-batch and between-batch components. Some of these variance components have also been estimated by independent and more familiar conventional methods for comparison.

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

Automotive Manufacturing Processes. Volume II - Manufacturing Processes for Passive Restraint Systems

DOT National Transportation Integrated Search

1981-02-01

Extensive material substitution and resizing of the domestic automotive fleet, as well as the introduction of new technologies, will require major changes in the techniques and equipment used in the various manufacturing processes employed in the pro...

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

PubMed

2003-04-22

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

40 CFR 61.144 - Standard for manufacturing.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., twine, rope, thread, yarn, roving, lap, or other textile materials. (2) The manufacture of cement... manufacturing facility, including air cleaning devices, process equipment, and buildings housing material...

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

PubMed

Steffen, Robert J; Blackstone, Eugene H; Smedira, Nicholas G; Soltesz, Edward G; Hoercher, Katherine J; Thuita, Lucy; Starling, Randall C; Mountis, Maria; Moazami, Nader

2017-11-01

Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant. Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival. Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Need low-cost networking? Consider DeviceNet

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

Moss, W.H.

1996-11-01

The drive to reduce production costs and optimize system performance in manufacturing facilities causes many end users to invest in network solutions. Because of distinct differences between the way tasks are performed and the way data are handled for various applications, it is clear than more than one network will be needed in most facilities. What is not clear is which network is most appropriate for a given application. The information layer is the link between automation and information environments via management information systems (MISs) and manufacturing execution systems (MESs) and manufacturing execution systems (MESs). Here the market has chosenmore » a de facto standard in Ethernet, primarily transmission control protocol/internet protocol (TCP/IP) and secondarily manufacturing messaging system (MMS). There is no single standard at the device layer. However, the DeviceNet communication standard has made strides to reach this goal. This protocol eliminates expensive hardwiring and provides improved communication between devices and important device-level diagnostics not easily accessible or available through hardwired I/O interfaces. DeviceNet is a low-cost communications link connecting industrial devices to a network. Many original equipment manufacturers and end users have chosen the DeviceNet platform for several reasons, but most frequently because of four key features: interchangeability; low cost; advanced diagnostics; insert devices under power.« less

21 CFR 1303.21 - Individual manufacturing quotas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... controlled substance listed in Schedule I or II, and who applies for a manufacturing quota, an individual... basic class. Any manufacturing quota fixed and issued by the Administrator shall be subject to his... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Individual manufacturing quotas. 1303.21 Section...

Manufacturing process of nanofluidics using afm probe

NASA Astrophysics Data System (ADS)

Karingula, Varun Kumar

A new process for fabricating a nano fluidic device that can be used in medical application is developed and demonstrated. Nano channels are fabricated using a nano tip in indentation mode on AFM (Atomic Force Microscopy). The nano channels are integrated between the micro channels and act as a filter to separate biomolecules. Nano channels of 4 to7 m in length, 80nm in width, and at varying depths from 100nm to 850 nm allow the resulting device to separate selected groups of lysosomes and other viruses. Sharply developed vertical micro channels are produced from a deep reaction ion etching followed by deposition of different materials, such as gold and polymers, on the top surface, allowing the study of alternative ways of manufacturing a nanofluidic device. PDMS (Polydimethylsiloxane) bonding is performed to close the top surface of the device. An experimental setup is used to test and validate the device by pouring fluid through the channels. A detailed cost evaluation is conducted to compare the economical merits of the proposed process. It is shown that there is a 47:7% manufacturing time savings and a 60:6% manufacturing cost savings.

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

PubMed

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.

Additive Manufacturing: Unlocking the Evolution of Energy Materials

PubMed Central

Zhakeyev, Adilet; Wang, Panfeng; Shu, Wenmiao; Wang, Huizhi

2017-01-01

Abstract The global energy infrastructure is undergoing a drastic transformation towards renewable energy, posing huge challenges on the energy materials research, development and manufacturing. Additive manufacturing has shown its promise to change the way how future energy system can be designed and delivered. It offers capability in manufacturing complex 3D structures, with near‐complete design freedom and high sustainability due to minimal use of materials and toxic chemicals. Recent literatures have reported that additive manufacturing could unlock the evolution of energy materials and chemistries with unprecedented performance in the way that could never be achieved by conventional manufacturing techniques. This comprehensive review will fill the gap in communicating on recent breakthroughs in additive manufacturing for energy material and device applications. It will underpin the discoveries on what 3D functional energy structures can be created without design constraints, which bespoke energy materials could be additively manufactured with customised solutions, and how the additively manufactured devices could be integrated into energy systems. This review will also highlight emerging and important applications in energy additive manufacturing, including fuel cells, batteries, hydrogen, solar cell as well as carbon capture and storage. PMID:29051861

Additive Manufacturing: Unlocking the Evolution of Energy Materials.

PubMed

Zhakeyev, Adilet; Wang, Panfeng; Zhang, Li; Shu, Wenmiao; Wang, Huizhi; Xuan, Jin

2017-10-01

The global energy infrastructure is undergoing a drastic transformation towards renewable energy, posing huge challenges on the energy materials research, development and manufacturing. Additive manufacturing has shown its promise to change the way how future energy system can be designed and delivered. It offers capability in manufacturing complex 3D structures, with near-complete design freedom and high sustainability due to minimal use of materials and toxic chemicals. Recent literatures have reported that additive manufacturing could unlock the evolution of energy materials and chemistries with unprecedented performance in the way that could never be achieved by conventional manufacturing techniques. This comprehensive review will fill the gap in communicating on recent breakthroughs in additive manufacturing for energy material and device applications. It will underpin the discoveries on what 3D functional energy structures can be created without design constraints, which bespoke energy materials could be additively manufactured with customised solutions, and how the additively manufactured devices could be integrated into energy systems. This review will also highlight emerging and important applications in energy additive manufacturing, including fuel cells, batteries, hydrogen, solar cell as well as carbon capture and storage.

Late outcomes of subcostal exchange of the HeartMate II left ventricular assist device: a word of caution.

PubMed

Yu, Sarah N; Takayama, Hiroo; Han, Jiho; Garan, Arthur R; Kurlansky, Paul; Yuzefpolskaya, Melana; Colombo, Paolo C; Naka, Yoshifumi; Takeda, Koji

2018-04-10

Previous studies have shown the usefulness of the subcostal exchange of the HeartMate II left ventricular assist device for device malfunction. However, long-term data are still limited. Between March 2004 and July 2017, 41 of 568 (7.2%) patients who had received a HeartMate II implant at our institution had a device exchange via a subcostal incision. We summarized early and late outcomes. Forty-one patients had a total of 48 subcostal pump exchanges. Indications for device exchange included device thrombosis (n = 31, 76%), driveline infection (n = 2, 5%) and driveline injury (n = 8, 19%). All of the procedures were successful, and there were no in-hospital deaths. A Kaplan-Meier survival curve showed 30-day and 1-year survival rates after subcostal exchange of 100% and 94.6%, respectively. However, 10 (25%) patients had left ventricular assist device-related infections following subcostal exchange that included 7 pump pocket infections and 3 driveline infections. Freedom from left ventricular assist device-related infection at 1 year after subcostal exchange was 79.3%. Thirteen (32%) patients had device malfunction due to pump thrombosis that required a 2nd device exchange. Seven patients had recurrent thrombosis. Three (7%) patients had a stroke. Freedom from device thrombosis and from a stroke event at 1 year was 74.4%. Subcostal pump exchange can be safely performed. However, there is a substantial risk of infection and recurrent thrombosis. Careful follow-up for late complications is mandatory.

Development of the Second Generation Berry Impact Recording Device (BIRD II)

PubMed Central

Xu, Rui; Li, Changying

2015-01-01

To quantitatively measure the impacts during blueberry harvesting and post-harvest handling, this study designed the second generation Berry Impact Recording Device (BIRD II) sensor with a size of 21 mm in diameter and a weight of 3.9 g, which reduced the size by 17% and the weight by 50% compared to the previous prototype. The sensor was able to measure accelerations up to 346 g at a maximum frequency of 2 KHz. Universal Serial Bus (USB) was used to directly connect the sensor with the computer, removing the interface box used previously. LabVIEW-based PC software was designed to configure the sensor, download and process the data. The sensor was calibrated using a centrifuge. The accuracy of the sensor was between −1.76 g to 2.17 g, and the precision was between 0.21 g to 0.81 g. Dynamic drop tests showed that BIRD II had smaller variance in measurements than BIRD I. In terms of size and weight, BIRD II is more similar to an average blueberry fruit than BIRD I, which leads to more accurate measurements of the impacts for blueberries. PMID:25664430

Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

PubMed

2004-03-16

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

An investigation into the feasibility of locating portable medical devices using radio frequency identification devices and technology.

PubMed

Britton, J

2007-01-01

Portable medical devices represent an important resource for assisting healthcare delivery. The movement of portable devices often results in them being unavailable when needed. Tracking equipment using radiofrequency identification technology/devices (RFID) may provide a promising solution to the problems encountered in locating portable equipment. An RFID technology trial was undertaken at Royal Alexandra Hospital, Paisley. This involved the temporary installation of three active readers and attaching actively transmitting radio frequency tags to different portable medical devices. The active readers and computer system were linked using a bespoke data network. Tags and readers from two separate manufacturers were tested. Reliability difficulties were encountered when testing the technology from the first manufacturer, probably due to the casing of the medical device interfering with the signal from the tag. Improved results were obtained when using equipment from the second manufacturer with an overall error rate of 12.3%. Tags from this manufacturer were specifically designed to overcome problems observed with the first system tested. Findings from this proof of concept trial suggest that RFID technology could be used to track the location of equipment in a hospital.

Data visualization methods, data visualization devices, data visualization apparatuses, and articles of manufacture

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

Turner, Alan E.; Crow, Vernon L.; Payne, Deborah A.

Data visualization methods, data visualization devices, data visualization apparatuses, and articles of manufacture are described according to some aspects. In one aspect, a data visualization method includes accessing a plurality of initial documents at a first moment in time, first processing the initial documents providing processed initial documents, first identifying a plurality of first associations of the initial documents using the processed initial documents, generating a first visualization depicting the first associations, accessing a plurality of additional documents at a second moment in time after the first moment in time, second processing the additional documents providing processed additional documents, secondmore » identifying a plurality of second associations of the additional documents and at least some of the initial documents, wherein the second identifying comprises identifying using the processed initial documents and the processed additional documents, and generating a second visualization depicting the second associations.« less

76 FR 39127 - Manufacturer of Controlled Substances; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

... Administration (DEA) to be registered as a bulk manufacturer of Remifentanil (9739) the basic class of controlled substance in schedule II. The company plans to utilize this facility to manufacture small quantities of the... primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in...

Utility of Big Area Additive Manufacturing (BAAM) For The Rapid Manufacture of Customized Electric Vehicles

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

Love, Lonnie J.

This Oak Ridge National Laboratory (ORNL) Manufacturing Development Facility (MDF) technical collaboration project was conducted in two phases as a CRADA with Local Motors Inc. Phase 1 was previously reported as Advanced Manufacturing of Complex Cyber Mechanical Devices through Community Engagement and Micro-manufacturing and demonstrated the integration of components onto a prototype body part for a vehicle. Phase 2 was reported as Utility of Big Area Additive Manufacturing (BAAM) for the Rapid Manufacture of Customized Electric Vehicles and demonstrated the high profile live printing of an all-electric vehicle using ONRL s Big Area Additive Manufacturing (BAAM) technology. This demonstration generatedmore » considerable national attention and successfully demonstrated the capabilities of the BAAM system as developed by ORNL and Cincinnati, Inc. and the feasibility of additive manufacturing of a full scale electric vehicle as envisioned by the CRADA partner Local Motors, Inc.« less

A manufacturer's perspective: Hewlett Packard Y2K action plan.

PubMed

Rapp, W N

1999-01-01

Medical device manufacturers must ensure that their devices are safe and effective including investigating issues involved with the century rollover. Manufacturers must begin early to evaluate their products in order to allow time to correct and distribute these product corrections and communicate to their customers so they can prepare for the Y2K event.

Using CORBA to integrate manufacturing cells to a virtual enterprise

NASA Astrophysics Data System (ADS)

Pancerella, Carmen M.; Whiteside, Robert A.

1997-01-01

It is critical in today's enterprises that manufacturing facilities are not isolated from design, planning, and other business activities and that information flows easily and bidirectionally between these activities. It is also important and cost-effective that COTS software, databases, and corporate legacy codes are well integrated in the information architecture. Further, much of the information generated during manufacturing must be dynamically accessible to engineering and business operations both in a restricted corporate intranet and on the internet. The software integration strategy in the Sandia Agile Manufacturing Testbed supports these enterprise requirements. We are developing a CORBA-based distributed object software system for manufacturing. Each physical machining device is a CORBA object and exports a common IDL interface to allow for rapid and dynamic insertion, deletion, and upgrading within the manufacturing cell. Cell management CORBA components access manufacturing devices without knowledge of any device-specific implementation. To support information flow from design to planning data is accessible to machinists on the shop floor. CORBA allows manufacturing components to be easily accessible to the enterprise. Dynamic clients can be created using web browsers and portable Java GUI's. A CORBA-OLE adapter allows integration to PC desktop applications. Other commercial software can access CORBA network objects in the information architecture through vendor API's.

Additive technology of soluble mold tooling for embedded devices in composite structures: A study on manufactured tolerances

NASA Astrophysics Data System (ADS)

Roy, Madhuparna

Composite textiles have found widespread use and advantages in various industries and applications. The constant demand for high quality products and services requires companies to minimize their manufacturing costs, and delivery time in order to compete in general and niche marketplaces. Advanced manufacturing methods aim to provide economical methods of mold production. Creation of molding and tooling options for advanced composites encompasses a large portion of the fabrication time, making it a costly process and restraining factor. This research discusses a preliminary investigation into the use of soluble polymer compounds and additive manufacturing to fabricate soluble molds. These molds suffer from dimensional errors due to several factors, which have also been characterized. The basic soluble mold of a composite is 3D printed to meet the desired dimensions and geometry of holistic structures or spliced components. The time taken to dissolve the mold depends on the rate of agitation of the solvent. This process is steered towards enabling the implantation of optoelectronic devices within the composite to provide sensing capability for structural health monitoring. The shape deviation of the 3D printed mold is also studied and compared to its original dimensions to optimize the dimensional quality to produce dimensionally accurate parts. Mechanical tests were performed on compact tension (CT) resin samples prepared from these 3D printed molds and revealed crack propagation towards an embedded intact optical fiber.

77 FR 5849 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... (DEA) to be registered as a bulk manufacturer of Remifentanil (9739), the basic class of controlled substance in schedule II. The company plans to utilize this facility to manufacture small quantities of the... manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this...

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

21 CFR 807.25 - Information required for device establishment registration and device listing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

24 CFR 982.623 - Manufactured home space rental: Housing assistance payment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Manufactured home space rental... Special Housing Types Manufactured Home Space Rental § 982.623 Manufactured home space rental: Housing...) Manufactured home space cost minus the total tenant payment. (ii) The rent to owner for the manufactured home...

24 CFR 982.623 - Manufactured home space rental: Housing assistance payment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Manufactured home space rental... Special Housing Types Manufactured Home Space Rental § 982.623 Manufactured home space rental: Housing...) Manufactured home space cost minus the total tenant payment. (ii) The rent to owner for the manufactured home...

24 CFR 982.623 - Manufactured home space rental: Housing assistance payment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Manufactured home space rental... Special Housing Types Manufactured Home Space Rental § 982.623 Manufactured home space rental: Housing...) Manufactured home space cost minus the total tenant payment. (ii) The rent to owner for the manufactured home...

10 CFR 32.54 - Same: Labeling of devices.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS... licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or.... The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing...

10 CFR 32.54 - Same: Labeling of devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS... licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or.... The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing...

Cost Accounting in the Automated Manufacturing Environment

DTIC Science & Technology

1988-06-01

1 NAVAL POSTGRADUATE SCHOOL M terey, California 0 DTIC II ELECTE R AD%$° NO 0,19880 -- THESIS COST ACCOUNTING IN THE AUTOMATED MANUFACTURING...PROJECT TASK WORK UNIT ELEMENT NO. NO NO ACCESSION NO 11. TITLE (Include Security Classification) E COST ACCOUNTING IN THE AUTOMATED MANUFACTURING...GROUP ’" Cost Accounting ; Product Costing ; Automated Manufacturing; CAD/CAM- CIM 19 ABSTRACT (Continue on reverse if necessary and identify by blo

Additive manufacturing of hybrid circuits

DOE PAGES

Bell, Nelson S.; Sarobol, Pylin; Cook, Adam; ...

2016-03-26

There is a rising interest in developing functional electronics using additively manufactured components. Considerations in materials selection and pathways to forming hybrid circuits and devices must demonstrate useful electronic function; must enable integration; and must complement the complex shape, low cost, high volume, and high functionality of structural but generally electronically passive additively manufactured components. This article reviews several emerging technologies being used in industry and research/development to provide integration advantages of fabricating multilayer hybrid circuits or devices. First, we review a maskless, noncontact, direct write (DW) technology that excels in the deposition of metallic colloid inks for electrical interconnects.more » Second, we review a complementary technology, aerosol deposition (AD), which excels in the deposition of metallic and ceramic powder as consolidated, thick conformal coatings and is additionally patternable through masking. As a result, we show examples of hybrid circuits/devices integrated beyond 2-D planes, using combinations of DW or AD processes and conventional, established processes.« less

Additive manufacturing and analysis of high frequency interconnects for microwave devices

NASA Astrophysics Data System (ADS)

Harper, Elicia K.

Wire bond interconnects have been the main approach to interconnecting microelectronic devices within a package. Conventional wirebonding however offers little control of the impedance of the interconnect and also introduces parasitic inductance that can degrade performance at microwave frequencies. The size and compactness of microchips is often an issue when it comes to attaching wirebonds to the microchip or other components within a microwave module. This work demonstrates the use of additive manufacturing for printing interconnects directly between bare die microchips and other components within a microwave module. A test structure was developed consisting of a GaAs microchip sandwiched between two alumina blocks patterned with coplanar waveguides (CPW). A printed dielectric ink is used to fill the gap between the alumina CPW blocks and the GaAs chip. Conductive interconnects are printed on top of the dielectric bridge material to connect the CPW traces to the bonding pads on the GaAs microchip. Simulations of these structures were modeled in the electromagnetics simulation tool by ANSYS, high frequency structure simulation (HFSS), to optimize the printed interconnects at 1-40 GHz (ANSYS Inc., Canonsburg, PA). The dielectric constant and loss tangent of the simulated dielectric was varied along with the dimensions of the conductive interconnects. The best combination of dielectric properties and interconnect dimensions was chosen for impedance matching by analyzing the insertion losses and return losses. A dielectric ink, which was chosen based on the simulated results, was experimentally printed between the two CPW blocks and the GaAs chip and subsequently cured. The conductive interconnects were then printed with an aerosol jet printer, connecting the CPW traces to the bonding pads on the GaAs microchip. The experimental prototype was then measured with a network analyzer and the measured data were compared to simulations. Results show good agreement between

Sealed container sampling device

NASA Technical Reports Server (NTRS)

Hennigan, T. J.

1969-01-01

Sampling device, by means of a tapered needle, pierces a sealed container while maintaining the seal and either evacuates or pressurizes the container. This device has many applications in the chemical, preservative and battery-manufacturing industries.

Image quality assessment for teledermatology: from consumer devices to a dedicated medical device

NASA Astrophysics Data System (ADS)

Amouroux, Marine; Le Cunff, Sébastien; Haudrechy, Alexandre; Blondel, Walter

2017-03-01

Aging population as well as growing incidence of type 2 diabetes induce a growing incidence of chronic skin disorders. In the meantime, chronic shortage of dermatologists leaves some areas underserved. Remote triage and assistance to homecare nurses (known as "teledermatology") appear to be promising solutions to provide dermatological valuation in a decent time to patients wherever they live. Nowadays, teledermatology is often based on consumer devices (digital tablets, smartphones, webcams) whose photobiological and electrical safety levels do not match with medical devices' levels. The American Telemedicine Association (ATA) has published recommendations on quality standards for teledermatology. This "quick guide" does not address the issue of image quality which is critical in domestic environments where lighting is rarely reproducible. Standardized approaches of image quality would allow clinical trial comparison, calibration, manufacturing quality control and quality insurance during clinical use. Therefore, we defined several critical metrics using calibration charts (color and resolution charts) in order to assess image quality such as resolution, lighting uniformity, color repeatability and discrimination of key couples of colors. Using such metrics, we compared quality of images produced by several medical devices (handheld and video-dermoscopes) as well as by consumer devices (digital tablet and cameras) widely spread among dermatologists practice. Since diagnosis accuracy may be impaired by "low quality-images", this study highlights that, from an optical point of view, teledermatology should only be performed using medical devices. Furthermore, a dedicated medical device should probably be developed for the time follow-up of skin lesions often managed in teledermatology such as chronic wounds that require i) noncontact imaging of ii) large areas of skin surfaces, both criteria that cannot be matched using dermoscopes.

Biocompatibility of Advanced Manufactured Titanium Implants-A Review.

PubMed

Sidambe, Alfred T

2014-12-19

Titanium (Ti) and its alloys may be processed via advanced powder manufacturing routes such as additive layer manufacturing (or 3D printing) or metal injection moulding. This field is receiving increased attention from various manufacturing sectors including the medical devices sector. It is possible that advanced manufacturing techniques could replace the machining or casting of metal alloys in the manufacture of devices because of associated advantages that include design flexibility, reduced processing costs, reduced waste, and the opportunity to more easily manufacture complex or custom-shaped implants. The emerging advanced manufacturing approaches of metal injection moulding and additive layer manufacturing are receiving particular attention from the implant fabrication industry because they could overcome some of the difficulties associated with traditional implant fabrication techniques such as titanium casting. Using advanced manufacturing, it is also possible to produce more complex porous structures with improved mechanical performance, potentially matching the modulus of elasticity of local bone. While the economic and engineering potential of advanced manufacturing for the manufacture of musculo-skeletal implants is therefore clear, the impact on the biocompatibility of the materials has been less investigated. In this review, the capabilities of advanced powder manufacturing routes in producing components that are suitable for biomedical implant applications are assessed with emphasis placed on surface finishes and porous structures. Given that biocompatibility and host bone response are critical determinants of clinical performance, published studies of in vitro and in vivo research have been considered carefully. The review concludes with a future outlook on advanced Ti production for biomedical implants using powder metallurgy.

Biocompatibility of Advanced Manufactured Titanium Implants—A Review

PubMed Central

Sidambe, Alfred T.

2014-01-01

Titanium (Ti) and its alloys may be processed via advanced powder manufacturing routes such as additive layer manufacturing (or 3D printing) or metal injection moulding. This field is receiving increased attention from various manufacturing sectors including the medical devices sector. It is possible that advanced manufacturing techniques could replace the machining or casting of metal alloys in the manufacture of devices because of associated advantages that include design flexibility, reduced processing costs, reduced waste, and the opportunity to more easily manufacture complex or custom-shaped implants. The emerging advanced manufacturing approaches of metal injection moulding and additive layer manufacturing are receiving particular attention from the implant fabrication industry because they could overcome some of the difficulties associated with traditional implant fabrication techniques such as titanium casting. Using advanced manufacturing, it is also possible to produce more complex porous structures with improved mechanical performance, potentially matching the modulus of elasticity of local bone. While the economic and engineering potential of advanced manufacturing for the manufacture of musculo-skeletal implants is therefore clear, the impact on the biocompatibility of the materials has been less investigated. In this review, the capabilities of advanced powder manufacturing routes in producing components that are suitable for biomedical implant applications are assessed with emphasis placed on surface finishes and porous structures. Given that biocompatibility and host bone response are critical determinants of clinical performance, published studies of in vitro and in vivo research have been considered carefully. The review concludes with a future outlook on advanced Ti production for biomedical implants using powder metallurgy. PMID:28788296

Implantation of a HeartMate II left ventricular assist device via left thoracotomy.

PubMed

Cho, Yang Hyun; Deo, Salil V; Schirger, John A; Pereira, Naveen L; Stulak, John M; Park, Soon J

2012-11-01

Left thoracotomy was used as an approach for the implantation of pulsatile ventricular assist devices. Avoiding the standard approach of median sternotomy is attractive in patients undergoing complicated redo cardiac surgery, especially with prior mediastinal radiation. We report a case of the use of left thoracotomy for the implantation of the HeartMate II axial-flow pump. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

Silicon Chemical Vapor Deposition Process Using a Half-Inch Silicon Wafer for Minimal Manufacturing System

NASA Astrophysics Data System (ADS)

Li, Ning; Habuka, Hitoshi; Ikeda, Shin-ichi; Hara, Shiro

A chemical vapor deposition reactor for producing thin silicon films was designed and developed for achieving a new electronic device production system, the Minimal Manufacturing, using a half-inch wafer. This system requires a rapid process by a small footprint reactor. This was designed and verified by employing the technical issues, such as (i) vertical gas flow, (ii) thermal operation using a highly concentrated infrared flux, and (iii) reactor cleaning by chlorine trifluoride gas. The combination of (i) and (ii) could achieve a low heating power and a fast cooling designed by the heat balance of the small wafer placed at a position outside of the reflector. The cleaning process could be rapid by (iii). The heating step could be skipped because chlorine trifluoride gas was reactive at any temperature higher than room temperature.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

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

Analysis of the interaction of deuterium plasmas with tungsten in the Fuego-Nuevo II device

NASA Astrophysics Data System (ADS)

Ramos, Gonzalo; Castillo, Fermín; Nieto, Martín; Martínez, Marco; Rangel, José; Herrera-Velázquez, Julio

2012-10-01

Tungsten is one of the main candidate materials for plasma-facing components in future fusion power plants. The Fuego-Nuevo II, a plasma focus device, which can produce dense magnetized helium and deuterium plasmas, has been adapted to address plasma-facing materials questions. In this paper we present results of tungsten targets exposed to deuterium plasmas in the Fuego Nuevo II device, using different experimental conditions. The plasma generated and accelerated in the coaxial gun is expected to have, before the pinch, energies of the order of hundreds eV and velocities of the order of 40,000 m s-1. At the pinch, the ions are reported to have energies of the order of 1.5 keV at most. The samples, analysed with a scanning electron microscope (SEM) in cross section show a damage profile to depths of the order of 580 nm, which are larger than those expected for ions with 1.5 keV, and may be evidence of ion acceleration. An analysis with the SRIM (Stopping Range of Ions in Matter) package calculations is shown.

Solid-State Additive Manufacturing for Heat Exchangers

NASA Astrophysics Data System (ADS)

Norfolk, Mark; Johnson, Hilary

2015-03-01

Energy densities in devices are increasing across many industries including power generation, high power electronics, manufacturing, and automotive. Increasingly, there is a need for very high efficiency thermal management devices that can pull heat out of a small area at higher and higher rates. Metal additive manufacturing (AM) technologies have the promise of creating parts with complex internal geometries required for integral thermal management. However, this goal has not been met due to constraints in fusion-based metal 3D printers. This work presents a new strategy for metal AM of heat exchangers using an ultrasonic sheet lamination approach.

Strategic drivers of contract manufacturing: Part I, The theory.

PubMed

Tomlinson, Geoff; Geimer, Harald

2002-12-01

Medical device manufacturers and diagnostics companies have significantly increased their use of contract manufacturers to outsource production of components. This, the first of a two-part article, reviews strategic benefits and best practices in outsourcing.

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

PubMed

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

2016-09-21

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

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

PubMed Central

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

2016-01-01

We report on the detailed electrical investigation of all-inkjet-printed thin-film transistor (TFT) arrays focusing on TFT failures and their origins. The TFT arrays were manufactured on flexible polymer substrates in ambient condition without the need for cleanroom environment or inert atmosphere and at a maximum temperature of 150 °C. Alternative manufacturing processes for electronic devices such as inkjet printing suffer from lower accuracy compared to traditional microelectronic manufacturing methods. Furthermore, usually printing methods do not allow the manufacturing of electronic devices with high yield (high number of functional devices). In general, the manufacturing yield is much lower compared to the established conventional manufacturing methods based on lithography. Thus, the focus of this contribution is set on a comprehensive analysis of defective TFTs printed by inkjet technology. Based on root cause analysis, we present the defects by developing failure categories and discuss the reasons for the defects. This procedure identifies failure origins and allows the optimization of the manufacturing resulting finally to a yield improvement. PMID:27649784

76 FR 62449 - Manufacturer of Controlled Substances; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

...), this is notice that on May 4, 2011, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa... Concentrate of Poppy Straw (9670) II Sufentanil (9740) II Fentanyl (9801) II The company will manufacture the...

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

PubMed

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

Accuracy of mechanical torque-limiting devices for dental implants.

PubMed

L'Homme-Langlois, Emilie; Yilmaz, Burak; Chien, Hua-Hong; McGlumphy, Edwin

2015-10-01

A common complication in implant dentistry is unintentional implant screw loosening. The critical factor in the prevention of screw loosening is the delivery of the appropriate target torque value. Mechanical torque-limiting devices (MTLDs) are the most frequently recommended devices by the implant manufacturers to deliver the target torque value to the screw. Two types of MTLDs are available: friction-style and spring-style. Limited information is available regarding the influence of device type on the accuracy of MTLDs. The purpose of this study was to determine and compare the accuracy of spring-style and friction-style MTLDs. Five MTLDs from 6 different dental implant manufacturers (Astra Tech/Dentsply, Zimmer Dental, Biohorizons, Biomet 3i, Straumann [ITI], and Nobel Biocare) (n=5 per manufacturer) were selected to determine their accuracy in delivering target torque values preset by their manufacturers. All torque-limiting devices were new and there were 3 manufacturers for the friction-style and 3 manufacturers for the spring-style. The procedure of target torque measurement was performed 10 times for each device and a digital torque gauge (Chatillon Model DFS2-R-ND; Ametek) was used to record the measurements. Statistical analysis used nonparametric tests to determine the accuracy of the MTLDs in delivering target torque values and Bonferroni post hoc tests were used to assess pairwise comparisons. Median absolute difference between delivered torque values and target torque values of friction-style and spring-style MTLDs were not significantly different (P>.05). Accuracy of Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly different than Biohorizons torque-limiting devices (P<.05). There is no difference between the accuracy of new friction-style MTLDs and new spring-style MTLDs. All MTLDs fell within ±10% of the target torque value. Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

21 CFR 807.65 - Exemptions for device establishments.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

NextFlex Flexible Hybrid Electronics Manufacturing

DTIC Science & Technology

2016-10-01

Defense AT&L: September-October 2016 32 ADVANCED MANUFACTURING N NextFlex Flexible Hybrid Electronics Manufacturing Eric Forsythe, Ph.D.  Benjamin...New York, in both Physics and Chemistry, where he worked on electronic interfaces and carrier transport in organic light-emitting devices in...Ohio. extFlex, America’s Flexible Hybrid Electronics Manu- facturing Innovation Institute, is a program formed out of a cooperative agreement awarded

New orthopedic devices and the FDA.

PubMed

Sheth, Ujash; Nguyen, Nhu-An; Gaines, Sean; Bhandari, Mohit; Mehlman, Charles T; Klein, Guy

2009-01-01

Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.

33 CFR 159.5 - Requirements for vessel manufacturers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Requirements for vessel manufacturers. 159.5 Section 159.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES General § 159.5 Requirements for vessel manufacturers. No...

33 CFR 159.5 - Requirements for vessel manufacturers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Requirements for vessel manufacturers. 159.5 Section 159.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES General § 159.5 Requirements for vessel manufacturers. No...

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

PubMed

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.

75 FR 76756 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

... Tetrahydrocannabinols (7370) I Methamphetamine (1105) II Nabilone (7379) II With regard to Gamma Hydroxybutyric Acid (2010), Tetrahydrocannabinols (7370), and Methamphetamine (1105) only, the company manufactures these...

The Consequences of Metric Production for Small Manufacturers. Volume II. Case Studies of Large Business-Small Business Interaction,

DTIC Science & Technology

1982-02-08

II 00 CASE STUDIES OF LARGE BUSINESS - SMALL BUSINESS INTERACTION ’C- DTIC. Henry H1. Hitchcock dlELECTE7 Joseph F. Coates Marcy M. Canavan AUGG261982...J wis&omWWS1ARET N W WASIINGTOW. OC NO$I THE CONSEQUENCES OF METRIC PRODUCTION FOR SMALL MANUFACTURERS Volume 11 CASE STUDIES OF LARGE BUSINESS ... SMALL BUSINESS INTERACTION Accesqi~r, For NTIS GRA&t DTIC TAB Unannoun~ced J’htiI’ctof _ Henry H. Hitchcock vi 1ribr i t o aes Joseph F. Coates Avail arid

French Sizing of Medical Devices is not Fit for Purpose

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

Kibriya, Nabil, E-mail: nabskib@yahoo.co.uk; Hall, Rebecca; Powell, Steven

PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels ofmore » interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.« less

21 CFR 1303.22 - Procedure for applying for individual manufacturing quotas.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturing quotas. Any person who is registered to manufacture any basic class of controlled substance listed in Schedule I or II and who desires to manufacture a quantity of such class shall apply on DEA Form 189 for a manufacturing quota for such quantity of such class. Copies of DEA Form 189 may be obtained...

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Nanochanneled Device and Related Methods

NASA Technical Reports Server (NTRS)

Goodall, Randy (Inventor); Hosali, Sharath (Inventor); Grattoni, Alessandro (Inventor); Fine, Daniel (Inventor); Hudson, Lee (Inventor); Ferrari, Mauro (Inventor); Liu, Xuewu (Inventor); Medema, Ryan (Inventor)

2013-01-01

A nanochannel delivery device and method of manufacturing and use. The nanochannel delivery device comprises an inlet, an outlet, and a nanochannel. The nanochannel may be oriented parallel to the primary plane of the nanochannel delivery device. The inlet and outlet may be in direct fluid communication with the nanochannel.

Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

PubMed

2017-12-20

The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss 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 image processing device for estimation of external blood loss' 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.

Solid state laser applications in photovoltaics manufacturing

NASA Astrophysics Data System (ADS)

Dunsky, Corey; Colville, Finlay

2008-02-01

Photovoltaic energy conversion devices are on a rapidly accelerating growth path driven by increasing government and societal pressure to use renewable energy as part of an overall strategy to address global warming attributed to greenhouse gas emissions. Initially supported in several countries by generous tax subsidies, solar cell manufacturers are relentlessly pushing the performance/cost ratio of these devices in a quest to reach true cost parity with grid electricity. Clearly this eventual goal will result in further acceleration in the overall market growth. Silicon wafer based solar cells are currently the mainstay of solar end-user installations with a cost up to three times grid electricity. But next-generation technology in the form of thin-film devices promises streamlined, high-volume manufacturing and greatly reduced silicon consumption, resulting in dramatically lower per unit fabrication costs. Notwithstanding the modest conversion efficiency of thin-film devices compared to wafered silicon products (around 6-10% versus 15-20%), this cost reduction is driving existing and start-up solar manufacturers to switch to thin-film production. A key aspect of these devices is patterning large panels to create a monolithic array of series-interconnected cells to form a low current, high voltage module. This patterning is accomplished in three critical scribing processes called P1, P2, and P3. Lasers are the technology of choice for these processes, delivering the desired combination of high throughput and narrow, clean scribes. This paper examines these processes and discusses the optimization of industrial lasers to meet their specific needs.

Space Manufacturing: The Next Great Challenge

NASA Technical Reports Server (NTRS)

Whitaker, Ann F.; Curreri, Peter; Sharpe, Jonathan B.; Colberg, Wendell R.; Vickers, John H.

1998-01-01

Space manufacturing encompasses the research, development and manufacture necessary for the production of any product to be used in near zero gravity, and the production of spacecraft required for transporting research or production devices to space. Manufacturing for space, and manufacturing in space will require significant breakthroughs in materials and manufacturing technology, as well as in equipment designs. This report reviews some of the current initiatives in achieving space manufacturing. The first initiative deals with materials processing in space, e.g., processing non-terrestrial and terrestrial materials, especially metals. Some of the ramifications of the United States Microgravity Payloads fourth (USMP-4) mission are discussed. Some problems in non-terrestrial materials processing are mentioned. The second initiative is structures processing in space. In order to accomplish this, the International Space Welding Experiment was designed to demonstrate welding technology in near-zero gravity. The third initiative is advancements in earth-based manufacturing technologies necessary to achieve low cost access to space. The advancements discussed include development of lightweight material having high specific strength, and automated fabrication and manufacturing methods for these materials.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

76 FR 13432 - In the Matter of Certain Display Devices, Including Digital Televisions and Monitors II; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-765] In the Matter of Certain Display Devices, Including Digital Televisions and Monitors II; Notice of Investigation AGENCY: U.S. International Trade... that a complaint was filed with the U.S. International Trade Commission on February 9, 2011, under...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Bio-Manufacturing to market pilot project

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

Dressen, Tiffaney

The Bio-Manufacturing to Market pilot project was a part of the AMJIAC, the Advanced Manufacturing Jobs and Innovation Accelerator Challenge grant. This internship program set out to further define and enhance the talent pipeline from the University and local Community Colleges to startup culture in East Bay Area, provide undergraduate STEM students with opportunities outside academia, and provide startup companies with much needed talent. Over the 4 year period of performance, the Bio-Manufacturing to Market internship program sponsored 75 undergraduate STEM students who were able to spend anywhere from one to six semesters working with local Bay Area startup companiesmore » and DOE sponsored facilities/programs in the biotech, bio-manufacturing, and biomedical device fields.« less

Non- contacting capacitive diagnostic device

DOEpatents

Ellison, Timothy

2005-07-12

A non-contacting capacitive diagnostic device includes a pulsed light source for producing an electric field in a semiconductor or photovoltaic device or material to be evaluated and a circuit responsive to the electric field. The circuit is not in physical contact with the device or material being evaluated and produces an electrical signal characteristic of the electric field produced in the device or material. The diagnostic device permits quality control and evaluation of semiconductor or photovoltaic device properties in continuous manufacturing processes.

A new manufacturing process to remove thrombogenic factors (II, VII, IX, X, and XI) from intravenous immunoglobulin gamma preparations.

PubMed

Park, Dong Hwarn; Kang, Gil Bu; Kang, Dae Eun; Hong, Jeung Woon; Lee, Min Gyu; Kim, Ki Yong; Han, Jeung Whan

2017-01-01

Coagulation factors (II, VII, IX, X, and particularly XIa) remaining in high concentrations in intravenous immunoglobulin (IVIG) preparations can form thrombi, causing thromboembolic events, and in serious cases, result in death. Therefore, manufacturers of biological products must investigate the ability of their production processes to remove procoagulant activities. Previously, we were able to remove coagulation factors II, VII, IX, and X from our IVIG preparation through ethanol precipitation, but factor XIa, which plays an important role in thrombosis, remained in the intermediate products. Here, we used a chromatographic process using a new resin that binds with high capacity to IgG and removes procoagulant activities. The procoagulant activities were reduced to low levels as determined by the thrombin generation assay: <1.56 mIU/mL, chromogenic FXIa assay: <0.16 mIU/mL, non-activated partial thromboplastin time (NaPTT): >250 s, FXI/FXIa ELISA: <0.31 ng/mL. Even after spiking with FXIa at a concentration 32.5 times higher than the concentration in normal specimens, the procoagulant activities were below the detection limit (<0.31 ng/mL). These results demonstrate the ability of our manufacturing process to remove procoagulant activities to below the detection limit (except by NaPTT), suggesting a reduced risk of thromboembolic events that maybe potentially caused by our IVIG preparation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Tele-manufactured affordable smartphone anterior segment microscope.

PubMed

Chiong, Hong Sheng; Fang, Joyce Lim Luann; Wilson, Graham

2016-11-01

The recent advances in mobile technology have made the smartphone a powerful and accessible tool. This article describe the development of a novel smartphone-based anterior segment microscope that is compatible with tele-manufacturing. The anterior segment microscope is equipped with both cobalt-blue and red-free filters that can be used for clinical photo-documentation. The digital files of the microscope are transferrable and compatible with additive-manufacturing. Therefore, the entire device can be locally manufactured with rapid prototyping techniques such as 3D printing. © 2016 Optometry Australia.

21 CFR 1304.22 - Records for manufacturers, distributors, dispensers, researchers, importers and exporters.

Code of Federal Regulations, 2010 CFR

2010-04-01

... other controlled or noncontrolled substances in finished form, (i) The name of the substance; (ii) The... manufactured; (E) The quantity used in quality control; (F) The quantity lost during manufacturing and the... controlled substances used in the manufacturing process; (vi) The quantity used to manufacture other...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

21 CFR 820.181 - Device master record.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

76 FR 81979 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... Cordova, California 95670, made application to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Thebaine (9333) II Poppy...

77 FR 5848 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... 12194, Research Triangle, North Carolina 27709, made application by renewal to the Drug Enforcement... substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and...

A Manufacturing Cost and Supply Chain Analysis of SiC Power Electronics Applicable to Medium-Voltage Motor Drives

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

Horowitz, Kelsey; Remo, Timothy; Reese, Samantha

Wide bandgap (WBG) semiconductor devices are increasingly being considered for use in certain power electronics applications, where they can improve efficiency, performance, footprint, and, potentially, total system cost compared to systems using traditional silicon (Si) devices. Silicon carbide (SiC) devices in particular -- which are currently more mature than other WBG devices -- are poised for growth in the coming years. Today, the manufacturing of SiC wafers is concentrated in the United States, and chip production is split roughly equally between the United States, Japan, and Europe. Established contract manufacturers located throughout Asia typically carry out manufacturing of WBG powermore » modules. We seek to understand how global manufacturing of SiC components may evolve over time by illustrating the regional cost drivers along the supply chain and providing an overview of other factors that influence where manufacturing is sited. We conduct this analysis for a particular case study where SiC devices are used in a medium-voltage motor drive.« less

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device packaging. 820.130 Section 820.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer...

21 CFR 820.120 - Device labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device labeling. 820.120 Section 820.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.120 Device labeling. Each manufacturer...

40 CFR 610.22 - Device integrity.

Code of Federal Regulations, 2012 CFR

2012-07-01

... RETROFIT DEVICES Test Procedures and Evaluation Criteria Evaluation Criteria for the Preliminary Analysis... to which device manufacture is standardized by means of drawings, specifications, and other... which test data support (b), (c) and (d). ...

40 CFR 610.22 - Device integrity.

Code of Federal Regulations, 2013 CFR

2013-07-01

... RETROFIT DEVICES Test Procedures and Evaluation Criteria Evaluation Criteria for the Preliminary Analysis... to which device manufacture is standardized by means of drawings, specifications, and other... which test data support (b), (c) and (d). ...

40 CFR 610.22 - Device integrity.

Code of Federal Regulations, 2014 CFR

2014-07-01

... RETROFIT DEVICES Test Procedures and Evaluation Criteria Evaluation Criteria for the Preliminary Analysis... to which device manufacture is standardized by means of drawings, specifications, and other... which test data support (b), (c) and (d). ...

40 CFR 610.22 - Device integrity.

Code of Federal Regulations, 2011 CFR

2011-07-01

... RETROFIT DEVICES Test Procedures and Evaluation Criteria Evaluation Criteria for the Preliminary Analysis... to which device manufacture is standardized by means of drawings, specifications, and other... which test data support (b), (c) and (d). ...

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

PubMed

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.

Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

PubMed

2007-02-01

The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Screening of Potential Landing Gear Noise Control Devices at Virginia Tech For QTD II Flight Test

NASA Technical Reports Server (NTRS)

Ravetta, Patricio A.; Burdisso, Ricardo A.; Ng, Wing F.; Khorrami, Mehdi R.; Stoker, Robert W.

2007-01-01

In support of the QTD II (Quiet Technology Demonstrator) program, aeroacoustic measurements of a 26%-scale, Boeing 777 main landing gear model were conducted in the Virginia Tech Stability Tunnel. The objective of these measurements was to perform risk mitigation studies on noise control devices for a flight test performed at Glasgow, Montana in 2005. The noise control devices were designed to target the primary main gear noise sources as observed in several previous tests. To accomplish this task, devices to reduce noise were built using stereo lithography for landing gear components such as the brakes, the forward cable harness, the shock strut, the door/strut gap and the lower truck. The most promising device was down selected from test results. In subsequent stages, the initial design of the selected lower truck fairing was improved to account for all the implementation constraints encountered in the full-scale airplane. The redesigned truck fairing was then retested to assess the impact of the modifications on the noise reduction potential. From extensive acoustic measurements obtained using a 63-element microphone phased array, acoustic source maps and integrated spectra were generated in order to estimate the noise reduction achievable with each device.

Mass production compatible fabrication techniques of single-crystalline silver metamaterials and plasmonics devices

NASA Astrophysics Data System (ADS)

Rodionov, Ilya A.; Baburin, Alexander S.; Zverev, Alexander V.; Philippov, Ivan A.; Gabidulin, Aidar R.; Dobronosova, Alina A.; Ryzhova, Elena V.; Vinogradov, Alexey P.; Ivanov, Anton I.; Maklakov, Sergey S.; Baryshev, Alexander V.; Trofimov, Igor V.; Merzlikin, Alexander M.; Orlikovsky, Nikolay A.; Rizhikov, Ilya A.

2017-08-01

During last 20 years, great results in metamaterials and plasmonic nanostructures fabrication were obtained. However, large ohmic losses in metals and mass production compatibility still represent the most serious challenge that obstruct progress in the fields of metamaterials and plasmonics. Many recent research are primarily focused on developing low-loss alternative materials, such as nitrides, II-VI semiconductor oxides, high-doped semiconductors, or two-dimensional materials. In this work, we demonstrate that our perfectly fabricated silver films can be an effective low-loss material system, as theoretically well-known. We present a fabrication technology of plasmonic and metamaterial nanodevices on transparent (quartz, mica) and non-transparent (silicon) substrates by means of e-beam lithography and ICP dry etch instead of a commonly-used focused ion beam (FIB) technology. We eliminate negative influence of litho-etch steps on silver films quality and fabricate square millimeter area devices with different topologies and perfect sub-100 nm dimensions reproducibility. Our silver non-damage fabrication scheme is tested on trial manufacture of spasers, plasmonic sensors and waveguides, metasurfaces, etc. These results can be used as a flexible device manufacture platform for a broad range of practical applications in optoelectronics, communications, photovoltaics and biotechnology.

Laser micromachining of biofactory-on-a-chip devices

NASA Astrophysics Data System (ADS)

Burt, Julian P.; Goater, Andrew D.; Hayden, Christopher J.; Tame, John A.

2002-06-01

Excimer laser micromachining provides a flexible means for the manufacture and rapid prototyping of miniaturized systems such as Biofactory-on-a-Chip devices. Biofactories are miniaturized diagnostic devices capable of characterizing, manipulating, separating and sorting suspension of particles such as biological cells. Such systems operate by exploiting the electrical properties of microparticles and controlling particle movement in AC non- uniform stationary and moving electric fields. Applications of Biofactory devices are diverse and include, among others, the healthcare, pharmaceutical, chemical processing, environmental monitoring and food diagnostic markets. To achieve such characterization and separation, Biofactory devices employ laboratory-on-a-chip type components such as complex multilayer microelectrode arrays, microfluidic channels, manifold systems and on-chip detection systems. Here we discuss the manufacturing requirements of Biofactory devices and describe the use of different excimer laser micromachined methods both in stand-alone processes and also in conjunction with conventional fabrication processes such as photolithography and thermal molding. Particular attention is given to the production of large area multilayer microelectrode arrays and the manufacture of complex cross-section microfluidic channel systems for use in simple distribution and device interfacing.

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

75 FR 10313 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule Gamma...

75 FR 10314 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug...

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

PubMed

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.

Association of HeartMate II left ventricular assist device flow estimate with thermodilution cardiac output.

PubMed

Hasin, Tal; Huebner, Marianne; Li, Zhuo; Brown, Daniel; Stulak, John M; Boilson, Barry A; Joyce, Lyle; Pereira, Naveen L; Kushwaha, Sudhir S; Park, Soon J

2014-01-01

Cardiac output (CO) assessment is important in treating patients with heart failure. Durable left ventricular assist devices (LVADs) provide essentially all CO. In currently used LVADs, estimated device flow is generated by a computerized algorithm. However, LVAD flow estimate may be inaccurate in tracking true CO. We correlated LVAD (HeartMate II) flow with thermodilution CO during postoperative care (day 2-10 after implant) in 81 patients (5,616 paired measurements). Left ventricular assist device flow and CO correlated with a low correlation coefficient (r = 0.42). Left ventricular assist device readings were lower than CO measurements by approximately 0.36 L/min, trending for larger difference with higher values. Left ventricular assist device flow measurements showed less temporal variability compared with CO. Grouping for simultaneous measured blood pressure (BP < 60, 60-70, 70-80, 80-90, and ≥90), the correlation of CO with LVAD flow differed (R = 0.42, 0.67, 0.48, 0.32, 0.32, respectively). Indicating better correlation when mean blood pressure is 60 to 70 mm Hg. Left ventricular assist device flow generally trends with measured CO, but large variability exists, hence flow measures should not be assumed to equal with CO. Clinicians should take into account variables such as high CO, BP, and opening of the aortic valve when interpreting LVAD flow readout. Direct flow sensors incorporated in the LVAD system may allow for better estimation.

Human-centered design (HCD) of a fault-finding application for mobile devices and its impact on the reduction of time in fault diagnosis in the manufacturing industry.

PubMed

Kluge, Annette; Termer, Anatoli

2017-03-01

The present article describes the design process of a fault-finding application for mobile devices, which was built to support workers' performance by guiding them through a systematic strategy to stay focused during a fault-finding process. In collaboration with a project partner in the manufacturing industry, a fault diagnosis application was conceptualized based on a human-centered design approach (ISO 9241-210:2010). A field study with 42 maintenance workers was conducted for the purpose of evaluating the performance enhancement of fault finding in three different scenarios as well as for assessing the workers' acceptance of the technology. Workers using the mobile device application were twice as fast at fault finding as the control group without the application and perceived the application as very useful. The results indicate a vast potential of the mobile application for fault diagnosis in contemporary manufacturing systems. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Database Approach to Computer Integrated Manufacturing

DTIC Science & Technology

1988-06-01

advanced application areas such as tactical weapons systems, industrial manufacturing systems, and -D, ........... . . .m - I I [ l~ ii i l I4...manufacturing industry . We will provide definitions for the functions which are most prevalent in our research. Figure 3 shows the basic processes partitioned...IGES) [Ref. 9] and the Product Definition Data Interface (PDDI) [Ref. 101. 11 The IGES specification is considered an industry standard for the

Additively manufactured porous tantalum implants.

PubMed

Wauthle, Ruben; van der Stok, Johan; Amin Yavari, Saber; Van Humbeeck, Jan; Kruth, Jean-Pierre; Zadpoor, Amir Abbas; Weinans, Harrie; Mulier, Michiel; Schrooten, Jan

2015-03-01

The medical device industry's interest in open porous, metallic biomaterials has increased in response to additive manufacturing techniques enabling the production of complex shapes that cannot be produced with conventional techniques. Tantalum is an important metal for medical devices because of its good biocompatibility. In this study selective laser melting technology was used for the first time to manufacture highly porous pure tantalum implants with fully interconnected open pores. The architecture of the porous structure in combination with the material properties of tantalum result in mechanical properties close to those of human bone and allow for bone ingrowth. The bone regeneration performance of the porous tantalum was evaluated in vivo using an orthotopic load-bearing bone defect model in the rat femur. After 12 weeks, substantial bone ingrowth, good quality of the regenerated bone and a strong, functional implant-bone interface connection were observed. Compared to identical porous Ti-6Al-4V structures, laser-melted tantalum shows excellent osteoconductive properties, has a higher normalized fatigue strength and allows for more plastic deformation due to its high ductility. It is therefore concluded that this is a first step towards a new generation of open porous tantalum implants manufactured using selective laser melting. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Composition, apparatus, and process, for sorption of gaseous compounds of group II-VII elements

DOEpatents

Tom, Glenn M.; McManus, James V.; Luxon, Bruce A.

1991-08-06

Scavenger compositions are disclosed, which have utility for effecting the sorptive removal of hazardous gases containing Group II-VII elements of the Periodic Table, such as are widely encountered in the manufacture of semiconducting materials and semiconductor devices. Gas sorption processes including the contacting of Group II-VII gaseous compounds with such scavenger compositions are likewise disclosed, together with critical space velocity contacting conditions pertaining thereto. Further described are gas contacting apparatus, including mesh structures which may be deployed in gas contacting vessels containing such scavenger compositions, to prevent solids from being introduced to or discharged from the contacting vessel in the gas stream undergoing treatment. A reticulate heat transfer structure also is disclosed, for dampening localized exothermic reaction fronts when gas mixtures comprising Group II-VII constituents are contacted with the scavenger compositions in bulk sorption contacting vessels according to the invention.

78 FR 12103 - Manufacturer of Controlled Substances; Notice of Application; GE Healthcare

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... in schedule II. The company plans to manufacture a radioactive product to diagnose Parkinson's disease; and to manufacture a bulk investigational new drug (IND) for clinical trials. Any other such...

Fabrication of Three-dimensional Paper-based Microfluidic Devices for Immunoassays.

PubMed

Fernandes, Syrena C; Wilson, Daniel J; Mace, Charles R

2017-03-09

Paper wicks fluids autonomously due to capillary action. By patterning paper with hydrophobic barriers, the transport of fluids can be controlled and directed within a layer of paper. Moreover, stacking multiple layers of patterned paper creates sophisticated three-dimensional microfluidic networks that can support the development of analytical and bioanalytical assays. Paper-based microfluidic devices are inexpensive, portable, easy to use, and require no external equipment to operate. As a result, they hold great promise as a platform for point-of-care diagnostics. In order to properly evaluate the utility and analytical performance of paper-based devices, suitable methods must be developed to ensure their manufacture is reproducible and at a scale that is appropriate for laboratory settings. In this manuscript, a method to fabricate a general device architecture that can be used for paper-based immunoassays is described. We use a form of additive manufacturing (multi-layer lamination) to prepare devices that comprise multiple layers of patterned paper and patterned adhesive. In addition to demonstrating the proper use of these three-dimensional paper-based microfluidic devices with an immunoassay for human chorionic gonadotropin (hCG), errors in the manufacturing process that may result in device failures are discussed. We expect this approach to manufacturing paper-based devices will find broad utility in the development of analytical applications designed specifically for limited-resource settings.

Additive manufacturing of microfluidic glass chips

NASA Astrophysics Data System (ADS)

Kotz, F.; Helmer, D.; Rapp, B. E.

2018-02-01

Additive manufacturing has gained great interest in the microfluidic community due to the numerous channel designs which can be tested in the early phases of a lab-on-a-chip device development. High resolution additive manufacturing like microstereolithography is largely associated with polymers. Polymers are at a disadvantage compared to other materials due to their softness and low chemical resistance. Whenever high chemical and thermal resistance combined with high optical transparency is needed, glasses become the material of choice. However, glasses are difficult to structure at the microscale requiring hazardous chemicals for etching processes. In this work we present additive manufacturing and high resolution patterning of microfluidic chips in transparent fused silica glass using stereolithography and microlithography. We print an amorphous silica nanocomposite at room temperature using benchtop stereolithography printers and a custom built microlithography system based on a digital mirror device. Using microlithography we printed structures with tens of micron resolution. The printed part is then converted to a transparent fused silica glass using thermal debinding and sintering. Printing of a microfluidic chip can be done within 30 minutes. The heat treatment can be done within two days.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

PubMed

Lehoux, P; Hivon, M; Williams-Jones, B; Miller, F A; Urbach, D R

2012-02-01

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

Scalability of carbon-nanotube-based thin film transistors for flexible electronic devices manufactured using an all roll-to-roll gravure printing system

PubMed Central

Koo, Hyunmo; Lee, Wookyu; Choi, Younchang; Sun, Junfeng; Bak, Jina; Noh, Jinsoo; Subramanian, Vivek; Azuma, Yasuo; Majima, Yutaka; Cho, Gyoujin

2015-01-01

To demonstrate that roll-to-roll (R2R) gravure printing is a suitable advanced manufacturing method for flexible thin film transistor (TFT)-based electronic circuits, three different nanomaterial-based inks (silver nanoparticles, BaTiO3 nanoparticles and single-walled carbon nanotubes (SWNTs)) were selected and optimized to enable the realization of fully printed SWNT-based TFTs (SWNT-TFTs) on 150-m-long rolls of 0.25-m-wide poly(ethylene terephthalate) (PET). SWNT-TFTs with 5 different channel lengths, namely, 30, 80, 130, 180, and 230 μm, were fabricated using a printing speed of 8 m/min. These SWNT-TFTs were characterized, and the obtained electrical parameters were related to major mechanical factors such as web tension, registration accuracy, impression roll pressure and printing speed to determine whether these mechanical factors were the sources of the observed device-to-device variations. By utilizing the electrical parameters from the SWNT-TFTs, a Monte Carlo simulation for a 1-bit adder circuit, as a reference, was conducted to demonstrate that functional circuits with reasonable complexity can indeed be manufactured using R2R gravure printing. The simulation results suggest that circuits with complexity, similar to the full adder circuit, can be printed with a 76% circuit yield if threshold voltage (Vth) variations of less than 30% can be maintained. PMID:26411839

Impact of Alternative Medical Device Approval Processes on Costs and Health

PubMed Central

George, Benjamin P.; Venkataraman, Vinayak; Dorsey, E. Ray

2014-01-01

Background Medical devices are often introduced prior to randomized‐trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out‐of‐trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP). Methods We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health. Results For manufacturers, profits were greatest under CSP—driven by faster market adoption of effective devices—followed by restrictive regulation. Societal health benefit in total quality‐adjusted life years was greatest under CSP. Insurers’ expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success. Conclusions Regulation restricting out‐of‐trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests. PMID:25185975

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.

PubMed

2003-06-02

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

More than a device: today's medical technology companies provide value through service.

PubMed

McCoy, Fred

2003-01-01

When physicians implant cardiac rhythm management devices, they establish a long-term relationship with those devices and with the manufacturers of those devices. The therapeutic value that each device will provide to its patient is enhanced throughout the life of the device by the services that the manufacturer provides. Services are provided prior to, during and long after implantation. Services include physician and allied health professional training, quality assurance programs, therapy outreach initiatives, on site technical support during device implantation and follow-up, technical service expertise and customer service support. The costs of these services are substantial. When assessed on a per device basis, the service costs may actually exceed the costs of manufacture. Further, the costs of these services are rising. Over the past five years, the number of implanted cardiac rhythm management devices has doubled. Industry field forces have tripled in size. Clearly, industry is dedicated to providing service as a critical element in achieving excellent patient outcomes.

Measurement of Device Parameters Using Image Recovery Techniques in Large-Scale IC Devices

NASA Technical Reports Server (NTRS)

Scheick, Leif; Edmonds, Larry

2004-01-01

Devices that respond to radiation on a cell level will produce histograms showing the relative frequency of cell damage as a function of damage. The measured distribution is the convolution of distributions from radiation responses, measurement noise, and manufacturing parameters. A method of extracting device characteristics and parameters from measured distributions via mathematical and image subtraction techniques is described.

Regulatory Requirements for Devices for the Handicapped.

ERIC Educational Resources Information Center

Stigi, John, Ed.; Rivera, Richard J., Ed.

This booklet explains in question/answer form the basic regulatory requirements established by the Food and Drug Administration (FDA) of the federal government concerning the manufacture, marketing and distribution of medical devices (including implantable devices and devices previously regulated as drugs) for persons with disabilities. Topics…

21 CFR 864.9750 - Heat-sealing device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Heat-sealing device. 864.9750 Section 864.9750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood...

21 CFR 864.9750 - Heat-sealing device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Heat-sealing device. 864.9750 Section 864.9750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood...

21 CFR 864.9750 - Heat-sealing device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Heat-sealing device. 864.9750 Section 864.9750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood...

Feasibility and Scaling of Composite Based Additive Manufacturing

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

Nuttall, David; Chen, Xun; Kunc, Vlastimil

2016-04-27

Engineers and Researchers at Oak Ridge National Lab s Manufacturing Demonstration Facility (ORNL MDF) collaborated with Impossible Objects (IO) in the characterization of PEEK infused carbon fiber mat manufactured by means of CBAM composite-based additive manufacturing, a first generation assembly methodology developed by Robert Swartz, Chairman, Founder, and CTO of Impossible Objects.[1] The first phase of this project focused on demonstration of CBAM for composite tooling. The outlined steps focused on selecting an appropriate shape that fit the current machine s build envelope, characterized the resulting form, and presented next steps for transitioning to a Phase II CRADA agreement. Phasemore » I of collaborative research and development agreement NFE-15-05698 was initiated in April of 2015 with an introduction to Impossible Objects, and concluded in March of 2016 with a visitation to Impossible Objects headquarters in Chicago, IL. Phase II as discussed herein is under consideration by Impossible Objects as of this writing.« less

Novel Polymeric Dielectric Materials for the Additive Manufacturing of Microwave Devices

NASA Astrophysics Data System (ADS)

O'Keefe, Shamus E.

The past decade has seen a rapid increase in the deployment of additive manufacturing (AM) due to the perceived benefits of lower cost, higher quality, and a smaller environmental footprint. And while the hardware behind most of AM processes is mature, the study and development of material feedstock(s) are in their infancy, particularly so for niche areas. In this dissertation, we look at novel polymeric materials to support AM for microwave devices. Chapter 1 provides an overview of the benefits of AM, followed by the specific motivation for this work, and finally a scope defining the core objectives. Chapter 2 delves into a higher-level background of dielectric theory and includes a brief overview of the two common dielectric spectroscopy techniques used in this work. The remaining chapters, summarized below, describe experiments in which novel polymeric materials were developed and their microwave dielectric properties measured. Chapter 3 describes the successful synthesis of polytetrafluroethylene (PTFE)/polyacrylate (PA) core-shell nanoparticles and their measured microwave dielectric properties. PTFE/PA core-shell nanoparticles with spherical morphology were successfully made by aerosol deposition followed by a brief annealing. The annealing temperature is closely controlled to exceed the glass transition (Tg) of the PA shell yet not exceed the Tg of the PTFE core. Furthermore, the annealing promotes coalescence amongst the PA shells of neighboring nanoparticles and results in the formation of a contiguous PA matrix that has excellent dispersion of PTFE cores. The measured dielectric properties agree well with theoretical predictions and suggest the potential of this material as a feedstock for AM microwave devices. Chapter 4 delves into the exploration of various polyimide systems with the aim of replacing the PA in the previously studied PTFE/PA core-shell nanoparticles. Fundamental relationships between polymer attributes (flexibility/rigidity and

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

PubMed

Tajstra, Mateusz; Sokal, Adam; Gwóźdź, Arkadiusz; Wilczek, Marcin; Gacek, Adam; Wojciechowski, Konrad; Gadula-Gacek, Elżbieta; Adamowicz-Czoch, Elżbieta; Chłosta-Niepiekło, Katarzyna; Milewski, Krzysztof; Rozentryt, Piotr; Kalarus, Zbigniew; Gąsior, Mariusz; Poloński, Lech

2017-07-01

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225). © 2016 Wiley Periodicals, Inc.

78 FR 46372 - Manufacturer of Controlled Substances; Notice of Registration; Research Triangle Institute

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by...

A Disposable Microfluidic Device with a Screen Printed Electrode for Mimicking Phase II Metabolism

PubMed Central

Vasiliadou, Rafaela; Nasr Esfahani, Mohammad Mehdi; Brown, Nathan J.; Welham, Kevin J.

2016-01-01

Human metabolism is investigated using several in vitro methods. However, the current methodologies are often expensive, tedious and complicated. Over the last decade, the combination of electrochemistry (EC) with mass spectrometry (MS) has a simpler and a cheaper alternative to mimic the human metabolism. This paper describes the development of a disposable microfluidic device with a screen-printed electrode (SPE) for monitoring phase II GSH reactions. The proposed chip has the potential to be used as a primary screening tool, thus complementing the current in vitro methods. PMID:27598162

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...

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.

PubMed

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.

Karl Otto Himmler, manufacturer of the first contact lens.

PubMed

Pearson, Richard M

2007-03-01

In 1889 August Müller (1864-1949) reported the correction of his own high myopia with a ground scleral contact lens that had been manufactured in Berlin two years earlier. This paper provides the first conclusive identification, based upon primary sources, of the manufacturer of these lenses. They were made by an optical engineer, Karl Otto Himmler (1841-1903), whose firm enjoyed, until the outbreak of World War II, an international reputation for the manufacture of microscopes and their accessories.

Comparative ex vivo evaluation of two electronic percussive testing devices measuring the stability of dental implants.

PubMed

Geckili, Onur; Bilhan, Hakan; Cilingir, Altug; Bilmenoglu, Caglar; Ates, Gokcen; Urgun, Aliye Ceren; Bural, Canan

2014-12-01

A comparative ex vivo study was performed to determine electronic percussive test values (PTVs) measured by cabled and wireless electronic percussive testing (EPT) devices and to evaluate the intra- and interobserver reliability of the wireless EPT device. Forty implants were inserted into the vertebrae and forty into the pelvis of a steer, a safe distance apart. The implants were all 4.3 mm wide and 13 mm long, from the same manufacturer. PTV of each implant was measured by four different examiners, using both EPT devices, and compared. Additionally, the intra- and interobserver reliability of the wireless EPT device was evaluated. Statistically significant differences (P <0.05) were observed between PTVs made by the two EPT devices. PTVs measured by the wireless EPT device were significantly higher than the cabled EPT device (P <0.05), indicating lower implant stability. The intraobserver reliability of the wireless EPT device was evaluated as excellent for the measurements in type II bone and good-to-excellent in type IV bone; interobserver reliability was evaluated as fair-to-good in both bone types. The wireless EPT device gives PTVs higher than the cabled EPT device, indicating lower implant stability, and its inter- and intraobserver reliability is good and acceptable.

49 CFR 393.11 - Lamps and reflective devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., meet the applicable requirements of 49 CFR 571.108 (FMVSS No. 108) in effect at the time of manufacture..., meet the requirements of subpart B of part 393 in effect at the time of manufacture. (2) Exceptions... devices and electrical equipment in effect at the time of manufacture. Trailers which are equipped with...

Humidification performance of 48 passive airway humidifiers: comparison with manufacturer data.

PubMed

Lellouche, François; Taillé, Solenne; Lefrançois, Frédéric; Deye, Nicolas; Maggiore, Salvatore Maurizio; Jouvet, Philippe; Ricard, Jean-Damien; Fumagalli, Bruno; Brochard, Laurent

2009-02-01

Heat and moisture exchangers (HMEs) are increasingly used in the ICU for gas conditioning during mechanical ventilation. Independent assessments of the humidification performance of HMEs are scarce. The aim of the present study was thus to assess the humidification performance of a large number of adult HMEs. We assessed 48 devices using a bench test apparatus that simulated real-life physiologic ventilation conditions. Thirty-two devices were described by the manufacturers as HMEs, and 16 were described as antibacterial filters. The test apparatus provided expiratory gases with an absolute humidity (AH) of 35 mg H(2)O/L. The AH of inspired gases was measured after steady state using the psychrometric method. We performed three hygrometric measurements for each device, measured their resistance, and compared our results with the manufacturer data. Of the 32 HMEs tested, only 37.5% performed well (>or= 30 mg H(2)O/L), while 25% performed poorly (< 25 mg H(2)O/L). The mean difference (+/- SD) between our measurements and the manufacturer data was 3.0 +/- 2.7 mg H(2)O/L for devices described as HMEs (maximum, 8.9 mg H(2)O/L) [p = 0.0001], while the mean difference for 36% of the HMEs was > 4 mg H(2)O/L. The mean difference for the antibacterial filters was 0.2 +/- 1.4 mg H(2)O/L. The mean resistance of all the tested devices was 2.17 +/- 0.70 cm H(2)O/L/s. Several HMEs performed poorly and should not be used as HMEs. The values determined by independent assessments may be lower than the manufacturer data. Describing a device as an HME does not guarantee that it provides adequate humidification. The performance of HMEs must be verified by independent assessment.

Efficient red organic electroluminescent devices by doping platinum(II) Schiff base emitter into two host materials with stepwise energy levels.

PubMed

Zhou, Liang; Kwok, Chi-Chung; Cheng, Gang; Zhang, Hongjie; Che, Chi-Ming

2013-07-15

In this work, organic electroluminescent (EL) devices with double light-emitting layers (EMLs) having stepwise energy levels were designed to improve the EL performance of a red-light-emitting platinum(II) Schiff base complex. A series of devices with single or double EML(s) were fabricated and characterized. Compared with single-EML devices, double-EML devices showed improved EL efficiency and brightness, attributed to better balance in carriers. In addition, the stepwise distribution in energy levels of host materials is instrumental in broadening the recombination zone, thus delaying the roll-off of EL efficiency. The highest EL current efficiency and power efficiency of 17.36 cd/A and 14.73 lm/W, respectively, were achieved with the optimized double-EML devices. At high brightness of 1000 cd/m², EL efficiency as high as 8.89 cd/A was retained.

Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.

PubMed

2018-01-02

The Food and Drug Administration (FDA or we) is classifying the whole slide imaging 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 whole slide imaging 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.

Improved Manufacturing Methods for Navy Peacoats

DTIC Science & Technology

1991-09-30

oaeration requir= S a heavy ;;erd, feed machine II n CC T is can e done either with a r I 2 .’" ark buttonhoie loc-tion with the I Ir fo I...AD-A243 702 F A S H I 0 N I INSTITUTE OF TECHNOLOGYI R E S EARCH DTIC I REPORT SELECTEI.. D D I IMPROVED MANUFACTURING METHODS FOR NAVY PEACOATS I I...A008. I IHenr A/Seesselberg Dir ctor, Advanced Apparel Manufacturing Technology Programs, Fashion Institute of Technology I Noah Bronner Research

Manufacturing of Wearable Sensors for Human Health and Performance Monitoring

NASA Astrophysics Data System (ADS)

Alizadeh, Azar

2015-03-01

Continuous monitoring of physiological and biological parameters is expected to improve performance and medical outcomes by assessing overall health status and alerting for life-saving interventions. Continuous monitoring of these parameters requires wearable devices with an appropriate form factor (lightweight, comfortable, low energy consuming and even single-use) to avoid disrupting daily activities thus ensuring operation relevance and user acceptance. Many previous efforts to implement remote and wearable sensors have suffered from high cost and poor performance, as well as low clinical and end-use acceptance. New manufacturing and system level design approaches are needed to make the performance and clinical benefits of these sensors possible while satisfying challenging economic, regulatory, clinical, and user-acceptance criteria. In this talk we will review several recent design and manufacturing efforts aimed at designing and building prototype wearable sensors. We will discuss unique opportunities and challenges provided by additive manufacturing, including 3D printing, to drive innovation through new designs, faster prototyping and manufacturing, distributed networks, and new ecosystems. We will also show alternative hybrid self-assembly based integration techniques for low cost large scale manufacturing of single use wearable devices. Coauthors: Prabhjot Singh and Jeffrey Ashe.

27 CFR 479.68 - Qualified manufacturer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Qualified manufacturer. 479.68 Section 479.68 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.68 - Qualified manufacturer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Qualified manufacturer. 479.68 Section 479.68 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.68 - Qualified manufacturer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Qualified manufacturer. 479.68 Section 479.68 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

27 CFR 479.68 - Qualified manufacturer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Qualified manufacturer. 479.68 Section 479.68 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

27 CFR 479.68 - Qualified manufacturer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Qualified manufacturer. 479.68 Section 479.68 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND...

Localized electrical fine tuning of passive microwave and radio frequency devices

DOEpatents

Findikoglu, Alp T.

2001-04-10

A method and apparatus for the localized electrical fine tuning of passive multiple element microwave or RF devices in which a nonlinear dielectric material is deposited onto predetermined areas of a substrate containing the device. An appropriate electrically conductive material is deposited over predetermined areas of the nonlinear dielectric and the signal line of the device for providing electrical contact with the nonlinear dielectric. Individual, adjustable bias voltages are applied to the electrically conductive material allowing localized electrical fine tuning of the devices. The method of the present invention can be applied to manufactured devices, or can be incorporated into the design of the devices so that it is applied at the time the devices are manufactured. The invention can be configured to provide localized fine tuning for devices including but not limited to coplanar waveguides, slotline devices, stripline devices, and microstrip devices.

Virtual manufacturing work cell for engineering

NASA Astrophysics Data System (ADS)

Watanabe, Hideo; Ohashi, Kazushi; Takahashi, Nobuyuki; Kato, Kiyotaka; Fujita, Satoru

1997-12-01

The life cycles of products have been getting shorter. To meet this rapid turnover, manufacturing systems must be frequently changed as well. In engineering to develop manufacturing systems, there are several tasks such as process planning, layout design, programming, and final testing using actual machines. This development of manufacturing systems takes a long time and is expensive. To aid the above engineering process, we have developed the virtual manufacturing workcell (VMW). This paper describes a concept of VMW and design method through computer aided manufacturing engineering using VMW (CAME-VMW) related to the above engineering tasks. The VMW has all design data, and realizes a behavior of equipment and devices using a simulator. The simulator has logical and physical functionality. The one simulates a sequence control and the other simulates motion control, shape movement in 3D space. The simulator can execute the same control software made for actual machines. Therefore we can verify the behavior precisely before the manufacturing workcell will be constructed. The VMW creates engineering work space for several engineers and offers debugging tools such as virtual equipment and virtual controllers. We applied this VMW to development of a transfer workcell for vaporization machine in actual manufacturing system to produce plasma display panel (PDP) workcell and confirmed its effectiveness.

78 FR 52802 - Manufacturer of Controlled Substances; Notice of Registration: Navinta, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Pentobarbital (2270) II...

A Modular Aerospike Engine Design Using Additive Manufacturing

NASA Technical Reports Server (NTRS)

Peugeot, John; Garcia, Chance; Burkhardt, Wendel

2014-01-01

A modular aerospike engine concept has been developed with the objective of demonstrating the viability of the aerospike design using additive manufacturing techniques. The aerospike system is a self-compensating design that allows for optimal performance over the entire flight regime and allows for the lowest possible mass vehicle designs. At low altitudes, improvements in Isp can be traded against chamber pressure, staging, and payload. In upper stage applications, expansion ratio and engine envelope can be traded against nozzle efficiency. These features provide flexibility to the System Designer optimizing a complete vehicle stage. The aerospike concept is a good example of a component that has demonstrated improved performance capability, but traditionally has manufacturing requirements that are too expensive and complex to use in a production vehicle. In recent years, additive manufacturing has emerged as a potential method for improving the speed and cost of building geometrically complex components in rocket engines. It offers a reduction in tooling overhead and significant improvements in the integration of the designer and manufacturing method. In addition, the modularity of the engine design provides the ability to perform full scale testing on the combustion devices outside of the full engine configuration. The proposed design uses a hydrocarbon based gas-generator cycle, with plans to take advantage of existing powerhead hardware while focusing DDT&E resources on manufacturing and sub-system testing of the combustion devices. The major risks for the modular aerospike concept lie in the performance of the propellant feed system, the structural integrity of the additive manufactured components, and the aerodynamic efficiency of the exhaust flow.

Challenges and Recent Developments in Hearing Aids: Part II. Feedback and Occlusion Effect Reduction Strategies, Laser Shell Manufacturing Processes, and Other Signal Processing Technologies

PubMed Central

Chung, King

2004-01-01

This is the second part of a review on the challenges and recent developments in hearing aids. Feedback and the occlusion effect pose great challenges in hearing aid design and usage. Yet, conventional solutions to feedback and the occlusion effect often create a dilemma: the solution to one often leads to the other. This review discusses the advanced signal processing strategies to reduce feedback and some new approaches to reduce the occlusion effect. Specifically, the causes of three types of feedback (acoustic, mechanical, and electromagnetic) are discussed. The strategies currently used to reduce acoustic feedback (i.e., adaptive feedback reduction algorithms using adaptive gain reduction, notch filtering, and phase cancellation strategies) and the design of new receivers that are built to reduce mechanical and electromagnetic feedback are explained. In addition, various new strategies (i.e., redesigned sound delivery devices and receiver-in-the-ear-canal hearing aid configuration) to reduce the occlusion effect are reviewed. Many manufacturers have recently adopted laser shell-manufacturing technologies to overcome problems associated with manufacturing custom hearing aid shells. The mechanisms of selected laser sintering and stereo lithographic apparatus and the properties of custom shells produced by these two processes are reviewed. Further, various new developments in hearing aid transducers, telecoils, channel-free amplification, open-platform programming options, rechargeable hearing aids, ear-level frequency modulated (FM) receivers, wireless Bluetooth FM systems, and wireless programming options are briefly explained and discussed. Finally, the applications of advanced hearing aid technologies to enhance other devices such as cochlear implants, hearing protectors, and cellular phones are discussed. PMID:15735871

Manufacturing Demonstration Facility: Roll-to-Roll Processing

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

Datskos, Panos G; Joshi, Pooran C; List III, Frederick Alyious

This Manufacturing Demonstration Facility (MDF)e roll-to-roll processing effort described in this report provided an excellent opportunity to investigate a number of advanced manufacturing approaches to achieve a path for low cost devices and sensors. Critical to this effort is the ability to deposit thin films at low temperatures using nanomaterials derived from nanofermentation. The overarching goal of this project was to develop roll-to-roll manufacturing processes of thin film deposition on low-cost flexible substrates for electronics and sensor applications. This project utilized ORNL s unique Pulse Thermal Processing (PTP) technologies coupled with non-vacuum low temperature deposition techniques, ORNL s clean roommore » facility, slot dye coating, drop casting, spin coating, screen printing and several other equipment including a Dimatix ink jet printer and a large-scale Kyocera ink jet printer. The roll-to-roll processing project had three main tasks: 1) develop and demonstrate zinc-Zn based opto-electronic sensors using low cost nanoparticulate structures manufactured in a related MDF Project using nanofermentation techniques, 2) evaluate the use of silver based conductive inks developed by project partner NovaCentrix for electronic device fabrication, and 3) demonstrate a suite of low cost printed sensors developed using non-vacuum deposition techniques which involved the integration of metal and semiconductor layers to establish a diverse sensor platform technology.« less

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

PubMed

Drum, Bruce

2004-01-01

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

A manufacturable process integration approach for graphene devices

NASA Astrophysics Data System (ADS)

Vaziri, Sam; Lupina, Grzegorz; Paussa, Alan; Smith, Anderson D.; Henkel, Christoph; Lippert, Gunther; Dabrowski, Jarek; Mehr, Wolfgang; Östling, Mikael; Lemme, Max C.

2013-06-01

In this work, we propose an integration approach for double gate graphene field effect transistors. The approach includes a number of process steps that are key for future integration of graphene in microelectronics: bottom gates with ultra-thin (2 nm) high-quality thermally grown SiO2 dielectrics, shallow trench isolation between devices and atomic layer deposited Al2O3 top gate dielectrics. The complete process flow is demonstrated with fully functional GFET transistors and can be extended to wafer scale processing. We assess, through simulation, the effects of the quantum capacitance and band bending in the silicon substrate on the effective electric fields in the top and bottom gate oxide. The proposed process technology is suitable for other graphene-based devices such as graphene-based hot electron transistors and photodetectors.

77 FR 47114 - Manufacturer of Controlled Substances; Notice of Application; AMRI Rensselaer, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... Marihuana (7360) I Tetrahydrocannabinols (7370) I Amphetamine (1100) II Lisdexamfetamine (1205) II... (Marihuana), the company plans to bulk manufacture cannabidiol as a synthetic intermediate, which will be...

MRP (materiel requirements planning) II implementation: a case study.

PubMed

Sheldon, D

1994-05-01

Manufacturing resource planning (MRP II) is a powerful and effective business planning template on which to build a continuous improvement culture. MRP II, when successfully implemented, encourages a disciplined yet nonthreatening environment centered on measurement and accountability. From the education that accompanies an MRP II implementation, the employees can better understand the vision and mission of the organization. This common goal keeps everyone's energy directed toward the same final objective. The Raymond Corporation is a major materiels handling equipment manufacturer headquartered in Greene, New York, with class "A" MRP II manufacturing facilities in Greene and Brantford, Ontario and an aftermark distribution facility in East Syracuse, New York. Prior to the implementation of MRP II in its Greene plant (from 1988 through 1990) good intentions and hard work were proving to be less than necessary to compete in the global market. Certified class "A" in February 1990. The Raymond Corporation has built a world-class organization from these foundations.

Modelling of double air-bridged structured inductor implemented by a GaAs integrated passive device manufacturing process

NASA Astrophysics Data System (ADS)

Li, Yang; Yao, Zhao; Zhang, Chun-Wei; Fu, Xiao-Qian; Li, Zhi-Ming; Li, Nian-Qiang; Wang, Cong

2017-05-01

In order to provide excellent performance and show the development of a complicated structure in a module and system, this paper presents a double air-bridge-structured symmetrical differential inductor based on integrated passive device technology. Corresponding to the proposed complicated structure, a new manufacturing process fabricated on a high-resistivity GaAs substrate is described in detail. Frequency-independent physical models are presented with lump elements and the results of skin effect-based measurements. Finally, some key features of the inductor are compared; good agreement between the measurements and modeled circuit fully verifies the validity of the proposed modeling approach. Meanwhile, we also present a comparison of different coil turns for inductor performance. The proposed work can provide a good solution for the design, fabrication, modeling, and practical application of radio-frequency modules and systems.

Design, Manufacturing and Characterization of Functionally Graded Flextensional Piezoelectric Actuators

NASA Astrophysics Data System (ADS)

Amigo, R. C. R.; Vatanabe, S. L.; Silva, E. C. N.

2013-03-01

Previous works have been shown several advantages in using Functionally Graded Materials (FGMs) for the performance of flextensional devices, such as reduction of stress concentrations and gains in reliability. In this work, the FGM concept is explored in the design of graded devices by using the Topology Optimization Method (TOM), in order to determine optimal topologies and gradations of the coupled structures of piezoactuators. The graded pieces are manufactured by using the Spark Plasma Sintering (SPS) technique and are bonded to piezoelectric ceramics. The graded actuators are then tested by using a modular vibrometer system for measuring output displacements, in order to validate the numerical simulations. The technological path developed here represents the initial step toward the manufacturing of an integral piezoelectric device, constituted by piezoelectric and non-piezoelectric materials without bonding layers.

Computers in manufacturing

NASA Astrophysics Data System (ADS)

Hudson, C. A.

1982-02-01

CAD/CAM advances and applications for enhancing productivity in industry are explored. Wide-spread use of CAD/CAM devices are projected to occur by the time period 1992-1997, resulting in a higher percentage of technicians in the manufacturing process, while the cost of computers and software will continue to fall and become more widely available. Computer aided design is becoming a commercially viable system for design and geometric modeling, engineering analysis, kinematics, and drafting, and efforts to bridge the gap between CAD and CAM are indicated, with particular attention given to layering, wherein individual monitoring of different parts of the manufacturing process can be effected without crossover of unnecessary information. The potentials and barriers to the use of robotics are described, with the added optimism that displaced workers to date have moved up to jobs of higher skill and interest.

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

PubMed

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.

PubMed

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.

Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.

PubMed

2014-07-25

The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

Ceramic Stereolithography: Additive Manufacturing for Ceramics by Photopolymerization

NASA Astrophysics Data System (ADS)

Halloran, John W.

2016-07-01

Ceramic stereolithography and related additive manufacturing methods involving photopolymerization of ceramic powder suspensions are reviewed in terms of the capabilities of current devices. The practical fundamentals of the cure depth, cure width, and cure profile are related to the optical properties of the monomer, ceramic, and photo-active components. Postpolymerization steps, including harvesting and cleaning the objects, binder burnout, and sintering, are discussed and compared with conventional methods. The prospects for practical manufacturing are discussed.

Innovation and the medical devices Farady partnership.

PubMed

Tavakoli, M; Dunkerton, S B

2005-06-01

Demand for development of new generation medical devices has led many governments to support medical-sector research. In the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical device manufacturers are outlined here.

PERFORMANCE EVALUATION OF TYPE I MARINE SANITATION DEVICES

EPA Science Inventory

This performance test was designed to evaluate the effectiveness of two Type I Marine Sanitation Devices (MSDs): the Electro Scan Model EST 12, manufactured by Raritan Engineering Company, Inc., and the Thermopure-2, manufactured by Gross Mechanical Laboratories, Inc. Performance...

NASA's In-Space Manufacturing Project: Materials and Manufacturing Process Development Update

NASA Technical Reports Server (NTRS)

Prater, Tracie; Bean, Quincy; Werkheiser, Niki; Ledbetter, Frank

2017-01-01

The mission of NASA's In-Space Manufacturing (ISM) project is to identify, design, and implement on-demand, sustainable manufacturing solutions for fabrication, maintenance and repair during exploration missions. ISM has undertaken a phased strategy of incrementally increasing manufacturing capabilities to achieve this goal. The ISM project began with the development of the first 3D printer for the International Space Station. To date, the printer has completed two phases of flight operations. Results from phase I specimens indicated some differences in material properties between ground-processed and ISS-processed specimens, but results of follow-on analyses of these parts and a ground-based study with an equivalent printer strongly indicate that this variability is likely attributable to differences in manufacturing process settings between the ground and flight prints rather than microgravity effects on the fused deposition modeling (FDM) process. Analysis of phase II specimens from the 3D Printing in Zero G tech demo, which shed further light on the sources of material variability, will be presented. The ISM project has also developed a materials characterization plan for the Additive Manufacturing Facility, the follow-on commercial multimaterial 3D printing facility developed for ISS by Made in Space. This work will yield a suite of characteristic property values that can inform use of AMF by space system designers. Other project activities include development of an integrated 3D printer and recycler, known as the Refabricator, by Tethers Unlimited, which will be operational on ISS in 2018. The project also recently issued a broad area announcement for a multimaterial fabrication laboratory, which may include in-space manufacturing capabilities for metals, electronics, and polymeric materials, to be deployed on ISS in the 2022 timeframe.

Development of a Laser Induced Fluorescence (LIF) system on the Plasma Material Interaction System (PLAMIS-II) device

NASA Astrophysics Data System (ADS)

Kang, I. J.; Lee, K. Y.; Lee, K. I.; Choi, Y.-S.; Cho, S. G.; Bae, M. K.; Lee, D.-H.; Hong, S. H.; Lho, T.; Chung, K.-S.

2015-12-01

A laser induced fluorescence (LIF) system has been developed for the plasma material interaction system (PLAMIS-II) device, which is equipped with a unique plasma gun composed of a LaB6 cathode and two anodes with electromagnets to generate a focused dense plasma. PLAMIS-II simulates the interactions of plasma with different materials and is to be used for the test of plasma facing components of fusion devices. The LIF system is composed of a seed laser with Littmann/Metcalf cavity and a master oscillator power amplifier to pump 3d4F7/2 metastable argon ion to 4p4D5/2 level at the wavelength of 668.61 nm, which has the following input parameters: laser power = 20 mW, line width < 100 kHz, and a mode-hop free tuning range > 70 GHz. For in-situ measurement of laser wavelength, the wavelength spectrum of an iodine cell was measured by a photo-transistor during LIF measurement. To measure argon ion temperature (Ti) and drift velocity (vd) in PLAMIS-II, the fluorescence light with the wavelength of 442.72 nm, emitted from 4p4D5/2 level to 4s4P3/2 level and passing through 1 nm band-width filter, was collected by the photomultiplier tube combined with a lock-in amplifier and a chopper with frequency of 3 kHz. Initial data of Ti and vd were analysed in terms of gas flow rate and applied power.

Hydrogen gas sensor and method of manufacture

DOEpatents

McKee, John M.

1991-01-01

A sensor for measuring the pressure of hydrogen gas in a nuclear reactor, and method of manufacturing the same. The sensor comprises an elongated tube of hydrogen permeable material which is connected to a pressure transducer through a feedthrough tube which passes through a wall at the boundary of the region in which hydrogen is present. The tube is pressurized and flushed with hydrogen gas at an elevated temperature during the manufacture of the sensor in order to remove all gasses other than hydrogen from the device.

Percutaneous closure of patent ductus arteriosus in children using amplatzer duct occluder II: relationship between PDA type and risk of device protrusion into the descending aorta.

PubMed

Masri, Samer; El Rassi, Issam; Arabi, Mariam; Tabbakh, Anas; Bitar, Fadi

2015-08-01

To compare the efficacy and safety of Amplatzer Duct Occluder II (ADOII) among the various patent ductus arteriosus (PDA) types, and to assess the association between development of aortic obstruction and the PDA type in terms of measurable parameters as the device angulation and distance of upper end protrusion into the aortic lumen. Retrospective cohort study involving 50 consecutive subjects who underwent ADO II device closure of PDA. The median age and weight at intervention were 13 months (5.5 months to 18 years) and 11 (6-67) kg respectively. The median smallest ductal diameter by angiography was 3.2 (1.9-5.4) mm. Thirty two patients had type A PDA, 5 had type C, 5 had type D, and 8 had type E. Residual shunt was seen in only 1 patient who had a tubular PDA and resolved within 2 months of the procedure. No device embolization or pulmonary side protrusion were noted. There was a 16% aortic protrusion rate. The median distance of protrusion of the upper end of the device into the aortic lumen was 3.1 (0-9) mm and the median angle formed between the aortic end of the device and the PDA take-off was 10.4 (0-80.6) degrees. These latter parameters of aortic obstruction were significantly higher in the non-conical PDA group as compared to the conical PDA. Nevertheless, there was no significant coarctation due to aortic retention disc protrusion. Device closure of PDA using the ADO II is a safe procedure for chosen types of PDA. We demonstrated a novel technique for objective assessment of device protrusion into the descending aorta based on measurable parameters. ADOII device closure of non-conical PDAs warrants closer follow ups. © 2015 Wiley Periodicals, Inc.

Manufacturing of the ISO 25178-70 material measures with direct laser writing: a feasibility study

NASA Astrophysics Data System (ADS)

Eifler, M.; Hering, J.; von Freymann, G.; Seewig, J.

2018-06-01

The standard ISO 25178-70 defines material measures for the calibration of 2D- and 3D-topography measurement devices. Some of the suggested material measures are established within the industrial application for a long time while others have not yet been extensively researched regarding their practical abilities. This paper describes a holistic and systematic investigation of the ISO 25178-70 material measures. The manufacturing of the suggested geometries is executed with two-photon laser lithography, alias direct laser writing (DLW). Since this manufacturing process is not yet frequently used in a material measures context, it is examined regarding its suitability for the fabrication of the ISO 25178-70 material measures. With DLW, it is possible to manufacture multiple material measures on one sample in order to enable a comprehensive calibration of optical topography measurement devices. The manufactured ISO 25178-70 geometries are examined using different 3D-topography measuring devices. In doing so, their abilities regarding the calibration of the devices can be evaluated and the practical feasibility of their industrial application is assessed. For the review of this practical usefulness, varying calibration and evaluation strategies are taken into account.

Method for anisotropic etching in the manufacture of semiconductor devices

NASA Technical Reports Server (NTRS)

Koontz, Steven L. (Inventor); Cross, Jon B. (Inventor)

1993-01-01

Hydrocarbon polymer coatings used in microelectronic manufacturing processes are anisotropically etched by hyperthermal atomic oxygen beams (translational energies of 0.2 to 20 eV, preferably 1 to 10 eV). Etching with hyperthermal oxygen atom species obtains highly anisotropic etching with sharp boundaries between etched and mask protected areas.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

PubMed

2016-07-13

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures 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 metallic biliary stent system for benign strictures' 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.

Optimization Manufacture of Virus- and Tumor-Specific T Cells

PubMed Central

Lapteva, Natalia; Vera, Juan F.

2011-01-01

Although ex vivo expanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for the ex vivo expansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation and in vitro culture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide. PMID:21915183

75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... methods for medical device comparative analyses, best practices and best design and analysis methods. II... the performance of medical devices (including comparative effectiveness studies). The centers...

Method for anisotropic etching in the manufacture of semiconductor devices

DOEpatents

Koontz, Steven L.; Cross, Jon B.

1993-01-01

Hydrocarbon polymer coatings used in microelectronic manufacturing processes are anisotropically etched by atomic oxygen beams (translational energies of 0.2-20 eV, preferably 1-10 eV). Etching with hyperthermal (kinetic energy>1 eV) oxygen atom species obtains highly anisotropic etching with sharp boundaries between etched and mask-protected areas.

77 FR 30028 - Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Gamma Hydroxybutyric Acid (2010) I Amphetamine (1100) II...

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

PubMed

Bruzzi, M S; Linehan, J H

2013-09-01

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

76 FR 21916 - Manufacturer of Controlled Substances; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-19

... Gamma Hydroxybutyric Acid (2010) I Tetrahydrocannabinols (7370) I Methamphetamine (1105) II...), Tetrahydrocannabinols (7370), and Methamphetamine (1105) only, the company manufactures these controlled substances in...

77 FR 60145 - Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., Missouri 63011, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Alfentanil (9737) II...

A UK medical devices regulator's perspective on registries.

PubMed

Wilkinson, John; Crosbie, Andy

2016-04-01

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

16 CFR 1505.4 - Manufacturing requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe... insulated to prevent the development of a shock or fire hazard that may result from element failure. A toy... intended; and (ii) Shall have no opening permitting entry of a 0.010-inch-diameter music wire that could...

16 CFR 1505.4 - Manufacturing requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe... insulated to prevent the development of a shock or fire hazard that may result from element failure. A toy... intended; and (ii) Shall have no opening permitting entry of a 0.010-inch-diameter music wire that could...

16 CFR 1505.4 - Manufacturing requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe... insulated to prevent the development of a shock or fire hazard that may result from element failure. A toy... intended; and (ii) Shall have no opening permitting entry of a 0.010-inch-diameter music wire that could...

16 CFR 1505.4 - Manufacturing requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe... insulated to prevent the development of a shock or fire hazard that may result from element failure. A toy... intended; and (ii) Shall have no opening permitting entry of a 0.010-inch-diameter music wire that could...

Kickbacks, courtesies or cost-effectiveness?: Application of the Medicare antikickback Law to the marketing and promotional practices of drug and medical device manufacturers.

PubMed

Bulleit, T N; Krause, J H

1999-01-01

This article summarizes the purposes and history of the antikickback law and describes its evolution into a potent weapon against the corruption of medical decision making in the procurement of prescription drugs and medical devices. The article also details a variety of strategies for reducing risks under the law in several key areas of importance to manufacturers. While the purposes of the law are laudable, its current broad interpretation may impede not only corruption, but also benign forms of customer relations and innovative approaches to cost-effective medical care.

77 FR 5849 - Manufacturer of Controlled Substances; Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... October 7, 2011, 76 FR 62449, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made... Sufentanil (9740) II Fentanyl (9801) II The company will manufacture the listed controlled substances in bulk... factors in 21 U.S.C. 823(a) and determined that the registration of Cambrex Charles City, Inc. to...

The pharmacotherapy of the HeartMate II, a continuous flow left ventricular assist device, in patients with advanced heart failure: integration of disease, device, and drug.

PubMed

Jennings, Douglas L; Chambers, Rachel M; Schillig, Jessica M

2010-10-01

Advanced heart failure continues to be a significant cause of morbidity and mortality in the US. Patients with advanced heart failure have a poor prognosis without cardiac transplantation. The use of left ventricular assist devices (LVADs) as destination therapy for these patients is therefore expected to increase in the coming years as technology advances. The HeartMate II, a continuous flow implantable device, is currently the only LVAD that has been approved by the Food and Drug Administration for destination therapy in patients with advanced heart failure. The pharmacotherapy associated with this device is very complex and, therefore, the need for expertly trained clinical pharmacists to care for this expanding patient population will also likely increase. Unfortunately, most pharmacists are unfamiliar with the effect of LVADs on the physiology and pharmacotherapy of a patient's heart failure. The purpose of this article is to give clinical pharmacists an introduction to the most common pharmacotherapeutic issues for patients with LVADs and present practical solutions for managing common drug therapy problems.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Additive manufacturing of lab-on-a-chip devices: promises and challenges

NASA Astrophysics Data System (ADS)

Zhu, Feng; Macdonald, Niall P.; Cooper, Jonathan M.; Wlodkowic, Donald

2013-12-01

This work describes a preliminary investigation of commercially available 3D printing technologies for rapid prototyping and low volume fabrication of Lab-on-a-Chip devices. The main motivation of the work was to use off-the-shelf 3D printing methods in order to rapidly and inexpensively build microfluidic devices with complex geometric features and reduce the need to use clear room environment and conventional microfabrication techniques. Both multi-jet modelling (MJM) and stereolithography (SLA) processes were explored. MJM printed devices were fabricated using a HD3500+ (3D Systems) high-definition printer using a thermo-polymer VisiJet Crystal (3D Systems) substratum that allows for a z-axis resolution of 16 μm and 25 μm x-y accuracy. SLA printed devices were produced using a Viper Pro (3D Systems) stereolithography system using Watershed 11122XC (DSM Somos) and Dreve Fototec 7150 Clear (Dreve Otoplastik GmbH) resins which allow for a z-axis resolution of 50 μm and 25 μm x-y accuracy. Fabrication results compared favourably with other forms of rapid prototyping such as laser cut PMMA devices and PDMS moulded microfluidic devices of the same design. Both processes allowed for fabrication of monolithic, optically transparent devices with features in the 100 μm range requiring minimal post-processing. Optical polymer qualities following different post-processing methods were also tested in both brightfield and fluorescence imaging of transgenic zebrafish embryos. Finally, we show that only ethanol-treated Dreve Fototec 7150 Clear resign proved to be non-toxic to human cell lines and fish embryos in fish toxicity assays (FET) requiring further investigation of 3D printing materials.

Waveguide device and method for making same

DOEpatents

Forman, Michael A [San Francisco, CA

2007-08-14

A monolithic micromachined waveguide device or devices with low-loss, high-power handling, and near-optical frequency ranges is set forth. The waveguide and integrated devices are capable of transmitting near-optical frequencies due to optical-quality sidewall roughness. The device or devices are fabricated in parallel, may be mass produced using a LIGA manufacturing process, and may include a passive component such as a diplexer and/or an active capping layer capable of particularized signal processing of the waveforms propagated by the waveguide.

Materials, Processes, and Facile Manufacturing for Bioresorbable Electronics: A Review.

PubMed

Yu, Xiaowei; Shou, Wan; Mahajan, Bikram K; Huang, Xian; Pan, Heng

2018-05-07

Bioresorbable electronics refer to a new class of advanced electronics that can completely dissolve or disintegrate with environmentally and biologically benign byproducts in water and biofluids. They have provided a solution to the growing electronic waste problem with applications in temporary usage of electronics such as implantable devices and environmental sensors. Bioresorbable materials such as biodegradable polymers, dissolvable conductors, semiconductors, and dielectrics are extensively studied, enabling massive progress of bioresorbable electronic devices. Processing and patterning of these materials are predominantly relying on vacuum-based fabrication methods so far. However, for the purpose of commercialization, nonvacuum, low-cost, and facile manufacturing/printing approaches are the need of the hour. Bioresorbable electronic materials are generally more chemically reactive than conventional electronic materials, which require particular attention in developing the low-cost manufacturing processes in ambient environment. This review focuses on material reactivity, ink availability, printability, and process compatibility for facile manufacturing of bioresorbable electronics. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Highly Efficient Multilayer Thermoelectric Devices

NASA Technical Reports Server (NTRS)

Boufelfel, Ali

2006-01-01

Multilayer thermoelectric devices now at the prototype stage of development exhibit a combination of desirable characteristics, including high figures of merit and high performance/cost ratios. These devices are capable of producing temperature differences of the order of 50 K in operation at or near room temperature. A solvent-free batch process for mass production of these state-of-the-art thermoelectric devices has also been developed. Like prior thermoelectric devices, the present ones have commercial potential mainly by virtue of their utility as means of controlled cooling (and/or, in some cases, heating) of sensors, integrated circuits, and temperature-critical components of scientific instruments. The advantages of thermoelectric devices for such uses include no need for circulating working fluids through or within the devices, generation of little if any noise, and high reliability. The disadvantages of prior thermoelectric devices include high power consumption and relatively low coefficients of performance. The present development program was undertaken in the hope of reducing the magnitudes of the aforementioned disadvantages and, especially, obtaining higher figures of merit for operation at and near room temperature. Accomplishments of the program thus far include development of an algorithm to estimate the heat extracted by, and the maximum temperature drop produced by, a thermoelectric device; solution of the problem of exchange of heat between a thermoelectric cooler and a water-cooled copper block; retrofitting of a vacuum chamber for depositing materials by sputtering; design of masks; and fabrication of multilayer thermoelectric devices of two different designs, denoted I and II. For both the I and II designs, the thicknesses of layers are of the order of nanometers. In devices of design I, nonconsecutive semiconductor layers are electrically connected in series. Devices of design II contain superlattices comprising alternating electron

21 CFR 1303.22 - Procedure for applying for individual manufacturing quotas.

Code of Federal Regulations, 2011 CFR

2011-04-01

... in Schedule I or II and who desires to manufacture a quantity of such class shall apply on DEA Form 189 for a manufacturing quota for such quantity of such class. Copies of DEA Form 189 may be obtained... Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing...

Biofouling detection monitoring devices: status assessment. Final report

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

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

1985-03-01

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

Accuracy of torque-limiting devices: A comparative evaluation.

PubMed

Albayrak, Haydar; Gumus, Hasan Onder; Tursun, Funda; Kocaagaoglu, Hasan Huseyin; Kilinc, Halil Ibrahim

2017-01-01

To prevent the loosening of implant screws, clinicians should be aware of the output torque values needed to achieve the desired preload. Accurate torque-control devices are crucial in this regard; however, little information is currently available comparing the accuracy of mechanical with that of electronic torque-control devices. The purpose of this in vitro study was to identify and compare the accuracy of different types of torque-control devices. Devices from 5 different dental implant manufacturers were evaluated, including 2 spring-type (Straumann, Implance) mechanical devices (MTLD), 2 friction-type (Biohorizons, Dyna) MTLDs, and 1 (Megagen) electronic torque-control device (ETLD). For each manufacturer, 5 devices were tested 5 times with a digital torque tester, and the average for each device was calculated and recorded. The percentage of absolute deviations from the target torque values (PERDEV) were calculated and compared by using 1-way ANOVA. A 1-sample t test was used to evaluate the ability of each device to achieve its target torque value within a 95% confidence interval for the true population mean of measured values (α=.05 for all statistical analyses). One-way ANOVAs revealed statistically significant differences among torque-control devices (P<.001). ETLD showed higher PERDEVs (28.33 ±9.53) than MTLDs (P<.05), whereas PERDEVS of friction-type (7.56 ±3.64) and spring-type (10.85 ±4.11) MTLDs did not differ significantly. In addition, devices produced by Megagen had a significantly higher (P<.05) PERDEV (28.33 ±9.53) other devices, whereas no differences were found in devices manufactured by Biohorizons (7.31 ±5.34), Dyna (7.82 ±1.08), Implance (8.43 ±4.77), and Straumann (13.26 ±0.79). However, 1-sample t tests showed none of the torque-control devices evaluated in this study were capable of achieving their target torque values (P<.05). Within the limitations of this in vitro study, MTLDs were shown to be significantly more accurate

Turbulent transport of He II in active and passive phase separators using slit devices and porous media

NASA Technical Reports Server (NTRS)

Yuan, S. W. K.; Lee, J. M.; Frederking, T. H. K.

1988-01-01

The turbulent transport mode of vapor liquid phase separators (VLPS) for He II has been investigated comparing passive porous plug separators with active phase separators (APS) using slits of variable flow paths within a common frame of reference. It is concluded that the basic transport regimes in both devices are identical. An integrated Gorter-Mellink (1949) equation, found previously to predict VLPS results of porous plugs, is employed to analyze APS data published in the literature. It is found that the Gorter-Mellink flow rate parameter for 9-micron and 14-micron APS slit widths are relatively independent of the slit width, having a rate constant of about 9 + or - 10 percent. This agrees with the early heat flow results for He II entropy transport at zero net mass flow in wide capillaries and slits.

Consumable core for manufacture of composite articles and related method

DOEpatents

Taxacher, Glenn Curtis; de Diego, Peter; Gray, Paul Edward; Monaghan, Philip Harold

2017-09-05

Systems, methods and devices adapted to ease manufacture of composite articles (e.g., ceramic composite articles), particularly composite articles which include a hollow feature are disclosed. In one embodiment, a system includes: a consumable core formed to be disposed within an inner portion of a composite precursor, the consumable core adapted to convert into an infiltrant during a manufacturing process and infiltrate the composite precursor.

The 1995 Medical Device Technology raw materials survey.

PubMed

Pearson, L S

1995-09-01

Using information supplied by manufacturers, this article reports on the use of raw materials and compounding and conversion practices in the European medical device manufacturing industry. The findings of the survey provide an indication of which materials are being used and how frequently, and the process of selecting suppliers.

49 CFR 393.11 - Lamps and reflective devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., reflective devices and associated equipment by the type of commercial motor vehicle. The diagrams in this... Table 1. All commercial motor vehicles manufactured on or after December 25, 1968, must, at a minimum... of the vehicle. Commercial motor vehicles manufactured before December 25, 1968, must, at a minimum...

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

Gastroresistant capsular device prepared by injection molding.

PubMed

Zema, Lucia; Loreti, Giulia; Melocchi, Alice; Maroni, Alessandra; Palugan, Luca; Gazzaniga, Andrea

2013-01-20

In the present work, the possibility of manufacturing by injection molding (IM) a gastro-resistant capsular device based on hydroxypropyl methyl cellulose acetate succinate (HPMCAS) was investigated. By performing as an enteric soluble container, such a device may provide a basis for the development of advantageous alternatives to coated dosage forms. Preliminarily, the processability of the selected thermoplastic polymer was evaluated, and the need for a plasticizer (polyethylene glycol 1500) in order to counterbalance the glassy nature of the molded items was assessed. However, some critical issues related to the physical/mechanical stability (shrinkage and warpage) and opening time of the device after the pH change were highlighted. Accordingly, an in-depth formulation study was carried out taking into account differing release modifiers potentially useful for enhancing the dissolution/disintegration rate of the capsular device at intestinal pH values. Capsule prototypes with thickness of 600 and 900 μm containing Kollicoat(®) IR and/or Explotab(®) CLV could be manufactured, and a promising performance was achieved with appropriate gastric resistance in pH 1.2 medium and break-up in pH 6.8 within 1h. These results would support the design of a dedicated mold for the development of a scalable manufacturing process. Copyright © 2012 Elsevier B.V. All rights reserved.

Objective and perceptual comparisons of two bluetooth hearing aid assistive devices.

PubMed

Clark, Jackie L; Pustejovsky, Carmen; Vanneste, Sven

2017-08-01

With the advent of Bluetooth technology, many of the assistive listening devices for hearing have become manufacturer specific, with little objective information about the performance provided. Thirty native English-speaking adults (mean age 29.8) with normal hearing were tested pseudo-randomly with two major hearing aid manufacturers' proprietary Bluetooth connectivity devices paired to the accompanying manufacturer's specific hearing aids. Sentence recognition performance was objectively measured for each system with signals transmitted via a land-line to the same iPhone in two conditions. There was a significant effect of participant's performance according to listening condition. There was no significant effect between device manufacturers according to listening condition, but there was a significant effect in participant's perception of "quality of sound". Despite differences in signal transmission for each devise, when worn by participants both the systems performed equally. In fact, participants expressed personal preferences for specific technology that was largely due to their perceived quality of sound while listening to recorded signals. While further research is necessary to investigate other measures of benefit for Bluetooth connectivity devices, preliminary data suggest that in order to ensure comfort and compatibility, not only should objective measures of the patient benefit be completed, but also assessing the patient's perception of benefit is equally important. Implications for Rehabilitation All professionals who work with individuals with hearing loss, become aware of the differences in the multiple choices for assistive technology readily available for hearing loss. With the ever growing dispensing of Bluetooth connectivity devices coupled to hearing aids, there is an increased burden to determine whether performance differences could exist between manufacturers. There is a growing need to investigate other measures of benefit for Bluetooth

Medical device software: defining key terms.

PubMed

Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian; Munafo, Paul M. (Technical Monitor)

2002-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA's Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aid in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI.

In situ manufacture of magnetic tunnel junctions by a direct-write process

NASA Astrophysics Data System (ADS)

Costanzi, Barry N.; Riazanova, Anastasia V.; Dan Dahlberg, E.; Belova, Lyubov M.

2014-06-01

In situ construction of Co/SiO2/Co magnetic tunnel junctions using direct-write electron-beam-induced deposition is described. Proof-of-concept devices were built layer by layer depositing the specific components one at a time, allowing device manufacture using a strictly additive process. The devices exhibit a magnetic tunneling signature which agrees qualitatively with the Slonczewski model of magnetic tunneling.

Simple and inexpensive microfluidic devices for the generation of monodisperse multiple emulsions

NASA Astrophysics Data System (ADS)

Li, Er Qiang; Zhang, Jia Ming; Thoroddsen, Sigurdur T.

2014-01-01

Droplet-based microfluidic devices have become a preferred versatile platform for various fields in physics, chemistry and biology. Polydimethylsiloxane soft lithography, the mainstay for fabricating microfluidic devices, usually requires the usage of expensive apparatus and a complex manufacturing procedure. Here, we report the design and fabrication of simple and inexpensive microfluidic devices based on microscope glass slides and pulled glass capillaries, for generating monodisperse multiple emulsions. The advantages of our method lie in a simple manufacturing procedure, inexpensive processing equipment and flexibility in the surface modification of the designed microfluidic devices. Different types of devices have been designed and tested and the experimental results demonstrated their robustness for preparing monodisperse single, double, triple and multi-component emulsions.

Effectiveness of comprehensive fixed appliance treatment used with the Forsus Fatigue Resistant Device in Class II patients.

PubMed

Franchi, Lorenzo; Alvetro, Lisa; Giuntini, Veronica; Masucci, Caterina; Defraia, Efisio; Baccetti, Tiziano

2011-07-01

To assess the dental, skeletal, and soft tissue effects of comprehensive fixed appliance treatment combined with the Forsus Fatigue Resistant Device (FRD) in Class II patients. Thirty-two Class II patients (mean age 12.7 ± 1.2 years) were treated consecutively with the FRD protocol and compared with a matched sample of 27 untreated Class II subjects (mean age 12.8 ± 1.3 years). Lateral cephalograms were taken before therapy and at the completion of comprehensive therapy. The mean duration of comprehensive treatment was 2.4 ± 0.4 years. Statistical comparisons were carried out with the Student's t-test (P < .05). The success rate was 87.5%. The FRD group showed a significant restraint in the sagittal skeletal position of the maxilla (also at the soft tissue level), a significant increase in mandibular length, and a significant improvement in maxillo-mandibular sagittal skeletal relationships. The treated group exhibited a significant reduction in overjet and a significant increase in molar relationship. The lower incisors were significantly proclined and intruded, while the lower first molars moved significantly in a mesial and vertical direction. The FRD protocol is effective in correcting Class II malocclusion with a combination of skeletal (mainly maxillary) and dentoalveolar (mainly mandibular) modifications.

Pump Thrombosis following HeartMate II Left Ventricular Assist Device Implantation in a Patient with Aspirin and Plavix Resistance.

PubMed

Ghodsizad, Ali; Badiye, A; Zeriouh, M; Pae, W; Koerner, M M; Loebe, M

2016-12-14

Despite advances in pump technology, thromboembolic events and pump thrombosis are potentially life-threatening complications in patients with continuous flow ventricular assist devices. Here we describe a patient with pump thrombosis following LVAD HeartMate II implantation presenting with Aspirin and Plavix resistance and signs of acute hemolysis as manifested by high LDH, changing pump power, pulse index and reduced pump flows.

Surface-Micromachined Microfluidic Devices

DOEpatents

Galambos, Paul C.; Okandan, Murat; Montague, Stephen; Smith, James H.; Paul, Phillip H.; Krygowski, Thomas W.; Allen, James J.; Nichols, Christopher A.; Jakubczak, II, Jerome F.

2004-09-28

Microfluidic devices are disclosed which can be manufactured using surface-micromachining. These devices utilize an electroosmotic force or an electromagnetic field to generate a flow of a fluid in a microchannel that is lined, at least in part, with silicon nitride. Additional electrodes can be provided within or about the microchannel for separating particular constituents in the fluid during the flow based on charge state or magnetic moment. The fluid can also be pressurized in the channel. The present invention has many different applications including electrokinetic pumping, chemical and biochemical analysis (e.g. based on electrophoresis or chromatography), conducting chemical reactions on a microscopic scale, and forming hydraulic actuators. Microfluidic devices are disclosed which can be manufactured using surface-micromachining. These devices utilize an electroosmotic force or an electromagnetic field to generate a flow of a fluid in a microchannel that is lined, at least in part, with silicon nitride. Additional electrodes can be provided within or about the microchannel for separating particular constituents in the fluid during the flow based on charge state or magnetic moment. The fluid can also be pressurized in the channel. The present invention has many different applications including electrokinetic pumping, chemical and biochemical analysis (e.g. based on electrophoresis or chromatography), conducting chemical reactions on a microscopic scale, and forming hydraulic actuators.

75 FR 6062 - Manufacturer of Controlled Substances Notice of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... controlled substances listed in schedules I and II: Drug Schedule Marihuana (7360) I Tetrahydrocannabinols (7370) I Cocaine (9041) I The Institute will manufacture small quantities of cocaine and marihuana...

Facts controllers and HVDC enhance power transmission (A manufacturer`s perspective)

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

Juette, G.; Renz, K.

1995-12-31

Various types of FACTS as well as HVDC have been available for some time. New ones have been developed recently. Their respective benefits are well proven and have been made known. System studies have to be done to make full use of FACTS and HVDC problem solving capabilities. Siemens is offering digital models for correct representation of several FACTS devices and HVDC in widely used time-based simulation study programs. The manufacturers are doing their homework. It is up to the utility industry to make use of it now!

77 FR 70825 - Manufacturer of Controlled Substances; Notice of Application; Norac

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-27

... Gamma Hydroxybutyric Acid (2010) I Tetrahydrocannabinols (7370) I Methamphetamine (1105) II...), tetrahydrocannabinols (7370), and methamphetamine (1105) only, the company manufactures these controlled substances in...

78 FR 34922 - Definition of Auditory Assistance Device

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Report and Order will apply to small businesses that choose to use, manufacture, design, import, or sell... production and marketing, and introduce more competition for such devices. The Commission decided that this... assistance devices using industry standard components employing relatively straight-forward designs at a...

78 FR 12104 - Manufacturer of Controlled Substances; Notice of Registration; Cedarburg Pharmaceuticals, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances... Badger Circle, Grafton, Wisconsin 53024, made application by renewal to the Drug Enforcement... substances: Drug Schedule 4-Anilino-N-phenethyl-4-piperidine ANPP) II (8333). Fentanyl (9801) II The company...

Qualification and Approval of Personal Computer-Based Aviation Training Devices

DOT National Transportation Integrated Search

1997-05-12

This Advisory Circular (AC) provides information and guidance to potential training device manufacturers and aviation training consumers concerning a means, acceptable to the Administrator, by which personal computer-based aviation training devices (...

76 FR 66994 - Manufacturer of Controlled Substances; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by their customers in analytical kits...

Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms. Final order.

PubMed

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms 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 flow cytometric test system for hematopoietic neoplasms' 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.

Dye molecular structure device open-circuit voltage correlation in Ru(II) sensitizers with heteroleptic tridentate chelates for dye-sensitized solar cells.

PubMed

Wu, Kuan-Lin; Li, Cheng-Hsuan; Chi, Yun; Clifford, John N; Cabau, Lydia; Palomares, Emilio; Cheng, Yi-Ming; Pan, Hsiao-An; Chou, Pi-Tai

2012-05-02

Dicarboxyterpyridine chelates with π-conjugated pendant groups attached at the 5- or 6-position of the terminal pyridyl unit were synthesized. Together with 2,6-bis(5-pyrazolyl)pyridine, these were used successfully to prepare a series of novel heteroleptic, bis-tridentate Ru(II) sensitizers, denoted as TF-11-14. These dyes show excellent performance in dye-sensitized solar cells (DSCs) under AM1.5G simulated sunlight at a light intensity of 100 mW cm(-2) in comparison with a reference device containing [Ru(Htctpy)(NCS)(3)][TBA](3) (N749), where H(3)tctpy and TBA are 4,4',4"-tricarboxy-2,2':6',2"-terpyridine and tetra-n-butylammonium cation, respectively. In particular, the sensitizer TF-12 gave a short-circuit photocurrent of 19.0 mA cm(-2), an open-circuit voltage (V(OC)) of 0.71 V, and a fill factor of 0.68, affording an overall conversion efficiency of 9.21%. The increased conjugation conferred to the TF dyes by the addition of the π-conjugated pendant groups increases both their light-harvesting and photovoltaic energy conversion capability in comparison with N749. Detailed recombination processes in these devices were probed by various spectroscopic and dynamics measurements, and a clear correlation between the device V(OC) and the cell electron lifetime was established. In agreement with several other recent studies, the results demonstrate that high efficiencies can also be achieved with Ru(II) sensitizers that do not contain thiocyanate ancillaries. This bis-tridentate, dual-carboxy anchor configuration thus serves as a prototype for future omnibearing design of highly efficient Ru(II) sensitizers suited for use in DSCs. © 2012 American Chemical Society

Diabetes Device Reimbursement in the EU-5

PubMed Central

Attorney, Elmar Schäfer; Schnell, Gerald; Bobáková, Tamara

2013-01-01

The reimbursement landscape for new and innovative diabetes devices in Europe is very heterogeneous and nontransparent, with each country employing different mechanisms, pathways, and requirements. This article provides an overview of how diabetes device reimbursement works in the outpatient setting in the five major European Union markets (France, Germany, Italy, Spain, and the United Kingdom; the EU-5). It will be of particular interest to manufacturers of innovative devices. Markets are first categorized as either a centralized or a regionalized reimbursement decision-making system, and implications for device reimbursement are explored. In the second part, specific requirements and success factors for wide reimbursement in the EU-5 are analyzed in detail. Gaining early acceptance by the main influencers (key opinion leaders and payers) is the first step. Equally important is the provision of convincing evidence, be this clinical, health–economic (cost-effectiveness), or a demonstration of cost savings (budget impact). In some countries, local usage data may be a requirement as well. Lastly, as payers’ willingness to pay stems directly from their perceived value of a device, a key success factor and a necessary precondition for manufacturers is to set the right price. PMID:23911192

Stoppers in RED II distraction device: is it possible to prevent pin migration?

PubMed

Mavili, Mehmet Emin; Vargel, Ibrahim; Tunçbilek, Gökhan

2004-05-01

Distraction osteogenesis has become popular for the treatment of hypoplastic congenital craniomaxillofacial anomalies. Rigid external distraction (RED II) after Le Fort III osteotomy was shown to be a highly effective treatment for the management of midface hypoplasia. This device is used with a halo vest, which is placed at the cranial equator. Intracranial penetration of the fixation pins of the halo is one of the complications of an external distraction device. To prevent pin penetration in rigid external distraction, the authors designed polylactic acid/polyglycolic acid (PLA/PGA) plates that were circular; the plates were 0.8 cm in diameter and had 1.5-mm holes in the center, through which the tip of the pins would pass. To quantify the applied torque by manual tightening of the screws of the distraction device and to measure intraosseous cone depth created by the penetration of the conical part of the screws with and without the PLA/PGA composite stopper, first an in vitro experiment was undertaken on cadaver. Then these PLA/PGA plaques, or stoppers, were placed over the bone surfaces of the cranium of the patients where the tip of the pins press. PLA/PGA stoppers are malleable and adapt their shape to the interactive forces between bone and the pins. They act as a second barrier, and spread the pressure of the screws to larger surfaces, thus securing better stabilization. The penetration of wider portions of the screw into scalp is reduced, minimizing the scalp damage caused by the screws. Biodegradable and biocompatible PLA/PGA stoppers avoid intracranial migration of the fixation pins, especially in children.

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

PubMed

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.

Additive manufacturing of three-dimensional (3D) microfluidic-based microelectromechanical systems (MEMS) for acoustofluidic applications.

PubMed

Cesewski, Ellen; Haring, Alexander P; Tong, Yuxin; Singh, Manjot; Thakur, Rajan; Laheri, Sahil; Read, Kaitlin A; Powell, Michael D; Oestreich, Kenneth J; Johnson, Blake N

2018-06-13

Three-dimensional (3D) printing now enables the fabrication of 3D structural electronics and microfluidics. Further, conventional subtractive manufacturing processes for microelectromechanical systems (MEMS) relatively limit device structure to two dimensions and require post-processing steps for interface with microfluidics. Thus, the objective of this work is to create an additive manufacturing approach for fabrication of 3D microfluidic-based MEMS devices that enables 3D configurations of electromechanical systems and simultaneous integration of microfluidics. Here, we demonstrate the ability to fabricate microfluidic-based acoustofluidic devices that contain orthogonal out-of-plane piezoelectric sensors and actuators using additive manufacturing. The devices were fabricated using a microextrusion 3D printing system that contained integrated pick-and-place functionality. Additively assembled materials and components included 3D printed epoxy, polydimethylsiloxane (PDMS), silver nanoparticles, and eutectic gallium-indium as well as robotically embedded piezoelectric chips (lead zirconate titanate (PZT)). Electrical impedance spectroscopy and finite element modeling studies showed the embedded PZT chips exhibited multiple resonant modes of varying mode shape over the 0-20 MHz frequency range. Flow visualization studies using neutrally buoyant particles (diameter = 0.8-70 μm) confirmed the 3D printed devices generated bulk acoustic waves (BAWs) capable of size-selective manipulation, trapping, and separation of suspended particles in droplets and microchannels. Flow visualization studies in a continuous flow format showed suspended particles could be moved toward or away from the walls of microfluidic channels based on selective actuation of in-plane or out-of-plane PZT chips. This work suggests additive manufacturing potentially provides new opportunities for the design and fabrication of acoustofluidic and microfluidic devices.

40 CFR 723.175 - Chemical substances used in or for the manufacture or processing of instant photographic and peel...

Code of Federal Regulations, 2010 CFR

2010-07-01

... manufacture and processing in the special production area. All manufacturing, processing, and use operations... shape or design during manufacture, (ii) which has end use function(s) dependent in whole or in part... production area, the ambient air concentration of the new chemical substance during manufacture, processing...

27 CFR 479.103 - Registration of firearms manufactured.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Registration of firearms manufactured. 479.103 Section 479.103 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.103 - Registration of firearms manufactured.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Registration of firearms manufactured. 479.103 Section 479.103 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.103 - Registration of firearms manufactured.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Registration of firearms manufactured. 479.103 Section 479.103 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.103 - Registration of firearms manufactured.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Registration of firearms manufactured. 479.103 Section 479.103 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.103 - Registration of firearms manufactured.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Registration of firearms manufactured. 479.103 Section 479.103 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

CdTe devices and method of manufacturing same

DOEpatents

Gessert, Timothy A.; Noufi, Rommel; Dhere, Ramesh G.; Albin, David S.; Barnes, Teresa; Burst, James; Duenow, Joel N.; Reese, Matthew

2015-09-29

A method of producing polycrystalline CdTe materials and devices that incorporate the polycrystalline CdTe materials are provided. In particular, a method of producing polycrystalline p-doped CdTe thin films for use in CdTe solar cells in which the CdTe thin films possess enhanced acceptor densities and minority carrier lifetimes, resulting in enhanced efficiency of the solar cells containing the CdTe material are provided.

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

Manufacturing Technology for Apparel Automation. Phase 1, 2 and 3 Activity.

DTIC Science & Technology

1987-10-15

A189 129 MANUFACTURING TECHNOLOGY FOR APPAREL AUTOMATION PHASE I t/l 2 AND I ACTIVITY(U) NORTH CAROLINA STATE UNIV ATRALEIGH SCHOOL OF TEXTILES E M...34III 1.8 - iai T ON HART St 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 MTC FILE coax Report: NCSU/DLA-87/2 CDRL A004 MANUFACTURING TECHNOLOGY FOR APPAREL...I Report: NCSU/DLA-87/2 CDRL A004 MANUFACTURING TECHNOLOGY FOR APPAREL AUTOMATION Phase I, II and III Activity Edwin M. McPherson North Carolina

Ubiquitous Robotic Technology for Smart Manufacturing System.

PubMed

Wang, Wenshan; Zhu, Xiaoxiao; Wang, Liyu; Qiu, Qiang; Cao, Qixin

2016-01-01

As the manufacturing tasks become more individualized and more flexible, the machines in smart factory are required to do variable tasks collaboratively without reprogramming. This paper for the first time discusses the similarity between smart manufacturing systems and the ubiquitous robotic systems and makes an effort on deploying ubiquitous robotic technology to the smart factory. Specifically, a component based framework is proposed in order to enable the communication and cooperation of the heterogeneous robotic devices. Further, compared to the service robotic domain, the smart manufacturing systems are often in larger size. So a hierarchical planning method was implemented to improve the planning efficiency. A test bed of smart factory is developed. It demonstrates that the proposed framework is suitable for industrial domain, and the hierarchical planning method is able to solve large problems intractable with flat methods.

Ubiquitous Robotic Technology for Smart Manufacturing System

PubMed Central

Zhu, Xiaoxiao; Wang, Liyu; Qiu, Qiang; Cao, Qixin

2016-01-01

As the manufacturing tasks become more individualized and more flexible, the machines in smart factory are required to do variable tasks collaboratively without reprogramming. This paper for the first time discusses the similarity between smart manufacturing systems and the ubiquitous robotic systems and makes an effort on deploying ubiquitous robotic technology to the smart factory. Specifically, a component based framework is proposed in order to enable the communication and cooperation of the heterogeneous robotic devices. Further, compared to the service robotic domain, the smart manufacturing systems are often in larger size. So a hierarchical planning method was implemented to improve the planning efficiency. A test bed of smart factory is developed. It demonstrates that the proposed framework is suitable for industrial domain, and the hierarchical planning method is able to solve large problems intractable with flat methods. PMID:27446206

Large-area copper indium diselenide (CIS) process, control and manufacturing

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

Gillespie, T.J.; Lanning, B.R.; Marshall, C.H.

1997-12-31

Lockheed Martin Astronautics (LMA) has developed a large-area (30x30cm) sequential CIS manufacturing approach amenable to low-cost photovoltaics (PV) production. A prototype CIS manufacturing system has been designed and built with compositional uniformity (Cu/In ratio) verified within {+-}4 atomic percent over the 30x30cm area. CIS device efficiencies have been measured by the National Renewable Energy Laboratory (NREL) at 7% on a flexible non-sodium-containing substrate and 10% on a soda-lime-silica (SLS) glass substrate. Critical elements of the manufacturing capability include the CIS sequential process selection, uniform large-area material deposition, and in-situ process control. Details of the process and large-area manufacturing approach aremore » discussed and results presented.« less

Adhesion testing device

NASA Technical Reports Server (NTRS)

LaPeyronnie, Glenn M. (Inventor); Huff, Charles M. (Inventor)

2010-01-01

The present invention provides a testing apparatus and method for testing the adhesion of a coating to a surface. The invention also includes an improved testing button or dolly for use with the testing apparatus and a self aligning button hook or dolly interface on the testing apparatus. According to preferred forms, the apparatus and method of the present invention are simple, portable, battery operated rugged, and inexpensive to manufacture and use, are readily adaptable to a wide variety of uses, and provide effective and accurate testing results. The device includes a linear actuator driven by an electric motor coupled to the actuator through a gearbox and a rotatable shaft. The electronics for the device are contained in the head section of the device. At the contact end of the device, is positioned a self aligning button hook, attached below the load cell located on the actuator shaft.

A hybrid life cycle inventory of nano-scale semiconductor manufacturing.

PubMed

Krishnan, Nikhil; Boyd, Sarah; Somani, Ajay; Raoux, Sebastien; Clark, Daniel; Dornfeld, David

2008-04-15

The manufacturing of modern semiconductor devices involves a complex set of nanoscale fabrication processes that are energy and resource intensive, and generate significant waste. It is important to understand and reduce the environmental impacts of semiconductor manufacturing because these devices are ubiquitous components in electronics. Furthermore, the fabrication processes used in the semiconductor industry are finding increasing application in other products, such as microelectromechanical systems (MEMS), flat panel displays, and photovoltaics. In this work we develop a library of typical gate-to-gate materials and energy requirements, as well as emissions associated with a complete set of fabrication process models used in manufacturing a modern microprocessor. In addition, we evaluate upstream energy requirements associated with chemicals and materials using both existing process life cycle assessment (LCA) databases and an economic input-output (EIO) model. The result is a comprehensive data set and methodology that may be used to estimate and improve the environmental performance of a broad range of electronics and other emerging applications that involve nano and micro fabrication.

21 CFR 807.81 - When a premarket notification submission is required.

Code of Federal Regulations, 2010 CFR

2010-04-01

... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

Method of making a silicon nanowire device

DOEpatents

None, None

2017-05-23

There is provided an electronic device and a method for its manufacture. The device comprises an elongate silicon nanowire less than 0.5 .mu.m in cross-sectional dimensions and having a hexagonal cross-sectional shape due to annealing-induced energy relaxation. The method, in examples, includes thinning the nanowire through iterative oxidation and etching of the oxidized portion.

Adaptive Blood Glucose Monitoring and Insulin Measurement Devices for Visually Impaired Persons.

ERIC Educational Resources Information Center

Petzinger, R. A.

1993-01-01

This article describes devices that people with visual impairments and diabetes can use to monitor blood glucose levels and measure insulin. A table lists devices, their manufacturers (including address and telephone number), and comments about the devices. (DB)

High energy devices versus low energy devices in orthopedics treatment modalities

NASA Astrophysics Data System (ADS)

Schultheiss, Reiner

2003-10-01

The orthopedic consensus group defined in 1997 the 42 most likely relevant parameters of orthopedic shock wave devices. The idea of this approach was to correlate the different clinical outcomes with the physical properties of the different devices with respect to their acoustical waves. Several changes in the hypothesis of the dose effect relationship have been noticed since the first orthopedic treatments. The relation started with the maximum pressure p+, followed by the total energy, the energy density; and finally the single treatment approach using high, and then the multiple treatment method using low energy. Motivated by the reimbursement situation in Germany some manufacturers began to redefine high and low energy devices independent of the treatment modality. The OssaTron as a high energy, single treatment electro hydraulic device gained FDA approval as the first orthopedic ESWT device for plantar fasciitis and, more recently, for lateral epicondylitis. Two low energy devices have now also gained FDA approval based upon a single treatment. Comparing the acoustic data, differences between the OssaTron and the other devices are obvious and will be elaborated upon. Cluster analysis of the outcomes and the acoustical data are presented and new concepts will be suggested.

16 CFR § 1505.4 - Manufacturing requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe... insulated to prevent the development of a shock or fire hazard that may result from element failure. A toy... intended; and (ii) Shall have no opening permitting entry of a 0.010-inch-diameter music wire that could...

42 CFR 447.510 - Requirements for manufacturers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... report must include: (1) AMP, calculated in accordance with section 1927(k)(1) of the Social Security Act... provided for in section 1927(k)(1) of the Social Security Act. (ii) A manufacturer may choose to... should be calculated based on section 1927(k)(1) of the Social Security Act, except the period covered...

Integration of 3D printing and additive manufacturing in the interventional pulmonologist's toolbox.

PubMed

Guibert, Nicolas; Mhanna, Laurent; Didier, Alain; Moreno, Benjamin; Leyx, Pierre; Plat, Gavin; Mazieres, Julien; Hermant, Christophe

2018-01-01

New 3D technologies are rapidly entering into the surgical landscape, including in interventional pulmonology. The transition of 2D restricted data into a physical model of pathological airways by three-dimensional printing (3DP) allows rapid prototyping and fabrication of complex and patient-specific shapes and can thus help the physician to plan and guide complex procedures. Furthermore, computer-assisted designed (CAD) patient-specific devices have already helped surgeons overcome several therapeutic impasses and are likely to rapidly cover a wider range of situations. We report herein with a special focus on our clinical experience: i) how additive manufacturing is progressively integrated into the management of complex central airways diseases; ii) the appealing future directions of these new technologies, including the potential of the emerging technique of bioprinting; iii) the main pitfalls that could delay its introduction into routine care. Copyright © 2017. Published by Elsevier Ltd.

Insertion of lithium into electrochromic devices after completion

DOEpatents

Berland, Brian Spencer; Lanning, Bruce Roy; Frey, Jonathan Mack; Barrett, Kathryn Suzanne; DuPont, Paul Damon; Schaller, Ronald William

2015-12-22

The present disclosure describes methods of inserting lithium into an electrochromic device after completion. In the disclosed methods, an ideal amount of lithium can be added post-fabrication to maximize or tailor the free lithium ion density of a layer or the coloration range of a device. Embodiments are directed towards a method to insert lithium into the main device layers of an electrochromic device as a post-processing step after the device has been manufactured. In an embodiment, the methods described are designed to maximize the coloration range while compensating for blind charge loss.

Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports.

PubMed

Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rohit; Adelstein, Evan; Jain, Sandeep; Saba, Samir

2017-03-01

Cardiac resynchronization therapy (CRT) is an important treatment for heart failure that requires constant ventricular pacing, placing a high energy burden on CRT defibrillators (CRT-D). Longer battery life reduces the need for device changes and associated complications, thereby affecting patient outcomes and cost of care. We therefore investigated the time to battery depletion of CRT-D from different manufacturers and compared these results with manufacturers' published product performance reports (PPRs). All CRT-D recipients at our institution between January 2008 and December 2010 were included in this study cohort. The patients were followed up to the endpoint of battery depletion and were otherwise censored at the time of death, last follow-up, or device removal for any reason other than battery depletion. A total of 621 patients [173 Boston Scientific (BSC), 391 Medtronic (MDT), and 57 St. Jude Medical (SJM)] were followed up for a median of 3.7 (IQR 1.6-5.0) years, during which time 253 (41%) devices were replaced for battery depletion. Compared with MDT devices, battery depletion was 85 and 54% less likely to happen with BSC and SJM devices, respectively (P < 0.001 for pairwise comparisons). Product performance reports from all manufacturers significantly overestimated battery longevity by more than 20% 6 years after device implantation. Large differences in CRT-D battery longevity exist between manufacturers. Industry-published PPRs significantly overestimate device longevity. These data have important implications to patients, healthcare professionals, hospitals, and third-party payers. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Current manufacturing processes of drug-eluting sutures.

PubMed

Champeau, Mathilde; Thomassin, Jean-Michel; Tassaing, Thierry; Jérôme, Christine

2017-11-01

Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Two general approaches can be followed: (i) the ones that add the API into the material during the manufacturing process of the suture and (ii) the ones that load the API to an already manufactured suture. Areas covered: This review provides an overview of the current manufacturing processes for drug-eluting suture production and discusses their benefits and drawbacks depending on the type of drugs. The mechanical properties and the drug delivery profile of drug-eluting sutures are highlighted since these implants must fulfill both criteria. Expert opinion: For limited drug contents, melt extrusion and electrospinning are the emerging processes since the drug is added during the suture manufacture process. Advantageously, the drug release profile can be tuned by controlling the processing parameters specific to each process and the composition of the drug-containing polymer. If high drug content is targeted, the coating or grafting of a drug layer on a pre-manufactured suture allows for preservation of the tensile strength requirements of the suture.

78 FR 33443 - Manufacturer of Controlled Substances; Notice of Registration; Norac, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... Gamma Hydroxybutyric Acid (2010) I Tetrahydrocannabinols (7370) I Methamphetamine (1105) II...), Tetrahydrocannabinols (7370), and Methamphetamine (1105) only, the company manufactures these controlled substances in...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

Manufacturing considerations for AMLCD cockpit displays

NASA Astrophysics Data System (ADS)

Luo, Fang-Chen

1995-06-01

AMLCD cockpit displays need to meet more stringent requirements compared with AMLCD commercial displays in areas such as environmental conditions, optical performance and device reliability. Special considerations are required for the manufacturing of AMLCD cockpit displays in each process step to address these issues. Some examples are: UV stable polarizers, wide-temperature LC material, strong LC glue seal, ESS test system, gray scale voltage EEPROM, etc.

Detecting Nano-Scale Vibrations in Rotating Devices by Using Advanced Computational Methods

PubMed Central

del Toro, Raúl M.; Haber, Rodolfo E.; Schmittdiel, Michael C.

2010-01-01

This paper presents a computational method for detecting vibrations related to eccentricity in ultra precision rotation devices used for nano-scale manufacturing. The vibration is indirectly measured via a frequency domain analysis of the signal from a piezoelectric sensor attached to the stationary component of the rotating device. The algorithm searches for particular harmonic sequences associated with the eccentricity of the device rotation axis. The detected sequence is quantified and serves as input to a regression model that estimates the eccentricity. A case study presents the application of the computational algorithm during precision manufacturing processes. PMID:22399918

3D-printed components for quantum devices.

PubMed

Saint, R; Evans, W; Zhou, Y; Barrett, T; Fromhold, T M; Saleh, E; Maskery, I; Tuck, C; Wildman, R; Oručević, F; Krüger, P

2018-05-30

Recent advances in the preparation, control and measurement of atomic gases have led to new insights into the quantum world and unprecedented metrological sensitivities, e.g. in measuring gravitational forces and magnetic fields. The full potential of applying such capabilities to areas as diverse as biomedical imaging, non-invasive underground mapping, and GPS-free navigation can only be realised with the scalable production of efficient, robust and portable devices. We introduce additive manufacturing as a production technique of quantum device components with unrivalled design freedom and rapid prototyping. This provides a step change in efficiency, compactness and facilitates systems integration. As a demonstrator we present an ultrahigh vacuum compatible ultracold atom source dissipating less than ten milliwatts of electrical power during field generation to produce large samples of cold rubidium gases. This disruptive technology opens the door to drastically improved integrated structures, which will further reduce size and assembly complexity in scalable series manufacture of bespoke portable quantum devices.

Rapid prototyping of multi-scale biomedical microdevices by combining additive manufacturing technologies.

PubMed

Hengsbach, Stefan; Lantada, Andrés Díaz

2014-08-01

The possibility of designing and manufacturing biomedical microdevices with multiple length-scale geometries can help to promote special interactions both with their environment and with surrounding biological systems. These interactions aim to enhance biocompatibility and overall performance by using biomimetic approaches. In this paper, we present a design and manufacturing procedure for obtaining multi-scale biomedical microsystems based on the combination of two additive manufacturing processes: a conventional laser writer to manufacture the overall device structure, and a direct-laser writer based on two-photon polymerization to yield finer details. The process excels for its versatility, accuracy and manufacturing speed and allows for the manufacture of microsystems and implants with overall sizes up to several millimeters and with details down to sub-micrometric structures. As an application example we have focused on manufacturing a biomedical microsystem to analyze the impact of microtextured surfaces on cell motility. This process yielded a relevant increase in precision and manufacturing speed when compared with more conventional rapid prototyping procedures.

A system approach for reducing the environmental impact of manufacturing and sustainability improvement of nano-scale manufacturing

NASA Astrophysics Data System (ADS)

Yuan, Yingchun

This dissertation develops an effective and economical system approach to reduce the environmental impact of manufacturing. The system approach is developed by using a process-based holistic method for upstream analysis and source reduction of the environmental impact of manufacturing. The system approach developed consists of three components of a manufacturing system: technology, energy and material, and is useful for sustainable manufacturing as it establishes a clear link between manufacturing system components and its overall sustainability performance, and provides a framework for environmental impact reductions. In this dissertation, the system approach developed is applied for environmental impact reduction of a semiconductor nano-scale manufacturing system, with three case scenarios analyzed in depth on manufacturing process improvement, clean energy supply, and toxic chemical material selection. The analysis on manufacturing process improvement is conducted on Atomic Layer Deposition of Al2O3 dielectric gate on semiconductor microelectronics devices. Sustainability performance and scale-up impact of the ALD technology in terms of environmental emissions, energy consumption, nano-waste generation and manufacturing productivity are systematically investigated and the ways to improve the sustainability of the ALD technology are successfully developed. The clean energy supply is studied using solar photovoltaic, wind, and fuel cells systems for electricity generation. Environmental savings from each clean energy supply over grid power are quantitatively analyzed, and costs for greenhouse gas reductions on each clean energy supply are comparatively studied. For toxic chemical material selection, an innovative schematic method is developed as a visual decision tool for characterizing and benchmarking the human health impact of toxic chemicals, with a case study conducted on six chemicals commonly used as solvents in semiconductor manufacturing. Reliability of

Workshop Report on Additive Manufacturing for Large-Scale Metal Components - Development and Deployment of Metal Big-Area-Additive-Manufacturing (Large-Scale Metals AM) System

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

Babu, Sudarsanam Suresh; Love, Lonnie J.; Peter, William H.

Additive manufacturing (AM) is considered an emerging technology that is expected to transform the way industry can make low-volume, high value complex structures. This disruptive technology promises to replace legacy manufacturing methods for the fabrication of existing components in addition to bringing new innovation for new components with increased functional and mechanical properties. This report outlines the outcome of a workshop on large-scale metal additive manufacturing held at Oak Ridge National Laboratory (ORNL) on March 11, 2016. The charter for the workshop was outlined by the Department of Energy (DOE) Advanced Manufacturing Office program manager. The status and impact ofmore » the Big Area Additive Manufacturing (BAAM) for polymer matrix composites was presented as the background motivation for the workshop. Following, the extension of underlying technology to low-cost metals was proposed with the following goals: (i) High deposition rates (approaching 100 lbs/h); (ii) Low cost (<$10/lbs) for steel, iron, aluminum, nickel, as well as, higher cost titanium, (iii) large components (major axis greater than 6 ft) and (iv) compliance of property requirements. The above concept was discussed in depth by representatives from different industrial sectors including welding, metal fabrication machinery, energy, construction, aerospace and heavy manufacturing. In addition, DOE’s newly launched High Performance Computing for Manufacturing (HPC4MFG) program was reviewed. This program will apply thermo-mechanical models to elucidate deeper understanding of the interactions between design, process, and materials during additive manufacturing. Following these presentations, all the attendees took part in a brainstorming session where everyone identified the top 10 challenges in large-scale metal AM from their own perspective. The feedback was analyzed and grouped in different categories including, (i) CAD to PART software, (ii) selection of energy source, (iii

Manufacturing techniques for gyroscopes in gravity probe B

NASA Technical Reports Server (NTRS)

Rasquin, J. R.

1976-01-01

The design of the fused silica gyroscope configuration is presented. The first gyroscope was made for erection and spin tests only and does not contain the angle readout loops necessary for a functioning experimental gyroscope. The rotor ball described is not coated with the ultimate material, niobium, but instead with a sandwich of titanium, cooper, and titanium for spin-up test purposes. Background, historical information, manufacturing procedures, and sketches for this gyroscope are included to provide a better understanding of the device and the techniques and special tools required to manufacture a fused silica gyroscope to the required specifications.

Design and high-volume manufacture of low-cost molded IR aspheres for personal thermal imaging devices

NASA Astrophysics Data System (ADS)

Zelazny, A. L.; Walsh, K. F.; Deegan, J. P.; Bundschuh, B.; Patton, E. K.

2015-05-01

The demand for infrared optical elements, particularly those made of chalcogenide materials, is rapidly increasing as thermal imaging becomes affordable to the consumer. The use of these materials in conjunction with established lens manufacturing techniques presents unique challenges relative to the cost sensitive nature of this new market. We explore the process from design to manufacture, and discuss the technical challenges involved. Additionally, facets of the development process including manufacturing logistics, packaging, supply chain management, and qualification are discussed.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis. Final order.

PubMed

2017-10-24

The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis 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 device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis'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.

Flexible Display and Integrated Communication Devices (FDICD) Technology. Volume 2

DTIC Science & Technology

2008-06-01

AFRL-RH-WP-TR-2008-0072 Flexible Display and Integrated Communication Devices (FDICD) Technology, Volume II David Huffman Keith Tognoni...14 April 2004 – 20 June 2008 4. TITLE AND SUBTITLE Flexible Display and Integrated Communication Devices (FDICD) Technology, Volume II 5a...14. ABSTRACT This flexible display and integrated communication devices (FDICD) technology program sought to create a family of powerful

"Real life" longevity of implantable cardioverter-defibrillator devices.

PubMed

Manolis, Antonis S; Maounis, Themistoklis; Koulouris, Spyridon; Vassilikos, Vassilios

2017-09-01

Manufacturers of implantable cardioverter-defibrillators (ICDs) promise a 5- to 9-year projected longevity; however, real-life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. Real-life longevity of ICDs may differ from that stated by the manufacturers. The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single- (n = 292) or dual-chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single-chamber devices and shortest for CRT devices. Latest-generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical

Virtex-II Pro SEE Test Methods and Results

NASA Technical Reports Server (NTRS)

Petrick, David; Powell, Wesley; Howard, James W., Jr.; LaBel, Kenneth A.

2004-01-01

The objective of this coarse Single Event Effect (SEE) test is to determine the suitability of the commercial Virtex-II Pro family for use in spaceflight applications. To this end, this test is primarily intended to determine any Singe Event Latchup (SEL) susceptibilities for these devices. Secondly, this test is intended to measure the level of Single Event Upset (SEU) susceptibilities and in a general sense where they occur. The coarse SEE test was performed on a commercial XC2VP7 device, a relatively small single processor version of the Virtex-II Pro. As the XC2VP7 shares the same functional block design and fabrication process with the larger Virtex-II Pro devices, the results of this test should also be applicable to the larger devices. The XC2VP7 device was tested on a commercial Virtex-II Pro development board. The testing was performed at the Cyclotron laboratories at Texas A&M and Michigan State Universities using ions of varying energy levels and fluences.

Radiation-tolerant imaging device

DOEpatents

Colella, Nicholas J.; Kimbrough, Joseph R.

1996-01-01

A barrier at a uniform depth for an entire wafer is used to produce imaging devices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imaging device. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO.sub.2 insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron's generated by the ionizing radiation. A manufacturer of CCD imaging devices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO.sub.2 layer.

78 FR 39340 - Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-01

... Methadone Intermediate (9254) II Tapentadol (9780) II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to Methadone Intermediate (9254) the company plans to produce Methadone HCL active pharmaceutical ingredients...

Multijunction photovoltaic device and method of manufacture

DOEpatents

Arya, Rejeewa R.; Catalano, Anthony W.; Bennett, Murray

1995-04-04

A multijunction photovoltaic device includes first, second, and third amorphous silicon p-i-n photovoltaic cells in a stacked arrangement. The intrinsic layers of the second and third cells are formed of a-SiGe alloys with differing ratios of Ge such that the bandgap of the intrinsic layers respectively decrease from the first uppermost cell to the third lowermost cell. An interface layer, composed of a doped silicon compound, is disposed between the two cells and has a lower bandgap than the respective n- and p-type adjacent layers of the first and second cells. The interface layer forms an ohmic contact with the one of the adjacent cell layers of the same conductivity type, and a tunnel junction with the other of the adjacent cell layers.

21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Testing Requirements... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device contains human blood or a blood component as a component of the final device, and the human blood or blood...

A Profile of Defense Manufacturing Costs and Enabling Technologies

DTIC Science & Technology

1992-01-01

RECEIVE MODULE F Missiles 75mm Cadmium Zinc Telluride F 94 GHZ MILLIMETER WAVE TRANSCEIVER F COMPOSITES FOR PASSIVE THERMAL MANAGEMENT F COMPOSITES FOR... PASSIVE THERMAL MANAGEMENT F Design standards for surface mount devices I Electro-optic Components Advanced Manufacturing PrDcess I FIBER OPTIC

21 CFR 509.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-packaging materials shall: (i) Have the heat exchange fluid used in existing equipment for manufacturing... manufacturing practices be replaced with a heat exchange fluid that does not contain PCB's. (ii) Eliminate to... (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's...

21 CFR 509.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-packaging materials shall: (i) Have the heat exchange fluid used in existing equipment for manufacturing... manufacturing practices be replaced with a heat exchange fluid that does not contain PCB's. (ii) Eliminate to... (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's...

21 CFR 109.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-packaging materials shall: (i) Have the heat exchange fluid used in existing equipment for manufacturing... manufacturing practices be replaced with a heat exchange fluid that does not contain PCB's. (ii) Eliminate to... (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's...

21 CFR 109.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-packaging materials shall: (i) Have the heat exchange fluid used in existing equipment for manufacturing... manufacturing practices be replaced with a heat exchange fluid that does not contain PCB's. (ii) Eliminate to... (Japan). PCB's are highly stable, heat resistant, and nonflammable chemicals. Industrial uses of PCB's...

Medical Device Innovation in the Era of the Affordable Care Act

PubMed Central

Mattke, Soeren; Liu, Hangsheng; Orr, Patrick

2016-01-01

Abstract In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments from the spectacular toward the prudent, which they dub “the end of sexy.” The authors explore consequences for manufacturers, investors, and policymakers. PMID:28083437

Method of forming crystalline silicon devices on glass

DOEpatents

McCarthy, Anthony M.

1995-01-01

A method for fabricating single-crystal silicon microelectronic components on a silicon substrate and transferring same to a glass substrate. This is achieved by utilizing conventional silicon processing techniques for fabricating components of electronic circuits and devices on bulk silicon, wherein a bulk silicon surface is prepared with epitaxial layers prior to the conventional processing. The silicon substrate is bonded to a glass substrate and the bulk silicon is removed leaving the components intact on the glass substrate surface. Subsequent standard processing completes the device and circuit manufacturing. This invention is useful in applications requiring a transparent or insulating substrate, particularly for display manufacturing. Other applications include sensors, actuators, optoelectronics, radiation hard electronics, and high temperature electronics.

Lithographic manufacturing of adaptive optics components

NASA Astrophysics Data System (ADS)

Scott, R. Phillip; Jean, Madison; Johnson, Lee; Gatlin, Ridley; Bronson, Ryan; Milster, Tom; Hart, Michael

2017-09-01

Adaptive optics systems and their laboratory test environments call for a number of unusual optical components. Examples include lenslet arrays, pyramids, and Kolmogorov phase screens. Because of their specialized application, the availability of these parts is generally limited, with high cost and long lead time, which can also significantly drive optical system design. These concerns can be alleviated by a fast and inexpensive method of optical fabrication. To that end, we are exploring direct-write lithographic techniques to manufacture three different custom elements. We report results from a number of prototype devices including 1, 2, and 3 wave Multiple Order Diffractive (MOD) lenslet arrays with 0.75 mm pitch and phase screens with near Kolmogorov structure functions with a Fried length r0 around 1 mm. We also discuss plans to expand our research to include a diffractive pyramid that is smaller, lighter, and more easily manufactured than glass versions presently used in pyramid wavefront sensors. We describe how these components can be produced within the limited dynamic range of the lithographic process, and with a rapid prototyping and manufacturing cycle. We discuss exploratory manufacturing methods, including replication, and potential observing techniques enabled by the ready availability of custom components.

Fabricating specialised orthopaedic implants using additive manufacturing

NASA Astrophysics Data System (ADS)

Unwin, Paul

2014-03-01

It has been hypothesised that AM is ideal for patient specific orthopaedic implants such as those used in bone cancer treatment, that can rapidly build structures such as lattices for bone and tissues to in-grow, that would be impossible using current conventional subtractive manufacturing techniques. The aim of this study was to describe the adoption of AM (direct metal laser sintering and electron beam melting) into the design manufacturing and post-manufacturing processes and the early clinical use. Prior to the clinical use of AM implants, extensive metallurgical and mechanical testing of both laser and electron beam fabrications were undertaken. Concurrently, post-manufacturing processes evaluated included hipping, cleaning and coating treatments. The first clinical application of a titanium alloy mega-implant was undertaken in November 2010. A 3D model of the pelvic wing implant was designed from CT scans. Novel key features included extensive lattice structures at the bone interfaces and integral flanges to fix the implant to the bone. The pelvic device was implanted with the aid of navigation and to date the patient remains active. A further 18 patient specific mega-implants have now been implanted. The early use of this advanced manufacturing route for patient specific implants has been very encouraging enabling the engineer to produce more advanced and anatomical conforming implants. However, there are a new set of design, manufacturing and regulatory challenges that require addressing to permit this technique to be used more widely. This technology is changing the design and manufacturing paradigm for the fabrication of specialised orthopaedic implants.

Manufacturing Process Simulation of Large-Scale Cryotanks

NASA Technical Reports Server (NTRS)

Babai, Majid; Phillips, Steven; Griffin, Brian

2003-01-01

NASA's Space Launch Initiative (SLI) is an effort to research and develop the technologies needed to build a second-generation reusable launch vehicle. It is required that this new launch vehicle be 100 times safer and 10 times cheaper to operate than current launch vehicles. Part of the SLI includes the development of reusable composite and metallic cryotanks. The size of these reusable tanks is far greater than anything ever developed and exceeds the design limits of current manufacturing tools. Several design and manufacturing approaches have been formulated, but many factors must be weighed during the selection process. Among these factors are tooling reachability, cycle times, feasibility, and facility impacts. The manufacturing process simulation capabilities available at NASA.s Marshall Space Flight Center have played a key role in down selecting between the various manufacturing approaches. By creating 3-D manufacturing process simulations, the varying approaches can be analyzed in a virtual world before any hardware or infrastructure is built. This analysis can detect and eliminate costly flaws in the various manufacturing approaches. The simulations check for collisions between devices, verify that design limits on joints are not exceeded, and provide cycle times which aide in the development of an optimized process flow. In addition, new ideas and concerns are often raised after seeing the visual representation of a manufacturing process flow. The output of the manufacturing process simulations allows for cost and safety comparisons to be performed between the various manufacturing approaches. This output helps determine which manufacturing process options reach the safety and cost goals of the SLI. As part of the SLI, The Boeing Company was awarded a basic period contract to research and propose options for both a metallic and a composite cryotank. Boeing then entered into a task agreement with the Marshall Space Flight Center to provide manufacturing

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

7 CFR 1430.610 - Misrepresentation and scheme or device.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false Misrepresentation and scheme or device. 1430.610... Disaster Assistance Payment Program II (DDAP-II) § 1430.610 Misrepresentation and scheme or device. (a) In... receive assistance under this program if the producer is determined by CCC to have: (1) Adopted any scheme...

[2011 after-service customer satisfaction survey of monitoring devices in Shanghai area].

PubMed

Wang, Lijun; Li, Bin; Qian, Jianguo; Cao, Shaoping; He, Dehua; Zheng, Yunxin

2013-01-01

In 2011, Shanghai Medical Equipment Management Quality Control Center launched the fifth after-sale service satisfaction survey for medical devices in Shanghai area. There are 8 classes medical devices involving in the survey. This paper demonstrates the investigation results of monitoring devices which are from different manufacturers.

High fidelity computational simulation of thrombus formation in Thoratec HeartMate II continuous flow ventricular assist device

PubMed Central

Wu, Wei-Tao; Yang, Fang; Wu, Jingchun; Aubry, Nadine; Massoudi, Mehrdad; Antaki, James F.

2016-01-01

Continuous flow ventricular assist devices (cfVADs) provide a life-saving therapy for severe heart failure. However, in recent years, the incidence of device-related thrombosis (resulting in stroke, device-exchange surgery or premature death) has been increasing dramatically, which has alarmed both the medical community and the FDA. The objective of this study was to gain improved understanding of the initiation and progression of thrombosis in one of the most commonly used cfVADs, the Thoratec HeartMate II. A computational fluid dynamics simulation (CFD) was performed using our recently updated mathematical model of thrombosis. The patterns of deposition predicted by simulation agreed well with clinical observations. Furthermore, thrombus accumulation was found to increase with decreased flow rate, and can be completely suppressed by the application of anticoagulants and/or improvement of surface chemistry. To our knowledge, this is the first simulation to explicitly model the processes of platelet deposition and thrombus growth in a continuous flow blood pump and thereby replicate patterns of deposition observed clinically. The use of this simulation tool over a range of hemodynamic, hematological, and anticoagulation conditions could assist physicians to personalize clinical management to mitigate the risk of thrombosis. It may also contribute to the design of future VADs that are less thrombogenic. PMID:27905492

Printed polymer photonic devices for optical interconnect systems

NASA Astrophysics Data System (ADS)

Subbaraman, Harish; Pan, Zeyu; Zhang, Cheng; Li, Qiaochu; Guo, L. J.; Chen, Ray T.

2016-03-01

Polymer photonic device fabrication usually relies on the utilization of clean-room processes, including photolithography, e-beam lithography, reactive ion etching (RIE) and lift-off methods etc, which are expensive and are limited to areas as large as a wafer. Utilizing a novel and a scalable printing process involving ink-jet printing and imprinting, we have fabricated polymer based photonic interconnect components, such as electro-optic polymer based modulators and ring resonator switches, and thermo-optic polymer switch based delay networks and demonstrated their operation. Specifically, a modulator operating at 15MHz and a 2-bit delay network providing up to 35.4ps are presented. In this paper, we also discuss the manufacturing challenges that need to be overcome in order to make roll-to-roll manufacturing practically viable. We discuss a few manufacturing challenges, such as inspection and quality control, registration, and web control, that need to be overcome in order to realize true implementation of roll-to-roll manufacturing of flexible polymer photonic systems. We have overcome these challenges, and currently utilizing our inhouse developed hardware and software tools, <10μm alignment accuracy at a 5m/min is demonstrated. Such a scalable roll-to-roll manufacturing scheme will enable the development of unique optoelectronic devices which can be used in a myriad of different applications, including communication, sensing, medicine, security, imaging, energy, lighting etc.

Tritium target manufacturing for use in accelerators

NASA Astrophysics Data System (ADS)

Bach, P.; Monnin, C.; Van Rompay, M.; Ballanger, A.

2001-07-01

As a neutron tube manufacturer, SODERN is now in charge of manufacturing tritium targets for accelerators, in cooperation with CEA/DAM/DTMN in Valduc. Specific deuterium and tritium targets are manufactured on request, according to the requirements of the users, starting from titanium target on copper substrate, and going to more sophisticated devices. A wide range of possible uses is covered, including thin targets for neutron calibration, thick targets with controlled loading of deuterium and tritium, rotating targets for higher lifetimes, or large size rotating targets for accelerators used in boron neutron therapy. Activity of targets lies in the 1 to 1000 Curie, diameter of targets being up to 30 cm. Special targets are also considered, including surface layer targets for lowering tritium desorption under irradiation, or those made from different kinds of occluders such as titanium, zirconium, erbium, scandium, with different substrates. It is then possible to optimize either neutron output, or lifetime and stability, or thermal behavior.

76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... intended for non-invasive aesthetic use will need to address the issues covered in the special controls... intended for non-invasive aesthetic use. (b) Classification. Class II (special controls). The special... into class II (special controls). The special control that will apply to the device is the guidance...

Paper-based CRP Monitoring Devices

NASA Astrophysics Data System (ADS)

Lin, Shang-Chi; Tseng, Chung-Yuh; Lai, Po-Liang; Hsu, Min-Yen; Chu, Shueh-Yao; Tseng, Fan-Gang; Cheng, Chao-Min

2016-12-01

Here, we discuss the development of a paper-based diagnostic device that is inexpensive, portable, easy-to-use, robust, and capable of running simultaneous tests to monitor a relevant inflammatory protein for clinical diagnoses i.e. C-reactive protein (CRP). In this study, we first attempted to make a paper-based diagnostic device via the wax printing method, a process that was used in previous studies. This device has two distinct advantages: 1) reduced manufacturing and assay costs and operation duration via using wax printing method to define hydrophobic boundaries (for fluidic devices or general POC devices); and, 2) the hydrophilicity of filter paper, which is used to purify and chromatographically correct interference caused by whole blood components with a tiny amount of blood sample (only 5 μL). Diagnosis was based on serum stain length retained inside the paper channels of our device. This is a balanced function between surface tension and chromatographic force following immune reactions (CRP assays) with a paper-embedded biomarker.

Automotive manufacturing assessment system. Volume II: product schedules of engine/drivetrain combinations. Final report Jun 77-Aug 78

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

Taylor, T. Jr; Cunningham, A.R.; Iannelli, D.A.

Volume II is part of a four volume set documenting areas of research resulting from the development of the Automotive Manufacturing Assessment System (AMAS) for the DOT/Transportation Systems Center. AMAS was designed to assist in the evaluation of industry's capability to produce fuel efficient vehicles. Engine/driveline changes are the second most important contribution to fuel economy (weight reduction being the first) and are of major importance towards meeting emission standards. Through extensive synthesis of vehicle specifications and other data, chronological presentations were developed to illustrate engines and transmissions in production, engine/transmission and model/engine combinations, and automatic vs. manual transmission availability.more » Also shown are the progression of engine/driveline changes from 1975 through 1978; the correlation of these changes with new vehicle introductions; the restrictions on available drive-train options due to emission requirements; and technological improvements including dieselization, fuel metering, lock-up torque converters, and front-wheel-drive.« less

Additive manufacturing of magnetic shielding and ultra-high vacuum flange for cold atom sensors.

PubMed

Vovrosh, Jamie; Voulazeris, Georgios; Petrov, Plamen G; Zou, Ji; Gaber, Youssef; Benn, Laura; Woolger, David; Attallah, Moataz M; Boyer, Vincent; Bongs, Kai; Holynski, Michael

2018-01-31

Recent advances in the understanding and control of quantum technologies, such as those based on cold atoms, have resulted in devices with extraordinary metrological performance. To realise this potential outside of a lab environment the size, weight and power consumption need to be reduced. Here we demonstrate the use of laser powder bed fusion, an additive manufacturing technique, as a production technique relevant to the manufacture of quantum sensors. As a demonstration we have constructed two key components using additive manufacturing, namely magnetic shielding and vacuum chambers. The initial prototypes for magnetic shields show shielding factors within a factor of 3 of conventional approaches. The vacuum demonstrator device shows that 3D-printed titanium structures are suitable for use as vacuum chambers, with the test system reaching base pressures of 5 ± 0.5 × 10 -10 mbar. These demonstrations show considerable promise for the use of additive manufacturing for cold atom based quantum technologies, in future enabling improved integrated structures, allowing for the reduction in size, weight and assembly complexity.

Energy conversion device with support member having pore channels

DOEpatents

Routkevitch, Dmitri [Longmont, CO; Wind, Rikard A [Johnstown, CO

2014-01-07

Energy devices such as energy conversion devices and energy storage devices and methods for the manufacture of such devices. The devices include a support member having an array of pore channels having a small average pore channel diameter and having a pore channel length. Material layers that may include energy conversion materials and conductive materials are coaxially disposed within the pore channels to form material rods having a relatively small cross-section and a relatively long length. By varying the structure of the materials in the pore channels, various energy devices can be fabricated, such as photovoltaic (PV) devices, radiation detectors, capacitors, batteries and the like.

78 FR 64018 - Manufacturer of Controlled Substances; Notice of Application; GE Healthcare

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... listed in schedule II. The company plans to manufacture a radioactive product to diagnose Parkinson's disease for distribution to its customers. Any other such applicant, and any person who is presently...

Hardness Assurance Techniques for New Generation COTS Devices

NASA Technical Reports Server (NTRS)

Lee, C. I.; Rax, B. G.; Johnston, A. H.

1996-01-01

Hardness Assurance (HA) techniques and total dose radiation characterization data for new generation linear and COTS devices from various manufacturers are presented. A bipolar op amp showed significant degradation at HDR, not at low dose rate environment. New generation low-power op amps showed more degradation at low voltage applications. HA test techniques for COTS devices are presented in this paper.

Treatment of Class II Division 2 Malocclusion Using the Forsus Fatigue Resistance Device and 5-Year Follow-Up

PubMed Central

Atik, Ezgi; Kocadereli, Ilken

2016-01-01

This case report presents the treatment of a 14-year-and-8-month-old boy with Class II division 2 mandibular retrusion, severe deep bite, and concave profile. The Forsus fatigue resistance device (FRD) was effective in correcting both skeletal and dental parameters. At 5-year posttreatment follow-up, the teeth were well aligned and the occlusion was stable. FRD application with appropriate treatment time can result with prominent changes in the facial profile and dentition, and the outcomes can be maintained at the long-term follow-up periods. PMID:27034855

40 CFR 60.703 - Monitoring of emissions and operations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Volatile Organic Compound Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor... recorder; or (ii) An organic monitoring device used to indicate the concentration level of organic... expressed in degrees Celsius or ±0.5 °C, whichever is greater; or (ii) An organic monitoring device used to...

40 CFR 60.663 - Monitoring of emissions and operations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Volatile Organic Compound (VOC) Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI... continuous recorder, or (ii) An organic monitoring device used to indicate the concentration level of organic... expressed in degrees Celsius or ±0.5 °C, whichever is greater, or (ii) An organic monitoring device used to...

40 CFR 60.703 - Monitoring of emissions and operations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Volatile Organic Compound Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor... recorder; or (ii) An organic monitoring device used to indicate the concentration level of organic... expressed in degrees Celsius or ±0.5 °C, whichever is greater; or (ii) An organic monitoring device used to...

40 CFR 60.663 - Monitoring of emissions and operations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Volatile Organic Compound (VOC) Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI... continuous recorder, or (ii) An organic monitoring device used to indicate the concentration level of organic... expressed in degrees Celsius or ±0.5 °C, whichever is greater, or (ii) An organic monitoring device used to...

40 CFR 60.663 - Monitoring of emissions and operations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Volatile Organic Compound (VOC) Emissions From Synthetic Organic Chemical Manufacturing Industry (SOCMI... continuous recorder, or (ii) An organic monitoring device used to indicate the concentration level of organic... expressed in degrees Celsius or ±0.5 °C, whichever is greater, or (ii) An organic monitoring device used to...

Method of forming crystalline silicon devices on glass

DOEpatents

McCarthy, A.M.

1995-03-21

A method is disclosed for fabricating single-crystal silicon microelectronic components on a silicon substrate and transferring same to a glass substrate. This is achieved by utilizing conventional silicon processing techniques for fabricating components of electronic circuits and devices on bulk silicon, wherein a bulk silicon surface is prepared with epitaxial layers prior to the conventional processing. The silicon substrate is bonded to a glass substrate and the bulk silicon is removed leaving the components intact on the glass substrate surface. Subsequent standard processing completes the device and circuit manufacturing. This invention is useful in applications requiring a transparent or insulating substrate, particularly for display manufacturing. Other applications include sensors, actuators, optoelectronics, radiation hard electronics, and high temperature electronics. 7 figures.

Photonomics: automation approaches yield economic aikido for photonics device manufacture

NASA Astrophysics Data System (ADS)

Jordan, Scott

2002-09-01

In the glory days of photonics, with exponentiating demand for photonics devices came exponentiating competition, with new ventures commencing deliveries seemingly weekly. Suddenly the industry was faced with a commodity marketplace well before a commodity cost structure was in place. Economic issues like cost, scalability, yield-call it all "Photonomics" -now drive the industry. Automation and throughput-optimization are obvious answers, but until now, suitable modular tools had not been introduced. Available solutions were barely compatible with typical transverse alignment tolerances and could not automate angular alignments of collimated devices and arrays. And settling physics served as the insoluble bottleneck to throughput and resolution advancement in packaging, characterization and fabrication processes. The industry has addressed these needs in several ways, ranging from special configurations of catalog motion devices to integrated microrobots based on a novel mini-hexapod configuration. This intriguing approach allows tip/tilt alignments to be automated about any point in space, such as a beam waist, a focal point, the cleaved face of a fiber, or the optical axis of a waveguide- ideal for MEMS packaging automation and array alignment. Meanwhile, patented new low-cost settling-enhancement technology has been applied in applications ranging from air-bearing long-travel stages to subnanometer-resolution piezo positioners to advance resolution and process cycle-times in sensitive applications such as optical coupling characterization and fiber Bragg grating generation. Background, examples and metrics are discussed, providing an up-to-date industry overview of available solutions.

Counterpropagating wave acoustic particle manipulation device for the effective manufacture of composite materials.

PubMed

Scholz, Marc-S; Drinkwater, Bruce W; Llewellyn-Jones, Thomas M; Trask, Richard S

2015-10-01

An ultrasonic assembly device exhibiting broadband behavior and a sacrificial plastic frame is described. This device is used to assemble a variety of microscopic particles differing in size, shape, and material into simple patterns within several host fluids. When the host fluid is epoxy, the assembled materials can be cured and the composite sample extracted from the sacrificial frame. The wideband performance means that within a single device, the wavelength can be varied, leading to control of the length scale of the acoustic radiation force field. We show that glass fibers of 50 μm length and 14 μm diameter can be assembled into a series of stripes separated by hundreds of microns in a time of 0.3 s. Finite element analysis is used to understand the attributes of the device which control its wideband characteristics. The bandwidth is shown to be governed by the damping produced by a combination of the plastic frame and the relatively large volume of the fluid particle mixture. The model also reveals that the acoustic radiation forces are a maximum near the substrate of the device, which is in agreement with experimental observations. The device is extended to 8-transducers and used to assemble more complex particle distributions.

IMPROVED EQUIPMENT CLEANING IN COATED AND LAMINATED SUBSTRATE MANUFACTURING FACILITIES (PHASE II)

EPA Science Inventory

The report discusses EPA efforts to identify, demonstrate, and publish pollution prevention information and opportunities for equipment cleaning for the coated and laminated substrate manufacturing industry. It summarizes initial data collected and summarized during industry obse...

27 CFR 478.40 - Manufacture, transfer, and possession of semiautomatic assault weapons.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., or slide action; (ii) Has been rendered permanently inoperable; or (iii) Is an antique firearm; (4... manufacturer stating that sales will only be made to law enforcement agencies, law enforcement officers, or...

27 CFR 478.40 - Manufacture, transfer, and possession of semiautomatic assault weapons.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., or slide action; (ii) Has been rendered permanently inoperable; or (iii) Is an antique firearm; (4... manufacturer stating that sales will only be made to law enforcement agencies, law enforcement officers, or...

27 CFR 478.40 - Manufacture, transfer, and possession of semiautomatic assault weapons.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., or slide action; (ii) Has been rendered permanently inoperable; or (iii) Is an antique firearm; (4... manufacturer stating that sales will only be made to law enforcement agencies, law enforcement officers, or...

27 CFR 478.40 - Manufacture, transfer, and possession of semiautomatic assault weapons.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., or slide action; (ii) Has been rendered permanently inoperable; or (iii) Is an antique firearm; (4... manufacturer stating that sales will only be made to law enforcement agencies, law enforcement officers, or...

27 CFR 478.40 - Manufacture, transfer, and possession of semiautomatic assault weapons.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., or slide action; (ii) Has been rendered permanently inoperable; or (iii) Is an antique firearm; (4... manufacturer stating that sales will only be made to law enforcement agencies, law enforcement officers, or...

Manufacturing of embedded multimode waveguides by reactive lamination of cyclic olefin polymer and polymethylmethacrylate

NASA Astrophysics Data System (ADS)

Kelb, Christian; Rother, Raimund; Schuler, Anne-Katrin; Hinkelmann, Moritz; Rahlves, Maik; Prucker, Oswald; Müller, Claas; Rühe, Jürgen; Reithmeier, Eduard; Roth, Bernhard

2016-03-01

We demonstrate the manufacturing of embedded multimode optical waveguides through linking of polymethylmethacrylate (PMMA) foils and cyclic olefin polymer (COP) filaments based on a lamination process. Since the two polymeric materials cannot be fused together through interdiffusion of polymer chains, we utilize a reactive lamination agent based on PMMA copolymers containing photoreactive 2-acryloyloxyanthraquinone units, which allows the creation of monolithic PMMA-COP substrates through C-H insertion reactions across the interface between the two materials. We elucidate the lamination process and evaluate the chemical link between filament and foils by carrying out extraction tests with a custom-built tensile testing machine. We also show attenuation measurements of the manufactured waveguides for different manufacturing parameters. The lamination process is in particular suited for large-scale and low-cost fabrication of board-level devices with optical waveguides or other micro-optical structures, e.g., optofluidic devices.

In vivo polymerization and manufacturing of wires and supercapacitors in plants

PubMed Central

Stavrinidou, Eleni; Nilsson, K. Peter R.; Singh, Sandeep Kumar; Franco-Gonzalez, Juan Felipe; Volkov, Anton V.; Jonsson, Magnus P.; Grimoldi, Andrea; Elgland, Mathias; Zozoulenko, Igor V.; Berggren, Magnus

2017-01-01

Electronic plants, e-Plants, are an organic bioelectronic platform that allows electronic interfacing with plants. Recently we have demonstrated plants with augmented electronic functionality. Using the vascular system and organs of a plant, we manufactured organic electronic devices and circuits in vivo, leveraging the internal structure and physiology of the plant as the template, and an integral part of the devices. However, this electronic functionality was only achieved in localized regions, whereas new electronic materials that could be distributed to every part of the plant would provide versatility in device and circuit fabrication and create possibilities for new device concepts. Here we report the synthesis of such a conjugated oligomer that can be distributed and form longer oligomers and polymer in every part of the xylem vascular tissue of a Rosa floribunda cutting, forming long-range conducting wires. The plant’s structure acts as a physical template, whereas the plant’s biochemical response mechanism acts as the catalyst for polymerization. In addition, the oligomer can cross through the veins and enter the apoplastic space in the leaves. Finally, using the plant’s natural architecture we manufacture supercapacitors along the stem. Our results are preludes to autonomous energy systems integrated within plants and distribute interconnected sensor–actuator systems for plant control and optimization. PMID:28242683

In vivo polymerization and manufacturing of wires and supercapacitors in plants.

PubMed

Stavrinidou, Eleni; Gabrielsson, Roger; Nilsson, K Peter R; Singh, Sandeep Kumar; Franco-Gonzalez, Juan Felipe; Volkov, Anton V; Jonsson, Magnus P; Grimoldi, Andrea; Elgland, Mathias; Zozoulenko, Igor V; Simon, Daniel T; Berggren, Magnus

2017-03-14

Electronic plants, e -Plants, are an organic bioelectronic platform that allows electronic interfacing with plants. Recently we have demonstrated plants with augmented electronic functionality. Using the vascular system and organs of a plant, we manufactured organic electronic devices and circuits in vivo, leveraging the internal structure and physiology of the plant as the template, and an integral part of the devices. However, this electronic functionality was only achieved in localized regions, whereas new electronic materials that could be distributed to every part of the plant would provide versatility in device and circuit fabrication and create possibilities for new device concepts. Here we report the synthesis of such a conjugated oligomer that can be distributed and form longer oligomers and polymer in every part of the xylem vascular tissue of a Rosa floribunda cutting, forming long-range conducting wires. The plant's structure acts as a physical template, whereas the plant's biochemical response mechanism acts as the catalyst for polymerization. In addition, the oligomer can cross through the veins and enter the apoplastic space in the leaves. Finally, using the plant's natural architecture we manufacture supercapacitors along the stem. Our results are preludes to autonomous energy systems integrated within plants and distribute interconnected sensor-actuator systems for plant control and optimization.

Technology optimization techniques for multicomponent optical band-pass filter manufacturing

NASA Astrophysics Data System (ADS)

Baranov, Yuri P.; Gryaznov, Georgiy M.; Rodionov, Andrey Y.; Obrezkov, Andrey V.; Medvedev, Roman V.; Chivanov, Alexey N.

2016-04-01

Narrowband optical devices (like IR-sensing devices, celestial navigation systems, solar-blind UV-systems and many others) are one of the most fast-growing areas in optical manufacturing. However, signal strength in this type of applications is quite low and performance of devices depends on attenuation level of wavelengths out of operating range. Modern detectors (photodiodes, matrix detectors, photomultiplier tubes and others) usually do not have required selectivity or have higher sensitivity to background spectrum at worst. Manufacturing of a single component band-pass filter with high attenuation level of wavelength is resource-intensive task. Sometimes it's not possible to find solution for this problem using existing technologies. Different types of filters have technology variations of transmittance profile shape due to various production factors. At the same time there are multiple tasks with strict requirements for background spectrum attenuation in narrowband optical devices. For example, in solar-blind UV-system wavelengths above 290-300 nm must be attenuated by 180dB. In this paper techniques of multi-component optical band-pass filters assembly from multiple single elements with technology variations of transmittance profile shape for optimal signal-tonoise ratio (SNR) were proposed. Relationships between signal-to-noise ratio and different characteristics of transmittance profile shape were shown. Obtained practical results were in rather good agreement with our calculations.

A guide to manufacturing CAR T cell therapies.

PubMed

Vormittag, Philipp; Gunn, Rebecca; Ghorashian, Sara; Veraitch, Farlan S

2018-02-17

In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling steps. For academia, big pharma and contract manufacturers it is difficult to obtain an overview over the process strategies and their respective advantages and disadvantages. This review details current production processes being used for CAR T cells with a particular focus on efficacy, reproducibility, manufacturing costs and release testing. By undertaking a systematic analysis of the manufacture of CAR T cells from reported clinical trial data to date, we have been able to quantify recent trends and track the uptake of new process technology. Delivering new processing options will be key to the success of the CAR-T cells ensuring that excessive manufacturing costs do not disrupt the delivery of exciting new therapies to the wide possible patient cohort. Copyright © 2018 Elsevier Ltd. All rights reserved.

FDA MAUDE data on complications with lasers, light sources, and energy-based devices.

PubMed

Tremaine, Anne Marie; Avram, Mathew M

2015-02-01

It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional

Microfabricated fuel heating value monitoring device

DOEpatents

Robinson, Alex L [Albuquerque, NM; Manginell, Ronald P [Albuquerque, NM; Moorman, Matthew W [Albuquerque, NM

2010-05-04

A microfabricated fuel heating value monitoring device comprises a microfabricated gas chromatography column in combination with a catalytic microcalorimeter. The microcalorimeter can comprise a reference thermal conductivity sensor to provide diagnostics and surety. Using microfabrication techniques, the device can be manufactured in production quantities at a low per-unit cost. The microfabricated fuel heating value monitoring device enables continuous calorimetric determination of the heating value of natural gas with a 1 minute analysis time and 1.5 minute cycle time using air as a carrier gas. This device has applications in remote natural gas mining stations, pipeline switching and metering stations, turbine generators, and other industrial user sites. For gas pipelines, the device can improve gas quality during transfer and blending, and provide accurate financial accounting. For industrial end users, the device can provide continuous feedback of physical gas properties to improve combustion efficiency during use.

Medical devices; hematology and pathology devices: reclassification of automated blood cell separator device operating by centrifugal separation principle. Final rule.

PubMed

2007-11-30

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.

Radiation-tolerant imaging device

DOEpatents

Colella, N.J.; Kimbrough, J.R.

1996-11-19

A barrier at a uniform depth for an entire wafer is used to produce imaging devices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imaging device. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO{sub 2} insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron`s generated by the ionizing radiation. A manufacturer of CCD imaging devices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO{sub 2} layer. 7 figs.

Microgravity Manufacturing Via Fused Deposition

NASA Technical Reports Server (NTRS)

Cooper, K. G.; Griffin, M. R.

2003-01-01

Manufacturing polymer hardware during space flight is currently outside the state of the art. A process called fused deposition modeling (FDM) can make this approach a reality by producing net-shaped components of polymer materials directly from a CAE model. FDM is a rapid prototyping process developed by Stratasys, Inc.. which deposits a fine line of semi-molten polymer onto a substrate while moving via computer control to form the cross-sectional shape of the part it is building. The build platen is then lowered and the process is repeated, building a component directly layer by layer. This method enables direct net-shaped production of polymer components directly from a computer file. The layered manufacturing process allows for the manufacture of complex shapes and internal cavities otherwise impossible to machine. This task demonstrated the benefits of the FDM technique to quickly and inexpensively produce replacement components or repair broken hardware in a Space Shuttle or Space Station environment. The intent of the task was to develop and fabricate an FDM system that was lightweight, compact, and required minimum power consumption to fabricate ABS plastic hardware in microgravity. The final product of the shortened task turned out to be a ground-based breadboard device, demonstrating miniaturization capability of the system.

Flexible devices: from materials, architectures to applications

NASA Astrophysics Data System (ADS)

Zou, Mingzhi; Ma, Yue; Yuan, Xin; Hu, Yi; Liu, Jie; Jin, Zhong

2018-01-01

Flexible devices, such as flexible electronic devices and flexible energy storage devices, have attracted a significant amount of attention in recent years for their potential applications in modern human lives. The development of flexible devices is moving forward rapidly, as the innovation of methods and manufacturing processes has greatly encouraged the research of flexible devices. This review focuses on advanced materials, architecture designs and abundant applications of flexible devices, and discusses the problems and challenges in current situations of flexible devices. We summarize the discovery of novel materials and the design of new architectures for improving the performance of flexible devices. Finally, we introduce the applications of flexible devices as key components in real life. Project supported by the National Key R&D Program of China (Nos. 2017YFA0208200, 2016YFB0700600, 2015CB659300), the National Natural Science Foundation of China (Nos. 21403105, 21573108), and the Fundamental Research Funds for the Central Universities (No. 020514380107).

Liquid acquisition devices for superfluid helium transfer

NASA Technical Reports Server (NTRS)

Dipirro, M. J.

1990-01-01

To transfer superfluid helium (He II) in the milli-g or micro-g environment in orbit, it is necessary to provide a reasonably steady supply of liquid to the inlet of the pump in the supply dewar. To accomplish this without providing an artificial gravity through acceleration requires a liquid acquisition device. Fluid swirl and electrostatic devices have been proposed to orientate the fluid. However, the simplest mechanisms appear to be the use of surface tension or the thermomechanical effect. This paper examines four concepts for providing He II to the inlet of a thermomechanical pump. The devices are a distributed thermomechanical pump, a distributed pump with a main thermomechanical pump, a screened channel system and a vane/sponge combination. Calculations on the efficiency of these types of liquid acquisition devices are made using laboratory data from tests involving small scale devices where applicable. These calculations show that the latter two types of liquid acquisition devices are the most efficient. Questions as to the probability of cavitation and the effect of the residual shuttle acceleration on their operation remain to be answered, however.