EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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marketplace In Focus 66 | Spring 2014 European Medical Device Technology emdt.co.uk Testing Electrical safety testing Japan-based dialysis manufacturer Nikkiso Company Ltd has specified the Rigel 288 electrical analyser for biomedical electrical safety testing. According to the company, this action led to improvements in testing procedures as part of an in- service annual safety check programme for its machines installed at hospitals and healthcare facilities throughout the country. The device combines automatic and manual test sequences, data logging and direct printing facilities. The analyser meets several international standards such as IEC / 62353, 60601-1, NFPA-99 and local variants. The earthbond test circuit allows accurate measurements at low currents resulting in a reduction in size and weight of the device. The analyser features a compact Bluetooth barcode scanner, enabling devices and equipment to be quickly identified, while test results can be stored internally and printed wirelessly to a small battery-operated printer. Information can be downloaded into asset management software Med-eBase, enabling the user to store and manage test results, email html test certificates to clients and schedule new work orders. Rigel Medical Bracken Hill, UK +44 191 5878701 www.rigelmedical.com Automatic inspection system Suited for manufacturing applications in which 100% inspection is normally required, an automated inspection system from Rudolph Technologies Inc. is capable of delivering fast, repeatable defect inspection throughout the medical device or semiconductor manufacturing process. The NSX-series macro defect inspection system detects any fault of 0.5 ┬Ám or larger in, for example, the pressure sensors manufactured in batches on silicon wafer substrates for use in precision monitoring of the pressure in catheter balloons employed in angioplasty. Engineered for speed, reliability and repeatability, the system can inspect such sensors both while they are on the substrates and after they have been put into individual devices. It not only finds yield-inhibiting defects in performing its quality assurance function, but also provides the manufacturer with process information. The supplier is able to respond to a customer's technical requirements for its own particular inspection system. Rudolph Technologies Inc. Flanders, NJ, USA +1 973 691 1300 www.rudolphtech.com Materials testing system A range of modularly designed single- column materials testing machines from Zwick Testing Machines Ltd offers medical and pharmaceutical device engineers application versatility in a small bench footprint. Suited for both R&D and quality assurance settings, the zwickiLine machines, featuring testControl II electronics and testXpert II control software, are available as a choice of units providing force capabilities between a maximum of 500 N and a maximum of 5 kN. Their application range can be attributed to an original operating concept, advanced drive technology, and their flexible measurement and control electronics. An entire test regimen can be performed independently of the PC via a display-equipped remote control. The Electrical safety analyser Fluke Biomedical offers the biomedical test market an electrical safety analyser that combines portability and ruggedness with the accuracy and reliability of its legacy analysers for quality assurance. Engineered to meet the needs of mobile technicians, the ESA609 analyser is lightweight, includes a functional hand strap, and has a rubberised case that helps prevent damage during transport and if accidentally dropped. It integrates all the functions necessary for testing medical devices when patient lead testing is not required, including line (mains) voltage, ground-wire (protective earth) resistance, equipment current, leakage current and point-to-point tests. Users need no training; the analyser's simple push-button design ensures quick testing and rapid transition between tests for complete basic testing in minutes. Heavy-duty switches make it easy for users to change polarity and configuration of the neutral connection between open and closed. The versatile analyser tests to such global electrical safety standards as ANSI/AAMI ES1, NFPA-99 and parts of IEC 62353 and IEC 60601-1. Fluke Biomedical Everett, WA, USA +1 440 248 9300 www.flukebiomedical.com ES430757_EMDT1405_066.pgs 04.29.2014 03:27 UBM black yellow magenta cyan

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