Testing and Inspection 15583

Originally Published MPMN September 2007

FOCUS ON EQUIPMENT

Testing and Inspection

X-Ray System Inspects a Range of Medical Devices and Components

A high-resolution microfocus x-ray inspection system is available from a supplier of scopes, x-ray systems, magnifiers, and video measurement systems. Applications for the system include inspection of overmolded electrical connectors, catheters, low-density plastic components, radiopaque markers in stents and implantable devices, and the presence and placement of internal components. The ViewX-1000 x-ray inspection system is also suited for general circuit-board inspection, which encompasses BGA, flip-chip, CSP, and solder joint integrity. Standard features include a 75-mm x-ray detector, an 80-kV 5-µm x-ray tube, z-axis movement of the x-ray tube, a joystick-controlled variable-speed x-y stage with a 75° sample rotation fixture, and an image-processing cpu with a 17-in. liquid-crystal display flat-panel monitor.
Scienscope International, Chino, CA
www.scienscope.com

Instrument Performs Electrodynamic Tests

Designed to conduct electrodynamic tests, a system is suited for applications ranging from the evaluation of suture tensile strength to the durability testing of fracture fixation devices. The ElectroPuls E1000 and E3000 models are equipped with user-friendly features that include a tuning wizard to ensure achievement of critical loads, a T-slot table for flexible test setups, and electrically operated crosshead lifts. Employment of a single-phase electrical supply enables placement of the system virtually anywhere. The system is also nonhydraulic and air-cooled.
Instron, Norwood, MA
www.instron.com

Measurement System Inspects Medical-Grade Plastics

A video stress and strain measurement system inspects strain patterns in clear and translucent plastic products. The Series PS100-Z system consists of a polarimeter equipped with a color CCD video camera with 6-32X zoom magnification and a high-resolution flat-panel liquid-crystal display or cathode-ray tube color monitor. Alternative camera and lens combinations are available. Using photoelasticity techniques, the system measures birefringence and detects unacceptable gradients of stress or strain in plastics that can cause cracking, warpage, and reduced material strength. Applications include medical-grade tubing, optical lenses, implantable components, and prosthetics.
Strainoptics Inc., Norht Wales, PA
www.strainoptics.com

X-Ray Equipment Enables Real-Time Stent Visibility

Helping stent manufacturers to comply with an FDA recommendation, a company’s inspection system provides indication of stent visibility on real-time and plane x-ray. The company’s MXRA real-time x-ray camera is characterized by its high resolution and acute sensitivity. These features allow detection of flaws in soft, hard-to-image materials such as molded plastics, rubber, PEEK, and silicones; however, the system is capable of inspecting ceramic and metal devices as well. Inspection can occur in still real-time x-ray images or digital video to observe device deployment as it occurs. Users can save, store, or send captured images. Moreover, the company has added a digital video recording option that lets users record and review device deployment as an x-ray video clip. The MedaScope system can be used for inspection of stents, guidewires, vascular closures, and drug-delivery devices. A portable version is also available.
Glenbrook Technologies Inc., Randolph, NJ
www.glenbrooktech.com

Automated System Provides Electrical Safety Testing

A medical device electrical safety test system provides fully automated testing to IEC 60601-1 and IEC 60601-2-49 standards. The Sentinel III system eliminates the need for operator interaction during F-Type leakage and mains-to-patient connection hipot testing. Able to be reconfigured for multipoint hipot, ground bond, and leakage current measurements, the system does not require the operator to connect or disconnect cables at any point during the test other than at the beginning and end of the test. General modules can be added to the standard configuration for additional points; the maximum number of patient connections is 16. Patient monitors, defibrillators, electrosurgical devices, multiple patient connection devices, and mains and internally powered devices can be tested using the system.
QuadTech, Maynard, MA
www.quadtech.com

Manifold Conducts Simultaneous Testing of 10 Parts

Connecting a manifold to a tester automates testing and increases productivity, according to the provider of the systems. When coupled with its hydraulic burst/leak tester, the company’s Smart manifold allows unattended testing of up to 10 parts at the same time. Featuring three test modes, the manifold enables users to pressurize all selected ports at once, each selected port individually, or only one port at a time. The addition of the company’s Windows-based Pressure Manager program lets users operate the tester via remote control and program tests that the instrument could not ordinarily perform alone. The tester is engineered for the testing and quality control of balloon angioplasty catheters.
Crescent Design, San Diego, CA
www.crescentdesign.com

Video Measurement System Is Suited for Inspection of Components with Complex Features

Offering repeatability and reproducibility, a two-axis video measurement system measures and inspects small precision-designed components with complex internal and external features. Combined with the Quadra-Chek 300 video microprocessor, the Merlin 300 provides a true view of the parts, enabling batch routines and form-feature measurements. Furthermore, a contrast teach facility allows the operator to easily determine the component edge, the company says. Features include high numerical aperture objective lenses that maximize illumination efficiency and long-life dimmable light-emitting diode surface substage illumination.
Vision Engineering, New Milford, CT
www.visioneng.com

Equipment Tests Interventional Devices

A company offers equipment designed for the testing of interventional devices. The interventional device testing equipment comparatively and quantitatively tests and records the performance features of such devices as catheters, guidewires, stent delivery systems, colonoscopes, endoscopes, and scope tools. Two- and 3-D testing that simulates the aortic arch for coronary procedures or the superficial femoral artery and illiac branches for peripheral applications is enabled by an adjustable track configuration. The equipment is also PC controlled. In addition, a data collection feature samples up to 100 data test points per centimeter of catheter or tubing and saves the data in spreadsheet format. Results can be used for FDA submissions, preclinical trial testing, competitive product testing, and product design calculations. Standard testing protocols include track force and push efficiency; optional test protocols consist of load cell assembly and catheter advancement. Proximal roller assemblies, torque test module upgrade software and electronics, and test hardware options are also offered.
Machine Solutions Inc., Flagstaff, AZ
www.machinesolutions.com

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