FDAAdvisoryCommittee.com Grants Fluke Biomedical 510(k) Clearance for New ProSim(TM) Vital Signs Simulators
Published: Sep 09, 2011
EVERETT, WA--(Marketwire - September 08, 2011) - The United States Food and Drug Administration (FDA) announced today it has granted the new Fluke Biomedical ProSim Vital Signs Simulators 510(k) clearance. These innovative new patient simulators, conceived and designed in partnership with biomedical technicians and clinical engineers around the globe, offer advanced technology for patient monitor testing.
The ProSim 8 all-in-one multifunction tester is the smartest patient simulator in the world for comprehensive patient monitor testing. Designed to perform most preventive maintenance (PM) testing in five minutes or less, ProSim 8 simultaneously simulates ECG, respiration, temperature, IBP/cardiac catheterization, cardiac output, NIBP, and SpO2 -- and is the only simulator in the world capable of testing new Masimo multi-wavelength SpO2 Rainbow SET -- in physiologically synchronized pulses.
For patient monitor troubleshooting on the go, the ProSim 4 quick-check touchscreen simulator provides one-touch testing for fast and simple patient monitor performance checks and troubleshooting in the field. Designed to get test results in as quickly as sixty seconds, ProSim 4 offers 12-lead ECG simulation, respiration, IBP and NIBP testing in the palm of your hand. Featuring stay-connected ECG posts to ensure secure lead connections and smart, no-hassle navigation, this quick-check tool with patient pre-sets and autosequences is your first line of defense for on-the-go troubleshooting and testing.
Roger Peniche, Director of Research and Development for Fluke Biomedical, described their commitment to user-centric design methodology employed to create the ProSim Vital Signs Simulators. "Our dedication to voice-of-the-customer business practices means all new-product development focuses on user-centered design methodology. Three and a half years, over 200 customer visits throughout the United States, France, Germany, United Kingdom, China and Japan, and our fleet of the top test-and-measurement engineers, industrial designers, and human-factors user interface experts all came together to bring you the most innovative device in the biomed toolbox."
One of those customer design partners, Seattle-based BMET Dennis McMahon, thinks Fluke Biomedical hit the mark with the new ProSim Vital Signs Simulators. "Where the connectors are, where the soft-keys are -- you made it small enough to be highly compact but big enough to allow for amazing manual dexterity. It's not too big, it's not too small -- you got it just right."
For more information on ProSim Vital Signs Simulators, visit www.flukebiomedical.com/prosim.
About Fluke Biomedical
Fluke Biomedical is the premiere, global provider of test and measurement equipment and services to the healthcare industry. We strive to be the best at delivering innovative solutions to improve quality of global health. We serve biomedical engineers, quality-assurance technicians, medical physicists, oncologists and radiation-safety professionals and are continually expanding our range of solutions to a broader range of health and safety professionals. For more information on Fluke Biomedical, visit www.flukebiomedical.com.
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