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Masimo Launches New Reusable SpCO® Sensor with Improved Accuracy and Reliability in Low Oxygen Saturation and Elevated Methemoglobin States
Date:4/28/2011

IRVINE, Calif., April 28, 2011 /PRNewswire/ -- Masimo Corporation (NASDAQ: MASI) announced today the availability of new, enhanced versions of its reusable, noninvasive carboxyhemoglobin (SpCO) sensors—with improved accuracy and reliability performance for patients with low oxygen saturation (SpO2) between 90% and 95% and elevated methemoglobin (SpMet®) between 0% and 2%.  

Low SpO2 and elevated SpMet states are known physiological factors that compromise SpCO accuracy and contribute to erroneous measurements.  Although this limitation still applies, the new sensors will provide enhanced SpCO performance when a patient's functional SpO2 is > 90%, as well as when their SpMet is < 2%.  All previous SpCO sensor versions still meet or exceed their accuracy specification of + 3% at one standard deviation compared to laboratory COHb values when properly applied per the manufacturer's directions for use (DFU).  The published accuracy specifications of SpCO-equipped monitors do not change as a result of this new enhancement.

Carbon monoxide (CO) poisoning is a major cause of morbidity and mortality.  At least 20,000 known exposures(1) and 439 deaths(2) a year are attributed to non-fire-related, unintentional CO poisoning cases in the U.S.  However, large registry trials show the prevalence of CO poisoning is far greater with approximately 50,000 ED visits per year.(3)  Because the symptoms of CO poisoning are nonspecific—ranging from mild headache, nausea, confusion, and dizziness to end-organ injury, such as myocardial infarction, stroke, and death—diagnosis is difficult and has historically relied on clinical suspicion and confirmation by invasive blood gas analysis. Unfortunately, it has been estimated that up to half of U.S. hospitals do not have
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4. Newtech, Inc., a Leading Chinese EMS Patient Monitoring Company, Partners With Masimo to Incorporate rainbow® SET Noninvasive Measurement Capabilities Into New Patient Monitors
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11. Mafraq Hospital Becomes First in United Arab Emirates to Deploy Masimo rainbow SET Pulse CO-Oximetry for State-of-the-Art Noninvasive Patient Monitoring
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