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SpCO Sensors non-invasively detect CO poisoning.

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May 4, 2011 - Available in handheld and bedside devices, rainbow® Reusable Direct Connect SpCO Sensors are suited for patients with low oxygen saturation of 90-95% and elevated methemoglobin between 0-2%. Units continuously measure total hemoglobin, oxygen content, carboxyhemoglobin, methemoglobin, Pleth Variability Index, and acoustic respiration rate. By allowing immediate and non-invasive assessment of toxic CO levels, sensors enable early detection of CO poisoning to facilitate life-saving treatment.

Masimo Launches New Reusable SpCO® Sensor with Improved Accuracy and Reliability in Low Oxygen Saturation and Elevated Methemoglobin States


(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)

Masimo, Inc.
2852 Kelvin Ave.
Irvine, CA, 92614
USA



Press release date: April 28, 2011

IRVINE, Calif., -- 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 invasive COHb testing ability--increasing the potential that many victims of CO poisoning could be overlooked and misdiagnosed.(4) Masimo SpCO allows immediate and noninvasive assessment of toxic CO levels--enabling early detection of CO poisoning that facilitates prompt, potentially life-saving treatment.

SpCO is part of the Masimo rainbow® SET platform--the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVI®), and acoustic respiration rate (RRa(TM)), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR). Available in handheld (Masimo Rad-57(TM)) and bedside devices (Masimo Radical-7(TM), Masimo Rad-87(TM)), SpCO provides clinicians and emergency first responders with a way to quickly, noninvasively evaluate and address the significant health and safety risks associated with CO poisoning--helping to save and sustain lives, minimize suffering, and enhance safety. The new, enhanced versions of the Masimo rainbow Reusable Direct Connect SpCO and DCI® SpCO sensors (previous part numbers 2201, 2407, 2202, 2069, 2640, 2070, 2696, 2697) will now be identified as ID code H. Customers who would like to purchase the enhanced ID code H sensors should call (800) 257-3810 in the U.S., +41 32 720 1111 internationally, or their local sales representative.

(1) Centers for Disease Control and Prevention. "Nonfatal, unintentional, non-fire-related carbon monoxide exposures--United States, 2004-2006." MMWR Morb Mortal Wkly Rep. 2008;57:896-899.

(2) Centers for Disease Control and Prevention. "Carbon monoxide-related deaths--United States, 1999-2004." MMWR Morb Mortal Wkly Rep. 2007;56:1309-1312.

(3) Keles A, Demircan A, Kurtoglu G. "Carbon monoxide poisoning: how many patients do we miss?" Eur J Emerg Med. 2008;15:154-157.

(4) Hampson NB, Scott KL, Zmaeff JL. "Carboxyhemoglobin measurement by hospitals: implications for the diagnosis of carbon monoxide poisoning." J Emerg Med. 2006;31:13-16.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care--helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow® SET Pulse CO-Oximetry(TM) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet(TM), a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring(TM), the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa(TM)). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Non-invasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pulse CO-Oximetry, Pulse CO-Oximeter, and SEDLine are trademarks or registered trademarks of Masimo Corporation.

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