First device to noninvasively measure carbon monoxide in the blood

28 February 2005

Irvince, Calif., USA. Masimo, the inventor of Read-Through Motion & Low Perfusion Pulse Oximetry, today announced the next breakthrough in the world of noninvasive patient monitoring; Masimo Rainbow(TM) SET Pulse CO-Oximetry. Masimo Rainbow SET employs revolutionary sensor, hardware and software designs that are able to collect more information noninvasively than previously believed possible. With the introduction of Masimo SET (Signal Extraction Technology) in 1996, Masimo solved the problem clinicians faced with inaccuracy and false alarms associated with pulse oximetry due to patient motion, low perfusion and other challenging conditions. Now, with Masimo Rainbow SET, Masimo ushers a new era where carbon monoxide and potentially other vital parameters can be safely and accurately monitored continuously and noninvasively.

Rainbow technology is based on system theory and adaptive signal
processing algorithms first introduced to the medical community with Masimo SET in 1996. Rainbow technology goes further with the ability to analyze information from a sophisticated new sensor technology that employs eight wavelengths. The Rainbow sensor generates an extraordinarily rich physiological data stream, which opens the door to monitoring additional parameters that presently require costly, inconvenient blood gas measurements that are often unavailable when the information is needed most.

In addition to Rainbow SET's current ability to noninvasively monitor the level of carbon monoxide in the blood, Masimo's engineering team is utilizing the additional data delivered by the Rainbow technology platform and sensors to qualify and document an array of new potential measurements and applications. The Masimo Rainbow SET platform has been developed with the intent to deliver accurate monitoring of parameters like methemoglobin (SpMet(TM)), and fractional arterial oxygen saturation (SpaO2(TM)), all measured noninvasively.

The first product built with Rainbow technology, Rad-57(TM), will be
debuted March 19 at the 2005 EMS Today convention in Philadelphia. The Rad-57 is a handheld Signal Extraction Pulse CO-Oximeter(TM) that noninvasively measures the percentage of hemoglobin bound with carbon monoxide (SCO(TM)). In the past, accurate measurement of carbon monoxide in the body required invasive procedures, and simply was not practical in most emergency situations where it is often needed. The Rad-57 will provide all clinicians and emergency workers reliable information on carbon monoxide poisoning in seconds, enabling timely decisions on appropriate treatment. Besides SpCO, the Rad-57 also measures SpO2, perfusion index and pulse rate utilizing Masimo
SET pulse oximetry, with its proven ability to read through motion and low perfusion. Rad-57 utilizes MX-1(TM), the new Masimo Rainbow SET Pulse CO-Oximetry OEM platform. Masimo will make MX-1 available to its OEM partners who wish to provide Pulse CO-Oximetry to their customers.

"Ten years ago, Masimo broke new ground by making pulse oximeters reliable during motion and low perfusion, using their Signal Extraction Technology. Masimo will advance pulse oximetry again with their new Rainbow technology. In the 25-year history of pulse oximetry, no one has produced an instrument that will function accurately on patients suffering from carbon monoxide poisoning," reports Dr. Steven Barker, Head of the Department of Anesthesiology at the University of Arizona College of Medicine. "As shown in my studies on animals (Anesthesiology 66:677-79, 1987), conventional pulse oximeters cannot distinguish between oxygenated hemoglobin and carboxyhemoglobin, falsely reporting both as oxygenated. Since
carboxyhemoglobin is a toxic form that can cause death at levels greater than 50%, the development of a pulse oximeter that can separately measure carboxyhemoglobin and oxyhemoglobin will be a major advance in healthcare.

Such a device would soon become a standard of care in emergency rooms, ambulances, and many other critical care settings." Joe E. Kiani, CEO of Masimo stated, "Solving unsolvable problems has been
the driving force behind Masimo's culture and mission. Our mission has been to Improve Patient Care and Reduce Cost of Care by Taking Noninvasive Patient Monitoring to New Sites and Applications. Masimo and Masimo Labs engineering team have been working for years to introduce the Rainbow platform. Rainbow represents a new era in noninvasive monitoring, and we are eager to deliver these new solutions that we know can save lives and improve outcomes for so
many patients. We are proud to once again introduce the next evolution of pulse oximetry."

Beginning in March, all Masimo Radical pulse oximeters will be shipped
"Rainbow Ready." Rainbow Ready Radical oximeters include Masimo SET
technology; and will permit customers to add Rainbow-specific parameters such as SpCO and additional potential parameters via simple software upgrade options. In addition, Masimo is creating a Rainbow upgrade program to allow its customers who purchased Radicals prior to the availability of this new platform to economically upgrade to Rainbow SET Pulse CO-Oximetry. Customers should contact their Masimo representative for complete details. In the months ahead, Masimo will introduce Rainbow SET compatibility in other new products.

Source: Masimo Corporation


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