IRVINE, Calif., Oct. 13, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance and CE Mark of its new Radical-7® with rainbow® Acoustic Monitoring capability for continuous display of the acoustic respiration rate (RRa™) waveform and measurements. Also new to the Radical-7 is an In Vivo Adjustment™ (pending FDA 510(k) clearance in the U.S.) that allows clinicians to, for the first time, adjust the noninvasive measurements to the specific patient and laboratory reference device they use for invasive blood testing.
rainbow® Acoustic Monitoring
The new Radical-7 provides clinicians with the option to measure RRa and display the acoustic waveform directly on the monitor screen with the pleth waveform overlayed—allowing them to observe changes in breathing upon inhalation and exhalation. With this new display capability, clinicians may be able to more readily detect respiratory pause events where there is an absence of breathing, high ambient noise that can degrade the acoustic signal, and improper sensor placement.
Respiration rate is defined as the frequency of breathing expressed as the number of breaths per minute and is considered a critical vital sign in assessing the physiological status of hospitalized patients; however, current methods for respiration rate monitoring are limited by reliability or patient tolerance. In contrast, Masimo rainbow Acoustic Monitoring is completely noninvasive and virtually unnoticeable to the patient—featuring an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck to detect upper