IRVINE, Calif., June 2, 2011 /PRNewswire/ — Masimo
(NASDAQ:
MASI) announced today FDA 510(k) Clearance, CE Mark, and
limited market release of the industry’s first single-patient-use
ear sensor. Compared to digit sensors, the Masimo E1™
enables faster detection of oxygen saturation changes during low
perfusion due to a variety of clinical factors, including sedative
or medication-induced vasoconstriction.(1,2,3) Compared to
reusable ear sensors, it also avoids cross-contamination risks for
patients and reduces the complexity of sensor management for
clinicians, including cleaning, storage, and transport. In
the limited market release, select clinicians around the world will
have the opportunity to use and evaluate the performance and
benefits of the E1 sensor.(Photo: http://photos.prnewswire.com/prnh/20110602/LA12943)
Due to the signal processing limitations of conventional pulse
oximetry during challenging conditions, clinicians often seek
alternative monitoring sites on the head. In spite of the
established need, available single-patient-use sensors for the head
have suffered from unreliability. While Masimo SET
Measure-through Motion and Low Perfusion pulse oximetry overcomes
the limitations of conventional pulse oximetry and offers reliable
true alarm detection and false alarm prevention during challenging
conditions, there are still some advantages to monitoring on the
head such as faster response to oxygenation changes during low
perfusion and the use of an alternative site when the digit is
unavailable.
As a single-patient-use ear sensor that is placed securely in
the cavum conchae (the deep hollow near the ear canal opening), the
E1 allows clinicians to combine Masimo SET performance with a
reliable alte
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