CE Mark for the Covidien’s Latest Nellcor™ Bedside SpO2 Monitoring System

Covidien has gained CE Mark approval for its Nellcor™ PM100N Bedside SpO2 Patient Monitoring System, the only commercially available bedside pulse oximetry (SpO2) monitor featuring home care and sleep study modes that complies with standards for medical electrical equipment used in the home health care environment.

Background

We’ve followed the progress of the Nellcor family for a few years now, most recently when its PM10N iteration gained FDA clearance in October 2014

The new PM100N provides continuous monitoring of blood oxygenation (SpO2) and pulse rate to help clinicians detect and respond to dangerous respiratory events sooner, along with patient trend data to allow clinicians to evaluate a patient’s clinical course. With Covidien-exclusive digital signal processing, the PM100N claims industry-leading speed and accuracy, and reliable pulse oximetry readings—even during low patient perfusion, motion and other forms of signal interference.

The pulse oximetry system was designed with features to help improve patient safety. It incorporates SatSeconds™ Alarm Management technology—available only on Covidien patient monitors— to help distinguish between serious and minor events, reducing clinically insignificant desaturation alarms. The monitor can also be password-protected to prevent lay users from inadvertently modifying settings.

Company comments

“At Covidien, we’re dedicated to improving patient care and safety, not only in the hospital, but also in home health care,” said Matt Anderson, vice president and general manager, Patient Monitoring, Respiratory and Monitoring Solutions, Covidien.

“Just because a patient is not in the hospital setting does not mean he or she no longer needs on-going care,” said Dr. Scott Kelley, chief medical officer, Respiratory and Monitoring Solutions, Covidien. “The availability of solutions to enable safe, quality care for patients in all settings, including the home, is something we are focused on at Covidien. This new system includes all of the leading Nellcor™ technology that clinicians have trusted for more than 30 years, with additional features that make it well suited to the home health care environment.”

Source: Covidien, plc., Business Wire

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