FDA clears Covidien Nellcor bedside SpO2 monitor

30 July 2012 (Last Updated July 30th, 2012 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system, designed to detect heart rate and oxygen saturation (SpO2) variations earlier and address respiratory complications sooner.

Covidien's Nellcor bedside SpO2 patient monitoring system

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system, designed to detect heart rate and oxygen saturation (SpO2) variations earlier and address respiratory complications sooner.

By utilising OxiMax technology, the Nellcor bedside SpO2 system continuously monitors SpO2 and pulse rate of adult, pediatric and neonatal patients and facilitates clinicians with instant access to comprehensive trending respiratory information.

During low perfusion or other challenging conditions, the Nellcor bedside SpO2 monitor uses digital signal processing to read SpO2 levels and to track patients.

"Nellcor bedside SpO2 system features an intuitive, multicolour screen and SatSeconds alarm management technology."

The Nellcor bedside SpO2 system features an intuitive, multicolour screen and SatSeconds alarm management technology to differentiate serious and minor events, to reduce clinically insignificant oxygen desaturation alarms.

Hospital technicians can set institutional defaults, replace the battery, perform diagnostics and maintain the monitor within the hospital to save time and resources, according to the company.

Robert J. White, Covidien respiratory and monitoring solutions president, said with the FDA approval, the new Covidien Nellcor bedside SpO2 patient monitoring system is available for sale in the US.

"Healthcare professionals on the general care floor, and in other lower acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats," White added.

"By giving them ready access to a patient's respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data."


Image: The Nellcor bedside SpO2 system detects heart rate and oxygen saturation variations earlier and addresses respiratory complications sooner. Photo courtesy of: Covidien.