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|Covidien Announces FDA 510(k) Clearance and CE Mark for Nellcor™ Bedside Respiratory Patient Monitoring System|
New system completes enhancement of entire pulse oximetry bedside monitoring portfolio
This new system provides continuous monitoring of blood oxygenation (SpO2) and pulse rate, along with trend data to help clinicians detect and respond to dangerous respiratory events sooner. The new Nellcor Bedside Respiratory Patient Monitoring system is upgradable onsite to accommodate new parameters and features, including Nellcor Respiration Rate software, thereby reducing service disruptions and costs for hospitals.
“We are pleased to announce clearance to market the Nellcor Bedside
Respiratory Patient Monitoring system in the U.S. and the EEA,” said
The new system features a color touch-screen graphical user interface and provides a variety of wired and wireless connectivity options to meet the various needs found in different hospital settings. It can connect to the Nellcor OxiNet III Remote Respiratory Monitoring system, enabling clinicians to monitor multiple patients from a central monitoring station on the general care floor.
A SatSeconds alarm management feature helps clinicians differentiate between serious and minor events, reducing clinically insignificant desaturation alarms and alarm fatigue. The monitoring system also features a Saturation Pattern Detection alert for automated, real-time detection of patterns of desaturation that indicate repetitive reductions in airflow.
The device meets current and upcoming standards, including compliance
with Restriction of the Use of Certain Hazardous Substances in
Electrical and Electronic Equipment (RoHS) and ISO 3rd Edition*
standards. The new system will be available in
*Restrictions of the Use of Certain Hazardous Substances in
Electrical and Electronic Equipment (RoHS) require medical devices sold