Covidien’s Nellcor™ Bedside Respiratory Patient Monitoring System Gains FDA And CE Mark

In short

Covidien has announced U.S. FDA 510(k) clearance and CE Mark approval for its next generation of Nellcor™ Bedside Respiratory Patient Monitoring system.

Background

As recently as early August Covidien announced the FDA 510(k) clearance of its Nellcor SpO2 bedside monitor, here. Now the company is trumpeting the clearance of its upgraded system, which 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.

The new system features a colour 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.

Covidien says the new system will be available in the United States and throughout the EEA in the next few months.

Company comments

“We are pleased to announce clearance to market the Nellcor Bedside Respiratory Patient Monitoring system in the U.S. and the EEA,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “With this addition, we now offer an updated portfolio of industry-leading bedside monitoring solutions that meet unique care needs in both high- and low-acuity settings, thus enhancing patient safety in hospitals throughout the world.”

Source: Covidien, Business Wire