Covidien Receives FDA Clearance for Bedside Monitoring System

The U.S. Food and Drug Administration has granted clearance to Covidien’s Nellcor Bedside SpO2 (saturation of peripheral oxygen) Patient Monitoring System. The system is designed to track SpO2 levels and pulse rate for adult, pediatric and neonatal patients, which according to the company will give clinicians instant access to comprehensive trending respiratory information, in turn allowing them to address respiratory complications sooner.

“We are pleased to announce the new Covidien Nellcor Bedside SpO2 Patient Monitoring System is approved for commercial release in the United States,” said Robert J. White, president of Respiratory and Monitoring Solutions, Covidien. “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. 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.”

The system also features enhanced digital signal processing for precise SpO2 readings during low perfusion or other challenging conditions that make it difficult to accurately track these patients. Its SatSeconds alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms. The monitor further offers an intuitive, multicolor screen that is touted to be easy to read in any light and from many angles. Additionally, hospital technicians can set institutional defaults, replace the battery, perform diagnostics and generally maintain the monitor within the hospital, saving time and resources.

The Nellcor Bedside SpO2 Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, and complies with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment directive for products sold in European Economic Area markets. The system arrived on the European market in January 2011.

Dublin, Ireland-based Covidien calls Mansfield, Mass. its home in the United States. The company produces technology and medical devices for the patient monitoring and respiratory care sectors.