Covidien’s Nellcor Bedside SpO2 Patient Monitoring System

Covidien’s Nellcor Bedside SpO2 Patient Monitoring System

BOULDER, Colo.–(BUSINESS WIRE)–Jul. 30, 2012– Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care solutions, today announced the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance to market the Covidien Nellcor™ Bedside SpO2 Patient Monitoring System. The new patient monitoring system is now available for sale in the U.S.

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (P …

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (Photo: Business Wire)

The Nellcor Bedside SpO2 system with OxiMax™ technology continuously monitors SpO2 and pulse rate for adult, pediatric and neonatal patients, giving clinicians instant access to comprehensive trending respiratory information. This enables clinicians to detect subtle, yet critical, heart rate and SpO2 variations earlier and thus 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, 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 Nellcor Bedside SpO2 Patient Monitoring 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 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 (RoHS) directive for products sold in European Economic Area markets.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.covidien.com&esheet=50357234&lan=en-US&anchor=www.covidien.com&index=2&md5=d6045bce4a0772738020896216e753f4 to learn more about our business.

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Coviden has been busy lately. In the last month or so, we’ve covered three pieces of news related to the Irish medical device company, including its OneShot renal denervation system, Endo GIA radial reload colon cutter/stapler and V-Loc knotless suturing technology.

Now, the company has announced the debut of the Nellcor SpO2 single parameter module for use with the Philips IntelliVue line of patient monitoring systems, including the MP40 through MP90 products and the MX 600, MX 700, and MX 800 monitors.

The module will be available in North America, Europe, and a number of other international markets. It uses the firm’s OxiMax pulse oximetry technology to monitor a patient’s respiratory function status.

Robert J. White, Coviden’s president of respiratory and monitoring solutions explains in a press release that the product’s broad compatibility enables it to be used “across all areas of the hospital, from the general care ward to critical care areas, such as the intensive care unit and neonatal care ward.”

The use of the pulse oximetry device with monitoring platforms provides clinicians with cardiac-based readings of SpO2 and pulse rate. This functionality supports its use in what the company’s chief medical officer, Scott Kelley, MD, describes as “challenging conditions” such as low perfusion.

The Nellcor OxiMax technology includes an alarm management feature to help clinicians distinguish between minor events and clinically significant fluctuations in desaturation.

Features according to Covidien:

Simple, intuitive operation and space-saving design.

The distinctive digital signal processing technology from Covidien.

Variable pitch beep tone which enables clinicians to hear point-by-point changes in SpO2.

Five-hour battery life with an optional ten-hour battery.

96-hour trend memory captured every four seconds.

Patient trend data can be stored on a PC for archive and analysis.

Easy-to-use jog dial for simple navigation and control of the display and monitoring system functions.

Compact, portable, lightweight, durable, easy-to-transport design with a built-in handle.

Multiple-language graphical user interface.

Capable of displaying plethysmographic waveforms, pulse amplitude, and current measured SpO2 and pulse rate.

Multicolor display screen with a black background which provides ideal contrast.

Back-up audible alarm.

On-screen help messages to assist the user in the use of the monitor.

Source : http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&id=1719745

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