Ireland-based Covidien has received 510(k) approval from the US Food and Drug Administration for its Nellcor Portable SpO2 Patient Monitoring System (PM10N).
The portable oximeter, which is equipped with home care and sleep study modes, can be used for motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2).
Covidien patient monitoring vice-president and general manager Matt Anderson said the new generation of portable monitors brings proven pulse oximetry technology to patients inside the hospital, in health care facilities, and even in their own homes.
"Because our pulse oximetry technology relies on cardiac signals, it mitigates signal interference, offering caregivers peace of mind," Anderson added.
Covidien has developed the system for use in multiple critical clinical screenings such as six minute walk test, critical congenital heart disease screening, and car seat challenge test.
The monitoring system features three-inch color LCD screen, and offers monitoring feature set including SpO2, pulse rate, SatSeconds alarm management, pleth waveform, blip bar and tabular trend information.
In addition, the system offers connectivity to analytics tools and patient management systems, and is compatible with the entire line of Nellcor sensors with OxiMax technology.