Covidien announced FDA 510(k) clearance for its Nellcor Portable SpO2 Patient Monitoring System (PM10N), which is touted as the only commercially available portable oximeter that is equipped with home care and sleep study modes, and complies with IEC 60601-1-11 standards for devices used in the home health care environment.

Part of Covidien’s respiratory function monitoring portfolio, this handheld patient monitor is ideal for fast, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2). It is touted as a useful tool for multiple critical clinical screenings, including: Six Minute Walk Test, Critical Congenital Heart Disease (CCHD) Screening and Car Seat Challenge Test.

With a simplified user interface, patients can clearly view their vital sign readings, and the settings cannot be easily altered by the patient, so clinicians can feel confident prescribing the home-use of this monitor. The system also features a sleep study mode that enables dimming the LCD display and silencing alarms to prevent the sleep.

The handheld patient monitor is ideal for fast, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2).“Because our pulse oximetry technology relies on cardiac signals, it mitigates signal interference, offering caregivers peace of mind,” said Matt Anderson, vice president & general manager, Patient Monitoring, Covidien.

The PM10N includes a three-inch color LCD screen, as well as connectivity to analytics tools and patient management systems. It is compatible with the entire line of Nellcor sensors with OxiMax technology and offers a robust monitoring feature set including SpO2, pulse rate, SatSeconds alarm management, pleth waveform, blip bar and tabular trend information. The monitor incorporates Nellcor digital signal processing technology to deliver reliable SpO2 and pulse rate values even during challenging conditions, such as patient motion, noise, signal interference and low perfusion, all of which can interfere with assessing a patient’s respiratory status.