The FDA has issued 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N), according to a Covidien announcement.
The system is 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 healthcare environment, the company says.
The convenient, handheld patient monitor is simple to use and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2). The device’s compact design and ability to perform in challenging conditions make it an ideal tool for multiple critical clinical screenings including: Six Minute Walk Test, Critical Congenital Heart Disease Screening and Car Seat Challenge Test, according to the company.
The lightweight system is user-friendly and features a home care mode that expands the utility of the monitor beyond the hospital to home-use environments. 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 disrupting patients’ sleep.
“Covidien’s new generation of portable monitors is easy to use and brings our proven pulse oximetry technology to patients inside the hospital, in health care facilities, and even in their own homes,” said Matt Anderson, vice president & general manager, Patient Monitoring, Covidien.
“Because our pulse oximetry technology relies on cardiac signals, it mitigates signal interference, offering caregivers peace of mind. They can count on Covidien to provide accurate patient data, even during difficult conditions. The development of this product exemplifies Covidien’s dedication to enhance patient care, both inside and beyond the hospital.”
The system can be used as a tool for the following critical clinical screenings:
- Six Minute Walk Test
- · Critical Congenital Heart Disease (CCHD) Screening
- · Car Seat Challenge Test
More information on the product portfolio is available on the company’s website.