The FDA has given Covidien clearance to introduce its Nellcor Portable SpO2 Patient Monitoring System the U.S. Though the device can be used in clinical environments, its particularly beneficial for at-home monitoring and for conducting sleep studies outside the clinic.
The device comes with a standard finger clip that allows tracking of the pulse rate and blood oxygenation while the patient is ambulatory. While at home, the person using the portable monitor can check their own readings, in the meantime preserving the data for clinicians to review during an office visit.
The device is compatible with all of Nellcor OxiMax sensors and offers SatSeconds alarm management, pleth waveform, blip bar, and tabular trend information. Additionally, it comes with a sleep mode that will dim the three-inch color LCD screen and silence the alarms to let patients get their z’s while the device is quietly monitoring the vitals.
Some of the applications of the device according to the announcement:
- Six Minute Walk Test – This test evaluates the response of all systems involved during exercise,
including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The Six Minute Walk Test provides an objective measurement of a patient’s exercise capacity.- Critical Congenital Heart Disease (CCHD) Screening – Every year, about 4,800 (or 11.6 per 10,000) babies in the United States alone are born with CCHD. These babies are at significant risk if this condition goes undiagnosed.
Since 1993, Nellcor™ pulse oximetry technology has been utilized on more than 33,000 newborns spanning five separate clinical studies evaluating the use of pulse oximetry for critical congenital heart disease screening.- Car Seat Challenge Test – According to the American Academy of Pediatrics guidelines, as part of the discharge process, each preterm infant born less than 37 weeks gestational age should have a period of observation in a car safety seat before hospital discharge to monitor for possible apnea, bradycardia or oxygen desaturation.
Product page: Nellcor Portable SpO2 Patient Monitoring System…
Press release: Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for Nellcor™ Portable SpO2 Patient Monitoring System…