FDA clears Nonin’s Model 3231 OEM/eHealth finger pulse oximeter

28 August 2014 (Last Updated August 28th, 2014 18:30)

The US Food and Drug Administration has granted clearance for Nonin Medical's Model 3231 OEM/eHealth finger pulse oximeter.

Nonin OEM-eHealth finger pulse oximeter

The US Food and Drug Administration has granted clearance for Nonin Medical's Model 3231 OEM/eHealth finger pulse oximeter.

The oximeter plugs into a telemedicine hub or kiosk through a USB connector to measure oxygen saturation and pulse rate in paediatric to adult patients.

Nonin Medical eHealth and OEM vice president Mark VanderWerf said: "Leading telemedicine providers such as HealthSpot and Bosch Healthcare have chosen to integrate the Nonin 3231 into their telehealth systems because they expect the 3231 to provide superior performance in the widest patient population, including challenging patients."

"Unlike some imported oximeters, Nonin's American-made Model 3231 is a medical device with clinically proven accuracy, not a health and wellness gadget.

"This is important to telemedicine providers because they are measuring and guiding decisions on real patients with real diagnosed diseases such as COPD, CHF and asthma. They depend on the clinical accuracy of a real medical device."

"The oximeter plugs into a telemedicine hub or kiosk through a USB connector to measure oxygen saturation and pulse rate in pediatric to adult patients."

The Model 3231 received EU certification in 2013 and its accuracy advantages include the company's PureSAT Pulse Oximetry (SpO2) technology, CorrectCheck technology and SmartPoint capture.

Nonin's PureSAT technology uses intelligent pulse-by-pulse filtering to provide precise oximetry measurements-even in the presence of motion, dark skin tones, low perfusion, rapid SpO2 changes and other challenging conditions.

The CorrectCheck technology provides feedback through a digital display if the patient's finger is not placed correctly in the device.

The company's SmartPoint capture automatically determines when a high quality measurement is ready to be stored, which helps ensure that each reading transmitted by the Model 3231 is accurate.

In September 2013, the company received FDA clearance for its wireless version of the product, the Nonin Bluetooth Smart Model 3230 finger pulse oximeter.


Image: Nonin Model 3231 OEM/eHealth finger pulse oximeter plugs into a telemedicine hub or kiosk through a USB connector. Photo: courtesy of PRNewsFoto/Nonin Medical.