To meet the current US consumer demand for pulse oximetry with the COVID-19 pandemic, we aligned with a pulse oximeter manufacturer to make pulse oximetry available for personal and in-home use. Clearance was granted for this device by prescription only; however, due to the COVID-19 pandemic, FDA is allowing the expanded offering of this device to the consumer for home use.
If Nonin is not the manufacturer, then who manufactured this product?
To meet the current US consumer demand for pulse oximetry with the COVID-19 pandemic, we aligned with a pulse oximeter manufacturer to make pulse oximetry available for personal and in-home use.
What is included with the purchase of this oximeter?
Can this unit be used on adults and pediatrics?
This fingertip is applicable for spot-checking SpO2 and pulse rate in adult and pediatric patients in homes and medical clinics.
How long should I wear the unit to get an accurate reading?
The fingertip oximeter will automatically display a reading after the oximeter has been properly placed on the finger for more than 2 seconds.
Where does this unit take a reading?
This fingertip oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a patient’s finger.
How do I turn my device on/off?
Insert finger into device until finger reaches the built-in backstop. Release clip and wait 2 seconds. The oximeter will power on automatically and start to measure.
What do I do if there is no SpO2 and PR reading?
Verify batteries are fresh. Try different fingers. Ensure good blood flow in fingers by rubbing gently.
How do you tell if the batteries are running low?
The icon of a low battery will appear on the screen when the battery voltages are low. By then, batteries need to be replaced.
How do you replace the batteries?
Remove the battery cover on the back of the device, using the arrows as a guide, and slide the cover away from you in the direction the arrows point. Insert two AAA size batteries into the battery compartment properly noting the polarity markings. Replace the cover, making sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.
Does this oximeter require calibration?
No calibration is required.
How do I clean my oximeter?
Surface clean with a soft cloth damped with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a 10% bleach solution. Then surface clean with a cloth damped ONLY with clean water and dry with a clean, soft cloth.