Indications for Use

The BabySat pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment.

Intended Use Population

Infant at least 1 month old and up to 18 months old and 6-30 lbs.


  • Not for patients under 1 month old or weighing less than 6 pounds
  • Not for patients older than 18 months or weighing more than 30 pounds
  • Not a substitute for a caregiver
  • Not for use as an apnea monitor