Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers

The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.

Inclusion criteria

• Subject is between 19 months and ≤ 60 months of age.
• Subject's current body weight is ≥ 6 lbs.
• Subject/legal guardian is fluent in both written and spoken English.
• Subject is willing and able to follow study requirements
• Legal guardian has provided consent.

Exclusion criteria

• Subject has preexisting cardiovascular or respiratory disease or conditions.
• Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
• The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting).
• Subject has skin irritation at the location of device placement.
• Subject has known allergies to adhesive.