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

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

The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.

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:

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

Exclusion Criteria:

1. Subject has preexisting cardiovascular or respiratory disease or conditions.
2. Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
3. 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).
4. Subject has skin irritation at the location of device placement.
5. Subject has known allergies to adhesive.