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