Overview
The objective of this study is to verify the form, fit and function of the Philips FAST technology with Masimo neonatal, infant and pediatric sensors for SpO2 monitoring in the respective indicated populations. The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient populations that have a range of different skin pigmentations, simultaneously with an FDA cleared pulse oximeter as a comparator.
Eligibility
Inclusion Criteria:
- Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor.
- Subject is less than 22 years of age (pediatric subject per US FDA definition).
Exclusion Criteria:
- Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown).
- Confounders of pulse oximetry per sensor direction for use (DFU).
- Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied.
- Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
- Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it.
- Subject with known allergic reactions to adhesive tapes.
- Subject is not suitable for the investigation at the discretion of the clinical research team.