Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations

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.