Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Exclusion Criteria

• •Influenced by device warning labels:
• •Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
• •Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
• •Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
• •Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).
• •Influenced by study design/environment:
• •Subjects who do not pass the health assessment for safe participation in the study procedures.
• •Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.