Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Inclusion Criteria:

• Subject aged 18 years or older or parent/legal guardian of subject aged less than 18years, willing and able to understand and provide written informed consent/assent.

• Weight and/or age within intended use of at least one SpO2 sensor under test at timeof enrollment.

• Willing and able to wear study devices in addition to SoC devices and during SoCprocedures.

• In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU,PCICU).

• Has arterial access and ability to have arterial blood samples drawn as part oftheir SoC and analyzed by CO-Oximetry.

Exclusion Criteria:

• Known pregnancy or lactating females (self-reported)

• Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intactskin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala).Note: Certain malformations may be allowed if determined it would not affectapplication of sensor with the pulse oximetry system.

• Self-reported severe contact allergies to standard adhesives or other materialsfound in pulse oximetry sensors. Note: Subject may be considered eligible if subjectcan wear non-adhesive sensor.

• Unwillingness or inability to remove nail polish or artificial nails from sensorapplication site.

• Nail fungus on sensor application site.

• Wearing and unable to remove jewelry from sensor application site.

• Dye injection within 48 hours of enrollment.

• Known dysfunctional hemoglobin levels (COHb >3%, MetHb >2%, and ctHb <10g/dl)

• Undergoing phototherapy for neonatal hyperbilirubinemia during arterial bloodsampling