Feasibility and Performance Evaluation of INVSENSOR00024

Feasibility and Performance Evaluation of INVSENSOR00024

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.

Inclusion Criteria:

• Less than or equal to 1 month (28 days) of age
• Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent.
• Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria:

• Subjects with both significant abnormal aortic arch and radial line in place
• Subjects with suspected or diagnosed critical congenital heart disease (CCHD)
• Subjects with underdeveloped skin
• Subjects with abnormalities at the planned application sites that would interfere with system measurements
• Subjects with known allergic reactions to foam/rubber products and adhesive tape
• Deformities of limbs, absence of feet, severe edema, and other at the discretion of the Principal Investigator