Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

Inclusion Criteria:

• Age between 18 and 45 years, inclusive
• Willing and able to provide written informed consent
• Healthy subjects

Exclusion Criteria:

• Pregnant women
• Presence of any cardiovascular or pulmonary disease
• Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
• Known allergy to intravenous contrast medium or heparin
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
• Patients deemed not suitable for the study at the discretion of the Investigator