Spot-Check Noninvasive Pulse CO-Oximeter Validation

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Inclusion Criteria:

• Male or female
• Age: Greater than one month
• Weight: Greater than or equal to 3kg
• Any racial or ethnic group
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
• If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

Exclusion Criteria:

• Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
• Subjects deemed not suitable for the study at the discretion of the investigator
• Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.