Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Inclusion Criteria:

• Age one month and older
• Weight greater than or equal to 3 kg
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

• Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
• Decision-impaired adult on behalf of a pediatric patient who is unable to assent
• 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.