Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Inclusion Criteria:

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

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.
• Decision-impaired adult and pediatric subjects who are unable to give consent and assent