Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

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