Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Test subjects	Rad-67 and DCI Mini Sensor	Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.

Primary Outcome Measures

Name	Time	Method
Repeatability and reproducibility of CO-oximeter and sensor	120 minutes	The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.

Secondary Outcome Measures