Anemia, Healthy
Conditions
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.
Interventions
DEVICERad-67 and DCI Mini Sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed