Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masimo Corporation
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Influenced by study design:
Subject is 18 to 50 years of age.
Subject weighs a minimum of 110 lbs.
Hemoglobin value ≥ 11 g/dL.
Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
CO value ≤ 3.0% FCOHb.
Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.
You may not be if
Influenced by device warning labels:
Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).
Influenced by study design/environment:
Subjects who do not pass the health assessment for safe participation in the study procedures.
Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
Clareo Health | Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
