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–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
18 years of age or older
Subject has given written informed consent to participate in the study
You may not be if
(\*) Pregnant or positive human chorionic gonadotropin (hCG) test
(\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
(\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
(\*) Subjects who are currently taking anticoagulant medication
(\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
(\*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
(\*) 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.
(\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
(\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff
Note: (\*) May be self-reported by subject
Clareo Health | Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
