Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation

Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.

Inclusion Criteria:Subjects must be able to understand and provide an informed consent to participate.Subject must be willing and able to comply with the study procedures.Subject must be ≥ 50 and <80 years of age.At least 30% of subjects shall be male and at least 30% of subjects shall be female.Subject with an arm circumference in the range of the reference device cuff selection.Subject with a wrist circumference in the range of the IMD wrist size selection.Exclusion Criteria:Subjects with physical characteristics that (e.g. tattoos, scarification, unusual bone structure) may prevent proper application of the device under test.Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.Patients with known sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, and trigeminy), and left bundle branch block.Patients with implantable defibrillators, pacemakers, neurostimulators, or other implantable or worn devices which may interfere with the Polso™ Watch, or be affected by the Polso™ Watch in normal operation and use.Patients with known Parkinson's disease, essential tremor, convulsive disorders, or other disorder which prevents them from keeping their forearm at rest.Patients with known elevated levels of Methemoglobin (MetHb) or Carboxyhemoglobin (COHb), or with anomalous hemoglobins.Patients with known severe anemia.Subjects with clinically apparent compromised circulation or peripheral vascular diseaseSubjects with clotting disorders or taking anticoagulants other than daily small doses of aspirin or similarSubjects that cannot tolerate sitting for up to 1 hour.Subjects that cannot perform the required blood pressure nduced cahnge procedure.Subject with a blood pressure (and other physiological parameters) demographic that has already been filled.Subjects with a known allergy to plastic, metals, and/or rubber.Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of non-invasive blood pressure cuff.Subjects who are pregnant.Subjects with BMI >35Subjects with BMI <20Subjects who gained or lost of >10% of their weight over a period of the last 6 months