Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation

Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021

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.

The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests:

1. Blood pressure measurement accuracy ("accuracy test")
2. Measurement accuracy after blood pressure change ("change test")
3. Blood pressure measurement accuracy throughout the specified stability-period ("stability test") To provide evidence that the device can track changes in blood pressure, this study includes study conditions that specifically induce changes in blood pressure.

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 hemoglobin.
• Patients with known severe anemia.
• Subjects with clinically apparent compromised circulation or peripheral vascular disease
• Subjects with clotting disorders or taking anticoagulants other than daily small doses of aspirin or similar
• Subjects that cannot tolerate sitting for up to 1 hour.
• Subjects that cannot perform the required blood pressure induced change 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 >35
• Subjects with BMI <20
• Subjects who gained or lost of >10% of their weight over a period of the last 6 months