Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing

Clinical Validation of the Norbert Health Device for Pulse Rate Measurement

The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.

Inclusion Criteria:

• Inclusion Criteria:
• Subjects must be 18 years or older
• Ability to comprehend written consent and provide informed consent
• Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)

Exclusion Criteria:

• Pregnant women
• Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
• Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
• Inability for subject to avoid extreme movement during measurement reading windows
• Inability for subject to raise their hand during measurement reading windows
• No heart arrythmias
• Discretion of the Principal investigator or clinical study staff