Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

The study had the following objectives:

1. Verify that the CoVa Monitoring System does not interfere with implanted devices.

2. Verify that implanted devices do not interfere with the functions of the CoVa
Monitoring System.

3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Inclusion Criteria:

- Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.

- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist
device.

- Subject and/or legally authorized person/representative is willing to undergo the
Informed Consent process prior to enrollment in the study.

- Subject is a candidate for this study based on the PI's opinion and knowledge of the
subject's condition.

Exclusion Criteria:

- Subject is participating in another clinical study that may affect the results of
either study.

- Subject is unable or not willing to wear electrode patches as required.

- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode
patches.

- Subject is considered by the PI to be medically unsuitable for study participation.