Vital Signs Patch Early Feasibility and Usability Study v1.0
Vital Signs Patch Early Feasibility and Usability Study v1.0
To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the
 in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and
 console. The VSP System will be incorporated into the study site's Information Technology
 infrastructure.
The primary objective of this clinical feasibility study is to evaluate the feasibility of
 the Vital Signs Patch System (VSP). The VSP will be incorporated into the study site's
 Information Technology infrastructure and worn by in-patients for a minimum of 3 days and for
 the duration of their hospital stay up to 7 days.

 The VSP will take and monitor vital signs in addition to the normal equipment the facility
 uses to monitor and take vital signs. This study will not be assessing safety and no
 comparator groups will be used. As this study will not be treating any particular disease or
 condition, no randomization or blinding is required. Subjects will be chosen as they are
 admitted in accordance with the general population characteristics, inclusion and exclusion
 criteria and willingness to sign the Informed Consent.

 This clinical study involves a device with no additional drugs administered.

 During this study, a single VSP System patch will be worn for up to 48 hours. The first patch
 will be placed using the NEHB configuration. After the first 48 hours, the NEHB-configured
 patch will be replaced with a new patch in the PAL configuration. The second patch can remain
 on the subject for the duration of the subject's hospital stay, or up to seven (7)
 consecutive days. Individual patient use will determine the duration of time that the second
 patch can be worn.
Inclusion Criteria:

 -  Adult male and female in-patients with vital signs considered 'stable' by clinical
 caregivers.

 Exclusion Criteria:

 -  Pediatric patients

 -  Female patients who are pregnant

 -  Patients with internal or external defibrillators

 -  Patients who have undergone surgery and still have a fresh incision on the chest.

 -  Patients with skin damage on the chest such as burns, irritation, infections, wounds,
 etc.

 -  Patients in the Critical Care Unit (CCU)

 -  Patients who otherwise satisfy any of the contraindications associated with the VSP
 system.