Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

Study Overview
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Brief Summary
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This study has the following objective: • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects. The μ-Cor validation will be demonstrated at two body locations: Side location (below left armpit) for study arm 1, and Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Detailed Description
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This study has the following objective: • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects. The μ-Cor validation will be demonstrated at two body locations: Side location (below left armpit) for study arm 1, and Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Official Title
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Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

Conditions
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Health Volunteer Validation Study

Intervention / Treatment
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* Other: Location


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 21 years of age or older. Subject is willing and able to sign the Informed Consent Form. Subject is healthy, able and willing to complete all the preparation steps and study procedures. Exclusion Criteria Female subject with a known pregnancy or unsure about pregnancy status. Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive. Subjects with skin breakdown in areas where device placement is required. Subjects with chronic lung disease or asthma. Subjects with a history of cardiovascular diseases. Subjects who are diabetic. Subjects living with kidney failure or dialysis. Subjects with a history of liver failure. Subjects with any known malignancy (i.e. cancer patients). Subjects with implanted devices in the thoracic region

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Side location<br>u-Cor device will be applied on side location | Other: Location<br> <br> |
| Front location<br>u-Cor device will be applied on front location | Other: Location<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD). | Immediately | 
| Posture | 90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position | Immediately | 
| Activity | μCor output is provided as active and not active. 90% correct classification of activity will be required of recordings. | Immediately | 
| Heart Rate |  | Immediately | 
| ECG |  | Immediately |