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

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

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:

1. Side location (below left armpit) for study arm 1, and
2. 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.

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:

1. Side location (below left armpit) for study arm 1, and
2. 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.

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