Validation of a Noninvasive Automated Blood Pressure Device

Study Overview
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Brief Summary
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The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.

Detailed Description
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A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically wrap the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.

Official Title
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Validation of a Noninvasive Automated Blood Pressure Device

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Blood pressure assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 12 to 92 years of age. generally healthy but can be on medication for blood pressure regulation. Exclusion Criteria: heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs. using a pacemaker to maintain a suitable heart rate. missing their natural left arm. exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time ( 40min) or prevent a BP reading taken from the left arm. Special populations, for example pregnant women and patients with known arrhythmias.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 92 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 |
| --- | --- |
| Single Group<br>85 eligible study participants | Device: Blood pressure assessment<br>* Validation of an automated blood pressure device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and Diastolic blood pressure (criteria 1 and 2) | Mean value of the differences of the paired (i.e., device under test - reference method) determinations for all study participants shall be within or equal to ± 5 mmHg with a standard deviation no greater than 8 mmHg (criterion 1). Standard deviation of the averaged paired determinations per participant shall meet the criterion 2 listed in the standard. | 60 minutes |