Validation of a Noninvasive Automated Blood Pressure Device

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.

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.