Accuracy of Non-Invasive Blood Pressure Measurement in Adults
Accuracy of Non-Invasive Blood Pressure Measurement in Adults
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational
 device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood
 pressure (BP) in adult subjects.
This study is a single-center blinded study that will enroll approximately 150 adult
 subjects. Trained auscultators will perform the standard auscultation BP measurements. They
 will be blinded to each other's measurements and from the ViSi measurements.

 The study population will be randomized into two groups based on the side of the blood
 pressure measurement: the left arm group (LAG) and the right arm group (RAG).

 The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification
 in order to ensure that the study subjects meet the required arm circumference and blood
 pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.
Inclusion Criteria:

 -  Subject is greater than 12 years of age at the time of screening.

 -  Subject's upper arm circumference is between 20cm and 55cm.

 -  Subject is willing to undergo the Informed Consent process prior to enrollment in the
 study.

 -  Subject is willing and able to participate for up to 60 minutes.

 Exclusion Criteria:

 -  Subject is participating in another clinical study that may interfere with the results
 of this study.

 -  Subject is unable to have a blood pressure measurement taken from either arm for any
 reason.

 -  Subject is evaluated by the Investigator and found to be medically unsuitable for
 participation in this study.