Vital USA, Inc.

The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.

Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019