Perin Health Devices
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
Inclusion Criteria: * Adults aged 18 years or older, * Willing and able to provide informed consent, * Able to comply with study procedure. Exclusion Criteria: * Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \> 42 cm), * Patient with a pacemaker, * History of reactions to medical adhesives, * Inability to comply with the study procedure, * Non-English Speaker.
The Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure.
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