Noninvasive Blood Pressure Validation Study

Noninvasive Blood Pressure Validation Study

The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.

Inclusion Criteria:

• Participant must have the ability to read and understand English and provide written informed consent.
• Participant must be willing and able to comply with study procedures and duration.
• Participant is an adult 22 - 90 years of age.
• Participant must have an arm circumference in the range of the reference and calibration cuffs.

Exclusion Criteria:

• Participant is unwilling to provide informed consent.
• Participants with deformities or abnormalities that may prevent proper application of the DUT
• Female participants who self-reported as pregnant, or who are self-reported as trying to get pregnant.
• Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other sensors (self-reported)
• Participant's screening BP exceed Measurement Range of the device (Systolic: 80-230 mmHg, Diastolic: 40-130 mm Hg)
• Participants with known heart arrhythmias.
• Participants with peripheral vascular disease.
• Participants with clotting disorders.
• History of bleeding disorders or personal history of prolonged bleeding from injury
• History of blood clots
• Hemophilia
• Participants that cannot tolerate sitting or standing for the duration of the study.
• Participant with a blood pressure demographic that has already been filled.
• Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally.
• Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.