Validation of Noninvasive Blood Pressure Device

Validation of Noninvasive Blood Pressure Device

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers.

The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

Inclusion Criteria:

• Age 18 years and older
• Site 1; Stage 1 only: Subjects with a history of hypertension (> 140/85 mmHg) or hypotension (< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
• Site 2; Stage 1 and 2: Subjects with systolic blood pressure < 140/90 mmHg.
• Ability to provide informed consent

Exclusion Criteria:

• Febrile subjects
• Subjects displaying respiratory symptoms, or with suspected respiratory illness
• Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
• Subjects with removed axillary lymph nodes or mastectomies
• Subjects with peripheral artery disease
• Pregnant women (patient reported)
• Subjects deemed not suitable for the study at the discretion of the investigator