Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Inclusion Criteria:

• Ability to provide written informed consent or have a legally authorized representative provide written informed consent
• Any volunteer subjects ≥ 18 years of age
• Subject must have the presence of normal sinus rhythm on ECG
• Subject will return for follow-up visit from 5 days to 8 days after study procedure

Exclusion Criteria:

• Any subject who is unable to provide written informed consent
• Any subject with the presence of peripheral vascular disease in either arm
• Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
• Any subject who cannot tolerate 21 repeated BP measurements
• Any subjects with clotting or bleeding disorders
• Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
• Any subject who is unable to have arterial line placed in the radial artery
• Any subject that cannot tolerate 4 fast flushes for the frequency response
• Any female subjects pregnant or lactating
• Any subject that has previously participated in this study
• Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit