NIBP Accuracy Study for Adult Subject Populations

The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.

Inclusion criteria

• Age requirement: 18 and over.
• Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
• Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
• Able to provide written informed consent.
• Expected to remain in the unit for the duration of the study procedure.

Exclusion criteria

• Have previously participated in this study (no subject may participate more than once).
• Pregnant and lactating women per site standard of care.
• Subjects with peripheral arterial diseases (causing left/right arm difference)
• Hemodynamically unstable subjects at the discretion of the investigator.
• Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
• Are suffering from infection(s) or immunocompromised patients that require isolation.
• PI or designee decision due to subject health conditions