NIBP Study for Neonate and Pediatric Subject Populations

Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations

The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.

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: 0 to < 18 years.
• For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
• For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
• Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 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 invasive blood pressure.
• 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).
• Subjects with peripheral arterial diseases (causing left/right arm difference).
• Hemodynamically unstable subjects Subjects with complications on vasoactive agents at 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 subjects that require isolation.
• For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.
• PI, designee or caring physician decision due to subject health conditions