ModPG3 Neo-Infant ISO 81060

Description

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions

Blood Pressure

Study Overview

Study Details

Study overview

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

ModPG3 Neonate and Infant AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

ModPG3 Neo-Infant ISO 81060

Condition
Blood Pressure
Intervention / Treatment

-

Contacts and Locations

Greenville

East Carolina University, Greenville, North Carolina, United States, 27834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    to 3 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    Yes

    Collaborators and Investigators

    Baxter Healthcare Corporation,

    Study Record Dates

    2025-08