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 Adult and Pediatric 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
152
* Connex Vital Sign Monitor with ModPG3 * Laptop * Blood Pressure Data Collection Software (not used for test report analysis) * USB cable * Power strip * Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
* Reference Sphygmomanometer1 * Reference Cuffs2 * Dual Auscultatory Stethoscope * Tape measure * Stopwatch
Baxter Investigational Site
Bologna, Italy
Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Time frame: Day 1 (up to 1 hour)
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