Clinical Validation of the Saadat Non-Invasive Blood Pressure Module According to the British Standard EN ISO 81060-2 Protocol

Authors

Najafabad Branch, Islamic Azad University

Abstract

This study was conducted according to the British Standard EN ISO 81060-2 guidelines. The aim was to validate the Saadat non-invasive blood pressure (NIBP) module accur­a­c­y and reliability against manual auscultatory general practitioners (GP), read­in­g­s. A total of 298 measurements and comparison proced­ur­es were performed on 95 adults without heart disease under the supervision of two GPs. In order to represent the relationships between the test device and the reference method, the Bland-Altman graphical plotting method was used. The mean differences and standard deviations (mean ± SD differences) between the readings of the Saadat NIBP module and determination of GPs as the reference method for systolic and diastolic were exceptionally close with: -2.22 ± 6.51 mmHg and -3.31±6.27 mmHg respectively. The Saadat NIBP module fulfilled the BS EN ISO 81060-2 requirements, which states that the mean ± SD of lower than 5±8 mmHg can be recommended for clinical use.

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