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

Subject Areas : Communication

Mohammadamin Haghayegh ¹ , Neda Behzadfar ²

1 - Najafabad Branch, Islamic Azad University
2 - Najafabad Branch, Islamic Azad University

Received: 2020-10-20 Accepted : 2020-11-15 Published : 2021-03-01

Keywords: Validation, Saadat NIBP, BS EN ISO 81060-2, manual auscultatory,

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 accur a c y and reliability against manual auscultatory general practitioners (GP), read in g s. A total of 298 measurements and comparison proced ur es 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.