Clinical Validation of the Saadat Non-Invasive Blood Pressure Module According to the British Standard EN ISO ۸۱۰۶۰-۲ Protocol

This study was conducted according to the British Standard EN ISO ۸۱۰۶۰-۲ 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 ۲۹۸ measurements and comparison proced­ur­es were performed on ۹۵ 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: -۲.۲۲ ± ۶.۵۱ mmHg and -۳.۳۱±۶.۲۷ mmHg respectively. The Saadat NIBP module fulfilled the BS EN ISO ۸۱۰۶۰-۲ requirements, which states that the mean ± SD of lower than ۵±۸ mmHg can be recommended for clinical use.

Keywords:

Saadat NIBP , Validation , BS EN ISO ۸۱۰۶۰-۲ , manual auscultatory