Clinical Validation of the Saadat NIBP Module According to the BS EN ISO 81060-2 Protocol

摘要

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.