Validation of the Saadat NIBP module according to the ANSI/AAMI-SP10 protocol

This study is conducted with the aim of validating the Saadat non-invasive blood pressure (NIBP) module accuracy and reliability against direct intra arterial pressure measurement (IBP) according to the ANSI/AAMI SP10-2002 guidelines. Measurement and comparison procedure were done in a static population of 19 adult patients with brachial catheterized arterial line with total measurements of 195 under supervision of a highly experienced cardiovascular anesthesiologist in accordance with the ANSI/AAMI SP10-2002 regulation. Data analysis was performed based on the protocol criteria. In order to represent relationships between the test device and the reference method, Bland-Altman graphical plotting method was used. The mean ± SD differences between the readings of Saadat NIBP device and IBP as the reference method for systolic, diastolic and map pressures were: -0.9 ± 6.95 mmHg for systolic, 2.57 ± 7.79 mmHg for Diastolic, and 3.89 ± 7.06 mmHg for Map. The Saadat NIBP module fulfilled the ANSI/AAMI SP10-2002 requirement that is the mean ± SD of lower than 5 ± 8 mmHg.