Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension

Abstract

To determine the accuracy of a new oscillometric home blood pressure (BP) monitor for arm BP measurement, the SAA-102, developed by the Sensacare Company. Evaluation of the SAA-102 was performed using validation protocols of the European Society of Hypertension (ESH), the Association for the Advancement of Medical Instrumentation (AAMI), and the British Hypertension Society (BHS). The SAA-102 monitor was assessed on 33 participants according to ESH requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg or more. Then the oscillometric monitor was tested on 85 participants according to AAMI criteria which require a mean device-observers discrepancy within 5+/-8 mmHg. Finally, the electronic device was evaluated on 93 participants according to BHS requirements, which are based on five phases: before-use calibration, in-use assessment, after-use calibration, static device validation and report of the results. The SAA-102 passed all phases of the ESH international protocol for both systolic and diastolic blood pressure (SBP and DBP). The SAA-102 passed also AAMI criteria for SBP and DBP. The mean discrepancy between the SAA-102 and observers was 0.1+/-4.6 and -2.7+/-5.2 mmHg, for SBP and DBP, respectively. According to BHS protocol, the oscillometric monitor achieved final grading of A/A for SBP and DBP, respectively. These data show that the SAA-102 device satisfies ESH, AAMI, and BHS protocols for both SBP and DBP and may be recommended for everyday use for BP monitoring at home and in clinical practice.