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

Abstract

To determine the accuracy of the SAW-102 wrist oscillometric blood pressure monitor developed by the Sensacare Company according to the protocols of the European Society of Hypertension (ESH), the Association for the Advancement of Medical Instrumentation (AAMI), and the British Hypertension Society (BHS). SAW-102 was assessed on 33 participants according to ESH requirements, based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg or more. Then SAW-102 was tested on 85 participants according to AAMI criteria requiring mean device-observers discrepancy within 5+/-8 mmHg. Subsequently, SAW-102 was evaluated on 88 participants according to BHS requirements. Finally, 15 participants with wrist circumference greater than the manufacturer's recommendation (19.5 cm) were studied (large wrist group). Efforts were made to secure a stable position of wrist and arm at the heart level. SAW-102 passed all phases of ESH international protocol for both systolic blood pressure (SBP) and diastolic blood pressure (DBP). SAW-102 passed AAMI criteria with mean differences between SAW-102 and observers of 3.8+/-7.5 and 1.5+/-6.0 mmHg, SBP and DPB, respectively. According to BHS protocol, the device achieved final grading of B/B for SBP and DBP, respectively. Large wrist group did not pass the first phase of ESH protocol. This study demonstrated that SAW-102 meets the BHS, ESH, and AAMI standards when measurements are done at the heart level and when the manufacturer's specifications, regarding wrist circumference, are respected. Our data also indicate that exceeding 19.5 cm wrist circumference is accompanied by dramatic decrease of the accuracy of the device.