Noninvasive blood pressure (BP) measurement is dependent on either auscultation or oscillometry. The Tensoval duo control device uses auscultatory and/or oscillometric technology to determine BP. We evaluated the accuracy of this device in adults according to the British Hypertension Society (BHS) protocol and the International Protocol of the European Hypertension Society.
Ethical approval was obtained and participants gave written informed consent. Eighty-five participants who fulfilled the protocol criteria were recruited. Nine sequential same arm measurements were taken from each participant by two trained observers, comparing the device to mercury sphygmomanometery. Data analysis was performed according to the respective protocol guidelines.
The device achieved an A grade for both systolic and diastolic pressures with 68, 91 and 98% of systolic and 73, 91 and 98% of diastolic differences within the ≤5, ≤10 and ≤15 mmHg categories of the BHS protocol. It maintained an A/A grade throughout the low, medium and high-pressure analysis. It also achieved the requirements of the Association for the Advancement of Medical Instrumentation (ANSI/AAMI SP10 protocol) with a mean difference (SD) of −2.4 (6.0) mmHg for systolic and 0.9 (6.3) mmHg for diastolic pressure. It also passed all the phases of the International Protocol.
The Tensoval duo control can be recommended for clinical and home care use in an adult population according to the criteria of the BHS protocol and the International Protocol. It is the first fully automated BP device for self-measurement to maintain an A/A grade throughout the low, medium and high-pressure ranges.