Abstract

Hypertension is a major cardiovascular risk factor. Therefore, the accuracy of blood pressure (BP) measurement with self-measuring devices is of fundamental importance. Consequently, emerging BP devices should be evaluated against the gold standard according to an established and proven protocol. Tel-O-GRAPH, a new oscillometric self-measuring device of brachial BP, was evaluated against auscultatory sphygmomanometry according to the BHS protocol. Bland-Altman plots were completed for systolic (SBP) and diastolic blood pressures (DBP), and the mean differences and SDs between the test device and the reference device were computed for all BP values. A total of 85 individuals (mean age 48.11±18.0 years; 61% men) were included after they provided informed consent. Overall, 510 measurements were performed. The mean device-observer difference was -0.2±6.6 for SBP and 0.2±6.6 for DBP. The device achieved grade A for SBP and DBP for both observers. Examination of the different BP ranges indicated grade B for SBP more than 160 mmHg and grade A for all BP ranges. Tel-O-GRAPH fulfilled the accuracy requirements of the BHS with the highest accuracy level (A) and can thus be used reliably in the oscillometric measurement of the brachial BP.

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