Validation of the blood pressure measurement device Beurer BM 28 according to the European Society of Hypertension International Protocol revision 2010.

Abstract

The aim of the present study was to validate the blood pressure (BP) monitor Beurer BM 28 according to the International Protocol of the European Society of Hypertension (ESH-IP) revision 2010. In 33 subjects of age 27-81 years, BP measurements were performed according to the ESH-IP protocol, which alternates reference mercury sphygmomanometer and device-under-test (Beurer BM 28) measurements, resulting in a total of 99 comparisons. As to part 1 of the protocol, an absolute difference within 5 mmHg between the Beurer BM 28 and the test device was found in 83 out of 99 comparisons for the SBP and 82 out of 99 comparisons for the DBP. In 95 out of 99 SBP comparisons and 96 out of 99 DBP comparisons, the difference was found to be within 10 mmHg, whereas only one outlier was noted with an SBP difference higher than 15 mmHg. Mean difference between the test device and the reference was 0.4 ± 4.4 mmHg for SBP, and 0.5 ± 4.3 mmHg for DBP. According to part 2 of the protocol, 30 out of 33 subjects for SBP, and 28 out of 33 for DBP had a minimum of two out of three comparisons staying within the range of 5 mmHg. In none of the subjects, all three comparisons stayed outside the 5 mmHg absolute difference, while in three subjects this was the case for the DBP. The Beurer BM 28 met all requirements of the ESH-IP revision 2010 and can be recommended for BP measurements in the study population under investigation.