Validation of the visocor HM40 wrist blood pressure measuring device according to the International Protocol

Abstract

The objective of this study was to determine the accuracy of the UEBE visocor HM40 device for blood pressure measurement at the wrist, tested according to the requirements of the International Protocol of the European Society of Hypertension (ESH). Device evaluation was performed in 33 patients whose age and blood pressure were within the intervals required by the ESH protocol. Their mean +/- SD age was 53.2 +/- 15.5 years (range 30-85 years), systolic blood pressure (SBP) was 142.8 +/- 21.8 mmHg (range 108-178 mmHg), diastolic blood pressure (DBP) was 87.0 +/- 15.4 mmHg (range 62-112 mmHg), and wrist circumference was 18.7 +/- 2.7 cm (range 15.5-21.5 cm). During the measurements, which were performed in the supine position, the patient's wrist was kept extended at the heart level with a support under the forearm. In total, 45 measurements were available for analysis in the first phase of the validation process, and 99 measurements in the second phase. The visocor HM40 passed all three phases of the ESH protocol for SBP and DBP. Mean blood pressure differences for the visocor HM40 monitor (device-observer) were -2.0 +/- 5.0 mmHg for SBP and -1.7 +/- 5.3 mmHg for DBP, respectively. These data show that the UEBE visocor HM40 wrist monitor met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.