Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol.

To evaluate the accuracy of the UEBE Visomat Comfort form device for home blood pressure measurement tested following the recommendations of the International Protocol of the European Society of Hypertension. Device evaluation was performed in 33 participants with a mean +/- standard deviation age of 56.5+/-18.3 years (range 30-91 years). Their systolic blood pressure (SBP) was 143.6+/-25.3 mmHg (range 94-180 mmHg), diastolic blood pressure (DBP) was 88.8+/-15.4 mmHg (range 64-116 mmHg), and upper arm circumference was 30.2+/-3.2 cm (range 24.5-39.0 cm). BP measurements were performed in the sitting position. The Visomat Comfort form passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean BP differences for the Visomat Comfort form (device-observer) were -2.5+/-5.9 mmHg for SBP and -2.4+/-5.4 mmHg for DBP. Similar device-observer differences were observed in the participants divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, these results indicate that the UEBE Visomat Comfort form monitor can be recommended for clinical use in the adult population over a wide range of arm circumferences.