Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension.

Background: Four electronic devices for self-measurement of brachial blood pressure (BP): the Omron M1 Plus, the Omron M6 Comfort, the Spengler KP7500 D, and the Microlife BP A100 Plus, were evaluated in four separate studies according to the International Protocol of the European Society of Hypertension (ESH).

Design: The International Validation Protocol is divided into 2 phases: the first phase is performed on 15 selected subjects (45 pairs of BP measurements); if the device passes this phase, 18 supplementary subjects are included (54 pairs of BP measurements) making a total number of 33 subjects (99 pairs of BP measurements) on which the final validation is performed.

Methods: The same methodology recommended by the ESH protocol was applied for the 4 studies.