Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol: the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check.

Abstract

Objective: Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the International Protocol of the European Society of Hypertension (ESH) in four separate studies. The Pic Indolor Personal Check, Comfort Check and My Check measure blood pressure (BP) at the brachial level; the Travel Check measures radial BP at the wrist level.

Methods: The International Protocol includes a total number of 33 subjects. In each study and for each subject, four BP measurements were performed simultaneously by two observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the observers and the device BP values (99 pairs) were classified into three categories (< or =5, < or =10, < or =15 mmHg).

Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were 0.1 +/- 2.9 and -0.1 +/- 3.8 mmHg for systolic and diastolic BP respectively for the Personal Check; -1.0 +/- 3.7 and 0.2 +/- 3.2 mmHg for the Comfort Check; -0.6 +/- 4.5 and -1.5 +/- 4.3 mmHg for the My Check; -0.1 +/- 2.0 and 0.6 +/- 1.7 mmHg for the Travel Check.

Conclusion: Readings of the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check devices differing by less than 5, 10 and 15 mmHg fulfill the International Protocol requirements and therefore can be used by patients for SBPM.