Objective: Three oscillometric devices for the self blood pressure measurement were evaluated according to the International Protocol of the European Society of Hypertension in three separate studies. The Omron M3 Intellisense and the Omron M2 Compact measures blood pressure (BP) at the brachial level; the Omron R3-I Plus measures BP at the wrist level.
Methods: The International Protocol is divided into two phases and includes a total number of 33 participants on whom the validation is performed. In each study, and for each participant, four BP measurements were taken simultaneously by two observers using mercury sphygmomanometers alternately with three measurements with the tested device. The difference between the observers and the device BP values was calculated for each measurement. The 99 pairs of BP differences were classified into three categories (< or =5, < or =10, < or =15 mmHg).
Results: All three tested devices passed the first and second phase of the validation process. The mean differences between the device and mercury readings were 1.9+/-3.0 and -1.0+/-2.3 mmHg for systolic and diastolic BP, respectively, for the Omron M3 Intellisense device, 2.5+/-5.4 and -2.3+/-3.6 mmHg for the Omron M2 Compact device, and 1.4+/-4.5 and 0.8+/-4.6 mmHg for the Omron R3-I Plus device.
Conclusion: Readings of the Omron M3 Intellisense, the Omron M2 Compact and the Omron R3-I Plus, differing by less than 5, 10, and 15 mmHg fulfill the International Protocol requirements and therefore can be used by patients for self blood pressure measurement.