Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension

Abstract

Background

Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the European Society of Hypertension (ESH) international protocol and its 2010 revision in four separate studies. The Omron^® M2, Omron M3, and Omron M6 measure blood pressure (BP) at the brachial level, while the Omron R2 measures BP at the wrist level.

Methods

The international protocol requires a total number of 33 subjects in which the validation is performed. The Omron M2 and Omron R2 were validated in 2009 according to the ESH international protocol, while the Omron M3 and Omron M6 were validated in 2010–2011 according to the 2010 ESH international protocol revision. The protocol procedures were followed precisely.

Results

All four tested devices passed the validation process. The mean differences between the device and mercury readings were 2.7 ± 5.0 and −1.4 ± 3.2 mmHg for systolic and diastolic BP, respectively, using the Omron M2 device, and 1.7 ± 3.2 and −0.9 ± 2.6 mmHg using the Omron M3, 1.6 ± 2.9 and −0.9 ± 2.5 mmHg using the Omron M6, and −1.1 ± 4.8 and −0.9 ± 4.3 mmHg using the Omron R2.

Conclusion

Readings from the Omron M2, Omron M3, Omron M6, and Omron R2, differing by less than 5, 10, and 15 mmHg, fulfill the ESH international protocol and its 2010 revision requirements. Therefore, each of these four devices can be used by patients for SBPM.

Keywords:

• Omron R2
• M2
• M3
• M6
• blood pressure measurement
• validation
• international protocol
• European Society of Hypertension

Acknowledgment

The authors thank the “Foundation-Medical Research Institutes” which contribute to the elaboration of a specific software for the data analysis.

Disclosure

The authors report no conflicts of interest in this work. The study was sponsored by Omron Healthcare Europe.