Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol

Background: Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies. Methods: The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple (R) iOS device such as an iPhone (R), iPad (R), or iPod (R). The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (<= 5 mmHg, <= 10 mmHg, <= 15 mmHg). The protocol procedures were followed precisely in each of the four studies. Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were: -1.8 +/- 5.1 mmHg and -0.4 +/- 2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5 +/- 4.6 mmHg and -1.2 +/- 4.3 mmHg for the Omron HEM-7420 device; -0.2 +/- 5.0 mmHg and 0.4 +/- 4.2 mmHg for the Withings BP-800 device; and 3.0 +/- 5.3 mmHg and 0.3 +/- 5.2 mmHg for the Polygreen KP-7670 device. Conclusion: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.