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

Jirar Topouchian, Davide Agnoletti, Jacques Blacher, Ahmed Youssef, Mirna N Chahine, Isabel Ibanez, Nathalie Assemani, Roland Asmar, Jirar Topouchian, Davide Agnoletti, Jacques Blacher, Ahmed Youssef, Mirna N Chahine, Isabel Ibanez, Nathalie Assemani, Roland Asmar

Abstract

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® iOS device such as an iPhone®, iPad®, or iPod®. 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.

Keywords: European Society of Hypertension International Protocol Revision; Omron HEM-7420; Omron M6 Comfort; Polygreen KP-7670; Withings BP-800; self-blood pressure measurement; validation.

Figures

Figure 1
Figure 1
Plots showing difference in blood pressure between the Omron M6 Comfort (HEM-7221-E) (Omron Healthcare, Kyoto, Japan) readings and the mean of two observer readings in 33 participants (n=99). (A) SBP and (B) DBP. Points in bold are multiple (superimposition). Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure.
Figure 2
Figure 2
Plots showing difference in blood pressure between the Omron HEM-7420 (Omron Healthcare, Kyoto, Japan) readings and the mean of the two observer readings in 33 participants (n=99). (A) SBP and (B) DBP. Points in bold are multiple (superimposition). Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure.
Figure 3
Figure 3
Plots showing difference in blood pressure between the Withings BP-800 (Withings, Paris, France) readings and the mean of the two observer readings in 33 participants (n=99). (A) SBP and (B) DBP. Points in bold are multiple (superimposition). Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure.
Figure 4
Figure 4
Plots showing difference in blood pressure between the Polygreen KP-7670 (Polygreen K-Jump, Taipei, Taiwan) readings and the mean of the two observer readings in 33 participants (n=99). (A) SBP and (B) DBP. Points in bold are multiple (superimposition). Abbreviations: DBP, diastolic blood pressure; SBP, systolic blood pressure.

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