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Vasc Health Risk Manag. 2014 Jan 16;10:33-44. doi: 10.2147/VHRM.S53968. eCollection 2014.

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.

Author information

  • 1Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France.
  • 2Faculty of Medicine of the Lebanese University, Beirut, Lebanon ; Foundation-Medical Research Institutes, Beirut, Lebanon.
  • 3Foundation-Medical Research Institutes, Beirut, Lebanon.
  • 4Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France ; Faculty of Medicine of the Lebanese University, Beirut, Lebanon ; Foundation-Medical Research Institutes, Beirut, Lebanon.

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

PMID:
24476688
PMCID:
PMC3897354
DOI:
10.2147/VHRM.S53968
[PubMed - indexed for MEDLINE]
Free PMC Article
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