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Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol

Journal of Human Hypertension volume 34, pages 735–738 (2020)Cite this article

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Abstract

The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for professional office BP monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was 1 ± 8/−2 ± 6 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 1 ± 7 mmHg for systolic BP and −2 ± 6 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The OMRON HBP-9031C professional BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.

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References

  1. Association for the Advancement of Medical Instrumentation American National Standard. ANSI/AAMI/ISO 81060-2:2013 non-invasive sphygmomanometers - part 2: clinical investigation of automated measurement type. 2013. http://my.aami.org/aamiresources/previewfiles/8106002_1306_preview.pdf#search=%27American+National+Standard.+ANSI%2FAAMI%2FISO+810602%3A2013+Noninvasive%27. Accessed 2 Jul 2019.

  2. Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens. 2018;36:472–8.

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Acknowledgements

We would like to thank Editage (www.editage.com) for their English language editing.

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Authors and Affiliations

  1. Omron Healthcare Co, Ltd, Muko City, Kyoto, 617-0002, Japan

    Kanako Saito & Yukiko Hishiki

  2. Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga, 520-0834, Japan

    Hakuo Takahashi

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  1. Kanako Saito
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  2. Yukiko Hishiki
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  3. Hakuo Takahashi
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Correspondence to Hakuo Takahashi.

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Saito, K., Hishiki, Y. & Takahashi, H. Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol. J Hum Hypertens 34, 735–738 (2020). https://doi.org/10.1038/s41371-020-0301-0

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  • DOI: https://doi.org/10.1038/s41371-020-0301-0

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