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Hakuo Takahashi,1,* Shingo Yamashita,2,* Nobuki Yakura2,* 1Department of Cardiology, Biwako Yoikuin Hospital, Otsu-shi, Shiga, 520-2144, Japan; 2Department of Technology Development, Omron Healthcare Co., Ltd, Muko-shi, Kyoto, 617-0003, Japan*These authors contributed equally to this workCorrespondence: Hakuo Takahashi, The Kansai Medical University, Department of Cardiology, The Biwako Yoikuin Hospital, 7-7-2 Ogaya, Otsu City, Shiga, 520-2144, Japan, Tel +81-80-3554-2657, Fax +81-77-502-0116, Email takahash304@gmail.comPurpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol.Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer’s instructions.Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was − 2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤ 5±≤ 8 mmHg. The mean differences between the two observers and Omron HEM-1026 were − 2.1 ± 5.71 mmHg for systolic BP and − 0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled.Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.Keywords: blood pressure monitoring device, validation study, international protocol |
