Evidence map›Paper›PMID 39070216›Full record

ArticleVascular health and risk management2024

Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.

Hakuo Takahashi, Shingo Yamashita, Nobuki Yakura

Abstract readValidation Study
In one paragraph

Article in Vascular health and risk management, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Hakuo Takahashi *Department of Cardiology, Biwako Yoikuin Hospital, Otsu-shi, Shiga, 520-2144, Japan.ORCID 0000-0002-6860-8691
Shingo Yamashita *Department of Technology Development, Omron Healthcare Co., Ltd, Muko-shi, Kyoto, 617-0003, Japan.ORCID 0000-0003-3788-5394
Nobuki Yakura *Department of Technology Development, Omron Healthcare Co., Ltd, Muko-shi, Kyoto, 617-0003, Japan.ORCID 0000-0003-1796-1097

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: 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.

Indexed as

Blood PressureBlood Pressure Monitoring, AmbulatoryEquipment DesignPredictive Value of TestsAdultAgedBlood Pressure MonitorsFemaleHumansMaleMiddle AgedObserver VariationReproducibility of ResultsUpper Extremityblood pressure monitoring deviceinternational protocolvalidation study

Identifiers

PMID39070216
PMCPMC11277893

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