Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).
| Autor: | Shi L; Department of Health Services, Fourth Military Medical University., Zhang XY; Department of Quality Control, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an., Sun JY; Experimental High school, Beijing Normal University, Beijing., Chen JF; Department of Geriatrics, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Ma YF; Department of Health Services, Fourth Military Medical University., Zhou KY; Department of Health Services, Fourth Military Medical University. |
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| Jazyk: | angličtina |
| Zdroj: | Blood pressure monitoring [Blood Press Monit] 2024 Feb 01; Vol. 29 (1), pp. 41-44. Date of Electronic Publication: 2023 Sep 14. |
| DOI: | 10.1097/MBP.0000000000000678 |
| Abstrakt: | Objective: To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). Methods: Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results. Results: A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively. Conclusion: The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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