Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)

Farahnaz Joukar,1– 3,* Sara Yeganeh,2,* Mohammadreza Naghipour,1 Soheil Hassanipour,3 Hossein-Ali Nikbakht,4 Fariborz Mansour-Ghanaei1– 3 1Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran; 2Caspian Digestive Disease Research...

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Main Authors:	Joukar F, Yeganeh S, Naghipour M, Hassanipour S, Nikbakht HA, Mansour-Ghanaei F
Format:	article
Language:	EN
Published:	Dove Medical Press 2020
Subjects:	validation electronics blood pressure monitor automated devices american association for the advancement of medical instrumentation Medical technology R855-855.5
Online Access:	https://doaj.org/article/6cf75d74fa6b4e118aa3ccbc8ea5c10e
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spelling	oai:doaj.org-article:6cf75d74fa6b4e118aa3ccbc8ea5c10e2021-12-02T13:11:41ZValidation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)1179-1470https://doaj.org/article/6cf75d74fa6b4e118aa3ccbc8ea5c10e2020-09-01T00:00:00Zhttps://www.dovepress.com/validation-of-omron-hbp-1100-e-professional-blood-pressure-measuring-d-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Farahnaz Joukar,1– 3,* Sara Yeganeh,2,* Mohammadreza Naghipour,1 Soheil Hassanipour,3 Hossein-Ali Nikbakht,4 Fariborz Mansour-Ghanaei1– 3 1Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran; 2Caspian Digestive Disease Research Center, Guilan University of Medical Sciences, Rasht, Iran; 3GI Cancer Screening and Prevention Research Center, Guilan University of Medical Sciences, Rasht, Iran; 4Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran*These authors contributed equally to this workCorrespondence: Fariborz Mansour-Ghanaei Tel +98(13)33535116Fax +98(13)33534951Email fmansourghanaei@gmail.comBackground: Blood pressure (BP) measurement accuracy is critical to the diagnosis and management of hypertension. The aim of the present study was to validate the Omron HBP-1100-E professional blood pressure measuring device in accordance with the American Association for the Advancement of Medical Instrumentation in Iranian adults.Materials and Methods: Simultaneous blood pressure auscultator measurements were obtained by two observers using mercury sphygmomanometers as a reference, sequentially with a measurement by using the Omron HBP-1100-E device. Absolute device-reference blood pressure differences were categorized into three error categories (within 5, 10, and 15 mmHg), and mean device-reference blood pressure difference (standard deviation) was calculated and evaluated using the American Association for the Advancement of Medical Instrumentation criteria.Results: A total of 85 participants (250 paired readings) were enrolled to the study. 26.8%, 55.6%, and 79.6% of the device-reference blood pressure differences agreed to within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 39.6%, 69.2%, and 81.6% of measurements for diastolic blood pressure, respectively, and failed to pass the protocol criteria. The mean device-reference blood pressure difference was 8.0 ± 13.1 mmHg for systolic BP and 2.2 ± 11.3 mmHg for diastolic BP, and was > 5.0 ± 8.0 mmHg (required criteria).Conclusion: Omron HBP-1100-E professional blood pressure monitor is not desirable for measuring the BP for Iranian adults as it overestimates blood pressure in this population.Keywords: validation, electronics, blood pressure monitor, automated devices, American Association for the Advancement of Medical InstrumentationJoukar FYeganeh SNaghipour MHassanipour SNikbakht HAMansour-Ghanaei FDove Medical Pressarticlevalidationelectronicsblood pressure monitorautomated devicesamerican association for the advancement of medical instrumentationMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 13, Pp 231-236 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	validation electronics blood pressure monitor automated devices american association for the advancement of medical instrumentation Medical technology R855-855.5
spellingShingle	validation electronics blood pressure monitor automated devices american association for the advancement of medical instrumentation Medical technology R855-855.5 Joukar F Yeganeh S Naghipour M Hassanipour S Nikbakht HA Mansour-Ghanaei F Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
description	Farahnaz Joukar,1– 3,* Sara Yeganeh,2,* Mohammadreza Naghipour,1 Soheil Hassanipour,3 Hossein-Ali Nikbakht,4 Fariborz Mansour-Ghanaei1– 3 1Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran; 2Caspian Digestive Disease Research Center, Guilan University of Medical Sciences, Rasht, Iran; 3GI Cancer Screening and Prevention Research Center, Guilan University of Medical Sciences, Rasht, Iran; 4Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran*These authors contributed equally to this workCorrespondence: Fariborz Mansour-Ghanaei Tel +98(13)33535116Fax +98(13)33534951Email fmansourghanaei@gmail.comBackground: Blood pressure (BP) measurement accuracy is critical to the diagnosis and management of hypertension. The aim of the present study was to validate the Omron HBP-1100-E professional blood pressure measuring device in accordance with the American Association for the Advancement of Medical Instrumentation in Iranian adults.Materials and Methods: Simultaneous blood pressure auscultator measurements were obtained by two observers using mercury sphygmomanometers as a reference, sequentially with a measurement by using the Omron HBP-1100-E device. Absolute device-reference blood pressure differences were categorized into three error categories (within 5, 10, and 15 mmHg), and mean device-reference blood pressure difference (standard deviation) was calculated and evaluated using the American Association for the Advancement of Medical Instrumentation criteria.Results: A total of 85 participants (250 paired readings) were enrolled to the study. 26.8%, 55.6%, and 79.6% of the device-reference blood pressure differences agreed to within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 39.6%, 69.2%, and 81.6% of measurements for diastolic blood pressure, respectively, and failed to pass the protocol criteria. The mean device-reference blood pressure difference was 8.0 ± 13.1 mmHg for systolic BP and 2.2 ± 11.3 mmHg for diastolic BP, and was > 5.0 ± 8.0 mmHg (required criteria).Conclusion: Omron HBP-1100-E professional blood pressure monitor is not desirable for measuring the BP for Iranian adults as it overestimates blood pressure in this population.Keywords: validation, electronics, blood pressure monitor, automated devices, American Association for the Advancement of Medical Instrumentation
format	article
author	Joukar F Yeganeh S Naghipour M Hassanipour S Nikbakht HA Mansour-Ghanaei F
author_facet	Joukar F Yeganeh S Naghipour M Hassanipour S Nikbakht HA Mansour-Ghanaei F
author_sort	Joukar F
title	Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
title_short	Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
title_full	Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
title_fullStr	Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
title_full_unstemmed	Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)
title_sort	validation of omron hbp-1100-e professional blood pressure measuring device according to the american association for the advancement of medical instrumentation protocol: the persian guilan cohort study (pgcs)
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/6cf75d74fa6b4e118aa3ccbc8ea5c10e
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Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS)

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