The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol
Abstract
BACKGROUND: The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society and the Association for the Advancement of Medical Instrumentation SP10 validation criteria. METHODS: Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study. RESULTS: The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6.0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/-5 (8) mmHg. CONCLUSIONS: The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.
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There is some inconsistency in the recommendations by scientific societies on the issue of miscuffing.
“However, there is some inconsistency in the recommendations by scientific societies on the issue of miscuffing [1,4,90,98–100].”
A device that has been successfully validated in a general population sample might not be accurate in a special population such as children, pregnancy, atrial fibrillation, chronic kidney disease, or arm circumference greater than 42 cm.
“A device that has been successfully validated in a general population sample might not be accurate in a special population [children, pregnancy, atrial fibrillation, chronic kidney disease (CKD), arm circumference >42 cm]”
In 2018, the AAMI, ESH and ISO developed a single universally acceptable standard, AAMI/ESH/ISO, ISO 81060-2:2018, intended to replace all previous protocols.
“In 2018, the AAMI, ESH and ISO developed a single universally acceptable standard (AAMI/ESH/ISO, ISO 81060-2:2018), which is intended to replace all previous protocols [90].”
Current recommendations for manual auscultatory devices require a cuff with the length of the inflatable bladder covering 75-100% of the mid-arm circumference and the width covering 37-50% of the length of the mid-arm.
“Current recommendations for manual auscultatory devices require a cuff with the length of the inflatable bladder covering 75–100% of the mid-arm circumference of the individual and the width covering 37–50% of the length of the mid-arm [90,98].”
For automated oscillometric upper arm-cuff devices, the cuff is also the signal sensor and each cuff size should be validated in an adequate number of individuals according to the validation standard used.
“For automated oscillometric upper arm-cuff devices, the cuff is also the signal sensor and each cuff size should be validated in an adequate number of individuals according to the validation standard used [90,98].”
The rules for the dimensions of the inflatable bladder do not necessarily apply for oscillometric devices, and the accuracy of each oscillometric device should be assessed in association with the recommended cuff size in validation studies.
“The above-mentioned rules for the dimensions of the inflatable bladder do not necessarily apply for oscillometric devices, and the accuracy of each oscillometric device should be assessed in association with the recommended cuff size in validation studies [90,98].”
An automated oscillometric device successfully validated in adults may not be accurate in children.
“An automated oscillometric device, which has been successfully validated in adults may not be accurate in children [90,91,182]”
An automated oscillometric device successfully validated in adults may not be accurate in pregnancy or preeclampsia.
“An automated oscillometric device, which has been successfully validated in adults may not be accurate in pregnancy or preeclampsia [90,191]”
A new Universal Standard for validation of BP monitors has been published in 2018.
“A new Universal Standard for validation of BP monitors has been published in 2018 [90]”
Citations
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STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT
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- O'Brien, 2000, Replacing the mercury sphygmomanometer, BMJ, 320, 815, 10.1136/bmj.320.7238.815 · DOI
- O'Brien, 1993, The British Hypertension Society protocol for the evaluation of blood pressure measuring devices, J Hypertens, 11, S2543
- O'Brien, 2002, Working Group on blood pressure monitoring of the European Society of Hypertension international protocol for validation of blood pressure devices in adults, Blood Press Monit, 7, 3, 10.1097/00126097-200202000-00002 · DOI
- O'Brien, 2003, A web site for blood pressure measuring devices: dableducational.com, Blood Press Monit, 8, 177, 10.1097/00126097-200308000-00010 · DOI
- El Assaad, 2003, Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the Omron M5-I and the Omron 705IT, Blood Press Monit, 8, 127, 10.1097/00126097-200306000-00006 · DOI
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- Cuckson, 2002, Validation of the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol, Blood Press Monit, 7, 319, 10.1097/00126097-200212000-00005 · DOI
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Metadata
- Authors
- Coleman, A., Freeman, P., Steel, S., & Shennan, A.
- Affiliations
- Guy's Hospital (GB)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- King's College London (GB)
- Corresponding author
- Coleman, Andrew
- Venue
- Blood Pressure Monitoring
- Published
- 2006-02
- Volume
- 11
- Issue
- 1
- Pages
- 27-32
- ISSN
- 1359-5237 (ISSN-L)
- OpenAlex
- W4230595223
- Cited by
- 179
- References
- 1
- Citations by year
- 2026: 5 · 2025: 1 · 2024: 10 · 2023: 11 · 2022: 14 · 2021: 9 · 2020: 11 · 2019: 12 · 2018: 15 · 2017: 12 · 2016: 4 · 2015: 7 · 2014: 10 · 2013: 11 · 2012: 7
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Blood Pressure Monitoring (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- oscillometric blood pressure monitor, British Hypertension Society protocol, home blood pressure monitoring, systolic and diastolic blood pressure
- MeSH terms
- Adult, Aged, Aged, 80 and over, Blood Pressure Determination, Diastole, Female, United Kingdom, Humans, Male, Middle Aged, Reference Values, Systole, Reproducibility of Results, Blood Pressure Monitors
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