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Omron HEM-7080IC

Device Name:HEM-7080IC
Device Model:HEM-7080IC
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Omron HEM-7080IC, to measure blood pressure, has passed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been compared to a validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalRecommended in certain condition(s)Validation in specific condition(s). See publications for details.
ESH (Europe)Self-measurement for adults and childrenPublished evidence
Japanese Society of HypertensionSelf-measurement (2016-2018)Implied equivalence to the Omron 705IT (HEM-759-E), M5-I (HEM-757-E) or T9P
Stride BPSelf-measurement for adults and childrenEquivalence claim without published evidence

Device Family:Omron 705CP-II (HEM-759-E2)B,D, Omron 705IT (HEM-759-E)B,D,P, Omron HEM-7080ICD,J,P, Omron HEM-7080ITJ, Omron HEM-759PJ, Omron IA2D, Omron M4-I (HEM-752-E)B,D, Omron M6 (HEM-7001-E)B,D, Omron M6 (HEM-7211-E)D, Omron M6 (HEM-7211-E8)D (B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, P Stride Equivalence)
Validation Publications

Godai K, Kabayama M, Saito K, Asayama K, Yamamoto K, Sugimoto K, Ohkubo T, Rakugi H, Kamide K. Validation of an automated home blood pressure measurement device in oldest-old populations. Hypertens Res. 2020 Jan;43(1):30-35. Epub: 2019 Sep 18. doi: 10.1038/s41440-019-0330-7. PMID: 31534190.

81060-2:2013 - Pass Very elderly (Age 85+ y)

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron 705IT (HEM-759-E)

El Assaad MA, Topouchian JA, Asmar RG. 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. 2003 Jun;8(3):127-33. PMID: 12900590.

ESH-IP:2002 - Pass General population

Stergiou GS, Yiannes NG, Rarra VC. Validation of the Omron 705 IT oscillometric device for home blood pressure measurement in children and adolescents: the Arsakion School Study. Blood Press Monit. 2006 Aug;11(4):229-34. PMID: 16810034.

ESH-IP:2002 - Pass Children amd adolescents (n=197)

SP10:2002 - Pass Children amd adolescents (n=197)

Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. PMID: 16410738.

BHS:1993 - Pass (A/A) General population

SP10:2002 - Pass General population

Omron M6 (HEM-7001-E)

Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT). Blood Press Monit. 2006 Jun;11(3):165-71. PMID: 16702826.

ESH-IP:2002 - Pass General population

Altunkan S, Ilman N, Kayatürk N, Altunkan E. Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults. Blood Press Monit. 2007 Aug;12(4):219-25. PMID: 17625394.

ESH-IP:2002 - Pass General population

Altunkan S, Iliman N, Altunkan E. Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients. Blood Press Monit. 2008 Apr;13(2):117-22. doi: 10.1097/MBP.0b013e3282f3fb50. PMID: 18347447.

ESH-IP:2002 - Pass General population

Omron M6 (HEM-7211-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2010 - Pass General population