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Omron M6 (HEM-7211-E8)

Device Name:M6
Device Model:HEM-7211-E8
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:Discontinued but still available
Description: The Omron M6 (HEM-7211-E8) is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

The technology used in the Omron M6 (HEM-7211-E8), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
ESH (Europe)Self-measurement for childrenPublished 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 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 and adolescents (n=197)

SP10:1992 - Pass Children and 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 HEM-7080IC

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)

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 Adults

ESH-IP:2002 - Pass Obese Adults

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 Elderly

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