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Omron IA2 (HEM-7011-C1)
Device Name:
IA2
Device Model:
HEM-7011-C1
Manufacturer:
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
Device Manual:
Click here to download the Device Manual
Description:
The Omron IA2 (HEM-7011-C1) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Omron IA2 (HEM-7011-C1), 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP ESH (Europe) Self-measurement for adults and children Published evidence
Device Family:
Omron 705CP-II (HEM-759-E2)B,D, Omron 705IT (HEM-759-E)B,D,P, Omron IA2 (HEM-7011-C1)D, 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, Omron HEM-7080ICD,J,P, Omron HEM-7080ITJ, Omron HEM-759PJ
Legend: 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, aged 85+ years

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

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