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Omron 705CP-II (HEM-759-E2)

Device Name:705CP-II
Device Model:HEM-759-E2
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

The technology used in the Omron 705CP-II (HEM-759-E2), 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.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence
ESH (Europe)Self-measurement for adults and 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)
Relevant Publications

Adler C, Ellert U, Neuhauser HK. Disagreement of the two oscillometric blood pressure measurement devices, Datascope Accutorr Plus and Omron HEM-705CP II, and bidirectional conversion of blood pressure values. Blood Press Monit. 2014 Apr;19(2):109-17. doi: 10.1097/MBP.0000000000000037. PMID: 24583967.

Measurements from the Omron 705CP-II (HEM-759-E2) are compared to those from the Datascope Accutorr Plus, though not in a formal validation.

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)

SP10:2002 - 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 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