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Omron R2 (HEM-6113-E)

Device Name:R2
Device Model:HEM-6113-E
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:Wrist
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

The technology used in the Omron R2 (HEM-6113-E), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationRecent clinical validation; older protocol
BIHS (UK and IRL)Previous recommendation, now archivedImplied equivalence to the Omron R7 (HEM 637-IT)
Stride BPSelf-measurement for adultsPublished evidence

Device Family:Boots 65-90-412B, Omron 637IT (HEM-637IT-E)B,D, Omron R2 (HEM-6113-E)B, Omron R2 (HEM-6113-FR)B, Omron R6 (HEM-6000-E7)B,D, Omron R6 (HEM-6052-2)B,D, Omron R7 (HEM-637-E2)B, Omron R7 (HEM-637-E7)D (B BIHS Derivative, D DET Equivalence)
Validation Publications

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:2002 - Pass General population

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 637IT (HEM-637IT-E)

Altunkan S, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly. Blood Press Monit. 2006 Apr;11(2):97-102. PMID: 16534412.

ESH-IP:2002 - Pass Elderly (Age>65)

Altunkan S, OztaƟ K, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults. Blood Press Monit. 2006 Apr;11(2):79-85. PMID: 16534409.

ESH-IP:2002 - Pass General population

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