Omron M3 Intellisense (HEM-7051-E)

Omron M3 Intellisense (HEM-7051-E)
Device Name:M3 Intellisense
Device Model:HEM-7051-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:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
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Assessment:

The technology used in the Omron M3 Intellisense (HEM-7051-E), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in four clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
BIHS (UK and IRL)Self-measurementPublished evidence
ESH (Europe)Self-measurementPublished evidence

Device Family:Boots 56-90-404B, Boots 56-90-420 (HEM-7115-BS)B, Omron HEM-7117B, Omron M2 (HEM-7117-E)B,D, Omron M2 (HEM-7119-E(V))D, Omron M2 Basic (HEM-7116-E)B,D, Omron M2 Basic (HEM-7116-E2(V))D, Omron M2 Basic (HEM-7116-E8(V))D, Omron M3 (HEM-7200-E)D, Omron M3 (HEM-7200-E8)D, Omron HEM-7051 (HEM-7051-SH)D (B BIHS Derivative, D DET Equivalence)
Validation Publications

Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The Omron M3 Intellisense (HEM-7051-E), the Omron M2 Compact (HEM 7102-E), and the Omron R3-I Plus (HEM 6022-E). Blood Press Monit. 2010 Feb;15(1):49-54. doi: 10.1097/MBP.0b013e3283354b11. PMID: 20032779.

ESH-IP:2002 - Pass General population

Akpolat T, Erdem E, Aydogdu T. Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population. Kidney Blood Press Res. 2012;35(2):82-8. Epub: 2011 Sep 10. doi: 10.1159/000330719. PMID: 21912183.

ESH-IP:2010 - Pass Stage 3-5 chronic kidney disease (Note: Modified protocol)

Relevant Publications

Mazoteras Pardo V, Becerro de Bengoa Vallejo R, Losa Iglesias ME, López López D, Palomo López P, Rodríguez Sanz D, Calvo Lobo C. The QardioArm Blood Pressure App for Self-Measurement in an Obese Population: Validation Study Using the European Society of Hypertension International Protocol Revision 2010. JMIR Mhealth Uhealth. 2018 Oct;6(10):e11632. Epub: 2018 Oct 25. doi: 10.2196/11632. PMID: 30361193. Available from: PMC6229517.

The use of this device for the reference measurements, in contravention to the ESH-IP 2010 protocol requirements, means that this study can be considered only as a comparison with the Qardio QardioArm A100. It cannot be considered as a validation study.

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

Omron M2 (HEM-7117-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:2002 - Pass General population

Omron M3 (HEM-7200-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