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Omron M3 Intellisense (HEM-7051-E)
Device Model:
HEM-7051-E
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:
Description:
The Omron M3 Intellisense (HEM-7051-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure 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.
Assessment:
The technology used in the Omron M3 Intellisense (HEM-7051-E), to measure blood pressure, has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
BIHS (UK and IRL) Self-measurement Published evidence
ESH (Europe) Self-measurement Published evidence
Stride BP Self-measurement for adults and chronic kidney disease (Preferred) Published evidence
Device Family:
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.

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Palomo-López P, Rodríguez-Sanz D, Calvo-Lobo C. Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation. JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137. PMID: 30888331. Available from: PMC6444211.

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 iHealth Track (KN-550BT). It cannot be considered as a validation study.

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Rodríguez-Sanz D, Casado-Hernández I, Calvo-Lobo C, Palomo-López P. QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010. J Med Internet Res. 2019 Dec 2;21(12):e14686. doi: 10.2196/14686. PMID: 31789600.

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.

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, Martínez-Jiménez EM, Calvo-Lobo C, Romero-Morales C, López-López D, Palomo-López P. QardioArm Blood Pressure Monitoring in a Population With Type 2 Diabetes: Validation Study. J Med Internet Res. 2020 Jul 24;22(7):e19781. doi: 10.2196/19781. PMID: 32706672. Available from: PMC7414407.

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: 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 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