Omron M3 Intellisense (HEM-7051-E)
The technology used in the Omron M3 Intellisense (HEM-7051-E), to measure blood pressure, has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| 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 | ||
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)
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.
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
