Omron R2 (HEM-6113-FR)
While the technology used in the Omron R2 (HEM-6113-FR), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Previous recommendation, now archived | Implied equivalence to the Omron R7 (HEM 637-IT) | ||
Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.
Measurements from the Omron R2 (HEM-6113-FR) are compared to those from the Omron BPM tester PA-350, though not in a formal validation.
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, Oztaş 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
Omron R2 (HEM-6113-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
