Omron R3 (HEM-6021-E)
The technology used in the Omron R3 (HEM-6021-E), to measure blood pressure, has passed in clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
|Medaval||★ Recommendation||Older clinical validation; older protocol; multiple clinical validations|
Eckert S, Gleichmann U, Zagorski O, Klapp A. Validation of the OMRON R3 blood pressure self-measuring device through simultaneous comparative invasive measurements according to protocol 58130 of the German Institute for Validation. Blood Press Monit. 1997 Aug;2(4):189-192. PMID: 10234115.
58130:1995 - Pass General population (Note: (n=75/15))
Dieterle T, Battegay E, Bucheli B, Martina B. Accuracy and 'range of uncertainty' of oscillometric blood pressure monitors around the upper arm and the wrist. Blood Press Monit. 1998;3(6):339-46. PMID: 10212375.
BHS:1993 - Fail General population (Note: No grades in abstract)
SP10:1992 - Fail General population
Watson S, Wenzel RR, di Matteo C, Meier B, Lüscher TF. Accuracy of a new wrist cuff oscillometric blood pressure device: comparisons with intraarterial and mercury manometer measurements. Am J Hypertens. 1998 Dec;11(12):1469-74. PMID: 9880129.
IA protocol - Pass General population (Note: (n=100))
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 R3 (HEM-6021-E) 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 R3-I Plus (HEM-6022-E)
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