Omron R3 (HEM-6021-E)

Device Name:R3
Device Model:HEM-6021-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:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Omron R3 (HEM-6021-E), to measure blood pressure, has passed in three clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; older protocol; multiple clinical validations

Device Family:Omron R3-I Plus (HEM-6022-E)D (D DET Equivalence)
Validation Publications

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, L├╝scher 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))

Relevant Publications

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.

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 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