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Omron HEM-6022

Device Model:HEM-6022
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:

While the technology used in the Omron HEM-6022, to measure blood pressure, has been claimed 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 there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2018)Implied equivalence to the Omron M2 Compact (HEM-7102-E), M3 Intellisense (HEM-7051-E), R3-I Plus (HEM-6022-E)

Device Family:Omron HEM-6022J, Omron R3 (HEM-6021-E)D, Omron R3-I Plus (HEM-6022-E)D,J (D DET Equivalence, J JHS Implied Equivalence)
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 R3 (HEM-6021-E)

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))

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