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Omron M3 (HEM-7154-E)

Omron M3 (HEM-7154-E)
Device Name:M3
Device Model:HEM-7154-E
Manufacturer:

Brand: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Sole: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Omron M3 (HEM-7154-E) is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The technology used in the Omron M3 (HEM-7154-E), to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Stride BPSelf-measurement for adults (Preferred)Equivalence claim without published evidence

Device Family:Omron BP765 (HEM-7311-ZSA)P, Omron Complete (HEM-7530T-E3)P, Omron M1 Basic (HEM-7121J-AF)P, Omron M1 Basic (HEM-7121J-LAF)P, Omron M2 Basic (HEM-7121J-E)B,P, Omron M3 (HEM-7131-E)D,P, Omron M3 (HEM-7154-E)P, Omron M3 IT (HEM-7131U-E)D,P, Omron M6 AC (HEM-7322-E)D,P, Omron M6 AC ME (HEM-7322-ME)P, Omron X2 Basic (HEM-7121J-EO)P (B BIHS Derivative, D DET Equivalence, P Stride 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 BP765 (HEM-7311-ZSA)

Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan;9(11):49-53. doi: 10.2147/VHRM.S72438. PMID: 25657587.

81060-2:2009 - Pass General population