Omron M2+ (HEM-7146-E)
Device Name:
M2+
Device Model:
HEM-7146-E
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood Pressure and PR
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 M2+ (HEM-7146-E) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron M2+ (HEM-7146-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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Stride BP | Self-measurement for adults (Preferred) | Equivalence to the Omron HEM-9200T claim without published evidence |
Device Family:
Omron HEM-9200TJ,P,Y, Omron X2 Smart+ (HEM-7146T2-ESL)P, Omron M2 Intelli IT+ (HEM-7146T2-EBK)P, Omron M2+ (HEM-7146-E)P, Omron M300 (HEM-7121J-D)P, Omron M300 Intelli IT (HEM-7143T1-D)P, Omron M1 Basic (HEM-7090-E)P, Omron M1 Basic (HEM-7090-LE)P, Omron JPN750 (HEM-7157-AP3)Y, Omron M2 Essential (HEM-7188-E)P, Omron M2+ (HEM-7188-LE)P, Omron M2+ Connect (HEM-7188T1-LE)P, Omron X2+ Connect (HEM-7188T1-LEO)P
Legend: J JHS Implied Equivalence, P Stride Equivalence, Y Internal declaration
Legend: J JHS Implied Equivalence, P Stride Equivalence, Y Internal declaration
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 HEM-9200T
Takahashi H, Saito K, Yakura N. Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol. J Hum Hypertens. 2022 Apr;36(4):416-419. Epub: 2021 Apr 9. doi: 10.1038/s41371-021-00536-1. PMID: 33837291.
81060-2:2013 - Pass General population