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Omron M2 Basic (HEM-7116-E)
Device Name:
M2 Basic
Device Model:
HEM-7116-E
Manufacturer:

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

Other: 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:
Discontinued but still available
Description:
The Omron M2 Basic (HEM-7116-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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Omron M2 Basic (HEM-7116-E), to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP BIHS (UK and IRL) Self-measurement Manufacturer declaration of equivalence to the Omron M3-I (HEM-7051-E)
Device Family:
Boots 56-90-404 (HEM-7041-BS)B, Boots 56-90-420 (HEM-7115-BS)B, Omron HEM-7117B, Omron M2 (HEM-7117-E)B,D, Omron M2 (HEM-7119-E(V))D, Omron M2 Basic (HEM-7116-E)B,D, Omron M2 Basic (HEM-7116-E2(V))D, Omron M2 Basic (HEM-7116-E8(V))D, Omron M3 (HEM-7200-E)D, Omron M3 (HEM-7200-E8)D, Omron M3 Intellisense (HEM-7051-E)B,D, Omron HEM-7051 (HEM-7051-SH)D
Legend: B BIHS Derivative, D DET 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 M2 (HEM-7117-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2002 - Pass General population

Omron M3 (HEM-7200-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2010 - Pass General population

Omron M3 Intellisense (HEM-7051-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

Akpolat T, Erdem E, Aydogdu T. Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population. Kidney Blood Press Res. 2012;35(2):82-8. Epub: 2011 Sep 10. doi: 10.1159/000330719. PMID: 21912183.

ESH-IP:2010 - Pass Stage 3-5 chronic kidney disease (Note: Modified protocol)

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