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Omron HEM-7101 (HEM-7101-SH)
Device Name:
HEM-7101
Device Model:
EM-7101-SH
Manufacturer:
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:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Omron HEM-7101 (HEM-7101-SH) 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 HEM-7101 (HEM-7101-SH), 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 ESH (Europe) Self-measurement Published evidence
Device Family:
Omron HEM-737B, Omron M2 Compact (HEM-7102-E)B,D, Omron MX2 Basic (HEM-742-E2)B,D, Omron HEM-7101 (HEM-7101-SH)D, Omron Pro Logic PL100 (HEM-7101-PR)B
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 HEM-737

Anwar YA, Giacco S, McCabe EJ, Tendler BE, White WB. Evaluation of the efficacy of the Omron HEM-737 IntelliSense device for use on adults according to the recommendations of the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 1998 Aug;3(4):261-265. PMID: 10212364.

SP10:1992 - Pass General population

Omron M2 Compact (HEM-7102-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

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