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Omron HEM-7121
Device Model:
HEM-7121
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
Availability according to Countries or Regions:
Australia and Japan
Description:
The Omron HEM-7121 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-7121, to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also 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 AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Japanese Society of Hypertension Self-measurement (Previous: 2016-2021) Implied equivalence to the Omron HEM-7130, HEM-7320F or HEM-7500F
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Latest: 2019-2022 A
Device Family:
Omron BP765 (HEM-7311-ZSA)B,P,Y, Omron HEM-7120J, Omron HEM-7121J, Omron HEM-7122J, Omron HEM-7130 (JP)B,J,P,Y, Omron HEM-7270CJ, Omron HEM-7280CJ, Omron HEM-7324CJ, Omron HEM-7510CJ, Omron HEM-8712 (JP)J, Omron HEM-7132 (V1)J, Omron M2 (HEM-7121-E)B,P, Omron M3 (HEM-7131-E)D,P, Omron M3 IT (HEM-7131U-E)D,P, Omron M6 AC (HEM-7322-E)D,P,Y, Omron M2 Basic (HEM-7120-E)B,P, Omron HEM-9200TJ,Y, Omron M3 Comfort (HEM-7134)J, Omron JPN500Y, Omron JPN600Y, Omron HEM-7280TY, Omron HEM-8713J, Omron HEM-8731J, Omron HEM-7271TJ, Omron HEM-7281TJ, Omron HEM-7313J, Omron HEM-7325TJ, Omron HEM-7511TJ, Omron HEM-9700TJ, Omron HEM-7130-HPJ, Omron HEM-7133J, Omron HEM-7310J, Omron M2 Eco (HEM-7120-AF)P, Omron M6 AC ME (HEM-7322-ME)P, Omron M3 (HEM-7154-E)P, Omron HCR-7101J, Omron HCR-7201J, Omron HCR-7409J, Omron HCR-7501TJ, Omron HCR-750ATJ, Omron HCR-7601TJ, Omron HCR-7006Z, Omron HCR-7102Z, Omron HCR-7104Z, Omron HCR-7106Z, Omron HCR-710YZ, Omron HCR-7202Z, Omron HCR-720KZ, Omron HCR-7402Z, Omron HCR-7502TZ, Omron HCR-7602TZ, Omron M2 Basic (HEM-7121J-E)B,P, Omron Complete (HEM-7530T-E3)B,P, Omron M1 Basic (HEM-7121J-AF)P, Omron M1 Basic (HEM-7121J-LAF)P, Omron X2 Basic (HEM-7121J-EO)P, Omron M2 Classic (HEM-7143-E)B, Omron M2 Intellisense (HEM-7143-E)B, Omron M2 Intelli IT (HEM-7143T-EBK)B, Omron HEM-7124 (HEM-7124-IN)Y, Omron HEM-7120 (HEM-7120-AP)Y, Omron HEM-7120 (HEM-7120-IN)Y, Omron HEM-7121 (HEM-7121-AP)Y, Omron HEM-7121 (HEM-7121-AU)Y, Omron HEM-7121 (HEM-7121-IN)Y, Omron HEM-7130 (HEM-7130-AP)Y, Omron HEM-7130 (HEM-7130-AU)Y, Omron HEM-7130 (HEM-7130-TH)Y, Omron HEM-7322 (HEM-7322-AP)Y, Omron HEM-7322 (HEM-7322-AU)Y, Omron HEM-8712 (HEM-8712-AP)Y, Omron HEM-8712 (HEM-8712-IN)Y, Omron HEM-7130-L (HEM-7130-LAP)Y, Omron HEM-7130-L (HEM-7130-LIN)Y, Omron HEM-7270 (HEM-7270-AP)Y, Omron HEM-7270 (HEM-7270-IN)Y, Omron HCR-7800T (HEM-7530T-J3)J
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
Validation Publications:

Posokhov IN, Praskurnichiy EA, Orlova OS, Sukhodolova EA, Lystseva AV. Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less. Blood Press Monit. Epub: 2024 Jul 2. doi: 10.1097/MBP.0000000000000715. PMID: 38958495.

81060-2:2019 - Fail Small Cuff Size

Relevant Publications:

Islam SMS, Cartledge S, Karmakar C, Rawstorn JC, Fraser SF, Chow C, Maddison R. Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Sep 14;7(10):e14706. doi: 10.2196/14706. PMID: 31628788 . Available from: mhealth.jmir.org.

The publication describes the Omron HEM-7121 being used as a validation control device.

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

Omron HEM-7120

Zhang P, Li X, Fang Z, Lu Y, Cui J, Du X, Hu R. Smartphone application-supported validation of three automatic devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B. Blood Press Monit. 2021 Dec 1;26(6):435-440. Epub: 2021 May 13. doi: 10.1097/MBP.0000000000000547. PMID: 34001755.

ESH-IP:2010 - Pass General population

Omron HEM-7130 (JP)

Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.

ESH-IP:2010 - Pass General population

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

Omron HEM-9700T

Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T. Blood Press Monit. 2019 Jun;24(3):146-150. Epub: 2019 Feb 14. doi: 10.1097/MBP.0000000000000368. PMID: 31026232. Available from: journals.lww.com.

81060-2:2013 - Pass Sitting position

81060-2:2013 - Pass Supine position

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