Omron HEM-7130 (JP)
Device Model:
HEM-7130
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
Device Manual:
Description:
The Omron HEM-7130 (JP) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 4-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The accuracy of the technology used in the Omron HEM-7130 (JP), to measure blood pressure, is certified by Medaval Ltd. It has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★★ Certified Accuracy Recent clinical validation; older protocol with certified adherence
BP BIHS (UK and IRL) Used as seed device for derivative(s)
BP ESH (Europe) Self-measurement Published evidence
BP Japanese Society of Hypertension Self-measurement (Latest: 2017-2022) Published evidence
BP Stride BP Self-measurement for adults (Preferred) Published evidence
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Previous: 2019-2020 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:

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

Medaval Certification Assessment

Certification ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron HEM-7130 upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1618) 5 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Omron HEM-7130, is certified by Medaval Ltd.

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-7121

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

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