Clinical validation supports our product 
quality

It’s not enough to just say we’re accurate. We have to prove it. That’s why we make sure every model of our OMRON blood pressure monitors meets the highest standards of precision and reliability.

The US Blood Pressure Validated Device Listing (VDL™)

Accurate measurement of blood pressure is essential for the diagnosis and management of hypertension. That’s why the American Medical Association (AMA) convened subject matter experts to develop criteria to help identify blood pressure monitors that have been tested and validated for clinical accuracy. Then, the National Opinion Research Center (NORC) at the University of Chicago was asked to manage an independent committee comprised of physician experts to review clinical evidence and determine whether blood pressure monitors meet the criteria for clinical accuracy. After review, blood pressure monitors that meet the criteria are published on a formal list called the US Blood Pressure Validated Device Listing (VDL) and are available at validatebp.org.

OMRON Healthcare, Inc., is 1 of the first 3 manufacturers with blood pressure monitors that meet the criteria upon review. Below are the OMRON blood pressure monitors included on the VDL:

  • Convened subject matter experts to develop criteria to help identify BP monitors that have been tested and validated for clinical accuracy.
  • Engaged the National Opinion Research Center at the University of Chicago (NORC) to manage an independent committee comprised of physician experts to review clinical evidence and determine whether BP monitors meet the criteria for clinical accuracy.
  • Published criteria-meeting, reviewed on a formal list called the US Blood Pressure Validated Device Listing (VDL) and available at validatebp.org.

 

OMRON Healthcare, Inc., is one of the first three manufacturers with BP monitors that meet the criteria upon review. Below are the OMRON BP monitors included on the VDL:

 

There are several internationally recognized testing protocols from major standards organizations: The Association for the Advancement of Medical Instruments (AAMI), the European Society of Hypertension (ESH), and the British Hypertension Society (BHS). The table below lists the testing conducted for each model.

These validations offer peace of mind not just for our customers but for physicians as well, who can rest assured that their patients are monitoring their health with the same reliability as the medical devices used in their examination rooms.

Model Number

Reference Number

ESH-IP
European Society of Hypertension International Protocol

AAMI
Association for the Advancement of Medical Instrumentation

BSH
British Hypertension Society

ISO 81060:2

Validation
BP4350 HEM-6232T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 22
BP5100 HEM-7122-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP5150 HEM-7142T2-ZAZ ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP5250 HEM-7151T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 21, 25
BP5350 HEM-7341T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP5450 HEM-7343T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP6100 HEM-6180-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 22
BP629 HEM-6200-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 1
BP629N HEM-6130-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 3
BP6350 HEM-6231T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 22
BP652 HEM-6052-CA; HEM-6052-Z; HEM-6052-ZCD6 ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 2
BP652N HEM-6300-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 3
BP653 HEM-6320T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 3
BP654 HEM-6320T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 3
BP7000 HEM-7600T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 19, 25
BP710 HEM-7113-Z; HEM-7113-CAN; HEM-7114-SW ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 1, 5
BP7100 HEM-7121-Z2 ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7150 HEM-7142T2-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7100CAN HEM-7121-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP710CANN HEM-7121-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 25
BP710N HEM-7121-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 25
BP7200 HEM-7150-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7250 HEM-7150T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7255 HEM-716CT2-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7250CAN HEM-7150T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP7350 HEM-7340T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 21, 25
BP7350CAN HEM-7340T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 21, 25
BP742 HEM-7200-Z; HEM-7200-Z(V); HEM-7200-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 1
BP742CANN HEM-7131-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 25
BP742N HEM-7131-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 25
BP7450 HEM-7342T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 21, 25
BP7450CAN HEM-7342T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 21, 25
BP760 HEM-7220-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 7
BP760N HEM-7320-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP761 HEM-7320T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 25
BP761N / BP761NC HEM-7320T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 9, 25
BP761CAN HEM-7320T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 10, 11, 25
BP761CANN HEM-7320T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 10, 11, 25
BP765 HEM-7311-ZSA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 12, 13, 25
BP765CAN HEM-7311-CACS ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 6, 25
BP785 HEM-7222-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 7
BP785N HEM-7321-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP786 HEM-7321T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP786N HEM-7321T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP786CAN HEM-7321T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP786CANN HEM-7321T-CA ESH-IP European Society of Hypertension International Protocol - Checked✓ ISO 81060:2 - Checked✓ 8, 25
BP7900 HEM-7530T-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ ISO 81060:2 - Checked✓ 6, 21, 25
BP791IT HEM-7222-ITZ ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 7
BP792IT HEM-7080-Z(V); HEM-7081-ITZ; HEM-7080-ITZ2; HEM-7080-ITCAN ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ BSH British Hypertension Society - Checked✓ 14
BP8000-M HEM-6410T-ZM AAMI Association for the Advancement of Medical Instrumentation - Checked✓ 20
HBP-1300 HBP-1300-Z ESH-IP European Society of Hypertension International Protocol - Checked✓ 15
HEM-705CPN HEM-759P-Z; HEM-759P-CAN; HEM-759P-B(C) ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ BSH British Hypertension Society - Checked✓ 16
HEM-712CLCN2 HEM-7051-ZL ESH-IP European Society of Hypertension International Protocol - Checked✓ 17
HEM-907XL HEM-907-Z2 ESH-IP European Society of Hypertension International Protocol - Checked✓ AAMI Association for the Advancement of Medical Instrumentation - Checked✓ BSH British Hypertension Society - Checked✓ 18
HEM-9200T HEM-9200T ISO 81060:2 - Checked✓ 25
HEM-9210T HEM-9210T ESH-IP European Society of Hypertension International Protocol - Checked✓ 23, 24
BP9310T BP9310T ESH-IP European Society of Hypertension International Protocol - Checked✓ 23, 24
BP9300T BP9300T ISO 81060:2 - Checked✓ 25

REFERENCES:

  1. Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for selfmeasurement of blood pressure according to the international protocol of the European Society of Hypertension. Vascular Health and Risk Management 2011:7;709-717.
  2. Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the OMRON M6 (HEM-7001-E) and the OMRON R7 (HEM 637-IT). Blood Press Monit 2006;11:165-171.
  3. Takahashi H, Yoshika M, Yokoi T. Validation of OMRON RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2013;9:265-72.
  4. Takahashi H. Validation of the OMRON M6W upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.
  5. Takahashi H. Validation of the OMRON M3W upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.
  6. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 AC (HEM-7322-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.
  7. Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: OMRON M6 Comfort, OMRON HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44.
  8. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 Comfort (HEM-7321-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.
  9. Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vascular Health and Risk Management 2007;3(4):389-400.
  10. El Assad M, Topouchian J, Asmar R. Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the OMRON M5-I and the OMRON 705IT. Blood Press Monit 2003;8(3):127-133.
  11. Stergiou GS, Yiannes NG, Rarra VC. Validation of the OMRON 705 IT oscillometric device for home blood pressure measurement in children and adolescents: The Arsakion School Study. Blood Pressure Monitoring 2006;11:229-234.
  12. White WB, Anwar YA. Evaluation of the overall efficacy of the OMRON office digital blood pressure HEM-907 monitor in adults. Blood Press Monit 2001;6:107-110.
  13. Omboni S, Riva I, Giglio I, Caldara G, Groppelli A, Parati G. Validation of the OMRON M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of Hypertension. Blood Pressure Monitoring 2007;12:233-242.
  14. Coleman A, Steel S, Freeman P, de Greeff A, Shennan A. Validation of the OMRON M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2008;13:49-54.
  15. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON HBP-1300 upper arm blood pressure monitor, in oscillometry mode, for clinic use in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 May 22. 4 p.
  16. Coleman A, Freeman P, Steel S, Shennan A. Validation of the OMRON 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2006;11:27-32.OMRON
  17. 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;15(1):49-54.
  18. El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the OMRON HEM-907 device for blood pressure measurement. Blood Press Monit 2002;7:237-241.OMRON
  19. Takahashi H. Validation of the OMRON EVOLV (HEM-7600T-E) upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dabl Educational Trust; 2016 November 28.
  20. Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ ISO81060-2:2013 guidelines: OMRON HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens. 2019;00:1–6.
  21. 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.
  22. Saito K, Hishiki Y, Takahashi H.　Validation of two automatic devices, OMRON HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010.　Vasc Health Risk Manag. 2019 Mar 6;15:47-55.
  23. Bekker M, Franx A, Lely AT, Van Den Heuvel J.　Validation of the iHealth Track and OMRON HEM-9210T automated blood pressure devices for use in pregnancy.　Pregnancy Hypertension: An International Journal of Women’s Cardiovascular Health, 2019-01-01, Volume 15, Pages 37-41
  24. Alpert BS. Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2: 2013 with two novel cuffs: wide-range and extra-large. Blood Press Monit. 2017 Jun;22(3):166-168.
  25. Peprah, Y.A., Lee, J.Y. & Persell, S.D. Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol. J Hum Hypertens 37, 134–140 (2023).

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