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Omron BP760N (HEM-7320-Z)

Device Name:BP760N
Device Model:HEM-7320-Z
Manufacturer:Sole: 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
Assessment:

The accuracy of the technology used in the Omron BP760N (HEM-7320-Z), to measure blood pressure, is certified by Medaval Ltd.

Accuracy AssessmentRecommendationBasis
Medaval★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adults and pregnancy (Preferred)Published evidence plus equivalence claim
 
Consumer BodyVersionQuartileComment
Amazon Best Sellers (US)2019A (4.2 / 5) 

Validation Publications

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

Medaval Certification Assessment

Cert ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron BP-760N (HEM-7320-Z) upper arm monitor, as validated according to the AAMI/ANSI/ISO 81060-2:2013 standard for a general study in adults. Medical Device Assessment. 2016 Aug 5;2016(1624) 4 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1624.pdf.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Omron BP760N (HEM-7320-Z), 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 M3 Comfort (HEM-7134-E)

Topouchian J, Hakobyan Z, Asmar J, Gurgenian S, Zelveian P, Asmar R. Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol. Vasc Health Risk Manag. 2018 Aug 31;14:189-97. doi: 10.2147/VHRM.S165524. PMID: 30214220. Available from: PMC6124447. eCollection 2018.

81060-2:2013 - Pass Normotensive Pregnancy, Hypertensive Pregnancy and Pre-eclampsia (n=45) (Note: Only one set of ISO results provided.)

BHS:1993 - Pass (A/A) Normotensive Pregnancy, Hypertensive Pregnancy and Pre-eclampsia (n=45)

Validation under the "Universal Protocol" is claimed, though only a consensus document was written, at that time, as referenced. Analysis appears to be according to Criterion 1 of ISO 81060-2:2013 and to BHS 1993.

Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.

ESH-IP:2010 - Pass General population

Omron M6 Comfort IT (HEM-7322U-E)

Chahine MN, Topouchian J, Zelveian P, Hakobyan Z, Melkonyan A, Azaki A, Diab R, Harb A, Asmar R. Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP). Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. PMID: 29343992. Available from: PMC5749560. eCollection 2018.

ESH-IP:2010 - Pass Type 2 Diabetes Mellitus