Omron Evolv (HEM-7600T-E)
Device Name:
Evolv
Device Model:
HEM-7600T-E
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:
Ireland
Device Manual:
Click here to download the Device Manual
Description:
The Omron Evolv (HEM-7600T-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. 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 Evolv (HEM-7600T-E), to measure blood pressure, has passed in two clinical validation studies, between general and pregnancy populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; older protocol; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and pregnancy (Preferred) Published evidence
BP MDR Criteria Pregnancy Published evidence
Device Family:
Omron Evolv (HEM-7600T-E)J,Y, Omron HEM-7600TJ, Omron HEM-7600T (HEM-7600T-AP3)Y
Legend: J JHS Implied Equivalence, Y Internal declaration
Validation Publications:

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

Relevant Publications:

Takahashi H. 欧州高血圧学会国際プロトコル(ESH-IP)改訂2010年版による家庭血圧監視装置Omron EVOLV(HEM-7600T-E),HEM-9210T,およびM3Comfort(HEM-7143-E)の妥当性確認. [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.] 日本臨床生理学会雑誌 [J Clin Physiol (Jpn)]. 2018 Feb 1;48(1):29-38. Retraction in: J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46.

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-7600T

Takahashi H, Saito K, Hishiki Y. Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 protocol in the general population without arrhythmias. Blood Press Monit. Epub: 2021 Feb 8. doi: 10.1097/MBP.0000000000000520. PMID: 33577185.

81060-2:2013 - Pass General population

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