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Omron HEM-7600T (HEM-7600T-AP3)
Device Name:
HEM-7600T
Device Model:
HEM-7600T-AP3
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
Description:
The Omron HEM-7600T (HEM-7600T-AP3) 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:
While the technology used in the Omron HEM-7600T (HEM-7600T-AP3), to measure blood pressure, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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.
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 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 Evolv (HEM-7600T-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 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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