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Omron R6 (HEM-6000-E7)
Device Name:
R6
Device Model:
HEM-6000-E7
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Omron R6 (HEM-6000-E7) 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 wrist. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Omron R6 (HEM-6000-E7), to measure blood pressure, has been compared to a clinically validated device, but not 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.
BP BIHS (UK and IRL) Previous recommendation, now archived (Archived) Manufacturer declaration of equivalence to the Omron 637IT (HEM-637IT-E)
Device Family:
Boots 65-90-412B, Omron R2 (HEM-6113-E)B, Omron R2 (HEM-6113-FR)B, Omron R7 (HEM-637-E7)D, Omron 637IT (HEM-637IT-E)B,D, Omron R6 (HEM-6000-E7)B,D, Omron R6 (HEM-6052-2)B,D, Omron R7 (HEM-637-E2)B
Legend: B BIHS Derivative, D DET Equivalence
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 637IT (HEM-637IT-E)

Altunkan S, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly. Blood Press Monit. 2006 Apr;11(2):97-102. PMID: 16534412.

ESH-IP:2002 - Pass Elderly (Age>65)

Altunkan S, Oztaş K, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults. Blood Press Monit. 2006 Apr;11(2):79-85. PMID: 16534409.

ESH-IP:2002 - Pass General population

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 Jun;11(3):165-71. PMID: 16702826.

ESH-IP:2002 - Pass General population

Omron R2 (HEM-6113-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2002 - Pass General population

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