🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
Omron RS3 (HEM-6130-E)
Device Name:
RS3
Device Model:
HEM-6130-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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Availability according to Countries or Regions:
Germany and Ireland
Device Manual:
Description:
The Omron RS3 (HEM-6130-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-star Medaval rating. 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 accuracy of the technology used in the Omron RS3 (HEM-6130-E), to measure blood pressure, is certified by Medaval Ltd. It has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval
BP BIHS (UK and IRL) Previous recommendation, now archived Published evidence
BP DHL (DE) General use (2013) Published evidence
BP Stride BP Self-measurement for adults Published evidence
Device Family:
Omron RS1 (HEM-6120-D)D, Omron RS2 (HEM-6121-E)B, Omron RS3 (HEM-6130-E)B,D,J,Y, Omron HEM-6130J, Omron HEM-6131 (HEM-6131-AP)Y, Omron HEM-6121 (HEM-6121-AP)Y
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, Y Internal declaration
Validation Publications:

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. Epub: 2013 May 28. doi: 10.2147/VHRM.S44569. PMID: 23745050.

ESH-IP:2010 - Pass General population

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:2007 - Pass General population (Note: 2013)

Medaval Certification Assessment

Certification ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron RS3 (HEM-6130-E) wrist monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1610) 6 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Omron RS3 (HEM-6130-E), is certified by Medaval Ltd.