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Omron M3500 NIBP Module

Device Model:M3500
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Omron M3500 NIBP Module is a clinically validated and certified 5-star automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for bedside patient monitoring.

The accuracy of the technology used in the Omron M3500 NIBP Module, to measure blood pressure, is certified by Medaval Ltd. It has passed in clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence; multiple clinical validations
ESH (Europe)Professional use for childrenPublished evidence
Stride BPOffice and hospital use for adults and children (Preferred)Published evidence

Device Family:Colin BP-608EVJ, Colin BP-A308J, Colin BP-A308DJ, Colin HBP-2070J, Colin HBP-2071J, Omron M3500 NIBP ModuleJ (J JHS Implied Equivalence)
Validation Publications

Chahine MN, Assemaani N, Sayed Hassan G, Cham M, Salameh P, Asmar R. Validation of the OMRON M3500 Blood Pressure Measuring Device Using Normal- and High-Speed Modes in Adult and Specific Populations (Obese and Children) According to AAMI Protocol. J Clin Hypertens (Greenwich). 2015 Aug;17(8):622-9. Epub: 2015 Apr 2. doi: 10.1111/jch.12540.. PMID: 25833259. Available from: onlinelibrary.wiley.com.

81060-2:2009 - Pass In Normal-speed mode (Note: 81060-2:2013 criteria fulfilled)

81060-2:2009 - Pass In High-speed mode (Note: 81060-2:2013 criteria fulfilled)

Medaval Certification Assessment

Cert ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Omron M3500 NIBP module, for hospital monitors, as validated according to the AAMI/ANSI/ISO 81060-2:2013 standard for a general study in adults and children. Medical Device Assessment. 2016 Aug 5;2016(1622) 7 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1622.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 M3500 NIBP Module, is certified by Medaval Ltd.