Omron M3500 NIBP Module

Description:

The Omron M3500 NIBP Module is a patient 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 upper arm. It is intended for bedside patient monitoring.

Assessment:

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 two clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★★★★ Certified Accuracy	Recent clinical validation; recent protocol with certified adherence; multiple clinical validations
BP	ESH (Europe)	Professional use for children	Published evidence
BP	Stride BP	Office and hospital use for adults and children (Preferred)	Published evidence

Device Family:

Colin HBP-2070J, Colin BP-608EVJ, Colin BP-A308J, Colin BP-A308DJ, Colin HBP-2071J, Omron M3500 NIBP ModuleJ
Legend: 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

Certification Image Medaval 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) 8 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 M3500 NIBP Module, is certified by Medaval Ltd.