Colin BP-A308D - Medaval

Description:

The Colin BP-A308D is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.

Assessment:

The technology used in the Colin BP-A308D, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Japanese Society of Hypertension	Professional use (Previous: 2016-2018)	Implied equivalence to the Omron M3500 NIBP Module

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 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 M3500 NIBP Module

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)