Colin BP-A308 - Medaval

Description:

The Colin BP-A308 is a patient monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.

Assessment:

The technology used in the Colin BP-A308, 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 (2016-2018)	Implied equivalence to the Omron M3500 NIBP Module or HBP-1300 (HBP-1300-E)

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)