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Colin HBP-2070

Device Model:HBP-2070
Manufacturer:Colin Medical Instruments Corp., 5850 Farinon Dr, San Antonio, TX 78249, UNITED STATES.
Measuring functions:Blood pressure, SpO2, Temperature, ECG, Respiration
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single, intermittent and continuous measurements
Availability:Available Currently
Description: The Colin HBP-2070 is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for bedside patient monitoring.
Assessment:

The technology used in the Colin HBP-2070, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionProfessional use (2016-2018)Implied equivalence to the Omron M3500 NIBP Module

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 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)