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Cardiovascular Suite 4.6.0

User Manual and Instructions For Use

Document number: TEC0002EN Rev. 22

February 14^th, 2023

Cardiovascular Suite is a software for the estimation of early markers of cardiovascular risk by ultrasound imaging of the vessel longitudinal section. In particular, the software is composed of two main modules of measurement: 1) the FMD-Studio for the measurement of Flow-Mediated Dilation (FMD) of the brachial artery, by processing sequences of ultrasound images; 2) the Carotid-Studio for measuring the Intima-Media Thickness (IMT) and the diameter of the carotid artery by processing sequences of ultrasound images that, when combined with an estimate of pressure, provides parameters of arterial elasticity. On single images, the software provides also a tool for the measurement of geometric and statistic parameters on portions of the image that are recognized manually by the operator as plaques. The system is able to process images (or sequences of images) recorded on files, or can process in real-time the video output of an ultrasound system.

In accordance with the Annex VIII CLASSIFICATION RULES of the Medical Device Regulation (EU) n. 2017/745, Cardiovascular Suite software is within the medical devices of Class II-a according to rule 11. The Quality Management System of QUIPU S.R.L is in compliance with the applicable requirements of Regulation (EU) 2017/745, Annex IX Chapter I and III, for the following devices types: Z11049082 - Various ultrasound instruments - software accessories. Cardiovascular Suite is a Medical Device of class II a, Type: Z11049082 - Various ultrasound instruments - software accessories, according to Regulation (EU) 2017/745.

This software is not to be used in any country without appropriate regulatory clearance, license, or registration as may be required by in country regulatory agencies.

The product labeling for the Cardiovascular Suite is comprised of the Manual and Instructions for Use, the login screen of the software as well as in the product license key, and product package leaflets.

A printed version of the User Manual and Instruction for Use can be requested at support@quipu.eu.

Adobe Acrobat Reader ver. 6 or later is recommended to correctly display the PDF version of the User Manual and Instruction for Use.