Cardiovascular Suite 4.5.1

User Manual and Instructions For Use

Document number: TEC0002EN Rev. 21

July 29th, 2022

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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 rules of application of chapter 1.4 of Annex IX of the European Directive 93/42/EEC and subsequent amended and the provisions of Chapter III of Annex IX of the European Directive 93/42/EEC and subsequent amendments, Cardiovascular Suite software is within the medical devices of Class IIa according to rule 10.
The product is in compliance with the legal requirements of the European Directive 93/42/EEC and subsequent amendments and supplements (European Directive 2007/47/EC) for medical devices.

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.

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