Introduction

Cardiovascular Suite 3.3 User Manual

Document number: TEC0002EN Rev.5

July 26th, 2017

Cardiovascular Suite is a software for the estimation of early markers of cardiovascular risk. In particular, the software is composed of two main modules of measurement: 1) the FMD-Studio for the measurement of Flow-Mediated Dilatation (FMD) of the brachial artery 2) the Carotid-Studio for measuring the Intima-Media Thickness (IMT) and the diameter of the carotid artery that, when combined with an estimate of pressure, provides parameters of arterial elasticity. The device is based on an algorithm that identifies the edges of the arterial vessel by analysing sequences of ultrasound images of the longitudinal section of the vessel itself. The system is able to process video files previously recorded or directly in real-time the video output of an ultrasound system.

According to the description and the intended use, which are showed in the subsequent chapters, and in accordance with the rules of application of chapter 1.4 of Annex IX of the Directive 93/42/EEC and subsequent amended and the provisions of Chapter III of Annex IX of 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 93/42/EEC and subsequent amendments and supplements (Directive 2007/47/EC) for medical devices.

The labelling is available on the login screen of the software.

For USA only:

Cardiovascular Suite is not FDA approved and can be utilized for investigational use only.