1. Manuals
  2. Brands
  3. Cardioline Manuals
  4. Medical Equipment
  5. Cubestress System
  6. User manual

Cardioline Cubestress System User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

All rights reserved © Cardioline SpA.
CARDIOLINE® is a registered trademark of Cardioline SpA.
This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation
by:
Cardioline Spa
Via Linz, 151
38121 Trento
Italy
1936
Cubestress System
User manual
Rev. 00 – 28.10.2019

Advertisement

Table of Contents
loading

Related Manuals for Cardioline Cubestress System

Summary of Contents for Cardioline Cubestress System

  • Page 1 Cubestress System User manual All rights reserved © Cardioline SpA. CARDIOLINE® is a registered trademark of Cardioline SpA. This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation Cardioline Spa...

  • Page 2: Table Of Contents

    Cubestress System Contents GENERAL INFORMATION ..........................2 1.1. Licensing terms ............................2 1.2. Other important information ......................... 2 SAFETY INFORMATION ............................ 3 SYMBOLS AND LABEL ............................6 3.1. Explanation of the symbols ........................6 3.2. Device label ............................. 6 INTRODUCTION ............................... 7 4.1.

  • Page 3: General Information

    The software and accompanying documents are protected by copyright. The user must comply with copyright law provisions. All rights relative to the software are the property of Cardioline S.p.A.. The transfer of software onto another computer by internet or data channel is not permitted.

  • Page 4: Safety Information

    Cubestress System GENERAL INFORMATION SAFETY INFORMATION Cardioline SpA shall be liable for the safety, reliability and functionality of the devices only if:  Assembly, modification or repair operations are carried out by Cardioline SpA or by one of its Authorised Assistance Centres;...
  • Page 5 Cubestress System GENERAL INFORMATION  When used in the patient area, it must be powered with an isolation transformer that complies with standard EN 6061-1 ed. 3.1 and a system of shielded cables must be used to connect the device to the LAN. The power cable shielding (when present) must be connected to a protective earth system appropriate for the area where the device is used.
  • Page 6 Cubestress System GENERAL INFORMATION  The devices that form part of the system can only be used with the compatible accessories and devices indicated in the respective operating manuals.  The Cubestress software must be installed on the computer supplied. The minimum requirements for the computer are indicated in the operating manual of the Cubestress software.

  • Page 7: Symbols And Label

    Cubestress System SYMBOLS AND LABEL SYMBOLS AND LABEL 3.1. Explanation of the symbols Symbol Description CE marking – compliance with European Union directives Manufacturer Product code Serial number Year of manufacture Refer to the user instructions Comply with the instructions in the user manual Separate collection of waste electrical and electronic equipment 3.2.

  • Page 8: Introduction

    4.3. Intended use Cubestress System is intended for the performance of cardiovascular stress tests. It aims to analyse ECG signals, acquired and transmitted wirelessly with the HD + / CLICKECG-HD units, and other biometric data (non-invasive blood pressure, SpO2), acquired with the unit mounted on an ergometer, during the performance of cardiovascular stress tests for the assessment and diagnosis of cardiac functions.

  • Page 9: Description Of The Device

    Patients under the influence of substances that may impair vigilance (alcohol, drugs, medication). 4.4. Description of the device Cubestress System is a family of systems for the performance of cardiovascular stress tests. The system consists of the following devices, both medical and non medical: ...
  • Page 10 Cubestress System INTRODUCTION  Computer on which the software is installed (with display, keyboard and mouse);  Optional ergometer, controlled by the software, for the performance of the physical test (xr50 + / xr100 + / xr100BP + / XR600R / XR600M / XR600P / XR450R / XR450M / XR450P);...

  • Page 11: Technical Specifications

    Cubestress System TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS 5.1. Applied harmonised standards STANDARD DESCRIPTION EN ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements EN 1041:2008 Information supplied by the manufacturer of medical devices...
  • Page 12 Cubestress System TECHNICAL SPECIFICATIONS STANDARD DESCRIPTION EN ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process 60950-1:2006/ A1:2010 / Information technology equipment - Safety - Part 1: General A2:2013 / A11:2009 / A12:2011...

  • Page 13: Warranty

    WARRANTY Cardioline S.p.A. guarantees this device for a period of 24 months from the date of sale. The date of sale shall be proven by a document, issued upon delivery, which must be submitted in the case of any claim under the warranty.

  • Page 14: Disposal

    Cubestress System DISPOSAL DISPOSAL Pursuant to (It.) Legislative Decree of 14 March 2014, no. 49, “Implementation of Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)”, the crossed-out "wheeled bin" symbol on the medical device indicates that, at the end of its service life, the product must be collected separately from other waste.
  • Page 15 Cubestress System...
  • Page 16 Head Office and Production Via Linz, 151 38121 Trento Italy T. +39 0463 850125 F. +39 0463 850088 Sales Office: Via F.lli Bronzetti, 8 20129 Milan, Italy T. +39 02 94750470 F. +39 02 94750471...

Table of Contents