Cardioline touchECG System User Manual
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Cardioline touchECG System User Manual

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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
touchECG System
User manual
Rev. 00 – 18.05.2020

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Summary of Contents for Cardioline touchECG System

  • Page 1 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

    System Contents GENERAL INFORMATION .........................3 1.1. Licensing terms ..........................3 1.2. Other important information ......................3 SAFETY INFORMATION ..........................4 2.1. Warnings on Bluetooth ........................6 2.1.1. Potential sources of interference of Bluetooth ................6 2.1.2. Obstacles for the wireless signal ....................7 2.1.3. Reducing the effects of the interference of other wireless devices .........8 SYMBOLS AND LABEL ..........................9...

  • Page 3: General Information

    System 4.1. Purpose of the manual ........................9 4.2. Recipients............................9 4.3. Intended use ............................9 4.4. Description of the device .........................10 TECHNICAL SPECIFICATIONS ........................11 5.1. Applied harmonised standards ......................11 WARRANTY ..............................13 DISPOSAL ..............................14...

  • Page 4: 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 5: Safety Information

    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 6: Warnings On Bluetooth

    System GENERAL INFORMATION potentials which might exist between the various points of an electricity distribution system or failures of the external equipment connected to the mains.  The quality of the signal may be adversely affected by the use of other medical equipment such as ultrasound machines.

  • Page 7: Warnings On Bluetooth

    System GENERAL INFORMATION Attention  The Glasgow algorithm is intended for automatic interpretation of ECGs at rest. The automatic interpretation provided by touchECG can only be considered if HD+ is used to acquire ECGs at rest. If HD+ is used to acquire signals while the patient is moving (for example during a stress test) the automatic interpretation may not be valid.

  • Page 8: Obstacles For The Wireless Signal

    System GENERAL INFORMATION  Intermittent HD+ disconnections  Loss of the ECG signal. Possible causes of interference of the Bluetooth signal may be:  Microwave ovens: using microwave ovens close to the computer/tablet may cause interference.  Satellite TV: the coaxial cable and connectors used with some satellite dishes may cause interference.

  • Page 9: Reducing The Effects Of The Interference Of Other Wireless Devices

    System GENERAL INFORMATION Wood Synthetic material Glass Water Medium Bricks Medium Marble Medium Plaster High Concrete High Bulletproof glass High Metal Very high 2.1.3. Reducing the effects of the interference of other wireless devices If a lot of wireless devices are connected to the computer/tablet or nearby, it may be required to encode the channels used by the Wi-Fi___33 devices.

  • Page 10: Symbols And Label

    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 11: Introduction

    HD+/CLICKECG-HD can use a standard patient cable or the ECG suction cable Handy VAQ. touchECG System is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by healthcare professionals at the patient house and in emergencies (ambulances).

  • Page 12: Description Of The Device

    ECG acquisition unit (HD+/CLICKECG-HD) with optional ECG suction cable (Handy VAQ);  Computer where the software is installed (with display, keyboard and mouse);  Optional Cardioline HD+ Bluetooth Dongle, for use as a Bluetooth receiver in place of the standard Bluetooth module of the computer;  Optional printer;...

  • Page 13: Technical Specifications

    System TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS 5.1. Applied harmonised standards STANDARD DESCRIPTION EN ISO 15223-1 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements EN 1041 Information supplied by the manufacturer of medical devices...
  • Page 14 System TECHNICAL SPECIFICATIONS STANDARD DESCRIPTION equipment and services; Part 1 ETSI 301 489-17 Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17 EN 62479 Assessment of the compliance of low-power electronic and electrical equipment with the basic restrictions related to...

  • Page 15: 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 16: Disposal

    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 17 System...
  • Page 18 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...

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