ECGWebApp User manual

1936 Rev. 10 – 30/04/2020

ECGWebApp

ECGWebApp

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 by:

Cardioline Spa Via Linz, 151 38121 Trento (TN) Italy

ECGWebApp

Contents

1. GENERAL INFORMATION ... 1

1.1. Other important information ... 1

1.2. System Requirements for Work Stations ... 1

1.3. Licensing terms ... 2

2. SAFETY INFORMATION ... 3

3. SYMBOLS AND LABEL ... 4

3.1. Explanation of the symbols ... 4

3.2. Device label ... 4

4. INTRODUCTION ... 5

4.1. Purpose of the manual ... 5

4.2. Recipients ... 5

4.3. Intended use... 5

4.4. Description of the device ... 6

ECGWebApp

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1.

GENERAL INFORMATION

This manual is an integral part of the device and should always be available as support material to the clinical practitioner or the operator. Strict compliance with the information contained in this manual is an essential prerequisite for a proper and reliable use of the device.

Have the operator read the manual thoroughly as the information related to the different chapters is only described once.

1.1.

Other important information

This manual was written with the utmost care. Should you find any details which do not correspond to those contained in this manual, please inform Cardioline SpA, who will proceed to correct such inconsistencies as soon as possible.

The information contained in this manual is subject to change without notice.

All changes will be in compliance with the regulations governing the manufacturing of medical equipment. All trademarks mentioned in this document are property of their respective owners. Their protection is guaranteed.

No part of this manual may be reprinted, translated or reproduced without the manufacturer's written authorisation.

The codes relating to this manual are listed below.

Language Code

ENGLISH 36510196_EN

1.2.

System Requirements for Work Stations

Firefox ver. 75 Edge ver. 81

Monitor ... 10" or larger (at least 18.5" is recommended) Resolution 1366x768 or higher

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1.3.

Licensing terms

By installing the software, the terms and conditions described as follows are accepted.

Object of this agreement is the consent of a use licence for the software and the operating manual. Cardioline SpA guarantees a personal licence, non-exclusive and non-transferable, for use of the software and the attached documents. The software and accompanying documents are protected by copyright. The user must comply with copyright law dispositions.

All rights relative to the software are the property of Cardioline SpA. The transfer of software onto another computer by internet or data channel is not permitted.

The programs and the attached documents cannot be changed, copied, merged with other programs or made available to third parties.

The user is deemed responsible for any damage stemming from non-compliance with the copyright, or from violation of the conditions reported in this agreement.

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2.

SAFETY INFORMATION

Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if: 1. Assembly, modification or repair operations are carried out by Cardioline SpA or by one of its

Authorised Assistance Centres;

2. The device must be used in compliance with the instructions contained in the user manual.

Always contact Cardioline SpA should you wish to connect any devices not mentioned in this manual.

Warnings

 This manual provides important information on proper use and safety of the device. Failure to comply with the described operating procedure, improper use of the device, ignoring the specifications and recommendations supplied, may cause severe physical injuries to the operators, patients and bystanders, or may damage the device.

 Have the operator carefully read and understand the contents of the operator manual and the other annexed documents before using the device.

 The accuracy of the measurements taken by this device complies with the specific requirement of standard IEC 60601-2-25.

Attention

 The device exclusively works with compatible Cardioline devices.

 Thoroughly read the instruction manuals of any devices that will be used alongside the ECGWebApp.

 The device does not require any calibration or special instrumentation for correct use and maintenance.

 When it is required to dispose of the CD support and/or packaging material, adhere to local waste disposal regulations.

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3.

SYMBOLS AND LABEL

3.1.

Explanation of the symbols

Comply with the instructions in the user manual

1936

Refer to the user instructions

Manufacturer

3.2.

Device label

ECGWebApp

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4.

INTRODUCTION

4.1.

Purpose of the manual

The manual is a user guide for the ECGWebApp device.

The following steps are described in the “Operating Guide” document provided with this manual:

 Use of the Cardioline ECGWebApp user interface.

 Use of the software to manage the ECGWebApp patient database.

 Use of the software to review resting ECG, ECG Stress, ECG Holter and Holter ABPM tests.

 Use of the software to manage users and their access to the ECGWebApp.

 Use of the software to manage the units.

 Using the software to display the referring devices.

 Troubleshooting.

4.2.

Recipients

This manual is intended for professional operators. Basic knowledge regarding the use of the software is assumed.

The minimum level of knowledge required for individual users varies according to the permissions attributed to them, as well as the operations that they can perform via the ECGWebApp. Namely, users who are allowed to review the tests are required to have clinical skills and detailed knowledge of the procedures and ECG tests.

4.3.

Intended use

The ECGWebApp is software intended for the reception of tests performed using Cardioline devices, to store them and review them online. Namely, the device allows you to review resting ECG tests by means of an ECG display where you can analyse the complete trace and perform measurements on it using callipers:

 The device receives resting ECG tests in SCP format via the internet and saves them on its own database.

 The device receives ECG Stress, ECG Holter and ABPM Holter tests in PDF format (PDF reports created by means of Cardioline Cube or Cubeholter software) via the internet and saves them on its own database.

 The device allows you to review resting ECG tests by means of an ECG display where you can analyse the complete trace and perform measurements using callipers. Any automatic interpretation

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provided for the ECG resting tests is not generated by the ECGWebApp, but by the device with which the trace was acquired.

 The device lets you review ECG Stress, ECG Holter and ABPM Holter tests via PDF report.

 The device must be used by professional and adequately trained personnel. It is not intended as the only means for determining the diagnosis.

The clinical function of ECGWebApp is limited to the ECG display and PDF viewer.

4.4.

Description of the device

The ECGWebApp is software that receives tests performed with Cardioline devices via the internet, saves them and allows them to be reviewed via the web. Namely, ECGWebApp is able to manage resting ECG, ECG holter, ABPM holter and ECG stress tests:

 Resting ECG tests: Resting tests are entirely managed online. Indeed, ECGWebApp receives the test, saves it on its own database in SCP format and lets you review it using an online ECG viewer, with which the trace can be fully analysed. The reviewed test is then saved on the database in SCP format. This way users can access tests and review them simply by opening the browser on their computer, without having to install additional applications locally.

 ECG Holter tests (with Holter function): With the ECGWebApp (with Holter option) you can fully manage the ECG Holter tests. Thanks to integration with Cardioline Cubeholter Web and WebUploader software, you can:

- receive work lists to be used when preparing the recorders (via WebUploader),

- receive the test in raw data format in the ECGWebApp, from a recording station (via WebUploader),

- download a test from ECGWebApp to review it with the Cubeholter Web software (locally installed on the reviewing station),

- save the reviewed test in raw data format, with its analysis and final report in PDF, in ECGWebApp so that it is always available online for consultation.

 ECG Holter tests (without Holter function): if ECGWebApp does not have the Holter option, it will only manage PDF reports generated by the Cubeholter WS software. Reviewing is possible by adding a page with the conclusions to the final PDF report.

 ABPM Holter tests (with ABPM function): With the ECGWebApp (with ABPM option) you can fully manage the ABPM Holter tests. Thanks to integration with Cardioline Cubeabpm and WebUploader software, you can:

- receive work lists to be used when preparing the recorders (via WebUploader),

- receive the test in raw data format in the ECGWebApp, from a recording station (via WebUploader),

- download a test from ECGWebApp to review it with the Cubeabpm software (locally installed on the reviewing station),

- save the reviewed test in raw data format, with its analysis and final report in PDF, in ECGWebApp so that it is always available online for consultation.

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 ABPM Holter (without ABPM function) and ECG stress tests: ABPM holter and ECG stress tests are managed as PDFs, generated by the Cardioline Cube Suite software. Reviewing is possible by adding a page with the conclusions to the final PDF report.

The ECGWebApp database consists of:

 Tests archive - resting ECG (in SCP format), ECG Holter (complete recording in raw data and/or in PDF format), ECG Stress tests (in PDF format) and ABPM Holter (complete recording in raw data and/or in PDF format).

 Patient archive – to which the tests are associated.

 User archive – who can access the ECGWebApp and perform various operations based on the permissions associated to them (for example, reviewing tests, managing patient demographics, etc.).

 Unit archive – clinics, hospitals and healthcare facilities that have sent tests, corresponding to the Department ID associated with the test.

 Device archive – list of devices that have sent tests to ECGWebApp.

It is possible to connect the ECGWebApp by using a standard internet browser (Internet Explorer, Chrome, Opera, etc.), in order to access the tests saved, as well as to patient, user and unit data.

The available options and functions (e.g. maximum number of sending devices, integration with other IT systems, etc.) depend on what configuration was specifically purchased and are saved in the provided hardware protection key, without which the software cannot be used.

NOTE: For the application to function, the USB hardware key must be inserted on the computer/server where the application is installed.

4.4.1.

Compatible devices

The tests can be acquired with the following Cardioline devices:

 Electrocardiographs:

o ECG100+/S and ECG200+/S range o TouchECG

 ECG Holter / ABPM holter devices (test transmission in raw data format) – only if ECGWebApp has the Holter / ABPM function:

o WebUploader

 ECG Holter devices (transmission of the final PDF report): o Cubeholter WS

o WebUploader – test to be processed before the transmission with Cubeholter WS to generate the PDF report

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 ABPM holter devices (transmission of the final PDF report): o Cubeabpm (part of Cube Suite)

o WebUploader – test to be processed before transmission with Cubeabpm to generate the PDF report

 ECG stress devices (transmission of the final PDF report) o Cubestress (part of Cube Suite)

If ECGWebApp has the Holter function, the ECG holter tests in raw data format can be downloaded to the local computer and reviewed by using the Cubeholter Web software (v. 3.0 and later versions).

If ECGWebApp has the ABPM function, the ABPM holter raw data exams can be downloaded to the local computer and reviewed using the Cubeabpm software

ECGWebApp

ECGWebApp

ECGWebApp

Sales office Via F.lli Bronzetti, 8 20129 Milan, Italy T. +39 02 94750470 F. +39 02 94750471 Production office Via Linz, 151 38121 Trento (TN), Italy T. +39 0463 850125 F. +39 0463 850088