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ECGEasyApp

User manual

Rev. 05 – 28/03/2019
ECGEasyApp

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
ECGEasyApp

Contents

1. GENERAL INFORMATION .........................................................................................................................1


1.1. Other important information ...........................................................................................................1
1.2. Minimum requirements for the Computer ......................................................................................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 .................................................................................................................5
4.4.1. Compatible devices ..................................................................................................................5
5. PREPARATION FOR USE............................................................................................................................7
5.1. Installing the software .....................................................................................................................7
5.2. Entering the software activation code .............................................................................................9
6. USING THE APPLICATION .........................................................................................................................10
6.1. Start up ECGEasyApp .......................................................................................................................10
6.2. Main menu .......................................................................................................................................11
6.3. HOME window .................................................................................................................................11
6.3.1. Find a test ................................................................................................................................13
6.3.2. Editing a test's data ..................................................................................................................13
6.3.3. View a test ...............................................................................................................................14
6.3.4. Deleting a test ..........................................................................................................................15
6.4. IMPORT window ..............................................................................................................................15
6.4.1. Importing tests to the computer..............................................................................................15
6.5. SETTINGS window ............................................................................................................................17
6.6. Customising the PDF report .............................................................................................................19
6.7. Closing the program.........................................................................................................................22
6.8. Database and configuration backup ................................................................................................23
6.9. Database archive limit......................................................................................................................23
ECGEasyApp

7. TECHNICAL SPECIFICATIONS ....................................................................................................................25


ECGEasyApp
1. GENERAL INFORMATION

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 the proper and reliable use of the device.
Have the operator read the manual thoroughly, as a great deal of the information 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 36519167_EN

1.2. Minimum requirements for the Computer


Operating system ............................ Windows 10 32/64 bit
Windows 8.1 32/64 bit (Italian)
Windows 7 32/64bit (Italian)
Processor......................................... Intel (or compatible) at least 2GHz
RAM ................................................ 4 GB (minimum)
Monitor ........................................... 10" or larger (at least 18.5" is recommended)
Resolution 1366x768 or higher
Connectivity .................................... Connection to Internet to send statistics/errors to Cardioline
Software pre-installed on computer PDF file reader
Compatible devices ......................... ECGxxxL / ECGxxxS range electrocardiographs or USB pen drive

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1. GENERAL INFORMATION

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. It is not permitted to transfer the
software to another computer through networks or data channels.
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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ECGEasyApp
2. SAFETY INFORMATION

2. SAFETY INFORMATION

Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if:
1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its
Authorised Service Centre;
2. the device is used in compliance with the instructions provided in the use 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 ECGEasyApp..
 The device does not require any calibration or special instrumentation for correct use and
maintenance.
 When it is required to dispose of the USB dongle and/or packaging material, adhere to local waste
disposal regulations.

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ECGEasyApp
3. SYMBOLS AND LABEL

3. SYMBOLS AND LABEL

3.1. Explanation of the symbols

Symbol Description

CE marking – compliance with the European Union directives

Refer to the user instructions

Manufacturer

3.2. Device label

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ECGEasyApp
4. INTRODUCTION

4. INTRODUCTION

4.1. Purpose of the manual


The manual is an installation and configuration guide for the ECGEasyApp application and its functions.

4.2. Recipients
This manual is intended for professional operators. Basic knowledge regarding the use of the software is assumed.
In particular, clinical skills and in-depth knowledge of ECG methods and tests are required to analyse the ECG
tracings.

4.3. Intended use


ECGEasyApp is a software application which allows you to import ECG tests via USB to the computer to store
and view them.
ECGEasyApp does not process the ECG tests.
ECGEasyApp must be used by professional and adequately trained personnel. It is not intended as the only
means for determining the diagnosis.

4.4. Description of the device


ECGEasyApp can receive ECG tests, in SCP format, via USB or connecting the electrocardiograph directly to
the computer through the USB cable or connecting a USB pen drive where the tests were previously stored
to the computer (for detailed instructions on how to store the ECG tests on a pen drive, see the user manual
of the electrocardiographs).
If no licence code has been entered, the application cannot import new tests.

The tests are stored in SCP format on a local database, inside of which you may perform searches.
The user may view the tests using a PDF viewer. The user can edit and customise the layout of the tracings
with specific commands (speed, amplitude, format, etc.). Commands regarding printing, saving PDF, sending
e-mail, etc. are made available by the viewer.

4.4.1. Compatible devices

The ECG tests can be transferred directly by the following Cardioline devices, connecting them to the
computer where ECGEasyApp is installed via a USB cable (for detailed instructions on how to store the ECG
tests on a pen drive, see the user manual of the electrocardiographs).

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4. INTRODUCTION

 Cardioline ECGxxxL Electrocardiographs


 Cardioline ECGxxxS Electrocardiographs

Or the tests can be transferred by connecting a USB pen drive where the ECG tests were previously stored in
SCP format to the computer.

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5. PREPARATION FOR USE

5. PREPARATION FOR USE

5.1. Installing the software


The ECGEasyApp software can be installed by using a USB dongle, inserting it in the specific port and clicking
the file “ECGEasyApp_Setup.exe” in the folder.

Click ECGEasyApp_Setup.exe to install the software

The installation management program opens automatically:


1. Click Next to go to the next step;

Setup wizard window

2. Click Install to automatically start the installation;

Click Install to begin the installation.

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3. Wait for the installation to be completed and then click Finish when the completed window appears.

Wait for the installation to be completed and then click Finish when the completed window appears

The program is launched automatically when installation is completed and will be set to start automatically
every time the computer starts up.

You can also configure how the application displays:


 Normal Windows mode (program window and icon in the taskbar): clicking on the icon opens or
hides the program window
 Display mode in the Tray Bar (Bottom Right of the Taskbar): clicking on the icon opens a menu that
opens the HOME window (OPEN), the IMPORT window (IMPORT) or closes the program (CLOSE).

Tray Bar

To set the display mode, you must open the command prompt window and type the following strings
followed by the Enter key:
 Normal view of Windows:
C: \ Users \ UserName \ AppData \ Local \ Cardioline \ PEA \ PEAUI.exe / normal
 Display in the Tray Bar:
C: \ Users \ UserName \ AppData \ Local \ Cardioline \ PEA \ PEAUI.exe / minimized

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5. PREPARATION FOR USE

5.2. Entering the software activation code


On first start-up, the application asks the user to enter the activation code (supplied by Cardioline) and the
device’s serial number to combine with it.

Entering the activation code and serial number

To confirm, or otherwise, the data entered, it is possible to use the buttons below:

 Save: to confirm the data entered;

 Delete: to delete the data entered.

On confirming the data entered, the application displays a message in which it confirms the correct code
entered, or detects an error and requests a new code to be entered.

At any time, it is possible to delete the activation code entered by entering another code from the
Impostazioni > Codice di attivazione [Settings > Activation code] window (see par. Errore. L'origine riferimento
on è stata trovata.), for example, to go to an Open licence.

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ECGEasyApp
6. USING THE APPLICATION

6. USING THE APPLICATION

6.1. Start up ECGEasyApp


To launch the ECGEasyApp program, simply click its desktop icon or in the applications list.

Program icon

Alternatively, you can select the program from the list of installed programs:

1. Click the Windows button in the tray bar (see figure below) to open the main Windows menu.

Windows button

2. Select the Cardioline group and then ECGEasyApp from the App list.

Select ECGEasyApp

Once the program is launched the HOME window is displayed:

HOME window

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6. USING THE APPLICATION

6.2. Main menu

Clicking the Menu button opens the navigation bar which allows you to access the different sections of
the program:

 HOME window

 IMPORT window

 SETTINGS window

 Exit program

The arrow allows you to close the navigation bar and to go back to the previous window.

Navigation bar of main menu

6.3. HOME window


The HOME window is the main window of the program.

The HOME window opens by clicking on the main menu or automatically at the end of an import.
It lists all the tests (if any) transferred and stored in the local database, the number of which is indicated at
the top right. The tests which were not opened (to edit or view) are written in boldface, while those already
open in normal fonts.

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The following are included for each test:


 ID: Patient ID
 Name and Surname: the patient's name and surname
 Year of birth / Age: the patient's year of birth and age
 Gender: the patient's gender
 Test Date: date the test was conducted
 Import Date: date the test was imported
 Actions: actions which can be taken on the test:

o Edit: to edit data of the patient and of the test (test date, notes and conclusions);

o View: to view the test on the PDF viewer (see Note);

o Delete: to delete the test.

Number of tests found /


Total number of tests in
archive

HOME window

Note: To view a test, the PDF file viewer program must be installed on the PC. The program issues a warning
message if it is not installed.

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6.3.1. Find a test

A test can be found from the HOME page based on:


 Import date or test date: by selecting the corresponding item (Import date/Test data) from the FIELD
drop down menu and the time range from the TIME PERIOD drop down menu.
 Free textual search by patient’s name/surname/ID: by writing the string to search for in the SEARCH
field and clicking the magnifier. The search is carried out within the time range selected in the
previous point.

Search by import data or test date Free textual search

The tests corresponding to the displayed parameters are viewed in the table.

6.3.2. Editing a test's data

From the HOME page, you may edit the data of a test by clicking Edit in the row corresponding to the
test, opening the data editing window. When the test is open, it is displayed in normal font instead of
boldface on the HOME page.
By writing in the relative fields you may modify the following:
 Patient's data:
o ID
o Name
o Surname
o Gender
o Date of birth
o Each and corresponding unit
o Race
o Pharmacological therapy

 Test data:
o Test date
o Notes
o Technician
o Conclusions
o Reviewing Physician

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Test data edit window

When the “Refertato da” [Reviewed by] field is completed, the test is marked as “Confermato” [Confirmed].
Vice-versa, if the field is not completed, the test is marked as “Non confermato” [Not confirmed].
The SCP file contains the saved information regarding the confirmed/not confirmed status, the date on
which the test was confirmed and the reviewing physician.
This information is also reported on the PDF report.

You may save the changes or not:

 Save: to save the changes in the SCP file stored in the database

 Undo: to undo the changes and thus the SCP file is not modified

6.3.3. View a test

From the HOME page, you may view the data of a test by clicking View in the row corresponding to the
test. When the test is open, it is displayed in normal font instead of boldface on the HOME page.
The test is viewed on the PDF viewer.
Using the tools supplied by the viewer (variable depending on the type of viewer used) you may save the test
in PDF format (on a local folder), print the test, send it via e-mail and so on.

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Example of display

6.3.4. Deleting a test

From the HOME page, you may delete a test by clicking Delete in the row corresponding to the test.
A window asks you to confirm the action:

 Confirm: to confirm deletion of the test from the database

 Undo: to undo the deletion and to keep the test

NOTE: If the folder containing the database is deleted, it will not be possible to recover the original files in SCP
format.

6.4. IMPORT window


The IMPORT window lists the tests (in SCP format) which the program identifies on the connected
electrocardiograph, on the pen drive or in the selected folder and which therefore can be imported in the
local database.

The IMPORT window is opened by clicking on the main menu or automatically by connecting an
electrocardiograph or pen drive to the computer, as described below.

6.4.1. Importing tests to the computer

There are different ways to transfer tests to the computer:


 By starting the application and connecting the electrocardiograph to the computer with a USB cable
or a USB pen drive where the tests were previously stored (for detailed instructions on how to

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connect the electrocardiograph and how to store the ECG tests on a pen drive, see the user manual
of the electrocardiographs);
 By opening the IMPORT window and selecting the folder from which to import the tests by clicking
(to search for and select the folder) or by writing the folder path in the FILE FOLDER field.

The application automatically identifies the SCP tests stored in the device, in the pen drive or in the folder
and shows them on the IMPORT window. The total number of tests found is displayed in the box at the top
right.

The following are displayed for each test:


 ID: Patient ID
 Name and Surname: the patient's name and surname
 Year of birth / Age: the patient's year of birth and age
 Gender: the patient's gender
 Test Date: date the test was conducted

It is possible to order the tests according to each of the fields above, by clicking the corresponding header in
the table. Subsequent clicks modify the order from ascending to descending and vice versa. An arrow next to
the field indicates whether the order is ascending or descending.

You may select which tests to import by means of:


 Individual selection/deselection: by checking the IMPORT box corresponding to each test to be
selected;
 Selection/deselection of all tests: by clicking the IMPORT box in the header of the table.

The number of tests selected is shown in the box to the left.

Click the arrow in the box to the left to import the tests.
When the import is completed, the program goes back to the HOME window, where all of the tests imported
appear in table format.

You may choose to delete or store the tests on the electrocardiograph, on the pen drive or in the folder at
the end of the import by enabling/disabling the DELETE AFTER IMPORT button.

ECGEasyApp with a SINGLE licence will highlight the tests that cannot be imported in red italics, since they
were carried out with an electrocardiograph that is not licenced in the application (serial number not
corresponding to the activation code entered).

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Importing Enabling DELETE AFTER IMPORT


selected tests
Number of tests
Selection of all
selected / Total
tests Order number of valid
Individual tests found
selection

Selection of tests to transfer

Important tests from a non-licenced electrocardiograph

6.5. SETTINGS window


The SETTINGS window allows you to manage the basic settings of the program valid for all the exams.

The window opens by clicking on the main menu.

You may set the following parameters:


 Program settings:
o Language: to set the program language;

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o Department/office name: name of department/office to be entered in the footer of the test


(only if the Ward/Office is blank in the imported test);
o Send statistics and errors: to enable/disable sending of statistics and errors to Cardioline
(see Note);
 PDF settings – to customise the display of the tracings:
o Tracing format: 12x1, 6x2, 3x4, 3x4+1, 3x4+3;
o Speed: 25, 50 mm/s;
o Amplitude: 5, 10, 20 mm/mV;
o Grid: complete, blank, partial;
o Grid colour: colour, black and white;
o Lead sequence: standard, Cabrera;
o Muscle filter: Off, 25, 40, 150 Hz.
o Report logo: image path to use as a logo in the PDF report;
o Customised report: on/off, if active, a customised PDF report is generated according to what
is indicated in the CustomReport.xml file (with an additional second page containing the
header, footer and text).
 Activation code – to view and manage the program’s activation code:
o Type of licence: none, single or open;
o Serial number: serial number of the licenced electrocardiograph;
o Activation code: licence activation code, the icon to the left of the field indicates the type of
licence: non-valid licence, single licence, open licence;

o Licence Delete Button : to delete the saved licence.

Settings window

Click to save the changes.

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Note: you may send statistics and errors to Cardioline. To do so, the computer must be connected to Internet
with an active and working link. Any information sent is collected only in order to trace and examine use of
this application and to correct any malfunctioning.

6.6. Customising the PDF report


By using the CustomReport.xml file, which is created automatically when setting the “Custom Report” option
to ON, it is possible to customise the PDF report generated by the program by adding a second report page.
The report would thus comprise a first page containing the test and a second page with the summary.
In particular, it is possible to customise the second page of the report by editing one or all of the following
fields of the CustomReport.xml file.
For text fields, it is possible to set:
 Text to enter: “text”;
 Font size: “FontHeight”;
 Type: “Type”;
 Underlined: “underlined” (true/false).

FIELD DESCRIPTION
ImageLogo Image path to use as a logo in the report.
For example:
<ImageLogo>logo.jpg</ImageLogo>

stringcustom1 First text line of the report’s header.


For example:
<stringcustom1>
<text>--------------</text>
<FontHeight>10</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom1>

stringcustom2 Second text line of the report’s header.


For example:
<stringcustom2>
<text>DIPARTIMENTO ATTIVITA’ AMBULATORIALI</text>
<FontHeight>10</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom2>

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FIELD DESCRIPTION
stringcustom3 Third text line of the report’s header.
For example:
<stringcustom3>
<text>REFERTO VISITA SPECIALISTICA</text>
<FontHeight>10</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom3>

Stringcustom4 Fourth text line of the report’s header.


For example:
<stringcustom4>
<text />
<FontHeight>10</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom4>
Stringcustom5 Fifth text line of the report’s header.
For example:
<stringcustom5>
<text>UNITA’ FUNZIONALE DI CARDIOLOGIA</text>
<FontHeight>9</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom5>

Stringcustom6 Sixth text line of the report’s header.


For example:
<stringcustom6>
<text> Responsabile dr.ssa Maria Cristina Ferretti</text>
<FontHeight>8</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom6>>

Stringcustom7 First text line of the report (before the medical report).
For example:
<stringcustom7>
<text> Reggio Emilia, on </text>
<FontHeight>8</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom7>

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FIELD DESCRIPTION
Stringcustom8 Second text line of the report (after the medical report).
For example:
<stringcustom8>
<text> Specialista in cardiologia</text>
<FontHeight>8</FontHeight>
<type>bold</type>
<underlined>false</underlined>
</stringcustom8>
Stringcustom9 Third text line of the report.
For example:
<stringcustom9>
<text>Presentare ai controlli successivi</text>
<FontHeight>14</FontHeight>
<type>regular</type>
<underlined>true</underlined>
</stringcustom9>
ImageFooter Image path to use in the footer
For example:
<ImageFooter>footer.png</ImageFooter>

FontAnagrafica Font size of demographics


For example:
<FontAnagrafica>10</FontAnagrafica>

FontReferto Font size of the medical report.


For example:
<FontReferto>8</FontReferto>

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Stringcustom1
Stringcustom2
Stringcustom1
Stringcustom3
Stringcustom4
Stringcustom5

Stringcustom7 Stringcustom6

Stringcustom8
Stringcustom9

Example of a customised PDF report and compatibility with the fields of the CustomReport.xml file

6.7. Closing the program

To close the program, click on the main menu.

A window asks you to confirm the action:

 Confirm: to confirm exiting and to close the program.

 Undo: to undo exiting and to keep the program active.

Exit confirmation window

Note: unlike what occurs in common Windows programs, this program is not closed by clicking the “x” at the
top right corner of the window.

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6.8. Database and configuration backup


The database backup can be executed by copying the folders of the program which are created
automatically in the user’s folder “Documenti\ECGEasyApp\database”.

6.9. Database archive limit


The program archive allows you to store up to 10,000 tests. When this limit is reached, the program
automatically cancels the tests starting from the oldest (verifying the import date) and stores them
automatically in the folder “Documenti\ECGEasyApp\history” in PDF format.

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7. TECHNICAL SPECIFICATIONS

7. TECHNICAL SPECIFICATIONS

Minimum Requirements for the Computer


Operating system ............................ Windows 10 32/64 bit
Windows 8.1 32/64 bit (Italian)
Windows 7 32/64bit (Italian)
Processor......................................... Intel (or compatible) at least 2GHz
RAM ................................................ 4 GB (minimum)
Monitor ........................................... 10" or larger (at least 18.5" is recommended)
Resolution 1366x768 or higher
Software pre-installed on computer PDF file reader

Program characteristics
Compatible devices ......................... ECGxxxL / ECGxxxS range electrocardiographs
Database capacity............................ 10000 tests
Format of stored tests ..................... SCP
Tests export ..................................... Saving locally in PDF format
ECG Viewer......................................  Gain: 5, 10, 20 mm/mV
 Speed: 25, 50 mm/s
 Tracing format: 3x4, 3x4+1, 3x4+3, 6x2, 12x1
 Muscle filter: off, 25, 40, 150 Hz.
 Grid: complete, blank, partial;
 Grid colour: colour / black and white;
 Lead sequence: standard, Cabrera;
 Muscle filter: Off, 25, 40, 150 Hz.
Test search ......................................  By patient’s name/surname/ID
 By test date/acquisition date
Test editing...................................... Modifying personal data, test data and conclusions

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7. TECHNICAL SPECIFICATIONS

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ECGEasyApp
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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