Cardioline touchECG - Software Manual
Cardioline touchECG - Software Manual
User manual
Rev. 14 – 05.03.2021
1936
touchECG
Cardioline Spa
Via Linz, 151
38121 Trento
Italy
touchECG
Contents
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.
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touchECG
1. GENERAL INFORMATION
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.
Language Code
English 36519163_EN
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2. SAFETY INFORMATION
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 the 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.
The device cannot be modified in any way.
Do not use the device if you suspect it is malfunctioning.
The device captures and presents the data that reflects the physiological condition of the patient;
this information can be examined by specialist medical staff and will be useful in providing an
accurate diagnosis. In any event, the data cannot be used as the only means to make an accurate
diagnosis of the patient.
The operators for whom this device is intended must have the required competence regarding
medical procedures and the treatment of patients. They must also be sufficiently trained in using the
device. Have the operator carefully read and understand the contents of the operator manual and
the other annexed documents before using the device for clinical applications. Inadequate
knowledge or training could be at a greater risk for the physical safety of operators, patients and
bystanders, or could damage the device.
US Federal Legislation restricts the sale of this device to prescription by a doctor.
The device is designed for use only with the HD+ acquisition unit. Refer to the HD+ user manual for
the risks and warnings associated with it and for its user instructions.
This device may be installed on a tablet, desktop computer or laptop (hereinafter the support
device), which satisfies the minimum requirements indicated in para. 1.1. To ensure the electrical
safety of the operator and patient during its operation, the following precautions must be observed:
If the support device is battery powered, do not connect it to an external power supply (for
recharging) or other electrical equipment (e.g. to another computer via USB or to a LAN
network) when using it in the patient area.
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2. SAFETY INFORMATION
If the support device is powered off the mains, it may not be used in the patient area. When
used in the patient area, it must be powered with an isolation transformer and shielded
cables must be used to connect it to the LAN. The power cable shielding (when present)
must be connected to an earthing system appropriate for the area where the device is used.
This will avoid electric shocks caused by different earth potentials which could exist between
the various points of an electricity distribution system, or else by failures of the external
equipment connected to the mains.
The HD+ acquisition unit for use with the device is protected against defibrillation. Check the HD+
unit's cables for cracks and breakage before using it.
Refer to the HD+ unit's user manual for the risks and warnings associated with it.
This device is designed to be used only with the electrodes specified in this manual. Strictly follow
the correct clinical procedures to prepare the skin before the application of the electrodes and
monitor the patient in order to avoid any irritation, inflammation or other skin reactions. The
electrodes are designed for short-term applications and must be promptly removed once the
examination is complete.
The ECG electrodes may cause skin irritation; check the skin for any irritations or inflammations.
To prevent any infections, use the disposable components (e.g. the electrodes) only once. To ensure
safety and use efficiency, do not use electrodes after their expiration date.
The quality of the signal produced by the device may be adversely affected by the use of other
medical equipment such as defibrillators and ultrasound machines.
The risks associated with the use of the device together with other equipment, such as pacemakers
and other stimulators, depend on the support device on which it is installed. The signal may be
subject to disturbance in any case.
The use of the device in combination with other high frequency (HF) surgical equipment depends on
the support device in question.
The operation may be adversely affected by the presence of strong magnetic fields such as those
produced by electro surgery equipment.
The use of the device in the presence of diagnostic imaging equipment, such as Magnetic Resonance
(MR) or Computer Axial Tomography (CAT), in the same room, depends on the support device in
question.
The software reports the battery level of the HD+ unit. The low battery warning is designed to work
solely with the HD+ unit using the batteries indicated in its user manual. If the battery level is low,
replace the HD+ unit's batteries and observe its user instructions.
Using a support device equipped with a GPRS or WLAN unit may interfere with other nearby
equipment. Check with local authorities or with providers of the spectrum of your structure to find
out whether any restrictions apply to use of the device in your area.
Do not leave the patient cable unattended in the presence of children as they could be accidentally
strangled.
Do not leave the electrodes unattended in the presence of children as they could cause suffocation
if accidentally swallowed.
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2. SAFETY INFORMATION
If you are printing PDF files, you need to set up a corresponding program so that the document is in
no way adapted or scaled. If you are using Acrobat Reader, you need to select “Actual Size” in “Page
management and size.” Otherwise you may get nondiagnostic quality prints.
In the case of Android, we recommend using printers approved by Cardioline, for which the
diagnostic quality of prints is ensured.
Attention
The device does not require any calibration or special instrumentation for correct use and
maintenance.
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.
The Glasgow 12-lead resting ECG Analysis Algorithm has specific criteria for patients of different
ages, gender and race. If the option is enabled, the algorithm can provide the doctor with an
automatic interpretation, which generates diagnostic messages on the ECG report. Validation is
required by a cardiologist or a doctor.
Notes
The movements of the patient may generate excessive noise and affect the quality of the ECG
tracing or the correct analysis of the device.
An appropriate preparation of the patient is important in order to guarantee a proper application of
the ECG electrodes and the correct operation of the device.
The incorrect positioning of the electrodes for the detection of the algorithm depends on the normal
physiology and on the order of the ECG leads and tries to identify the most likely exchange.
However, it is recommended to check the positioning of the electrodes of the same group (limbs or
chest).
If the electrodes are not properly connected to the patient, or one or more patient leads are
damaged, the display will indicate that the leads in question are disconnected. When the ECG is
printed, these leads will come out on paper as a square wave.
The accuracy of the measurements taken by this device complies with the specific requirement of
standard IEC 60601-2-25.
The device is a Class IIa in compliance with Directive 93/42/EEC.
The device is a “prescription device” under the terms of FDA regulations.
The HD+ unit must be connected to the support device running the software before use.
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2. SAFETY INFORMATION
It is important to learn how to minimise wireless interference that may cause slow performance and
disconnections from Bluetooth devices.
Specifically, there might be interferences and it is required to make an operation check if the following are
found:
Inability to couple a Bluetooth device to the computer/tablet
Intermittent HD+ disconnections
Loss of the ECG signal.
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2. SAFETY INFORMATION
The position of the device and the construction materials may affect Bluetooth performance. If possible,
avoid obstacles or move the Bluetooth device for the signal to travel through fewer obstacles. For example,
avoid placing the computer/tablet under a metal desk and the HD+ device on top of a desk.
Below is a chart showing the radio signal-blocking ability of the most common devices:
Wood Low
Synthetic material Low
Glass Low
Water Medium
Bricks Medium
Marble Medium
Plaster High
Concrete High
Bulletproof glass High
Metal Very high
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 WiFi devices.
To reduce the interference between WiFi devices and Bluetooth to the minimum try these solutions:
Change channels of the wireless network;
Connect to a 5 GHz wireless network (if possible);
Place the HD+ close to the computer/tablet.
Reduce to the minimum the number of Bluetooth devices connected to the computer/tablet or
nearby.
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3. SYMBOLS AND LABEL
Symbol Description
Manufacturer
Android
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4. INTRODUCTION
4. INTRODUCTION
4.2. Recipients
This manual is intended for professional healthcare operators. They are therefore presumed to have specific
knowledge of medical procedures and terminology, as required by clinical practice.
touchECG is designed for use with the Cardioline HD+ device. The Cardioline HD+ device acquires the ECG
signal and sends it via Bluetooth to the PC on which the touchECG software is installed. touchECG software is
designed to only work with the Cardioline HD+ device.
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4. INTRODUCTION
The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with
specific criteria for patients of different age, sex and race. If this option is enabled, the algorithm can provide
the referring physician with an automatic report, generating diagnostic messages in the ECG report.
For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors
for its use with adults and children (see list of accessory equipment).
The device installs on any PC, tablet or notebook with the minimum requisites listed in para. 1.1.
It prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode,
and 3, 6 or 12 printout channels of the rhythm strip.
The device can be sold as a system that may include, depending on the sale configurations:
1. HD+ unit
2. HandyVAQ suction-operated patient cable
3. Computer (tablet or all-in-one PC)
4. Thermal battery-powered printer (Windows version only)
5. Trolley (tablet model or digital model)
Each device in the system comes with its own user manual and accessories.
Note: the Glasgow Algorithm Interpretation is always loaded on the device but can be enabled or disabled
according to the acquired options. The Glasgow interpretation program can only be enabled or disabled by
using the activation code provided by Cardioline (see Para. 10.2).
The Glasgow interpretation program runs the automatic interpretation as well as the readings on the ECG
traces. In any case, if the Glasgow interpretation program is disabled, only the readings are printed, whereas
the automatic interpretation is not printed.
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4. INTRODUCTION
Some buttons, such as trace speed, width, filter and so on, allow you to select parameter values and
change when clicked on to reflect the current value. The trace speed button, for instance, allows you
to select a different value with each click, and cycles through the possible rates (5, 10, 25, 50 mm/s).
It changes to display the currently selected value (5, 10, 25 or 50).
Other buttons activate/deactivate their value and change to reflect this.
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4. INTRODUCTION
3
2
4
Main window with full User Interface
2
3
4
Main window with quick User Interface
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4. INTRODUCTION
Top bar
Icon Description
Attention!
Side bar
C indicates the controls only featured in the full user interface
W indicates the controls only featured in the Windows version
Main window
Menu 1
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4. INTRODUCTION
Patient window
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4. INTRODUCTION
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4. INTRODUCTION
Menu 1
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4. INTRODUCTION
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5. PREPARATION FOR USE
Download the installation software from the internet, if an internet connection is available, by
typing: ttp://update.cardioline.com/touchecg in the address bar of the browser and clicking Install
Note: this mode uses the ClickOnce technology described below.
Note: if there is no Internet connection to install the application, the touchECG.application file in the
installation archive must be launched.
The software installation is launched automatically after having launched the setup program and is
completed when the touchECG program begins and a desktop icon is created.
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5. PREPARATION FOR USE
Confirmation window
The installation modes that use the Microsoft ClickOnce technology make it possible to:
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5. PREPARATION FOR USE
It is possible to install TouchECG on Android operating system simply from the Android Play Store:
1. Launch the Play Store by clicking on its icon (in the App list)
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5. PREPARATION FOR USE
.
Select TouchECG and click on INSTALL
4. Wait for the installation to be completed. Completion of the installation is notified in the top bar of
the home page or in the standby screen.
Installation completed
touchECG icon
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5. PREPARATION FOR USE
Alternatively, you can select the program from the list of installed programs:
1. On Windows operating system, click on the Windows button in the application bar (see picture
below) to open the main Windows menu.
Windows button
Select touchECG
NOTE: from TouchECG version 3.42 onwards, with Android operating system, the first time the program is
launched a message is displayed, asking permission to access to the device’s memory.
Note: if the “Boot Screen” mode is selected (see par. 5.2.1) TouchECG is started with a home screen that lets
you enter the Ward ID.
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5. PREPARATION FOR USE
Start page
If no HD+ has been configured yet (see para. 5.3), TouchECG will start in DEMO mode showing a screen with
sample traces. Video traces are marked with the word “DEMO,” just as saved and printed tests.
Demo mode can be also enabled by selecting HD+ “Demo” in settings (see para. 8.2).
DEMO Mode
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5. PREPARATION FOR USE
For the ClickOnce version for Windows, every week, when the program is closed, the software automatically
searches for any available updates and alerts to this with a dialogue window.
Dialogue window”
It is possible to set up TouchECG for it to start with a window to manually enter the Ward ID. This feature is
useful if the device is often moved between wards with different Ward ID or in case of replacement
equipment.
If the Boot Screen setting is enabled (see par. 8.2), upon start-up the window pictured below is displayed, in
which the Ward ID may be entered.
The entered Ward ID is also saved in the program settings and becomes the default one.
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5. PREPARATION FOR USE
HD+ transmits via Bluetooth. Before making the connection, make sure that Bluetooth is available and
enabled on the computer. If the computer does not have an integrated Bluetooth interface, use a USB
Bluetooth adapter.
Note: the HD+ unit must be enabled to connect to touchECG. If the HD+ unit was purchased previously to or
separately from touchECG, check with Cardioline SpA that it is properly enabled.
Power up the computer running touchECG and check that Bluetooth is available and enabled, then proceed
as follows:
2. On the computer/tablet device, click on the Bluetooth devices icon in the Windows application bar
and select Add a Bluetooth device.
3. In the Manage Bluetooth devices window, wait for the HD+ to be detected and added to the list of
devices, with a name like HDPlusxxxxxxxx (where xxxxxxxx is the device's serial number) and the
wording “Ready for pairing”.
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5. PREPARATION FOR USE
4. Click on the device and select Pair. Wait for the pairing procedure to complete, after which the HD+
will be connected to the system (the word “Connected” will display beneath the device).
Power up the device running touchECG and check that Bluetooth is available and enabled, then proceed as
follows:
1. From the computer/tablet device, open Settings and go to the Bluetooth section.
2. Ensure Bluetooth connectivity is enabled (picture below A).
3. Insert the HD+ unit's batteries and turn it on.
4. Click on the Search button (picture below B) to start HD+ search and wait for the HD+ device to be
detected and added to the list of devices (picture below C), with a name like HDPlusxxxxxxxx (where
xxxxxxxx is the device's serial number).
B
A
C
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5. PREPARATION FOR USE
5. Click on the device to perform the pairing. Wait for the pairing procedure to complete, after which
the HD+ will be connected to the system.
HD+ Pairing
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5. PREPARATION FOR USE
Once the HD+ unit is connected to the computer, you must configure touchECG to communicate with it.
Proceed as follows:
1. Launch touchECG (see para. 5.2).
3. Open the System tab and open the HD+ serial number dropdown menu which contains a list of all
devices paired with the computer. Now select the serial number of the HD+ to want to connect to.
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5. PREPARATION FOR USE
Settings window
Now touchECG will connect with the HD+ and the message “Searching for HD+” will display in the message
area.
If the selected HD+ is not enabled to work with touchECG, the message “HD+ NON E' LICENZIATO PER IL
TOUCHECG 3” (HD+ NOT LICENSED FOR TOUCHECG 3) will display. Contact Cardioline SpA to enable the
acquisition unit.
If touchECG is unable to connect to the acquisition unit, because it is out of range or switched off, the
message “HD+ not found" will display. Check that the acquisition unit is switched on and within range.
When the connection to the HD+ is successful, the message “HD+ found" displays in the message area.
Note: the list of acquisition units paired with the computer always includes the "DEMO” device. Selecting this
unit launches touchECG demo mode, which displays traces and runs the application even though no actual
acquisition unit is connected. The demo mode trace was acquired with an ECG simulator and includes special
signal conditions including disconnected leads and abnormal rhythms.
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5. PREPARATION FOR USE
Virtual keyboard
Note: if Windows is in tablet mode, it enables the virtual keyboard by default directly from the PC settings
and, in this case, the “Virtual Keyboard" option in the touchECG must be disabled.
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5. PREPARATION FOR USE
A Google account which must be the same on your computer and the Android device you want to
print from.
You also need to configure the printer by following the steps below:
1. Add your printer to Google Cloud Print:
a. Start Chrome on your computer
b. Click on Menu in the top right corner (it looks like three horizontal lines)
c. Click on Settings
d. Click on Show Advanced Options.
e. Scroll down the list and click on Manager in the Google Cloud Printing section.
f. Click on Add printers.
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5. PREPARATION FOR USE
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5. PREPARATION FOR USE
3. Print from your Android tablet: if the Google account configured on your tablet is the same enabled
on your computer, you can print from the tablet on the configured printer. To do so, follow the
instructions provided under section 6.6.5 and select a printer from the window that is automatically
opened by the programme.
Attention: we recommend in any case the use of printers approved by Cardioline, for which the diagnostic
quality of prints is ensured.
Note: The printer manufacturer can make printing configurations alternative to that described available.
Cardioline is not able to provide support on configurations different from that described. We recommend
referring to the instructions provided by the printer manufacturer.
Other commands can be added, each separated by a comma‘,’ and enclosed in inverted commas ‘”’.
For Standard setup version:
%AppData%"\Microsoft\Windows\Start Menu\Programs\Cardioline\touchECG\touchECG.lnk"
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5. PREPARATION FOR USE
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5. PREPARATION FOR USE
Where:
<NAME> = name of the dl plug-in file written without the “dl” extension
<PATH> = path written with “\” at the end
<PATHFILE> = path and file name
<URL> = web address/url
%AppData%"\Microsoft\Windows\Start Menu\Programs\Cardioline\touchECG\touchECG.appref-
ms"
"-g,-d,C:\temp\gdt\input\,-pg,Cardioline.TouchPlugWebApp,-ps,Cardioline.TouchPlugWebApp,-u,uploader,-
p,cardioline,-l, http://213.209.216.187:9091/ecgwebapp/rest".
Note: there must be NO space between the topics for the ClickOnce version.
%AppData%"\Microsoft\Windows\Start Menu\Programs\Cardioline\touchECG\touchECG.lnk"
-pg -Cardioline.TouchPlugWebApp -a
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6. EXECUTION OF THE EXAMINATION
NOTES: If the work flow allows it, it is good practice to connect the patient to the device and to enter his/her
ID data before recording a tracing. This minimises artefacts on the tracings introduced during connection of
the patient and positioning of electrodes.
Ensure that the patient fully understands the procedure and knows what to expect before connecting the
electrodes.
Privacy is very important to allow the patient to be relaxed.
Reassure the patient that the procedure is painless, and that he/she will only feel the electrodes on
the skin.
Make sure that the patient is relaxed and in a comfortable position. If the table is narrow, insert the
hands of the patient under the buttocks to ensure the muscles are relaxed.
Once the electrodes are connected, ask the patient to remain still and not to talk. Explain that this is
important to ensure a good ECG acquisition.
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6. EXECUTION OF THE EXAMINATION
It is important that the patient's skin be perfectly clean. There is a natural electrical resistance on the surface
the skin, generated by sources such as hair, sebum, and dry or dead skin. Adequately prepare the skin to
minimise the aforementioned effects and optimise the quality of the ECG signal.
To prepare the skin:
If necessary, shave the skin area where the electrode must be applied.
Wash the area with hot soapy water.
Dry the skin vigorously with an abrasive pad, such as a 2x2 or 4x4 gauze, to remove dead skin cells
and fat.
Note: Pay attention not to cause abrasions, discomfort or bruises on the skin. Always observe the utmost
clinical discretion when preparing the patient.
It is important to position the electrodes properly in order to acquire a good electrocardiographic signal.
Indeed low impedance ensures a better waveform, reducing noise. Quality electrodes should be used.
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6. EXECUTION OF THE EXAMINATION
Note: It is important to locate the fourth intercostal space for an accurate positioning and monitoring of the
precordial leads. It is possible to locate the fourth intercostal space starting from the first intercostal space.
Given the variable conformation of the patient, palpating the first intercostal space accurately can be
difficult. Therefore, it is advisable to locate the second intercostal space by first palpating the small bone
protrusion known as the Angle of Louis, formed by the junction of the manubrium and the body of the
sternum. This protrusion of the sternum identifies the junction point of the second rib, and the space
immediately below it corresponds to the second intercostal space. Palpate and count following the trunk until
the fourth intercostal space is located.
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6. EXECUTION OF THE EXAMINATION
Since touchECG acquires and temporarily stores the entire trace acquired when it is launched and connected
to an active HD+, the bottom of the screen (A) displays a continuous trace which corresponds to the entire
trace acquired up to that time.
The lead displayed in the continuous trace can be modified from the Settings menu (see par. 8.2) or by
clicking on the continuous trace itself.
On the blue continuous trace there are time markers identifying the duration of the acquired signal,
identified at 1s intervals for the first 10s, and 10s intervals for the first minute, and at 1 min intervals
thereafter.
Any bookmarks (see par.6.3.3) are marked on the continuous trace as vertical orange lines identified by a tag
indicating the progressive number.
Rhythm lead
The top bar displays a set of information icons whereas the side bar contains the buttons that correspond to
the functions available which, depending on whether the “Quick user interface” setting is active or not, allow
you to modify the track display mode, acquire a test, access the settings menu, and so on.
In case of signal loss caused by Bluetooth problems, the “Attention” icon appears in the top bar. If more than
4 ms of signal are lost, the message “Weak signal” also appears.
The signal can be acquired just the same, but if the acquired signal were to show consecutive signal losses of
at least 100 ms or an overall loss of 1 s, the test would be classified as low quality (see par. 6.6).
Attention icon
Note: By default the touchECG is set to “Quick user interface”. Should you wish the “Full user interface” it
must be selected from the settings (see par. 8.2.6).
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6. EXECUTION OF THE EXAMINATION
A
Real time display window with Full user interface
A
Real time display window with Quick user interface
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6. EXECUTION OF THE EXAMINATION
HD+ connected / not Indicates whether the HD+ device is connected via Bluetooth.
connected
Heartbeat sound on / off Indicates whether the heartbeat sound is on or off. If it is on,
the unit beeps for each heartbeat.
Menu 1
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6. EXECUTION OF THE EXAMINATION
Menu 2
If full user interface mode is enabled (“Quick user interface” setting = Off) it is possible to change the speed,
amplitude, format and muscle filter applied to the tracings by clicking on the corresponding buttons.
Each button cycles through its available values, and applies them to the traces. For example, the speed
button can take the values 5, 10, 25 and 50 mm/s, and each time you click the button it will move to the next
value in the sequence.
The button itself displays the value.
We list the values of the parameters and the button labels below.
Speed
5 mm/s
10 mm/s
25 mm/s
50 mm/s
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6. EXECUTION OF THE EXAMINATION
Amplitude
5 mm/mV
10 mm/mV
20 mm/mV
Muscle filter
25 Hz
40 Hz
150 Hz Note: The 150 Hz filter only works on 1000 Hz acquisitions and
is only available in the Windows version.
off
Note: the 25 Hz filter is stronger than the 40 Hz filter. Setting the filter to “off” disables
muscle filtering of the traces.
Format
6+6
3x1 (I-II-II)
12x1
If any electrodes are disconnected, the message “Lead disconnected" displays in the message area, followed
by the list of leads in question, and the icon Attention displays in the top bar.
The waveforms of the disconnected leads are displayed as square waves (see below).
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6. EXECUTION OF THE EXAMINATION
If all the leads are disconnected, all ECG traces display as square waves and the message “Lead
disconnected: all" displays. In the same way, if the disconnected lead is N/RL, the message “Lead
disconnected: all" displays and all leads display as square waves.
If the patient cable is connected from the connector on the HD+ unit, the ECG traces display as flat lines.
6.3.3. Bookmark
The real time display window allows you to assign bookmarks to events and interesting points of the signal
by clicking with the mouse (or with your finger if using a touchscreen device) in the trace area at the time of
interest.
The selected event is marked with vertical orange line identified by a progressive number visible in the
continuous trace at the bottom of the screen.
If a test is acquired, the bookmark is also shown in the ECG test.
In the Windows version the bookmark is included in the ECG test acquired in Review mode as well as in the
test acquired in automatic acquisition mode (see par. 6.5.1 and 6.5.2). In the Android version, which does
not include the Review feature, the bookmark is shown in the test acquired in automatic mode (see para.
6.5.1 and 6.5.2).
You can set touchECG to enter bookmarks automatically as set intervals. The “Automatic bookmark" function
in Settings (para. 8.2) enables you to select the interval in minutes between bookmarks.
The “Save test on Bookmark” function, on the other hand, automatically creates a 10 s test on every
bookmark. If the automatic print function is active, the created test is also printed out.
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6. EXECUTION OF THE EXAMINATION
Id button
The data can be entered manually or automatically by selecting the patient from a work list or the
examinations archive.
The window is organised into 3 sections, each of which has a number of entry fields.
The sections are:
Main information: the basic patient details
Clinical information: weight, height, therapy, etc.
Other information: contact details
Patient window
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6. EXECUTION OF THE EXAMINATION
Fields:
Main information
Clinical information
Weight and unit of the patient's weight Numerical field. The units can be
measurement chosen from kg/g/lb/oz
Height and unit of the patient's height Numerical field. The units can be
measurement chosen from cm/in/mm
Systolic the patient's systolic pressure, in numerical field
mmHg
Diastolic the patient's diastolic pressure, numerical field
in mmHg
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6. EXECUTION OF THE EXAMINATION
Other information
Order number the reservation number for the alphanumeric text field
examination
(visible or editable depending on
the selected configuration)
New patient Deletes any existing patient data and creates a new patient
Back Closes the patient window without saving the entered data.
Note: Make sure that the data have been deleted and re-entered before running an ECG for a new patient;
the patient details are not reset automatically after the examination. The patient details are only deleted
automatically when the device is switched off or you press New patient.
The data can be entered manually into the fields in the Patient window.
Once entered, you can save the details by clicking OK or abort the operation with Back.
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6. EXECUTION OF THE EXAMINATION
Click on Search in the patient window to search for a patient in the local archive; select a patient and load his
details.
Search button
It is possible to restrict the search by filling in all or part of the Id, Name, Surname fields of the Patient
window before clicking the Search button.
touchECG will only search in the local archive for tests in which the patient records match the entered data,
starting from the ID and then moving on to the surname and lastly, the name.
Alternatively, you can launch a search in the Examinations Archive by entering the word you are looking for
in the Search field. touchECG will search the local archive only for examinations in which the word in
question is found in the Id or Name/Surname fields.
Click on the column labels (e.g. “ID” or “Name and Surname) to order the list in increasing/decreasing order
by the field in question.
You can select an examination by clicking on its line in the list and use OK and Back to save the data or abort
the operation.
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The connectivity function (if available on the support device) enables you to load the patient details
automatically by selecting them from a work list. For details on configuring the ECG unit, see par. 7.
Click on Work List in the patient window to download and display a work list.
You can select an order from the displayed work list by clicking on the line in question, and then select it
(OK), delete (Delete) or abort (Back).
You can also update the work list by pressing Update to download it again.
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Work list
Update Update the work list, deleting the current list and downloading
it again.
Delete Deletes the order selected from the list (locally, not on the
server from which the list has been downloaded).
OK Closes the window, saves the selection and loads the selected
patient data.
Back Closes the window without saving the selection or loading the
selected patient data.
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10 s of tracing can be acquired in automatic mode by pressing the Auto button in the real time display
window or by clicking the central button on the HD+ acquisition device.
Once you press Auto, the program acquires 10s of data and creates an examination.
Auto button
During acquisition, the display will show “Waiting for 10s automatic acquisition" in the message area.
touchECG acquires and temporarily stores the entire trace received from the time the HD+ unit was
switched on and connected. This way, when you press Auto, touchECG analyses the last 10s of trace and if
the data are valid (without disconnected leads or dropouts) immediately creates the examination without
acquiring other data.
On the other hand, if the last 10s of trace are not valid, the program waits for the next 10s to be acquired. In
this case the user can force acquisition of the traces by pressing QA Override (this button is enabled once
Auto has been pressed). This way the electrocardiograph will create an examination of the data acquired up
to that moment.
Likewise, if 10s of signal have not yet been acquired, touchECG waits for them to arrive, but in this case you
cannot force acquisition (QA Override is disabled).
QA Override button
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Once the acquisition is completed, the trace is displayed as a printout preview which you can print out, save,
edit by changing the patient details, etc., as described in para. 6.6.
Note: The temporary storage capacity is 30 minutes. Once exhausted, touchECG deletes the first minute and
continues storing new data. This means that the device's memory always holds the last 30 minutes of signal.
Note: the QA Override button is only enabled after you press Auto, and only if the last 10s of trace are not
valid for creating an examination.
Click on Review in the real time display window to access ECG examination Review mode.
This mode displays a preview of the entire trace recorded since the unit was launched and connected to an
HD+ unit up to when you press the Review button, for 30 minutes at most.
This preview then allows you to select 10s portions for creating ECG examinations.
Review button
The centre of the window displays a portion of the trace in the selected format, the duration of which
depends on the size of the screen. The bottom bar displays the continuous trace. The portion of trace
displayed at the centre is highlighted in orange on the continuous trace as shown in figure (A).
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To change the part of trace displayed, click on the continuous trace (with the right mouse button or double-
clicking in the case of a touch screen): this will display a part of the trace centred on the on the point in
which you have clicked.
If the recorded trace is long and cannot be displayed entirely in the bottom bar, a scrolling bar appears
enabling you to scroll and display the continuous trace.
You can set the speed, amplitude, format and muscle filter applied to the traces by clicking on the respective
buttons.
Each button cycles through its available values, and applies them to the traces. For example, the speed
button can take the values 5, 10, 25 and 50 mm/s, and each time you click the button it will move to the next
value in the sequence.
The button itself displays the value.
Click on Id to set the patient details for the examination, as described in par. 6.4.
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Bookmark
A
Display in Review mode
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Saving registration
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Speed
5 mm/s
10 mm/s
25 mm/s
50 mm/s
Amplitude
5 mm/mV
10 mm/mV
20 mm/mV
Muscle filter
25 Hz
40 Hz
150 Hz Note: The 150 Hz filter only works on 1000 Hz acquisitions and
is only available in the Windows version.
off
Note: the 25 Hz filter is stronger than the 40 Hz filter. Setting the filter to “off” disables muscle
filtering of the traces.
Format
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6+6
12x1
Note: The temporary storage capacity is 30 minutes. Once exhausted, touchECG deletes the first minute and
continues storing new data. This means that the device's memory always holds the last 30 minutes of signal.
Pressing the Manual key on the real time display screen starts continuous printing of the ECG tracing. The
printout can be interrupted by pressing Stop, which is enabled as soon as manual mode is launched.
The output of the manual print is set from the "Output" field on the Manual Settings tab. It may be, for
Windows environments printer, PDF or both, for the Android version only PDF will be possible.
PDF printing will only contain the default rhythm derivation, as well as printing the compacted 1x1.
Pages to print
If the support device's default printer is a PDF file writer, manual printing creates multiple PDF files in
sequence.
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The print preview shows at the top the boxes with patient’s data (A), automatic measurements and
interpretation (B), if enabled on the device.
In the Android version it is possible to click on the icon at the top right to collapse or expand this section, so
as to leave more room to the tracings.
It is possible to change the patient details (clicking on area A, see par.6.6.2) and the interpretation (clicking
on area B, see par.6.6.3), using the calipers tools (enabled/disabled with the Caliper button) and zoom (by
“pinching” the touchscreen or using the mouse scroll button for a normal screen) as support for the medical
report.
Note: if the acquired signal were to show consecutive signal losses of at least 100 ms or an overall loss of 1 s,
the test would be classified as low quality and this indication would appear in the interpretation box.
If full user interface mode is enabled (Quick user interface setting = Off) it is also possible to change the
speed, amplitude, format and muscle filter applied to the tracings by clicking on the corresponding buttons
(see par. 6.6.1). The changes are applied to both the preview and the printed and saved examination (if any).
The Urgent button enables you to attribute the “Urgent” status to the examination, as described in par.
6.6.4, while the Transmit, Print and Save buttons enable you to transmit the examination to an external
system, print and save it (par. 6.6.4 and 6.6.6).
Finally, the Launch App button launches an external application, as configured in the Settings (e.g. a web
browser), while Send email sends the examination by email as a PDF (par. 6.6.7).
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A B
A B
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Menu 1
Erase and repeat It allows you to delete the exam from the local archive and
keep the same personal data of the patient by returning to
real-time mode.
Back Closes the window and returns to the main window in real
time with the same data as the patient's personal data or
with clean personal data, depending on the user's response
to the question proposed.
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Menu 2
If full user interface mode is enabled (“Quick user interface” setting = Off) it is possible to change the speed,
amplitude, format and muscle filter applied to the tracings by clicking on the corresponding button. The
display mode applies to both the printout and the saved file (if any).
Each button cycles through its available values, and applies them to the traces. For example, the speed
button can take the values 25 and 50 mm/s, and each time you click the button it will move to the next value
in the sequence.
The button itself displays the value.
All possible values of the parameters and the button labels are listed below:
Speed
50 mm/s
25mm/s
Amplitude
5 mm/mV
10 mm/mV
20 mm/mV
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Muscle filter
25 Hz
40 Hz
Note: the 25 Hz filter is stronger than the 40 Hz filter. Setting the filter to “off” disables muscle
filtering of the traces.
Format
You can open the Patient window to modify the current patient data by clicking on the patient ID area as
show in figure (A).
The data can be entered/edited manually as described in par.6.4.2 or from a work list, as described in par.
6.4.4.
Note: if you access the Patient window from the examination preview window, the automatic patient details
entry options from the examinations archive are not available.
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If the program's interpretation option is enabled and “Automatic interpretation” is enabled in Settings, an
automatic interpretation is added to the examination. With the “Automatic interpretation” function (Par.
8.2.2) you can choose whether to display the automatic interpretation text in summary or extended mode,
or not display it at all.
The interpretation can be modified, or entered if not present, by clicking on the Interpretation area, as
shown in figure (B).
The automatic interpretation window allows you to edit the interpretation text, assign an overall evaluation
to the examination (Unknown, Normal, Abnormal, Borderline) and enter the name of the doctor.
The acquired examination is in the “Not Confirmed” status until the name of the doctor is entered in the
“Doctor” field of the Automatic Interpretation window. This way the examination switches to the
“Confirmed” status. Vice-versa, if the “Doctor” field remains empty or is deleted, the examination switches
to the “Not Confirmed” status.
Buttons
OK Closes the window, saves the data and changes the test status
to “Confirmed” if the “Doctor” field is filled in. The current
printing format (speed, amplitude, sampling rate, trace format,
muscle filter) is also saved in the test.
If the “Doctor” field is empty, the test will be “Not confirmed”
and any previously saved printing format will be deleted.
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Back Closes the window without saving the data and leaves the
examination's status set to “Not Confirmed".
Note: if the name of a doctor is not entered, the status of the examination remains “Not Confirmed”.
The acquired examinations can be identified as “urgent”, for example for flagging as such in Cardioline
ECGWebApp or in an external archive.
Once the examination has been created, you can flag it as “urgent” by clicking on Urgent. When this key is
pressed, the corresponding icon changes and the acquired examination is given the "urgent" status. Pressing
the key again toggles the "urgent" status.
If the automatic saving option is enabled, the examination is re-saved automatically every time the "urgent"
status is modified (i.e. every time the Urgent button is pressed). If on the other hand the automatic saving
option is not enabled, the examination must be saved manually at each modification by pressing the
Save/Update button.
If an examination must be acquired urgently, it can be started without entering the patient's data, but simply
by pressing the Auto key on the real time display screen.
The resulting examination can be printed, saved or transmitted as it is without the patient's details, or you
can enter the details as described in para. 6.6.2.
You can enable the “Auto Stat” option in Settings to flag all acquired examinations as urgent. This is useful
when the program is used in an ambulance or an emergency ward. You can always cancel the urgent flag by
pressing the Urgent button.
Note: To transmit the examination as urgent, it must be sent after having modified the status.
If the automatic printing option is enabled (par. 8.2), the examination is printed automatically at the end of
the acquisition. Likewise, if the automatic saving option is enabled (par. 8.2), the examination is saved
automatically at the end of the acquisition.
If these options are not enabled, you can print out and save the examination with the Print and Save/Update
buttons (to save an examination or overwrite an existing one).
If you press Save/Update, the examination is saved in the local touchECG database and, if the settings are
correct (par. 8.2), on the computer as well, as an SCP file and/or PDF in the specified folders.
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Footer:
o On the left: amplitude, speed, filters;
o In the centre: department name
o On the right: device model, software version.
Note: if the support device's default printer is a PDF file writer, printing launches this writer which creates a
PDF file.
Attention: If you are printing PDF files, you need to set up a corresponding program so that the document is in
no way adapted or scaled. If you are using Acrobat Reader, you need to select “Actual Size” in “Page
management and size.” Otherwise you may get non diagnostic quality prints.
Note: In case of Android operating systems, you should configure the printer first as described in section 5.5.
touchECG can transmit an examination to an external system (e.g. a Cardioline ECGWebApp system, an
examination management system, a CIS/PCS DICOM system, etc.), as described in par. 7.
If the automatic transmission option is enabled (par. 8.2), the examination is transmitted automatically at
the end of the acquisition. If the program fails to transmit the examination (no network connection, for
instance), the automatic transmit function periodically attempts to send the untransmitted examinations
until it is successful in doing so.
If the automatic transmission option is not enabled, you can transmit the examination by pressing the
Transmit button. See par. 7.3 for further details.
If one or more tests fail/s to send the application will try sending again until it is successful. When the
examination has been transmitted, the system displays the message “Examination transmitted".
If the user tries to close the application when there are still tests that need to be sent, a message window
will open warning the user that there are unsent tests.
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You can also transmit a specific examination or all untransmitted examinations from the examinations
archive window, as described in par.6.7.
Note: if the automatic transmit function is enabled, the automatic save function is also enabled.
Note: if the delete test after sending feature is enabled (only available if the Privacy option is active) the
test(s) is deleted after being transmitted successfully.
At the end of acquisition, you can send the examination by email by clicking on Email in Menu 2.
touchECG creates and opens a new email message in the computer's default email application, and attaches
the examination as a PDF report.
You can also send the examination by email from the examinations archive window, as explained in par. 6.7.
Note: in the Windows version, to send the examination by email, your email application must support the EML
format.
Note: in the Windows version, if no email application is configured, you will be prompted to open the “eml”
file with an application.
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1 2
The top left of the screen displays the number of examinations in the archive.
The following fields are displayed in order for each examination:
Id: the patient's identification code
Name and surname: the patient's name and surname
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Click on the column labels (e.g. “ID” or “Name and Surname) to order the list in increasing/decreasing order
by the field in question.
The “Search" field allows you to search for an examination containing the string entered in the “ID” or
“Name and Surname" fields.
In the Test Archive window you can select a test by clicking on the corresponding line to display it, transmit it
to an external system, print it out, send it by email as a PDF report or delete it, using the respective buttons.
You can also select multiple tests (only for Windows version) by clicking on the corresponding lines while
holding down the CTRL key. It is therefore possible to perform the same action on all selected tests using the
corresponding buttons: transmit them to an external system, print them out or delete them.
Transmit all transmits all so far untransmitted examinations at the same time.
If you select an examination, you can automatically load the patient details associated with it by pressing Ok.
This closes the Examinations Archive window and loads the patient details into the real time display window.
Buttons
Send email Sends the selected examination by email (as a PDF report)
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OK Closes the window and loads the patent data associated with
the selected examination.
Back Closes the window without loading the patent data associated
with the selected examination.
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As described in par. 4.4, touchECG may be equipped with two different connectivity options, with different
protocols:
Standard connectivity: for connection to external systems using a standard internet protocol
(http/https). In this mode, touchECG can connect to Cardioline ECGWebApp or other on-line systems
(e.g. GDT systems).
The following protocols are available:
o Receiving work lists:
˗ Cardioline: for connection with Cardioline ECGWebApp or with other systems in the
network
˗ GDT: for connection to GDT systems (only available in the Windows version)
˗ Text file: for importing work lists generated by other systems (only available in the
Windows version)
˗ XML: to connect with systems that support this Protocol (only available in the
Windows version)
o Transmitting examinations
˗ Cardioline: for connection with Cardioline ECGWebApp or with other systems in the
network
˗ GDT (Standard): for connection to GDT systems (only available in the Windows
version)
˗ XML: to connect with systems that support this Protocol (only available in the
Windows version)
DICOM connectivity (optional): for connecting to external systems running the DICOM protocol. This
allows you to integrate the system into any PACS DICOM system for managing hospital work flows.
The following protocols are available:
o Receiving work lists:
˗ Cardioline: for connecting with DICOM systems
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o Transmitting examinations
˗ Cardioline: for connection with Cardioline ECGWebApp
It is possible to implement other communication protocols, as well as allow the Android version to
communicate through the GDT and XML protocols.
Through ad hoc projects it is also possible to include other communication formats and protocols.
touchECG, finally, can export examinations as SCP and PDF files to specific folders on the computer and send
PDF examination reports via email.
Note: as indicated in par. 10, the connectivity options (Standard / DICOM) as well as the interpretation
options (none / Glasgow) are not linked to the touchECG software but to the HD+ acquisition unit in question.
It follows that whether an examination is transmitted in Standard or DICOM mode depends on the HD+ unit
used to acquire the examination.
To receive a work list, click on Id in the real time display window (1) and then Work List in the Patient window
(2), as described in par. 6.4.
2
Id button in the real time display window and Work list button in the Patient window.
The work list is downloaded and displayed, and you can select an order to load (thus also loading the patient
details) or delete from the list.
See par. 6.4.4 for further details about work lists.
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The work list can be acquired automatically (option -g) using the command line and, if necessary, always
automatically by launching the acquisition of a test in Auto mode (option -a) ; while if you only want to go
directly to the work list screen without making the choice of the first patient, you can use the -w option.
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Note: in the Windows version, to send the examination by email, your email application must support the EML
format.
Note: in the Windows version, if no email application is configured, the message “Could not send, no email
application installed” will be displayed.
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Windows:
C:\Users\[NomeUtente]\Documents\touchECG\scp
C:\Users\[NomeUtente]\Documents\touchECG\pdf
Android:
/storage/emulated/0/Documents/touchECG/scp
/storage/emulated/0/Documents/touchECG/pdf
If you set the “Filename format" you can specify the structure of the filenames of saved PDF and SCP files.
The “Automatic SCP export" and “Automatic PDF export" options automatically export the examinations
after they have been acquired.
You can also export the SCP / PDF files after completing the examination, by clicking Display in the
Examinations Archive. This opens the examinations Preview window, which contains the commands for
processing examinations, including saving (see para. 6.6 and 6.7).
If the setting "Include filtered data in the SCP file" is enabled (see par. 8.2.6) the filtered tracks are saved in
the SCP file, with the same filter applied on the screen. Vice versa, the raw data are saved.
GDT mode allows you to connect to systems using the GDT format.
You can then receive worklists and send examinations in GDT format.
To launch TouchECG automatically from a GDT system, launch the program from the command line as
described in Par. 5.5.
To connect to GDT systems, click on “GDT” in the “Receiving protocol”, “Transmission protocol" and
“Protocol configuration" fields in the CONNECTIVITY tab in Settings (see para. 8.2)
You must also configure the fields which appear after having selected “Protocol Configuration”:
Work list folder: path of the folder containing the work lists created by the GDT system
Examinations folder: path of the folder in which touchECG saves the GDT format examinations, for
uploading to the GDT system
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ATTENTION: if the name of the file with the GDT extension is also entered in the path of the exam
folder, the system creates a file with exactly that name while otherwise a causal name with the GDT
extension is created.
Eg :
Exam folder C: \ GDT \ OUT \ RX_EDP.GDT => a file is created in the chosen folder with the name
RX_EDP.GDT
Exam folder C: \ GDT \ OUT => a file is created in the chosen folder with the causal name ADNAN £
432423DFDSF £ 43.GDT
Attach PDF examination: if enabled, allows you to attach a PDF examination report to the GDT
examination file
GDT settings
As mentioned, the structure and content of the PDF report which is attached to the GDT test is defined
according to the touchECG settings.
If the Standard Connectivity option is available, Cardioline mode allows you to connect to the Cardioline
ECGWebApp application.
This means you can receive work lists prepared in Cardioline ECGWebApp and send SCP format examinations
to it.
Connection URL: address of the server running Cardioline ECGWebApp to which you wish to connect
Username: username used by touchECG to automatically access Cardioline ECGWebApp (this must
be a user authorised to transmit examinations – for details, refer to the Cardioline ECGWebApp user
manual)
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Password: password for the username with which touchECG automatically accesses Cardioline
ECGWebApp
If the DICOM connectivity option is available, touchECG can connect to external DICOM systems.
To connect in DICOM mode, click on “Cardioline” in the “Receiving protocol”, “Transmission protocol" and
“Protocol configuration" fields in the CONNECTIVITY tab in Settings (par. 8.2)
You must also configure the fields which display when you click on “Protocol configuration":
Text file mode allows you to receive work lists as text files.
For each order in the work list there must be a text file containing the patient details with a structure similar
to the following:
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All or only some of the fields may be present, and they must be separated by tab characters. The fields
correspond to the following details and take the following values:
To import a work list as a text file, select “Text file” in the “Receiving protocol” and “Protocol configuration”
fields in the CONNECTIVITY tab of Settings (par. 8.2)
You must also configure the fields which display when you click on “Format configuration":
Work list folder: folder containing the text format work list
Format: indicates the format of the work list (only “Standard” is currently available)
Note: Text file mode is only available for receiving work lists, it cannot be used for transmitting examinations.
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XML mode allows you to connect to systems using the XML format.
You can then receive work lists in XML format and send tests in XML format.
To connect in XML mode, select “XML” in the “Receive protocol”, “Send protocol” and “Protocol
configuration” fields in the CONNECTIVITY tab of the Settings (see par.8.2)
You must also configure the fields which appear after having selected “Protocol Configuration”:
Examinations folder: path of the folder in which touchECG saves the XML format examination file.
XML settings
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8. DEVICE SETTINGS
2
Opening the Settings window
The Settings window has several panels, each of which has data entry fields:
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Settings Window
Buttons
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8.2.1. PACS
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8. DEVICE SETTINGS
8.2.2. ECG
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8. DEVICE SETTINGS
8.2.4. Auto
8.2.5. Connectivity
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DICOM connectivity:
IP address
Username Standard connectivity only: Alphanumeric text field
username with which touchECG automatically
accesses Cardioline ECGWebApp
Password Standard connectivity only: Alphanumeric text field
password for the username with which
touchECG automatically accesses Cardioline
ECGWebApp
Protocol configuration – Text file (Windows version only)
Work list folder Folder containing the text format work list Alphanumeric text field
(selectable with the mouse using the "Browse"
button).
Format Format of the work list (only “Standard” is Standard
currently available)
Protocol configuration – XML (Windows version only)
Test folder Path of the folder in which touchECG saves the Alphanumeric text field
test file in XML format (selectable with the
mouse using the "Browse" button).
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8. DEVICE SETTINGS
8.2.6. Other
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8. DEVICE SETTINGS
8.2.7. License
8.2.8. Safety
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Subsequent log-ins to the Settings section will require the PIN to be entered, as shown in the figure, which
must be entered in the text field shown.
Buttons
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9. SET THE DEVICE IN ACCORDANCE WITH GDPR (General Data Protection Regulation) – Windows only
Using the Windows File Explorer tool, open the folder that contains the database folder, for example
C:\Users\a.falappi\AppData\Local\touchECG;
Select the database folder, right-click and select “Properties”;
Click “Advanced” and check the selection “Encrypt content..”
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10. UPDATING THE SOFTWARE AND OPTIONS
Every week when the program is closed, if an active network connection is available, touchECG checks for
any software updates on-line. If any are available, you can download and install them automatically as
described in par. 5.1.
For Android systems, updates will be made available directly on Play Store. These updates will therefore be
notified in Play Store as soon as available, and it will be possible to download them from there and install
them with the usual procedures for Android apps.
The options available on touchECG are controlled by the HD+ unit connected to it. Indeed, depending on the
options enabled on the HD+, the corresponding touchECG options are enabled or not. It follows that
depending on the acquisition unit in use and its enabled options, the touchECG may have different enable
functionality.
The options enabled on the HD+ unit connected to touchECG are summarised in the LICENZA (LICENSE) tab
in Settings (par. 8.2).
Note: since the available functions depend on the HD+ unit you are using, these functions will be reflected in
the acquired examinations.
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For example, an examination acquired by an HD+ without the interpretation option enabled will not have an
automatic interpretation, while an examination acquired to the same touchECG with an HD+ unit with the
interpretation option enabled will have an automatic interpretation.
In the same way, an examination acquired by an HD+ unit without the DICOM connectivity option cannot be
transmitted to a PACS system, while an examination acquired to the same touchECG but with an HD+ unit
with its DICOM connectivity option enabled can be transmitted to a PACS system.
To update the available options, and activate new ones, you must enable them on the HD+ unit.
To do so, request the activation code for the options in question from Cardioline SpA.
Once you have the code, connect the HD+ unit you wish to update to the computer and select it in the
Settings window, as described in par. 5.3.
You can now open the LICENZA (LICENSE) tab and enter the activation code in the respective field. If the
code is valid, the Update license button enables; click on it to start the update process.
When the update completes, the new enabled options are listed in the LICENZA (LICENSE) tab.
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11. MAINTENANCE AND TROUBLESHOOTING
For the maintenance of the HD+ acquisition unit, refer to its user manual.
In the same way, for the maintenance of the support device, refer to the user manual supplied with the
computer.
If necessary, contact Cardioline SpA or an authorised distributor for assistance or to report malfunctions and
anomalies.
Note: the computer should not be serviced in the patient area; make sure that you have taken all necessary
precautions to eliminate electrical hazards (see par. 2).
11.3. Bluetooth
No issues related to “pairing” the HD+ Cardioline device with the touchECG system have been found on
tested systems.
Please also note that the correct start-up procedure of the HD+ system and touchECG is:
first switch on the HD+ unit
then start touchECG
This prevents having to place the HD+ device in error (fast flashing blue). If this problem arises it is advisable
to wait for the HD+ to switch off automatically or remove the batteries and turn it back on.
If the Bluetooth signal is “lost”, the user is warned by a message that appears.
If you repeatedly experience any Bluetooth related problems it is advisable to proceed as follows:
Move the HD+ closer to the touchECG;
Disable WiFi on the tablet/computer being used;
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11. MAINTENANCE AND TROUBLESHOOTING
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12. TECHNICAL SPECIFICATIONS
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12. TECHNICAL SPECIFICATIONS
ECG acquisition mode ........................Automatic (12 leads), Manual (3/6 leads), Review (12 leads)
Lead configuration .............................Standard, Cabrera
ECG measurements ...........................All leads, medians, corrected
HR
Average RR
PR Interval
QRS Duration
QT and QTc (Hodges formula) intervals
QTc Bazett interval
QTc Fridericia interval
max R[V5];[V6] and S[V1]
Sokolow-Lyon Index
P, R, T axis
ECG interpretation.............................Glasgow algorithm for adults, paediatric, STEMI (optional)
ECG interpretation parameters ..........Race, sex, age, drugs
Memory.............................................Internal archive up to 1000 ECGs
Processing Options
Interpretation ....................................Glasgow algorithm for adults, paediatric, STEMI
Connectivity ......................................DICOM
Exported formats
SCP-PDF-XML-GDT .............................Standard format
DICOM...............................................Included in DICOM connectivity option
HL7 ....................................................Optional
Connectivity
USB-LAN-WiFi ....................................Dependent on support device (computer)
Printing
Resolution .........................................Variable in relation to printer
Paper type .........................................Variable in relation to printer
Sensitivity/gain ..................................5, 10, 20 mV/mm
Automatic print speed .......................25, 50 mm/s
Automatic print .................................3, 3+1, 6, 12 channels; Standard or Cabrera;
Automatic print formats ....................12x1, 6x2, 3x4, 3x4+1, 3x4+3
Manual print speed............................5, 10, 25, 50 mm/sec
Manual printing .................................3, 6, 12 channels; Standard or Cabrera;
Manual print formats.........................12x1, 6+6, 3x1
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12. TECHNICAL SPECIFICATIONS
The device implements a high-pass linear-phase filter, with a cutoff frequency of 0.67Hz, to remove the drift
of the entirely digital baseline.
The filter effectively reduces the artefacts induced by the respiratory movement without introducing
distortions on the reproduction of the ST segment, as specifically recommended in "cf. Paul Kligfield et al.,
Recommendations for the Standardization and Interpretation of the Electrocardiogram Part I, Circulation.
2007;115:1306-1324”:
To reduce artifactual distortion of the ST segment, the 1990 AHA document recommended that the
low-frequency cutoff be 0.05 Hz for routine filters but that this requirement could be relaxed to 0.67
Hz or below for linear digital filters with zero phase distortion. The ANSI/AAMI recommendations of
1991, affirmed in 2001, endorsed these relaxed limits for low-frequency cutoff for standard 12-lead
ECGs, subject to maximum allowable errors for individual determinants of overall input signal
reproduction. These standards continue to be recommended
The high-pass filter meets the requirements set by IEC 60601-2-25 2nd Ed. in terms of low-frequency
impulse response:
“A 0,3 mV × s (3 mV for 100 ms) impulse input shall not produce a displacement greater than 0.1 mV
outside the region of the impulse.”
The acquisition (sampling and filtering) system of the device complies with AHA recommendations (Paul
Kligfield et al., Circulation 2007) for both paediatric and adult ECGs. The high frequency response of the
system is 150Hz or 300Hz, depending on the filter applied.
The device also offers the option of applying, only in display and printing mode, digital linear-phase filters
with a cutoff frequency of 25Hz or 40Hz, which reduce the bandwidth of the printed signal in order to
reduce the effects of high frequency noise ("muscular" noise). As a consequence of the application of these
filters, the resulting signal no longer meets the minimum requirements on the high frequency response
reported in the above recommendations.
The device can also be configured to selectively eliminate interference induced by the electricity network
(50Hz or 60Hz, depending on the country where the device is installed).
The network filter complies with the requirements of IEC 60601-2-25 2nd Ed.
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12. TECHNICAL SPECIFICATIONS
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
EN ISO 13485 Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971 Medical devices - Application of risk management to medical
devices
EN 60601-2-25 Medical electrical equipment - Part 2-25: Particular
requirements for the basic safety and essential performance of
electrocardiographs.
Partly applied – Applied in conjunction with HD+
IEC 60601-1-11 Medical electrical equipment -- Part 1-11: General
requirements for basic safety and essential performance --
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment.
Partly applied – Applied in conjunction with HD+
EN 62304 Medical device software - Software life cycle processes
EN 62366 Medical devices - Application of usability engineering to
medical devices
12.3. Accessories
CODE DESCRIPTION
81018027 HD+
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13. WARRANTY
13. WARRANTY
Cardioline SpA guarantees this device for a period of 24 months from the date of sale. The date of purchase
shall be proven by a document, issued upon delivery, which shall be submitted in the case of any claim under
the warranty.
The warranty covers restoring the device operation free of charge for malfunctions relating to installation or
the software itself.
This warranty does not cover defects resulting from:
tampering, third party negligence, including servicing or maintenance by unauthorised personnel;
failure to comply with the user instructions, improper use or use of the equipment other than that
for which it was manufactured;
damage caused by fires, explosions or natural disasters;
use of unauthorised software;
other circumstances not attributable to manufacturing defects.
Cardioline Spa declines all liability for any damage which may be caused, directly or indirectly, to persons or
property as a consequence of non-compliance with all the prescriptions specified in the manual, especially
warnings regarding installation, safety, use and maintenance of the equipment, as well as non-operation of
the equipment.
For restoration/repairs, contact Cardioline SpA or an authorised service centre. Labour is free of charge while
the risks and costs of transport are borne by the customer.
The warranty expires after 24 months from the date of purchase; any subsequent assistance will be charged
at normal labour rates.
Any derogation from the present warranty conditions shall be valid only if expressly approved by Cardioline
SpA.
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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