cubestresslite
User manual
Rev. 10 – 05/07/2019
1936
cubestresslite
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
cubestresslite
Contents
1.
GENERAL INFORMATION .........................................................................................................................1
1.1.
Minimum Requirements for the computer ......................................................................................1
1.2.
Licensing terms ................................................................................................................................1
1.3.
Other important information ...........................................................................................................2
2.
SAFETY INFORMATION .............................................................................................................................3
3.
SYMBOLS AND LABEL ...............................................................................................................................7
4.
5.
6.
3.1.
Explanation of the symbols ..............................................................................................................7
3.2.
Device label ......................................................................................................................................7
INTRODUCTION ........................................................................................................................................9
4.1.
Purpose of the manual .....................................................................................................................9
4.2.
Recipients.........................................................................................................................................9
4.3.
Intended use ....................................................................................................................................9
4.4.
Description of the device .................................................................................................................10
4.5.
General overview .............................................................................................................................10
4.5.1.
Control Panel ...........................................................................................................................11
4.5.2.
Toolbar .....................................................................................................................................13
4.5.3.
Status Bar .................................................................................................................................14
4.5.4.
Main menu ...............................................................................................................................14
4.5.5.
Display windows.......................................................................................................................16
PREPARATION FOR USE............................................................................................................................17
5.1.
Installing the software .....................................................................................................................17
5.2.
Connecting and configuring the HD+ acquisition unit......................................................................17
5.3.
System installation ...........................................................................................................................17
5.3.1.
Installation of the systems with Digital model trolley ..............................................................17
5.3.2.
Installation of the systems with Full model trolley ..................................................................23
EXECUTION OF THE EXAMINATION..........................................................................................................29
6.1.
General procedure ...........................................................................................................................29
6.2.
Before acquisition ............................................................................................................................29
6.2.1.
Preparing the patient ...............................................................................................................29
6.2.2.
Connecting the patient ............................................................................................................30
6.3.
Program start-up..............................................................................................................................31
6.4.
Start and execution of the examination ...........................................................................................32
cubestresslite
6.4.1.
Enter a pressure measurement ...............................................................................................34
6.4.2.
End the examination ................................................................................................................34
6.5.
Defining a protocol ..........................................................................................................................35
6.5.1.
Create a new protocol .............................................................................................................35
6.5.2.
Modifying a protocol ................................................................................................................37
6.5.3.
Default protocols .....................................................................................................................37
6.6.
Signal display windows.....................................................................................................................38
6.6.1.
6.7.
Display modes ..................................................................................................................................40
6.7.1.
ECG - Real Time Mode .............................................................................................................40
6.7.2.
ST Trend Mode.........................................................................................................................41
6.8.
7.
Printing the examination..................................................................................................................42
POST-ANALYSIS AND REPORT CREATION .................................................................................................45
7.1.
General information.........................................................................................................................45
7.2.
Managing the video .........................................................................................................................45
7.2.1.
8.
Displaying the Stress Test.........................................................................................................46
7.3.
Printing Reservations .......................................................................................................................47
7.4.
Compiling the Diagnosis ...................................................................................................................47
7.5.
Printing the Report ..........................................................................................................................48
SYSTEM SETTINGS ....................................................................................................................................51
8.1.
General information.........................................................................................................................51
8.1.1.
9.
Real Time ECG window ............................................................................................................38
Configuration of communication port .....................................................................................51
TROUBLESHOOTING .................................................................................................................................53
10. WARRANTY ..............................................................................................................................................55
cubestresslite
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.
This manual is to be regarded as part of the cubesuite manual, of which cubestresslite is one of the specific
features. Have the operator read the cubesuite manual thoroughly, as a great deal of the information is only
described once.
1.1.
Minimum Requirements for the computer
cubestress Lite can be installed on any computer that meets the following minimum requisites:
Operating System ............................
Windows 7, 8.1 or 10
Processor.........................................
Intel core i5 o or higher
RAM ................................................
At least 4GB
Free space on Hard Disk ..................
At least 500GB
Monitor ...........................................
At least 1280X1024
Output .............................................
8 USB / RS232 / LPT (thermal printer)
Multimedia ......................................
DVD-player and speakers
Safety Standard
IEC 60950-1
1.2.
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.
1
cubestresslite
1. GENERAL INFORMATION
1.3.
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
36510179_EN
2
cubestresslite
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
3

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 par. 1.1. To ensure the electrical
safety of the operator and patient during its operation, the following precautions must be observed:
cubestresslite
2. SAFETY INFORMATION
4

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.

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 electrosurgery 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.
cubestresslite
2. SAFETY INFORMATION

Do not leave the electrodes unattended in the presence of children as they could cause suffocation
if accidentally swallowed.
Attention

The device does not require any calibration or special instrumentation for correct use and
maintenance.
Notes
5

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.
cubestresslite
2. SAFETY INFORMATION
6
cubestresslite
3. SYMBOLS AND LABEL
3.
SYMBOLS AND LABEL
3.1.
Explanation of the symbols
Refer to the cubesuite manual for a complete description of the symbols.
3.2.
Device label
Refer to the cubesuite manual.
7
cubestresslite
3. SYMBOLS AND LABEL
8
cubestresslite
4. INTRODUCTION
4.
INTRODUCTION
4.1.
Purpose of the manual
This manual covers the cubestresslite product
The manual represents a guide for the execution of the following operations:

Reasonable use of the device, of the function keys and of the sequence of menus.

Preparation of the device for use (Section 5)

Execution of an examination (Section 6)

Post-analysis and report creation (Section 7)

Program configuration (Section 8)

Troubleshooting (Section 9)
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.
4.3.
Intended use
cubestresslite is intended for the performance of electrocardiographic examinations under stress (stress
tests). In any case, a Cardiologist must validate the data presented.
cubestresslite is intended for use in hospitals, clinics and outpatient departments of any size.
9

The device acquires, analyses, displays and prints out electrocardiograms and electrocardiographic
examinations under stress.

The device must be used by a doctor or by specialised staff on behalf of an authorised doctor in
clinical facilities. It is not intended as the only means for determining the diagnosis.

The device can be used on adult and paediatric patients.

The device must not be used as a physiological monitoring of vital signs.
cubestresslite
4. INTRODUCTION
4.4.
Description of the device
cubestresslite integrates into a single application all the typical procedures for stress test: management of
patient preparation, real time on-screen display of the 12 leads, tracing printing (also in real time), automatic
handling of ergometers, automatic archiving, printing and exporting in electronic form of the final document.
cubestresslite can operate as a single workstation or it can share the database with other networkconnected cube workstations.
The device installs on any PC, with the minimum requisites listed in par. 1.1.
The cubestresslite device includes:
1. CD software
2. User manual
The device can be sold as a system that may include, depending on the sale configurations:
1. HD+ acquisition device
2. HandyVAQ suction-operated patient cable
3. Computer (tablet or all-in-one PC)
4. Printer
5. Isolation transformer
6. Trolley (full model or digital model)
Each system device comes with its own user manual and accessories.
4.5.
General overview
Cubestresslite shares the overall UI with the cubesuite software, from which you access to the main specific
window of the cubestresslite program.
Refer then to the cubesuite manual for a general description of the overall interface and its key features.
The main window of the cubestresslite program is shown in figure.
10
cubestresslite
4. INTRODUCTION
A B
D
E
F
C
Cubestresslite main window
A. Application bar
B. Main menu
C. Control Panel
D. Toolbar
E. Status Bar
F. Display Windows
4.5.1. Control Panel
It’s a vertical area on the right side of the Main Window, which contains the information and the control keys
of the examination.
11
cubestresslite
4. INTRODUCTION
Control Panel
A. Heart Rate (HR): value of HR in beats per minute (bpm).
B. Percentage Value: percentage ratio between current Heart Rate (HR) and Theroetical Maximum
Heart Rate (HRMax).
C. Pressure: Systolic and Diastolic Pressure in mmHg. Pressing the button shows a window allowing you
to manually enter the measurement.
D. Double Product: current value of the product between Heart Rate (HR) and Systolic Pressure.
E. Test Time: Total time of the test, Exercise and Recovery phases.
F. Step Data – name of the step in progress
G. Step Data – values of the step in progress: value of the load, in Watts or in km/H; step time and
expected duration of the step.
H. Protocol – current protocol name
I.
Protocol – Change phase key: press this key to move to the next phase.
L. Protocol – Emergency button: pressing this button brings the load to zero.
M. Protocol – Step control keys: with these buttons you can move on to the next step (+), extend the
current step (=), return to the previous step (-).
N. Protocol – List of Protocol Steps: shows a list of the steps planned for the current phase.
12
cubestresslite
4. INTRODUCTION
4.5.2. Toolbar
It is located under the main Menu and allows quick access, using graphical buttons (icons), to the most
common operations.
Toolbar
Print Button
This button give immediate access to the Print Page operations.
Buttons for changing the Display Mode
These buttons allow immediate access to the Display Mode.
Buttons for selecting Sensitivity, Speed and Channels of ECG tracing
These buttons allow selecting the display properties of the ECG tracing: sensitivity, speed and channels
shown (see par. 1.5).
Averaging Button
This button allows accessing the Averaging Window, for manual marker setting.
Reset Button
This button allows correcting any leads drift due to electrode polarisation.
13
cubestresslite
4. INTRODUCTION
4.5.3. Status Bar
It is a horizontal bar on the bottom of the Main Window, and displays various information about the status
of the test in progress.
Some information can be edited with a click of the mouse: a window that allows seeing more details
appears.
A
C
B
D
E
F
Status Bar
A. Name of the phase in progress
B. Patient and Medical Report data
C. Active filters
D. Comments list
E. Alarms list
F. Any error message
4.5.4. Main menu
Located under the Application bar, collects the main controls of the program.
Each menu entry is described below.
Entry
Key
Icon
-
-
Setup
-
-
Protocols
-
-
Description
Application menu
Exit
Closes the program
Function menu
Display menu
14
It gives access to the Setup Window that allows setting up
the program.
It gives access to the Protocol Window that allows setting
up the protocols.
cubestresslite
4. INTRODUCTION
Opens the Real Time ECG Mode
Real Time ECG page
F2
Trend page
F3
Opens the Trend Mode
Sensitivity -
SHIFT+
DOWN
Decreases the ECG sensitivity.
Sensitivity +
SHIFT+
UP
Increases the ECG sensitivity.
Speed -
CTRL+
DOWN
Decreases the ECG speed.
Speed +
CTRL+
UP
Increases the ECG speed.
Rotates 6 channels
F10
Rotates the channel in groups of 6 (in windows with 6 or
12 ECG leads)
Displays 12 channels
F11
Displays all 12 ECG channels (in windows with 6 or 12 ECG
leads).
Marker Positioning
F9
Opens the window to edit the Marker.
ECG menu
Test Menu
Test start
Starts the Stress Test.
Pressure
Opens the window to enter the pressure.
Patient data
Opens the window to edit the patient data.
Filters
Opens the window to edit the filters of the ECG signal.
Comment
Opens the window to enter a comment.
Protocol menu
Next phase
Moves to the next phase of the test.
Next step
Moves to the next step.
Previous step
Moves to the previous step.
Extends the Step
Extends the current step (resets the counter).
Help menu
15
F8
cubestresslite
4. INTRODUCTION
?
-
-
Gives information about the program version.
4.5.5. Display windows
The Windows are rectangular portions of the screen that allow accessing various display modes of the ECG
tracing and of the analysis results. The available Windows are listed in the Table.
16
Window
Description
Real Time ECG
ECG real-time scrolling (1/6/12 channels)
Trend
trend of the test and clinical variables
cubestresslite
5. PREPARATION FOR USE
5.
PREPARATION FOR USE
5.1.
Installing the software
Refer to the cubesuite manual for software installation instructions.
5.2.
Connecting and configuring the HD+ acquisition unit
To acquire the electrocardiographic signal, the HD+ acquisition device must be connected to the computer
running the software (configured appropriately).
Refer to the cubesuite manual for installation and configuration instructions of the acquisition device.
5.3.
System installation
As mentioned in par. 4.4, the device may be supplied as a system, consisting of the cube software, the HD+
acquisition device, the computer (desktop or all-in-one PC), the isolation transformer, the trolley and other
listed devices.
Depending on the system configuration, the following additional installation steps may be required.
5.3.1. Installation of the systems with Digital model trolley
First of all assemble the trolley by following the instructions below:
1. Assemble the central tube, aligning the holes and fully tightening the screws (figure A). Fit the cover
on the top of the tube (figure B).
17
cubestresslite
5. PREPARATION FOR USE
A
B
2. Insert the support for the central tube into the base and insert the tube into the support. Align the
holes and fully tighten the screws.
18
cubestresslite
5. PREPARATION FOR USE
3. Insert the following into the central tube in this order: the printer shelf, the main shelf, the basket
and the support for the all-in-one computer.
The Digital model trolley is suitable for use with an all-in-one computer.
Once the trolley has been mounted, you can proceed with the installation of the all-in-one computer and
any other accessories.
1. Fasten the all-in-one computer to its support plate, matching the holes of the plate with the holes at
the back of the computer (monitor) and using the screws the screws provided.
19
cubestresslite
5. PREPARATION FOR USE
Fastening plate and fastening the computer with the screws
2. Place the thermal battery-powered printer (if available) on the opposite shelf and connect it to the
all-in-one computer using the USB cable provided.
3. If the HandyVAQ ECG suction cable is available, fix the cable-holder support to the trolley and fasten
the HandyVAQ to the cable-holder support.
HandyVAQ cable support and HandyVAQ assembled
20
cubestresslite
5. PREPARATION FOR USE
4. Connect the HandyVAQ (if available) to the HD+ acquisition device and to the PC: connect connector
(A) to the patient cable connector of the HD+ (A) and the USB connector (B) to a USB port on the PC
(see figure).
B
A C
5. Connect the ergometer to the PC using the opto-insulated serial cable supplied with the ergometer.
If your computer has a serial port, plug the serial cable (A) to the port on your computer (B), as
shown in figure (C).
A
B
C
If the computer has no serial port, you need to use a serial-USB adaptor.
a. Install the drivers found in the cube installation disk in the folder:
C:\Users\damicma1\Documents\Cube_installer\Cube_135_released\support\ergometer_tool
\USB driver for XR50_Microtel\CP210x_VCP_Windows_rel6.6.1
21
cubestresslite
5. PREPARATION FOR USE
b. Insert the USB plug of the adapter (C) into the USB port on your computer and wait until the
hardware is installed.
c. Connect the serial cable of the Ergometer (A) to the serial-USB converter provided (B).
d. In the Windows control panel Devices And Printers > Device Manager > COM and LPT ports
check the serial port number assigned to the adapter, required to configure the
cubestresslite software.
A
When the system has been mounted it should appear as follows:
System assembled
22
B
C
cubestresslite
5. PREPARATION FOR USE
5.3.2. Installation of the systems with Full model trolley
The full model trolley is already mounted, but you need to assemble the computer and the other
components:
2. Fasten the monitor support:
a. Remove the drawer
b. Fasten the monitor support to the trolley by tightening the 3 screws and the washers
supplied using the wrenches (1 and 2).
c. Put the drawer back in its place.
3. Fasten the LCD monitor:
a. Remove the 4 screws on the monitor (indicated by the letter E in the figure). Do not reuse
the screws.
b. Fasten the LCD monitor to the support using the 4 Phillips screws provided (3), contained in
the accessory bag.
4. Connect the cables, using the slots located on the arm of the monitor support to place the cables as
shown below:
a. Main shelf: keyboard and mouse, thermal printer cable (if present)
23
cubestresslite
5. PREPARATION FOR USE
b. Top shelf: monitor cable, monitor power supply cable, audio cable, USB extension for
bluetooth dongle (if present).
(A)
Back
(B)
Monitor support
5. Install the isolation transformer, if available:
a. Insert the power supply plug into the transformer and fasten the cable with the ‘power cord
restraint Kit’.
b. Remove the drawer from the trolley and place the transformer in the compartment (see
picture). Fasten the transformer on the rear of the trolley with the screw. The system power
switch is located on the left side of the trolley.
c. The transformer is factory-set at 230V; for 115V power supply refer to its user manual.
24
cubestresslite
5. PREPARATION FOR USE
6. Installing the printer:
a. Plug the power supply and USB cables into the printer.
b. Slide the cables through the rear panel of the trolley and place the printer on the special
compartment on the shelf, as shown in figure.
When installing a thermal printer, this must be positioned on the main shelf, behind keyboard and
mouse, and not in the printer compartment.
7. Installing the computer:
a. Connect all cables to the computer by passing them through the rear panel of the trolley.
Place the computer on the shelf of the special compartment, as shown in figure.
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cubestresslite
5. PREPARATION FOR USE
8. If the HandyVAQ ECG suction cable is available, fix the cable-holder support to the trolley using the
holes located on the back of the trolley (A), and fasten the HandyVAQ to the cable-holder.
A
9. Connect the HandyVAQ (if available) to the HD+ acquisition device and to the PC: connect connector
(A) to the patient cable connector of the HD+ (B) and the USB connector (C) to a USB port on the PC
(see figure).
B
A C
10. Connect the ergometer to the PC using the opto-insulated serial cable supplied with the ergometer.
To make the connection plug the serial cable connector (A) to the serial port of the supplied serialUSB converter (B), and connect the USB connector of the converter (C) to a USB port on the
computer.
In the full stress systems, the serial-USB adapter is normally pre-installed at the factory. If not, follow
the steps for installing the drivers described in step 5 of the previous chapter.
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cubestresslite
5. PREPARATION FOR USE
A
B
C
11. Activate the trolley by switching on the green button on the back of the trolley.
When the system has been mounted it should appear as in the figure below:
System assembled
27
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5. PREPARATION FOR USE
28
cubestresslite
6. EXECUTION OF THE EXAMINATION
6.
EXECUTION OF THE EXAMINATION
6.1.
General procedure
To execute an examination proceed as follows:
1. Prepare and connect the patient (par. 6.2).
2. Start the program (par. 6.3).
3. Define a test protocol (par. 6.4).
4. Display the signal (par. 6.6 and 6.7).
5. Print the examination (par. 6.8).
6. End the examination (par. 6.4.2).
6.2.
Before acquisition
6.2.1. Preparing the patient
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 signal acquisition.
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:
29

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.
cubestresslite
6. EXECUTION OF THE EXAMINATION
NOTE: Pay attention not to cause abrasions, discomfort or bruises on the skin. Always observe the utmost
clinical discretion when preparing the patient.
6.2.2. Connecting the patient
It is important to position the electrodes properly in order to acquire a good electrocardiographic signal.
Indeed a low impedance ensures a better waveform, reducing noise. Quality electrodes should be used.
Connect the electrodes as follows:
1. Expose the arms and legs of the patient to connect the relevant leads.
2. Position the electrodes on the flat and fleshy parts of the arms and legs.
3. If a limb is not available, position the electrodes on a blood-supplied stump.
4. Attach the electrodes to the skin as indicated in the following figure. Test the correct adherence, and
therefore the good contact, by pulling the electrode. If the electrode moves freely, replace it. If the
electrode does not move easily, a good electrical contact is ensured.
Correct positioning of the electrodes
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
30
cubestresslite
6. EXECUTION OF THE EXAMINATION
immediately below it corresponds to the second intercostal space. Palpate and count following the trunk until
the fourth intercostal space is located.
6.3.
Program start-up
You need to start the cube software from the Windows Start Menu to start the test.
Start > Programs > Cardioline > Cube
When the Login Window appears, enter User Name and Password.
You can use the default values:
User Name = MED1
Password = MED1
For more details about creating users refer to the cubesuite manual.
At startup, the main window of the program opens, where you can start a new examination by choosing one
of these two ways:
1. Press the top left “New Test” button;
2. select a patient from the patient list, click with the right mouse button and select from the dropdown menu “New Examination”.
In both cases, a wizard starts: first, you must select as examination type “Stress Test” (see Figure).
The procedure leads automatically to the beginning of the examination and the opening of the Stress Test
program.
New examination window
31
cubestresslite
6. EXECUTION OF THE EXAMINATION
6.4.
Start and execution of the examination
After choosing “New examination” and selecting Stress-test from the drop down menu as explained in the
previous paragraph, a wizard starts, allowing beginning the examination.
Specifically you need to:
1. Enter patient data
2. Press the Next key until the opening of the screen with the directions for positioning the electrodes
3. press the Start button, which opens the window displaying the signal in real time
4. wait until the averaged complexes are calculated and press the “Start Stress Test” button.
5. Configure the markers and the reference lead: once you start the test, the program opens the
“Global markers configuration” utility, which allows editing the markers with the sliders “QRS Start”,
“J Point” and “T End” and changing the reference lead by pressing the LEAD key.
32
cubestresslite
6. EXECUTION OF THE EXAMINATION
6. Select the protocol: select the operating Protocol from the list, choosing the type of ergometer and
protocol.
7. Now the examination is in the “Pre-exercise” warm-up phase of the patient. By pressing the “Start
Exercise” button you can start the stress test.
33
cubestresslite
6. EXECUTION OF THE EXAMINATION
6.4.1. Enter a pressure measurement
During the examination you can enter blood pressure measurements by pressing the PA key. If the
ergometer is equipped with pressure meter, the PA key starts automatic measuring and receives the
reading, otherwise the value can be entered manually.
The OK key saves the automatic reading of the ergometer or the manually-entered value.
6.4.2. End the examination
The programme will automatically follow the steps of the exercise.
Under normal conditions, when the Doctor considers the exercise concluded, press the Start Recovery key to
start the recovery phase, which ends by pressing the Test End key.
If you need to end the test before the Recovery phase, press several times the Change Phase key.
You can always trigger the Emergency Stop command, which brings the load to zero.
When the examination is completed, the test is automatically stored, the Stress Test management is closed
and the Post-Analysis program automatically opens: it is used for reporting and printing the Report of the
just-completed examination.
At the end of the test the program closes and the examination opens in reporting mode.
34
cubestresslite
6. EXECUTION OF THE EXAMINATION
To insert the report you have to press the key with the patient’s name.
6.5.
Defining a protocol
To set the operating parameters of the ergometers, use the Protocol window accessible from Menu:
Menu > Function > Protocols.
The program has a set of default protocols to choose from, which can be modified by the user. It is also
possible to create custom protocols.
6.5.1. Create a new protocol
To create a new protocol you must select from the window Protocols > New protocol.
This enables a wizard for quick protocol definition.
35
cubestresslite
6. EXECUTION OF THE EXAMINATION
Protocols Window
Proceed as follows:
1. Select the protocol type “Cycle Ergometer, Treadmill or Generic” and assign a name
2. Select the load and duration data and follow the wizard.
36
cubestresslite
6. EXECUTION OF THE EXAMINATION
3. Set the recovery data and press the End key.
6.5.2. Modifying a protocol
To modify an existing protocol you must select it from the list by double clicking.
The window shows the details of the phases and steps of the protocol in the 3 boxes below: Pre-exercise,
Exercise, Recovery.
To edit a phase, select a step, click the right mouse button and select the desired action:

New: inserts a new step after those present.

Insert: inserts a new step after the selected one.

Edit: allows editing the step parameters.

Delete: deletes the selected step
6.5.3. Default protocols
The table below shows the cubestresslite default protocols, divided by ergometer type.
Ergometer
type
Ergometer
Treadmill
37
Protocol
Step
tot
Step
Duration
Load/speed
increment
25W X 2 m
16
120"
25 W
25-400 W
25W X 3m
16
180"
25 W
25-400 W
10W X 1m
39
60"
10 W
10-400 W
RAMP
Slope incr.
continuos, incremental
Load
range
25-400 W
50W X 2m
14
120"
50 W
50-700 W
30W X 2m
13
120"
30 W
30-390 W
30W X 3m
13
180"
30 W
30-390 W
60"
Fixed
3.2km/h
Naughton
Km/h
8
Slope
range
3.50°
3.2 Km/h
0-22°
cubestresslite
6. EXECUTION OF THE EXAMINATION
Ergometer
type
Generic
6.6.
Protocol
Step
tot
Step
Duration
Load/speed
increment
Slope incr.
Load
range
Slope
range
mod. Naughton
Km/h
8
60"
Fixed
2.0km/h
3.50°
2 Km/h
0-22°
Bruce Km/h
7
180"
1022°
Mod. Bruce
Km/h
7
180"
0-18°
Balke km/h
10
60"
Fixed
4.8 Km/h
2.50°
2.7-9.6
Km/h
2.7-8
Km/h
Fixed
4.8 Km/h
Tilt Test
60
60"
/
/
/
/
2°
0-22°
Signal display windows
During the test the electrocardiographic signal is displayed in the Real Time ECG window, which allows
viewing the leads in real time throughout the duration of the examination.
6.6.1. Real Time ECG window
The Real Time ECG Window is present throughout the test and allows monitoring the patient during the test
showing the leads of the electrocardiographic signal in real time.
The size of the window depends on the chosen display mode (see par. 6.7).
Depending on the display mode, you can choose which lead or which groups of leads to display.
The window has a status bar at the bottom that shows the basic signal information: amplitude, speed, heart
rate and elapsed time of the test.
Real Time ECG window
38
cubestresslite
6. EXECUTION OF THE EXAMINATION
Change Amplitude and Speed
The amplitude and speed of th e l e ads can be edited through the Toolbar buttons.
Icon
Function
Description
Amplitude
Changes the values in 1, 5, 10, 20, 40 mm/mV
Speed
Changes the values in 1, 5, 10, 12.5, 25, 50, 100, 200
mm/s
Changing the channels displayed
You can change the channels displayed through the Toolbar buttons.
Icona
Tasto
Funzione
Descrizione
F10
Rotates 6 channels
Rotates the channel in groups of 6 (in
windows with 6 or 12 ECG leads)
F11
Displays 12 channels
Displays all 12 ECG channels (in windows
with 6 or 12 ECG leads).
Changing the display colours
The look and colours of the window can be changed by accessing:
Menu > Functions > Setup > ECG.
39
cubestresslite
6. EXECUTION OF THE EXAMINATION
6.7.
Display modes
The display windows are grouped in combinations called Display Mode, each containing at least the Real
Time ECG window.
You can switch from one mode to another by using the corresponding buttons on the Toolbar.
The Table summarises the available Modes.
Icon
Key
Mode
F2
ECG - Real Time Mode
F3
Trend Mode
6.7.1. ECG - Real Time Mode
The ECG - Real Time Mode comprises 3 windows:
1. The Real Time ECG window, in 6/12 channels mode.
2. Averaging 12 window, with the average beats updated in real time.
3. Baseline Averaging 12 window, with the baseline average beats.
The Real Time ECG Mode allows controlling both the ECG tracing in real time and the morphologies of AVG
beats, in real time and compared to the baseline tracing.
Customising the AVG
From Setup (Menu>Functions>Setup>AVG) you can customise the colours of the AVG tracings.
All the operations described for the Real Time ECG window are also available.
40
cubestresslite
6. EXECUTION OF THE EXAMINATION
A
B
C
ECG - Real Time Mode
A. Real Time ECG window
B. AVG real time window
C. AVG baseline window
6.7.2. ST Trend Mode
The ST Trend Mode comprises 3 windows:
1. The Zoom ECG window, in 6/12 channels mode.
2. The Trend window, which shows the trend of the main variables of the test and the results of the ST
analysis in real time on all 12 channels.
3. The ST Trend window, which shows the trend of the results of the ST analysis updated in real time
for all 12 channels.
The Mode is particularly useful to assess the progress of the test as a whole, thanks to the presence of Heart
Rate, Pressure, Load and Double product charts.
The window with the ST Trend contains two types of information at the same time:
41

amplitude of ST segment elevation, represented by the height of the vertical section

sloping of ST segment, represented with the following colours: RED = positive slope, BLUE = negative
slope
cubestresslite
6. EXECUTION OF THE EXAMINATION
Modifying the look of the Trend windows
From Menu>Function>Setup>Trend you can activate the filtering of the data presented on the trend and
change the colours of the various graph sections.
All the operations described for the Real Time ECG window are also available.
A
B
C
Trend Mode
A.
Real Time ECG window
B.
Trend window
C.
ST Analysis window
6.8.
Printing the examination
During the test the Real Time ECG Printing is possible, that prints the ECG displayed in real time.
The AUTO Printing allows to print 10 seconds of ECG tracing in the selected format; AUTO printing can be
performed automatically every step, phase, 60 seconds or 180 seconds, or started by clicking the Toolbar
button.
42
cubestresslite
6. EXECUTION OF THE EXAMINATION
Icona
Tasto
Funzione
Descrizione
-
AUTO printing
12, 12+AVG, 6+6, 6+6+AVG
You can choose print format and the printer to be used from Menu> Function> Setup> Printing.
Print setup
43
cubestresslite
6. EXECUTION OF THE EXAMINATION
44
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
7.
POST-ANALYSIS AND REPORT CREATION
7.1.
General information
The program cubestresslite can be used, in addition to managing the stress test in real time, to review the
examination, carry out a detailed analysis of the results and print the examination report. This phase is called
Post-Analysis.
The Post-Analysis can be carried out in two ways:
1. automatically at the end of the Stress Test: when in the Recovery phase press the “Test End” button,
the current window closes and is replaced by the Post-Analysis window;
2. manually from the examinations archive: from cubesuite, select the examination you want to
analyse and start the Post-analysis program with a “double click”.
Closing the recovery
phase
Choosing an
examination from the
manager program
Starting the Post-Analysis
Accessing the Post-Analysis program
7.2.
Managing the video
The Post-Analysis program has the same type of windows as the Stress Test Manager program, except for
the Real Time ECG window, replaced by the Zoom ECG window.
The Display Modes are the same, with the following exceptions:
45

ECG Review Mode: the Real Time ECG Window is replaced by the Contents window, which
summarises the data of the various phases of the test

Trend Mode: the Real Time ECG Window is replaced by the AVG window with the 12 leads in column
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
The function of the Control Panel becomes displaying all the test data (heart rate, blood pressure, double
product, the name of the phase and of the stage, load, etc.), relating to the instant in which the Zoom of the
ECG Window is placed.
Contents Window
7.2.1. Displaying the Stress Test
There are several ways to “navigate” inside the Stress Test recording and revising the interesting parts.
Event List Scrolling
You can display the lists of the alarms and the comments recorded during the test and scroll all the recorded
events.
Each element of the lists works as a bookmark, i.e. by clicking on it the ECG window focuses on that event.
Scrolling the Step List
Another way to navigate through the test is to use the list of step performed.
46
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
7.3.
Printing Reservations
From the ECG Zoom and Compacted ECG Window you can select a signal section and open the Drop-down
Menu with the right mouse button. The menu features as the last entry print booking: the track selected
ECG was then added automatically to your Report. The program also requires entering a comment, which
appears as a reminder in the list of ECG sections reserved.
7.4.
Compiling the Diagnosis
To compile the diagnosis, you must access the reporting window, via the button in the Status Bar of the
program.
The window shown in the Figure, consisting of 3 tabs, pops up:

Conclusions: makes available to the Doctor the Interrupted for field and the free text field for
Diagnosis; as an aid to compiling, you can insert classical expressions (phrase book).

Patient Database: contains automatically the data (modifiable) of the patient, which the user entered
at the beginning of the test.

Examination: contains the essential examination data (Date And Time, Directions, Therapy, Reporting
Doctor).
We recommend that you verify the accuracy of the automatic fields (patient data and Reporting Doctor) and
change them if desired.
At the end, to confirm, press the OK key, to undo changes press Cancel.
Normally, the next phase is to prepare and print the Report; see the next paragraph.
47
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
Reporting Windows
7.5.
Printing the Report
Icon
Key
Function
Description
-
REPORT printing
Compiling and printing the Report
-
Preview
compiling and displaying the Report
To print the Report, simply press the Print key in the Toolbar.
If you wish to display a Report preview before printing, press the Preview key.
In both cases the Report Configuration window pops up (Figure 2.5), in which the user can choose which
elements to include in the Report.
48
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
A
B
C
D
E
F
G
H
Report Configuration window
A. Cover (examination data and conclusions) and Table (list of the steps performed).
B. Table of measurement on ST and/or QT sections.
C. Averaging: average heartbeat tracing, with average calculated on 4 seconds or on the whole
duration of the step.
D. Trend of measurements of ST and QT sections or just ST
E. Compacted: printing of the complete test, from 1 to 12 channels.
F. ECG - Manual sections selection: includes all the reserved ECG; from the list you can exclude one or
more events with a click of the mouse.
G. ECG - Real time sections selection: includes all the ECG sections printed in real time during the test;
from the list you can exclude one or more events.
H. ECG - Comments sections selection: includes all ECG sections corresponding to comments entered
during the session; from the list you can exclude one or more events.
49
cubestresslite
7. POST-ANALYSIS AND REPORT CREATION
50
cubestresslite
8. SYSTEM SETTINGS
8.
SYSTEM SETTINGS
8.1.
General information
To customise the interface and set the program parameters, use the Setup window:
Menu> Function> Setup.
The window is organised on multiple tabs:

ECG: ECG colors; duration and number of rows of the Compacted ECG window

ECG Ex: ECG filters; group of leads for “sextuple under stress”; maximum HR thresholds for male and
female

Peripherals: input port and device type for any ergometers or blood pressure monitors; only one
type of ergometer (cycle or treadmill) can be set at a time: for example if you have a cycle
ergometer, you must select “NO” in the treadmill field.

Printouts: printer and format to be used for automatic, continuous and report printing

Trends: colors and scales of the Trend charts; any filtering of data entered in the Trend, to use in the
event of garbled lead

Medians: colours of the charts and markers, scale of representation in the AVG window with 1
channel

QRS Detector: channels in which to search for the QRS complex and algorithm parameters (we
recommend choosing the channels with minimal artifacts)

Input: Perform all the steps reported in the “cubesuite” manual to install the drivers for the devices
and the Bluetooth pairing (if required). Choose both the communications port (COM or USB) and the
associated device type.

Header: name of the Institute and Department for the print header
8.1.1. Configuration of communication port
It is possible to select the communication port (COM or USB) and the associated device type as shown in the
table.
51
cubestresslite
8. SYSTEM SETTINGS
Type of the device
Configuration
Notes
clickecg
Only for cube suite version
1.4.X.1.
clickecgBT
Only for cube suite version
1.4.X.1.
HD+
Only for cube suite version
1.4.X.2.
Demo file
NOTE: ECG acquisition devices Cardioline clickecg and clickecgBT are no longer sold but can still be used as
indicated. They cannot coexist with the Cardioline HD+ device.
52
cubestresslite
9. TROUBLESHOOTING
9.
TROUBLESHOOTING
The program may display these error messages.
Problem
Cause
Patient First and Last name
fields are empty
Search BT device…
The bluetooth acquisition Verify that the bluetooth
device is not detected.
device is turned on,
running and connected.
The USB acquisition device Verify that the USB device
is not detected.
is turned on, running and
connected.
The ergometer is not Verify that the ergometer
detected.
is turned on, running and
connected.
Communication interrupted
For further information, refer to the Cube Suite manual.
53
Solution
Compile the Patient First
and Last name fields.
cubestresslite
9. TROUBLESHOOTING
54
cubestresslite
10. WARRANTY
10.
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 restoration free of charge of the device's function, for malfunctions relating to the
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.
55
Head Office and Production
Via Linz, 151
38121 Trento
Italy
T. +39 0463 850125
F. +39 0463 850088
56
Sales Office:
Via F.lli Bronzetti, 8
20129 Milan, Italy
T. +39 02 94750470
F. +39 02 94750471