Cardioline cubestresslite User manual

1936
Rev. 10 –05/07/2019
cubestresslite
User manual

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
3.1. Explanation of the symbols..............................................................................................................7
3.2. Device label......................................................................................................................................7
4. 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
5. 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
6. 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. Real Time ECG window ............................................................................................................38
6.7. Display modes..................................................................................................................................40
6.7.1. ECG - Real Time Mode .............................................................................................................40
6.7.2. ST Trend Mode.........................................................................................................................41
6.8. Printing the examination..................................................................................................................42
7. POST-ANALYSIS AND REPORT CREATION .................................................................................................45
7.1. General information.........................................................................................................................45
7.2. Managing the video .........................................................................................................................45
7.2.1. Displaying the Stress Test.........................................................................................................46
7.3. Printing Reservations .......................................................................................................................47
7.4. Compiling the Diagnosis...................................................................................................................47
7.5. Printing the Report ..........................................................................................................................48
8. SYSTEM SETTINGS....................................................................................................................................51
8.1. General information.........................................................................................................................51
8.1.1. Configuration of communication port .....................................................................................51
9. TROUBLESHOOTING.................................................................................................................................53
10. WARRANTY ..............................................................................................................................................55

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1. GENERAL INFORMATION
1
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.

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1. GENERAL INFORMATION
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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

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2. SAFETY INFORMATION
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2. SAFETY INFORMATION
Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if:
1. Assembly, modification or repair operations are carried out by Cardioline SpA or by one of its
Authorised Assistance Centres;
2. The device must be used in compliance with the instructions contained in the user manual.
Always contact Cardioline SpA should you wish to connect any devices not mentioned in this manual.
Warnings
This manual provides important information on 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:

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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.

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2. SAFETY INFORMATION
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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
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
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3. SYMBOLS AND LABEL
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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.

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3. SYMBOLS AND LABEL
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cubestresslite
4. INTRODUCTION
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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.
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.

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4. INTRODUCTION
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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 network-
connected 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.

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4. INTRODUCTION
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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.

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4. INTRODUCTION
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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.

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4. INTRODUCTION
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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.

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4. INTRODUCTION
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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.
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
Description
Application menu
Exit
-
-
Closes the program
Function menu
Setup
-
-
It gives access to the Setup Window that allows setting up
the program.
Protocols
-
-
It gives access to the Protocol Window that allows setting
up the protocols.
Display menu
A
B
C
D
E
F

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4. INTRODUCTION
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Real Time ECG page
F2
Opens the Real Time ECG Mode
Trend page
F3
Opens the Trend Mode
ECG menu
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.
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
F8
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

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4. INTRODUCTION
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?
-
-
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.
Window
Description
Real Time ECG
ECG real-time scrolling (1/6/12 channels)
Trend
trend of the test and clinical variables