Cardioline Cubestress System User manual

1936
Rev. 00 –28.10.2019
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
Cubestress System
User manual

Cubestress System
Contents
1. GENERAL INFORMATION ................................................................................................................................ 2
1.1. Licensing terms ....................................................................................................................................... 2
1.2. Other important information................................................................................................................. 2
2. SAFETY INFORMATION.................................................................................................................................... 3
3. SYMBOLS AND LABEL ...................................................................................................................................... 6
3.1. Explanation of the symbols .................................................................................................................... 6
3.2. Device label ............................................................................................................................................. 6
4. INTRODUCTION ............................................................................................................................................... 7
4.1. Purpose of the manual ........................................................................................................................... 7
4.2. Recipients ................................................................................................................................................ 7
4.3. Intended use............................................................................................................................................ 7
4.4. Description of the device ....................................................................................................................... 8
5. TECHNICAL SPECIFICATIONS........................................................................................................................... 10
5.1. Applied harmonised standards.............................................................................................................. 10
6. WARRANTY....................................................................................................................................................... 12
7. DISPOSAL.......................................................................................................................................................... 13

Cubestress System
1. GENERAL INFORMATION
2
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 operator. Strict compliance with the information contained in this manual is an essential
prerequisite for the proper and reliable use of the device.
The operator should read the manual thoroughly, as a great deal of the information is only provided once.
1.1. Licensing terms
By installing the software, the terms and conditions described below are accepted.
The object of this agreement is granting the licence for use of the software and the operating manual.
Cardioline S.p.A. 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 provisions.
All rights relative to the software are the property of Cardioline S.p.A.. The transfer of software onto another
computer by internet or data channel is not permitted.
The programs and the attached documents cannot be changed, copied, merged with other programs or
made available to third parties.
The user is deemed responsible for any damage arising from non-compliance with the copyright, or from
breach of the conditions set forth in this agreement.
1.2. Other important information
This manual was written with the utmost care. Should you find any details that do not agree with the
contents of this manual, please inform Cardioline S.p.A., who will correct such inconsistencies as promptly 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 the property of their respective owners. Their protection is
guaranteed.
No part of this manual may be reprinted, translated or copied without the manufacturer's written
authorisation.
The codes relating to this manual are listed below.
Language
Code
English
36510219_ENG

Cubestress System
2. GENERAL INFORMATION
3
2. SAFETY INFORMATION
Cardioline SpA shall be liable for the safety, reliability and functionality of the devices only if:
Assembly, modification or repair operations are carried out by Cardioline SpA or by one of its
Authorised Assistance Centres;
The device is 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, misuse of the device, ignoring the specifications
and recommendations provided, may cause severe physical injuries to the operators, patients and
bystanders, or may damage the device.
Each device that forms part of this system is supplied with its own operating manual. For the correct
use and the safety of the system, you must read the manuals supplied carefully and comply with the
instructions and recommendations contained therein.
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 represent the physiological condition of the patient;
this information can be examined by specialist medical personnel and will be useful in providing an
accurate diagnosis. In any event, the data must not be used as the only means to make an accurate
diagnosis of the patient.
The operators that this device is intended for must have the required skills regarding medical
procedures and the treatment of patients. They must also be appropriately trained in using the
device. The operator must 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 might pose a greater risk for the physical safety of operators, patients and
bystanders, or might damage the device.
This device is installed on a computer. To ensure the electrical safety of the operator and patient
during its operation, the following precautions must be taken:
If the computer is powered by the power supply mains, it cannot be used in the patient
area.

Cubestress System
2. GENERAL INFORMATION
4
When used in the patient area, it must be powered with an isolation transformer that
complies with standard EN 6061-1 ed. 3.1 and a system of shielded cables must be used to
connect the device to the LAN. The power cable shielding (when present) must be
connected to a protective earth system appropriate for the area where the device is used.
This will prevent electric shocks caused by different earth potentials which might exist
between the various points of an electricity distribution system, or failures of the external
equipment connected to the mains.
The quality of the signal may be adversely affected by the use of other medical equipment such as
ultrasound machines.
The device is intended for external use and is not intended for direct cardiac application.
There is an explosion hazard. Do not use the device in the presence of flammable anaesthetics.
There is no safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
The device is not designed for use with high-frequency (HF) surgical equipment and does not provide
any protective means against hazards to the patient.
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 is not recommended in the presence of medical diagnostic imaging equipment
such as Magnetic Resonance Imaging (MRI) or Computerised Axial Tomography (CAT) in the same
premises.
This device may cause interference with the RF channel: microwave ovens, diathermy units with LAN
(distributed spectrum), amateur radios and government radars.
The HD+ unit for use with the device is protected against defibrillation. Check the HD+ unit's cables
for cracks and breakage before using it.
The Handy Vaq suction cable is not protected from defibrillation; it must, therefore, be removed
before a defibrillation.
Please refer to the operating manuals of the individual devices supplied for the risks and warnings
related thereto, including instructions on the use of electrodes, patient cables, connection cables
and on use with other medical equipment.
Using a computer equipped with a GPRS or WLAN unit may interfere with other equipment nearby.
Check with local authorities or with providers of the spectrum of your facility to find out whether
any restrictions apply to use of the device in your area.
Do not leave the cables unattended in the presence of children as they might be accidentally
strangled.
Do not leave the electrodes unattended in the presence of children as they might cause suffocation
if accidentally swallowed.
The system cannot be used outdoors.

Cubestress System
2. GENERAL INFORMATION
5
The devices that form part of the system can only be used with the compatible accessories and
devices indicated in the respective operating manuals.
The Cubestress software must be installed on the computer supplied. The minimum requirements
for the computer are indicated in the operating manual of the Cubestress software.
The devices that form part of the system must be inter-connected as described in the respective
operating manuals.
Attention
The analysis algorithm is intended for the analysis of ECG traces acquired with the HD+ unit. The
algorithm provides an analysis of the traces and a classification of heartbeats, events, calculation of
medians and of the ST/QT section. Validation by a cardiologist or a doctor is always required.
Contraindications
The device may not be used with the following categories of patients:
patients who report discomfort or who suffer from dizziness, nausea or pain;
patients under the influence of substances (alcohol, drugs, medication) that may impair
individual lucidity.
Notes
The movements of the patient may generate excessive noise and affect the quality of the ECG trace
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 it 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
viewed on video or printed, these leads will be shown on the chart as a square wave.
The accuracy of the measurements taken by this device complies with standard IEC 60601-2-25.
The device is Class II in compliance with Directive 93/42/EEC.

Cubestress System
3. SYMBOLS AND LABEL
6
3. SYMBOLS AND LABEL
3.1. Explanation of the symbols
Symbol
Description
CE marking –compliance with European Union directives
Manufacturer
Product code
Serial number
Year of manufacture
Refer to the user instructions
Comply with the instructions in the user manual
Separate collection of waste electrical and electronic equipment
3.2. Device label

Cubestress System
4. INTRODUCTION
7
4. INTRODUCTION
4.1. Purpose of the manual
This manual covers the product Cubestress System.
The manual describes the system and its intended use. Please refer to the operating manuals of the
individual products for their detailed operation and to the manual of the Cubestress rel. 4.xy software for
operation of the system as a whole.
4.2. Recipients
This manual is intended for professional healthcare operators. They are therefore assumed to have specific
knowledge of medical procedures and terminology, as required by clinical practice.
4.3. Intended use
Cubestress System is intended for the performance of cardiovascular stress tests. It aims to analyse ECG
signals, acquired and transmitted wirelessly with the HD + / CLICKECG-HD units, and other biometric data
(non-invasive blood pressure, SpO2), acquired with the unit mounted on an ergometer, during the
performance of cardiovascular stress tests for the assessment and diagnosis of cardiac functions. Stress may
be induced with the use of the software-controller ergometer.
HD + / CLICKECG-HD may use a standard patient cable or a Handy Vaq ECG suction cable.
Cubestress System also makes it possible to review and report a previously performed and recorded stress
test.
The device may only be used in stress tests and for the rehabilitation of cardiac and cardiovascular patients.
If the device is used for other purposes, the manufacturer may not be held liable for personal injury or
damage to property deriving by the unintended use of the equipment.
The device is designed to assess and diagnose cardiac function. In any case the results of the analyses
performed by Cubestress System must be validated by a physician.
The device is intended to display, store and analyse ECG signals during the performance of
cardiovascular stress tests
The device is indicated for use in clinical contexts, by a physician or trained personnel acting on
behalf of an authorised physician.
The device is intended to provide data analyses that must be examined by a physician.
The device is not intended as the only means of diagnosis.
The device is not intended for use as a physiological monitor of vital signs.

Cubestress System
4. INTRODUCTION
8
The data provided by Cubestress are significant only when read by a physician and used together
with all other relevant patient data.
The device is intended for use with adult and paediatric patients (in accordance with the AHA
guidelines on testing), without gender limitation. The following limitations apply:
oErgometers for bicycles (xr50 + / xr100 + / xr100BP +) may be used on adults and children
(older than 2 and up to 12 years of age):
Patient height: approx. 120 cm - 210 cm;
Allowed patient weight:
oSaddle with manual height regulation up to 160 kg;
oSaddle with height regulation assisted by gas spring (optional) up to 200
kg;
oSaddle with electric height regulation with digital indication of the current
height (optional), up to 200 kg;
oThe treadmills (XR600R / XR600M / XR600P / XR450R / XR450M / XR450P) may be used on
adults and paediatric patients from 3 years of age onwards without specific limitations;
oHandy VAQ may be used on patients older than seven, also based on body size.
The device is not intended for sterile use or outdoor use.
If Handy Vaq is used, the electrodes must be removed before defibrillation.
The device must not be used in potentially explosive areas or in the presence of flammable gases,
such as anaesthetic agents.
The device is not intended for direct cardiac application.
The device must not used in an MRI suite.
If the device is used in the patient area, non-ME equipment (computers, printers, etc.) must be
powered via the IMED 1000 isolation transformer.
The following patient categories are excluded from use of the device:
Patients with discomfort or dizziness, nausea or pain.
Patients under the influence of substances that may impair vigilance (alcohol, drugs, medication).
4.4. Description of the device
Cubestress System is a family of systems for the performance of cardiovascular stress tests.
The system consists of the following devices, both medical and non medical:
Software for viewing, analysing and printing ECG traces and for management of the tests
(Cubestress);
ECG acquisition unit (HD + / CLICKECG-HD) with optional ECG suction cable (Handy VAQ);

Cubestress System
4. INTRODUCTION
9
Computer on which the software is installed (with display, keyboard and mouse);
Optional ergometer, controlled by the software, for the performance of the physical test (xr50 + /
xr100 + / xr100BP + / XR600R / XR600M / XR600P / XR450R / XR450M / XR450P);
Optional printer;
Optional isolation transformer (IMED 1000 3rd Ed);
Optional trolley.
The patient may be connected to the HD + ECG acquisition unit via a standard patient cable with electrodes
or via the Handy VAQ ECG suction cable. The unit is, in its turn, connected to the computer via Bluetooth,
thus transmitting the ECG signals to the computer wirelessly. The Cubestress software displays and analyses
such signals for reviewing by the operator.
The ergometer is connected to the computer via opto-isolated serial or USB cables and is controlled by the
Cubestress software, automatically or with manual input by the operator.
The devices that form part of the system must be inter-connected as described in the respective operating
manuals.
For a detailed description of the individual devices and of their operation, please refer to the related
operating manuals.

Cubestress System
5. TECHNICAL SPECIFICATIONS
10
5. TECHNICAL SPECIFICATIONS
5.1. Applied harmonised standards
STANDARD
DESCRIPTION
EN ISO 15223-1:2016
Medical devices -- Symbols to be used with medical device
labels, labelling and information to be supplied -- Part 1:
General requirements
EN 1041:2008
Information supplied by the manufacturer of medical devices
EN ISO 13485:2016
Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971:2012
Medical devices - Application of risk management to medical
devices
EN 60601-1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
EN 60601-1-2:2015
Medical electrical equipment -- Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
EN 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability
EN 60601-2-25:2015
Medical electrical equipment -- Part 2-25: Particular
requirements for the safety of electrocardiographs
EN60529:2001
Degrees of protection provided by enclosures (IP Code),
Edition 2.1
EN 62304:2006/Amd 1:2016
Medical device software - Software life-cycle processes
EN 62366:2008
Medical devices - Application of usability engineering to
medical devices
VDE 0750-238:2002
Medical electrical equipment - Part 238: Particular
requirements for the safety of crank ergometers
EN ISO 81060-1:2012
Non-invasive sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement type
EN 1060-3:2010
Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure
measuring systems

Cubestress System
5. TECHNICAL SPECIFICATIONS
11
STANDARD
DESCRIPTION
EN ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation
and testing within a risk management process
EN 60950-1:2006/ A1:2010 /
A2:2013 / A11:2009 / A12:2011
Information technology equipment - Safety - Part 1: General
requirements
EN 55032:2015
Electromagnetic compatibility of multimedia equipment -
Emission Requirements
EN 55035:2017
Electromagnetic compatibility of multimedia equipment.
Immunity requirements
ETSI 301 489 V.1.9.2
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 1
ETSI 301 489-17 V.3.1.1
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17
EN 62479:2010
Assessment of the compliance of low-power electronic and
electrical equipment with the basic restrictions related to
human exposure to electromagnetic fields (10 MHz to 300
GHz)
EN 62311:2019
Assessment of electronic and electrical equipment related to
human exposure restrictions for electromagnetic fields (0 Hz to
300 GHz)
ETSI 300 328 V2.1.1 (2016-11)
ETSI EN 300 328 V2.1.1 (2016-11)Wideband transmission
systems; Data transmission equipment operating in the 2,4
GHz ISM band and using wide band modulation techniques

Cubestress System
6. WARRANTY
12
6. WARRANTY
Cardioline S.p.A. guarantees this device for a period of 24 months from the date of sale. The date of sale
shall be proven by a document, issued upon delivery, which must be submitted in the case of any claim
under the warranty.
The warranty covers restoring device operation free of charge for proven malfunctions relating to
installation or to the software.
The 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, misuse or use of the equipment other than its intended
purpose;
damage caused by fires, explosions or natural disasters;
use of unauthorised software;
other circumstances not attributable to manufacturing defects.
Cardioline Spa disclaims 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 requirements specified in the manual, especially
regarding installation, safety, use and maintenance of the equipment, as well as non-operation of the
equipment.
For restoration/repairs, contact Cardioline S.p.A. 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 exception to these warranty conditions shall be valid only if expressly approved by Cardioline S.p.A.

Cubestress System
7. DISPOSAL
13
7. DISPOSAL
Pursuant to (It.) Legislative Decree of 14 March 2014, no. 49, “Implementation of Directive 2012/19/EU on
Waste Electrical and Electronic Equipment (WEEE)”, the crossed-out "wheeled bin" symbol on the medical
device indicates that, at the end of its service life, the product must be collected separately from other
waste. Therefore, when disposing of the product at the end of its service life, the user is required to contact
the supplier or the manufacturer.
Appropriate separate collection to allow for the subsequent recycling of the decommissioned device, with
environmentally-compatible treatment and disposal, helps to prevent any negative effects on the
environment and health and to promote the recycling of the materials which the device consists of.
The illegal disposal of the product by the user entails the application of administrative sanctions pursuant to
Italian Legislative Decree no. 22/1997 (Article 50 et seq. of Italian Legislative Decree no. 22/1997).

Cubestress System
14

15
Head Office and Production
Via Linz, 151
38121 Trento
Italy
T. [phone]
F. [phone]
Sales Office:
Via F.lli Bronzetti, 8
20129 Milan, Italy
T. [phone]
F. [phone]