Cardioline touchECG System User manual

1936
Rev. 00 –18.05.2020
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
touchECG System
User manual

touchECG System
Contents
1. GENERAL INFORMATION .........................................................................................................................3
1.1. Licensing terms ................................................................................................................................3
1.2. Other important information...........................................................................................................3
2. SAFETY INFORMATION.............................................................................................................................4
2.1. Warnings on Bluetooth....................................................................................................................6
2.1.1. Potential sources of interference of Bluetooth........................................................................6
2.1.2. Obstacles for the wireless signal..............................................................................................7
2.1.3. Reducing the effects of the interference of other wireless devices.........................................8
3. SYMBOLS AND LABEL ...............................................................................................................................9
3.1. Explanation of the symbols..............................................................................................................9
3.2. Device label......................................................................................................................................9
4. INTRODUCTION........................................................................................................................................10
4.1. Purpose of the manual.....................................................................................................................10
4.2. Recipients.........................................................................................................................................10
4.3. Intended use ....................................................................................................................................10
4.4. Description of the device.................................................................................................................11
5. TECHNICAL SPECIFICATIONS ....................................................................................................................12
5.1. Applied harmonised standards ........................................................................................................12
6. WARRANTY ..............................................................................................................................................14
7. DISPOSAL .................................................................................................................................................15
1. GENERAL INFORMATION .........................................................................................................................2
1.1. Licensing terms ................................................................................................................................2
1.2. Other important information...........................................................................................................2
2. SAFETY INFORMATION.............................................................................................................................3
2.1. Warnings on Bluetooth....................................................................................................................5
2.1.1. Potential sources of interference of Bluetooth........................................................................5
2.1.2. Obstacles for the wireless signal..............................................................................................6
2.1.3. Reducing the effects of the interference of other wireless devices.........................................7
3. SYMBOLS AND LABEL ...............................................................................................................................8
3.1. Explanation of the symbols..............................................................................................................8
3.2. Device label......................................................................................................................................8
4. INTRODUCTION........................................................................................................................................9

touchECG System
4.1. Purpose of the manual.....................................................................................................................9
4.2. Recipients.........................................................................................................................................9
4.3. Intended use ....................................................................................................................................9
4.4. Description of the device.................................................................................................................10
5. TECHNICAL SPECIFICATIONS ....................................................................................................................11
5.1. Applied harmonised standards ........................................................................................................11
6. WARRANTY ..............................................................................................................................................13
7. DISPOSAL .................................................................................................................................................14

touchECG System
1. GENERAL INFORMATION
3
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
36519188_ENG

touchECG System
2. GENERAL INFORMATION
4
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.
When used in the patient area, it’s necessary to use a battery powered computer 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

touchECG System
2. GENERAL INFORMATION
5
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 electro surgery 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.
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 touchECG software must be installed on the computer supplied. The minimum requirements for
the computer are indicated in the operating manual of the touchECG software.
The devices that form part of the system must be inter-connected as described in the respective
operating manuals.

touchECG System
2. GENERAL INFORMATION
6
Attention
The Glasgow algorithm is intended for automatic interpretation of ECGs at rest. The automatic
interpretation provided by touchECG can only be considered if HD+ is used to acquire ECGs at rest. If
HD+ is used to acquire signals while the patient is moving (for example during a stress test) the
automatic interpretation may not be valid.
The Glasgow 12-lead resting ECG Analysis Algorithm has specific criteria for patients of different
ages, gender and race. If the option is enabled, the algorithm can provide the doctor with an
automatic interpretation, which generates diagnostic messages on the ECG report. Validation is
required by a cardiologist or a doctor.
Notes
The movements of the patient may generate excessive noise and affect the quality of the ECG 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.
The HD+ unit must be connected to the support device running the software before use.
2.1. Warnings on Bluetooth
2.1.1. Potential sources of interference of Bluetooth
It is important to learn how to minimise wireless interference that may cause slow performance and
disconnections from Bluetooth devices.
Specifically, there might be interferences and it is required to make an operation check if the following are
found:
Inability to couple a Bluetooth device to the computer/tablet

touchECG System
2. GENERAL INFORMATION
7
Intermittent HD+ disconnections
Loss of the ECG signal.
Possible causes of interference of the Bluetooth signal may be:
Microwave ovens: using microwave ovens close to the computer/tablet may cause interference.
Satellite TV: the coaxial cable and connectors used with some satellite dishes may cause
interference. Check whether the cables are damaged thus causing radio interferences (RF leakage).
Replace the cables if interference is suspected.
Power supply: some external electricity sources such as power lines, electrical railroad tracks and
power stations, may cause interference. Avoid placing the computer/tablet near wall power lines or
close to junction boxes.
2.4 GHz or 5 GHz telephones: cordless telephones operating in the 2.4 GHz or 5 GHz range may cause
interference with other wireless devices when used to place calls.
Wireless RF video: wireless video transmitters that operate in the 2.4 GHz or 5 GHz range may cause
interference with other wireless devices.
Wireless speakers: wireless speakers that operate in the 2.4 GHz or 5 GHz range may cause
interference with other wireless devices.
Certain external VDUs and LCD displays: certain displays emit harmonic interferences, especially in
the 2.4 GHz band between channels 11 and 14. These interferences may be stronger if using a
notebook computer with a closed display and a connected external monitor.
Inadequately shielded cables: external hard disks or other devices with poorly shielded cables can
interfere with wireless devices. If disconnecting or switching off the device reduces the
interferences, try replacing the cable that connects the device to the computer/tablet.
Other wireless devices: other wireless devices that operate in the 2.4 GHz or 5 GHz band (nearby
microwave transmitters, wireless cameras, baby monitors, Wi-Fi devices) may cause interferences
with Bluetooth connections.
Enabling GPS operation: if the GPS function is enabled on the device in use, it may create
interference with the Bluetooth signal. If losses of Bluetooth signal packets are noted, it is
recommended to disable the GPS function.
2.1.2. Obstacles for the wireless signal
The position of the device and the construction materials may affect Bluetooth performance. If possible,
avoid obstacles or move the Bluetooth device for the signal to travel through fewer obstacles. For example,
avoid placing the computer/tablet under a metal desk and the HD+ device on top of a desk.
Below is a chart showing the radio signal-blocking ability of the most common devices:
Material
Potential interference

touchECG System
2. GENERAL INFORMATION
8
Wood
Low
Synthetic material
Low
Glass
Low
Water
Medium
Bricks
Medium
Marble
Medium
Plaster
High
Concrete
High
Bulletproof glass
High
Metal
Very high
2.1.3. Reducing the effects of the interference of other wireless devices
If a lot of wireless devices are connected to the computer/tablet or nearby, it may be required to encode the
channels used by the Wi-Fi___33 devices.
To reduce the interference between Wi-Fi___33 devices and Bluetooth to the minimum try these solutions:
Change channels of the wireless network;
Connect to a 5 GHz wireless network (if possible);
Place the HD+ close to the computer/tablet.
Reduce to the minimum the number of Bluetooth devices connected to the computer/tablet or
nearby.

touchECG System
3. SYMBOLS AND LABEL
9
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

touchECG System
4. INTRODUCTION
10
4. INTRODUCTION
4.1. Purpose of the manual
This manual covers the product touchECG 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 touchECG 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
touchECG System is intended for the acquisition of resting ECG exams to check and diagnose cardiac
functions. However, a physician must validate the results of the analysis performed by the ECG device.
It’s intended to analyse ECG signals, acquired and wirelessly transmitted with the HD+/CLICKECG-HD
acquisition unit. HD+/CLICKECG-HD can use a standard patient cable or the ECG suction cable Handy VAQ.
touchECG System is intended for use in hospitals, clinics and outpatient departments of any size. It is suited
for use by healthcare professionals at the patient house and in emergencies (ambulances).
The analysis of ECG traces and the automatic interpretation must always be validated by a physician. The
device can't diagnose the patient condition by itself, but only display the results of the ECG interpretation
according to Glasgow Resting ECG Analysis program.
The device is intended to acquire, analyse, display and print out electrocardiograms.
The device is intended to provide interpretation of the data for review by a physician.
The device is intended for use by a physician or by health professionals on behalf of an authorized
doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.
The device's interpretation of the ECG is only significant if used together with an additional analysis
by the physician and by an assessment of all the patient's important data.
The device is not intended to be used as a vital signs physiological monitor.
The device is intended for use on adult and paediatric (according to AHA guidelines on exercises test
- paediatric is not available for devices marketed in the United States) patients with no limitations in
gender. The following limitations apply:
Handy VAQ can be used preferably on patients of age over seven, also dependent on body size

touchECG System
4. INTRODUCTION
11
The device is not intended for sterile use or use outdoors.
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 for direct cardiac application.
The device is not for use in an MRI suite.
If the device is used in the patient environment non-ME equipment (computer, printer, etc.) must be
battery powered.
4.4. Description of the device
touchECG System is a family of systems for the acquisition of resting ECG exams.
The system is made of the following devices, which are both medical and non-medical:
Software for the display, analysis and printing of ECG traces and for exam management (touchECG);
ECG acquisition unit (HD+/CLICKECG-HD) with optional ECG suction cable (Handy VAQ);
Computer where the software is installed (with display, keyboard and mouse);
Optional Cardioline HD+ Bluetooth Dongle, for use as a Bluetooth receiver in place of the standard
Bluetooth module of the computer;
Optional printer;
Optional battery pack;
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 touchECG software displays and analyses
such signals for reviewing 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.

touchECG System
5. TECHNICAL SPECIFICATIONS
12
5. TECHNICAL SPECIFICATIONS
5.1. Applied harmonised standards
STANDARD
DESCRIPTION
EN ISO 15223-1
Medical devices -- Symbols to be used with medical device
labels, labelling and information to be supplied -- Part 1:
General requirements
EN 1041
Information supplied by the manufacturer of medical devices
EN ISO 13485
Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971
Medical devices - Application of risk management to medical
devices
EN 60601-1
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
EN 60601-1-2
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
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability
EN 60601-2-25
Medical electrical equipment -- Part 2-25: Particular
requirements for the safety of electrocardiographs
EN 60529
Degrees of protection provided by enclosures (IP Code),
Edition 2.1
EN 62304
Medical device software - Software life-cycle processes
EN 62366
Medical devices - Application of usability engineering to
medical devices
EN 60950-1
Information technology equipment - Safety - Part 1: General
requirements
EN 55032
Electromagnetic compatibility of multimedia equipment -
Emission Requirements
EN 55035
Electromagnetic compatibility of multimedia equipment.
Immunity requirements
ETSI 301 489
Electromagnetic Compatibility (EMC) standard for radio

touchECG System
5. TECHNICAL SPECIFICATIONS
13
STANDARD
DESCRIPTION
equipment and services; Part 1
ETSI 301 489-17
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17
EN 62479
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
Assessment of electronic and electrical equipment related to
human exposure restrictions for electromagnetic fields (0 Hz to
300 GHz)
ETSI 300 328
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band and using wide band
modulation techniques

touchECG System
6. WARRANTY
14
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.

touchECG System
7. DISPOSAL
15
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).

touchECG System
16

17
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]