Smarty Saver Plus User manual

SMARTY Saver Plus
User Manual
Semi-Automatic External Defibrillator
Rev.1.7

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QUICK START GUIDE

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©by A.M.I Italia S.r.l.
These instructions for use may not be reproduced - either as a whole or partially - without our consent, nor may
they be transmitted, electronically stored or be translated in another language.
Breaches of this prohibition do not only violate our copyright, but also compromise the truthfulness and accuracy
of the information contained in this manual.
These instructions for use are subject to amendment.
A.M.I Italia S.r.l.
Via Cupa Reginella, 15/A - 80010 Quarto (NA) Italy
Tel. [phone] [phone]
Fax [phone]
e-mail [email protected] http://www.amiitalia.com

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Table of Contents
1 Introduction............................................................................................................................................... 7
1.1 Preamble....................................................................................................................................... 7
1.2 Use in conformity with the provisions.......................................................................................... 7
1.3 Warranty....................................................................................................................................... 7
1.4 Exclusion of liability....................................................................................................................... 7
1.5 Instructions ................................................................................................................................... 7
1.6 Counterindications........................................................................................................................ 7
1.7 Information on the version........................................................................................................... 8
1.8 Symbols used in the manual......................................................................................................... 8
1.9 Contact details of the manufacturer............................................................................................. 8
2 Safety instructions..................................................................................................................................... 9
2.1 HAZARD statements...................................................................................................................... 9
2.2 WARNINGS.................................................................................................................................... 9
2.3 Instructions for DISPOSAL........................................................................................................... 11
2.4 Classifications.............................................................................................................................. 11
3 Device description ................................................................................................................................... 12
3.1 Information on the defibrillator.................................................................................................. 12
3.2 Procedure for the activation of the defibrillator ........................................................................ 12
4 Device description ................................................................................................................................... 13
4.1 General structure........................................................................................................................ 13
4.2 Keys, icons and indicators........................................................................................................... 14
4.3 Standard and optional accessories of the device ....................................................................... 15
5 SMARTY Saver Plus power supply and accessories................................................................................. 16
5.1 Non-rechargeable battery SMT-C14031..................................................................................... 16
5.1.1 Insertion and removal of the batteries.......................................................................... 17
5.2 Defibrillation pads....................................................................................................................... 18
5.2.1 Pre-connected universal defibrillation pads SMT-C2001............................................... 18
5.2.2 Pre-connected Face-to-Face universal defibrillation pads SMT-C2002......................... 18
5.2.3 Placement of the defibrillation pads.............................................................................. 19
5.2.4 Adult and Paediatric mode............................................................................................. 19
5.3 CPR Quality module .................................................................................................................... 20
6 Self-test.................................................................................................................................................... 21
6.1 ACTIVATION test ......................................................................................................................... 21
6.2 AUTOMATIC test ......................................................................................................................... 22

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6.3 ON test ........................................................................................................................................ 22
6.4 Control LEDs................................................................................................................................ 22
7 Defibrillation............................................................................................................................................ 23
7.1 “Chain of survival”....................................................................................................................... 23
7.2 Switching SMARTY Saver Plus on................................................................................................ 23
7.3 Preparing the patient.................................................................................................................. 24
7.4 Place the pads............................................................................................................................. 24
7.5 Heartbeat analysis ...................................................................................................................... 25
7.6 Defibrillable rhythm.................................................................................................................... 26
7.7 Change of rhythm ....................................................................................................................... 27
7.8 Non-defibrillable rhythm ............................................................................................................ 27
7.9 Cardio-Pulmonary Resuscitation................................................................................................. 27
8 Recording, displaying and storing the data............................................................................................. 29
8.1 Files that can be stored............................................................................................................... 29
8.2 Storage of data on a PC............................................................................................................... 29
8.3 µSD memory Card....................................................................................................................... 30
9 Maintenance............................................................................................................................................ 31
9.1 Maintenance after use................................................................................................................ 31
9.2 Scheduled maintenance.............................................................................................................. 31
9.3 Cleaning....................................................................................................................................... 32
9.4 Storage........................................................................................................................................ 32
9.5 Guide to identifying faults .......................................................................................................... 33
10 Technical specifications........................................................................................................................... 34
10.1 Physical characteristics ............................................................................................................... 34
10.2 Environmental requirements...................................................................................................... 34
10.3 Reference regulatory frameworks.............................................................................................. 34
10.4 Table of Alarms ........................................................................................................................... 35
10.5 Controls and indicators............................................................................................................... 35
10.6 Data memory .............................................................................................................................. 35
10.7 Defibrillator................................................................................................................................. 36
10.8 Efficiency of the energy delivered .............................................................................................. 37
10.9 Patient analysis system............................................................................................................... 38
10.10 ECG Analysis operation............................................................................................................... 38
10.11 Defibrillator battery .................................................................................................................... 38
10.12 Internal back-up energy source .................................................................................................. 38
10.13 Defibrillation pads....................................................................................................................... 39
10.14 Timing of Shock cycles ................................................................................................................ 39
10.15 Bluetooth module....................................................................................................................... 39
11 Compliance with electromagnetic emission standards........................................................................... 40
11.1 Guidelines and manufacturer declaration - Electromagnetic emissions.................................... 40

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11.2 Guidelines and manufacturer declaration - Electromagnetic immunity .................................... 40
11.3 Recommended separation distances between portable and mobile RF communication devices
and the SMARTY Saver Plus device.......................................................................................................... 42
12 Symbols.................................................................................................................................................... 43
13 Certifications............................................................................................................................................ 44
13.1 CE certificate ............................................................................................................................... 44
14 SMARTY Saver Series defibrillator warranty ........................................................................................... 46

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1Introduction
1.1 Preamble
Thank you for choosing the defibrillator manufactured by A.M.I. Italia S.r.l. SMARTY Saver Plus model.
In order to use the device correctly, you must read this user manual carefully before use. This user manual contains the
instructions for the use of SMARTY Saver Plus in compliance with its functionality and purpose. For an error-free
operation, it is fundamental that you comply with the requirements of this manual, in order to guarantee the safety of
the patient, of the rescuer and that of third parties.
This manual forms an integral part of the defibrillator and must always be kept in close proximity to the defibrillator, so
that it may be easily consulted whenever needed.
Note: In order to guarantee the correct and fast traceability of the product and to receive information regarding all
implemented updates, the user is requested to register the device at the appropriate section of the AMI ITALIA
website www.amiitalia.com.
1.2 Use in conformity with the provisions
The SMARTY Saver Series devices can be used only if the conditions indicated in this user manual are complied with.
All uses that differ from the intended use shall be understood not to comply with the provisions and may cause
harm/damage to persons and/or property; in such case, A.M.I. Italia S.r.l. hereby declines all liability.
1.3 Warranty
The SMARTY Saver Series devices are under warranty for 5 (five)* years.
The non-rechargeable battery SMT-C14031 is under warranty for 3 (three)* years in Stand-by mode (with battery
activation tests, daily self-tests and without the AED being switched on).
This information refers to new batteries that are fully charged and kept at a temperature of 20°C and 45% humidity.
*For more information, please see paragraph 14 “Warranty contract for SMARTY Saver series defibrillators”
1.4 Exclusion of liability
Liability rights in case of harm/damageto persons or to property shall be excluded, if attributable to one of the causes below:
–Using the device for uses other than its intended use.
–Using and maintaining the device inappropriately.
–Using the device and/or its accessories when they are visibly or partially damaged.
–Failing to comply with the instructions of the user manual concerning the precautions, use, maintenance and
repair of the device.
–Using non-original accessories and spare parts and/or of accessories and spare parts that are not approved by
the manufacturer.
–Performing arbitrary operations, repairs or modifications of the device.
–Arbitrarily exceeding the performance limits.
–Failing to supervise the parts that are subject to wear and tear.
1.5 Instructions
SMARTY Saver Plus device may be used only if the patient:
–is unconscious and
–is not breathing and
–has no heartbeat
1.6 Counterindications
SMARTY Saver Plus device may not be used if the patient:
–is conscious or
–is breathing normally or
–has a heartbeat

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1.7 Information on the version
This user manual has a version number; this varies each time the manual is updated due to changes in the device’s
operation or to the device itself. The contents of this user manual shall be subject to amendment without advance
notice.
Version number: 1.7
Issue date: 06/04/2021
1.8 Symbols used in the manual
This user manual uses various symbols that indicate the various precautions for use:
SYMBOL
INDICATION
DESCRIPTION
HAZARD
It signals an immediate risk to the safety of
persons, which might result in death and damage
to the device or its parts
WARNING
It signals an unsafe situation or practice which
might lead to serious injury to persons and
damage to the device or its parts.
1.9 Contact details of the manufacturer
A.M.I. Italia S.r.l.
REGISTERED OFFICE
Via G. Porzio Centro Direzionale Isola G/2 - 80143 Napoli (NA) Italy
MANUFACTURE, LABORATORIES, OFFICES
Via Cupa Reginella, 15/A - 80010 Quarto (NA) Italy
Tel: [phone] - Fax: [phone]
A.M.I. International KFT
REGISTERED OFFICE
Dòzsa Gyorgyùt 86/b 3/1 1068 - Budapest Hungary
MANUFACTURE, LABORATORIES, OFFICES
Kőzúzóu. 5/A - 2000 Szentendre Hungary
Tel: [phone]
Request for assistance
email: [email protected]m
website: www.amiitalia.com
Tel: [phone]

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2Safety instructions
For the correct use of a SMARTY Saver Series defibrillator, the users must be aware of the safety factors listed below.
We recommend that you read them carefully.
The SMARTY Saver Series defibrillators and their accessories comply with the rules and regulations on safety that are
currently in force and with the provisions of the directives on medical products.
The device and its accessories must be deemed to be safe in the case of application in compliance with the provisions
and if the descriptions and instructions listed in this user manual are complied with.
Below please find the main precautions for the correct and safe use of the defibrillator, divided - for easier consultation
- in hazard statements, warnings and instructions for disposal.
2.1 HAZARD statements
➢Use SMARTY Saver Plus in compliance with what is laid down in this user manual.
Read these instructions and, in particular, the safety instructions carefully.
➢In compliance with IEC standards (section 0), use of the SMARTY Saver plus device or of its accessories is not allowed in
the presence of inflammable substances (gasoline or similar) or in an oxygen-rich atmosphere or an atmosphere rich in
inflammable gases/vapours.
➢Do not recharge the single-use batteries SMT-C14031: risk of explosion!
➢Avoid contact of the batteries with open flames. Do not expose to fire.
➢Do not cause a short-circuit of the battery terminals.
➢In case of leakage of fluids or strange odours from the batteries, keep them away from fire to prevent the possible
combustion of leaking electrolytes.
➢Shock hazard. The device generates high voltage and hazardous current levels. Do not open SMARTY Saver Plus do not
remove the panels and do not attempt to repair it. SMARTY Saver Plus does not contain components that can be
repaired by the users. In order to perform repairs, SMARTY Saver Plus must be sent to an authorised technical support
centre.
➢Do not apply the defibrillation pads on the patient’s chest if nitroglycerine plasters are present. Only place the
electrodes once you have removed the plasters. Otherwise there is a risk of explosion.
➢Do not touch the patient and prevent third parties from coming into contact with the patient during the defibrillation
shock. Avoid all contact between:
•parts of the patient’s body
•conducting liquids (such as gel, blood, or saline solution)
•metal objects near the patient (such as the bed frame or a stretching device) that may potentially act as
conductors for the defibrillation current
➢Before using the device, make sure that the patient is safe; if necessary, move them carefully to a protected location, as
set forth by the AHA/ERC directives.
➢Do not immerse any part of SMARTY Saver Plus or its accessories in water or other liquids.
➢Do not allow liquids to enter SMARTY Saver Plus or its accessories. Avoid pouring liquids on the device and its
accessories. Otherwise, damage may be caused or there may a risk of fire or shock. Do not sterilise SMARTY Saver Plus
and/or its accessories.
2.2 WARNINGS
➢Avoid the formation of air bubbles between the skin and the defibrillation pads. The formation of air bubbles during
defibrillation may cause severe burns to the patient’s epidermis. To avoid the formation of air bubbles, make sure that
the electrodes are in full contact with the skin. Do not use electrodes whose gel has dried out and check its expiry date
before use.
➢Do not delay treatment in case of patients with an implanted pacemaker and perform an attempt at defibrillation if the
patient has lost consciousness and is not breathing or is not breathing normally.
➢Do not apply the defibrillation electrodes directly on an implanted pacemaker, to avoid possible device interpretation
errors and to avoid damaging the pacemaker with the defibrillation pulse.
During the application of the electrodes:
• Do not apply the electrodes directly on an implanted device.
• Apply the electrodes at least 2.54 cm (1 inch) from any implanted device.
If a pacemaker is present, the defibrillators of the Smarty Saver series will, in any case, make it possible to release the
shock, unless, although they envisage a treatment of the ECG signal such as to guarantee an accurate rejection of the
artefacts, the interference of the pacemaker is such (e.g. due to the electrodes being placed in a way that does not
comply with the warning indicated) as to alter the ECG signal and not allow the shock.

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➢RF (radiofrequency) interference from devices such as mobile phones and radio two-way transmitters, can cause
SMARTY Saver Plus to malfunction. SMARTY Saver Plus must be kept at least 2 metres away from such RF devices, as
indicated in the IEC/EN 61000-4-3 standards. Keep at sufficient distance from other therapeutic and diagnostic sources
of energy (e.g. diathermy, high-frequency surgery, magnetic tomography).
➢Use SMARTY Saver Plus only if you have followed a BLS-AED or ALS-AED training course.
➢Before using the device, make sure that it is not obviously damaged.
➢Do not use universal defibrillation pads SMT-C2001 in paediatric mode on adult patients (older than 8 and weighing
more than 25 kg). In fact, in paediatric mode, SMARTY Saver Plus automatically reduces the maximum energy that can
be delivered to 50J.
➢Place the patient cables in such a way as to reduce the possibility of them getting entangled in or strangling the patient.
➢In a domestic environment, keep the defibrillator away from the reach of children and pets.
➢Disconnect the patient from equipment that is sensitive to high voltage pulses, or equipment that is not defibrillator-
proof, before delivering the shock.
WARNING
➢Do not allow the defibrillation electrodes to touch or to come into contact with ECG electrodes, pads, transdermal
plasters, etc. Otherwise, the formation of electric arcs and burns to the patient could be caused during defibrillation;
the current may even be dispersed.
➢Place the defibrillation pads as indicated in this user manual and on the packaging.
➢Do not use the defibrillation pads if the gel has come away from the support or if it appears torn, divided or dry.
➢If damage has been found, in no case should you switch SMARTY Saver Plus on.
➢Before using the device, remove metal objects from the patient’s body (including necklaces or bracelets, etc.).
➢Do not use defibrillation pads other than those supplied by the manufacturer. Otherwise, the defibrillator may perform
false interpretations.
➢Do not use the defibrillation pads if they are damaged, even partly.
➢Do not touch the patient or the defibrillation pads during the automatic analysis of the heartbeat.
➢Moving or transporting the patient during the analysis of the heartbeat by the device may lead to a wrong or untimely
diagnosis. Reduce movements to a minimum while the heartbeat is being analysed. If the device is used in a moving
ambulance, stop the vehicle and only start driving after the shock has been delivered.
➢In order to use SMARTY Saver Plus, you must have followed a basic or advanced training course for cardiopulmonary
resuscitation with use of defibrillator (BLS-AED or ALS-AED course).
➢Avoid using the universal defibrillation pads SMT-C2001 in adult mode on children (aged 1-8 or weighing 8-25 kg). In
fact, in adult mode, SMARTY Saver does not automatically reduce the maximum energy that can be delivered to 50J and
may, therefore, become hazardous for the paediatric patient.
➢Avoid using the universal defibrillation pads SMT-C2001 in adult mode on children (aged 1-8 or weighing 8-25 kg).
When paediatric mode is set, the maximum energy that can be delivered is 50J.
➢If needed, before applying the defibrillation pads dry the patient’s chest and remove excess hair.
➢Do not subject SMARTY Saver Plus, its accessories and/or its parts to falls and/or strong impacts.
➢Do not use damaged accessories and/or parts; otherwise, the device may be caused to malfunction.
➢Use solely original accessories and/or spare parts.
➢Avoid handling the device, its accessories or its parts too aggressively to avoid possible damage. Inspect the entire
system regularly.
➢Sanitise the device in compliance with the rules of paragraph 10.3, and, in any case, always make sure that the device is
switched off, without battery and with the pads disconnected.
➢The defibrillation pads are single-use, to be used on just one patient. Do not reuse the defibrillation pads; throw them
away after use and replace them with a new pair.
➢The defibrillation pads are not sterile or sterilisable.
➢The intense or prolonged administration of cardiopulmonary resuscitation with the defibrillation electrodes applied to
the patient can damage the electrodes. Replace them if they are damaged due to use or handling.
➢Inappropriate maintenance may damage SMARTY Saver Plus or cause it to malfunction. Comply with what is described
in this User Manual.
➢Use the non-rechargeable batteries SMT-C14031 of A.M.I. Italia S.r.l. by the indicated expiry date.
➢Remove the batteries from the device only if it has been off for at least 5 seconds. Otherwise, the device and the
batteries may be damaged.
➢SMARTY Saver Plus, its parts and accessories are manufactured non-sterile and non-sterilisable.
➢Do not expose SMARTY Saver Plus, its parts or accessories to direct light or high temperatures.
➢In case of failed connection or communication with the compatible Q-CPR module (SMT-C14034), SMARTY Saver Plus
will emit, in any case, the audio signal as metronome for the compressions, to help the operator in their operations.
➢All products, product data and specifications are subject to modification to improve their reliability, functionality,
design or other aspects.