A.M.I Italia Saver One P User manual

USER MANUAL
DUAL MODE DEFIBRILLATOR
SEMIAUTOMATIC/MANUAL
Rev. 12.4

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QUICK START GUIDE

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©by A.M.I Italia S.r.l.
These instructions for use cannot, without our consent, be completely or partially reproduced, transmitted, stored
electronically or translated into another foreign language or computer language. Breaches of this prohibition not only
violate our copyright, but also reduce our ability to provide accurate and up-to-date information to the user and to the
operator of the device.
These instructions for use are subject to amendments.
A.M.I Italia S.r.l.
Via Cupa Reginella, 15 - 80010 Quarto (NA) Italy
Tel. [phone] [phone]
Fax [phone]
e-mail [email protected]m http://www.amiitalia.com
Printed in Italy

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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 Disclaimer of liability..................................................................................................................... 7
1.5 Instructions ................................................................................................................................... 7
1.6 Counterindications........................................................................................................................ 8
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 Warnings for use in ECG Monitoring .......................................................................................... 11
2.4 Instructions for DISPOSAL........................................................................................................... 12
3 Device description ................................................................................................................................... 13
3.1 Device information...................................................................................................................... 13
3.2 Classifications.............................................................................................................................. 14
4 Description of device details ................................................................................................................... 15
4.1 General structure of the device.................................................................................................. 15
4.2 Keys, icons and indicators........................................................................................................... 16
4.3 Mini status display ...................................................................................................................... 16
4.4 TFT colour display ....................................................................................................................... 17
4.5 Standard and optional accessories of the device ....................................................................... 18
5 Parts and accessories of the Saver One P................................................................................................ 20
5.1 Batteries...................................................................................................................................... 20
5.1.1 Non-rechargeable batteries SAV-C0903 (Li-SOCl2) and SAV-C0904 (Li-MnO2).............. 20
5.1.2 Rechargeable SAV-C0011 battery (Li ion) ...................................................................... 21
5.1.3 Recommendations for proper maintenance of battery SAV-C0011.............................. 21
5.1.4 Insertion and removal of the batteries.......................................................................... 22
5.2 Recharging station for rechargeable batteries ........................................................................... 22
5.2.1 Structure of the battery charger.................................................................................... 23
5.2.2 Recharge procedure....................................................................................................... 23
5.3 Defibrillation pads....................................................................................................................... 24
5.3.1 Adult defibrillation PADs SAV-C0846 ............................................................................. 24
5.3.2 PADs for Children SAV-C0016 ........................................................................................ 24
5.3.3 Face-to-Face SAV-C0599 universal defibrillation pads .................................................. 25
5.3.4 Universal Face-to-Face SAV-C0599 Defibrillation PADs Management .......................... 26
5.3.5 Placement of the defibrillation pads.............................................................................. 26
5.4 Q-CPR SENSOR ............................................................................................................................ 27
5.5 2-pole ECG cable SAV-C0017 ...................................................................................................... 28
5.5.1 Placement of the electrodes.......................................................................................... 28

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5.6 Memory Card .............................................................................................................................. 29
5.7 Martel MCP7830 thermal printer (SAV-C1070).......................................................................... 30
5.7.1 Printer structure............................................................................................................. 30
6 Saver One P selection menu.................................................................................................................... 31
6.1 Main Menu.................................................................................................................................. 31
6.2 Settings Menu............................................................................................................................. 32
6.3 System information Menu .......................................................................................................... 33
6.3.1 Power supply Sub menu................................................................................................. 34
6.4 Print Menu .................................................................................................................................. 35
7 Self-test.................................................................................................................................................... 37
7.1 LED and mini status display......................................................................................................... 37
7.2 ACTIVATION test ......................................................................................................................... 38
7.3 AUTOMATIC test ......................................................................................................................... 39
7.4 ON test ........................................................................................................................................ 39
8 SEMI-AUTOMATIC Defibrillation ............................................................................................................. 40
8.1 Switching on the Saver One P ..................................................................................................... 40
8.2 Adult and Paediatric mode ......................................................................................................... 40
8.3 Placement of the defibrillation pads........................................................................................... 41
8.4 Heartbeat analysis ...................................................................................................................... 41
8.5 Shockable rhythm ....................................................................................................................... 42
8.6 Non-shockable rhythm................................................................................................................ 43
8.7 Change of rhythm ....................................................................................................................... 43
8.8 CPR .............................................................................................................................................. 44
9 MANUAL defibrillation............................................................................................................................. 46
9.1 Starting manual mode................................................................................................................. 46
9.1.1 Asynchronous defibrillation........................................................................................... 47
9.1.2 Synchronized Defibrillation............................................................................................ 48
9.2 Energy selection.......................................................................................................................... 49
9.3 Charging Phase............................................................................................................................ 50
9.4 Shock delivery ............................................................................................................................. 51
9.5 Disarming the device................................................................................................................... 51
10 ECG Monitoring ....................................................................................................................................... 52
10.1 Activation of ECG Monitoring mode........................................................................................... 52
10.2 Description of ECG Monitoring feature ...................................................................................... 54
11 Recording, printing and storing rescue data ........................................................................................... 56
11.1 Data recording ............................................................................................................................ 56
11.2 Printing of rescue data................................................................................................................ 57
11.2.1 Martel MCP7830 Printer Installation............................................................................. 57
11.2.2 Selection of the data to be printed................................................................................ 58
11.2.3 Printing........................................................................................................................... 59
11.3 Storage of data on a PC............................................................................................................... 59
12 Maintenance............................................................................................................................................ 60

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12.1 After each use............................................................................................................................. 60
12.2 Scheduled maintenance.............................................................................................................. 60
12.3 Cleaning....................................................................................................................................... 61
12.4 Storage........................................................................................................................................ 61
12.5 Troubleshooting guide................................................................................................................ 62
13 Technical specifications........................................................................................................................... 63
13.1 Physical characteristics ............................................................................................................... 63
13.2 Environmental requirements...................................................................................................... 63
13.3 Regulatory framework ................................................................................................................ 64
13.4 Technical Alarms Table ............................................................................................................... 64
13.5 Physiological Alarms Table (only in Monitoring mode) .............................................................. 64
13.6 Controls and indicators............................................................................................................... 64
13.7 Data storage................................................................................................................................ 65
13.8 Defibrillator................................................................................................................................. 65
13.9 Efficiency of the energy delivered .............................................................................................. 66
13.10 Patient analysis system in semi-automatic mode....................................................................... 68
13.11 ECG Analysis operation............................................................................................................... 68
13.12 ECG Monitoring........................................................................................................................... 68
13.13 Display......................................................................................................................................... 69
13.14 Non-rechargeable battery........................................................................................................... 69
13.15 Rechargeable battery.................................................................................................................. 69
13.16 Internal back-up battery ............................................................................................................. 70
13.17 Battery charger ........................................................................................................................... 70
13.18 Thermal printer........................................................................................................................... 70
13.19 Defibrillation pads....................................................................................................................... 71
13.20 ECG Cable.................................................................................................................................... 71
13.21 Charge time................................................................................................................................. 71
13.22 Bluetooth Module....................................................................................................................... 71
14 Compliance with electromagnetic emission standards........................................................................... 72
14.1 Guidelines and manufacturer declaration - Electromagnetic emissions.................................... 72
14.2 Guidelines and manufacturer declaration - Electromagnetic immunity .................................... 72
14.3 Recommended separation distance between portable and mobile RF communication
equipment and Saver One device............................................................................................................ 74
15 Symbols.................................................................................................................................................... 75
16 Certifications............................................................................................................................................ 76
16.1 CE certificate ............................................................................................................................... 76
16.2 IMQ Mark.................................................................................................................................... 78
17 Saver One Series Defibrillator Warranty ................................................................................................. 79
18 Product registration................................................................................................................................. 80

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1INTRODUCTION
1.1 PREAMBLE
Thank you for choosing the defibrillator manufactured by A.M.I. Italia S.r.l. model Saver One P.
In order to use the device correctly, you must read this user manual carefully before use. The User Manual of Saver
One P contains the instructions for its use in compliance with its function and purpose. For error-free operation and to
achieve the right performance, it is fundamental to comply with the requirements of this user manual, to guarantee
the safety of the patient, of the rescuer and of any third parties. As an integral part of the defibrillator, this manual
must always be kept close to the product so that it can be easily referenced in case of need.
Note: In order to guarantee the correct and fast traceability of the product and to receive information regarding all
implemented updates, the user is required 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 device Saver One P can be used exclusively if the conditions indicated in this user manual are complied with. Any
use that differs from that required is understood to be non-compliant with the provisions and may cause damage to
people and/or property. In that case A.M.I. Italia S.r.l. hereby disclaims all liability.
1.3 WARRANTY
The device Saver One P has a guarantee of 6 (six)*years.
The SAV-C0903 and SAV-C0904 non-rechargeable batteries are guaranteed for 4 (four)*years in stand-by mode
(assuming one activation test, daily self-tests and no AED power-up). This information refers to new batteries, that are
fully charged and stored at a temperature of 20°C and 45% humidity.
*For more information refer to Chapter 17 “Saver One Series defibrillators warranty”
1.4 DISCLAIMER OF LIABILITY
The rights of liability are excluded in cases of damage to people or property, if attributable to one of the indicated
causes:
–Use of the appliance not in compliance with the provisions.
–Inadequate use and maintenance of the appliance.
–Using the device and/or its accessories when they are visibly or partially damaged.
–Failure to comply with the instructions in the user manual concerning precautions, operation, maintenance
and repair of the appliance.
–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
The Saver One P can only be used if the patient:
–is unconscious
–is not breathing and...
–has no heartbeat

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1.6 COUNTERINDICATIONS
The Saver One P cannot be used if the patient
–is conscious or..
–is breathing normally or..
–has a heartbeat
1.7 INFORMATION ON THE VERSION
This user manual has a version number. The version number changes every time the manual is updated for changes
made to the operation of the device or to the device itself. The contents of this user manual shall be subject to
amendment without advance notice. The information on the version of this manual is as follows.
Version number: 12.4
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
Indicates an immediate risk to the safety of people, which also
involves death and damage to the device or parts thereof
WARNING
Indicates an unsafe situation or practice which leads to serious
injury to persons and damage to the device or parts thereof
1.9 CONTACT DETAILS OF THE MANUFACTURER
You can contact our company at the following addresses:
A.M.I. Italia S.r.l.
REGISTERED OFFICE
Via G. Porzio Centro Direzionale Isola G/2
80143 Naples (NA) Italy
PRODUCTION SITE ITALY - PRODUCTION, LABORATORIES, OFFICES
Via Cupa Reginella, 15/A
80010 Quarto (NA) Italy
Phone: [phone] - Fax: [phone]
PRODUCTION SITE HUNGARY - PRODUCTION, LABORATORIES, OFFICES
A.M.I. International KFT
Kőzúzó u. 5/A
2000 Szentendre (Hungary)
Phone: [phone]
Request for assistance
email: [email protected]m
Tel.: [phone]
Website: www.amiitalia.com

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2SAFETY INSTRUCTIONS
For correct use of the Saver One P defibrillator, users must be aware of the safety factors listed below.
We recommend that you read them carefully.
The Saver One P defibrillator, individually and in connection with its standard and optional (original) accessories,
complies with the safety regulations currently in force and with the provisions of the directives on medical products.
The appliance and its accessories are to be considered safe in the case of application according to the provisions and if
the descriptions and indications in this user manual are complied with.
The following are the main precautions to be taken for the correct and safe use of the defibrillator, broken down for
ease of referencing into hazard statements, warning statements and disposal instructions.
2.1 HAZARD STATEMENTS
➢Use the Saver One P in accordance with the requirements of this user manual. Carefully read these instructions for use
and in particular the safety instructions indicated therein.
➢In accordance with IEC/EN standards (section 3.2), the use of the Saver One P device or its accessories in the presence of
flammable substances (petrol or similar) or in an atmosphere enriched with oxygen or flammable gases/vapours is not
allowed.
➢Do not recharge SAV-C0903 and SAV-C0904 disposable batteries. Explosion hazard!
➢Avoid contact of the batteries with naked 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 any leaking
electrolytes from igniting.
➢Shock hazard. The device generates high voltage and hazardous current levels. Do not open the Saver One P, do not
remove the panels and do not attempt to repair it. The Saver One P contains no components that users can repair. For
repair purposes, the Saver One P must be sent to an authorized technical support centre.
➢Do not apply the electrodes to the patient's chest if nitro-glycerine patches are present. Only place the electrodes once
you have removed the plasters. Otherwise there is a risk of causing an 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 bed frame or stretching device) that are indirect routes for the
defibrillation current.
➢Before using the device ensure the patient’s safety, if necessary move them carefully and put them in a safe place as per
the international guidelines AHA/ERC.
➢Do not immerse any part of the Saver One P, its parts or accessories in water or other liquids.
➢Do not allow liquids to enter the Saver One P, its parts or accessories. Avoid pouring liquids on the device and its
accessories. Failure to do so may cause damage or cause a risk of fire or electric shock. Do not sterilize the Saver One P 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 fully adhere to the skin. Do not use electrodes whose gel has dried; check the expiration date before use.
➢Do not delay treatment in patients with an implanted pacemaker and perform a defibrillation attempt if the patient has
lost consciousness and is not breathing or not breathing normally. The Saver One P is equipped with a pacemaker
detection system that ignores the signal it emits; however, with some types of pacemakers, the Saver One O may
advise against a defibrillation shock.
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
➢RF (radio frequency) interference, caused by devices such as mobile phones and two-way radios, can cause the Saver
One P to malfunction. The Saver One P must be kept at least 2 metres away from these RF devices, as indicated in the
standards IEC/EN 61000-4-3. Keep at sufficient distance from other therapeutic and diagnostic sources of energy (e.g.
diathermy, high-frequency surgery, magnetic tomography).
➢Use the Saver One P only if you have passed a BLS-D or ALS-D training course.
➢Before using the device, make sure that it is not obviously damaged.

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➢The infrared interface emits optically invisible radiation. The emission diode complies with IEC/EN 60825-1 Class 1 "Eye
Save".
➢Do not use Paediatric Defibrillation PADs (SAV-C0016) on adult patients (older than 8 years and weighing more than
25kg). When using Paediatric Defibrillation PADs the Saver One P (Ref: SVP-B0006, SVP-B0007) automatically switches
to paediatric mode, reducing the maximum deliverable energy to 50J.
➢Do not use SAV-C0599 Universal Face to Face Defibrillation PADs in paediatric mode on adult patients (older than 8
years and weighing over 25kg). By setting the paediatric mode in the menu, the Saver One P (Ref. SVP-B0006-U, SVP-
B0006-U-Q, SVP-B0007-U, SVP-B0007-U-Q) switches to paediatric mode, reducing the maximum deliverable energy to
50J.
➢Place the patient cables so as to reduce the possibility of entangling or strangling the patient.
➢In a domestic environment, keep the defibrillator away from the reach of children and pets.
➢Do not apply the defibrillation electrodes directly on an implanted pacemaker to avoid any reading errors by the device
and to avoid damage to the pacemaker through the defibrillation pulse.
➢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 detached from the support or if it appears torn, detached or dry
➢If damage has been observed, do not operate the Saver One P under any circumstances.
➢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 use defibrillation PADs if the expiry date has been exceeded.
➢When applying the ECG SAV-C0017 cable make sure it is not in contact with any conductive element. Ensure that all
ECG electrodes are properly secured to the patient.
➢Do not touch the patient or PADs during heart rhythm analysis.
➢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 the Saver One P, one must have completed a training course for basic or advanced cardio-pulmonary
resuscitation with the use of a defibrillator (BLS-D or ALS-D course).
➢Avoid the use of adult defibrillation PADs (SAV-C0846) on children (ages 1-8 years or weighing 8-25kg), in this case the
Saver One P (Ref. SVD-B0006, SVD-B0007) 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 Face to Face SAV-C0599 defibrillation PADs in adult mode on children (aged 1-8 or weighing
8-25 kg). In fact, in adult mode the Saver One P (Ref. SVP-B0006-U, SVP-B0006-U-Q, SVP-B0007-U, SVP-B0007-U-Q)
does not automatically reduce the maximum deliverable energy to 50J and therefore can become potentially dangerous
for the paediatric patient, therefore set the paediatric mode correctly from the menu if necessary.
➢If needed, before applying the defibrillation PADs dry the patient’s chest and remove excess hair
➢Do not allow Saver One P, its accessories, its parts to be dropped and/or subjected to hard 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 regulations indicated in paragraph 12.3 and always make sure that the device
is switched off with the battery removed and 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.
➢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.
➢Inadequate maintenance may damage the Saver One P or cause it to malfunction. Comply with what is described in this User
Manual.
➢Use non-rechargeable batteries SAV-C0903 and SAV-C0904 by A.M.I.Italia S.r.l. by the indicated expiry date.
➢Recharge the rechargeable Li-ion battery (SAV-C0011) at least once every 4 months to ensure its perfect operation and extend its
life.
➢Rechargeable Li-ion batteries model (SAV-C0011) must only be charged using charger model CBACCS1 (SAV-C0012) by