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

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A.M.I. Italia S.r.l. otherwise the batteries may be damaged.
➢Remove the batteries from the device only if it has been off for at least 5 seconds. Otherwise the device and the battery
can be seriously damaged.
➢Saver One P, its parts and accessories are non-sterile and non-sterilisable.
➢Do not expose the Saver One P, its parts or accessories to direct light or high temperatures.
➢The Battery Charger CBACCS1 (SAV-C0012) must only be used with the Meanwell power supply model GS40A15-P1J
(SAV-C0013) supplied by A.M.I. Italia S.r.l. The use of different power supplies might undermine the correct operation of
the battery charger and damage the rechargeable batteries model (SAV-C0011).
➢In order to protect the battery life (SAV-C0903 /SAV-C0904) and guarantee automatic daily tests, after installing it, it is
advisable not to remove the battery from the device unless it is to be replaced.
➢The removal of the battery from the device and its subsequent insertion, involves a complete self-test of the AED which
implies non-negligible consumption of the battery itself. Furthermore, if the battery is not properly attached it could be
damaged.
➢All products, product data and specifications are subject to modification to improve their reliability, functionality,
design or other aspects.
2.3 WARNINGS FOR USE IN ECG MONITORING
➢The monitoring mode based on the use of the screen, for the purpose of identifying an ECG rhythm, is an important aid
for the specific use of the device itself, i.e. the detection of a shockable rhythm leading to the subsequent decision to
release a therapeutic shock. The monitoring mode is intended for those environments or rescue conditions where
experienced operators, or under specialized medical supervision, may have the benefit of evaluating patients with a high
risk of a cardiac event that can be life threatening. By switching defibrillator operation from the analysis mode to the
monitoring mode, the device continues to analyse the patient's ECG and, if a potentially shockable rhythm is detected,
the operator can return to defibrillation mode and prepare to administer the shock. In any case, do not use the device in
"ECG Monitoring" mode in environments such as operating rooms or intensive care units and consequently with medical
equipment typical of such environments (such as an electrosurgical unit). Moreover, for the intended use, the device
does not guarantee completely suitable display performance in patients with pacemakers.
➢Use the device only with accessories (patient cables, electrodes, adhesive clips) supplied by AMI Italia following the
instructions in this manual for their application.
➢Take care not to let the conductive parts of the electrodes come into contact with other conductive parts, including the
earth.
➢As a precaution, if there is a defibrillator connected to the patient that may deliver a defibrillation shock, avoid touching
the patient while undergoing ECG Monitoring and, to ensure the necessary protection, use only accessories (patient
cables, electrodes, adhesive clips) supplied by AMI Italia and listed in this manual.
➢In patients with pacemakers, the heart rate reading might count pacemaker pulses even in the event of cardiac arrest or
some arrhythmias. In this case, do not rely completely on alarms related to the counting of beats. Continuously monitor
patients with pacemakers and follow the instructions in this manual regarding the pacemaker pulse rejection capabilities
of this device.
➢In patients with pacemakers, the values displayed by the device may not be sufficiently accurate. In this case, these
should not be used to draw medical conclusions.
➢The device is able to recognise and manage T waves appropriately up to a maximum width of 1 mV.
➢To monitor whether the electrodes have been applied to the patient, the device injects a sinusoidal current of Ipp =
0.5mA and f = 25.2 KHz.
➢The frequency of the QRS complexes is calculated by making the arithmetic average over 3 consecutive intervals (4 QRS
complexes) and the value shown on the display is updated every second.
➢Delays in monitoring mode alarm condition determination are limited to within 5 seconds, except for LOW FREQUENCY
and ASYSTOLE alarms where the alarm delay remains within 10 seconds. In this case, in lower limit conditions (30bpm), 2
seconds elapse between two consecutive beats, and since the QRS detection algorithm requires 4 complexes, the time
required to detect an LF alarm condition is longer than 6 seconds. For the ASYSTOLE warning, having to exclude first that
it is not an LF condition and then confirm that it is ASYSTOLE, the warning time is longer than the previous one by about 2
seconds (about 8 seconds).
➢The device takes less than 3 seconds to switch from the indication of 80 bpm to 120 bpm and vice versa.
➢The device takes less than 3 seconds to switch from the indication of 80 bpm to 40 bpm and vice versa.
➢For the two waveforms of fast ventricular tachycardia: 195 bpm @ Vpp=2mV, 1mV, 4mV and 206 bpm@ Vpp=1mV,
0.5mV, 2mV, the device signals the alarm condition within 5 seconds.
➢In the event of an alarm, the sound emitted is composed of at least 4 different frequencies so that it can be heard even by
people who have partially impaired hearing. Icons and descriptions of the detected alarm status are shown on the display
simultaneously.
➢The device guarantees 35 hours of continuous monitoring with a new, fully charged battery.

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2.4 INSTRUCTIONS FOR DISPOSAL
➢The Saver One P, its parts and accessories must not be disposed of with other household waste within the European
community. To prevent possible harm to the environment or to persons’ health caused by incorrect disposal of waste,
recycle this product responsibly, also to promote a sustainable use of resources. In order to discard the used product,
go to the appropriate waste collection centre or take it to the area distributor. It will then be possible to recycle the
product with safety for the environment

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3DEVICE DESCRIPTION
3.1 DEVICE INFORMATION
The Saver One P is a professional external defibrillator called DUAL-MODE because it is able to operate in two
defibrillation modes: Semi-automatic mode and Manual mode (Synchronous and Asynchronous).
Its use is indicated to medical personnel but being able to operate in semi-automatic mode it can also be used by
professional healthcare personnel. In the semi-automatic mode it is able to automatically detect and analyse the
victim's heart rhythm and deliver one or more defibrillation shocks if ventricular fibrillation or ventricular tachycardia
(monomorphic or polymorphic with beat> 180) is detected. In manual mode instead all the phases of the treatment
are manual under the total discretion and decision of the doctor. The energy is supplied by a biphasic truncated
exponential (BTE) electrical shock able to adapt to the patient's thoracic impedance. The Saver One P is available in
the following versions:
Saver One P 200J (SVP-B0006) –Maximum deliverable energy 200J Standard opt.
Saver One P 360J (SVP-B0007) –Maximum deliverable energy 360J Standard opt.
Saver One P 200J (SVD-B0006-U) - Max. deliverable energy 200J Univer. Face to Face PADs opt.
Saver One P 360J (SVP-B0007-U) - Max. deliverable energy 360J Univer. Face to Face PADs opt.
Saver One P 200J (SVP-B0006-Q) –Maximum deliverable energy 200J Q-CPR opt.
Saver One P 360J (SVP-B0007-Q) –Maximum deliverable energy 360J Q-CPR opt.
Saver One P 200J (SVD-B0006-U-Q) - Max. deliverable energy 200J Univer. Face to Face PADs and Q-CPR opt.
Saver One P 360J (SVP-B0007-U-Q) - Max. deliverable energy 360J Univer. Face to Face PADs and Q-CPR opt.
It can be used with the following battery types:
•SAV-C0903 - Non-rechargeable battery - it requires no maintenance, is guaranteed to operate in standby
mode for 4 years or carry out a high number of shocks
•SAV-C0904 - Non-rechargeable battery - it requires no maintenance, is guaranteed to operate in standby
mode for 4 years or carry out a high number of shocks
•SAV-C0011 - Rechargeable battery - recommended for intensive defibrillator use
The device is equipped with a large 5.7-inch LCD colour display that shows all the information relating to the
treatment and its functional status. Furthermore, the Saver One P has a mode that allows the patient's ECG
monitoring to be performed using a special 2-pole ECG cable (SAV-C0017) with detection of 1 lead (II) or directly from
the PADs.
The device allows the rescue data to be recorded on an SD Memory Card so that they can be displayed on a PC or
printed directly on the Martel MCP7830 printer (optional function). During non-use, if the battery is installed, the
device carries out daily self-tests to check its functional condition, in order to guarantee its prompt use when needed.
On the keyboard of the device there is a mini LCD display and a two-colour LED (red/green) to view the outcome of
the functional tests and to know the functional status of the device even if switched off (stand-by mode).

14
3.2 CLASSIFICATIONS
The Saver One P defibrillator is classified as follows:
UMDNS code
11132
GMDN code
17882
CND code
Z12030502
RDM [(It.) Medical Device Register] number
114299 / 1536326
CIVAB [Biomedical Equipment Information and Assessment
Centre] code
DEF02
Class in accordance with Directive 2007/47/EC
IIb
Type of protection from electric shock
Powered Internally
Type of patient insulation
BF
CF (only for ECG cable)
Protection rating against penetration by liquids
IPx4
Protection rating against penetration by dust
IP5x
Degree of safety in the presence of inflammable anaesthetic
mixtures with air, oxygen or nitrous oxide
Not protected
Sterilisation or disinfection method suggested by the supplier
See Paragraph 12.3
Operation mode
Continuous operation

15
4DESCRIPTION OF DEVICE DETAILS
4.1 GENERAL STRUCTURE OF THE DEVICE
No.
Description
1
Compartment for PADS connector or ECG
cable
2
Microphone for environmental recordings
3
Mini status display
4
Carry handle
5
Battery (removable)
6
TFT colour display
7
IrDA port (service only)
8
Keypad with buttons
9
Speaker
No.
Description
10
USB port
11
Battery contact tabs
12
SD Card port
13
SD Memory Card port
14
Gasket
Figure 1
1
2
4
5
6
7
8
Figure 2
14
3
11
13
10
9
12

16
4.2 KEYS,ICONS AND INDICATORS
No.
Function
No.
Function
1
UP navigation key
To scroll up the menu
6
Mini status display
To check the functional status of the device
2
Navigation key ENTER
To enter the menu and confirm the
selection made
7
Disarm Button
It allows the device to be disarmed in
manual mode
3
DOWN navigation key
To scroll down the menu
8
Energy Select Button
To select the energy to be delivered in
manual mode
4
Control LEDs
LED (red/green) to check the functional
status of the device
9
Charge Button
To carry out charging of the device in
manual mode
5
ON/OFF button
To switch the device on or off
10
Shock button
Fitted with LEDs to deliver a defibrillation
shock if indicated
4.3 MINI STATUS DISPLAY
The mini display is designed to inform the user about the functional status of the device and its battery even when the
device is switched off (stand-by mode).
No.
Description
1
Functional status of the device
2
Remaining battery level
Figure 3
1
4
3
5
6
8
2
1
2
7
9
10

17
4.4 TFT COLOUR DISPLAY
No.
Description
No.
Description
1
Indicates the OPERATIVE mode
9
Indicates the number of VFs and/or VTs detected by the
device
AED:
Semi-automatic Defibrillation
AED MODE
ASYNCHRONOUS:
Manual Asynchronous
Defibrillation
ASYNC
MONITORING: ECG Monitoring
ECG
10
Indicates the duration of the rescue
SYNCHRONOUS:
Manual Synchronous
Defibrillation
SYNC
2
Indicates the type of patient to be treated and
Compression/Insufflation Ratio:
Adult 30:2
Paediatric 30:2 or 15:2
11
Indicates not to touch the patient in certain operations
3
Indicates the patient's heart rate
12
Indicates peak "R" detection for shock delivery in
"Manual Synchronous" mode
4
Indicates the patient's measured thoracic impedance
13
Energy charged and subsequently delivered
5
Progressive charging bar
14
ECG track of the patient
6
Indicates the residual space on the SD Card memory
15
Text prompt that instructs on the operation to be
performed
7
Indicates the remaining battery level
16
Indicates whether the recording microphone is active
8
Indicates the number of shocks administered
17
Indicates current date and time
2
3
4
5
6
7
10
13
14
15
16
Figure 4
1
12
11
9
8
17

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4.5 STANDARD AND OPTIONAL ACCESSORIES OF THE DEVICE
The Saver One P defibrillator comes with the following standard accessories:
Code
Image
Quantity
Description
SVP-B0006
SVP-B0006-U
SVP-B0006-Q
SVP-B0006-U-Q
1 Unit
(Version 200J or 360J)
Saver One P 200J
SVP-B0007
SVP-B0007-U
SVP-B0007-Q
SVP-B0007-U-Q
Saver One P 360J
SAV-C0846
1 Unit
Pre-connected Adult PADs
for standard models only
(without -U option)
SAV-C0904
1 Unit
Non-rechargeable battery
Li-MnO2
SAV-C0916
1 Unit
Carry case
SAV-C1005-HU
1 Unit
User Guide
SAV-C0599
1 Unit
Pre-connected Universal Face to
Face PADs
(only for models with -U option)
SMT-C14034
1 Unit
Q-CPR sensor
(only for models with -Q option)

19
The following optional Saver One P accessories can be purchased separately:
Code
Image
Quantity
Description
SAV-C0903
1 Unit
Non-rechargeable battery
Li-SOCl2
SAV-C0011
1 Unit
Rechargeable Li-Ion battery
SAV-C0012
1 Unit
CBACCS1 Charger
SAV-C0013
1 Unit
GS40A15-P1J Power supply
SAV-C0014
1Unit
(Contains 3 items)
01 CBACCS1 Charger
01 P66A-3P2JA Power supply
unit
01 Power supply cable
SAV-C0016
1 Unit
Children PADs
for standard models only
(without -U option)
SAV-C0017
1 Unit
2-way ECG cable
SAV-C0019
1 Unit
CD-ROM Saver View Express
SAV-C0907
1 Unit
SD Card
SAV-C1070
1 Unit
Thermal printer MARTEL
MCP7830
SAV-C0027
1 Unit
Memory Card reader for PC

20
5PARTS AND ACCESSORIES OF THE SAVER ONE P
5.1 BATTERIES
The Saver One P defibrillator can work with the following different types of batteries:
•(SAV-C0903) Non-rechargeable battery
•(SAV-C0904) Non-rechargeable battery
•(SAV-C0011) Rechargeable battery
For devices Saver One D and Saver One P, considering the higher consumption due to the presence of the TFT display,
AMI ITALIA recommends using the rechargeable battery SAV-C0011 (combined to the charging station SAV-C0014)
rather than the disposable battery SAV-C0903/SAV-C0904.
5.1.1 Non-rechargeable batteries SAV-C0903 (Li-SOCl2) and SAV-C0904 (Li-
MnO2)
The non-rechargeable batteries (SAV-C0903, based on Li-SOCl2technology, or SAV-C0904, based on Li-MnO2
technology) are supplied fully charged and ready for use. They have been designed for long autonomy and require no
maintenance.
Both Saver One P non-rechargeable battery types in standby mode have an estimated life of 4 (four) years assuming a
battery activation test, daily self-tests and no AED power-up. Both are capable of a high number of discharges, which
varies depending on the version of the device:
Saver One P Standard 200J 250 complete rescue cycles (shocks at 200J. and CPR)
Saver One P Power 360J 160 complete rescue cycles (shocks at 360J. and CPR)
If the remaining battery level is low, the Saver One P informs the user via audio and visual messages.
The Saver One P will give a low battery warning when the level is ≤5% (WARNING) and a very low battery warning
when the level is ≤ 1% (ALARM).
WARNING: Remaining capacity level of Battery equal to or less than 5%.
This notice will only be provided in Operating mode as indicated in paragraph 7.1.
With a 5% battery the Saver One P makes it possible to administer about 14 shocks or 40 days of
stand-by
ALARM: Remaining capacity level of Battery equal or less than 1%.
This warning will be issued both in Stand-by and in operating mode, as indicated in paragraph 7.1.
With a 1% battery the Saver One P administers about 7 shocks or 20 days of stand-by
In this condition, it is not recommended to use the device: replace the
battery.
!!ATTENTION!!
In order to protect the battery life (SAV-C0903 /SAV-C0904) and guarantee automatic daily tests, after installing it,
it is advisable not to remove the battery from the device unless it is to be replaced.
The removal of the battery from the device and its subsequent insertion, involves a complete self-test of the AED
which implies a non-negligible consumption of the battery capacity.
Furthermore, if the battery is not properly attached it could be damaged.
Figure 5