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Related Manuals for A.M.I Italia Saver One P
Summary of Contents for A.M.I Italia Saver One P
- Page 1 ANUAL EFIBRILLATOR EMIAUTOMATIC ANUAL...
- Page 2 QUICK START GUIDE...
- Page 3 ©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.
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Page 4: Table Of Contents
Keys, icons and indicators ......................16 Mini status display ........................16 TFT colour display ........................17 Standard and optional accessories of the device ............... 18 Parts and accessories of the Saver One P ....................20 Batteries ............................20 5.1.1 Non-rechargeable batteries SAV-C0903 (Li-SOCl ) and SAV-C0904 (Li-MnO ) .... - Page 5 ACTIVATION test ......................... 38 AUTOMATIC test ......................... 39 ON test ............................39 SEMI-AUTOMATIC Defibrillation ......................40 Switching on the Saver One P ..................... 40 Adult and Paediatric mode ......................40 Placement of the defibrillation pads ................... 41 Heartbeat analysis ........................41 Shockable rhythm ........................
- Page 6 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 ........................
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Page 7: Introduction
SE 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. -
Page 8: Counterindications
1.6 C OUNTERINDICATIONS The Saver One P cannot be used if the patient – is conscious or.. – is breathing normally or.. – has a heartbeat 1.7 I NFORMATION 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. -
Page 9: Safety Instructions
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. - Page 10 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.
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Page 11: Warnings For Use In Ecg Monitoring
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. -
Page 12: Instructions For Disposal
NSTRUCTIONS FOR ➢ 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. -
Page 13: Device Description
3.1 D EVICE 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. -
Page 14: Classifications
3.2 C LASSIFICATIONS 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 DEF02 Centre] code Class in accordance with Directive 2007/47/EC... -
Page 15: Description Of Device Details
ESCRIPTION OF DEVICE DETAILS 4.1 G ENERAL STRUCTURE OF THE DEVICE Figure 1 Description Compartment for PADS connector or ECG cable Microphone for environmental recordings Mini status display Carry handle Battery (removable) TFT colour display IrDA port (service only) Keypad with buttons Speaker Figure 2 Description... -
Page 16: Keys, Icons And Indicators
4.2 K ICONS AND INDICATORS Figure 3 Function Function UP navigation key Mini status display To scroll up the menu To check the functional status of the device Navigation key ENTER Disarm Button To enter the menu and confirm the It allows the device to be disarmed in selection made manual mode... -
Page 17: Tft Colour Display
4.4 TFT COLOUR DISPLAY Figure 4 Description Description Indicates the OPERATIVE mode AED: AED MODE Indicates the number of VFs and/or VTs detected by the Semi-automatic Defibrillation device ASYNCHRONOUS: Manual Asynchronous ASYNC Defibrillation MONITORING: ECG Monitoring Indicates the duration of the rescue SYNCHRONOUS: Manual Synchronous SYNC... -
Page 18: Standard And Optional Accessories Of The Device
4.5 S TANDARD 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 Saver One P 200J SVP-B0006-Q SVP-B0006-U-Q 1 Unit SVP-B0007 (Version 200J or 360J) SVP-B0007-U... - Page 19 The following optional Saver One P accessories can be purchased separately: Code Image Quantity Description Non-rechargeable battery SAV-C0903 1 Unit Li-SOCl Rechargeable Li-Ion battery SAV-C0011 1 Unit CBACCS1 Charger SAV-C0012 1 Unit GS40A15-P1J Power supply SAV-C0013 1 Unit 01 CBACCS1 Charger...
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Page 20: Parts And Accessories Of The Saver Onep
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 ≤... -
Page 21: Rechargeable Sav-C0011 Battery (Li Ion)
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 ≤... -
Page 22: Insertion And Removal Of The Batteries
5.1.4 Insertion and removal of the batteries To be able to operate, a battery must be inserted in the Saver One P. Below are detailed instructions for correctly installing the batteries (rechargeable or non-rechargeable) in the Saver One P. Figure 8 Figure 7 •... -
Page 23: Structure Of The Battery Charger
5.2.1 Structure of the battery charger Figure 14 Description Function Charger LED Indicates the battery charge level or the functional status of battery charger Power supply Input for 12V, 5A power supply connector Battery contacts Contacts for energy exchange between charger and batt The Battery charger (SAV-C0012) must only be used with the AC/DC power supply unit/adapter supplied by A.M.I. -
Page 24: Defibrillation Pads
5.3 D EFIBRILLATION PADS The Saver One P supports the use of the following defibrillation PADs depending on the patient to be treated and the device model: • Adult defibrillation PADs model SAV-C0846 (only for models SVP-B0006 and SVP-B0007) •... -
Page 25: Face-To-Face Sav-C0599 Universal Defibrillation Pads
5.3.3 Face-to-Face SAV-C0599 universal defibrillation pads Face-to-Face universal defibrillation PADs are pre-gelled and disposable. They must be used in adult/paediatric patients (age >1 year). The defibrillation PADs are supplied in a single sealed package showing the expiry date (typically 24 months). On the expiry date, the PADs must be replaced even if not used. -
Page 26: Universal Face-To-Face Sav-C0599 Defibrillation Pads Management
5.3.4 Universal Face-to-Face SAV-C0599 Defibrillation PADs Management The SAV-C0599 defibrillation PADs are managed by the models that provide for patient selection (see paragraph 6.1) with the aid of the display: after the device is switched on, the display immediately shows the screen in which the operator is asked to select adult or paediatric patient, using the menu navigation keys, which are designated separately for the two types of patients for greater safety. -
Page 27: 5.4 Q-Cpr Sensor
5.4 Q-CPR SENSOR The Saver One P (Ref: SVP-B0006-Q, SVP-B0006-U-Q, SVP-B0007-Q, SVP-B0007-U-Q) makes it possible to provide feedback on proper execution of cardiac massage thanks to the proprietary AMI Italia external accessory module (figure 17) to perform CPR Quality (Q-CPR) to be interposed between the rescuer's hands and the patient's chest. -
Page 28: 2-Pole Ecg Cable Sav-C0017
The SAV-C0017 ECG cable is fitted with two clip terminals for disposable pre-gelled electrodes (optional). The ECG cable can read the patient's lead II to show the ECG trace on the Saver One P display. The SAV-C0017 ECG cable can only be used if the Saver One P is set in "ECG MONITORING" operating mode (see Chapter 10). -
Page 29: Memory Card
C. Insert the Memory Card with the contacts facing upwards as shown in the figure and push it until it is completely inserted The data recorded directly on the internal memory of the Saver ONE P can be downloaded via the USB port on the back of the device (figure 21). -
Page 30: Martel Mcp7830 Thermal Printer (Sav-C1070)
ARTEL THERMAL PRINTER The Saver One P defibrillator can print the ECG trace and patient data using the external thermal printer model Martel MCP7830 (SAV-C1070). The communication between printer and defibrillator is wireless thanks to the IrDA port of the Saver One P (located on the left side of the defibrillator) and that of the printer. -
Page 31: Saver One Pselection Menu
SELECTION MENU The Saver One P menu allows you to make multiple selections, settings and view useful information about the device and the rescue. All the settings that can be selected to use the device to its full potential will be described in detail in the next paragraphs. -
Page 32: Settings Menu
After pressing the ENTER key, the following screen will be shown on the Saver One P display: Below is a description of the messages that appear on the display: Image Function To select the desired operating mode. To access the settings submenu... -
Page 33: System Information Menu
After pressing the ENTER key, the following screen will be shown on the Saver One P display: Image Function Possible variations To increase or decrease the sound level (voice + acoustic Volume 10% - 100% signals) To enable or disable the microphone for recording... -
Page 34: Power Supply Sub Menu
After pressing the ENTER key, the following screen will be shown on the Saver One P display: Image Function Possible variations Model Indicates the device model Saver One P Device Serial No. Device identification number Indicates the software version installed Firmware version Axx.xxxxMxx.xxxx... -
Page 35: Print Menu
After pressing the ENTER key the following screen will appear on the display: Image Function Possible variations Non-rechargeable / Type Indicates the type of battery installed Rechargeable Capacity Indicates the remaining battery capacity 0 – 100% Indicates how many times the rechargeable battery has been recharged No. - Page 36 After pressing the ENTER key the following screen will appear on the display: Image Function Possible variations To select rescue events recorded on memory Archive YYMMDDxx.AED card Indicates the selected rescue and the total amount of recorded rescues Indicates the date and time of the selected 2011/02/12 13:22 dd/m/year - hh:mm rescue...
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Page 37: Self-Test
TEST The Saver One P has been designed to be a totally safe device, always ready for use and able to automatically and constantly check correct operation, reducing maintenance operations to the minimum. The Saver One P performs self-test types: •... -
Page 38: Activation Test
The following screens will appear on the colour TFT display: ❖ Switch off the device If it does not need to be used immediately, switch off the Saver One P and leave the battery inserted to ensure periodic self-testing (see Paragraph 7.3) If the shock button is not pressed within the time limit indicated by the countdown, the Saver One P detects an error. -
Page 39: Automatic Test
The device is now ready for use and will provide the operator with the first instructions to start the intervention. If it does not need to be used immediately, switch off the Saver One P and leave the battery inserted to ensure... -
Page 40: Semi-Automatic Defibrillation
(default setting). The procedures to follow to use the device in this mode are set out below. Push the device’s on button The Saver One P will emit an acoustic signal to confirm switching on; the ON/OFF button will be lit steady green. The following screens will be shown in sequence on the colour display: If the test is successful, the device will continue to the next steps. -
Page 41: Placement Of The Defibrillation Pads
If the defibrillation PADs have been correctly applied and the connector is inserted in the appropriate compartment, the Saver One P automatically analyses the heart rhythm of the patient. This information is highlighted by voice (audio) and visual (colour display) prompts, as shown in the following table:... -
Page 42: Shockable Rhythm
To shock, press the shock button within 15 seconds If the shock button is not pressed within 15 seconds of the shock alert, the Saver One P will automatically disarm. This information is highlighted by voice (audio) and visual (colour display) prompts, as shown in the following table:... -
Page 43: Non-Shockable Rhythm
Saver One P 200J: The first shock is administered at 150J energy the following ones at 200J Saver One P 360J: The first shock is carried out at an energy of 200J the second at 250J the subsequent ones at 360J The detected impedance value must be between 20 and 200 Ohm;... -
Page 44: Cpr
Ratio 15/2 for about 2 minutes (10 cycles) This option can be selected from the* menu of Saver One P and allows the operator to have voice instructions during paediatric CPR depending on whether you want to operate with 30/2 or 15/2 ratio. - Page 45 1 second Follow the voice and text instructions of the Saver One The Saver One P will repeat STEP 1 to 3 for about 2 P until the device stops the CPR phase (about 2 minutes...
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Page 46: Manual Defibrillation
Moreover, the voice and text guide on the CPR manoeuvre is disabled in this mode. Given the possibility of the Saver One P to be used by paramedics, in semi-automatic mode, the manual mode is protected by a password which must only be used by medical personnel. -
Page 47: Asynchronous Defibrillation
The defibrillation pulse can, therefore, be released at any time as there are no periods of vulnerability detectable defibrillation, in which energy is released asynchronously with respect to the cardiac cycle. After activating this mode, the following screen will appear on the Saver One P display: Figure 32... -
Page 48: Synchronized Defibrillation
Cardioversion can be used to treat atrial fibrillation or flutter and certain atrial, ventricular or junction tachycardias. After activating this mode, the following screen will appear on the Saver One P display: Figure 34 Once selected, to exit the "Manual Synchronous" mode, you must select a different mode or turn off the Saver One P. -
Page 49: Energy Selection
Pressing the Energy button accesses the relevant menu from which the operator can select the energy they believe should be delivered. After selecting the energy to be delivered, the Saver One P automatically exits the menu and returns to the main screen. The selectable energy levels vary depending on the version of the SAVER ONE P used: Saver One P200J: 50J –... -
Page 50: Charging Phase
9.3 C HARGING HASE If the operator is ready to deliver the shock, they must press the CHARGE button in order to "arm" the device and then be able to shock. Figure 36 This information is highlighted by voice (audio) and visual (colour display) prompts, as shown in the following table: Voice prompts Text Video Display... -
Page 51: Shock Delivery
(press and hold) If the shock button is pressed the Saver One P defibrillator will guide the operator through CPR. If CPR guidance has been enabled in the settings menu, the device will guide the operator through voice and text prompts; otherwise, the device will be muted for about 2 minutes. -
Page 52: Ecg Monitoring
Using the 2-pole ECG cable SAV-C0017 The Saver One P allows you to view one single ECG channel by analysing lead II. Since the use of this mode is indicated for specialized medical personnel, in order to be started, it requires entering a security password (see the following paragraphs for more information). - Page 53 In the menu, select "ECG Monitoring" If the password entry request has been set up, the following screen will be displayed when accessing the two modes: At this point you need to enter the security password. This safeguard (optionally configurable at the Customer's request) can be used to avoid random selection errors by personnel not authorised to use this mode.
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Page 54: Description Of Ecg Monitoring Feature
10.2 D ECG M ESCRIPTION OF ONITORING FEATURE Once the ECG Monitoring mode has been selected, an icon-based MENU is shown on the right side of the display to manage the functions provided in this mode. In addition, other icons relating to events and/or statuses that appear during use of the Monitoring mode can appear on the upper part of the display. - Page 55 Code Displayed message Description Priority Alarm signalling delay (max) Cardiac Low frequency Detection of a slow sinus rhythm HIGH < 10 sec * Asystole Detection of an absent sinus rhythm HIGH < 10 sec * Fibrillation Detected Detection of ventricular fibrillation. HIGH <...
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Page 56: Recording, Printing And Storing Rescue Data
PRINTING AND STORING RESCUE DATA The Saver One P defibrillator is able to record and store both the SERVICE data of the device and the complete data of the rescue operations carried out. Data recording and storing is carried out automatically (cannot be disabled by the user) both on the internal memory of the device and on the memory card when installed (with the exception of recording voices and environmental noise). -
Page 57: Printing Of Rescue Data
11.2 P RINTING OF RESCUE DATA The Saver One P defibrillator allows you to print data stored in the memory directly from the device by using the portable thermal printer model Martel MCP7830 (SAV-C1070) Rescue data can only be printed if the data has been previously stored on the memory card. -
Page 58: 11.2.2 Selection Of The Data To Be Printed
11.2.2 Selection of the data to be printed After interfacing the printer with the Saver One P defibrillator, the operator must select the data and start printing. Printing of the data will only be possible if a memory card has been installed in the defibrillator and it contains the data of one or more rescues. -
Page 59: 11.2.3 Printing
11.3 S TORAGE OF DATA ON A The rescue data recorded by the Saver One P defibrillator can be stored, analysed and printed from a Personal Computer using the Saver View Express management software. Figure 40... -
Page 60: Maintenance
If not used, check the expiry date of the PADs, if expired replace them with a new package. 12.2 S CHEDULED MAINTENANCE Thanks to the tests carried out in total autonomy by Saver One P, routine maintenance will require a simple and quick inspection, following the operations described in the table: Check before... -
Page 61: Cleaning
12.4 S TORAGE The Saver One P must be stored in a place where the environmental and safety conditions indicated in the table below are complied with, according to the temperature and humidity indicated in chapter 13.2. If installed it is advisable to keep the device with the battery always inserted to allow it to carry out the periodic self-diagnostic tests. -
Page 62: Troubleshooting Guide
12.5 T ROUBLESHOOTING GUIDE The following table lists the symptoms, the possible causes and the possible corrective actions of the problems that may arise. For more information on the implementation of corrective actions, refer to the other sections of the operator's manual. -
Page 63: Technical Specifications
13 T ECHNICAL SPECIFICATIONS The technical specifications of the Saver One P defibrillator, its parts and accessories are shown below. 13.1 P HYSICAL CHARACTERISTICS Category Rated specifications Dimensions 26.5 x 21.5 x 7.5 cm with SAV-C0903/SAV-C0904 battery: 1.99 Kg + Adult PADs (2.08 Kg) -
Page 64: Regulatory Framework
13.3 R EGULATORY FRAMEWORK Regulations and Directives DIRECTIVE 2007/47/EC IEC/EN 60601-1 IEC/EN 60601-1-2 IEC/EN 60601-1-4 IEC/EN 60601-1-6 IEC/EN 60601-1-8 IEC/EN 60601-1-11 IEC/EN 60601-1-12 IEC/EN 60601-2-4 IEC/EN 60086-4 IEC/EN 60529 DIRECTIVE 2014/53/EU - RED IEC/EN 60601-2-27 except points 202.6.2.101, 201.12.1.101.12.13, 208.6.6.2.101, not executed because the device is not intended for use in environments such as operating theatres or intensive care units (see section warnings for use of monitoring mode) 13.4 T... -
Page 65: Data Storage
Device information Stored data Rescue data, Environmental voices and sounds, Rescue ECG trace, AEDFILE.aed Vital parameters of the patient analysed and detected by the Saver One P Data display Through PC Saver View Express Software (Microsoft Windows compatible) 13.8 D... -
Page 66: Efficiency Of The Energy Delivered
13.9 E FFICIENCY OF THE ENERGY DELIVERED Impedance Shocks at 50 J (Paediatric) Energy delivered (Joules) Energy set (J) 25 Ohm 18.6 50.2 50 Ohm 12.3 49.2 75 Ohm 48.6 100 Ohm 48.4 125 Ohm 48.75 150 Ohm 175 Ohm 48.3 Impedance Shocks at 150 J... - Page 67 Impedance Shocks at 250 J Energy delivered Energy set (J) (Joules) 25 Ohm 56.6 246.4 50 Ohm 32.3 246.8 75 Ohm 23.7 244.95 100 Ohm 19.4 244.8 125 Ohm 15.8 241.75 150 Ohm 13.3 242.4 175 Ohm 11.5 11.4 241.15 Impedance Shocks at 350 J Energy...
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Page 68: Patient Analysis System In Semi-Automatic Mode
Specificity 99% Complies with IEC/EN60601-2-4 guidelines If used on a patient with the characteristics listed in the use criteria, the Saver One P defibrillator is designed to recommend a defibrillating shock when it detects the right impedance and when the following situations occur: Shockable rhythms Ventricular Fibrillation peak-to-peak amplitude at least 200µVolts... -
Page 69: Display
13.13 ISPLAY Category Rated specifications Type Colour TFT with LED backlight Visible area 5.7” (diagonal) - 112 x 80 mm Resolution 640 x 480 pixels ECG tracing displayed 1 (Lead II) ECG tracing speed 25 mm/sec (default) •Patient’s heart rate (bpm) •Patient thoracic impedance (Ω) •VF or VT detected (numeric value) •Shocks delivered (numeric value) -
Page 70: Internal Back-Up Battery
13.16 NTERNAL BACK UP BATTERY Category Rated specifications Type Battery Coin Cell (LiMnO2) Purpose Preserving configuration data (date/time, etc.) Voltage - Capacity 3 VDC – 1000mAh Maintains data for 3 years (without external battery) Duration Maintains data for 6 years (with external battery inserted within 12 months) 13.17 ATTERY CHARGER Category... -
Page 71: Defibrillation Pads
13.19 EFIBRILLATION PADS Category ADULTS CHILDREN Universal Face to Face REF (Model) SAV-C0846 SAV-C0016 SAV-C0599 Cable and connector external to Cable, connector and PADs Cable and connector Series the bag inside packaging external to the bag Adult age >8 years or weight > Child age <... -
Page 72: Compliance With Electromagnetic Emission Standards
UIDELINES AND MANUFACTURER DECLARATION LECTROMAGNETIC EMISSIONS The Saver ONE P was designed to be used in electromagnetic environments with features listed below. The customer or the user of the Saver ONE P must ensure that it is used in such an environment. - Page 73 Test level Conformity Electromagnetic environment Immunity test IEC/EN 60601-1 Level Guidelines Supply frequency Power frequency magnetic fields must be at (magnetic field) levels that do not exceed those of stations 50/60 Hz 3 A/m 80 A/m located in typical heavy industry applications, power plants and control rooms of high-voltage IEC/EN 61000-4-8 substations.
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Page 74: Recommended Separation Distance Between Portable And Mobile Rf Communication
AVER NE DEVICE The Saver ONE P must be used in an electromagnetic environment in which radiated RF interference is controlled. The customer or the operator of the Saver ONE P can help prevent electromagnetic interference by maintaining the minimum distances recommended below, between the portable and mobile RF communications equipment (transmitters) and the Saver ONE P, based on the maximum output power of the communication devices. -
Page 75: Symbols
15 S YMBOLS Universal ILCOR symbols for AEDs IMQ Mark Hazard High Electrical Voltage CE marking with identification number General Warnings: Please refer to the IP54 Level of Protection of the device against dust accompanying documents before using and water (including the battery) the device Type BF, Defibrillation-proof device Serial Number... -
Page 76: Certifications
16 C ERTIFICATIONS 16.1 CE CERTIFICATE... -
Page 78: Imq Mark
16.2 IMQ M... -
Page 79: Saver One Series Defibrillator Warranty
SVD-B0005-U-Q) sold used; in such case, the warranty must be offered by the reseller of Saver ONE P (code SVP-B0006 or SVP-B0007, code SVP-B0006-U or SVP- the used product with exclusion of all liability, also indirect, of A.M.I. B0007-U, code SVP-B0006-Q or SVP-B0007-Q, code SVP-B0006-U-Q or... -
Page 80: Product Registration
18 P RODUCT REGISTRATION In order to guarantee correct and rapid traceability of the product sold, we kindly ask you to complete the form below and send it by fax or registered letter to A.M.I. Italia S.r.l., or register on the AMIITALIA website www.amiitalia.com...