AED Saver One User Manual

AED Saver One User Manual

External automatic defibrillator for public access
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User Manual
External AUTOMATIC Defibrillator
for public access
Rev.
12.2

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Summary of Contents for AED Saver One

  • Page 1 User Manual External AUTOMATIC Defibrillator for public access Rev. 12.2...
  • Page 2 AUTOMATIC QUICK USE GUIDE...
  • Page 3 AUTOMATIC ©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. Infractions against this prohibition not only violate our copyright, but also reduce our ability to provide accurate and up-to-date information to the user and the operator of the device.
  • Page 4: Table Of Contents

    General structure of the device ....................... 13 Keys, icons and indicators ....................... 14 Status display ........................... 14 Standard and optional accessories of the device ................15 Parts and accessories of the Saver One ....................16 Saver One Batteries ......................... 16 5.1.1 Non-rechargeable Li-SOCl battery (SAV-C0903) ..............
  • Page 5 AUTOMATIC Test ..........................25 POWER ON Test ..........................26 Information button ..........................27 Defibrillation ............................28 Switching on the Saver One ......................28 Preparation of the patient ....................... 29 Positioning the PADs ........................29 Cardiac rhythm analysis ........................30 Shockable rhythm ..........................31 Change of rhythm ..........................
  • Page 6 Guidelines and manufacturer's declaration - Electromagnetic emissions ........46 12.2 Guidelines and manufacturer's declaration - Electromagnetic immunity ........46 12.3 Recommended separation distance between portable and mobile RF communication equipment and Saver One device ..........................48 Simbology ............................49 Certifications ............................50 14.1 EC Certificate ........................... 50 14.2...
  • Page 7: Introduction

    1.2 Use in accordance with provisions The device Saver One can be used exclusively if the conditions indicated in the user manual are respected. Any use not as prescribed meaning not in accordance with the provisions can cause damage to people or objects. In such cases A.M.I.
  • Page 8: Version Information

    AUTOMATIC 1.7 Version information This user manual has a version number. The version number changes every time the manual is updated for changes made to the function of the device or to the device itself. The contents of this user manual are subject to change without notice.
  • Page 9: Safety Instructions

     Do not allow liquids to enter the Saver One its parts or accessories. Avoid spilling liquid 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 or its accessories.
  • Page 10: Indications Of Disposal

     In order to use the Saver One , you 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) ...
  • Page 11: Description Of The Device

    Rechargeable battery Li-ion (SAV-C0011), recommended for those who use the defibrillator intensively The Saver One Automatic has been designed to be used not only by medical personnel but also by lay personnel who have duly completed a training course on cardio-pulmonary resuscitation with the use of the defibrillator (BLS-D). The Saver One Automatic is equipped with voice commands that instruct the rescuer in every phase of resuscitation.
  • Page 12: Classifications

    AUTOMATIC 3.2 Classifications The Automatic Saver One defibrillator is classified as follows: Code UMDNS 11132 Code GMDN 47910 Code CND Z12030503 Directory number RDM 1402426 / 1535126 Code CIVAB DEF03 Class of belonging according to directive 2007/47/CE Type of protection against electric shock...
  • Page 13: Description Of Device Details

    AUTOMATIC Description of device details 4.1 General structure of the device Image 1 Description Compartment for PADS connector or ECG cable Microphone for environmental recordings Status mini display Carrying handle Battery compartment Keyboard with buttons and light icons IrDA port (service only, present only in the models with TFT display) Loudspeaker Image 2...
  • Page 14: Keys, Icons And Indicators

    "Do Not Touch" Indicator Luminous LED (red / green) allows you to Icon equipped with LEDs indicating not to check the functional status of the AED. touch the patient during certain operations "Automatic Shock" indicator Icon equipped with LEDs indicating that ON / OFF button Allows you to switch the device on or off.
  • Page 15: Standard And Optional Accessories Of The Device

    1 Unit Li-SOCl battery SAV-C1005-HU 1 Unit User guide Carry bag SAV-C0916 1 Unit The following are the optional Saver One accessories that can be purchased separately: Code Image Quantity Description SAV-C0011 1 Unit ACC Rechargeable Li ion battery SAV-C0012...
  • Page 16: Parts And Accessories Of The Saver One

    New and fully charged battery, constant temperature at 20°C and relative humidity without condensation 45% If the remaining battery level is low, the Saver One informs the user via audio and visual messages. will give a low battery warning when the level is ≤5% (WARNING) and a very low battery The Saver One warning when the level is ≤...
  • Page 17: Rechargeable Li Ion Battery (Sav-C0011)

    If the remaining battery level is low, the Saver One informs the user via audio and visual messages. The Saver One 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 or less than 5%.
  • Page 18: Inserting And Removing The Batteries

    AUTOMATIC 5.1.4 Inserting and removing the batteries To be able to operate the Saver One the insertion of a battery is required. Below are detailed instructions for correctly installing the batteries (rechargeable or non-rechargeable) in the Saver One. Image 6 Image 7 ...
  • Page 19: Recharging Station For Rechargeable Batteries

    AUTOMATIC 5.2 Recharging station for rechargeable batteries The charging station (SAV-C0013) allows you to recharge rechargeable batteries with Li-ion technology ACC model (SAV-C0011) of the Saver One. The charging station consists of the following parts:  Charger (SAV-C0012) image (10) ...
  • Page 20: Recharge Procedure

    100% Number of consecutive flashes Fixed Defibrillation PADs The Saver One allows the use of two different defibrillation PADs depending on the patient to be treated:  Defibrillation PADs for Adults model SAV-C0846  Defibrillation PADs for Children model SAV-C0016...
  • Page 21: Defibrillation Pads For Adults Sav-C0846

    AUTOMATIC 5.3 Defibrillation PADs for Adults SAV-C0846 The Saver One allows the use of two different defibrillation PADs depending on the patient to be treated:  Defibrillation PADs for Adults model SAV-C0846  Defibrillation PADs for Children model SAV-C0016 5.3.1 Defibrillation PADs for Adults SAV-C0846 The SAV-C0846 defibrillation PADs are pre-gelled disposable types.
  • Page 22: Positioning Of Defibrillation Pads

    Always refer to the instructions given both on the packaging of the PADs and directly on each individual pad. The PADs of the Saver One are polarized type; do not reverse the positioning of each single pad. Position Pad 1 immediately below the patient's right collarbone...
  • Page 23: Memory Card And Usb

    C. Insert the Memory Card with the contacts facing upwards as shown in the image and push it until it is completely inserted The data recorded directly on the internal memory of the Saver One can be downloaded via the USB port on the back of the device (image 16).
  • Page 24: Auto Test

    AUTOMATIC Auto test The Saver One has been designed to be a totally safe device, always ready for use and able to automatically and constantly verify correct operation, minimizing maintenance operations. The Saver One performs different types of self-tests: ...
  • Page 25: Activation Test

    If no error is detected the following screen will be shown on the display:  Turn off the device If it is not to be used immediately turn off the Saver One and leave the battery inserted to ensure that periodic self- diagnostic tests are performed (see Section 6.3) 6.3 AUTOMATIC Test...
  • Page 26: Power On Test

    AUTOMATIC 6.4 POWER ON Test The Saver One performs self-diagnostic tests each time it is turned on, either from the power button or by inserting the battery. Following to the battery insertion a diagnostic test of ACTIVATION is performed. This self-test involves a fair amount of energy consumption.
  • Page 27: Information Button

    Below is a detailed description of the procedure for using this button and the information displayed:  Switch on the device The Saver One will carry out the automatic power on test after which it will be ready for use. “i”...
  • Page 28: Defibrillation

    (default setting). Below are the procedures to follow to use the device in this mode. Press the power button on the device The Saver One will emit an acoustic signal to confirm the power on, the ON / OFF button will be lit fixed green. The following screens will appear on the LCD display:...
  • Page 29: Preparation Of The Patient

    AUTOMATIC 8.2 Preparation of the patient In order to correctly position the defibrillation PADs on the chest, it is necessary to carry out the following preliminary operations: Image 19 Remove clothing from the patient's chest If the patient's chest has thick hair it might be necessary to shave the Pads positioning points.
  • Page 30: Cardiac Rhythm Analysis

    AUTOMATIC 8.4 Cardiac rhythm analysis The Saver One automatically analyses the patient's heart rhythm. This phase is highlighted by the following commands: Voice commands Display Luminous Icons Keyboard Icon do not touch Do not touch the patient the patient on with...
  • Page 31: Shockable Rhythm

    Saver One 200J: The first shock is delivered to energy of 150J the following at 200J Saver One 360J: The first shock is delivered to energy of 200J the second at 250J the following at 360J The detected impedance value must be between 20 and 200 Ohm; if a value outside this range is detected, it is required to position the PADs.
  • Page 32: Change Of Rhythm

    Voice commands Display Shock cancelled 8.7 Non-shockable rhythm If the Saver One does not detect a VF or a VT during heart rate analysis, it will inform the operator using the following commands: Voice commands Shock not recommended All rhythms other than VF and VT will be considered as non-shockable. For more information, paragraph 10.6.
  • Page 33 1 second. Visual LUMINOUS ICON Follow the voice and text instructions of the Saver One until The Saver One will repeat STEP 1 to 3 for about 2 minutes the device stops the CPR phase (about 2 minutes)
  • Page 34: Recording, Viewing And Archiving The Data

    Recording, viewing and archiving the data The Saver One 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 archiving is done automatically (cannot be deactivated by the user) both on the internal memory of the device and on the memory card when installed.
  • Page 35: Maintenance

    10.1 After each use After using the Saver One defibrillator it is necessary to proceed with the following operations in order to prepare the device for the next use: 1. Check the presence of the memory card and its remaining capacity (see paragraph 5.3) 2.
  • Page 36: Cleaning

    10.4 Preservation The Saver One must be stored in a place where the environmental and safety conditions indicated in the table below are observed according to the temperature and humidity indicated in the chapter 12.2. If installed it is advisable to keep the device with the battery always inserted to allow it to carry out periodic self-diagnostic tests.
  • Page 37: Troubleshooting Guide

    AUTOMATIC 10.5 Troubleshooting 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 user's manual. If the failure of the unit persists, request assistance.
  • Page 38: Technical Specifications

    AUTOMATIC Technical specifications The technical specifications of the Saver One defibrillator, its parts and accessories are shown below. 11.1 Physical characteristics Category Nominal specifications Dimensions 26,5 x 21,5 x 7,5 cm With battery Li-SOCl 1,95 Kg including Adult Pads (SAV-C0903)
  • Page 39: Alarms Table

    Daily self-tests, Errors found, Device usage data, AED1LOG.txt Device information Archived data Rescue events, voices and environmental noises, ECG tracing of rescue, AEDFILE.aed Vital parameters of the patient analysed and detected by the Saver One Data display Via PC Saver View Express software (Microsoft Windows compatible)
  • Page 40: Defibrillator

    AUTOMATIC 11.7 Defibrillator Category Nominal specifications Waveform Biphasic Truncated Exponential (BTE) The waveform parameters are automatically adjusted according to the patient's impedance. In the graph on the left t represents the duration of phase 1 (ms), t represents the duration of phase 2 (ms), t is the delay between phases, U indicates the peak voltage, t...
  • Page 41: Efficiency Of Delivered Energy

    AUTOMATIC 11.8 Efficiency of delivered energy Impedance Shock of 50 J (Paediatric) Energy delivered Set Energy (Joules) 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 Shock of 150 J Energy Set Energy...
  • Page 42 AUTOMATIC Impedance Shock of 250 J Energy Set Energy delivered (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 Shock of 350 J Energy...
  • Page 43: Patient Analysis System

    99% Respects the guidelines IEC/EN 60601-2-4 2002(3) sources AHADB, MITDB and EDB Specificity If used on a patient who has the characteristics listed in the usage criteria, the Saver One defibrillator is designed to recommend a defibrillating shock when it detects the right...
  • Page 44: Rechargeable Battery

    AUTOMATIC 11.12 Rechargeable battery Category Nominal specifications SAV-C0011 REF (Model) Type Li ion (lithium ions) Rechargeable 21,6 VDC - 2100 mAh Voltage Capacity Standard 200J 250 continuous shocks Power 360J 160 continuous shocks ECG analysis 21 continuous hours ≤ 2,5 hours with charging station SAV-C0012 Charging time Shelf Life 2 years or 300 charge/shock cycles (the one that occurs first)
  • Page 45: Defibrillation Pads

    AUTOMATIC 11.15 Defibrillation PADs Category ADULTS CHILDREN REF (Model) SAV-C0846 SAV-C0016 Series Cable and connector outside the envelope Cable, connector and PADs into the envelope) Adults age >8 years or weight > 25Kg Children age 1 - 8 years or weight < 25Kg Patient range Disposable Intended use...
  • Page 46: Compliance With Electromagnetic Emission Standards

    12.1 Guidelines and manufacturer's declaration - Electromagnetic emissions The Saver One was designed to be used in electromagnetic environments with features listed below. The customer or the user of the Saver One must ensure that it is used in such an environment.
  • Page 47 RF transmitters, consider conducting an electromagnetic site survey. If the power of the fields measured in the location in which the AED is used exceeds the specific RF compliance level mentioned above, it will be necessary to monitor the AED to verify its correct functioning.
  • Page 48: Recommended Separation Distance Between Portable And Mobile Rf Communication Equipment And Saver One Device

    Saver One device The Saver One must be used in an electromagnetic environment in which radiated RF interference is controlled. The customer or the operator of the Saver One 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 , based on the maximum output power of the devices of communication.
  • Page 49: Simbology

    AUTOMATIC Simbology ILCOR Universal Symbols for AED IMQ brand High Voltage Electrical Hazard CE mark with identification number General Notices: Refer to the consultation IP54 Degree of protection of the appliance against of accompanying documents before using dust and water (including battery)
  • Page 50: Certifications

    AUTOMATIC Certifications 14.1 EC Certificate...
  • Page 51 AUTOMATIC...
  • Page 52: Imq Brand

    AUTOMATIC 14.2 IMQ Brand...
  • Page 53: Saver One Defibrillator Warranty

    Saver One defibrillator of A.M.I. Italia rendered illegible or otherwise tampered with; S.r.l and is not transferable or assignable to third parties. - if the warranty seal (opening of the device) on the Saver One DAE is The Saver One defibrillators are as follows: removed;...
  • Page 54: Product Registration

    AUTOMATIC Product registration In order to guarantee a correct and rapid traceability of the product sold, we ask you to complete the form below and send it by fax or registered letter to A.M.I. Italia S.r.l.
  • Page 55 AUTOMATIC...

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