AED Saver One S1 Series User Manual

External semi-automatic defibrillator for public access
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User Manual
External Semi-automatic Defibrillator
for public access
Rev.
4.2

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Summary of Contents for AED Saver One S1 Series

  • Page 1 User Manual External Semi-automatic Defibrillator for public access Rev.
  • Page 2 SEMI-AUTOMATIC QUICK USE GUIDE...
  • Page 3 SEMI-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

    4.2 Keys, icons and indicators ........................14 4.3 Status display ............................14 4.4 Standard and optional accessories of the device .................. 15 5 Parts and accessories of the Saver One S1 Series ..................16 5.1 Batteries ..............................16 5.1.1 Non rechargeable Li-SOCl battery (SAV-C1032) ..............
  • Page 5 6.4 POWER ON Test ............................. 25 7 Information button ............................26 8 Defibrillation ..............................27 8.1 Switching on the Saver One S1 Series ....................27 8.2 Preparation of the patient ........................28 8.3 Positioning the PADs ..........................28 8.4 Cardiac rhythm analysis ......................... 29 8.5 Shockable Rhythm ..........................
  • Page 6 12.1 Guidelines and manufacturer's declaration - Electromagnetic emissions .......... 45 12.2 Guidelines and manufacturer's declaration – Electromagnetic immunity .......... 45 12.3 Recommended separation distance between portable and mobile RF communication equipment and the device Saver One S1 Series ......................47 13 Simbology ..............................48 14 Certifications ............................... 49 14.1 EC Certificate ............................
  • Page 7: Introduction

    So that you can correctly use the device it is necessary, before usage, to carefully read this user manual. The User Manual of Saver One S1 Series contains the instructions for its use in compliance with its function and purpose. For a function free of error and to achieve the right benefits, it is fundamental to respect the prescriptions indicated in this user manual, to guarantee the safety of the patient, of the rescuer and of any third parties.
  • Page 8: Version Information

    SEMI-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 open the Saver One S1 Series , do not remove the panels and do not attempt to repair it. The Saver One S1 Series contains no components that users can repair. For repair purposes, the Saver One S1 Series P must be sent to an authorized technical service center.
  • Page 10: Indications Of Disposal

     The Saver One S1 Series, its parts and accessories must not be disposed of with other household waste within the European community. To prevent possible damage to the environment or human health caused by incorrect waste disposal, recycle this product responsibly also to promote sustainable use of resources.
  • Page 11: Description Of The Device

     Rechargeable Li-ion battery (SAV-C1033) for heavy-duty defibrillator users The Saver One S1 Series has been designed to be used not only by medical personnel but also by lay personnel who have duly completed a basic cardiopulmonary resuscitation training course using the defibrillator (BLS-D).The Saver One S1 Series is equipped with voice commands that instruct the rescuer in each phase of resuscitation.
  • Page 12: Classifications

    SEMI-AUTOMATIC 3.2 Classifications The Saver One S1 Series defibrillator is classified as follows: Code UMDNS 11132 Code GMDN 47910 Code CND Z12030501 Directory number RDM 1793108 / 1793112 Code CIVAB DEF01 Class of belonging according to directive 2007/47/CE Type of protection against electric shock...
  • Page 13: Description Of Device Details

    Carrying handle IrDA port (service only, present only in the models with TFT display) Keyboard with buttons and light icons Loudspeaker Image 2 Description USB port Compartment for SD Memory Card SD Memory Card insertion Saver One S1 Series battery compartment...
  • Page 14: Keys, Icons And Indicators

    Allows you to switch the device on or off. deliver a defibrillation shock if indicated Status mini display “i” button Allows to control the state of the AED and Allows in operating mode to show useful battery in stand-by and get useful information on the device information during operative phases 4.3 Status display...
  • Page 15: Standard And Optional Accessories Of The Device

    1 Unit Non-rechargeable SAV-C1032 1 Unit Li-SOCl battery SAV-C1076 1 Unit User guide The following are the optional Saver One S1 Series accessories that can be purchased separately: Code Image Quantity Description SAV-C1033 1 Unit ACC Rechargeable Li ion battery Charger...
  • Page 16: Parts And Accessories Of The Saver One S1 Series

    If the remaining battery level is low, the Saver One S1 Series informs the user via audio and visual messages. The Saver One S1 Series will give a low battery warning when the level is ≤5% (WARNING) and a very low battery warning when the level is ≤...
  • Page 17: Rechargeable Li Ion Battery (Sav-C1033)

    If the remaining battery level is low, the Saver One S1 Series informs the user via audio and visual messages. The Saver One S1 Series will give a low battery warning when the level is ≤5% (WARNING) and a very low battery warning when the level is ≤...
  • Page 18: Inserting And Removing The Batteries

    5.1.3 Inserting and removing the batteries To be able to operate the Saver One S1 Series the insertion of a battery is required. Below are detailed instructions for correctly installing the batteries (rechargeable or non-rechargeable) in the Saver One S1 Series.
  • Page 19: Battery Charger Structure

    SEMI-AUTOMATIC 5.2.1 Battery charger structure Image 14 Function Description Charger LED Indicates the battery charge level or the functional status of battery charger Supply Input for 12V, 5A power supply connector Battery contacts Contacts for energy exchange between charger and battery The Battery Charger (SAV-C1035) must only be used with the AC/DC power supply/adapter supplied by A.M.I.
  • Page 20: Defibrillation Pads

    SEMI-AUTOMATIC 5.3 Defibrillation PADs The Saver One S1 Series 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 21: 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 S1 Series are polarized type; do not reverse the positioning of each single pad. Image 18...
  • Page 22: 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 S1 Series can be downloaded via the USB port on the back of the device (image 21).
  • Page 23: Auto Test

    SEMI-AUTOMATIC 6 Auto test The Saver One S1 Series 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 S1 Series performs different types of self-tests: ...
  • Page 24: 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 S1 Series and leave the battery inserted to ensure that periodic self-diagnostic tests are performed (see Section 6.3) If the shock button is not pressed within the time limit indicated by the countdown, the Saver One S1 Series detects an error.
  • Page 25: Automatic Test

    From this moment the device will be ready to be used and will provide the operator with the first instructions to start the intervention. If not to be used immediately, switch off the Saver One S1 Series and leave the battery inserted to ensure periodic self- testing (see Section 6.3).
  • Page 26: 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 S1 Series will carry out the automatic power on test after which it will be ready for use. “i”...
  • Page 27: 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 S1 Series will emit an acoustic signal to confirm the power on, the ON/OFF button will be lit fixed green.
  • Page 28: Preparation Of The Patient

    SEMI-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: 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 29: Cardiac Rhythm Analysis

    SEMI-AUTOMATIC 8.4 Cardiac rhythm analysis The Saver One S1 Series 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 the patient on with fixed light...
  • Page 30: Shockable Rhythm

    Shock button was not pressed If, on the other hand, the shock button was pressed the Saver One S1 Series will deliver the defibrillation shock. In this phase the shock button will no longer flash and the device will inform the user through the following commands:...
  • Page 31: Change Of Rhythm

    Display Shock cancelled Rhythm changed 8.7 Non-shockable rhythm If the Saver One S1 Series during cardiac rhythm analysis does not detect a VF or a VT, it will inform the user through the following commands: Voice commands Shock not recommended All rhythms other than VF and VT will be considered as non-shockable.
  • Page 32 1 second. Visual LUMINOUS ICON Follow the voice and text instructions of the Saver One S1 The Saver One S1 Series will repeat STEP 1 to 3 Series until the device stops the CPR phase (about 2 for about 2 minutes...
  • Page 33: Recording, Viewing And Archiving The Data

    9 Recording, viewing and archiving the data The Saver One S1 Series 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 34: Maintenance

    10.1 After each use After using the Saver One S1 Series defibrillator it is necessary to proceed with the following operations in order to prepare the device for the next use: Check the presence of the memory card and its remaining capacity (see paragraph 5.4 )
  • Page 35: Cleaning

    10.4 Preservation The Saver One S1 Series 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 11.2. 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 36: Troubleshooting Guide

    Try switching off the device and does not start. For about 60 The shock button does not work repeating the test. If the problem seconds the AED requires the properly persists, ask for assistance. press of the button, then automatically switches off, signalling on the mini LCD “Error 85”.
  • Page 37: Technical Specifications

    SEMI-AUTOMATIC 11 Technical Specifications The technical specifications of the Saver One S1 Series defibrillator, its parts and accessories are shown below. 11.1 Physical characteristics Category Nominal specifications Dimensions 29,5 x 23,0 x 11,5 cm With battery Li-SOCl 2,4 Kg + Adult Pad (2,5 Kg)
  • Page 38: Alarms Table

    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 S1 Series Data display Via PC Saver View Express software (Microsoft Windows compatible)
  • Page 39: Defibrillator

    SEMI-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 40: Efficiency Of Delivered Energy

    SEMI-AUTOMATIC 11.8 Efficiency of delivered energy Impedance Shock of 50 J (Paediatric) Energy Set Energy delivered (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 41 SEMI-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 42: Patient Analysis System

    ECG analysis 35 continuous hours Duration in Standby It has an estimated duration of 4 (five) years if installed in the AED, assuming an activation (installed battery) test, daily self-tests without turning on the AED * New and fully charged battery at a constant temperature of 20°C and relative humidity without condensation 45%...
  • Page 43: Rechargeable Battery

    SEMI-AUTOMATIC 11.12 Rechargeable battery Category Nominal specifications REF (Model) SAV-C1033 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-C1035 Charging time Shelf Life 2 years or 300 charge/shock cycles (the one that occurs first)
  • Page 44: Defibrillation Pads

    SEMI-AUTOMATIC 11.15 Defibrillation PADs Category ADULTS CHILDREN REF (Model) SAV-C0846 SAV-C0016 Series Cable and connector outside the envelope Cable PADs and connector inside the envelope Adults age >8 years or weight > 25Kg Children age 1 - 8 years or weight < 25Kg Patient range Intended use Disposable...
  • Page 45: Compliance With Electromagnetic Emission Standards

    The Saver One S1 Series was designed to be used in electromagnetic environments with features listed below. The customer or the user of the Saver One S1 Series must ensure that it is used in such an environment. Emissions test...
  • Page 46 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 47: Recommended Separation Distance Between Portable And Mobile Rf Communication Equipment And The Device Saver One S1 Series

    Saver One S1 Series The Saver One S1 Series must be used in an electromagnetic environment in which radiated RF interference is controlled. The customer or the operator of the Saver One S1 Series can help prevent electromagnetic interference by...
  • Page 48: Simbology

    SEMI-AUTOMATIC 13 Simbology ILCOR Universal Symbols for AED IMQ brand High Voltage Electrical Hazard CE mark with identification number General Notices: Refer to the consultation IP56 Degree of protection of the appliance against of accompanying documents before using dust and water (including battery)
  • Page 49: Certifications

    SEMI-AUTOMATIC 14 Certifications 14.1 EC Certificate...
  • Page 50 SEMI-AUTOMATIC...
  • Page 51: Imq Certificate

    SEMI-AUTOMATIC 14.2 IMQ CERTIFICATE...
  • Page 52: Saver One S1 Series Defibrillator Warranty

    Saver One S1 Series defibrillator of - if the warranty seal (opening of the device) on the Saver One S1 Series A.M.I. Italia S.r.l and is not transferable or assignable to third parties.
  • Page 53: Product Registration

    SEMI-AUTOMATIC 16 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 54 SEMI-AUTOMATIC...

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