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Related Manuals for AED Save One D
Summary of Contents for AED Save One D
- Page 1 User Manual External Semiautomatic Defibrillator with Display Rev. 12.2...
- Page 2 QUICK USE 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. 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.
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Page 4: Table Of Contents
Summary Introduction ............................... 8 Preface ............................... 8 Use in accordance with provisions ....................8 Guarantee ............................8 Exclusion from liability ........................8 Indications ............................8 Counter indications ........................... 8 Version information ........................... 9 Symbols in the manual ........................9 Manufacturer contacts ........................9 Safety instructions ........................... - Page 5 5.2.2 PADs for Children SAV-C0016 ....................24 5.2.3 Positioning of defibrillation PADs .................... 25 2-pole ECG cable SAV-C0017 ......................26 5.3.1 Positioning of the electrodes ....................26 Memory Card ........................... 27 Martel MCP7830 thermal printer (SAV-C1070) ................28 5.5.1 Printer structure ........................28 Saver One D selection menu ........................
- Page 6 10.2.3 Print execution ........................51 10.3 Data storage on PC .......................... 51 Maintenance ............................52 11.1 After each use ..........................52 11.2 Ordinary maintenance ........................52 11.3 Cleaning ............................53 11.4 Preservation............................. 53 11.5 Troubleshooting Guide ........................54 Technical specifications ........................55 12.1 Physical characteristics ........................
- Page 7 Certifications ............................68 15.1 EC Certificate ........................... 68 15.2 IMQ Brand ............................70 Saver One Series Defibrillator Warranty ..................... 71 Product registration ..........................72...
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Page 8: Introduction
(four)* years in Stand-by mode (assuming a battery activation test, daily self-tests without turning on the AED). This information refers to new batteries, fully charged at a temperature of 20°C and humidity of 45%. For more information consult Chapter 16 “Saver One Series defibrillators warranty”... -
Page 9: Version Information
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 10: Safety Instructions
2 Safety instructions For a correct use of the Saver One D defibrillator, users must be aware of the safety factors listed below. Please read them carefully. The Saver One D defibrillator, individually and in connection with its standard and optional (original) accessories, complies with the safety regulations currently in force and is in compliance with the provisions of the directives on medical products. -
Page 11: Indications Of Caution
(SAV-C0903) unless it is to be replaced. The removal of the battery and the subsequent insertion involves a complete test of the AED which considerably consumes its capacity. Furthermore, if the battery is not properly attached it could be damaged. -
Page 12: Cautions For Use In Ecg Monitoring
Cautions for use in ECG Monitoring The monitoring mode based on the use of the screen, for the purpose of identifying an ECG rhythm, represents an important aid for the specific use of the device itself, i.e. the detection of a shockable rhythm for the eventual subsequent decision to release of a therapeutic shock. -
Page 13: Description Of The Device
Device Information The Saver One D is called AED or Automatic External Defibrillator equipped with TFT display and mini LCD. The device was designed to be used by lay personnel as well as by healthcare personnel who have duly achieved and passed a BLSD course according to international guidelines. -
Page 14: Classifications
Classifications The Saver One D defibrillator is classified as follows: Code UMDNS 11132 Code GMDN 47910 Code CND Z12030501 Directory number RDM 238278 / 1535710 Code CIVAB DEF01 Class of belonging according to directive 2007/47/CE Type of protection against electric shock Internally powered Type of patient isolation CF (only for ECG cables) -
Page 15: Description Of Device Details
4 Description of device details 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 TFT colour display IrDA port (service only) Keyboard with buttons Loudspeaker Image 2 Description... -
Page 16: Keys, Icons And Indicators
Keys, icons and indicators Image 3 Function Function Navigation key UP ON / OFF button Allows you to scroll up the menu Allows you to switch the device on or off Navigation key ENTER Status mini display Allows you to enter the menu and confirm It allows you to check the functional status the selection you made of the device... -
Page 17: Tft Colour Display
TFT colour display Image4 Description Description Indicates the OPERATIVE MODE DAE: Indicates the number of VFs and / or VTs detected by Semiautomatic defibrillation MODE the device MONITORING: ECG monitoring Indicates the type of patient to be treated and Ratio Compressions/Insufflations: Energy in charge and subsequently delivered Adult 30:2 Paediatric 30:2 (requires children pads) -
Page 18: Standard And Optional Accessories Of The Device
Standard and optional accessories of the device The Saver One D defibrillator comes with the following standard accessories: Code Image Quantity Description SVD-B0004 Saver One D 200J 1 Unit (Version 200J or 360J) Saver One D 360J SVD-B0005 SAV-C0846 1 Unit Adult Pads Non-rechargeable SAV-C0903... -
Page 19: Parts And Accessories Of The Saver One D
(SAV-C0011) ACC Rechargeable Li ion battery For AED models Saver One D and Saver One P, considering the higher consumption due to the presence of the TFT display, AMI ITALIA recommends the use of the rechargeable battery SAV-C0011 (combined to the charging station SAV-C0014) rather than the disposable battery SAV-C0903. -
Page 20: Rechargeable Li - Ion Battery (Sav-C0011)
5.1.2 Rechargeable Li - ion battery (SAV-C0011) The rechargeable battery with Li-ion technology (SAV-C0011) of the Saver One D is suitable for those who use the defibrillator intensively. Being rechargeable, it allows operators to reduce management costs and guarantee a greater number of interventions. -
Page 21: Inserting And Removing The Batteries
5.1.4 Inserting and removing the batteries To be able to operate the Saver One D the insertion of a battery is required. Below are detailed instructions for correctly installing the batteries (rechargeable or non-rechargeable) in the Saver One D. Image 7 Image 8 ... -
Page 22: Recharging Station For Rechargeable Batteries
5.1.5 Recharging station for rechargeable batteries The charging station (SAV-C0014) allows you to recharge rechargeable batteries with Li-ion technology ACC model (SAV-C0011) of the Saver One D. The charging station consists of the following parts: Charger (SAV-C0012) image (11) ... -
Page 23: Recharge Procedure
5.1.7 Recharge procedure Place the charger on a perfectly horizontal shelf and firmly attached to the floor Connect the power supply (SAV-C0013) to the charger and then to the power outlet The LED on the charger will flash green, indicating that it is ready to charge Insert the battery to be charged into the battery charger as shown in image (15) Image15 The recharging station allows you to recharge exclusively original ACC rechargeable Li ion batteries (SAV-C0011) of... -
Page 24: Pads For Defibrillation
PADs for defibrillation The Saver One D 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 5.2.1 Defibrillation PADs for Adults SAV-C0846 The SAV-C0846 defibrillation PADs are pre-gelled disposable types. -
Page 25: Positioning Of Defibrillation Pads
5.2.3 Positioning of defibrillation PADs The correct placement of the PADs is essential for an efficient analysis of the patient's heart rhythm and for the consequent delivery of the shock (if necessary). 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 D are polarized type;... -
Page 26: 2-Pole Ecg Cable Sav-C0017
2-pole ECG cable SAV-C0017 The SAV-C0017 ECG cable is equipped with two clip terminals for single-use pre-gelled electrodes (optional). The ECG cable is able to carry out the detection of the patient's derivation II and the relative display of the ECG tracking on the Saver One D display. -
Page 27: Memory Card
Memory Card The Saver One D allows the recording of data on the internal memory as well as on the external memory card. Supported memory cards are SD/SDHC cards with capacities up to 8GB Image 18 To install a Memory Card in the Saver One D follow this procedure: The memory card must be inserted before attaching the battery B. -
Page 28: Martel Mcp7830 Thermal Printer (Sav-C1070)
Martel MCP7830 thermal printer (SAV-C1070) The Saver One D defibrillator can print the ECG tracing and patient data using the external thermal printer model Martel MCP7830 (SAV-C1070). The communication between printer and defibrillator is wireless thanks to the use of the IrDA port of the Saver One D (located on the left side of the defibrillator) and that of the printer. -
Page 29: Saver One D Selection Menu
6 Saver One D selection menu The Saver One D menu allows you to make multiple selections, settings and view useful information about the device and the rescue. In the next paragraphs all the settings that can be selected to use the device to its full potential will be described in detail. -
Page 30: Settings Menu
Settings Menu Enter the MAIN menu and using the navigation keys on the defibrillator keyboard, select the SETTINGS item and press the enter key. After pressing the ENTER key, the following screen will be shown on the Saver One D display: Image Function Possible variations... -
Page 31: System Information Menu
System information Menu Enter the MAIN menu and using the navigation keys on the defibrillator keyboard, select the SYSTEM INFORMATION item and press the enter key. After pressing the ENTER key, the following screen will be shown on the Saver One D display: Image Function Possible variations... -
Page 32: Power Supply Submenu
6.3.1 Power Supply Submenu Enter the SYSTEM INFORMATION menu and use the navigation keys on the defibrillator keyboard to select the item POWER and press the enter key. After pressing the ENTER key, the following screen will be shown on the Saver One D display: Image Function Possible variations... -
Page 33: Print Menu
After pressing the ENTER key, the following screen will be shown on the Saver One D display: Image Function Possible variations Allows you to select rescue events recorded 000000L0.AED Archive on memory card Indicates the selected rescue and the total 53/53... -
Page 34: Auto Test
7 Auto test The Saver One D 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 D performs different types of self-tests: ... -
Page 35: Activation Test
ACTIVATION test The Saver One D performs functional tests only if the battery is installed. Each time a battery is inserted, the device will perform a diagnostic ACTIVATION test. During this test the device performs a complete control (firmware/hardware), which involves a consumption of the battery equal to a shock, therefore it is advisable, once performed, not to remove the battery from the device. -
Page 36: Automatic Test
AUTOMATIC test The Saver One D has been designed to always be ready in the moment of real need. The device is equipped with a mode, called stand-by, in which when the device is switched off (with battery installed) it performs diagnostic tests automatically on a daily basis. -
Page 37: Defibrillation
8 Defibrillation If you need to help a person with sudden cardiac arrest, remember to implement the sequence of actions recommended by ERC and AHA 2017. The ERC has established a rescue protocol to be respected during the resuscitation of a person suffering from sudden cardiac arrest. -
Page 38: Remove Clothes
Remove clothes The Saver One D suggests to the operator -before correctly positioning the defibrillation PADs on the patient- how to ascertain the patient's condition. This information is highlighted by voice commands (audio messages) and visual commands (colour display), as shown in the table below: Voice commands Text If the patient is unconscious and... -
Page 39: Cardiac Rhythm Analysis
Cardiac rhythm analysis If the defibrillation PADs have been correctly applied and the connector is inserted in the appropriate compartment, the Saver One D automatically analyses the heart rhythm of the patient. This information is highlighted by voice (audio) and visual (colour display) commands, as shown in the following table: Video Display Voice commands Text... -
Page 40: Shockable Rhythm
Shockable rhythm If the Saver One D after having analysed the patient's heart rhythm recognizes a VF or VT, this information is highlighted by voice (audio) and visual (colour display) commands, as shown in the following table: Video Display Voice commands Text Shock recommended Shock recommended... -
Page 41: Non-Shockable Rhythm
If the shock button is pressed, the Saver One D will perform the defibrillation shock. This information is highlighted by voice (audio) and visual (colour display) commands, shown in the table; in addition the shock button will stop flashing. Text Voice commands Shock delivered Shock delivered... -
Page 42: Cpr
The Saver One D defibrillator will guide the operator to CPR (Cardio Pulmonary Resuscitation) in one of the following cases: A shockable rhythm was detected and a defibrillation shock was delivered A non-shockable rhythm was found A shockable rhythm was found but the shock button was not pressed ... - Page 43 The following table shows the main operations to be performed and the relative visual-text-vocal commands provided by Saver One D. Type of command Instruction Operations to be performed (Saver One D) Saver One D A. Verify that patient is on a rigid surface B.
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Page 44: Ecg Monitoring
9 ECG monitoring The Saver One D defibrillator can also be used to monitor the patient's ECG tracing. The "ECG Monitoring" mode allows the operator to monitor the patient's cardiac rhythm in total safety by disabling automatic defibrillation (in order to perform defibrillation, exit the current mode and select semi-automatic defibrillation). - Page 45 From the menu select the "ECG Monitoring" item If the password entry request has been configured, the following screen will be displayed when accessing one of the two modes: At this point you need to enter the security password. This protection (optionally configurable at the Customer's request) can be used to avoid random selection errors by personnel not adept at using this mode.
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Page 46: Description Of Ecg Monitoring Feature
Description of ECG Monitoring feature Once the ECG Monitoring mode has been selected, an icon-based MENU is presented on the right side of the display to manage the functionalities provided in this mode. In addition, other icons relating to events and/or states that appear during the use of Monitoring mode can appear on the upper part of the display. - Page 47 The physiological alarms detected are: Code Displayed message Description Priority Alarm signaling delay (max) Cardiac Low frequency Detection of a slow sinus rhythm < 10 sec * HIGH Asystole Detection of an absent sinus rhythm HIGH < 10 sec * Fibrillation Detected Detection of a ventricular fibrillation.
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Page 48: Recording, Printing And Archiving Of Rescue Data
AEDFILE.aed This file stores the rescue data such as: environmental recordings (audio), ECG tracing, patient data (FC and Ω) and all rescue events. This type of file can be redisplayed on a PC using the PC Saver View Express software. -
Page 49: Printing Of Rescue Data
Printing of rescue data 10.2 The Saver One D 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. To proceed with data printing, the operator will have to perform the following operations: Install the printer (Saver One D communication >>... -
Page 50: Selection Of The Data To Be Printed
In the print menu select the ARCHIVE item and select the rescue data to print. Each single file with the .AED extension corresponds to the recording of the data of one single rescue. It is possible to select the file by consulting the information directly below its name (date and time of beginning of rescue). -
Page 51: Print Execution
10.2.3 Print execution From the print menu, after selecting the desired file, select the PRINT item to start printing The following screen will be displayed in which the operator can check the print progress. If the operator wishes to interrupt the printing procedure, they must select the PRINT item again and confirm; printing will be interrupted and we automatically return to the previous menu. -
Page 52: Maintenance
11 Maintenance The Saver One D defibrillator was designed to make maintenance operations as simple and autonomous as possible. In fact, thanks to the control tests carried out in total autonomy by the device, it is not necessary to perform any extraordinary maintenance, but only routine maintenance which consists of a frequent visual check of the LED and the control display, together with a visual inspection of the relative accessories. -
Page 53: Cleaning
Cleaning 11.3 The structure of the Saver One D defibrillator, including the connection port of the defibrillation electrodes, can be sanitized using a soft cloth dampened with one of the cleaning solutions listed below: Isopropyl alcohol (70% solution) Soap water Bleach (30 ml per litre of water) Detergents containing ammonia Detergents containing glutaraldehyde... -
Page 54: Troubleshooting Guide
The shock button does not work test is not started. For about 60 retesting. If the problem persists, properly seconds the AED requires to call for assistance press the button and then it turns off automatically, signalling “Error” on the mini LCD. -
Page 55: Technical Specifications
Atmospheric pressure (altitude calculated min -382 mt and max 3955 mt) Normal use: Keep the AED device within the operating and standby ranges (not Operating functional the storage and transport ranges) so that the device is ready for use. conditions... -
Page 56: Technical Alarms Table
AED1LOG.txt Daily self-tests, Errors found, Device usage data, Archived data Device information AEDFILE.aed Rescue events, voices and environmental noises, ECG tracing of rescue, Vital parameters of the patient analysed and detected by the Saver One D Data display Via PC Saver View Express software (Microsoft Windows compatible) -
Page 57: Defibrillator
Defibrillator 12.8 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 58: Efficiency Of Delivered Energy
Efficiency of delivered energy 12.9 Impedance Shock of 50 J (Paediatric) Energy delivered delivered (Joules) (Joules) Set energy(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 Shock of 150J Energy... - Page 59 Impedance Shock of 250 J Energy delivered (Joules) Set energy 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 delivered...
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Page 60: Patient Analysis System
Patient analysis system 12.10 Category Nominal specifications Determines the patient's impedance and evaluates the ECG rhythm and signal quality to Function determine whether or not the shock delivery is appropriate. 20- 200 Ω Impedance range ≥4 seconds (with new fully charged battery) in compliance to IEC/EN 60601-2-4 ECG analysis time 97% Respects the guidelines IEC/EN 60601-2-4 2002 (3) sources AHADB, MITDB and EDB Sensibility... -
Page 61: Display
160 continuous shocks with new fully charged battery Monitoring ECG monitoring duration 24 hours continuously 4 years if installed in the AED, assuming an activation test, daily self-tests without turning on the Duration in Standby (battery installed) * New and fully charged battery at a constant temperature of 20°C and relative humidity without condensation 45% Rechargeable battery 12.15... -
Page 62: Internal Back-Up Battery
Internal back-up battery 12.16 Category Nominal specifications Type Battery Coin Cell (LiMnO2) Purpose Maintaining configuration data (date / time, etc.) 3 VDC Voltage Maintains data for 3 years (without external battery) Duration Maintains data for 6 years (with external battery inserted within 12 months) Rechargeable battery charger 12.17 Category... -
Page 63: Ecg Cables
ECG Cables 12.20 Category Nominal specifications Code SAV-C0017 Type Single cable with connector and terminals Reusable Intended use 2 poles with CLIP terminals (button) Terminals Coding International IEC /EN Model Timing of Shock cycles 12.21 Charging time performance in accordance with 60601-2-4 (201.101) Specific Result The maximum time between the beginning of the ECG rhythm analysis and the completion of the... -
Page 64: Compliance With Electromagnetic Emission Standards
Guidelines and manufacturer's declaration - Electromagnetic immunity Recommended distances between portable and mobile radiofrequency communication equipment and the AED Guidelines and manufacturer's declaration - Electromagnetic emissions 13.1 The Saver One D was designed to be used in electromagnetic environments with features listed below. The customer or... - Page 65 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.
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Page 66: Recommended Separation Distance Between Portable And Mobile Rf Communication Equipment And Saver One Device
Recommended separation distance between portable and mobile RF 13.3 communication equipment and Saver One device The Saver One D must be used in an electromagnetic environment in which radiated RF interference is controlled. The customer or the operator of the Saver One D 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 D, based on the maximum output power of the devices of communication. -
Page 67: Simbology
14 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 68: Certifications
15 Certifications EC Certificate 15.1... -
Page 70: Imq Brand
IMQ Brand 15.2... -
Page 71: Saver One Series Defibrillator Warranty
The original purchaser is considered to be the - if the Saver One AED series serial number is modified, deleted, final user of the product purchased. This limited warranty is granted only rendered illegible or otherwise tampered with;... -
Page 72: Product Registration
17 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.
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