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Summary of Contents for Smarty Saver Plus
- Page 1 SMARTY Saver Plus User Manual Semi-Automatic External Defibrillator...
- Page 2 SEMI-AUTOMATIC QUICK START GUIDE...
- Page 3 SEMI-AUTOMATIC ©by A.M.I Italia S.r.l. These instructions for use may not be reproduced - either as a whole or partially - without our consent, nor may they be transmitted, electronically stored or be translated in another language. Breaches of this prohibition do not only violate our copyright, but also compromise the truthfulness and accuracy of the information contained in this manual.
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Page 4: Table Of Contents
General structure ........................13 Keys, icons and indicators ......................14 Standard and optional accessories of the device ............... 15 SMARTY Saver Plus power supply and accessories ................. 16 Non-rechargeable battery SMT-C14031 ..................16 5.1.1 Insertion and removal of the batteries ................17 Defibrillation pads ........................ - Page 5 ON test ............................22 Control LEDs ..........................22 Defibrillation ............................23 “Chain of survival”........................23 Switching SMARTY Saver Plus on ....................23 Preparing the patient ........................24 Place the pads ..........................24 Heartbeat analysis ........................25 Defibrillable rhythm ........................26 Change of rhythm ........................
- Page 6 11.2 Guidelines and manufacturer declaration - Electromagnetic immunity ........40 11.3 Recommended separation distances between portable and mobile RF communication devices and the SMARTY Saver Plus device ......................42 12 Symbols ..............................43 13 Certifications ............................44 13.1 CE certificate ..........................44...
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Page 7: Introduction
Use in conformity with the provisions The SMARTY Saver Series devices can be used only if the conditions indicated in this user manual are complied with. All uses that differ from the intended use shall be understood not to comply with the provisions and may cause harm/damage to persons and/or property;... -
Page 8: Information On The Version
SEMI-AUTOMATIC Information on the version This user manual has a version number; this varies each time the manual is updated due to changes in the device’s operation or to the device itself. The contents of this user manual shall be subject to amendment without advance notice. -
Page 9: Safety Instructions
➢ In compliance with IEC standards (section 0), use of the SMARTY Saver plus device or of its accessories is not allowed in the presence of inflammable substances (gasoline or similar) or in an oxygen-rich atmosphere or an atmosphere rich in inflammable gases/vapours. - Page 10 RF (radiofrequency) interference from devices such as mobile phones and radio two-way transmitters, can cause SMARTY Saver Plus to malfunction. SMARTY Saver Plus must be kept at least 2 metres away from such RF devices, as indicated in the IEC/EN 61000-4-3 standards. Keep at sufficient distance from other therapeutic and diagnostic sources of energy (e.g.
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Page 11: Instructions For Disposal
DISPOSAL ➢ SMARTY Saver Plus, its parts and accessories must not be disposed of with other household waste within the European Union. 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. -
Page 12: Device Description
The energy is delivered through a biphasic truncated exponential (BTE) electrical shock that can self-adapt to the patient’s thoracic impedance. SMARTY Saver Plus assists the operator in properly performing cardiac massage, during Cardio-Pulmonary Resuscitation, thanks to the external CPR Quality sensor (SMT-C14034). -
Page 13: Device Description
SMARTY Saver Plus label Battery compartment µSD Memory Card compartment USB-C port (for the exclusive use of A.M.I. Italia) Plate connector SMARTY Saver Plus device microphone SMARTY Saver Plus logo SMARTY Saver Plus speaker Keyboard with buttons and illuminated icons... -
Page 14: Keys, Icons And Indicators
SEMI-AUTOMATIC Keys, icons and indicators Function Function Paediatric Selection Button Green control LED Selection of the paediatric patient type In stand-by mode: using universal plates correct operation status of the device Adult Selection Button Red control LED Selection of the adult patient type In stand-by mode: using universal plates device error status... -
Page 15: Standard And Optional Accessories Of The Device
SEMI-AUTOMATIC Standard and optional accessories of the device The SMARTY Saver Plus defibrillator is supplied with the following accessories: Code Image Quantity Description SMARTY Saver Plus 1 Unit SM3-B1003 Semi-Automatic 200J Pre-connected universal pads 1 Pair SMT-C2001 for adult and paediatric use... -
Page 16: Smarty Saver Plus Power Supply And Accessories
If the level of residual charge in the battery is low, the user will be informed with audio and visual messages. SMARTY Saver Plus will issue a warning of a low battery with a level ≤5% and an empty battery alarm with level ≤ 1%: •... -
Page 17: Insertion And Removal Of The Batteries
SEMI-AUTOMATIC 5.1.1 Insertion and removal of the batteries Below please find detailed instructions for the correct installation of the battery in the device SMARTY Saver Plus. • Place the device as shown in figure (first on the left) • Place the battery as shown in figure (central) •... -
Page 18: Defibrillation Pads
SMT-C2002: Pre-connected “face-to-face” universal defibrillation pads Depending on the patient to be treated, you must select on the keyboard of the SMARTY Saver Plus device the type of patient (adult age >8 or weight >25 kg / paediatric age from 1 to 8 or weight <25 kg). The use of this type of pads is, in general, contraindicated in patients younger than 12 months and weighing less than 10 kg. -
Page 19: Placement Of The Defibrillation Pads
Adult and Paediatric mode SMARTY Saver Plus makes it possible to use universal defibrillation plates, i.e. that can be used on adult (age >8 or weight >25 kg) and paediatric (age from 1 to 8 or weight <25 kg) patients. -
Page 20: Cpr Quality Module
This external device (class I) is, in fact, able to measure the depth and the frequency of the compressions performed and to send this feedback to the SMARTY Saver Plus device via Bluetooth according to the international AHA / ERC... -
Page 21: Self-Test
(see Paragraph 6.2) If the shock button is not pushed within 60 seconds, SMARTY Saver Plus detects an error and switches off; disconnect and reconnect the battery to repeat the activation test and push the shock button within the time limit, to complete the test. -
Page 22: Automatic Test
This test is performed in order to check the proper operation of the device before use, is automatic and takes a few seconds. When the on button is pushed, SMARTY Saver Plus will emit an acoustic signal, confirming it is on, and the control LED will go off. -
Page 23: Defibrillation
Push the device’s on button SMARTY Saver Plus will emit an acoustic signal confirming it is on, the ON/OFF button will turn green. If the on self-test has a positive outcome, the device will suggest to the operator the first operations to be performed... -
Page 24: Preparing The Patient
SEMI-AUTOMATIC Preparing the patient In order to be able to place the defibrillation pads on the chest, you must perform the preliminary operations below: • Remove clothing from the patient’s chest • If the patient’s chest is very hairy, you must shave the places where the Pads will be placed. -
Page 25: Heartbeat Analysis
Heartbeat analysis in progress Adult or child lit without blinking The analysis software of SMARTY Saver Plus has been designed to recommend the treatment with defibrillation shock only if the patient is suffering from the following arrhythmias: Peak-to-peak amplitude of min. 200 µVolts... -
Page 26: Defibrillable Rhythm
To deliver the shock, push the shock button within 15 seconds from the voice message, making sure that no one is touching the patient. If the shock button is not pushed within 15 seconds from the shock warning, SMARTY Saver Plus will disarm automatically. -
Page 27: Change Of Rhythm
Voice messages Shock cancelled Rhythm changed Non-defibrillable rhythm If, during the analysis of the heartbeat, SMARTY Saver Plus does not detect a VF o a VT, it will inform the operator with the following commands: Voice messages Shock not recommended All rhythms other than VT and VF will be assessed as non-defibrillable. - Page 28 Air is blown in breathing normally for about 1 second Visual ILLUMINATED ICON Follow the voice and text instructions of SMARTY Saver Plus until steps 1 to 3 will be repeated for approximately 2 minutes the device completes the CPR phase (approximately 2 minutes).
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Page 29: Recording, Displaying And Storing The Data
Storage of data on a PC The data recorded by the SMARTY Saver Plus defibrillator and saved on the µSD external memory can be stored in, analysed by and printed from a PC with the management software Saver View Express (SAV-C0950). -
Page 30: Μsd Memory Card
Memory cards supported are µSD/SDHC cards with a capacity of up to 32 GB. To install the memory card in SMARTY Saver Plus, please follow the procedure below: A. Make sure the device is switched off and place it on a hard and stable surface and remove the battery (see par. -
Page 31: Maintenance
Maintenance after use After having used the SMARTY Saver Plus defibrillator, it is necessary to perform the following operations to ready the device for subsequent uses: Check the presence of the memory card (if present) and its residual capacity... -
Page 32: Cleaning
Do not sterilise SMARTY Saver Plus or its accessories. Storage SMARTY Saver Plus must be placed in a place that complies with the environmental and safety conditions of the table below and at the temperature and humidity indicated in paragraph 10.2 The device must be stored with the battery always inserted, to allow periodic self-testing. -
Page 33: Guide To Identifying Faults
SEMI-AUTOMATIC Guide to identifying faults The table below lists the device’s statuses, the possible causes and the possible corrective actions that will resolve issues that have emerged. For more details regarding the implementation of corrective actions, please refer to the specific sections of this user manual. -
Page 34: Technical Specifications
SEMI-AUTOMATIC Technical specifications Below please find the technical specifications of the SMARTY Saver Plus defibrillator, its parts and accessories. 10.1 Physical characteristics Category Rated specifications 200 x 213 x 71 mm (handle folded) Dimensions 257.x 213 x 71 mm (handle extended) 1.62 Kg (including Pads and battery) -
Page 35: Table Of Alarms
SEMI-AUTOMATIC 10.4 Table of Alarms Priority Cause Visual signal HIGH Device ready to administer shock Blinking shock button HIGH Battery empty (capacity < 1%) Blinking control LED 10.5 Controls and indicators Category Rated specifications • ON/OFF: switches the device on and off •... -
Page 36: Defibrillator
SEMI-AUTOMATIC 10.7 Defibrillator Category Rated specifications Waveform Biphasic Truncated Exponential (BTE) The waveform parameters are regulated automatically depending on the patient’s autonomy 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 the phases, U indicates the peak voltage, is the end voltage. -
Page 37: Efficiency Of The Energy Delivered
SEMI-AUTOMATIC 10.8 Efficiency of the energy delivered Impedance Shocks at 50 J (Paediatric) Energy Tpos Tneg delivered Energy set (J) (ms) (ms) (Joules) 25 Ohm 54.8 50 Ohm 50.7 75 Ohm 51.8 100 Ohm 52.0 125 Ohm 52.3 150 Ohm 51.9 175 Ohm 52.5... -
Page 38: Patient Analysis System
Specificity 99% in compliance with the standards IEC/EN 60601-2-4 If used on a patient with the characteristics listed in the use criteria, the SMARTY Saver Plus defibrillator is designed to suggest a defibrillating shock when it detects the right impedance... -
Page 39: Defibrillation Pads
SEMI-AUTOMATIC 10.13 Defibrillation pads Category ADULT/CHILD SMT-C2001 Pre-connected universal plates Code SMT-C2002 Face-to-face pre-connected universal plates Packaging Cable and connector external to the bag Patient range Adult age >8 years or weight > 25Kg Child age 1 - 8 years or weight < 25Kg Intended use Single-use Number of shocks... -
Page 40: Compliance With Electromagnetic Emission Standards
Recommended distances between portable and mobile radiofrequency communication equipment and the 11.1 Guidelines and manufacturer declaration - Electromagnetic emissions SMARTY Saver Plus was designed to be used in electromagnetic environments with the following characteristics. Emissions test Compliance Electromagnetic environment - Guidelines The AED uses RF energy only for its internal operation. - Page 41 SEMI-AUTOMATIC Test level Electromagnetic environment Immunity test IEC/EN 60601-1 Compliance level Guidelines Supply frequency Power frequency magnetic fields must be at levels (magnetic field) that do not exceed those of stations located in 3 A/m 80 A/m 50/60 Hz typical heavy industry applications, power plants and command rooms of high-voltage substations.
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Page 42: Recommended Separation Distances Between Portable And Mobile Rf Communication Devices
RF communication devices and the SMARTY Saver Plus device SMARTY Saver Plus must be used in an electromagnetic environment in which interference from radiated RF is controlled. The customer or operator of SMARTY Saver Plus can help prevent electromagnetic interference by maintaining the minimum distances between portable and mobile RF communication devices (transmitters) and SMARTY Saver Plus recommended below, based on the maximum output power of the communication devices. -
Page 43: Symbols
SEMI-AUTOMATIC Symbols Universal ILCOR symbols for AEDs Certification body marking Hazard High Electrical Voltage CE marking with identification number 1282 General Warnings: Please refer to the IP56 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 44: Certifications
SEMI-AUTOMATIC Certifications 13.1 CE certificate... - Page 45 SEMI-AUTOMATIC...
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Page 46: Smarty Saver Series Defibrillator Warranty
SMARTY Saver defibrillator and Lastly, this warranty shall not be valid for the SMARTY Saver AEDs that may not be leased or assigned to third parties. were sold used; in such case, the warranty must be offered by the reseller The SMARTY Saver Series defibrillators are as follows: of the used product with exclusion of all liability, also indirect, of A.M.I.
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