Smarty SaverGeo User Manual

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SEMI-AUTOMATIC

SMARTY SaverGeo

User Manual

Semi-Automatic External Defibrillator

for Public Access

DOC ID: AMI-AED-IFU02-05-ENG

REV: 03.01

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Page 1 SEMI-AUTOMATIC SMARTY SaverGeo User Manual Semi-Automatic External Defibrillator for Public Access DOC ID: AMI-AED-IFU02-05-ENG REV: 03.01...
Page 2: Quick Use Guide
SEMI-AUTOMATIC QUICK USE 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.
Page 4: Table Of Contents
Description of device details ........................17 General structure ......................... 17 Keys, icons and indicators ......................18 Device Packaging Contents ......................19 Details of Parts of SMARTY SaverGeo ....................20 Battery SMT-C14032 ........................20 5.1.1 Insertion and removal of the batteries ................21 Defibrillation pads ........................
Page 5 POWER ON test ......................... 28 Control LEDs ..........................29 Defibrillation ............................30 “Chain of survival” ........................30 Switching SMARTY SaverGeo on ..................... 30 Preparing the patient ........................31 Place the pads ..........................31 Heartbeat analysis ........................32 Defibrillable rhythm ........................33 Change of rhythm ........................
Page 6 Guidelines and manufacturer declaration - Electromagnetic immunity ........60 12.3 Recommended separation distances between portable and mobile RF communication devices and the SMARTY SaverGeo device ......................62 13 Symbols ..............................63 14 SMARTY Saver Series defibrillator warranty ..................64 15 Declaration of Medical Substances ......................66 16 Additional Information ..........................
Page 7: Introduction
In order to use the device correctly, you must read this user manual carefully before use. This user manual contains the instructions for the use of SMARTY SaverGeo in compliance with its functionality and purpose. For an error-free operation, it is fundamental that you comply with the requirements of this manual, in order to guarantee the safety of the patient, of the rescuer and that of third parties.
Page 8: Use In Conformity With The Provisions
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 9: Indications
SEMI-AUTOMATIC 10. Better compliance with resuscitation protocols 11. AEDs are low-energy portable electronic devices designed to treat VF (Ventricular Fibrillation) 12. Improve survival in victims of sudden cardiac arrest & Increase survival in OHCA & to hospital discharge. 13. Easy to handle. 14.
Page 10: Contact Details Of The Manufacturer
SEMI-AUTOMATIC 1.14 Contact details of the manufacturer A.M.I. Italia S.r.l. REGISTERED OFFICE Viale Campi Flegrei n.55, 80124 Napoli ITALIA PRODUCTION SITE ITALY PRODUCTION, LABORATORIES, OFFICES Via Cupa Reginella, 15/A 80010 Quarto (NA) ITALY Ph. +39 081 806 0574 Fax. +39 081 876 4769 PRODUCTION SITE ITALY PRODUCTION Via San Francesco a Patria snc Località...
Page 11: Safety Instructions
SEMI-AUTOMATIC Safety instructions For the correct use of a SMARTY SaverGeo Series defibrillator, the users must be aware of the safety factors listed below. We recommend that you read them carefully. The SMARTY SaverGeo Series defibrillators and their accessories comply with the rules and regulations on safety that are currently in force and with the provisions of the directives on medical products.
Page 12  Avoid using the universal defibrillation PADs SMT-C2001 and face to face PADs SMT-C2002 in adult mode on children (aged 1-8 or weighing 10-25 kg). In fact, in adult mode, SMARTY SaverGeo does not automatically reduce the maximum energy that can be delivered to 50J and may, therefore, become hazardous for the paediatric patient.
Page 13: Instructions For Disposal
Instructions for DISPOSAL  SMARTY SaverGeo, 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 local distributor.
Page 14: Description Of The Device
The presence of the SIM card and of the Geoloc module make it possible for SMARTY SaverGeo to transmit and receive data over the mobile telephony network, to make hands-free calls, to be located and to track of its movements. These features make it suitable for installation in public areas and in moving vehicles, such as trains, buses and ambulances.
Page 15: Additional Functions Of Smarty Savergeo
Telemetry SMARTY SaverGeo connects to the portal automatically - at least once per day - sending a log that contains detailed information on its status; should SMARTY SaverGeo not manage to connect (due to absence of cover or malfunctions), AMISAVERCLOUD will notify the user of the lack of service by SMS or e-mail.
Page 16: Procedure For The Activation Of The Defibrillator
(*) The SIM cards supplied by the manufacturer may be used only and exclusively in the SMARTY SaverGeo devices; it is recommended to use the SIM card supplied only with the SMARTY SaverGeo device with which it has been associated.
Page 17: Description Of Device Details
SIM card compartment Battery compartment µSD Memory Card compartment USB-C port (for the exclusive use of (A.M.I. Italia S.r.l.) PADs connector Geoloc microphone SMARTY SaverGeo device microphone SMARTY SaverGeo logo Geoloc speaker SMARTY SaverGeo speaker Keyboard with buttons and illuminated icons...
Page 18: Keys, Icons And Indicators
SEMI-AUTOMATIC Keys, icons and indicators Function Function Paediatric Selection Button “ON/OFF” button Selection of the paediatric patient type Switch the device on/off using universal pads Adult Selection Button Green control LED Selection of the adult patient type In stand-by mode: using universal pads correct operation status of the device Red control LED...
Page 19: Device Packaging Contents
SEMI-AUTOMATIC Device Packaging Contents The SMARTY SaverGeo defibrillator is supplied with the following accessories & components: Image Quantity Description SMARTY SaverGeo 1 Unit Semi-Automatic 200J SM5-B1005 Pre-connected universal pads SMT-C2001 1 Pair for adult and paediatric use (Class III device)
Page 20: Details Of Parts Of Smarty Savergeo
SEMI-AUTOMATIC Details of Parts of SMARTY SaverGeo Battery SMT-C14032 The non-rechargeable battery SMT-C14032 is made up of 2 packs:  1 pack only for the AED power supply  1 pack only for the internal radio module power supply It is supplied with the AED, fully charged and ready to use; it has been designed for long-lasting autonomy and to perform approximately 200 full rescue cycles (shocks at 200J and CPR).
Page 21: Insertion And Removal Of The Batteries
Before to connect the patient to the defibrillator, depending on the patient to be treated, you must select on the keyboard of the SMARTY SaverGeo device the type of patient (adult age >8 or weight >25 kg / paediatric age from 1 to 8 or weight <25 kg).
Page 22: Pre-Connected Universal Defibrillation Pads Smt-C2001
Face-to-Face universal defibrillation pads SMT-C2002 are universal, single-use and pre-gelled. The term “face-to-face” indicates that the pads are electrically paired so that the SMARTY SaverGeo device can measure their effectiveness - based on the quality of the gel’s conductibility - and warn - using control LEDs - when it has declined.
Page 23: Placement Of The Defibrillation Pads
5.2.4 Adult and Paediatric mode SMARTY SaverGeo makes it possible to use universal defibrillation pads, 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 24: Q-Cpr Module
SEMI-AUTOMATIC 5.3 Q-CPR module The Q-CPR module (SMT-C14034) is a class I wireless Bluetooth-based external sensor that uniquely connects to an A.M.I. Italia S.r.l.’s compatible defibrillator to assist the operator for the correct execution of cardiopulmonary resuscitation (CPR). The A.M.I. Italia S.r.l.’s AED equipped with this option, while turning ON, will search automatically via Bluetooth for the paired external handy dongle and, if it recognized, will be connected to it.
Page 25: 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 SaverGeo 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 26: The Geoloc Sim Card
SEMI-AUTOMATIC Defibrillator can send the ECG trace of the actual connected patient during the rescue (with no reference to personal data of the patient) User can activate a hand-free call (Vivo Call) from the defibrillator towards one of three pre-recorded numbers in case of any further assistance required.
Page 27: Saverviewexpress
Self-test SMARTY SaverGeo was designed to be a totally safe device, always ready to use and able to automatically and constantly check the proper operation of its parts, reducing maintenance operations by the user to a minimum.
Page 28: Automatic Test
If the shock button is pressed correctly, it will stop flashing and the device will launch the activation test. If the shock button is not pushed within 60 seconds, SMARTY SaverGeo 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 29: Control Leds
SEMI-AUTOMATIC Control LEDs The control LEDs are placed on the keyboard of SMARTY SaverGeo. Based on the various colours of the control LED, the operator can independently deduce the operation status of the defibrillator and of its main accessories. The table below shows the control LED blinking codes:...
Page 30: Defibrillation
Switch on the defibrillator and follow the audio instructions to restore normal heartbeat. Continue until the arrival of medical personnel. Switching SMARTY SaverGeo on Push the device’s ON/OFF button As confirmation, the leds of the ON/OFF button will light up steady green.
Page 31: 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 32: Heartbeat Analysis
Heartbeat analysis in progress Adult or child lit without blinking The analysis software of SMARTY SaverGeo 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 33: 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 SaverGeo will disarm automatically.
Page 34: Change Of Rhythm
Voice messages Shock cancelled Rhythm changed Non-defibrillable rhythm If, during the analysis of the heartbeat, SMARTY SaverGeo does not detect a VF or 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 35 SEMI-AUTOMATIC The table below shows the main operations to be performed during CPR and the related visual/voice/text commands provided by SMARTY SaverGeo. Type of SMARTY SaverGeo instructions Operations to be performed command A. Check that the patient is on a firm surface B.
Page 36: Recording, Displaying And Storing The Data
400 hours of recordings/data. Storage of data on a PC The data recorded by the SMARTY SaverGeo defibrillator and saved on the µSD external memory can be stored in, analysed by and printed from a PC with the management software SaverViewExpress (SAV-C0019).
Page 37: Possible Residual Risks And Remedies
SEMI-AUTOMATIC Possible Residual Risks and Remedies: RESIDUAL RISK ASSOCIATED HAZARD WITH THE END CONCLUSION ID’S USER The device is configured for public use and intended to be maintained by the installer. As a standard practice the installer/owner of the device contacts the dealer/distributor for any service/battery replacement queries.
Page 38 SEMI-AUTOMATIC requirements. As part risk management process, all possible risk control measures are implemented to reduce the risk to acceptable levels in a reasonably practicable way. The information of safety to the target user is communicated in the form of Instructions for Use. Hence the occurrence of defined hazardous situations is very rare.
Page 39 SEMI-AUTOMATIC defined hazardous situations is very rare. The external cardiac defibrillator is supplied in neatly packed condition and the information is printed on the product label. The clear instructions are available in IFU as well. If the external cardiac defibrillator package is damaged or wet the user need to discard that product, if he/she fails the usage may result in Infection.
Page 40 SEMI-AUTOMATIC Instruction for use mentioned with clear instructions with pictorial reference for every option/mode to be used. Also, the device overlay is printed with pictorial information of usage of the device and the device delivers clear voice prompt in local language. Hence the benefit of this device outweighs this residual risk.
Page 41 SEMI-AUTOMATIC opening of the external cardiac defibrillator package are communicated to the end user through the IFU, package label supplied along with each pack. This residual risk cannot be controlled by the manufacturer, and this risk occurrence is only be eliminated when the end user strictly adheres to the information of IFU and label.
Page 42 SEMI-AUTOMATIC This hazard occurrence due to the disposal of device so, IFU captures the clear information regarding the disposal of device in disposal section user can refer that, and also warnings for the user of possible side effects is give in the Instruction for use.
Page 43 SEMI-AUTOMATIC log about installed devices. Device also intimates the manufacturer/owner whenever reaches battery condition. So the chance of leaving the device with low battery condition is very remote. Hence the benefits of the device outweigh this residual risk The device discharges the charged energy within 15 seconds from the time charged.
Page 44: Final Residual Risk Status
SEMI-AUTOMATIC Final Residual Risk Status RESIDUAL TOTAL HAZ ID LEADING HAZARDOUS SITUATION STATUS RISK HAZARDS DETAILS  Unauthorized access  Inadequate knowledge on product usage  Used in contaminated environment  Lack of awareness towards the maintenance of the device ...
Page 45: Maintenance
10.1 Maintenance after use After having used the SMARTY SaverGeo 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. (4.1 & 5.4)
Page 46: Cleaning
Do not sterilise SMARTY SaverGeo or its accessories. 10.4 Storage SMARTY SaverGeo 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 11.2 The device must be stored with the battery always inserted, to allow periodic self-testing.
Page 47: Guide To Identifying Faults
SEMI-AUTOMATIC 10.5 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 48: Service
 The manufacturer/dealer/Representative shall not be responsible for any un-authorized service/Repair/Modification on this equipment. Technical specifications Below please find the technical specifications of the SMARTY SaverGeo defibrillator, its parts and accessories. 11.1 Physical characteristics Category Rated specifications 200 x 213 x 71 mm (handle folded)
Page 49: Reference Regulatory Frameworks
SEMI-AUTOMATIC 11.3 Reference regulatory frameworks List of Applicable Standards S.NO STANDARD TITLE QMS STANDARD Medical devices – Quality management systems EN ISO 13485:2016/A11:2021 Risk Management Standard Medical devices – Application of risk management to medical devices EN ISO 14971:2019/A11:2021 Safety & Applicability Standards Medical electrical equipments –...
Page 50 SEMI-AUTOMATIC Automatic External Defibrillators And Remote-Control Defibrillators, ANSI/AAMI DF39:1993 1°ed Usability Requirement Standards Medical electrical equipments – Part 1: General requirements for basic EN 60601-1-6:2010+A1:2015 + safety and essential performance – Collateral standard: Usability A2:2020 Medical devices – Application of usability engineering to medical EN 62366-1:2015+AC:2015 +AC: 2016+A1:2020 devices...
Page 51: Table Of Alarms
SEMI-AUTOMATIC 16. MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional 17. MDCG 2021-5 Guidance on standardisation for medical Devices Guidance note integration of the UDI within an organisation’s quality management 18. MDCG 2021-19 system 19.
Page 52: Defibrillator
SEMI-AUTOMATIC 11.7 Defibrillator Category Rated specifications Biphasic Truncated Exponential (BTE) Waveform 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, t is the end voltage.
Page 53: Efficiency Of The Energy Delivered
SEMI-AUTOMATIC 11.9 Efficiency of the energy delivered Impedance Shocks at 50 J (Paediatric) Energy Tpos Tneg Energy set delivered (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 Impedance...
Page 54: 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 SaverGeo defibrillator is designed to suggest a defibrillating shock when it detects the right impedance and...
Page 55: Defibrillation Pads
SEMI-AUTOMATIC 11.14 Defibrillation pads Category ADULT/CHILD SMT-C2001 Pre-connected universal pads #(Models) SMT-C2002 Face-to-face pre-connected universal pads 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 tolerated...
Page 56 The feedback CPR module is present only in some models: Quality Monitoring Note: The below variants are incorporated with Bluetooth CPR Quality Monitoring. SMARTY SaverPlus & SMARTY SaverGeo Bar-Graph for CPR LED’s shall show a bar graph to know the intensity and quality of CPR performed by the user...
Page 57: Cyber Security Safety Applicability
AMIAMISAVERCLOUD platform Remote call sent  The SMARTY SaverGeo system allows the ECG to be transmitted in real time to to cloud via Air AMISAVERCLOUD and, through the web portal, it is possible to monitor the signal.
Page 58 SEMI-AUTOMATIC The following modules are used: Data Storage ECG Module Audio Processing Module MAIN Module Telecommunication Signal Processing Module Module Fibrillation Detector Main Module is the central processing module, where all the communication and control will be handled. Audio Processing module handles coding/decoding, playing/recording. Data Storage module handles the data storage for ECG, sound and events as a file.
Page 59: Software Requirements
SEMI-AUTOMATIC d. Telecommunication Module The function of TLC.MAIN is connected to the Cloud using Air Carrier to transfer data from/to it. Data transmitted are:  Session log (ARM and TLC modules);  Config params (ARM and TLC modules);  Firmware updates (ARM and TLC modules); ...
Page 60: Compliance With Electromagnetic Emission Standards
 Recommended distances between portable and mobile radiofrequency communication equipment and the AED 12.1 Guidelines and manufacturer declaration - Electromagnetic emissions SMARTY SaverGeo was designed to be used in electromagnetic environments with the following characteristics. Emissions test Compliance Electromagnetic environment - Guidelines...
Page 61 SEMI-AUTOMATIC Test level Electromagnetic environment Immunity test IEC/EN 60601-1 Compliance 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 typical heavy industry applications, power plants and command IEC 61000-4-8...
Page 62: Recommended Separation Distances Between Portable And Mobile Rf Communication Devices And The Smarty Savergeo Device
12.3 Recommended separation distances between portable and mobile RF communication devices and the SMARTY SaverGeo device SMARTY SaverGeo must be used in an electromagnetic environment in which interference from radiated RF is controlled. The customer or operator of SMARTY SaverGeo can help prevent electromagnetic interference by maintaining the minimum distances between portable and mobile RF communication devices (transmitters) and SMARTY SaverGeo recommended below, based on the maximum output power of the communication devices.
Page 63: Symbols
SEMI-AUTOMATIC An additional factor of 10/3 is used in the calculation of the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency NOTE 3: interval from 80 MHz to 2.5 GHz to reduce the possibility that portable/mobile equipment can interfere, if accidentally brought into the patient’s area.
Page 64: Smarty Saver Series Defibrillator Warranty
 purchased. This limited warranty is granted solely to Non-rechargeable batteries: Three (3) years (in the original buyer of the SMARTY Saver defibrillator Stand-by mode, supposing a battery activation and may not be leased or assigned to third parties. test, daily self-tests, without the AED being...
Page 65 Saver defibrillators of A.M.I. Italia S.r.l. in strict manufacturer is covered, modified or erased compliance with the instructions contained in the user Lastly, this warranty shall not be valid for the SMARTY manual Saver AEDs that were sold used; in such case, the...
Page 66: Declaration Of Medical Substances
SEMI-AUTOMATIC Declaration of Medical Substances By design, this SMARTY SaverGeo Defibrillator does not incorporate any medicinal substances. Additional Information  All operations for this device are mentioned in this user manual. No special operating instructions required for the intended use of this device.
Page 67 SEMI-AUTOMATIC...