Related Manuals for Progetti Rescue SAM 4.0
Summary of Contents for Progetti Rescue SAM 4.0
- Page 1 INSTRUCTIONS FOR USE Semi-Automated External Defibrillator (AED) Rescue SAM 4.0 PROGETTI S.r.l. Rev. 1.0 Strada del Rondello, 5 2024-05 10028 Trofarello (TO) ITALY...
- Page 3 RESCUE STEPS 1. PUSH THE ON/OFF BUTTON 2. FOLLOW THE VOICE INSTRUCTIONS 3. IF INSTRUCTED, PRESS THE RED “SHOCK” BUTTON PUSH THE ON/OFF BUTTON FOLLOW THE VOICE INSTRUCTIONS IF INSTRUCTED, PRESS THE RED “SHOCK” BUTTON...
- Page 4 AED users should be trained on the correct use according to such protocol. Please read this User Manual carefully and thoroughly before using the RESCUE SAM 4.0 AED. This Manual contains instructions on how to operate, maintain and store the device correctly.
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Page 5: Disclaimer
User Manual. PROGETTI S.r.l. shall not be held liable for any accidental damage caused to the Rescue SAM 4.0 AED and its accessories during transport to the customer or during use. - Page 6 • QUALITY & REGULATORY DEPT. - quality@progettimedical.com For continuous improvement, the Manufacturer is pleased to welcome any customer's opinion and suggestions on the device and/or this user manual. Therefore, please contact PROGETTI’s Quality & Regulatory department at the email address quality@progettimedical.com.
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Page 7: Table Of Contents
RESCUE SAM 4.0 User Manual Rev.1.0 TABLE OF CONTENTS DISCLAIMER ................................2 INTRODUCTION ..............................6 INTENDED USE ..............................7 1.1.1 INTENDED CLINICAL CONDITIONS AND CLINICAL BENEFIT ................. 7 1.1.2 INTENDED PATIENTS’ POPULATION ......................7 1.1.3 INTENDED USERS ............................8 1.1.4 INTENDED USE ENVIRONMENT ........................ - Page 8 RESCUE SAM 4.0 User Manual Rev.1.0 GENERAL CHARACTERISTICS ..........................49 ENVIRONMENTAL CONDITIONS ........................49 DISPOSABLE MULTIFUNCTION ELECTRODES ....................50 BATTERY ................................51 DEFIBRILLATION .............................. 51 8.5.1 WAVEFORM CHARACTERISTICS ......................... 53 ECG ACQUISITION ............................54 ECG ANALYSIS ..............................54 CE MARKING AND APPLIED STANDARDS ......................55 ELECTROMAGNETIC EMISSIONS ........................
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Page 9: Introduction
ECG and indicates whether or not a shockable rhythm is detected. The semi-automatic version of Rescue SAM 4.0 will NOT shock a patient automatically; it will only advise the operator if the shock is necessary. The SHOCK button is enabled only when a shockable rhythm is detected and the device is charged and ready to shock. -
Page 10: Intended Use
INTENDED CLINICAL CONDITIONS AND CLINICAL BENEFIT The Rescue SAM 4.0 AED is intended to be used for the external cardiac defibrillation of a victim of Sudden Cardiac Arrest (SCA), i.e. a person who is unconscious, unresponsive and not breathing. In this case, the AED will recommend to release a shock to the patient aimed at restoring the physiological heart rhythm. -
Page 11: Intended Users
AED by laypeople, namely nonprofessional healthcare staff. 1.1.4 INTENDED USE ENVIRONMENT Rescue SAM 4.0 is intended to be used indoors or outdoors. However, it shall NOT be used in the following environmental conditions: • with a high oxygen concentration;... -
Page 12: Description Of The Medical Device
RESCUE SAM 4.0 User Manual Rev.1.0 2. DESCRIPTION OF THE MEDICAL DEVICE OVERVIEW LEFT SIDE FRONT VIEW RIGHT SIDE IDENTIFICATION ICON FUNCTION BATTERY Device power source. ON/OFF Push this button to turn the device on. Push this button again BUTTON for 4 seconds to turn the device off. - Page 13 RESCUE SAM 4.0 User Manual Rev.1.0 However, if the user turns on the device and applies the electrodes on the patient AFTER 15 seconds, the patient’s type CANNOT be changed anymore. The user shall restart the device to be able to select the patient’s type again.
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Page 14: Graphic User Interface
RESCUE SAM 4.0 User Manual Rev.1.0 Insert the data download cable into this port and connect it to DATA a computer at the other end to download the data recorded DOWNLOAD during the AED use. The AED can be connected to a computer... - Page 15 RESCUE SAM 4.0 User Manual Rev.1.0 If the LED of this pictogram are flashing, the user shall begin the Cardiopulmonary Resuscitation (CPR) following the metronome sound (“beep-beep-beep”) and the LED flashing light. PERFORM CPR LED ON If all LED are flashing, the following situations may occur: •...
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Page 16: Status Indicator
RESCUE SAM 4.0 User Manual Rev.1.0 2.2.2 STATUS INDICATOR The status indicator is located on the front panel of the device and it provides information on its status. The LED of the status indicator may have different colours, each one with a specific meaning, described in the following table. -
Page 17: Accessories
RESCUE SAM 4.0 User Manual Rev.1.0 ACCESSORIES PROGETTI recommends using the Rescue SAM 4.0 AED only in combination with the accessories listed in the table below. The use of other accessories may damage the device and affect its performance. •... - Page 18 The transport bag is supplied only upon the customer’s request. It is intended to ease the device transport OPTIONAL and improve protection from knocks and/or the ingress of water or foreign substances into Rescue SAM 4.0 and its accessories throughout the stand-by period. PRG005_ Handle HANDLE_...
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Page 19: Detachable Components
DETACHABLE COMPONENTS The table below summarizes the detachable components of Rescue SAM 4.0. PROGETTI recommends using the Rescue SAM 4.0 AED only in combination with the items listed in the following table to avoid damaging the device and/or affecting its performance. -
Page 20: Symbols
RESCUE SAM 4.0 User Manual Rev.1.0 SYMBOLS The following table explains the meaning of each symbol included on the labels of the device, its accessories and its outer carton box. SYMBOL DESCRIPTION SYMBOL DESCRIPTION CE Marking & Notified Body’s Catalogue number... - Page 21 RESCUE SAM 4.0 User Manual Rev.1.0 Do NOT use if the package is Operating temperature range damaged and consult the (for disposable multifunction instructions for use. electrodes) Latex free Unique device identifier Single-use: do not reuse Medical device Non-sterile device...
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Page 22: Safety Information
GENERAL INFORMATION Before and after using Rescue SAM 4.0, please ensure that the main unit is safe and in perfect condition (integrity of cables and electrodes, condition of the battery). Also, make sure that the battery charge is sufficient and the battery itself is in good condition. - Page 23 WARNING Alternative current pathways may cause electrical arches and patient skin burns during defibrillation and may divert the defibrillating energy away from the heart. Use only PROGETTI® disposable multifunction electrodes (pads) ELECTRODES or those purchased from authorized distributors. Unapproved (PADS) WARNING accessories may affect the device’s performance.
- Page 24 RESCUE SAM 4.0 User Manual Rev.1.0 should only be used immediately before use. Do NOT use the electrodes (pads) after their expiration date. ELECTRODES Ensure that the sealed bag that contains the electrodes (pads) is (PADS) sealed and intact before using them. Otherwise, replace it with WARNING an intact one.
- Page 25 The device does NOT contain any parts that can be repaired by the user. MAINTENANCE If replacement and/or repair of Rescue SAM 4.0 or any of its WARNING accessories is necessary, please contact the manufacturer or an authorized service centre.
- Page 26 RESCUE SAM 4.0 User Manual Rev.1.0 Do NOT use the battery after the expiration date indicated on its BATTERY label. Please contact the manufacturer or its authorized CAUTION distributor for a replacement. ELECTRODES Observe all the information on the disposable multifunction (PADS) electrodes package.
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Page 27: Set-Up Procedure
Rev.1.0 4. SET-UP PROCEDURE Before using Rescue SAM 4.0, please ensure that the main unit is safe and in operational status (integrity of cables and electrodes, battery sufficiently charged). Rescue SAM 4.0 is designed to be stored in a “ready-to-use” condition. This section describes how to prepare the device, so that if and when you need it, few steps are required to begin using the device. - Page 28 RESCUE SAM 4.0 User Manual Rev.1.0 Insert the connector of the disposable multifunction electrodes into the port located in the top right corner of the device. Make sure that the connector is orientated correctly and push it in to lock it in position.
- Page 29 Rev.1.0 Check that the self-test is successfully passed. As soon as the battery is correctly locked in the battery compartment, Rescue SAM 4.0 turns on and starts an automatic self-test. The “Self-Test” voice prompt will be reproduced, the status indicator will light up in solid green, and the “do not touch the patient”...
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Page 30: Inserting The Device Into Its Transport Bag
Picture C INSERTING THE DEVICE INTO ITS TRANSPORT BAG Rescue SAM 4.0 has a dedicated transport bag where it can be stored, ready to be used. Please follow these instructions to place the device correctly in the transport bag: 1. Ensure that the battery has been placed in its compartment and the device has passed the self-test successfully. -
Page 31: Defibrillation Procedure
Check that the STATUS INDICATOR LED flashes GREEN (meaning that the battery is inserted, it is sufficiently charged and the disposable multifunction electrodes are connected to the AED correctly). The AED is ready for use. Rescue SAM 4.0 can automatically distinguish between the types of electrodes connected to the main unit. 3 cases are possible: SUITABLE PATIENT’S POPULATION... - Page 32 RESCUE SAM 4.0 User Manual Rev.1.0 After this time has elapsed, the button deactivates and the user shall restart the device to be able to select the patient’s type again. RS4-DFBAD01PRC – WHITE CONNECTOR ADULT: age ≥ 8 years old and weight ≥ 25 kg (including pregnant women).
- Page 33 RESCUE SAM 4.0 User Manual Rev.1.0 Press the ON/OFF button until the AED turns on. Verify that the STATUS INDICATOR LED is GREEN. Depending on the case, please take a look at the following table that describes the actions needed to solve each situation and be able to proceed.
- Page 34 RESCUE SAM 4.0 User Manual Rev.1.0 and connect the suitable electrodes for the patient’s type (see case A for the connection procedure). Disposable Disconnect the expired disposable multifunction electrodes from the AED multifunction by firmly pulling the connector and connecting a pair of valid ones (see electrodes already case A for the connection procedure).
- Page 35 RESCUE SAM 4.0 User Manual Rev.1.0 Follow the voice and visual instructions to apply the electrodes to the patient correctly. 3.1 “Stay calm. Follow the voice instructions. Make sure emergency services are called now.” Meaning: as soon as the AED is turned on, it is recommended to call for help.
- Page 36 RESCUE SAM 4.0 User Manual Rev.1.0 should be adhesive to ensure adequate contact with the ADULT PATIENT patient’s skin. Otherwise, please discard the electrodes and replace them with a new pair. PAEDIATRIC Please place the electrode on the patient (adult or...
- Page 37 RESCUE SAM 4.0 User Manual Rev.1.0 CASE A – SHOCKABLE RHYTHM 4.A.1 “Shock advised. Do not touch the patient” Meaning: the AED has determined that a shock is recommended and the unit is going to begin charging, preparing for a defibrillation shock. The user and the bystanders should stand clear of the patient.
- Page 38 RESCUE SAM 4.0 User Manual Rev.1.0 4.A.3 “Start CPR. Place heel of one hand on centre of chest. Place heel of other hand directly on top of first hand. Lean over patient with elbows straight. Press patient's chest down rapidly.”...
- Page 39 Inform the relevant people that Rescue SAM 4.0 and its accessories were used, so that an operator can put the device back into service by cleaning it and connecting a new pair of disposable...
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Page 40: Summary Of Device Operation
RESCUE SAM 4.0 User Manual Rev.1.0 SUMMARY OF DEVICE OPERATION The following flowchart summarizes how Rescue SAM 4.0 works. Each green box contains a voice prompt reproduced by the device during the rescue. - Page 41 RESCUE SAM 4.0 User Manual Rev.1.0 A description of the voice prompts is given in the table below. NOTE: voice prompts are available in one language (standard). The second/third language is available upon the Customer’s request (optional). The user can switch from one language to the other by pressing the language selection button located on the device’s front panel.
- Page 42 RESCUE SAM 4.0 User Manual Rev.1.0 The operator shall NOT touch the patient. “Do not touch the patient” The AED has started the analysis of the ECG signal (electrocardiogram) to determine whether a shockable or non-shockable rhythm is present. During the analysis, “Analysing heart rhythm.”...
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Page 43: Memory And Data Transfer
It can be disabled upon the customer’s request. EVENTS VIEW PROGETTI S.r.l. offers the possibility to see the events recorded by the AED on a computer through a data download and management software: PG Data Manager. This software is available on the PROGETTI’s website, www.progettimedical.com. -
Page 44: Data Download Procedure
RESCUE SAM 4.0 User Manual Rev.1.0 NOTE: please be informed that during the process of downloading the data stored in the device, this data will be transferred and sent to a secure server, where it will be stored for 7 years. This data will not be disclosed to third parties and does not contain any personal data. -
Page 45: Storage And Maintenance
The Rescue SAM 4.0 battery pack should be installed while cleaning the device. • Do NOT immerse Rescue SAM 4.0 or any of its parts and accessories in any liquid. Do NOT allow liquids to get into the unit. Use a soft cloth to clean the case to avoid abrasion and damage. -
Page 46: Maintenance
RESCUE SAM 4.0 User Manual Rev.1.0 MAINTENANCE PROGETTI S.r.l. recommends an electrical safety and functional check at least ONCE a year as part of preventive maintenance. WARNING: Rescue SAM 4.0 does NOT contain any user-repairable parts. Only technicians authorized by the manufacturer can perform preventive and corrective maintenance on Rescue SAM 4.0. -
Page 47: Manual Self-Test
RESCUE SAM 4.0 User Manual Rev.1.0 7.3.1 MANUAL SELF-TEST The manual self-test is intended to assess the proper functionality of the AED. It requires the operator’s action and it starts every time the battery is inserted in its compartment. For a greater safeguard, the manufacturer recommends performing a manual self-test at least once every 3 months. -
Page 48: Automatic Self-Tests
“Powering down” voice prompt and enters the standby mode. The status indicator will be flashing and RED. Rescue SAM 4.0 has NOT passed the self-test and it is NOT ready for use (non-operational). Please contact the manufacturer’s technical assistance department for support. -
Page 49: Checklist
RESCUE SAM 4.0 User Manual Rev.1.0 7.3.3 CHECKLIST The following checklist may be used as a starting point for an Operator’s Checklist aimed at documenting the periodic checks carried out on the device and recording the results of each test. The table should NOT be intended as an exhaustive list: new checks can be added according to the user’s needs. -
Page 50: Troubleshooting
Rev.1.0 7.3.4 TROUBLESHOOTING The following table lists some common problems that may arise during the use of Rescue SAM 4.0. The table also describes the possible cause(s) and action(s) required to solve the problem and restore the device functionality. NOTE: Rescue SAM 4.0 does not contain any user-repairable parts. -
Page 51: Disposal And Recycling
At the end of the AED expected service life (7 years), dispose of the device according to the local applicable laws. Rescue SAM 4.0 and its accessories are classified as electrical or electronic equipment, according to European Directive 2012/19/EU. Thus, the manufacturer recommends NOT disposing of Rescue SAM 4.0 and its electrical/electronic accessories in municipal waste. -
Page 52: Technical Specifications
RESCUE SAM 4.0 User Manual Rev.1.0 8. TECHNICAL SPECIFICATIONS GENERAL CHARACTERISTICS DIMENSIONS 250 x 260 x 80 mm WEIGHT Approx. 2.2 kg, with the battery and the electrodes connected INGRESS PROTECTION IP55 Standard: 1 language NUMBER OF LANGUAGES Optional: 1 or 2 additional languages It is contained in the internal flash memory of the CPU and it is essential for the device control and proper functioning. -
Page 53: Disposable Multifunction Electrodes
RESCUE SAM 4.0 User Manual Rev.1.0 DISPOSABLE MULTIFUNCTION ELECTRODES DISPOSABLE DISPOSABLE DISPOSABLE MULTIFUNCTION MULTIFUNCTION MULTIFUNCTION ELECTRODES FOR ELECTRODES FOR ELECTRODES FOR BOTH ADULT AND ADULTS PAEDIATRIC PATIENTS PAEDIATRIC PATIENTS REF: RS4-DFB01PRC REF: RS4- REF: RS4- DFBAD01PRC DFBPED01PRC PRODUCT CODE For adult patients (≥ 8 For adult patients (≥... -
Page 54: Battery
RESCUE SAM 4.0 User Manual Rev.1.0 BATTERY MODEL (REF) DFBSAM4.0RS4B TYPE , 4.2Ah, LiMnO non-rechargeable DEFIBRILLATION CAPACITY 250 shocks at 200 J at 25°C ESTIMATED DURATION DURING 10 hours of continuous functioning, i.e. shockable rhythm CONTINUOUS USE recognition and defibrillation with a 50-ohm load at 25°C... - Page 55 RESCUE SAM 4.0 User Manual Rev.1.0 The device partially charges the capacitor during the patient’s heart rhythm analysis (ECG signal analysis) before determining whether a shock is required (pre-charge). • SHOCK button enabled and lit up RED. INDICATION OF CHARGE •...
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Page 56: Waveform Characteristics
RESCUE SAM 4.0 User Manual Rev.1.0 8.5.1 WAVEFORM CHARACTERISTICS The diagram shows a biphasic truncated exponential waveform released by the AED as an example. The waveform is adjusted to compensate for the patient's measured impedance. Its length and amplitude vary according to the defibrillation energy value and the measured impedance. -
Page 57: Ecg Acquisition
RESCUE SAM 4.0 User Manual Rev.1.0 ECG ACQUISITION BAND 0.25 - 60 Hz CMRR 120 dB INPUT IMPEDANCE 500 k SAMPLING FREQUENCY 1200 sample/s Filters aimed at improving the signal removing FILTERING power interference and baseline oscillation. HEART RATE RANGE 30 –... -
Page 58: Ce Marking And Applied Standards
RESCUE SAM 4.0 User Manual Rev.1.0 CE MARKING AND APPLIED STANDARDS The device bears the CE marking and it belongs to the risk class IIb according to the Medical Device Directive (MDD) 93/42/EEC. Medical electrical equipment - Part 1: General requirements... -
Page 59: Electromagnetic Emissions
RESCUE SAM 4.0 User Manual Rev.1.0 ELECTROMAGNETIC EMISSIONS RESCUE SAM 4.0 is designed to be used in the electromagnetic environment specified below. The user or operator must ensure that it is used in such an environment. EMISSION TEST CONFORMITY SUPPORT FOR ELECTROMAGNETIC CONDITIONS Rescue SAM 4.0 uses radiofrequency (RF) energy only for... -
Page 60: Electromagnetic Immunity
RF transmitters. If the measured field strength in the location where Rescue SAM 4.0 is used exceeds the above RF compliance level, Rescue SAM 4.0 should be observed to check it is working normally. If any abnormal operation is observed, additional... -
Page 61: Separation Distances
RESCUE SAM 4.0 User Manual Rev.1.0 8.11 SEPARATION DISTANCES Rescue SAM 4.0 is intended to be used in an electromagnetic environment in which RF interference is controlled. The owner or user of Rescue SAM 4.0 should prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Rescue SAM 4.0 as recommended below,... -
Page 62: Manufacturer's Contacts
Rev.1.0 9. MANUFACTURER'S CONTACTS PROGETTI S.r.l. is the manufacturer of Rescue SAM 4.0 and it is responsible for placing it on the market. The following table lists the manufacturer’s contacts the user can refer to for any communication and information/clarification request. -
Page 63: Warranty Information
At its sole discretion, PROGETTI S.r.l. shall have the right to repair or replace the Automated External Defibrillator (AED) Rescue SAM 4.0. In the event of repair, PROGETTI S.r.l. will have the right, at its sole discretion, to repair the part with a new, repaired, identical or similar part. -
Page 64: Warranted Technical Support
The exclusive remedy for any loss or damage arising from any cause shall be as specified above. PROGETTI S.r.l. shall in no event be liable for consequential or incidental damage of any kind, including, but not limited to, exemplary, special, punitive damages, or financial losses of any kind, business interruption, loss of profits or personal injury, even if PROGETTI S.r.l. -
Page 65: Warranty Certificate
PROGETTI S.r.l. This warranty does not cover any accessories. PROGETTI undertakes, at its sole discretion, to replace parts and components free of charge and under warranty in its laboratories. …………………………………………………………………………………………………... -
Page 66: Eu Declaration Of Conformity
RESCUE SAM 4.0 User Manual Rev.1.0 11. EU DECLARATION OF CONFORMITY... - Page 67 RESCUE SAM 4.0 User Manual Rev.1.0...
- Page 68 RESCUE SAM 4.0 User Manual Rev.1.0...
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