Progetti RESCUE SAM User Manual

Progetti RESCUE SAM User Manual

Bi-phasic semi-automatic external defibrillator
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EN - User Manual AUTOMATIC Ver. 1.0

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Summary of Contents for Progetti RESCUE SAM

  • Page 1 EN - User Manual AUTOMATIC Ver. 1.0...
  • Page 2 RESCUE SAM User Manual vers.1.0 Jun. 2015 RESCUE STEPS 1. PUSH ON/OFF BUTTON 2. FOLLOW VOICE PROMPTS PUSH ON/OFF BUTTON FOLLOW VOICE PROMPTS...
  • Page 3 RESCUE SAM User Manual vers.1.0 Jun. 2015 Thank you for choosing the RESCUE SAM AED. The RESCUE SAM defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) patient management protocols. These operating instructions include information and procedures related to all features of the RESCUE SAM defibrillator.
  • Page 4: Table Of Contents

    4.3.1 Call for Help..............................11 4.3.2 Preparing the Patient ............................11 4.3.3 Opening the Pad Package ..........................12 4.3.4 Connecting Defibrillation Pads to the RESCUE SAM..................12 4.3.5 Applying Pads to the Patient........................... 12 4.3.6 Preparation of the pediatric patient ....................... 13 4.3.7 Follow RESCUE SAM AED Prompts ........................
  • Page 5 RESCUE SAM User Manual vers.1.0 Jun. 2015 5.2.2 Software for data downloads.......................... 16 ....................... 16 UNCTIONING AND NTERFACE PROCEDURE ............................16 OFTWARE DOWNLOAD MAINTAINING AND TROUBLESHOOTING THE RESCUE SAM AED...............17 ................................. 17 ESTS ............................17 OUTINE AINTENANCE : ....................... 17...
  • Page 6: Introduction To The Rescue Sam Aed

    Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The RESCUE SAM has two operational push-button controls, one info-button ans several LED indicators.
  • Page 7: The Rescue Sam Aed

    A. Speaker. The speaker projects the voice prompts when the RESCUE SAM is on. B. Instructions LEDs. This LEDs will flash according to the voice prompts. C. ON/OFF button. Push button to turn the RESCUE SAM on. Push again to disarm and turn the AED off.
  • Page 8: Indications

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Indications The RESCUE SAM is indicated for use on victims of sudden cardiac arrest (“SCA”) when the patient is: • Unconscious and unresponsive. • Not breathing. For patients under 8 years old, use child/ infant electrode pads. Do not delay therapy to determine exact age or weight.
  • Page 9: Dangers, Warnings And Cautions

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Dangers, Warnings and Cautions This chapter includes a list of danger, warning, and caution messages that relate to the Progetti Srl RESCUE SAM and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the RESCUE SAM or accessories.
  • Page 10: Usage Environment

    Spilling fluids into the RESCUE SAM CAUTION may damage it or present a fire or shock hazard. Do not autoclave or gas sterilize the RESCUE SAM or its accessories. The RESCUE SAM should be stored and used only CAUTION...
  • Page 11: Improper Device Performance

    AED operation. In accordance with IEC 801.3, a distance of 2 meters between RF devices and the RESCUE SAM is recommended. Although the RESCUE SAM is designed for a wide CAUTION variety of field use conditions, rough handling beyond specifications can result in damage to the unit.
  • Page 12: Patient Analysis

    RESCUE SAM User Manual vers.1.0 Jun. 2015 2.2.3 Patient Analysis Aggressive or prolonged CPR to a patient with WARNING defibrillation pads attached can cause damage to the pads. Replace the defibrillation pads if they become damaged during use. CPR rates above the American Heart Association...
  • Page 13: Maintenance

    Improper maintenance can cause the RESCUE SAM CAUTION not to function. Maintain the RESCUE SAM only as described in this User Manual. The AED contains no user serviceable parts – do not take the unit apart.
  • Page 14: Setting Up The Rescue Sam Aed

    This chapter describes the steps required to make your Progetti Srl RESCUE SAM AED operational. The RESCUE SAM is designed to be stored in a “ready” state. This chapter tells you how to make the device ready, so that if and when you need it, few steps are required to begin using the device.
  • Page 15: Connecting The Pads

    The Status Indicator should periodically blink with a green light. If it blinks with a red light or does not blink at all, the RESCUE SAM needs servicing – refer to the “Checking the Status Indicator” section for more information.
  • Page 16: Using The Rescue Sam Aed

    Concise and easily understandable voice messages and prompts guide the operator through the use of the unit. The following sections describe in detail how to use the RESCUE SAM. The basic steps for use are: • Turn the RESCUE SAM ON by pressing the ON/OFF button.
  • Page 17: Opening The Pad Package

    4.3.4 Connecting Defibrillation Pads to the RESCUE SAM The RESCUE SAM is designed to be stored with the defibrillation pad connector attached to the unit, while the pads themselves remain sealed in their package. This reduces the time needed to setup and start treatment in an emergency.
  • Page 18: Preparation Of The Pediatric Patient

    RESCUE SAM User Manual vers.1.0 Jun. 2015 4.3.6 Preparation of the pediatric patient If the patient is an infant or child under the age of 8 years or weight less than 25kg (55 lbs), the device must be used with the attenuated defibrillation electrodes for children. Do not delay the procedure to define the exact weight or age.
  • Page 19 “Do not touch the patient” – This indicates that the RESCUE SAM is trying to analyze the patient’s heart rhythm and that the operator should not touch the patient. This message will be spoken at the beginning of the analysis period and also if motion or interference has been detected.
  • Page 20: Memory And Data Transfer

    5.1.1 View events Sam Data Manager is an application software based on Windows, it is able to read the data recorded inside the RESCUE SAM, showed and manage it on the PC. The main function for Sam Data Manager are: ...
  • Page 21: Interface Data Downloads

    5.2.1 Module data download Fig. 1 RESCUE SAM defibrillator is supplied with a special adapter (Fig. 1) complete of USB cable and power adapter. This interface module allow the power supply for the defibrillator only for the data download from the internal memory of the RESCUE SAM.
  • Page 22: Maintaining And Troubleshooting The Rescue Sam Aed

    Manually initiated Self- Tests may be run to test the RESCUE SAM’s systems, including the charging and shocking functions (the shock is internally dissipated, i.e. no voltage will be present at the pads) at any time by tacking off the battery pack and reinserting it.
  • Page 23: Cleaning

    • The battery pack should be installed when cleaning the RESCUE SAM. • Do not immerse the RESCUE SAM in fluids or allow fluids to enter the unit. Use a soft cloth to wipe the case clean.
  • Page 24: Troubleshooting

    Return unit for service Battery insertion Unit needs servicing Return unit for service self-test failed Repair The RESCUE SAM contains no user serviceable parts. If the unit need servicing, return to an authorized service center. Refer to “Contacts” section for contact information.
  • Page 25: Rescue Sam Aed Accessories

    The Progetti Srl self-adhesive defibrillation/monitoring pad assembly comes in a “leads-out” sealed package that allows the device to be stored with pads connected. When the RESCUE SAM is used, the operator needs only to remove the pad packaging, tear open the package and turn the device on to administer care.
  • Page 26: Technical Specifications

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Technical Specifications 8.1.1 Physical Category Specification Size (29 x 28 x 9 cm) Weight Approximately 2.2Kg with Battery pack 8.1.2 Environmental Category Specification Operating / Temperature ÷ ÷ 46°C (23 115°F) Maintenance Humidity 5% –...
  • Page 27: Waveform Specifications

    8.1.5 Patient Analysis System The RESCUE SAM Patient Analysis System ensures that the pad/patient impedance is within the proper range and analyzes the patient’s ECG rhythm to determine whether a shock is required. In an initial ECG signal conditioning stage, ECG data are received and digital processing is done to remove baseline wander and high-frequency noise.
  • Page 28: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity

    8.1.6 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity Electromagnetic emissions The RESCUE SAM is intended for use in the electromagnetic environment specified below. The customer or the user of the RESCUE SAM should assure that it is used in such an environment Electromagnetic...
  • Page 29 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RESCUE SAM is used exceeds the applicable RF compliance level above, the RESCUE SAM should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary, such as reorienting or relocating the RESCUE SAM.
  • Page 30: Battery Pack

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Separation Distances The RESCUE SAM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RESCUE SAM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RESCUE SAM as recommended below, according to the maximum output of the communications equipment.
  • Page 31: Self-Adhesive Defibrillation/Monitoring Pads

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Battery label: RESCUE SAM BATTERY ELRS-002 06/2014 S062010 12VDC, 4.2Ah Self-Adhesive Defibrillation/Monitoring Pads Use only the Pads supplied or approved by Progetti Srl. Category Specification Model number DFBAD01PRC Type Adult Intended use Disposable...
  • Page 32: Glossary Of Symbols

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Glossary of Symbols RESCUE SAM Defibrillator Symbol Description Power ON/OFF button Info button Status Led BF type, defibrillation proof equipment Attention: Refer to the User Manual. Instructions in the User Manual. 0068 CE Marking...
  • Page 33: Contacts

    RESCUE SAM User Manual vers.1.0 Jun. 2015 Lithium Manganese Dioxide battery. Follow local regulations on battery disposal or recycling. Attention: Refer to user manual. CE marking Contacts PROGETTI S.r.l. Strada del Rondello, 5 10028 TROFARELLO (TO) ITALY Phone: +39 011 644738...
  • Page 34: Warranty Information

    Exclusive Remedy At Progetti Srl’s sole discretion, Progetti Srl shall have the option to repair or replace. In the event of replacement, Progetti Srl shall have the right at its sole discretion to replace the item with a new, or refurbished, same or similar item.
  • Page 35 RESCUE SAM User Manual vers.1.0 Jun. 2015 When the need for maintenance arises: Please contact PROGETTI S.r.l. or its authorized representatives immediately. Prepare a summary of the problems. Also include the name of model, product serial number, date of purchase, name of sales...
  • Page 36: Warranty Certificate

    PROGETTI S.r.l.. This warranty does not cover any accessories. PROGETTI S.r.l. will replace damaged parts and components, according to its option. PROGETTI S.r.l. will replace cost free those parts and components under guarantee in its laboratory. CLIENT:_________________________________________________ _________________________________________________...
  • Page 37: Declaration Of Conformity

    14 J 1993 ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER. THE DEFIBRILLATOR MODEL RESCUE SAM IS MANUFACTURED BASED ON LEAD – FREE COMPONENTS, ACCORDING TO ROHS, DIRECTIVE 2011/65/CEE. NOTIFIED BODY : ISTITUTO DI RICERCHE E COLLAUDI M. MASINI S.r.l.
  • Page 38 RESCUE SAM User Manual vers.1.0 Jun. 2015 www.progettimedical.com Rescue SAM Public access defibrilaltor...

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