Progetti RESCUE SAM BI phasic User manual

EN - User Manual
IT - Manuale di istruzioni
FR - Manuel d’utilisation
ES - Manual de instrucciones

RESCUE SAM User Manual vers.1.0 March 2011
RESCUE STEPS
1. PUSH ON/OFF BUTTON
2. FOLLOW VOICE PROMPTS
3. IF INSTRUCTED PRESS “SHOCK” BUTTON
1PUSH ON/OFF BUTTON
2
FOLLOW VOICE PROMPTS
3IF INSTRUCTED PRESS “SHOCK” BUTTON

RESCUE SAM User Manual vers.1.0 March 2011
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. Your RESCUE SAM defibrillator may not have all of these features.
Please read this Operator’s Manual carefully and thoroughly before using the RESCUE SAM AED. This
Manual contains instructions on how to operate and maintain the RESCUE SAM.
It is very important that you fully understand all the necessary instructions discussed in this manual so as
to act quickly in an emergency.
PROGETTI S.r.l. designs and manufactures all of its products in accordance with international standards
(93/42/EEC). This ensures that PROGETTI S.r.l. provides products of high quality and reliability.
In this regard:
Only persons authorized by PROGETTI S.r.l. should do the servicing of the device. You
should operate this device in accordance with the instructions specified in this manual.
To ensure safety and reliability, use only parts and accessories recommended by PROGETTI S.r.l.
IMPORTANT Notices
Progetti Srl shall not be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this material.
Information in this document is subject to change without notice.
Limited Warranty
The “Limited Warranty” shipped with Progetti S.r.l. AED products serves as the sole and exclusive
warranty provided by Progetti S.r.l., with respect to the products contained herein.
Copyright
Copyright © 2011 Progetti Srl.
All rights reserved

RESCUE SAM User Manual vers.1.0 March 2011
Contents
1 INTRODUCTION TO THE RESCUE SAM AED ......................................................................................................... 1
1.1 OVERVIEW ............................................................................................................................................................ 1
1.2 THE RESCUE SAM AED ........................................................................................................................................ 2
1.3 INDICATIONS ......................................................................................................................................................... 3
1.4 CONTRAINDICATIONS .............................................................................................................................................. 3
1.5 OPERATOR TRAINING REQUIREMENTS ........................................................................................................................ 3
2 DANGERS, WARNINGS AND CAUTIONS .............................................................................................................. 4
2.1 SHOCK, FIRE HAZARD, EXPLOSION............................................................................................................................. 4
2.1.1 Electricity........................................................................................................................................................... 4
2.1.2 Battery Pack ...................................................................................................................................................... 4
2.1.3 Usage Environment ........................................................................................................................................... 4
2.1.4 Defibrillation/Shock Delivery............................................................................................................................. 5
2.1.5 Maintenance ..................................................................................................................................................... 5
2.2 IMPROPER DEVICE PERFORMANCE............................................................................................................................. 6
2.2.1 Usage Environment ........................................................................................................................................... 6
2.2.2 Pads................................................................................................................................................................... 6
2.2.3 Patient Analysis................................................................................................................................................. 7
2.2.4 Shock Delivery ................................................................................................................................................... 7
2.2.5 Maintenance ..................................................................................................................................................... 8
3 SETTING UP THE RESCUE SAM AED..................................................................................................................... 9
3.1 OVERVIEW ............................................................................................................................................................ 9
3.2 INSTALLING AND REMOVING THE BATTERY PACK .......................................................................................................... 9
3.3 CONNECTING THE PADS......................................................................................................................................... 10
3.4 STORING THE RESCUE SAM AED.......................................................................................................................... 10
4 USING THE RESCUE SAM AED ............................................................................................................................11
4.1 CHECKING RESCUE SAM STATUS .......................................................................................................................... 11
4.2 TURNING ON THE RESCUE SAM AED .................................................................................................................... 11
4.3 PREPARATION...................................................................................................................................................... 11
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 Follow RESCUE SAM AED Prompts .................................................................................................................. 13
5 MAINTAINING AND TROUBLESHOOTING THE RESCUE SAM AED .......................................................................14
5.1 SELF-TESTS ......................................................................................................................................................... 14
5.2 ROUTINE MAINTENANCE ....................................................................................................................................... 14
5.3 MAINTENANCE RELATED VOICE PROMPTS: ............................................................................................................... 14
5.4 CLEANING........................................................................................................................................................... 15
5.5 STORAGE ............................................................................................................................................................ 15
5.6 OPERATOR’SCHECKLIST......................................................................................................................................... 15

RESCUE SAM User Manual vers.1.0 March 2011
5.7 TROUBLESHOOTING .............................................................................................................................................. 16
5.8 REPAIR............................................................................................................................................................... 16
6 RESCUE SAM AED ACCESSORIES ........................................................................................................................17
6.1 DEFIBRILLATION/MONITORING PADS ....................................................................................................................... 17
6.2 BATTERY PACKS ................................................................................................................................................... 17
6.2.1 Battery Status Indicator .................................................................................................................................. 17
6.3 RECYCLING INFORMATION...................................................................................................................................... 17
6.3.1 Preparation ..................................................................................................................................................... 17
6.3.2 Packaging........................................................................................................................................................ 17
7 TECHNICAL SPECIFICATIONS ..............................................................................................................................18
7.1.1 Physical ........................................................................................................................................................... 18
7.1.2 Environmental ................................................................................................................................................. 18
7.1.3 Defibrillator ..................................................................................................................................................... 18
7.1.4 Waveform Specifications................................................................................................................................. 19
7.1.5 Patient Analysis System .................................................................................................................................. 19
7.1.6 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity................................ 20
7.2 BATTERY PACK ..................................................................................................................................................... 22
7.3 SELF-ADHESIVE DEFIBRILLATION/MONITORING PADS ................................................................................................. 23
8 GLOSSARY OF SYMBOLS ....................................................................................................................................24
9 CONTACTS.........................................................................................................................................................25
10 WARRANTY INFORMATION...............................................................................................................................26
WARRANTY CERTIFICATE ...........................................................................................................................................28
DECLARATION OF CONFORMITY ................................................................................................................................29

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RESCUE SAM User Manual vers.1.0 March 2011
1 Introduction to the RESCUE SAM AED
This User Manual provides information to guide trained operators in the use and maintenance of the
RESCUE SAM series Semi-Automatic External Defibrillator (“AED”) and its accessories. This chapter
includes an overview of the AED, a discussion of when it should and should not be used, and information
on required operator training.
1.1 Overview
The RESCUE SAM is a Semi-Automatic External Defibrillator (“AED”) that is designed to be easy to use,
portable and battery powered.
Voice prompts and visual indicators provide a simple interface for the operator. The RESCUE SAM is
capable of recording event information including ECG and SHOCK/NO-SHOCK recommendations.
When connected to a patient who is unconscious and not breathing, the RESCUE SAM performs the
following tasks:
• Prompts the operator to take necessary actions to enable analysis.
• Automatically analyzes the patient’s ECG.
• Determines whether a shockable rhythm is present.
• Charges the defibrillation capacitor and arms the SHOCK button if it detects a shockable rhythm.
• Prompts the operator to press the SHOCK button when the device is ready and a shock is
recommended.
• Delivers a shock once the device has determined a shock is required and the SHOCK button has
been pressed.
• Repeats the process if additional shocks are required.
The RESCUE SAM will NOT shock a patient automatically; it will only advise the operator. The SHOCK
button is enabled only when a shockable rhythm is detected and the device is charged and ready to
shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must
press the SHOCK button to initiate defibrillation.
The RESCUE SAM uses two self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if
necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are
provided in a single-use, disposable package.
The RESCUE SAM determines proper pad-to-patient contact by monitoring the impedance between the
two pads (impedance varies with the electrical resistance of the patient’s body). Visual and audio
prompts inform the operator of possible problems with patient contact. 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.
Defibrillation energy is delivered as an impedance compensated biphasic truncated exponential
waveform. The device delivers 200 Joules into a 50-ohm load when using adult pads or when using
attenuated child / infant pads, 50J of defibrillation energy into a 50-ohm load. Energy delivered does not
change significantly with patient impedance, although the duration of the generated waveform will vary.
The RESCUE SAM is designed to deliver up to 200J of defibrillation energy through a patient impedance
range of 25 – 175 ohms.
Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) lithium battery
pack that provides for long standby life and low maintenance operation. Each pack is marked with an
expiration date.
The RESCUE SAM records event documentation on its internal memory.

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RESCUE SAM User Manual vers.1.0 March 2011
1.2 The RESCUE SAM AED
A. Speaker. The speaker projects the voice prompts when the RESCUE SAM is on.
B. SHOCK button. This button will flash when a shock is recommended - push this button to deliver
the shock to the patient. This button is disabled at all other times.
C. Instructions LEDs. This LEDs will flash according to the voice prompts .
D. ON/OFF button. Push button to turn the RESCUE SAM on. Push again to disarm and turn the AED
off.
E. Information button and LED.
F. Pads connector port. Insert Patient Pads Connector into this port to connect pads to RESCUE SAM.
G. Battery pack. The battery pack provides a replaceable main power source for the RESCUE SAM.
H. Battery pack opening. Insert the battery pack firmly into this opening until the latch clicks into
place.
I. Battery pack eject lever. This lever releases the battery pack from the RESCUE SAM. To remove
the battery pack, push the lever and extract the battery pack from the unit.
J. Status Indicator. When the unit is off, this indicator blinks green to indicate the unit is fully
operational and blinks red to indicate unit needs attention from the user or servicing.
F
H
I
G

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RESCUE SAM User Manual vers.1.0 March 2011
1.3 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.
1.4 Contraindications
The RESCUE SAM should not be used if the patient shows any of the following signs:
• Conscious and/or responsive.
• Breathing.
• Has a detectable pulse.
1.5 Operator Training Requirements
In order to safely and effectively operate the RESCUE SAM, a person shall have met the following
requirements:
• RESCUE SAM and/or defibrillation training as required by local, state, provincial,
or national regulations.
• Any additional training as required by the authorizing physician.
• Thorough knowledge and understanding of the material presented in this User Manual.

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RESCUE SAM User Manual vers.1.0 March 2011
2 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. The entire list is presented here for convenience.
2.1 Shock, Fire Hazard, Explosion
2.1.1 Electricity
DANGER Hazardous electrical output. This equipment is for
use only by qualified personnel.
2.1.2 Battery Pack
DANGER:
Immediate hazards that will result in serious
personal injury or death.
WARNING:
Conditions, hazards, or unsafe practices that may
result in serious personal injury or death.
CAUTION:
Conditions, hazards, or unsafe practices that may
result in minor personal injury, damage to the
RESCUE SAM, or loss of data.
CAUTION Follow all battery pack labeling instructions. Do not
install battery packs after the expiration date.
WARNING Lithium battery packs are not rechargeable. Any
attempt to recharge a lithium battery pack may
result in fire or explosion.
WARNING Do not immerse battery pack in water or other
liquids. Immersion in fluids may result in fire or
explosion.
WARNING Do not attempt to recharge, short-circuit, puncture,
or deform battery. Do not expose battery to
temperatures above 50°C. Remove battery when
depleted.
CAUTION Recycle or dispose of lithium battery packs in
accordance with local laws. To avoid fire and
explosion hazard, do not burn or incinerate the
battery.