Gima RESCUE SAM FULL AUTOMATIC AED DEFIBRILLATOR, RESCUE SAM AED DEFIBRILLATOR User guide

RESCUE SAM User Manual vers.2.5 Feb. 2021

RESCUE STEPS

1. PUSH ON/OFF BUTTON

2. FOLLOW VOICE PROMPTS

3. IF INSTRUCTED PRESS “SHOCK” BUTTON

1 PUSH ON/OFF BUTTON

2

FOLLOW VOICE PROMPTS

3 IF INSTRUCTED PRESS “SHOCK” BUTTON

RESCUE SAM User Manual vers.2.5 Feb. 2021

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 Notice

Considering the defibrillator as an emergency healthcare device, Progetti Srl recommends to submit
RESCUE SAM AED to a preventive maintenance program (functional check and electrical safety check)
annually.

For further information, please contact the technical service of Progetti Srl by mail at
[e-mail] or by phone [phone].

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.2.5 Feb. 2021

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 ........................................................................................................................................... 5

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

3.5 POSITIONING THE DEFI PADS INSIDE THE CARRYING BAG (OPTIONAL) ............................................................................... 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 Preparation of the pediatric patient ............................................................................................................... 13

4.3.7 Follow RESCUE SAM AED Prompts .................................................................................................................. 13

5 MEMORY AND DATA TRANSFER ........................................................................................................................15

5.1 HOW REGISTRATION AND MEMORY MANAGEMENT WORK ............................................................................................ 15

5.1.1 View events ..................................................................................................................................................... 15

5.2 INTERFACE DATA DOWNLOADS ................................................................................................................................ 16

5.2.1 Module data download ................................................................................................................................... 16

RESCUE SAM User Manual vers.2.5 Feb. 2021

5.2.2 Software for data downloads .......................................................................................................................... 16

5.3 FUNCTIONING AND INTERFACE PROCEDURE ............................................................................................................... 16

5.4 SOFTWARE DOWNLOAD ......................................................................................................................................... 16

6 MAINTAINING AND TROUBLESHOOTING THE RESCUE SAM AED .......................................................................17

6.1 SELF-TESTS ......................................................................................................................................................... 17

6.2 ROUTINE MAINTENANCE ....................................................................................................................................... 17

6.3 MAINTENANCE RELATED VOICE PROMPTS: ............................................................................................................... 17

6.4 CLEANING ........................................................................................................................................................... 18

6.5 STORAGE ............................................................................................................................................................ 18

6.6 OPERATOR’S CHECKLIST......................................................................................................................................... 18

6.7 TROUBLESHOOTING .............................................................................................................................................. 19

6.8 REPAIR ............................................................................................................................................................... 19

7 RESCUE SAM AED ACCESSORIES ........................................................................................................................20

7.1 DEFIBRILLATION/MONITORING PADS ....................................................................................................................... 20

7.2 BATTERY PACKS ................................................................................................................................................... 20

7.2.1 Battery Status Indicator .................................................................................................................................. 20

7.3 RECYCLING INFORMATION ...................................................................................................................................... 20

7.3.1 Preparation ..................................................................................................................................................... 20

7.3.2 Packaging ........................................................................................................................................................ 20

8 TECHNICAL SPECIFICATIONS ..............................................................................................................................21

8.1.1 Physical ........................................................................................................................................................... 21

8.1.2 Environmental ................................................................................................................................................. 21

8.1.3 Defibrillator ..................................................................................................................................................... 21

8.1.4 Waveform Specifications ................................................................................................................................. 22

8.1.5 Patient Analysis System .................................................................................................................................. 22

8.1.6 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity ................................ 23

8.2 BATTERY PACK ..................................................................................................................................................... 25

8.3 SELF-ADHESIVE DEFIBRILLATION/MONITORING PADS ................................................................................................. 26

9 GLOSSARY OF SYMBOLS ....................................................................................................................................27

10 CONTACTS .........................................................................................................................................................28

11 WARRANTY INFORMATION ...............................................................................................................................29

WARRANTY CERTIFICATE ...........................................................................................................................................31

DECLARATION OF EU CONFORMITY ...........................................................................................................................32

1

RESCUE SAM User Manual vers.2.5 Feb. 2021

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.2.5 Feb. 2021

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. Il permet d’écouter encore le message sur l'état du système.

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

HI G

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RESCUE SAM User Manual vers.2.5 Feb. 2021

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.2.5 Feb. 2021

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.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

2.1.3 Usage Environment

DANGER

Possible explosion hazard if used in the presence of
flammable anesthetics or concentrated oxygen.

DANGER

The RESCUE SAM has not been evaluated or
approved for use in hazardous locations as defined
in the National Electric Code standard. In
compliance with IEC classification the RESCUE SAM
is not to be used in the presence of flammable
substance/air mixtures.

CAUTION

Do not immerse any portion of this product in water
or other fluids. Do not allow fluids to enter the
device. Avoid spilling any fluids on this device or
accessories. Spilling fluids into the RESCUE SAM
may damage it or present a fire or shock hazard.
Do not autoclave or gas sterilize the RESCUE SAM
or its accessories.

CAUTION

The RESCUE SAM should be stored and used only
within the range of environmental conditions
specified in the technical specifications.

2.1.4 Defibrillation/Shock Delivery

WARNING

Defibrillation current can cause operator or
bystander injury. Do not touch the patient during
defibrillation. Do not touch equipment connected to
the patient or metal objects in contact with the
patient during defibrillation. Disconnect other
electrical equipment from the patient before
defibrillating. Disconnect the RESCUE SAM from the
patient prior to use of other defibrillators.

WARNING

Improper use can cause injury. Use the RESCUE
SAM only as instructed in the User Manual. The
RESCUE SAM delivers electrical energy that can

potentially cause death or injury if it is used or
discharged improperly. Do not discharge with
defibrillation pads touching or gel surface exposed.

WARNING

Disconnect all non-defibrillator proof equipment
from the patient before defibrillation to prevent
electrical shock hazard and potential damage to
that equipment.

CAUTION

Avoid contact between parts of the patient’s body

and conductive fluids such as water, gel, blood or
saline, and metal objects, which may provide
unwanted pathways for defibrillating current.

2.1.5 Maintenance

WARNING

Electrical shock hazard. Dangerous high voltages
and currents are present. Do not open unit, remove
covers, or attempt repair. There are no user
serviceable components in the RESCUE SAM. Refer
servicing to qualified service personnel.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

2.2 Improper Device Performance

2.2.1 Usage Environment

WARNING

Radio frequency (RF) interference from RF devices
such as cellular phones and two-way radios can
cause improper AED operation. In accordance with
IEC 801.3, a distance of 2 meters between RF
devices and the RESCUE SAM is recommended.

CAUTION

Although the RESCUE SAM is designed for a wide
variety of field use conditions, rough handling
beyond specifications can result in damage to the
unit.

2.2.2 Pads

WARNING

Use only Progetti Srl disposable self-adhesive
defibrillation/monitoring pads, battery packs, and
other accessories supplied by Progetti Srl or its
authorized distributors. Substitution of non-Progetti
Srl approved accessories may cause the device to
perform improperly.

CAUTION

Follow all defibrillation pad label instructions. Use
defibrillation pads prior to their expiration date. Do
not re-use defibrillation pads. Discard defibrillation
pads after use (in the event of suspected pad
malfunction, return pads to Progetti Srl for testing).

WARNING

The defibrillation pads are intended for one time
use only and must be discarded after use. Reuse
can lead to potential cross infection, improper
performance of the device, inadequate delivery of
therapy and/or injury to the patient or operator.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

2.2.3 Patient Analysis

WARNING

Aggressive or prolonged CPR to a patient with
defibrillation pads attached can cause damage to
the pads. Replace the defibrillation pads if they
become damaged during use.

WARNING

CPR rates above the American Heart Association
guidelines of 100 BPM (beats per minute) can
cause incorrect or delayed diagnosis by the patient
analysis system.

WARNING

Do not place adult defibrillation pads in the
anterior-posterior (front-back) position. A shock or
no shock decision may be inappropriately advised.
The RESCUE SAM requires that the adult
defibrillation pads be placed in the anterior-anterior
(front-front) position.

WARNING

Some very low amplitude or low frequency rhythms
may not be interpreted as shockable VF rhythms.
Also some VT rhythms may not be interpreted as
shockable rhythms.

WARNING

Handling or transporting the patient during ECG
analysis can cause incorrect or delayed diagnosis,
especially if very low amplitude or low frequency
rhythms are present. During analysis and from

“Shock Advised” until “Shock Delivered,” patient

movement and vibration must be minimized.

WARNING

In patients with cardiac pacemakers, the RESCUE
SAM may have reduced sensitivity and not detect
all shockable rhythms. If you know the patient has
an implanted pacemaker, do not place electrodes
directly over an implanted device.

2.2.4 Shock Delivery

WARNING

Do not allow defibrillation pads to touch each other,
or to touch other ECG electrodes, lead wires,
dressings, transdermal patches, etc. Such contact
can cause electrical arcing and patient skin burns
during defibrillation and may divert defibrillating
energy away from the heart.

WARNING

During defibrillation, air pockets between the skin
and defibrillation pads can cause patient skin burns.
To help prevent air pockets, make sure self­adhesive defibrillation pads completely adhere to
the skin. Do not use dried out or expired
defibrillation pads.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

2.2.5 Maintenance

WARNING

Periodic user-initiated and automatic self-tests are
designed to assess the RESCUE SAM’s readiness for
use. However, no degree of testing can assure
performance or detect abuse, damage, or a defect
that occurred after the most recent test is
completed.

WARNING

Use of damaged equipment or accessories may
cause the device to perform improperly and/or
result in injury to the patient or operator.

CAUTION

Improper maintenance can cause the RESCUE SAM
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.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

3 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.

3.1 Overview

The following components and accessories are included with your RESCUE SAM. Replacement and other
accessories are detailed in the “RESCUE SAM Accessories” section. Before getting started, identify each

component and ensure that your package is complete.

3.2 Installing and Removing the Battery Pack

The lithium battery pack provides power to the RESCUE SAM.

Do not install the battery pack after the expiration date printed on the label. The battery pack is non­rechargeable.

To insert the battery pack into the RESCUE SAM, orient the battery pack so that the label faces up. Make
certain that the battery opening in the side of the AED is clean and clear of any foreign objects. Insert
the battery pack into the opening in the side of the AED. Slide the pack all the way in until the latch
clicks. If the pack does not slide all the way in, it is most likely inserted upside down. Once fully
inserted, the battery pack surface should be flush with the side of the AED.

To remove the battery pack, push the battery release lever and pull the battery pack out.

After battery insertion the RESCUE SAM runs an automatic self test that verifies the readiness for rescue

operation. With battery inserted, press the flashing red button to switch to the standby status. Upon

passing the self test the status green LED will flash. If the self test does not pass the status red LED will
flash.

RESCUE SAM and

Battery pack

User Manual

Defibrillation pads

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RESCUE SAM User Manual vers.2.5 Feb. 2021

3.3 Connecting the Pads

The RESCUE SAM defibrillation/monitoring pads are supplied sealed in a pouch with the connector and
part of the cable exposed. This allows the pads to be stored in a pre-connected state for rapid
deployment during an emergency.

CAUTION: DO NOT remove the defibrillation pads from the sealed package until the pads are to be
used. The packaging should be opened only immediately prior to use, otherwise the pads may dry out
and become non-functional.

Note: The RESCUE SAM is designed to be stored with the pads connector already installed. This
simplifies the procedure for setting up and operating the device in an emergency.

First, check to ensure that the pad package has not expired. Pads past their expiration date should not
be used and should be discarded.

Insert the connector end of the defibrillation pad cable into the pads connector port on the bottom-left
corner of the RESCUE SAM. Insert pads connector firmly until it is fully seated in the unit.

CAUTION: The pads are intended for one time use only and must be discarded after use or if the
package has been opened.

3.4 Storing the RESCUE SAM AED

The RESCUE SAM (preferably with pads attached) should be stored in environmental conditions within
range of the specifications - refer to the “Environmental” section of “Technical Specifications”. The unit
should also be stored so that the Active Status Indicator can be readily seen.

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.

Progetti Srl recommends storing your AED in an easily accessible location.

3.5 Positioning the defi pads inside the carrying bag (optional)

1. Connect the pre-connected defi pads to the defibrillator as shown in the picture below

2. Insert the pre-connected defi pads inside the carrying bag as shown in the picture

3. Close the bag cover

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RESCUE SAM User Manual vers.2.5 Feb. 2021

4 Using the RESCUE SAM AED

This chapter describes how to use the RESCUE SAM. The RESCUE SAM was designed for simple
operation, allowing the operator to focus on the patient.

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.

• Connect pads to AED if not yet connected.

• Place pads on patient (follow instructions on pad package).

• Follow voice prompts.

• Press SHOCK button if instructed by the AED.

4.1 Checking RESCUE SAM Status

STATUS LED:

- Flashing Green: The RESCUE SAM is in standby mode and ready for a

rescue operation.

- Solid Green: The RESCUE SAM is switched ON.

- Flashing Red: The RESCUE SAM has detected a system error.

- Solid Red: The RESCUE SAM has detected a system error during

self-test. The RESCUE SAM will be inoperable.

- Solid Blue: The RESCUE SAM is in data base operation mode.

4.2 Turning on the RESCUE SAM AED

Press the ON/OFF button to turn the RESCUE SAM on. The Status LED will illuminate green anytime the
AED is on. Voice prompts will guide the operator in the use of the unit. To turn the unit off, press the
button again. The Status LED will indicate the state of the unit.

4.3 Preparation

4.3.1 Call for Help

As soon as the AED is turned on it is recommended to call for help. This indicates that the first step in a
rescue should always be to contact professional emergency services.
If another person is available, the user should direct that person to call for help and then continue the
rescue without delay.

4.3.2 Preparing the Patient

Prepare the patient by removing any clothing from the patient’s chest. Wipe away moisture from the
chest if necessary (the defibrillation pads will stick better on dry skin). If necessary, shave excessive
chest hair, which can prevent effective patient-electrode contact. To ensure that electrode pads fully
contact the patient’s skin, check that no jewelry or other objects are directly underneath where the pads
will be placed.

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RESCUE SAM User Manual vers.2.5 Feb. 2021

4.3.3 Opening the Pad Package

Open the pad package by tearing along the dotted line, starting at the black arrow (follow directions on
the package). Pull the protective backing from the pads and check that the pads are:

• Free from obvious signs of damage.

• Clean of excessive debris (for example, dirt if the pad was dropped).

• Not dried out, and that the gel is sticky and will adhere to the patient.

• Not expired. Do not use pads after the expiration date printed on the package.

If any of these conditions is found, use a new set of pads.

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.
The AED should be stored with the pad connector plugged into the unit. However, if pads were damaged
or not properly connected, you may need to substitute a new set of pads during an emergency. The pad
connector is on the bottom left corner of the AED.

To remove an old set of pads, pull firmly on the pad connector. Do not reuse used pads. Insert the
connector for the new pads as shown. The connector will only fit in one way – if the connector does not
fit, rotate the connector before trying again. Insert connector firmly until it is completely seated in the
unit.

4.3.5 Applying Pads to the Patient

Correct pad placement is essential for effective analysis of the patient’s cardiac rhythm and subsequent
shock delivery (if required). Remove the pads from the pad package by tearing the package along the
dotted line near the top of the package. Remove the pads from the package and follow the directions and
diagram showing proper defibrillation pad placement located on the defibrillation pad package. Peel off
the protective backing from each pad before placing it as shown on the picture on the pad. Peel the
backing off only when the pad is ready to be placed. Place the pads with the sticky side of the pad on the
patient’s skin. Place the pads as shown in the left side diagram.
On the right side of the diagram are indicated each pad position marking printed on.

Pads position marking Pads placement

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RESCUE SAM User Manual vers.2.5 Feb. 2021

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.
Remove the electrodes from the package by tearing the package along the dotted line near the end of the
pack. Remove the pads from the package and follow the directions and the schema for the correct
placement of defibrillation electrodes placed on the packaging of the defibrillation electrodes and on the
electrodes. Remove the protective coating from each electrode before placing them. Remove the coating
only when the electrode is ready to be applied. Place the electrodes with the adhesive side of the
patient's skin. Place the electrodes as shown in the diagram. The placement of pediatric electrodes in
children under the age of 8 years is different from that of adults or children older than 8 years.
Follow the instructions in the figure shown here.

Children under 8 years old: Place one pad in the center of the chest and one pad on the back as shown.

4.3.7 Follow RESCUE SAM AED Prompts

“Attach Pads” – This indicates that the pads are not attached to the patient or the pads connector is

not plugged in. Check that the pads are properly placed and fully adhering to the patient and that there
are no air bubbles between the pads and the patient. Make sure that the pads are not touching each
other. If the pads are not sticking due to moisture, dry the patient. If the pads are not sticking due to
excessive hair, shave or clip excessive chest hair. If the prompts continue, try replacing the pads with a
new set. The “attach pads” blue LEDs will flash red during this message. If the pads are not attached
within 3 minutes the RESCUE SAM will switch off automatically.

“Analyzing heart rhythm” - Once the RESCUE SAM has determined that the pads are making a

good connection to the patient, the AED will start the ECG rhythm analysis. The unit analyzes the ECG
signal and determines whether a shockable or non-shockable rhythm is present. While analyzing, the AED

will continue to monitor the pad connections and will abort analysis if it detects any pad problems.

“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. The “do not touch
patient” blue LED will flash during this message.

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“No shock advised” – This indicates that the RESCUE SAM has determined that a shock is not

required. The unit will not charge and the SHOCK button will not be enabled. The user will be prompted

to begin CPR, if needed, for a period of two minutes.

“Shock advised” – This indicates that the RESCUE SAM has determined that a shock is recommended

and the unit will begin charging in anticipation of a defibrillation shock.

“Stand clear” – This indicates that the RESCUE SAM is charging and that the operator and others

should stand clear of the patient. Analysis will continue during this phase and the “stand clear” blue LED
will continue to flash. A tone will sound to indicate charging progress. If the unit detects a rhythm change

to a non-shockable one, charging will abort and the user will be prompted to begin CPR, if needed, for a
period of two minutes.

“Press the red shock button” – This indicates that the RESCUE SAM has fully charged, that the

heart rhythm analysis algorithm still indicates a shock is recommended, and the unit is ready to deliver a
shock. The operator should press the SHOCK button to deliver the shock. The “Shock” button will be lit

red during this phase.

“No shock delivered” – This indicates that the RESCUE SAM has aborted shock mode and internally

discharged. If while waiting for the shock button to be pressed, the unit detects a rhythm change to a

non-shockable rhythm, the unit will cancel the shock. Also, if the shock button is not pressed within 15

seconds of the initial “press the red shock button” prompt, the unit will automatically cancel the shock.

“Begin CPR, press hard and fast in the center of the chest ” – This indicates that the user

should perform CPR for two minutes. The unit will not be monitoring the patient’s ECG rhythm during this
required two-minute CPR period. The “CPR” blue LED will flash and a timing sound will be emitted at 100
beats/minute.

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5 Memory and data transfer

Rescue SAM defibrillator has an internal memory capable of recording ECG traces and events happened
during the emergency phases.

5.1 How registration and memory management work

The internal defibrillator memory is able to record up to 8 sessions, every session could be long up to 60
minutes. Once the 8 session will be complete the defibrillator will replace and rewrite automatically the
oldest session.

The data inside the device are kept also when the defibrillator is turned OFF.

Progetti s.r.l. company offers as optional the possibility to see the registration on a computer by an
interface of data download and software management.

WARNING

RESCUE SAM defibrillator is able to record for single
event 60 minutes. If the data collected exceed this
limit, the following ones will be not recorded.

WARNING

RESCUE SAM overwrite the oldest event. Be sure to
archive the data on a PC in order to avoid to lost
past events.

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:

• The rescue staff is able by the software to rebuild a cardiac event starting from the moment when

the AED is turned ON and connected to the patient until to the RESCUE SAM where turned OFF.

• It allows to medical staff to review the event in every moment.

• It allows to service point and to the manufacturer a clear and detailed reconstruction of all events

and the proper use of the AED analyzing the performance of the device.

• It provides to the technicians extra parameters for the detection of faults in equipment suspected

of improper operation.

WARNING

Sam Data Manager 1.0 is an application software
stand-alone that could not be used when the AED is
working, it is developed only to support the analysis
post event of the data recorded on the internal
memory.

WARNING

The recording of an event must be brought to the
competent medical facility in the area to allow to
examine the data.

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5.2 Interface data downloads

Available from the optional accessories, Progetti S.r.l. provides for RESCUE SAM defibrillator a special
adapter and related software management. This kit allows the user to download the data registered
during the usage and allows to transfer this data on a personal computer for read, management and
archive by the software “Sam Data Manager”

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.

5.2.2 Software for data downloads

Sam Data Manager is an application based on PC that allow to review ECG data and other parameters
related to the patients and to the performance of the device after an emergency situation.

Sam Data Manager is able to be installed on different Windows platforms, Windows XP and Windows 7.
The minimum requirements for the PC system and for guarantee suitable performance are the follow:

o Processor Pentium dual core o 1 Gb of RAM o 100 Mbyte hard disk free space

5.3 Functioning and Interface procedure

For the data download is sufficient to follow this simple operation:

o Insert the interface module into the RESCUE SAM without connect the USB cable to the PC
o Connect the power supply to the interface by the appropriate charger
o Wait for the RESCUE SAM led status become BLU
o Connect the USB cable to the PC
o Start the program SAM DATA MANAGER on the PC and follow the video instruction

5.4 Software download

The software RESCUE SAM – SAM DATA MANAGER is available for free download from our web site
www.progettimedical.com after login in the reserved area.

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6 Maintaining and Troubleshooting the RESCUE SAM AED

This chapter describes the maintenance and troubleshooting procedures for the RESCUE SAM. The Self­Tests that are performed by the device are described along with the frequency and nature of periodic
maintenance for which the owner/operator is responsible. A troubleshooting guide is provided to help
diagnose user serviceable problems.

The RESCUE SAM contains no user serviceable parts.

6.1 Self-Tests

Power-On Self-Tests are performed every time the unit is turned on and test the basic operation of the
unit. The unit also performs daily, weekly and monthly self-tests automatically (without any intervention
from the operator) to check the integrity of the unit’s hardware and software. Manually initiated Self­Tests 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.

Note: manually initiated Self-Tests will use approximately one shock’s worth of energy from the battery
pack and running manually initiated Self-Tests will reduce the usable capacity of the battery.

6.2 Routine Maintenance

Although the RESCUE SAM is designed to be very low maintenance, simple maintenance tasks must be

performed by the owner/operator on a regular basis to ensure the unit’s dependability.

For a greater safeguard, we suggest to the Users to make a manual Selftest at least every 3 months,
pushing the Info button.

6.3 Maintenance Related Voice Prompts:

“System error “ – This indicates that the RESCUE SAM has failed the self-test and is non-operational

and needs servicing.

“Battery low” – This indicates that the battery pack capacity is low and should be replaced soon. The

AED will still be able to deliver at least a minimum of four defibrillation shocks the first time this message
is spoken.

Daily

Monthly

After Each Use

Action

o

o

o

Check that the Status Indicator is flashing
green

o

o

Check the condition of the unit and
accessories

o

Replace pads

O

Check pads and battery pack expiration
dates

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6.4 Cleaning

Periodically clean the RESCUE SAM of any dirt or contaminants on the case and connector socket. The
following are important guidelines to be adhered to when cleaning the device:

• 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.

• Do not use abrasive materials or strong solvents such as acetone or acetone based cleaning agents.

The following cleaning agents are recommended for cleaning the RESCUE SAM case and the
connector socket:

- Soapy water

- Ammonia based cleaners

- Hydrogen peroxide

- Isopropyl alcohol (70 percent solution)

- Chlorine bleach (30 ml / liter water)

• Ensure that the connector socket is completely dry before reinstalling the pads cable

6.5 Storage

The RESCUE SAM should be placed in a readily accessible location in an orientation where the Status
Indicator in the bottom center of the panel can be easily seen. In general, the unit should be stored in
clean, dry and moderate temperature conditions. Make sure that the environmental conditions of the
storage location are within the ranges detailed in the “Environmental” section.

6.6 Operator’s Checklist

The following checklist may be used as the basis for an Operator’s Checklist. The table should be copied
and filled out as recommend by the schedule in the “Routine Maintenance” section. As each item is

completed it should be checked off.

Progetti Srl RESCUE SAM Operator’s Checklist

Serial Number:

_______________________________________________________________

Location:

______________________________________________________________________

Date:

Check unit and accessories for damage, dirt and

contamination. Clean or replace as necessary.

Check that spare battery pack and pads available .

Check that battery pack and pads not past expiration

dates.

Check status flashing green.

Comments:

Inspected by: (signature)

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6.7 Troubleshooting

The following table lists the common causes for problems, the possible cause and the possible corrective
actions. Refer to the other sections of the User Manual for detailed explanations on how to implement the
corrective actions. If the unit continues to be non-functional, refer the unit for servicing.

6.8 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.

Symptom

Possible Cause

Corrective Action

Unit will not turn
on

Battery pack not inserted

Insert battery pack

Battery pack depleted or non­functional

Replace battery pack
Unit is non-functional

Return unit for service

Unit immediately
turns off

Battery pack depleted

Replace battery pack

Unit is non-functional

Return unit for service

STATUS is solid
red

Unit detected an error

Return unit for service

STATUS does not
blink at all

Battery pack not inserted

Insert battery pack

Battery pack non-functional

Replace battery pack

Unit is non-functional

Return unit for service

Battery insertion
self-test failed

Unit needs servicing

Return unit for service

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7 RESCUE SAM AED Accessories

This chapter describes the components and accessories that can be used with the Progetti Srl RESCUE
SAM. Information on obtaining replacement components and accessories is included in the “Contacts”

section.

7.1 Defibrillation/Monitoring Pads

The RESCUE SAM is used with Progetti Srl self-adhesive defibrillation/monitoring pads for adults or with
attenuated pediatric pads for infants and children. These pads (also known as “electrodes”) serve two
functions:

• Allow the unit to read the patient’s electrocardiograph (ECG) rhythm.

• Deliver defibrillation energy to the patient when needed.

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.

7.2 Battery Packs

The Progetti Srl AED uses a lithium battery pack. The battery pack is inserted into the battery pack
opening on the side of the AED and latches into place.

The battery is based on a lithium battery technology and provides the AED with a long shelf and
standby life.

7.2.1 Battery Status Indicator

The Status Indicator is located on the RESCUE SAM front panel and is used to indicate battery pack
status in stand-by mode. A periodically blinking green LED indicates that the battery pack status is OK
and the battery pack is ready for use. A blinking red LED indicates a battery pack problem.

7.3 Recycling Information

At the end of its useful life, recycle the defibrillator and its accessories.

7.3.1 Preparation

Items should be clean and contaminant-free prior to being recycled. When recycling used disposable
electrodes, follow local clinical procedures.

7.3.2 Packaging

Packaging should be recycled in accordance with local and national requirements.

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8 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 /
Maintenance

Temperature

-5 ÷ 46°C (23 ÷ 115°F)

Humidity

5% – 95% (non-condensing)

Standby /
Storage

Temperature

-20 ÷ 50°C (-4 ÷ 122°F)

Humidity

5% – 95% (non-condensing)

Shock / Drop Abuse Tolerance

Meets IEC60601-1 clause 21

Sealing

IEC 60529 class IP54; Splash Proof,
Dust Protected (Battery pack
installed)

ESD

Meets EN 61000-4-2:2001

EMC (Emission)

EN 60601-1-2:2001+A1:2006,
method EN 55011:1998 Group 1
Level B

EMC (Immunity)

EN 60601-1-2:2001+A1:2006,
method EN 61000-4-3:1998 Level 3

8.1.3 Defibrillator

Category

Specification

Waveform

Biphasic Truncated Exponential

Energy

200 J nominal delivered into a 50 ohm
load

Charge control

Automatic by Patient Analysis System

Charge time from shock-advised

Typically <8 seconds with a fresh
battery pack. Charge time may
increase with used battery pack and for
temperatures below 10°C.

Charge complete indication

• SHOCK button lit red.

• “Press Shock button” voice prompt

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Shock delivery

Shock is delivered by a single SHOCK
button

Disarm

Automatic

If Patient Analysis System decides
rhythm is no longer shockable, or
within 15 seconds after Charge
complete, if operator has not pressed
SHOCK button.

Manual

button at any time to disarm and turn
off the device.

8.1.4 Waveform Specifications

The RESCUE SAM delivers a nominal 200J Biphasic Truncated Exponential waveform to patients with
impedances ranging from 25 to 175 ohms.

The waveform is adjusted to compensate for measured patient impedance. Nominal phase times and
energy delivered are shown in the tables below.

Patient

Impedance

(Ohms)

Phase A,

Duration (msec)

Phase B,

Duration (msec)

Energy Delivered

(Joules)

25 6 6

200J+/-10%

50 8 6

200J+/-10%

75 8 8

200J+/-10%

100

10

8

200J+/-10%

125

10

10

200J+/-10%

150

12

10

200J+/-12%

175

12

10

200J+/-12%

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.

The ECG signal are then processed by the ECG signal analysis routines. The arrhythmia detection process
determines whether or not to advise shocking the patient by examining the outputs of these analyses.

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8.1.5.1 Patient Analysis System Performance

Rhythm Class

Sample
Size

Performance

Specifications

Shockable Rhythm –
Ventricular Fibrillation

220

>97%

Meets the IEC60601-2-4:2004
Sensitivity > 90%

Shockable Rhythm –
Ventricular Tachycardia

165

>95%

Meets the IEC60601-2-4:2004
Sensitivity > 75%

Non-Shockable Rhythm
– Normal Sinus Rhythm

130

99%

Meets the IEC60601-2-4:2004
Specificity >95%

Non-Shockable Rhythm
– Asystole

148

100%

Meets the IEC60601-2-4:2004
Specificity > 95%

Non-Shockable Rhythm
– All other non­shockable rhythms

219

>98%

Meets the IEC60601-2-4:2004
Specificity > 95%

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

Emissions Test

Compliance

Electromagnetic
environement guidance

RF Emissions

CISPR 11

Group 1

Class B

The RESCUE SAM uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

The RESCUE SAM is suitable for use in all
establishments including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

not applicable

Voltage fluctuations

IEC 61000-3-3

not applicable

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Electromagnetic immunity

Immunity test

IEC 60601 test
level

Compliance
level

Electromagnetic environment ­guidance

Electrostatic
discharge (ESD)
IEC 60601-4-2

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

No other ESD requirements are
necessary.

Electrical fast
transient/burst
IEC 61000-4-4

±2 kV for power line supply lines
±1 kV for input/output lines

Not applicable
Surge
IEC 61000-4-5

±1 kV line(s) to line(s)
±2 kV line(s) to earth

Not applicable

Immunity test

IEC 60601
test level

Compliance
level

Electromagnetic environment ­guidance

Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11

Not applicable

Not applicable

Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should
not be greater than levels characteristic
of a typical location in a commercial or
hospital environment.

Radiated RF
IEC 61000-4-3

10 V/m
80 MHz to 2.5
GHz

10 V/m

Portable and mobile RF
communications equipment should be
used no closer to any part of the
RESCUE SAM , including cables, than
necessary. The recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter is shown in the
following table.
Interference may occur in the vicinity
of equipment marked with the following
symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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.

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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.

Recommended separation distances between portable and mobile RF communications

equipment and the RESCUE SAM

Separation distance according to frequency of transmitter (m)

Rated

maximum

output

power of

transmitter

(W)

150 kHz to

80 MHz

outside ISM

bands

d = 1.16√P

150 kHz to

80 MHz

inside ISM

bands

d = 1.2√P

80 MHz to

800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

0.01

0.01

0.12

0.12

0.23

0.1

0.1

0.37

0.38

0.73

1 1 1.17

1.20

2.30

10

10

3.69

3.79

7.27

100

100

11.67

12.00

23.00

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note 1: As 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz
to 6,795 MHz; 13,553 MHz to 13,567; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

8.2 Battery pack

Category

Specification

Model number

ELRS-002

Battery type

12VDC, 4200 mAh, Lithium/Manganese Dioxide.
Disposable, recyclable, non-rechargeable.

Capacity

A new battery typically will provide 200 shocks or 4 hours
of operating time at 25°C.

Shelf-life (prior to installation)

Typically 5 years

Standby-life (after installation)

Typically 4 year

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Battery label:

RESCUE SAM BATTERY ELRS-002
06/2014 S062010

12VDC, 4.2Ah

8.3 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

Adhesion

Self-adhesive

Active gel surface area

105 cm2 each (nominal)

Cable/connector type

Integrated

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RESCUE SAM User Manual vers.2.5 Feb. 2021

9 Glossary of Symbols

RESCUE SAM Defibrillator

Symbol

Description

Power ON/OFF button

Info button

Status Led

SHOCK button

BF type, defibrillation proof equipment

Attention: Refer to the User Manual.
Instructions in the User Manual.

0068

CE Marking

Serial Number

Battery

Symbol

Description

Lot Number

Expiration date
Do not mutilate or open the battery

Do not expose the battery to high heat or open flames.

Do not incinerate the battery.

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Do not crush the battery.

Lithium Manganese Dioxide battery.

Follow local regulations on battery disposal or recycling.

Attention: Refer to user manual.
CE marking

10 Contacts

PROGETTI S.r.l.

Strada del Rondello, 5
10028 TROFARELLO (TO)
ITALY

Phone: [phone]
FAX: [phone]
HOME PAGE: www.progettimedical.com

Department :
GENERAL INFO : [e-mail]
SALES DEPARTMENT : [e-mail]
EXPORT DEPARTMENT : [e-mail]
SERVICE DEPARTMENT : [e-mail]
SHIPMENT : [e-mail]

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11 Warranty Information

ORIGINAL END USER’S LIMITED WARRANTY

COVERAGE
Progetti Srl, provides a limited warranty that the defibrillator and its associated accessories ( batteries
and pads), whether purchased concurrently with the defibrillator as part of a configuration or separately,
shall be substantially free from defects in material and workmanship. Progetti Srl’s limited warranty shall
only extend to the original end user, where the original end user purchased the items from an authorized
Progetti Srl, retailer. This limited warranty may not be assigned or transferred. The terms of the Limited
Warranty in effect as of the date of original purchase shall apply to any warranty claims.

Length of Warranty
The defibrillator’s limited warranty is for a period of five (5) years from the date of purchase. The
battery’s limited warranty is for a period of four (4) years from the date of purchase, but in no event shall
the limited warranty period extend past the date printed on the battery. Single use accessories
(disposable pads) shall have a limited warranty up to use or for a period up to the expiration date,
whichever is earlier. The limited warranty for all other accessories is for a period of one (1) year from
the date of purchase, or to the expiration date, whichever is earlier.

Limited Warranty Limitations
This limited warranty does not cover damage of any sort resulting from, but not limited to, accidents,
improper storage, improper operation, alterations, unauthorized service, tampering, abuse, neglect, fire,
flood, war. Additionally, this limited warranty does not cover damage of any sort to the defibrillator or its
associated accessories resulting from the use of the defibrillator with unapproved accessories or use of
the accessories with unapproved medical devices. The defibrillator and its associated accessories are not
warranted to be compatible with any other medical device.

Limited Warranty Voided

The limited warranty is immediately voided if: the defibrillator or its associated accessories are serviced
or repaired by any entity, including persons, not authorized by Progetti Srl, ; specified maintenance is
not performed; the defibrillator is used with one, or more, unauthorized accessories; the associated
accessories are used with an unauthorized defibrillator; or the defibrillator or associated accessories are
not used in accordance with Progetti Srl, approved instructions.

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. Determination of a similar item shall be at the sole discretion of
Progetti Srl. In the case of replacement, the replacement at a minimum shall reflect the prorated time
remaining for the item based on the remaining limited warranty period. In no event, shall the limited
warranty period of a replacement item extend past the limited warranty period of the item it is replacing.

Warranty Service

Only PROGETTI S.r.l. or its authorized representatives should service the device. If unauthorized
personnel service the device during the warranty period, the warranty will become null and void.

When the device is not functioning properly, it has to be submitted for maintenance immediately.

When any abnormalities are found in the device or when a danger to bodily harm exists, the device has
to be repaired fast and adequately by authorized personnel.

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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
representative, customer information

Main service center:

Obligations and Warranty Limits

THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES, TO
THE DEGREE PERMITTED BY APPLICABLE STATE LAW, ALL OTHER EXPRESS OR IMPLIED WARRANTIES,
INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
A PARTICULAR PURPOSE.
NO PERSON (INCLUDING ANY AGENT, DEALER, OR REPRESENTATIVE OF PROGETTI SRL, ) IS
AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANTY CONCERNING THE DEFIBRILLATOR OR
ITS ASSOCIATED ACCESSORIES, EXCEPT TO REFER TO THIS LIMITED WARRANTY.
THE EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY
CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE. PROGETTI SRL, SHALL IN NO EVENT BE LIABLE
FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO,
EXEMPLARY DAMAGES, SPECIAL, PUNITIVE, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS
INTERRUPTION OF ANY NATURE, LOSS OF PROFITS OR PERSONAL INJURY, EVEN IF PROGETTI SRL,
HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES, HOWEVER OCCASIONED, WHETHER BY
NEGLIGENCE OR OTHERWISE, UNLESS APPLICABLE STATE LAW DOES NOT ALLOW SUCH EXCLUSION OR
LIMITATION.

PROGETTI S.r.l

Strada del Rondello, 5

10028 TROFARELLO (TO)

Phone:[phone]

Fax: + 39- 011- 645822

Email: [e-mail]

Web site: www.progettimedical.com

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RESCUE SAM User Manual vers.2.5 Feb. 2021

WARRANTY CERTIFICATE

This device is warranted against defects in materials and workmanship.

The warranty does not apply if the product has not been properly used as suggested in the user manual,
has been damaged by accident or misuse, has been damaged as the result of service or modification by
an entity other than 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:____________________________________________________

____________________________________________________

___________________________________________________

DEVICE: AED Defibrillator

Model: RESCUE SAM SN _____________________

VALIDITY starting from : _____/_____/__________

Delivery date:_________ Invoice N°_____________________ dated__________________

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RESCUE SAM User Manual vers.2.5 Feb. 2021

Declaration of EU conformity