Gima RESCUE LIFE 7 AED DEFIBRILLATOR User guide

Rescue LIFE

EXTERNAL BIPHASIC

DEFIBRILLATOR and MONITOR

USER MANUAL

ELPRO S.r.l.

Strada del Rondello, 5
10028 Trofarello (TO)
ITALY

Rev. 3.1

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TABLE OF CONTENTS

GENERAL AND SAFETY INFORMATION ................................................................... 1

SAFETY INSTRUCTIONS ........................................................................................................................ 2

RESPONSIBILITY FOR INFORMATION .................................................................................................... 2

GENERAL ............................................................................................................................................ 2

CAUTIONS .......................................................................................................................................... 3

SHOCK OR FIRE HAZARDS .................................................................................................................... 4

POSSIBLE ELECTRICAL INTERFERENCE .................................................................................................. 4

POSSIBLE IMPROPER DEVICE PERFORMANCE ....................................................................................... 5

POSSIBLE DEVICE SHUTDOWN OR NOT SWITCHING ON ........................................................................ 5

ELECTRICAL SAFETY GUIDELINES .......................................................................................................... 5

SYMBOLS USED ................................................................................................................................... 6

INTRODUCTION .......................................................................................................................... 8

UNPACKING AND INSPECTING ............................................................................................................. 8

DEVICE OPERATION AND STORAGE GUIDELINES ................................................................................... 8

.......................................................................................................................................................... 8

CLEANING AND MAINTENANCE ........................................................................................................... 9

CONNECTING TO POWER .................................................................................................................. 10

BATTERY CHARGE.............................................................................................................................. 11

WARRANTY ...................................................................................................................................... 12

SERVICE ............................................................................................................................................ 13

OPERATIONAL .......................................................................................................................... 14

PRODUCT DESCRIPTION .................................................................................................................... 14

INTENDED USE (patients group and medical conditions) .................................................................... 15

INDICATIONS .................................................................................................................................... 16

CONTRAINDICATIONS ....................................................................................................................... 16

FRONT PANEL DESCRIPTION .............................................................................................................. 17

FRONT PANEL KEYS ........................................................................................................................... 17

FUNCTION KEYS (F1-F5) ..................................................................................................................... 18

LIGHT INDICATORS ............................................................................................................................ 19

CONNECTIONS .................................................................................................................................. 19

START SCREEN INTERFACE ................................................................................................................. 21

OPERATIONAL SCREEN ...................................................................................................................... 22

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OPERATIONAL SCREEN FEATURES ...................................................................................................... 23

SET-UP MENU ................................................................................................................................... 24

DEVICE AND PATIENT PREPARATION ......................................................................................... 26

Product Check................................................................................................................................... 26

How to test the defibrillator .............................................................................................................. 26

HOW TO USE THE ECG PATIENT CABLE CONNECTION AND ELECTRODES PLACEMENT ........................... 27

ECG CONNECTION ............................................................................................................................. 27

DEFIBRILLATION THERAPY ........................................................................................................ 29

GENERAL INFORMATION FOR PROFESSIONAL USER ........................................................................... 29

HOW TO PREPARE THE PATIENT ......................................................................................................... 31

How to prepare the pediatric patient ................................................................................................ 32

DEFIBRILLATION MODE ............................................................................................................. 33

DEFIBRILLATOR PROCEDURE IN MANUAL MODE ................................................................................ 34

DEFIBRILLATOR PROCEDURE IN ADVISORY MODE (ADV) .................................................................... 35

AUTOMATED EXTERNAL DEFIBRILLATION (AED) ........................................................................ 36

INDICATIONS FOR USE ....................................................................................................................... 36

ECG ANALYSIS ALGORITHM ............................................................................................................... 37

CPR PROTOCOL ................................................................................................................................. 37

SELECTING THE AED OPERATION MODE ............................................................................................. 38

DEFIBRILLATOR PROCEDURE IN SEMIAUTOMATIC MODE (AED) .......................................................... 38

SEMIAUTOMATIC (AED) MODE FLOW CHART ..................................................................................... 40

AUDIO AND TEXT PROMPTS .............................................................................................................. 41

PACEMAKER (OPTIONAL) .......................................................................................................... 42

PACEMAKER SCREEN ......................................................................................................................... 43

HOW TO PREPARE THE PATIENT ......................................................................................................... 44

PACING PROCEDURE .............................................................................................................. 44

SpO2 MONITORING ................................................................................................................... 45

PULSE OXIMETRY SENSORS ............................................................................................................... 46

SETTING THE ALARM ......................................................................................................................... 46

NIBP (NON-INVASIVE BLOOD PRESSURE) ......................................................... 47

INTRODUCTION ............................................................................................................... 47

Operational Overview ....................................................................................................................... 47

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TERMINOLOGY FOR NIBP .................................................................................................... 48

Warnings & Precautions DURING THE NIBP MESURAMENT ................................................................ 49

Cuff Selection & Placement ............................................................................................................... 51

Activation and operation of the NIBP mode ....................................................................................... 52

Nibp set-up menu ............................................................................................................................. 53

Operation sequence .......................................................................................................................... 54

Appendix 1 ................................................................................................................................. 55

Appendix 2 ................................................................................................................................. 57

Appendix 3 ................................................................................................................................. 57

DATA BASE ......................................................................................................................... 59

DESCRIPTION .................................................................................................................................... 59

RECORDING ...................................................................................................................................... 60

DATA BASE SCREEN ................................................................................................................ 60

DATA RETRIEVAL ............................................................................................................................... 61

DATE AND TIME SETUP ............................................................................................................. 62

PRINTING AND PAPER CHANGE ................................................................................................ 62

AUTO TEST ............................................................................................................................... 63

RESCUE LIFE CHECKLIST............................................................................................. 65

APPENDIX A ............................................................................................................................. 66

CLINICAL INFORMATION ................................................................................................................... 66

How does biphasic waveform defibrillate?......................................................................................... 66

Ease in compensation of patient impedance ...................................................................................... 68

More efficient than monophasic waveform ....................................................................................... 68

Enough Energy for restoring heart rhythm ......................................................................................... 70

REFERENCES ..................................................................................................................................... 72

APPENDIX B ............................................................................................................................. 73

ACCESSORIES AND MODULES ............................................................................................................ 73

APPENDIX C ............................................................................................................................. 74

TECHNICAL SPECIFICATIONS .............................................................................................................. 74

IMPENDANCE LIMITS ........................................................................................................................ 75

SYNC/NO SYNC MODE ....................................................................................................................... 75

CHARGING TIME TO ACHIEVE THE MAXIMUM ENERGY (230 JOULE) ................................................... 75

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APPENDIX D ............................................................................................................................. 76

TECHNICAL FEATURES ....................................................................................................................... 76

APPENDIX E – INSTRUCTION FOR USE FOR DISPOSABLE MULTIFUNCTION ELECTRODES FOR

DEFIBRILLATOR ......................................................................................................................... 81

OPERATING INSTRUCTION ........................................................................................................ 83

DECLARATION OF EC CONFORMITY ........................................................................................... 88

APPENDIX E .............................................................................................................................. 89

WARRANTY CERTIFICATE ................................................................................................................... 89

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GENERAL AND SAFETY INFORMATION

Thank you for choosing the RESCUE LIFE.

The RESCUE LIFE monitor/defibrillator is a complete acute cardiac care response system

designed for basic life support (BLS) and advanced life support (ALS) patient

management protocols.

RESCUE LIFE is designed to monitor the patient ECG signals and to deliver defibrillation

shocks in MANUAL, ADVISORY or AED mode. This Operator’s Manual contains all the

information that a user needs to operate the RESCUE LIFE properly.

ELPRO S.r.l. reserves the right to make changes on the device specifications contained

in this manual at any time without prior notice or obligation to customer.

If you have any problems regarding the operation of the device, please do not hesitate

to contact the manufacturer.

These operating instructions include information and procedures related to all features

and options of the RESCUE LIFE monitor / defibrillator.

Your RESCUE LIFE monitor/defibrillator may not have all of these features or optional.

Please read this Operator’s Manual carefully and thoroughly before using the RESCUE

LIFE. This Manual contains instructions on how to operate and maintain the RESCUE

LIFE.

It is very important that you fully understand all the necessary instructions discussed

in this manual so as to act quickly in an emergency.

ELPRO S.r.l. designs and manufactures all of its products in accordance with

international standards (93/42/EEC) and subsequent amendments. This ensures that

ELPRO S.r.l. provides products of high quality and reliability.

In this regard:

ONLY PERSONS AUTHORIZED BY ELPRO S.R.L. SHOULD DO THE SERVICING OF THE DEVICE.
THERE ARE NO USER SERVICEABLE PARTS IN THIS 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

ELPRO S.R.L.

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SAFETY INSTRUCTIONS

The following conditions are used either in this User Manual or on the RESCUE LIFE

defibrillator/monitor:

DANGER IMMEDIATE HAZARDS THAT WILL RESULT IN SERIOUS PERSONAL INJURY OR DEATH.
WARNING HAZARDS OR UNSAFE PRACTICES THAT MAY RESULT IN SERIOUS PERSONAL INJURY OR

DEATH.

CAUTION HAZARDS OR UNSAFE PRACTICES THAT MAY RESULT IN MINOR PERSONAL INJURY, PRODUCT

DAMAGE, OR PROPERTY DAMAGE.

RESPONSIBILITY FOR INFORMATION

It is the obligation of our customers to ensure that the appropriate person(s) within

their organization have access to this information, including general safety information

which are given in this manual.

GENERAL

Assure yourself prior and after the use of the RESCUE LIFE that the unit is in safe and

usable condition (cables integrity, pads, battery status).

Assure that the battery charge, ECG trace, selected energy value, SYNC mode and

status battery are well functioning.

RESCUE LIFE is not intended for use in areas of highly inflammable anesthetics or other

inflammable substances, especially in high concentration of oxygen areas.

RESCUE LIFE does not have to be put or used nearby a nuclear spin tomography plant,

which is turned on.

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CAUTIONS

• MANUAL MODE DEFIBRILLATION MUST BE PERFORMED ONLY BY HIGHLY TRAINED MEDICAL PERSONNEL.

• NEVER PUT IN CONTACT THE SHOCK PADDLES (SHORT CIRCUIT).

• BE SURE THAT BOTH SURFACES OF THE SHOCK PADDLES ARE COMPLETELY MOISTENED WITH GEL.

• THE SHOCK PADDLES MUST BE HELD AT DISTANCE FROM OTHER ELECTRODES AND ANY METAL PARTS IN

CONTACT WITH THE PATIENT. THIS CONTACT CAN CAUSE ELECTRICAL ARCING AND PATIENT SKIN BURNS
DURING DEFIBRILLATION AND MAY DIVERT DEFIBRILLATING ENERGY AWAY FROM THE HEART MUSCLE

• THE SHOCK PADDLES INCLUDING HANDLES SHOULD ALWAYS BE CLEANED THOROUGHLY AFTER USE.

• IN ORDER TO PREVENT ACCIDENTALLY CREATING CURRENT PATH FOR THE DEFIBRILLATION IMPULSE, THE

PARTS OF THE PATIENT BODY, SUCH AS THE HEAD OR LIMBS MUST NOT BE IN TOUCH WITH METAL PARTS,
BED FRAMES OR STRETCHERS. THE PATIENT MUST NOT BE TOUCHED DURING DEFIBRILLATION.

• DURING DEFIBRILLATION WITH CONNECTED ECG CABLE ENSURE THAT ALL BINDING CLIPS ARE

CONNECTED WITH THE PATIENT.

• WHEN DEFIBRILLATING CHILDREN (UNDER THE AGE OF 8 YEARS AND WEIGHING LESS THAN 25 KG) DO

NOT EXCEED 4J/KG AND DO NOT USE THE ADVISORY OR AED MODE.

• DISCONNECT FROM THE PATIENT EVERY DEVICE THAT IS NOT EQUIPPED WITH APPLICATED PART

PROTECTED BY DEFIBRILLATION.

• THE PATIENT CABLE PROVIDED BY ELPRO S.R.L. IS DEFIBRILLATION PROTECTED AND IT CAN BE

CONNECTED.

• DO NOT REUSE DISPOSABLE DEFIBRILLATION PADS. CHECK THAT THE CASE IS IN GOOD CONDITION

AND THAT THE DISPOSABLE PADS HAVE NOT YET REACHED THEIR EXPIRATION DATE.

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SHOCK OR FIRE HAZARDS

The defibrillator delivers up to 230 joules of electrical energy.

Unless properly used as described in these operating instructions, this electrical energy

may cause serious injury or death.

Do not attempt to operate this device unless thoroughly familiar with these operating

instructions and the function of all controls, indicators, connectors, and accessories.

Do not disassemble the defibrillator. It contains no operator serviceable components

and dangerous high voltages may be present. Contact authorized service personnel for

repair.

DO NOT IMMERSE ANY PORTION OF THIS DEFIBRILLATOR IN WATER OR OTHER FLUIDS. AVOID SPILLING

ANY FLUIDS ON DEFIBRILLATOR OR ACCESSORIES. SPILLED LIQUIDS MAY CAUSE THE DEFIBRILLATOR AND
ACCESSORIES TO PERFORM INACCURATELY OR FAIL.

DO NOT CLEAN WITH KETONES OR OTHER FLAMMABLE AGENTS.
DO NOT AUTOCLAVE OR STERILIZE THIS DEFIBRILLATOR OR ACCESSORIES UNLESS OTHERWISE

SPECIFIED.

USE CARE WHEN OPERATING THIS DEVICE CLOSE TO OXYGEN SOURCES (SUCH AS BAG-VALVE-MASK

DEVICES OR VENTILATOR TUBING). TURN OFF GAS SOURCE OR MOVE SOURCE AWAY FROM PATIENT
DURING DEFIBRILLATION.

POSSIBLE ELECTRICAL INTERFERENCE

Using cables, electrodes, or accessories not specified for use with this defibrillator may

result in increased emissions or immunity from electromagnetic or radio frequency

interference (RFI) which could affect the performance of this defibrillator or of

equipment in close proximity. Use only parts and accessories specified in these

operating instructions. This defibrillator may cause electromagnetic interference (EMI)

especially during charge and energy transfers. EMI may affect the performance of

equipment operating in close proximity.

Verify the effects of defibrillator discharge on other equipment prior to using the

defibrillator in an emergency, if possible.

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POSSIBLE IMPROPER DEVICE PERFORMANCE

Using other manufacturers’ cables, electrodes, or batteries may cause the device to

perform improperly and may invalidate the safety agency certifications. Use only the

accessories that are specified in these operating instructions.

POSSIBLE DEVICE SHUTDOWN OR NOT SWITCHING ON

Always check that the battery is fully charged.

WHEN OPERATING ON BATTERY POWER, THE LARGE CURRENT DRAW REQUIRED FOR DEFIBRILLATOR

CHANGING MAY CAUSE THE DEFIBRILLATOR TO REACH SHUTDOWN VOLTAGE LEVELS WITH NO LOW BATTERY
WARNING. IF THE DEFIBRILLATOR SHUTS DOWN WITHOUT WARNING, OR IF A BATTERY LOW MESSAGE
APPEARS ON THE MONITOR SCREEN, THE OPERATOR HAS TO CONNECT IMMEDIATELY THE AC POWER CORD
TO AN OUTLET.

ELECTRICAL SAFETY GUIDELINES

Use only the original power cord during recharging. The right value for the AC power

supply is: 100V to 240V, 50 / 60 Hz AC.

During recharging, do not place the device where the environmental conditions exceed
the storage conditions specified.

DURING OPERATION, THE DEVICE SHOULD BE PLACED AWAY FROM SOURCES OF

ELECTROMAGNETIC INTERFERENCE SUCH AS MOTORS, GENERATORS, X-RAY EQUIPMENT, RADIO
TRANSMITTERS, CELLULAR MOBILE TELEPHONES AND OTHERS, AS THESE MIGHT INTERFERE WITH
THE SIGNALS BEING ACQUIRED.

The RESCUE LIFE is classified as follows:

Class II equipment, applied parts BF for pads, SpO2 and NIBP connector and CF for

ECG cable (EN 60601-1).

The Electromagnetic compatibility level is Class A group 1 according to the EN 60601-

1-2 (Electromagnetic Compatibility Requirements).

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SYMBOLS USED

The symbols below may be found in this manual or in rear sticker or accessories of

Rescue LIFE defibrillator.

Symbol

Description of symbol

Identification of device

Serial Number of device

Manufacturer identification

Date of production

Defibrillation-proof BF type

Defibrillation-proof CF type

Alternated

Class II

Danger of an electrical shock

The user must to consult the instructions for use for
important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be
presented on the medical device itself.

Indicates the need for the user to consult the instructions
for use.

Do not use AED mode on NEWBORN

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Follow local regulations on battery disposal or recycling
CE Mark & Notified Body identification

Fragile content, handle with care (on the package)

To keep dry and to not exposure to weathering (on the
package)

To keep up (on the package)

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INTRODUCTION

UNPACKING AND INSPECTING

Be sure that you have all the required supplies and accessories including cables and

ECG paper, when you remove the RESCUE LIFE defibrillator/monitor from the container

used for the shipment. Verify the defibrillator and all accessories for any sign of damage

that may have occurred during shipping. If possible, save the shipping container and

foam inserts in case you must ship the defibrillator in the future.

DEVICE OPERATION AND STORAGE GUIDELINES

Do not operate or store the device in conditions that are beyond the following specified
limits.

• Operating Conditions

Temperature -5 °C to 46 °C
Humidity 10 % to 95 % (non-condensing)

• Storage Conditions (without disposable defibrillation electrodes)

Temperature -20 °C to 50 °C
Humidity 10 % to 95 % (non-condensing)

• Storage Conditions (with disposable defibrillation electrodes)

Temperature 5 °C to 35 °C
Humidity 20 % to 80 % (non-condensing)

DO NOT STORE THE DEVICE IN AREAS WITH HIGHLY FLUCTUATING TEMPERATURES

DO NOT OPERATE OR STORE THE DEVICE IN ENVIRONMENTS WITH HIGH

CONCENTRATION OF FLAMMABLE GAS OR ANESTHETICS.

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CLEANING AND MAINTENANCE

After each use, clean the defibrillator and the reusable pads using a soft, damp cloth

moistened with any of the following solvents:

• Water and soap.

• Clorexina and water mixture (30 ml clorexina/liter of water).

• Ammonia.

• Hydrogen peroxide.

If necessary, sterilize just the defibrillation pad part touching the patient skin only

with liquid CIDEX.

DO NOT IMMERSE ANY PART OF THE DEFIBRILLATOR IN FLUIDS.
DO NOT LET ANY FLUID ENTER THE CASE OF THE DEVICE DO NOT USE ABRASIVE MATERIALS IN CLEANING

THE UNIT, ESPECIALLY ON THE LCD DISPLAY.

DO NOT STERILIZE THE DEVICE.
DO NOT REUSE THE DISPOSABLE PADS.

POSSIBLE EQUIPMENT DAMAGE.
DO NOT CLEAN ANY PART OF THIS DEVICE OR ACCESSORIES WITH BLEACH, BLEACH DILUTION, OR

PHENOLIC COMPOUNDS. DO NOT USE ABRASIVE OR FLAMMABLE CLEANING AGENTS. DO NOT ATTEMPT TO
STERILIZE THIS DEVICE OR ANY ACCESSORIES UNLESS OTHERWISE SPECIFIED IN ACCESSORY OPERATING

INSTRUCTIONS.

The operator has to do daily maintenance checks that will help ensure that the device

stays in perfect operational condition.

Check the case of the device for any apparent damage.

Check the ports (defibrillator lead port, patient cable port, AC plug and cable, paddles).

Check the accessories, especially the defibrillation pads and cables, to see that they are

in good condition.

Check the battery status and if the level is low attach the power cord to the AC line.

The internal nickel-metal hydride battery is rechargeable and intended to be used for

standby operation. The defibrillator automatically switches to battery power when the

power cord is disconnected from an AC outlet or from the defibrillator.

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CONNECTING TO POWER

The RESCUE LIFE defibrillator/monitor operates on AC (line) power or with internal

rechargeable Lithium-Ion battery.

You can switch from battery to AC power or AC power to battery while the device is on

and in use by plugging in or unplugging the AC power cord.

AC Operation

The AC Mains LED illuminates, when the RESCUE LIFE defibrillator/monitor operates on

AC power. When the defibrillator is not in use, maintain better the battery charge

connecting the power cord to an AC outlet and turn off the defibrillator.

Battery Operation

The defibrillator automatically switches to battery power when the power cord is

disconnected from an AC outlet or from the defibrillator. The internal Lithium-Ion

battery is rechargeable and intended to be used for standby operation.

A new, completely charged battery provides approximately 150 shocks at 230 J

discharges, 250 minutes of pacing, or approximately 330 minutes of continuous

monitoring before the defibrillator turns off.

Connect instantly the power cord into an AC outlet to continue use and start recharging

the battery, when the LOW BATTERY message appears on the screen.

If low battery messages often appear, the battery may need to be replaced.

Please contact ELPRO S.r.l. or qualified service personnel for assistance.

In order to improve the monitoring performance we suggest to connect the defibrillator

to AC power after each use to recharge the battery.

Normally, new fully depleted batteries recharge for 3 hours to regain full capacity.

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BATTERY CHARGE

When the message of the battery status displays a value under 25%, batteries should

be charged. Insert the power supply cord in the RESCUE LIFE socket (located on the

back side) and connect to the AC line. The battery status led will switch on.

When the charge finished the led will switch off. To see the battery charge status switch

on the device with pads connector not attached.

When the battery value is under 10% a message appears on display: “CHARGE BATTERY

OR SYSTEM WILL SHUT OFF”. Insert the power supply cord in RESCUE LIFE socket,

otherwise system will shout down automatically in 2 minutes.

During this time defibrillation functions are disabled.

WHEN THE DEVICE IS OFF, DO NOT LEAVE THE AC CHARGER CONNECTED MORE THAN 3 HOURS. IF AFTER

THIS TIME THE CHARGING LIGHT DOES NOT GO OFF, PLEASE CONTACT THE SERVICE CENTER FOR
CHANGING THE BATTERIES.

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WARRANTY

Every device that goes out of the assembly line passes through a full reliability tests. In

case of problems, our maintenance and exchange policies are in accordance with the

relevant consumer protection laws and regulations in the particular country where the

device is sold.

The warranty period of this device is one year after the date of purchase. Other warranty

period may be agreed with the users.

When the device malfunctions during the warranty period it will be repaired free of

charge by our service centers.

When you submit the device for maintenance, please specify the details as listed below:

- Product name.

- Product serial number.

- Date of purchase.

- Name of sales representative.

- Information of customer and a brief description of the problems encountered.

All of the service works for the product must be undertaken only by the producer or its

authorized agents.

If unauthorized personnel render repairing service during the warranty period, this

warranty becomes null and void.

ELPRO S.r.l. has no information regarding the performance or effectiveness of its

RESCUE LIFE defibrillators if they are used with defibrillation electrodes or other parts

and supplies from other sources. Using defibrillation electrodes, adapter devices, or

other parts and accessories from other sources than ELPRO S.r.l. is not recommended.

If device failure is attributable to defibrillation electrodes or other parts or supplies not

manufactured by ELPRO S.r.l., this may void the warranty.

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SERVICE

We remind that only ELPRO 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.

Regularly maintenance and testing of the RESCUE LIFE defibrillator/monitor and

accessories will help to detect and prevent possible electrical and mechanical

discrepancies.

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.

When the need for maintenance arises please contact ELPRO 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.

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OPERATIONAL

PRODUCT DESCRIPTION

RESCUE LIFE is an external defibrillator and monitor for acute cardiac care response

used by authorized healthcare providers in hospital and clinic settings.

The RESCUE LIFE defibrillator and monitor is available only with the biphasic

defibrillation waveform. The delivered energy is adjusted to the patient impedance to

obtain the best result. It is a battery powered, lightweight and portable device designed

to deliver defibrillation shocks during rescue operations.

In manual mode the user has to do the analysis of the ECG trace of the patient and set

the energy level of the shock to be delivered. The energy range is from 1 to 230 Joules.

During synchronized cardio-version, the defibrillating shock is delivered in less than 50

milliseconds of the occurrence of the ECG 'R' peak.

The RESCUE LIFE in the basic configuration has only the manual mode available and

the ECG monitoring can be done by defibrillation pads (1 trace) or by 5 wire ECG

monitoring cable assembly from ELPRO S.r.l.

The RESCUE LIFE can be supplied with (optional) 10 wire ECG cable.

Optional module: RESCUE LIFE can be ordered with ADVISORY/AED mode, Pacemaker,

SpO2 as well as NIBP. On the AED version RESCUE LIFE includes a mass storage memory

for recording the ECG trace and events.

Integrated thermal printer allows the hardcopy of the ECG traces.

The RESCUE LIFE may be equipped with disposable defibrillation pads. Through these

pads, the electrical signal from the patient’s heart is acquired. The defibrillation shock

is delivered also through the same defibrillation pads.

IN CHILDREN UNDER THE AGE OF 8 YEARS OR WEIGHING LESS THAN 25 KG DO NOT EXCEED 4 JOULE/KG.

DO NOT USE AED MODE IN NEWBORN.

IF BATTERIES ARE NOT FULLY CHARGED AFTER A 3 HOURS CHARGING PERIOD, PLEASE CONTACT THE ELPRO

S.R.L. OR ITS AUTHORIZED REPRESENTATIVES

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INTENDED USE (PATIENTS GROUP AND MEDICAL CONDITIONS)

In manual mode the RESCUE LIFE is intended for use by health care professionals and

emergency rescue personnel who have been trained in advanced cardiac life support.

The user must know how to interpret ECG's, decide the energy level required and when

the defibrillation is necessary.

RESCUE LIFE is designed for any group of patients to treat:

- Ventricular Fibrillation (VF)

- Fine Ventricular Fibrillation (FVF)

- Ventricular Tachycardia (VT) with a rate higher than 150 bpm (beats per minute)

RESCUE LIFE is designed for to be used on pediatric patients, adult patients

and on "special patients" (e.g. pregnancy women) according to the ECR Guidelines

2015 - Section 4 "Cardiac arrest in special circumstances" par. C - SPECIAL PATIENTS.

Moreover it is designed to treat, by means of Synchronous defibrillation (cardioversion),

patients with ECG's that show the presence of Atrial Fibrillation. It is designed to monitor

patient ECG by means of the multiple signal acquisition electrodes.

The pacing option is indicated for treating patients with symptomatic bradycardia.

When used in AED mode, the RESCUE LIFE is a semiautomatic defibrillator that provides

a prompted treatment protocol and ECG analysis using special analysis algorithm. This

software algorithm analyzes the patient’s electrocardiographic (ECG) rhythm and

indicates whether or not a shockable rhythm is detected.

AED mode requires operator interaction in order to defibrillate the patient.

AED MODE ON RESCUE LIFE IS RECOMMENDED FOR USE BY PERSONNEL WHO ARE AUTHORIZED BY A
PHYSICIAN OR MEDICAL DIRECTOR AND HAVE, AT A MINIMUM, THE FOLLOWING SKILLS AND TRAINING:

• CPR TRAINING

• AED TRAINING EQUIVALENT TO THAT RECOMMENDED BY THE AMERICAN HEART

ASSOCIATION (AHA) OR THE EUROPEAN RESUSCITATION COUNCIL (ERC)

• TRAINING IN THE USE OF THE RESCUE LIFE DEFIBRILLATOR IN AED MODE

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INDICATIONS

Asynchronous defibrillation – the shock delivery is not synchronized with the ECG 'R'

peak.

In asynchronous defibrillation, the RESCUE LIFE is indicated for use on patients with

the following symptoms:

• Unconsciousness

• Absence of normal breathing and

• Lack of detectable pulse.

• Rhythms need a shock.

Synchronous defibrillation – the shock delivery is synchronized with the 'R' peak of the

patient’s ECG.

In synchronous defibrillation, the RESCUE LIFE is indicated for use on patients with

ECG's that show the presence of Atrial Fibrillation.

CONTRAINDICATIONS

The RESCUE LIFE should not be used in defibrillation mode on patients that:

• Are conscious

• Are breathing normally

• Have detectable pulse.

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FRONT PANEL DESCRIPTION

FRONT PANEL KEYS

Keys on the right part are used to manage main defibrillation function.

ON/OFF

BUTTON

Power On-Off push button of RESCUE LIFE. At switch on,
if the paddles are disconnected, the battery status and
clock set-up screen will appear. In this case to start ECG
monitoring press F1 key.
To access the DATA BASE (only on the AED models) press
F2 key (MEMORY).
To switch off the RESCUE LIFE press once the ON/OFF
button. To power-off the device press the On-Off key only
once.

SPEED DIAL

Used to select energy and modify the settings on MENU
screen or in other sub-menus. When pressed, menu
screen will appear on the display.

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CHARGE
BUTTON

This key start the charge for the shock.
(This key is active only when disposable pads are used).
To start the charge with the standard pads press both
push buttons on the pads handles.

SHOCK

BUTTON

When the red light inside this key is on it means that
RESCUE LIFE is ready to defibrillate. Pressing this key will
release the defibrillation shock. (This key is active only
when disposable pads are used).

To release the shock with the standard pads press both
push buttons on the pads handles.

FUNCTION KEYS (F1-F5)

These keys are used for different functions, according to the screen where they are
used.

KEY

INITIAL

SCREEN

OPERATIONAL

SCREEN

PACEMAKER SCREEN

F1

START

OPERATION

DISARM –

Internal discharge

Select the pace maker
rhythm. To set the
requested rhythm use
the Speed dial.

F2

MEMORY

DATABASE

PRINT –

Start/stop printing

Select pace maker
current. Set the current
intensity using the
Speed Dial.

F3

AUTOTEST

PACER – Enable

Pacemaker

Set the pace maker
mode: manual or on
demand

F4

SET CLOCK

SYNC – enable

Sync or No Sync
Mode

Switch on/off the pace
maker

F5

MENU – default
parameters setup

Exit the pace maker
mode

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LIGHT INDICATORS

Indicator (LED)

CONNECTION TO

AC LINE

CASE A

CASE B

CASE A

When the LED indicator is green lighted it informs that
connection to AC line is carried.

CASE B

When the connection to AC line is removed the LED
will switch off.

Indicator (LED)

BATTERY

CHARGE

CASE A

CASE B

CASE A

When the LED indicator is blue lighted it informs that
battery are in charging (by connection to AC line)

CASE B

When the battery charge is finished the LED will
switch off.

CONNECTIONS

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DEFIBRILLATION

PADS INPUT

It connects the defibrillation pads lead (APEX,
STERNUM) to RESCUE LIFE. For connecting the
lead, push in the connector and turn it right. For
disconnecting the lead, pull the lead lever and turn
left the connector.

ECG PATIENT

CABLE

ECG patient cable input. RESCUE LIFE displays 3,
6 or 12 traces

SpO2 INPUT

(optional)

When the SpO2 sensor is connected, saturation
values and heart rate are displayed.

NIBP CONNECTOR

(optional)

When NIBP tube and cuff are connected the NIBP
function can be used.

AC POWER

SUPPLY INPUT

(back side)

RESCUE LIFE AC power supply and battery charger.
USE ONLY THE ORIGINAL AC POWER CORD!

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START SCREEN INTERFACE

The start screen will be displayed when RESCUE LIFE is switched on with the

defibrillation paddles disconnected.

Battery status and clock are shown.

Using function keys it is possible to enter in different screens.

START – F1: to enter in Operational screen

MEMORY – F2: to enter in Database screen

TEST – F3: to enter in Auto Test screen

SETCLK – F4: to set date and time

To switch off RESCUE LIFE press once On/Off button.

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OPERATIONAL SCREEN

At power ON, if the paddles are connected the RESCUE LIFE will start the operation.

If the paddles are not connected the start screen will be displayed. Press START – F1

key to enter in operational screen.

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OPERATIONAL SCREEN FEATURES

In the Operational screen are shown all vital parameter and message as well as function

button and some setting.

MESSAGGE ZONE: area where messages are shown.

ECG TRACE: area where ECG trace is shown. In menu it is possible to choose traces to

display, signal gain and speed.

BATTERY STATUS INDICATOR: battery status is shown. If charge value is under 40

% indicator is yellow and if value is under 10 % indicator is red. Connecting power cord

indicator becomes green.

When the battery value is under 10% a message appears on display. Insert the power

supply cord in RESCUE LIFE socket, otherwise system will shout down automatically in

2 minutes. During this time defibrillation functions are disabled.

DATE AND TIME: date and time are shown.

OPERATION MODE: operation mode selected is shown. It is possible to select

MANUAL, ADVISORY (ADV) and SEMIATUMATIC (AED) mode.

ALARMI ZONE: area where alarm are shown.

HEART RATE: heart rate is shown. It is possible to activate or deactivate acoustic beep

of heartbeat.

ENERGY SELECTION: energy set is shown. To set energy turn knob clockwise to

increase energy and counterclockwise to decrease energy.

CHARGE/DISCHARGE INFORMATION: when charging starts the status bar indicates

the progress of the charge.

It also indicates when discharge is done and the amount of discharge when the charge

level of the battery is under 15 %.

SYNC STATUS: it is shown if the sync mode is active or not.

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SPO2 DATA (optional): when the SpO2 sensor is connected, it indicates the oxygen

saturation and the heart rate acquired.

NIBP DATA (optional): when the NIBP cuff is connected, it indicates the non-invasive

blood pressure.

ECG DATA: it shown signal gain and speed and the operating mode (MONITOR ­DIAGNOSTIC).

Using functional keys it is possible to manage some function.

DISARM – F1: It allows to discharge the capacitor internally once it has been

charged.

PRINT – F2: it allows to start and stop printing.

PACER – F3: it allows to enter in Pacemaker screen (optional).

SYNC – F4: it allows to activate and deactivate sync mode.

MENU – F5: it allows to open menu.

SET-UP MENU

The START-UP menu is accessible pressing the F5 key (MENU) or the Speed Dial on the

operational screen and all the values can be changed using the Speed Dial.

Pressing the Speed Dial will select the field to change and rotating the Speed Dial will

change the field value.

The entered values can be stored (when the ‘SAVE SETUP’) is selected and will be used

as default values when RESCUE LIFE is switched on.

If the user needs to change the values only for the actual session then after changing

the desired values should exit the start-up menu pressing the F5 key (MENU).

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When menu screen is open the only keys to be active are F5 and Speed Dial.

SET-UP MENU FIELDS:

DEF MODE: select the function mode: manual (MANUAL), advisory (ADV) or

semiautomatic (AED).

ECG TRACE: select ECG traces that the user choose to display or print. When the patient

cable is connected, users can select which groups of traces to display. When the patient

cable is disconnected, the ECG trace is acquired by defibrillation pads (lead II).

ECG MODE: it refers to the bandwidth of the signal. In MONITOR mode bandwidth in

0,6 Hz to 40 Hz, in DIAGNOSTIC mode bandwidth is 0,05 Hz to 120 Hz. Notch filter is

always active. If the ECG trace is acquired by defibrillation pads active mode is

MONITOR.

ECG SETUP: select the speed of ECG traces (display and printer) and the ECG gain.

ALARMS: to set alarms.

HR MAX: set the maximum heart rate alarm.

HR MIN: set the minimum heart rate alarm.

SpO2 MIN: set the SpO2 minimum alarm.

SOUND: enable/disable all the alarms

HR BEEP: Enable/disable the heart rate beep.

PRINT MODE: Set the print mode automatic or manual.

NIBP SETUP: set NiBP parameters.

SAVE: Save the actual settings as default and exit the menu.

EXIT: exit the menu.

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The HR BEEP is not stored and when the machine is switched on, will be active (heart

rate beep on). For patient safety reason, it can be set to off only for the actual working

session.

DEVICE AND PATIENT PREPARATION

PRODUCT CHECK

Check carefully the content of the packing for any damage that might have been occured

during shipping.

Check carefully all the accessories to ensure that the unit comes with the complete

accessories necessary for a proper use of the device.

HOW TO TEST THE DEFIBRILLATOR

It is possible to charge without attaching the pads to the patient and discharge internally

from the standard paddles only for the defibrillator testing and only selecting 1 joule.

If the defibrillator is charged using this mode the standard impedance of 50 ohm is

assumed.

ELPRO S.r.l. recommended to make one functional check, preventive
maintenance and electrical safety test at least once a year.

WHEN THE RESCUE LIFE IS CHARGED WITH THE PADDLES NOT ATTACHED TO THE PATIENT AND THE

ENERGY IS SET TO A VALUE HIGHER THAN 150 J THE CHARGED ENERGY WILL BE LIMITED TO 150 J.

IN THIS CASE THE MESSAGE “ENERGY LIMIT” WILL BE DISPLAYED.
TO OBTAIN THE BEST SHOCK RESULT IT IS STRONGLY RECOMMENDED TO CHARGE THE ENERGY WITH THE

PADDLES ATTACHED TO THE PATIENT.

NEVER CHARGE THE DEFIBRILLATOR WITH THE PADDLES IN CONTACT BETWEEN THEM.

MAKE SURE THAT THE CONTACT GEL IS SPREAD ONLY ON THE PADDLES AND NOT ALL OVER PATIENT CHEST.
IF THIS INDICATION IS NOT FOLLOWED BURNS TO PATIENT CHEST AND DEFIBRILLATOR FAULTS MAY OCCUR.

PROVIDE AN INTERVAL OF AT LEAST 60 SECONDS BETWEEN THE CYCLE OF CHARGE / DISCHARGE
WHEN THE ELECTRODES ARE NOT CONNECTED TO THE PATIENT.

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HOW TO USE THE ECG PATIENT CABLE CONNECTION AND ELECTRODES

PLACEMENT

The ECG (electrocardiogram) is a recording of the electrical activity of the heart. The

ECG is obtained by placing either electrodes or paddles on the patient and allows the

heart’s electrical activity to be monitored and recorded. ECG monitoring allows to

identify and interpret the cardiac rhythms or dysrhythmias and calculation of heart rate.

ECG Electrode Requirements

Electrode quality is critical for obtaining an undistorted ECG signal. Always check the

date code on electrode packages for the Use By date before applying the electrodes to

a patient. Do not use electrodes with expired Use By date codes. Disposable electrodes

are intended for a single use.

For best ECG monitoring results, use silver/silver chloride (Ag/AgCl) electrodes.

Other types of electrodes will display the post-defibrillation ECG in less time than

expected.

Possible misinterpretation of ECG data.

The frequency response of the monitor screen is intended only for basic ECG rhythm

identification; it does not provide the resolution required for diagnostic and ST segment

interpretation. For diagnostic or ST segment interpretation, or to enhance internal

pacemaker pulse visibility, attach the ECG cable and then print the ECG rhythm.

ECG CONNECTION

Connect the patient cable in its proper port ‘ECG’, placed on the frontal panel of the

device.

The 5 wires and 10 wires (optional) ECG cable can be used.

Follow the drawings below for the electrodes connection.

Limb lead electrodes placement:

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Precordial lead electrodes sites for the 10 wires ECG cable:

Figure. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
derivations on frontal and orizzontal planes.

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DEFIBRILLATION THERAPY

GENERAL INFORMATION FOR PROFESSIONAL USER

Defibrillation is only one aspect of the medical care required to resuscitate a patient

with a shockable.

A direct current defibrillator applies a brief, intense pulse of electricity to the heart

muscle. The RESCUE LIFE defibrillator/monitor delivers this energy through disposable

pads, standard paddles or internal paddles applied to the patient’s chest.

Successful resuscitation is associated to the length of time between the onset of a heart

rhythm that does not circulate blood (ventricular fibrillation, pulseless ventricular

tachycardia) and defibrillation. The American Heart Association has identified the

following as critical links in the chain of survival from cardiac arrest:

Early access

Early CPR by first responders or bystanders

Early defibrillation

Early advanced life support

ECG rhythm. Depending on the situation, other supportive measures may include:

Cardiopulmonary resuscitation (CPR)

Administration of supplemental oxygen

Drug therapy

The physical state of the patient may affect the likelihood of successful defibrillation.

Thus, failure to resuscitate a patient is not a reliable indicator of defibrillator

performance. Patients will often exhibit a muscular reaction (like a jump or a twitch)

during an energy transfer. The absence of such a response is not a reliable indicator of

actual energy delivery or device performance. For further information, refer to the

booklet, Defibrillation: What You Should Know.

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Indications

Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias,

like a ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this

energy in the synchronized way is a method for treating atrial fibrillation, atrial flutter,

paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular

tachycardia.

The biphasic defibrillation waveform used in this device has only been clinically tested

on adults; it has not been tested on pediatric patients.

Contraindications

Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA)

such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

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HOW TO PREPARE THE PATIENT

Evaluate the patient condition; he must exhibit the symptoms for which the defibrillation

is indicated and these symptoms are:

Unconsciousness

Absence of normal breathing

Lack of detectable pulse.

If the patient exhibits the above symptoms, do the following:

Remove clothing from the patient’s chest. Dry the area, and clip or shave excessive

chest hair. Then apply the pads.

In the case of use of disposable plates, open the package by tearing 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. The correct placement of pads is indispensable for effective

analysis of the patient’s cardiac rhythm and subsequent shock delivery (if required).

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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HOW TO PREPARE THE PEDIATRIC PATIENT

Apply the pads as shown in the picture. In the case of use of disposable plates. Open

the package by tearing 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. Put 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.

The device must be used with the attenuated defibrillation electrodes for children, if the

patient is an infant or a child under the age of 8 years or weight less than 25kg (55

lbs). Do not delay the procedure to define the exact weight or age.

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.

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DEFIBRILLATION MODE

With RESCUE LIFE users can choose between three operating modes: manual, advisory

and semiautomatic.

In MANUAL mode users have to analyze heart rhythm and decide time and energy value

to use for the defibrillation while in other modes RESCUE LIFE automatically analyze

heart rhythm.

In ADVISORY mode (ADV) RESCUE LIFE only analyzes and suggest if patient needs

defibrillation, after that users have to choose energy value, charge defibrillator and

deliver the shock.

In SEMIAUTOMATIC mode (AED) RESCUE LIFE analyzes heart rhythm and helps

operators with visible and audible prompts. If patient needs a defibrillation RESCUE LIFE

automatically charge with energy value of 200 Joule.

Operators only should to deliver shock and perform CPR when indicated.

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DEFIBRILLATOR PROCEDURE IN MANUAL MODE

1. Switch on the device pressing the ON/OFF button. Connect and lock the paddles

plug to start the operation. The ECG signal will be displayed and by default the

energy is set to 150 J.

2. Place the paddles (set in adult or in pediatric version) on the patient chest and

analyze the ECG trace in order to decide if defibrillation is necessary.

3. Select the energy level required using the Speed Dial.

4. If you are using the standard paddles press both push buttons on the handles to

start charging.

5. If you are using disposable pads press the CHARGE button on the device panel to

start charging.

6. On the screen the charge status bar indicates that the charging procedure is on; at

the same time the ascending sound will start.

7. When the charge ends the red light on the SHOCK button will turn on indicating

that RESCUE LIFE is ready for defibrillation.

8. To release the defibrillation shock, press both push buttons on the standard

paddles. If using disposable pads press the SHOCK key in the front panel

to release the defibrillation shock.

9. The shock has to be released within 25 sec from the charge completed; after 25 sec

the RESCUE LIFE will discharge internally.

10. If the defibrillation is not required, press the DISARM (F1) key to discharge

internally.

11. If the SYNC function is on, SYNCHRONIZED CARDIOVERSION can be done.

DO NOT TOUCH THE PATIENT DURING DEFIBRILLATION.

WHEN THE MESSAGE “ATTACH PADS” IS DISPLAYED ON THE SCREEN AND THE CHARGE IS STARTED, THE

DEVICE ASSUMES A STANDARD IMPEDANCE OF 50 OHM. IF THE MESSAGE “ATTACH PADS” PERSISTS WHEN
THE SHOCK HAS TO BE DELIVERED, THE DEVICE WILL DISCHARGE INTERNALLY

THE MESSAGE “ATTACH PADS” CAN BE DISPLAYED ALSO IN PRESENCE OF A NO SUFFICIENT ELECTRIC

CONTACT BETWEEN THE PADS AND THE PATIENT SKIN; IN THIS CASE ADD CONDUCTIVE GEL AND PRESS
STRONGLY THE DEFIBRILLATION PADS ON THE PATIENT SKIN. DURING SYNC MODE, THE SHOCK WILL NOT
BE RELEASED IF THE ECG TRACE IS NOT STABLE AND THE QRS COMPLEX IS NOT VALID.

WHEN USING SYNC MODE MAKE SURE THAT THE ECG TRACE HAS A STABLE BASE LINE AND THE HEART

RATE IS STABLE. DEFIBRILLATING IN SYNC MODE WITH A DISTURBED ECG SIGNAL IS DANGEROUS
BECAUSE THE MACHINE WILL NOT BE ABLE TO IDENTIFY CORRECTLY THE ‘R’ PEAK TO SYNCHRONIZE TO.

THE MACHINE CAN DELIVER A SYNC SHOCK USING AS INPUT THE ECG CABLE OR THE PADS, BUT IT IS

RECOMMENDED TO USE THE PADS INPUT FOR THE BEST RESULT.

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DEFIBRILLATOR PROCEDURE IN ADVISORY MODE (ADV)

1. Switch on the device pressing the ON/OFF button. Connect and lock the paddles

plug to start the operation. The ECG signal will be displayed and by default the

energy is set to 150 J. To set advisory mode open menu and select advisory in DEF

MODE.

2. Place the paddles on the patient chest and let RESCUE LIFE analyze the ECG trace

in order to decide if defibrillation is necessary.

3. If RESCUE LIFE recognizes a patient needs defibrillation select the energy level

required using the Speed Dial.

4. If you are using the standard paddles press both push buttons on the handles to

start charging.

5. If you are using disposable pads press the CHARGE button on the device panel to

start charging.

6. On the screen the charge status bar indicates that the charging procedure is on; at

the same time the ascending sound will start.

7. When the charge ends the red light on the SHOCK button will turn on indicating

that RESCUE LIFE is ready for defibrillation.

8. To release the defibrillation shock, press both push buttons on the

standard paddles. If using disposable pads press the SHOCK key in the

front panel to release the defibrillation shock.

9. The shock has to be released within 25 sec from the charge completed; after 25 sec

the RESCUE LIFE will discharge internally.

10. If the defibrillation is not required, press the DISARM (F1) key to discharge

internally.

DO NOT TOUCH THE PATIENT DURING HEART RHYTHM ANALYSIS.

DO NOT TOUCH THE PATIENT DURING DEFIBRILLATION.

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AUTOMATED EXTERNAL DEFIBRILLATION (AED)

When RESCUE LIFE is set on advisory or semiautomatic mode, after applying the

defibrillation pads to the patient’s chest, it will automatically analyze the patient’s

electrocardiogram (ECG) and advises the operator if the rhythm is shockable or not.

In advisory mode the user should select the energy, charge and deliver the shock.

In the semiautomatic mode RESCUE LIFE guides the operator through the rescue

procedure using visible and audio prompts and will charge automatically at a fixed

energy of 200J when a shockable rhythm is detected. The operator should only deliver

the shock and perform CPR when indicated.

INDICATIONS FOR USE

The RESCUE LIFE with the semiautomatic option is intended to be used by personnel

who have been trained in its operation. The operator should be qualified by training in

basic life support, CPR/AED. The device is indicated for emergency treatment of victims

exhibiting the following symptoms of a sudden cardiac arrest:

un-consciousness, absence of normal breathing and lack of detectable pulse. If the

victim is breathing post-resuscitation, the RESCUE LIFE should be left attached to allow

for acquisition and detection of the ECG rhythm. If a shockable ventricular

tachyarrhythmia recurs, the device will charge automatically and advise the operator to
deliver therapy.

MAKE SURE THAT ALL ELECTRONIC DEVICES WHICH MAY DISTURB THE ECG SIGNAL MUST BE

SWITCHED OFF OR PLACED AT A SAFE DISTANCE FROM RESCUE LIFE BEFORE DEFIBRILLATION.

PLEASE MAKE SURE NOBODY TOUCHES THE PATIENT DURING THE DEFIBRILLATION.

DO NOT USE THE AED MODE IN NEWBORN.

DO NOT CREATE A SHORT CIRCUIT BETWEEN THE DEFIBRILLATION PADS.
DO NOT PLACE THE PADS TOO CLOSE BETWEEN THEM. MAKE SURE THAT THE PADS ARE NOT TOUCHING

THE ECG CABLE LEADS OR OTHER METALLIC PARTS THAT CAN CAUSE PATIENT SKIN BURNS.

ENSURE A GOOD CONNECTION BETWEEN PADS AND PATIENT SKIN TO PROVIDE AN EFFECTIVE

DEFIBRILLATION.

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ECG ANALYSIS ALGORITHM

The features available with the AED include the following:

• Ventricular Fibrillation (VF) and Fine Ventricular Fibrillation (FVF).

• Ventricular Tachycardia with a rater higher than 150 bpm (beats per minute).

• Asystole threshold less than 0.15 mV.

• Non-Committed shock, when the rhythm changes from shockable to non

shockable.

CPR PROTOCOL

The CPR protocol is consistent with the guidelines recommended by the European

Resuscitation Council (ERC)1.

1

“European Resuscitation Council (ERC) Guidelines for cardiopulmonary resuscitation

(CPR)”, European Resuscitation Council, vol. 81/2010.

Upon detecting a shockable cardiac rhythm, the RESCUE LIFE charges automatically at

a 200J energy level and advises the operator to press the SHOCK button to deliver a

shock; then advises the operator to check the patient pulse and start CPR for 120

seconds with a chest compression. If the shock is not released within 25 sec from the

indication, the defibrillator will discharge internally.

During CPR the ECG analysis is interrupted and the CPR time will be displayed (120

seconds).

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SELECTING THE AED OPERATION MODE

To enter the AED operation mode (semiautomatic) enter in menu and select

semiautomatic in DEF MODE after connecting pads.

THE AED OPERATION MODE CAN BE SET ENTERING ONLY THE DISPOSABLE PADS OR
ENTERING THE 2ND DERIVATION. THE DEFIBRILLATOR RESCUE LIFE TURN ON ALWAYS ON THE
2

ND

DERIVATION.

IF A PATIENT IS MONITORED WITH OTHER DERIVATIONS, REMEMBER TO SELECT THE 2ND
ONE THROUGH SPEED DIAL FOR CHANGING TO THE AED OPERATION MODE. USING THE
DISPOSABLE PADS, PLEASE SELECT THE PADS DERIVATION.

At switch on the defibrillator, by default, is set to the MANUAL mode.

DEFIBRILLATOR PROCEDURE IN SEMIAUTOMATIC MODE (AED)

1. Switch on the device pressing the ON/OFF button. Connect and lock the disposable

pads plug to start the operation.

2. Place the disposable pads on the patient chest then open menu and select AED in

DEF MODE. When RESCUE LIFE recognizes pads are connected hearth rhythm

analysis starts. At the same time “REC” message will appear on the display, below

status battery indicator. It means that device will record for 1 minute the ECG trace

on the USB FLASH STORAGE.

3. If RESCUE LIFE recognizes a shockable rhythm it automatically will charge energy to

a value of 200 Joule. On the screen the charge status bar indicates that the charging

procedure is on; at the same time the ascending sound will start.

4. When the charge ends the red light on the SHOCK button will turn on indicating

that RESCUE LIFE is ready for defibrillation. At the same time an audio alert will

notify that RESCUE LIFE is ready to deliver the shock.

5. To release the defibrillation shock, press the SHOCK key in the front panel.

The shock has to be released within 25 sec from the charge completed; after 25

sec the RESCUE LIFE will discharge internally.

6. If the defibrillation is not required, press the DISARM (F1) key to discharge

internally.

7. When discharge has been delivered CPR phase starts. During this phase RESCUE

LIFE guides operator by enunciating the time of 120 s.

8. At the end of CPR RESCUE LIFE analyzes heart rhythm again. If it recognizes a

shockable rhythm it automatically will charge energy to a value of 200 Joule (point

3 of this paragraph) otherwise CPR phase starts again.

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DO NOT TOUCH THE PATIENT DURING HEART RHYTHM ANALYSIS.

DO NOT TOUCH THE PATIENT DURING DEFIBRILLATION.

TURNING OFF THE DEFIBRILLATOR BEFORE RECORDING IS FINISHED IT WILL PRODUCE LOSS
OF DATA IN THE MEMORY.

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SEMIAUTOMATIC (AED) MODE FLOW CHART

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AUDIO AND TEXT PROMPTS

PROMPTS

MEANING

CONNECT PADS

Indicates that you have to connect the pads to the
defibrillator.

ATTACH PADS

Indicates that the user have to attach the defibrillator
electrode pads to the bare chest of the patient

ANALYZING
HEART RHYTHM

Indicates that the device is doing an analysis of the
patient’s ECG

SHOCK ADVISED

Indicates that the patient has a shockable ECG rhythm.

PRESS THE RED
BUTTON NOW

Indicates that the user have to press the SHOCK button
for the delivery of a defibrillation shock. At this time, the
SHOCK button light is on (red).

SHOCK
DELIVERED

Indicates on the display that the device has delivered a
defibrillation shock.

NO SHOCK
ADVISED

Indicates that the patient has a non-shockable ECG
rhythm.

BEGIN CPR NOW

The user should perform CPR for 120 seconds.

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PACEMAKER (OPTIONAL)

ABOUT NON INVASIVE PACEMAKER

A non-invasive pacemaker is a device that delivers an electrical stimulus to the heart,

causing cardiac depolarization and myocardial contraction. The energy is delivered

through large adhesive disposable electrodes placed on the chest. In addition to

noninvasive pacing, other supportive measures may be necessary.

Among other factors, it is recognized that successful pacing of a patient depends to the

length of time between the onset of a dysrhythmia and the initiation of pacing. Rapid

pacing and prompt follow-up care are essential. The physiologic state of the patient may

affect the probability of successful pacing or of skeletal muscle activity. The failure to

successfully pace a patient is not a reliable indicator of pacemaker performance. In the

same way, the patient’s muscular response to pacing is not a reliable indicator of energy

delivered.

Indications

Non-invasive pacing is indicated for symptomatic bradycardia in patients with a pulse.

Contraindications

Non-invasive pacing is contraindicated for the treatment of ventricular fibrillation and

asystole.

On the operational screen, pressing the F3 key (PACER) the RESCUE LIFE will open the

pacemaker mode and will display the pacemaker menu.

IF THE PADDLES ARE NOT ATTACHED TO THE PATIENT THE MACHINE WILL NOT ENTER THE
PACEMAKER MODE.
THE ECG TRACE WILL BE DISPLAYED AND THE DEMAND MODE IS AVAILABLE ONLY IF THE PATIENT
CABLE IS CONNECTED (THE PADDLES ARE USED FOR PACING SO THEY CANNOT ACQUIRE THE
ECG TRACE).

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PACEMAKER SCREEN

In the PACING DATA area you can see pacing rhythm and current values and if pacing is activate

or deactivate.

Using function keys it is possible to set pacing parameter.

KEY

FUNCTION

RYTHM – F1

Press key and use the Speed Dial to change
the value to set the pacing rhythm.

CURRENT – F2

Press key and use the Speed Dial to change
the value to set the pacing current.

MANUAL /

DEMAND - F3

Press key to change the pace maker
operation mode.

ON / OFF - F4

Press key to start and stop the pacer.

EXIT – F5

Press key to exit.

Pressing EXIT key you will return to the operational screen.

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HOW TO PREPARE THE PATIENT

The connection of the electrodes is possible in two ways, depending on what you want:

• ANTERIOR-POSTERIOR Connection (only pacing).

Front pad positioned on the left part of the chest, halfway between the xiphoid

apophysis and the left nipple at the sites V2-V3.

Back pad positioned immediately below the left shoulder blade side of the spine

at the same level than the front.

• ANTERIOR-ANTERIOR connection - (for defibrillation and pacing).

Front pad positioned below the right clavicle.

Lateral plate positioned on the middle axillary line at the height of his left

nipple, position V6.

PACING PROCEDURE

1. Switch on the device pressing the ON/OFF button. Connect and lock the disposable

pads plug to start the operation.

2. Place the disposable pads on the patient then press PACER – F3 key.

3. Press F1 then use the Speed Dial to set the value of the pacing rhythm, then press

F1 key again.

4. Press F2 then use the Speed Dial to set the value of the pacing current, then press

F2 key again.

5. Press F3 to select pacing mode (default mode is fixed).

6. Press F4 key to start pacing, then press F4 key again to stop pacing.

7. Press F5 key to exit and return to operational screen.

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SpO2 MONITORING

The SPO2 Module measures functional oxygen saturation in the blood. The measurement

determines the oxygenated hemoglobin as a percentage of the hemoglobin that can

transport oxygen.

Pulse oximetry works by having light emitting

diodes pass red and infra-red light into

arteriolar vascular beds such as a finger or a

toe and having the light detected by a photo

detector afterwards.

Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of

light over time. The arteriolar bed normally pulsates and absorbs variable amounts of

light during the pulsations. The ratio of light absorbed is translated into a measurement

of functional oxygen saturation (SpO2).

Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin

differ in their absorption of red and infrared light (spectrophotometry), and that the

volume of arterial blood in tissue (and hence, light absorption by that blood) changes

during the pulse (plethysmography). A pulse oximeter determines SpO2 by passing red

and infrared light into an arteriolar bed and measuring changes in light absorption

during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) in

the oximetry sensor serve as light sources; a photo diode serves as the photo detector.

Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of

red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. To

identify the oxygen saturation of arterial hemoglobin, the monitor uses the pulsatile

nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular

bed, and blood volume and light absorption increase. During diastole, blood volume and

light absorption reach their lowest point. The pulse oximeter bases its SpO2

measurements on the difference between maximum and minimum absorption

(measurements at systole and diastole). By doing so, it focuses on light absorption by

pulsatile arterial blood, eliminating the effects of non pulsatile absorbers such as tissue,

bone, and venous blood.

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PULSE OXIMETRY SENSORS

The RESCUE LIFE is equipped with a SpO2 sensor that is designed to be used with a

finger of the patient.

Other sensors from the manufacturer could also be used with the RESCUE LIFE.

The following table shows all available sensors that may be used with the RESCUE LIFE.

Choose the sensors to suit the weight of the patient.

Reusable sensors may be reused on different patients after cleaning and disinfecting.

Do not use other sensors aside from the ones recommended.

Before using, carefully read the sensor directions for use, including all warnings,

CAUTIONS AND INSTRUCTIONS.

SETTING THE ALARM

The SpO2 alarm can be set to warn you if the SpO2 value goes outside of the defined

lower limit.

The alarm can be set by accessing in “ALARMS” in the Menu screen.

If the SPO2 value falls below the specified limits, an alarm tone alerts you.

RLFS-004.1

Adult SpO2 digital finger sensor

RLFS-004.2

Pediatric SpO2 digital finger sensor

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NIBP (NON-INVASIVE BLOOD PRESSURE)

INTRODUCTION

The RESCUE LIFE NIBP option is based on the Advantage A+ module platform

available in the series of oscillometric OEM NIBP technologies from SunTech Medical®.

The Advantage series of OEM NIBP technologies provides the simplicity of the

oscillometric technique of acquiring blood pressure with the most reliable, flexible and

clinically accurate modules in the industry.

Advantage OEM NIBP technologies have been integrated in many different medical

devices throughout the world including general multi-parameter patient monitors,

cardiac output monitors, dialysis machines, defibrillators, 24-hour ABPM devices,

anesthetic delivery devices as well as several niche market devices.

The Advantage A+ module provides the highest NIBP performance in the smallest

complete package available. SunTech Medical designed the Advantage A+ to meet the

needs of the most challenging clinical application with internal automatic modes, low

voltage communication protocols, the lowest power consumption in the industry and

readily equipped to integrate the Advantage RMT technology option for the highest level

of motion tolerant performance.

OPERATIONAL OVERVIEW

For pediatric and adult patient populations, blood pressure measurements made with

the Advantage series of OEM NIBP technologies are equivalent to those obtained by

trained observers using the cuff/stethoscope auscultatory method within the limits

prescribed by ANSI/AAMI SP10: 2002 (mean error difference of ± 5 mmHg or less,

standard deviation of 8 mmHg or less) as well as EN1060-4:2004.

For neonatal patient populations, blood pressure measurements made with the

Advantage series of OEM NIBP technologies are equivalent to those obtained by intra-

arterial blood pressure devices within the limits prescribed by ANSI/AAMI SP10: 2002

(mean error difference of ± 5 mmHg or less, standard deviation of 8 mmHg or less) as

well as EN1060-4:2004.

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TERMINOLOGY FOR NIBP

Oscillometry

The oscillometric method of blood pressure measurement is a non-invasive method that

monitors the amplitude of cuff pressure changes during cuff deflation to determine

arterial blood pressure. The cuff pressure is first elevated above the patient systolic

blood pressure level and the cuff begins to deflate at a certain rate. The initial rise in

amplitude of these pressure fluctuations during cuff deflation corresponds closely to the

systolic blood pressure. As the cuff is further deflated, these pressure fluctuations

increase in amplitude until a peak is reached which is usually referred to as the mean

arterial pressure (MAP). As cuff deflation continues, the diastolic pressure can be

determined based upon the rapidly diminishing amplitude of the pressure fluctuations.

Thus systolic, MAP and diastolic blood pressures can be accurately obtained by

supervising the pressure fluctuations while controlling the cuff deflation rate.

mmHg

Millimeters of Mercury, which is the most common unit of measure for pressure in non-

invasive blood pressure.

NIBP

Non-invasive blood pressure.

bpm

Beats per minute, which is the most common unit of measure for pulse rate.

Advantage OEM NIBP Technology Series

Term encompassing all of the Advantage OEM NIBP technologies and module platforms.

Patient Populations

There are three major patient groups which are formally defined as neonate (up to 28

days), pediatric (29 days to 12 years) and adult (13 years and older).

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WARNINGS & PRECAUTIONS DURING THE NIBP MESURAMENT

This device should not be used when oscillometric pulses may be altered by other

devices or techniques such as External Counterpulsation (ECP) or Intra Aortic Balloon

Pump Counterpulsation.

DO NOT USE THE NIBP MODULE FOR ANY PURPOSE OTHER THAN SPECIFIED IN THIS MANUAL
WITHOUT WRITTEN CONSENT AND APPROVAL FROM ELPRO S.R.L.

DO NOT USE IN THE PRESENCE OF FLAMMABLE GASEOUS ANESTHESIA AGENTS BECAUSE
OF FLAME HAZARD.

DO NOT ATTACH THE CUFF TO A LIMB BEING USED FOR IV INFUSIONS AS THE CUFF INFLATION
CAN BLOCK THE INFUSION, POTENTIALLY CAUSING HARM TO THE PATIENT.

SUBSTITUTION OF A COMPONENT DIFFERENT FROM THAT SUPPLIED MAY RESULT IN
MEASUREMENT ERROR. REPAIRS SHOULD BE UNDERTAKEN ONLY BY PERSONNEL
TRAINED OR AUTHORIZED BY ELPRO S.R.L.

Accuracy of any blood pressure measurement may be affected by the position of the

subject, his or her physical condition and use outside of the operating instructions

detailed in this manual. Interpretation of blood pressure measurements should be made

only by a physician or trained medical staff.

The RESCUE LIFE NIBP module is designed to work with SunTech® cuffs and hoses. The

use of cuffs and hoses not supplied by SunTech® may compromise performance and

accuracy.

If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen

saturation results will be altered when the cuff occludes the brachial artery.

To obtain accurate blood pressure readings, the cuff must be the correct size, and also

be correctly fitted to the patient. Incorrect size or incorrect fitting may result in

incorrect readings.

When a cuff is going to be positioned on a patient for an extended length of time, be

sure to occasionally check the limb for proper circulation. The module may not operate

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correctly if used or stored outside the relevant temperature or humidity ranges

described in the Performance specifications.

Adverse Reactions

Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including

the formation of urticaria (allergic reaction including raised edematous patches of skin

or mucous membranes and intense itching) caused by the fabric material of the cuff.

Petechia (a minute reddish or purplish spot containing blood that appears in the skin)

formation or Rumple-Leede phenomenon (multiple petechia) on the forearm following

the application of the cuff, which may lead to Idiopathic thrombocytopenia (spontaneous

persistent decrease in the number of platelets associated with hemorrhagic conditions)

or phlebitis (inflammation of a vein) may be observed.

User Responsibility

This module is designed to perform in conformity with the description thereof contained

in this operation manual when operated, maintained and repaired in accordance with

the instructions provided.

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CUFF SELECTION & PLACEMENT

It is important to select the cuff size that is appropriate to the diameter of the patient’s

upper arm. Use the Range Lines on the inside of the cuff to determine the correct size

cuff to use.

Wrap the cuff around the arm making sure that the Artery Marker is aligned over the

brachial artery as shown in Figure. If possible, do not wrap the cuff over the patient’s

clothing. The cuff should fit snug to the patient’s arm for maximum oscillometric signal

quality. An appropriate sized cuff should be placed on the non-dominate arm where the

lower edge of the cuff is located 2cm above the antecubital fossa (interior bend of the

elbow).

Ensure that the air hose from the monitor to the cuff is not compressed, crimped or

damaged.

The midpoint of the subject upper arm should be supported at heart level for proper

measurement accuracy. When the cuff is below heart level, measurement results may

be higher and when the cuff is above heart level, measurement results may be lower

than comparative results obtained at heart level.

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USING A CUFF THAT IS THE WRONG SIZE MAY GIVE FALSE AND MISLEADING RESULTS.

THE NIBP MODULE IS DESIGNED TO WORK WITH SUNTECH CUFFS AND HOSES. THE USE OF CUFFS AND HOSES
NOT SUPPLIED BY SUNTECH MAY COMPROMISE PERFORMANCE AND ACCURACY.

DO NOT ATTACH THE CUFF TO A LIMB BEING USED FOR IV INFUSIONS AS THE CUFF INFLATION CAN BLOCK

THE INFUSION, POTENTIALLY CAUSING HARM TO THE PATIENT.

If the blood pressure cuff is on the same limb as a pulse oximeter probe, the oxygen

saturation results will be altered when the cuff occludes the brachial artery.

Intra-arm differences vary between people. Do not assume that measurements from

both arms are same.

When a cuff is going to be positioned on a patient for an extended length of time, be

sure to occasionally check the limb for proper circulation.

ACTIVATION AND OPERATION OF THE NIBP MODE

To activate the NIBP mode, press the ‘MENU’ (F5) key form the operational Rescue Life

screen.

On the menu select NIBP than ON using the jog.

WHEN IN NIBP MODE, IT IS POSSIBLE TO SELECT ENERGY AND DEFIBRILLATE. IF THE DEFIBRILLATOR IS
MEASURING THE PRESSURE WHEN ENERGY IS CHARGED PRESSURE MEASURING WILL BE STOPPED
TO RETURN TO THE DEFIBRILLATOR FUNCTIONS AND SETUPS PRESS ‘EXIT’ (F5) KEY.

On the right side of the graphic screen the following NIBP values are displayed:

Patient type: ‘ADULT’ (default), ‘PEDIATRIC’ or ‘NEONATAL’

Systolic pressure: ‘SYS’

Diastolic pressure: ‘DIA’

Mean arterial pressure: ‘MEAN’

Cuff pressure: ‘PRESS’

Operation mode: ‘MANUAL’ (default), ‘AUTO’

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On the bottom side of the screen the function keys (F1…F5) are the commands for the

NIBP:

START/STOP – F1: to start or abort the NIBP measurement in manual or automatic

mode.

PRINT – F2: to print the last NIBP measurement in manual mode or paper

feed. If the last measurement was already printed it will only

perform paper feed. In automatic operation mode will perform

only paper feed as the last measurement is automatically printed.

CLEAR – F3: to clear the last measurement values (SYS,DIA,MEAN).

SET – F4: to enter the NIBP set up menu.

EXIT – F5: to exit the NIBP and return to the defibrillator functions.

NIBP SET-UP MENU

Pressing the SET – F4 key the NIBP set-up menu is displayed.

To modify the values press the selection jog to choose the field then rotate the selection

jog to change the value assigned to the field.

To exit the set-up menu press the SET – F4 key.

PATIENT: select the patient type: ADULT, PEDIATRIC or NEONATAL.

MODE: select the measurement mode: MANUAL or AUTOMATIC.

AUTO INTERVAL: select the automatic measurement interval: 1,2,3,4,5,10,15,30,60

or 90min.

PRINT MODE: select manual or automatic hardcopy only for MANUAL measurement

mode. In automatic measurement mode the printing is always

automatic.

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By default when entering the NIBP mode the set-up is:

PATIENT: ADULT

MODE: MANUAL

AUTO INTERVAL: 5 min

PRINT MODE: AUTO

OPERATION SEQUENCE

Before any measurement please select the right patient type (set-up menu).

For a manual NIBP measurement, place the cuff according with paragraph “cuff selection

& placement“ and press the START - F1 key.

At the end of the measurement the values for ‘SYS’, ’DIA’ and ‘MEAN’ pressure will be

displayed and printed (if the automatic print mode is active). In manual print mode

press the PRINT - F2 key to get the hardcopy of the measurement.

For an automatic measurement enter the set menu, select the automatic mode and the

time interval then press the START - F1 key.

At each selected time interval the measurement will be taken automatically and printed.

In both modes if the STOP - F1 key is pressed while measuring, the process will be

aborted and the pressure will be released.

If an error was found during the measurement it will be reported on the display with a

code number and on the hardcopy with a brief description. Please see the remedies in

the errors Appendix 1.

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Appendix 1

Error Code List & Definitions

If more than one error occurs during a single measurement, the higher numbered error

code will be displayed.

EC 1 Weak or no oscillometric signal

Corrective Action: Check that the cuff is in the correct position.

Check the patient.

Check that the cuff is properly tightened.

Check that there is no excessive clothing between the arm and the

cuff.

Check that the correct size cuff is being applied.

EC 2 Artifact / erratic oscillometric signal

Corrective Action: The patient may have been moving too much.

Check that the cuff is in the correct position.

Check that the correct size cuff is being applied.

EC 4 Exceeded measurement time limit

Corrective Action: The patient may have been moving too much.

Check that the cuff is properly tightened.

Check that the cuff is in the correct position.

Check that the correct size cuff is being applied.

Check that there is no excessive clothing between the arm and the

cuff.

EC 85 Pneumatic Blockage

Corrective Action: Check that the hose has no sharp bends or is pinched.

Check that the patient is not lying on the cuff.

Check that the cuff is in the correct position.

EC 86 BP reading terminated by user

Corrective Action: Check the patient.

Take another BP measurement.

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EC 87 Inflate Timeout, Air Leak or Loose Cuff

Corrective Action: Check that the hose is connected to the system and the cuff.

Check that the cuff is properly tightened.

Check that the cuff is in the correct position.

Check that the correct size cuff is being applied.

Check that the cuff is not leaking air.

Check that the hose connections are not damaged or loose.

EC 88 Safety Timeout

Corrective Action: Check the patient.

Check that the cuff is in the correct position.

The patient may have been moving too much.

Take another BP measurement.

EC 89 Cuff Overpressure

Corrective Action: Check that the correct size cuff is being applied.

Check that the hose has no sharp bends or is pinched.

Check that the cuff is in the correct position.

Check that the patient is not lying on the cuff.

EC HIGHER THEN 89 System error

Corrective Action: Service may be required. Call ELPRO S.r.l. representative.

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Appendix 2

Accessories

Part #

Description

RLFS-0010.1

RLFS-0010.2

RLFS-011

NIBP Cuff, Adult

NIBP Cuff, Pediatric

NIBP Cable

Appendix 3

Specifications

• Method of Measurement:

Oscillometric. Diastolic values correspond to Phase 5 Korotkoff sounds.

• Blood Pressure Range:

Systolic:

ADULT 40 – 260 mmHg

PEDIATRIC 40 – 160 mmHg

NEONATE 40 – 130 mmHg

MAP:

ADULT 26 – 220 mmHg

PEDIATRIC 26 – 133 mmHg

NEONATE 26 – 110 mmHg

Diastolic:

ADULT 20 – 200 mmHg

PEDIATRIC 20 – 120 mmHg

NEONATE 20 – 100 mmHg

• Pulse Rate Range:

30 to 220 BPM

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• Pulse Rate Accuracy: ± 2% or ± 3 BPM, whichever is greater

• Cuff Deflate Rate:

Deflation step size varies with heart rate, cuff pressure and cuff volume.

• Initial Inflation Pressure:

ADULT 160 mmHg (default)

PEDIATRIC 120 mmHg (default)

NEONATE 90 mmHg (default)

• Subsequent Inflation Pressure:

ADULT Previous Systolic + 30 mmHg

PEDIATRIC Previous Systolic + 30 mmHg

NEONATE Previous Systolic + 20 mmHg

• Clinical Accuracy:

Meets accuracy requirements of ANSI/AAMI SP10:2002 and EN1060-4:2004.

• Pressure Transducer Accuracy:

3 mmHg between 0 mmHg and 300 mmHg for operating conditions between - 5°

C and 46° C.

• Operating Conditions:

- 5° C to 46° C, 10% to 95% non-condensing humidity

• Storage Conditions:

-20° C to 50° C, 15% to 95% non-condensing humidity (without Disposable

multifunction electrodes for defibrillator);

• Altitude:

Measurement accuracy is not affected by altitude

• Auto Interval Periods: 1, 2, 3, 4, 5, 10, 15, 30, 60 and 90 minutes

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• Patient Safety:

Internal operating software ensures that:

Maximum cuff inflation time is limited to 75 seconds

Duration of blood pressure reading is limited to:

130 seconds (Adult mode)

120 seconds (Adult Motion Tolerant mode)

90 seconds (Pediatric mode)

75 seconds (Neonate mode)

Additional redundant safety circuitry oversees normal operation and will override

to abort a BP measurement if:

cuff pressure exceeds 300 mmHg (Adult & Pediatric modes) or 150 mmHg

(Neonate mode) at any time the cuff has been inflated for 180 seconds

above 15 mmHg (Adult & Pediatric modes) or 90 seconds above 5 mmHg

(Neonate mode).

• Regulatory Standards:

The Module meets all relevant parts of the following Safety/Regulatory

Standards:

IEC 60601-1

IEC/EN 60601-2-30

AAMI SP10

OIML R 16-2

EN1060-1

EN1060-3

EN1060-4

DATA BASE

DESCRIPTION

The memory is based on a flash disk. The machine will register 30 events and after that

it will replace the oldest events.

The data base is composed of Files and Records.

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Each time the machine is switched on, automatically a File with the current date will be

created.

In each File RESCUE LIFE can store up to 30 Records of 1 minute length.

Each Record holds the actual ECG trace data (acquired from lead II of pads or the ECG

patient cable) and the initial recording time stamp.

RECORDING

The recording is available only in AED mode.

The recording will start automatically each time the ANALISYS starts.

When RESCUE LIFE is recording, on the top side of the display, below battery status

indicator a “REC” is shown. Recording duration is 1 minute which is the Record length.

NEVER SWITCH OFF THE MACHINE UNTIL THE RECODING STOPS.

IF THE MACHINE IS SWITCHED OFF DURING THE RECORDING THE DATA MAY BE LOST.

MAKE SURE THAT THE CLOCK IS UPDATED SO THE FILES RECORDED DATE AND TIME WILL BE CORRECT.

DATA BASE SCREEN

With function keys users can manage Data Base.

KEY

FUNCTION

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DOWN – F1

To scroll next 10 record.

TOP – F2

To scroll previous 10 record.

PRINT - F3

To print data.

BACK - F4

To move to previous selection.

EXIT – F5

To exit Data Base.

DATA RETRIEVAL

The Memory consultation is a very accurate analysis phase of the ECG Trace. For this

reason, we recommend to do it in a not-emergency situation.

The access to the data base management and data view/print is done from the initial

screen. Just disconnect the paddles connector and switch on the machine.

In the initial screen the data base can be accessed pressing the MEMORY – F2 key

when the label has the white color.

On the data base screen the left window shows the files list with the corresponding

opening date while the right window shows records.

The list starts with the most recent file. Pressing the DOWN – F1 key the next 10 files

will be shown. Pressing the TOP –F2 key the previous 10 file will be shown.

Pressing the Speed Dial will select a file from the list and rotating Speed Dial will move

the selection within the list.

After the file selection pressing again the Speed Dial will show on the top right window

the selected file the number of records in the file and a list of the starting time of each

record.

Rotating the Speed Dial is possible to select the desired record and pressing the Speed

Dial will show on the bottom side of the screen the ECG graph of the selected record.

Rotating the Speed Dial is possible to scroll the view within the record in multiples of 6

seconds. Once decided the desired view pressing the PRINT - F3 key a hardcopy will

start and will stop at the end of the record or if the PRINT key is pressed again.

The BACK - F4 key is used to come back to previous selection.

The EXIT - F5 key is used to exit Data Base and return to initial screen.

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Switch off defibrillator by pressing On/Off key.

On the graphic hardcopy if a defibrillation shock was recorded the graph will show the

base line for about 1 second (shock event).

DATE AND TIME SETUP

To set-up the real time clock, switch on the RESCUE LIFE with paddles connector

disconnected.

On the screen will be displayed the battery status, the date and time. The SETCLK-F4

key enables the clock set-up. With the Speed Dial select the value to change and

rotating it the value can be modified. Press the Speed Dial once the value has been

changed.

To exit the clock set-up press again the SETCLK - F4 key.

PRINTING AND PAPER CHANGE

The printing can be done in manual mode or automatic mode.

To select print mode enter the menu and select MANUAL or AUTOMTIC mode from PRINT

MODE.

MANUAL MODE

To start printing press the PRINT - F2 key. The hardcopy will start with the set-up

parameters and with the ECG trace. The hardcopy will keep the LCD display set-up

(amount of the traces, group, speed the gain)

To stop the printing, press again the PRINT – F2 key.

If SpO2 sensor is connected (optional) in hardcopy user will found value of oxygen

saturation.

AUTOMATIC MODE

RESCUE LIFE will print an ECG frame of 6 seconds when the charge starts.

When the shock is released the energy delivered, as well as the time stamp will be

printed together with a 6 seconds after shock ECG frame.

The manual printing (using F2 key, “PRINT”) is operational independently of the printing

mode.

Do not leave the device without supervise during printing. The thermal printer can be

damage by a prolonged use.

When the paper is finished the green light on the printer cover button will switch on.

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To replace the paper, push the green button and open the printer cover. Insert a new

paper roll with the thermo-sensible side up and then close the cover. Push the FEED

key (on the printer panel) until the paper comes out straight.

To print all the traces of ECG signal start printing after selecting the leads I, II, III.

While print is in progress enter the menu and select the successive derivations, aVR,

aVL, aVF. Repeat until you have printed all leads. Then stop printing.

AUTO TEST

RESCUE LIFE is equipped with internal auto test that checks the correct functioning of

the device.

It is advisable to do the test at least once a week. It 'also possible to print the report.

On the initial screen, press the function key TEST - F3 to access the test screen.

Press START – F1 key to start auto test. RESCUE LIFE will do internal tests and will

show results.

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If during the check the RESCUE LIFE founds some fault, the system will indicate it. Note

the error code and communicate it to the authorized technical service.

Pressing the PRINT - F3 you can print the test report.

EVERY REPORT HARDCOPY REFERS TO THE LAST TEST. IF YOU NEED A SECOND HARDCOPY DO AUTO TEST
AND PRINT THE REPORT AGAIN.

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RESCUE LIFE CHECKLIST

ELPRO Srl recommend using the following checklist to monitor the status of RESCUE

LIFE. It includes all the tests for checking the functionality and the safety.

Operator should test the defibrillator at least once a week.

It is possible to do a discharge test by connecting the test load (optional) using the

cable adapter for disposable pads.

CONDITION

Check integrity of the enclosure and the keys and make sure the unit
is clean.

OK

KO

ACCESSORIES

Check and clean the accessories. Check the integrity of the power,
ECG and SpO2 (optional) cable. Check expiration date of disposable
pads and ECG electrodes.

OK

KO

AUTO TEST

Perform auto test as explained in the section (page 65 )

OK

KO

PADDLES

Check the integrity of the paddles, the connector and the cable. Make
sure the paddles are clean and free of traces of gel. To test the
paddles switch on defibrillator, set an energy of 1 Joule, charge the
capacitor by pressing the buttons on the paddles and release the
discharge into the air, taking care not to touch the paddles together.

OK

KO

VOICE

Switch on defibrillator, select ADVISORY mode from the menu and
verify that voices are audible.

OK

KO

AED

If you have the test load (optional) it is possible to simulate a
condition of asystole, and verify that the AED module works properly,
recognizing that condition and recording data.
Turn on the defibrillator, connect the load test and select semi
automatic (AED) by the menu. Wait for the defibrillator recognizes
asystole and the recording coming to an end.
Switch off defibrillator then check in Data Base if record was recorded
properly.

OK

KO

PRINT

Switch on the defibrillator and press PRINT key. Print will start. Press
PRINT key again to stop print. Check the quality of the printed report.

OK

KO

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APPENDIX A

CLINICAL INFORMATION

Sudden cardiac arrest (SCA) associated with ventricular fibrillation (VF) remains a

leading cause of unexpected death in the Western world. It has been estimated that

chances for survival from SCA decrease approximately 7% to 10% with each passing

minute and that survival rates after 12 minutes are only 2% to 5%.

The most common cause of SCA is ventricular fibrillation (VF), a lethal heart rhythm,

and survival depends on the rapid treatment called de-fibrillation, an electrical shock

sent to the heart to resume normal and healthy heart rhythm.

So early defibrillation is the sole definitive determinant of survival and is the key factor

in cardiopulmonary resuscitation. Currently, fewer than 5% of the 250,000 persons who

experience out-of-hospital cardiac arrest each year survive to hospital discharge.

HOW DOES BIPHASIC WAVEFORM DEFIBRILLATE?

For defibrillation to be successful, a sufficient amount of electrical current must be

delivered to the heart muscle. How to deliver the electrical current to the heart muscle

is the core technique to defibrillate the heart.

Successful defibrillation would be done when the cell membranes of the heart are

“coated” with positive ions on one side and negative ions on the other side, enough to

depolarize nearly 100 percent of the cardiac cells at the same instant. Optimal current

is determined with the pressure (this means electric Voltage) that controls what an

amount of current can be pushed and the duration of time the current flows. This

defibrillation current is commonly described in joules of energy. Energy is a measure of

the amount of current, voltage, and duration of time the current flows.

When the Defibrillation shock is delivered, current flow is affected by transthoracic

impedance, the body’s resistance from electrode to heart. Impedance is dependent on

the anatomy of the chest, skin surface, air in the chest, hair, fat and bone, as well as

the size and location of the defibrillation electrodes.

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Research has shown that chest resistance can vary significantly from patient to patient.

Patients with low impedance are generally easier to defibrillate because the flow of

current meets little resistance. Those with higher impedance may be more difficult to

defibrillate. According to the International Guidelines 2000 by the American Heart

Association (AHA) in collaboration with the International Liaison Committee On

Resuscitation (ILCOR), average adult impedance is 70-80 ohms. Defibrillation energy

should be designed to optimize the delivery of current over a wide range of patient

impedances. Too much current to the myocardial cells can cause damage to the cells

and result in an unsuccessful defibrillation. Too little current to the myocardial tissue

cells will not depolarize the cells and result in an unsuccessful defibrillation.

The waveform biphasic technology:

1) Makes it easy to compensate the shock waveform to match the patient impedance,

2) Is more efficient than monophasic technology,

3) Delivers enough energy for restoring heart rhythm.

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EASE IN COMPENSATION OF PATIENT IMPEDANCE

Through Biphasic technology, defibrillation shock delivery is controlled while taking into

consideration the patient’s impedance. The patient’s impedance is measured through

the defibrillator electrodes. According to the measured patient’s impedance, e-cube

Biphasic technology adjusts the duration of current flow to optimize the effectiveness

of the shock delivery. E-cube Biphasic technology is based on 3 core technologies. 1

The technology for measuring the patient’s impedance. 2 The technology for controlling

the voltage level to be delivered. 3 The technology for controlling the duration of current

flow.

These technologies can adjust the parameters of the shock waveform to match the

transthoracic impedance of the patient. Biphasic technology increases the duration of

current flow for patients with high impedance. When escalating energy, for example

150J to 180J, it delivers the electrical energy with higher voltage level if the patient’s

impedance does not vary.

MORE EFFICIENT THAN MONOPHASIC WAVEFORM

The electrical therapy delivered by transthoracic cardiac defibrillators has changed little

since the introduction of direct-current defibrillation more than 30 years ago.

Throughout this time, the industry-standard shock waveform for external defibrillators

has been a monophasic damped sine (MDS) waveform, in which current flows in one

direction throughout the shock. Many well-organized emergency medical systems, using

monophasic devices for early defibrillation, have documented better than 20% survival

to hospital discharge for cardiac arrest patients found in ventricular fibrillation (VF).

Attempts to improve this survival rate have adapted proposals to change the waveform
and energy level of defibrillation shocks [6].

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Extensive animal and human data with implanted devices demonstrate that biphasic

waveforms offer substantial reductions in defibrillation thresholds and produce less

myocardial dysfunction than monophasic waveforms [1], [2], [3], [4].

The defibrillation efficacy of the 150-J biphasic waveform was superior to that of the

200-J to 360-J conventional escalating-energy monophasic waveforms for 115 patients

who presented with VF [5].

The difference between monophasic and biphasic waveform is qualitatively similar but

varies quantitatively for different parameter values. The fundamental difference is that

first phase of the biphasic pulse acts as a pre-pulse to remove inactivation from the

heart cell, accelerating its recovery, and thereby lowering the activation threshold for

defibrillation prior to second phase of biphasic pulse which is reversed current flow.

ENOUGH ENERGY FOR RESTORING HEART RHYTHM

The Biphasic Truncated Exponential waveform uses lower energy than the Monophasic

waveform. But the lower energy of biphasic shock is more efficient than high energy of

the monophasic shock for defibrillation to restore heart rhythm.

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In a multicenter, randomized, controlled trial of 150J biphasic waveform compared with

200J and 360J monophasic waveforms done in humans, Schneider et al [5] showed that

“the 150-J biphasic waveform defibrillated at higher rates, resulting in more patients

who achieved a return of spontaneous circulation. Although survival rates to hospital

admission and discharge did not differ, discharged patients who had been resuscitated

with biphasic shocks were more likely to have good cerebral performance.”

Positive evidence for safety and clinical effectiveness of biphasic truncated exponential

waveforms for internal and external use was ascertained by the AHA ECC committee

[8], [9].

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REFERENCES

[1] Chapman PD, Vetter JW, Souza JJ, Wetherbee JN, Troup PJ. Comparison of
monophasic with single and dual capacitor biphasic waveforms for nonthoracotomy
canine internal defibrillation. J Am Coll Cardiol. 1989;14:242.5.
[2] Kavanagh KM, Tang ASL, Rollins DL, Smith WM, Ideker RE. Comparison of the
internal defibrillation thresholds for monophasic and double and single capacitor
biphasic waveforms. J Am Coll Cardiol. 1989;14:1343.9.
[3] Winkle RA, Mead RH, Ruder MA, et al. Improved low energy defibrillation efficacy in
man with the use of a biphasic truncated exponential waveform. Am Heart J.
1989;117:122.7.
[4] Ruppel R, Siebels J, Schneider MA, Kuck KH. The single endocardial lead
configuration for ICD implantation: biphasic versus monophasic waveform [abstract]. J
Am Coll Cardiol. 1993;21:128A.
[5] T. Schneider, et al. Multicenter, Randomized, Controlled Trial of 150-J Biphasic
Shocks Compared With 200- to 360-J Monophasic Shocks in the Resuscitation of Out­of-Hospital Cardiac Arrest Victims. Circulation. 2000;102:1780-1787.)
[6] Steven L. Higgins, et al. A comparison of biphasic and monophasic shocks for
external defibrillation. Prehospital Emergency Care 2000;4:305.313
[7] J. P. KEENER , T. J. LEWIS. The Biphasic Mystery: Why a Biphasic Shock is More
Effective than a Monophasic Shock for De5brillation. J. theor. Biol. (1999) 200, 1-17
[8] AHA, Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care: an international consensus on science. Circulation 2000;102
(Suppl 1).
[9]. U. Achleitner, et al. Waveform analysis of biphasic external defibrillators,
Resuscitation 50 (2001) 61–70

[10] European Resuscitation Council Guidelines for Resuscitation 2015 Section 2.
Adult basic life support and automated external defibrillation
[11] European Resuscitation Council Guidelines for Resuscitation 2015 Section 3.
Adult advanced life support
[12] European Resuscitation Council Guidelines for Resuscitation 2015 Section 4.
Cardiac arrest in special circumstances
[13] European Resuscitation Council Guidelines for Resuscitation 2015 Section 5.
Guidelines for post-resuscitation care of the European Resuscitation Council Guidelines
for Resuscitation 2015
[14] European Resuscitation Council Guidelines for Resuscitation 2015 Section 6.
Paediatric life support

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APPENDIX B

ACCESSORIES AND MODULES

Part #

Description

RLFS-001

RLFS-002.1

RLFS-002.2

RLFS-004.1

RLFS-004.2

RLFS-005

RLFS-006

RLFS-007.1

RLFS-007.2

RLFS-008

RLFS-009

RLFS-0010.1

Standard Electrodes for defibrillation

5-leads ECG cable

10-leads ECG cable

Adult SpO2 sensor

Pediatric SpO2 sensor

AC Adapter

Disposable electrodes cable

Adult disposable electrodes for defibrillation

Pediatric disposable electrodes for defibrillation

Travel bag

Paper roll

NIBP Cuff, Adult

RLFS-0010.2

RLFS-011

RLFS-012

NIBP Cuff, Pediatric

NIBP Cable

User Manual

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APPENDIX C

TECHNICAL SPECIFICATIONS

Waveform time-impedance

Following flow-charts show typical defibrillation impulses considering the impedance

between the defibrillation electrodes for a maximum of 230 Joule:

150J, 25ohm 230J,50ohm

230J,75ohm 230J,100ohm

230J,125ohm 230J,150ohm

For impedance value of 40ohm or less the

230J,175ohm maximum energy is 150J. If the energy is set to a

value higher then 150J the machine will set

automatically the energy to 150J. For impedance

values different from 50 ohm the accuracy of the

released energy is +/- 15%. For impedance of 50

ohm the accuracy is +/- 10%.

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IMPENDANCE LIMITS

RESCUE LIFE does not release the shock if the patient impedance is less than 25 ohm

or over 200 ohm.

SYNC/NO SYNC MODE

When the RESCUE LIFE is on it is automatically set on no-sync mode.

Only the operator can set the sync/no-sync mode which is clearly displayed on the

screen. The device can not automatically set the sync mode.

In the sync mode the device releases the defibrillation shock only when the ‘R’ peak in

the ‘QRS’ complex is detected.

The maximum response time between the “R” peak and the defibrillation shock is less

than 60ms.

CHARGING TIME TO ACHIEVE THE MAXIMUM ENERGY (230 JOULE)

When the device is connected to the AC supply (nominal AC voltage) and batteries are

100% charged :< 8 sec.

When the device is connected to the AC supply (AC voltage 90%) after 15 shocks :<

10 sec.

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APPENDIX D

TECHNICAL FEATURES

ECG Monitoring

• Patient connection:

Defibrillation pads and 5 or 10 wire ECG cable.

• Bandwidth:

0.6 to 40 Hz (-3 dB) in monitor mode.

0.05 to 120 Hz (-3 dB) in diagnostic mode.

• ECG trace parameters:

Velocity : 5,10,25, 50 mm/sec.

Gain: 2,5, 5, 10, 20, 40 mm/mV with patient cable. AUTO with pads.

Alarm: HR max settable 250 bpm and HR min 20 bpm.

Filters: 50/60 Hz, EMG filter, base line.

Traces: 3+3+1 (I,II,III – aVR,aVF,aVL, V) with 5 wires patient cable.

Traces: 3+3+6 (I,II,III – aVR,aVF,aVL – V1 to V6) with 10 wires patient cable.

• Heart rate:

Digital readout on the display from 20 a 300 bpm (± 5% or ±3 bpm, on higher

value).

Defibrillator

• Operation mode:

Manual, Advisory, Semiautomatic AED.

• Defibrillabile impedance:

Compensated from 25 ohm to 200 ohm.

• Energy charging time:

< 8 sec (with batteries fully charged).

• Manual Mode:

Syncro/Asyncro.

• Defibrillation pads:

Standard or disposable, adult and pediatric.

• Waveform:

Biphasic Truncated Esponential (BTE) with impedance compensation.

HiCAP Technology (Large Storage Capacitor).

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Display

• LCD Display color TFT.

• LCD Dimensions: high contrast 7 inches 800X600 pixels.

Device Dimensions

• Dimensions: 369 x 240 x 340 mm (L x W x H).

• Weight 5.5 kg approximately.

AC charger power supply

• Input: 100 ~ 240 V AC 50/60 Hz max - inverter 12 V car adapter (optional).

Battery pack

• 15.0 V – 3.2 Ah Lithium-Ion battery (internal rechargeable).

• charging time maximum 3 hours.

• capacity: 150 shocks at 230 J (battery fully charged).

Manual mode

• Energy range:

1 – 230 J (from 1 – 10 J in 1 J steps; from 10 – 230 J in 10 J steps).

• Commands:

Multifunction Trim Knob. Charge and shock button directly in the front panel

for hands free defibrillation.

• Paddles:

Reusable adult & pediatric defibrillator paddles with charge/shock command.

Disposable defibrillator pads.

• Operating mode:

ECG « R » wave synchro or asynchro mode.

• Indicators:

Battery and main led indicators.

Clear and visible backlight color buttons.

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AED mode

• Energy:

Fixed energy at 200 J.

• Protocol:

ERC 2010 CPR Guidelines with voice and text prompts.

• Shockable rhythms:

VF with amplitude >0.15 mV and VT with rhythm >150 bpm.

• Sensitivity:

Shockable rhythm VF > 95%.

Shockable rhythm VT > 75%.

• Specificity:

Normal sinusoidal rhythm > 99%.

Asystole and other non-shockable rhythms > 95%.

SpO2 (optional)

• SpO2 range:

0 – 100%.

• HR range:

30 – 250 bpm.

• Accuracy:

70 – 100 % ~ 2% for adults with finger clip sensor.

• Alarm:

Adjustable min 50 %.

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NIBP (optional)

• Technique:

oscillometric.

• NIBP Accuracy:

Meets ANSI/AAMI SP10-2002, EN 1060-4.

• Patient Application:

Adult/Paediatric/Neonatal.

• Systolic Range:

Adult: 40-260mmHG, Pediatric: 40-160 mmHG, Neonatal: 40-130 mmHG.

• Range MAP:

Adult: 26-220 mmHG, Paediatric: 26-133mmHG, Neonatal: 26-110 mmHG.

• Diastolic Range:

Adult: 20-200 mmHG, Paediatric: 20-120 mmHG, Neonatal: 20-100 mmHG.

• PR RANGE:

30-220 BPM.

• PR Accuracy:

+/-2% or +/3 bpm.

• Transducer Accuracy:

+/- 3 mmHg over full range in operating conditions.

• Operating Modes:

Manual, Long Term Automatic, Stat, Service.

• Auto Interval Periods:

1,2,3,4,5,10,15,30,60 and 90 minutes.

• Safety & Regulatory Standards:

IEC60601-1, IEC/EN60601-2-30, AAMI SP10, OIML R 16-2.

EN1060-1, EN1060-3, EN1060-4.

External pacemaker (optional)

• Type: rectangular wave.

• Operating mode: Fixed, on demand.

• Pulse rate: 30 bpm to 250 bpm, adjustable in steps of 5 bpm.

• Impulse duration: 22.5 ms.

• Pulse current: 0 to 150 mA, adjustable in steps of 5 mA.

• Amplitude: max 150 V.

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Printer

• Type:

Integrated thermal printer 200 dpi for ECG traces and events documentation

hardcopy including HR/SpO2 values.

• Paper Speed:

5, 10, 25, 50 mm/sec.

• Paper width:

58 mm.

• Operating model:

Manual, automatic (10” pre and post shock recording).

Environmental

• Temperature (without Disposable Multifunction Electrodes for defibrillator):

Operational -5° - 46° C.

Storage -20° - 50° C.

Relative humidity 10 - 95%.

Temperature (without Disposable Multifunction Electrodes for defibrillator):

Operational -5° - 46° C.

Storage 5° - 35° C.

Relative humidity 20 - 80%.

• Isolation:

ECG connector type CF - Pads, NIBP and SpO2 connector type BF.

• Water proof:

Class IPX4.

Standards & Safety

• Standard:

EN 60601-2-4; EN 60601-1; EN 60601-1-2; Class II, type BF/CF.

• EC Mark 93/42/EEC :

Medical device, Class IIb.

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APPENDIX E – INSTRUCTION FOR USE FOR DISPOSABLE
MULTIFUNCTION ELECTRODES FOR DEFIBRILLATOR

Disposable Multifunctional

Electrodes for Defibrillator

(defibrillation, synchronized stimulation, transcutaneous cardiac stimulation, ECG monitoring)

DFBAD01STD / DFBAD01PRC (Adult)

DFBPED01STD / DFBPED01PRC (Pediatric)

0068

V2.0

Rev. 2018/02

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References

[1] Ian Jacobs, Kjetil Sunde, et al. “Part 6: Defibrillation. 2010 International Consensus on Cardiopulmonary

Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations”
Circulation 2010;122:S325-S337

[2] Jerry Nolan et al. “European Resuscitation Council Guidelines for Resuscitation 2010” Resuscitation Vol.

81, 2010, Editor Jerry Nolan, Bath, UK

[3] A. Luciano et al., "BODY-MASS INDEX REFERENCE CURVES FOR CHILDREN AGED 3-19 YEARS FROM

VERONA, ITALY", European journal of clinical nutrition, 51(1), 1997, pp. 6-10

[4] Edward J. Sondik, et al. “2000 CDC Growth Charts for the United States: Methods and Development”

Vital and Health Statistics. Series 11, Number 246: May 2002

[5] John M. Field et al. “2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation

and Emergency Cardiovascular Care” Circulation 2010, 122:S640-S946 Journal of the American Heart
Association Editor Mary Fran Hazinski, RN, MSN

[6] Luis A. Pagan-Carlo, Kirk T. Spencer, et al. “Transthoracic defibrillation: importance of avoiding

electrode placement directly on the female breast” Journal of American College of Cardiology

1996;27:449-452

[7] Edward A. Panacek, Mark A. Munger et al. “Report of nitropatch explosions complicating defibrillation”

American Journal of Emergency Medidicine 1992;10:128-9

[8] Keith Wrenn “The hazards of defibrillation through nitroglicerin patches” Annals of Emergency

Medicine 1990;19:1327-8

[9] Johannes C. Manegold, Carsten W. Israel et al. “External cardioversion of atrial fibrillation in patients

with implanted pacemaker or cardioverter-defibrillator sistems: a randomized comparison of
monophasic and biphasic shock energy application” European Heart Journal 2007;28:1731-8

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DISPOSABLE MULTIFUNCTION ELECTRODES

OPERATING INSTRUCTION

CAUTION

Federal (USA) law restricts this device to sale by or on the order of a physician.

IMPORTANT

The product is intended for use in non-sterile environment by authorized personnel only. Before using
the product, the user should deeply understand these instructions.

DESCRIPTION

The disposable multifunction electrodes PROGETTI are constituted by a pair of adhesive pads provided with
gels and direct connection to cables and defibrillators which may be used in place of the manuals reusable
paddles [1].

PACKAGING

Each pair of PROGETTI disposable multifunction electrodes is packaged in sealed envelopes of opaque
material suitable to protect the gel from light and moisture. Envelopes are included in the carton sales
package along with a copy of the operating instructions.

INDICATIONS

The disposable multifunction electrodes PROGETTI are indicated for:

• Transthoracic external defibrillation.

• Transthoracic synchronized cardioversion.

• Transthoracic ECG Monitoring.

• Temporary transthoracic cardiac pacing (non-invasive).

PROGETTI disposable multifunction electrodes allow the user to effectively operate in the treatment of
rhythm disorders related to the above-mentioned applications, without the risk of accidental electrocution
related to the use of normally available reusable paddles.

CONTRAINDICATIONS

• PROGETTI disposable multifunction electrodes for adults are generally contraindicated in patients younger

than 8 years old [2] (weighing less than 25kg [3][4])), but can be used if the size of the chest allow it, taking
care that one pad do not come in contact with the other one. Follow the operating instructions of the
defibrillator for energy to be delivered.

• The use of PROGETTI disposable multifunction electrodes in versions for adult or adult/paediatric is

generally contraindicated in patients aged less than 12 months (weighing less than 10kg).

• The use of PROGETTI pediatric disposable multifunction electrodes is generally contraindicated in patients

older than 8 years old [2] (weighing more than 25kg [3][4]);

• Do not apply on skin that shows signs of irritation or injury.

MODE OF USE

External Defibrillation and synchronized cardioversion: the disposable multifunction electrodes are able to
transfer to the patient the electrical energy supplied by the defibrillator up to a maximum value of 360J in
the adult version and of 100J in the paediatric version [5].

The depolarization of the critical mass of the myocardium, which is essential for the success of the therapy,
is only possible if it is crossed by a current of appropriate intensity: the active surface of the electrodes is
optimized for this purpose. It is therefore appropriate, in addition to a targeted selection of the positioning
sites, to apply the adhesive pads in such a way that their contact surface with the skin is maximum. The
choice of power to supply is at the discretion of the operator.

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In paediatric applications the Guidelines for cardiopulmonary resuscitation recommend a supply of energy
of 2-4J / kg; the recommended starting level is of 2 J / kg and it is preferable not to exceed 100J in order to
avoid burns [5].

ATTENTION PROGETTI disposable multifunction electrodes can withstand up to 50 defibrillation shocks.
ATTENTION Do not supply a shock with manual metal paddle above the disposable electrode pads or ECG

electrodes.

Non-invasive transthoracic pacing: PROGETTI disposable multifunction electrodes can be used for non­invasive transthoracic pacing. To minimize the threshold of pacing it is appropriate to apply the adhesive
plates in the manner described above. It is also necessary to have a good understanding of the equipment
you want to use and follow the manufacturer's instructions.

ATTENTION It is good practice to replace PROGETTI disposable multifunction electrodes after 8 hours,
checking, in case of prolonged pacing (greater than 30 minutes), the skin of the patient for signs of
irritation.

ATTENTION Replace PROGETTI disposable multifunction electrodes after 30 minutes if the supplied pulses
are monophasic and longer than 20ms.

ECG monitoring: PROGETTI disposable multifunction electrodes can also be used for ECG monitoring.

ATTENTION If the tracing is not sufficiently clear, use an ECG patient cable, if it is present, and a separate
set of ECG electrodes.

MODE OF APPLICATION

• The multifunction electrodes can be applied to the patient even in the mere suspicion that a severe

arrhythmic disease may develop.

• The points where it is possible to apply the adhesive electrodes are listed in “PLACEMENT AND POLARITY”.

• Uncover the chest and prepare the skin. Remove excessive hair [1]. Slightly abrade the skin surface to

reduce the contact impedance. Avoid applying the adhesive pad on the nipple or breast tissue [6].

• Remove any debris (dirty, greasy and debris), using non-flammable cleaners. Finally, make sure the

application sites are clean and dry.

• Open the package and remove multifunction electrodes.

• Gently remove the protective liner, starting from the tab to expose the adhesive and conduction areas.

• In case of multifunctional electrodes with clips remove the protective support.

• Apply the adhesive pads one-to-one starting with one side and pressing progressively over the entire

surface to avoid the formation of air bubbles and ensure complete adhesion to the skin. Keep the adhesive
pads well separated one from the other and be careful not to overlap them with other objects (ECG
electrodes, cables, transdermal patches, clothing etc.) [7][8].

• Do not replace the adhesive pads once applied. If the position must be changed, remove and replace with

new multifunction electrodes.

• To remove the adhesive plate without irritating the patient's skin, lift an edge and gently pull back. Hold at

the same time the skin with the other hand.

• For multifunctional electrodes without clip: connect the electrodes to the defibrillator or the adapter cable

by following the instructions for use of the defibrillator.

• For multifunctional electrodes with clips: connect the clip to the cable of the defibrillator for the correct

polarity, observing the instructions for use of the defibrillator.

• For on demand pacing, separately connect ECG monitoring electrodes.

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POSITIONING AND POLARITY

The international guidelines indicate various placements as equally effective for the treatment of atrial or
ventricular arrhythmias [5].

The following figures show the application sites commonly used and recommended by most manufacturers
of defibrillators. Choose the most appropriate points of application of the therapy according to
manufacturer's instructions for use of the defibrillator to be used.

For ease of placement and for training purposes, the anterior-lateral side (Fig.1) is preferred for
arrhythmias defibrillation and cardioversion; the anterior-posterior side (Fig.2) is more common in
hemodynamics and in transthoracic pacing and recommended in case of use of electrodes for adults on
pediatric patients.

Fig.1

• Defibrillation

• Cardioversion

• Pacing

• Monitoring (it

provides a track
Lead II)

Fig.2

• Pacing

• Monitoring

• Defibrillation

• Cardioversion

To maintain the proper signal polarity, apply the electrode pads in the indicated positions (the apex is
identified by the symbol of the heart). However note that for the purpose of the therapy, it is not relevant
which electrode pad (apex / sternum) is placed in one of the two positions [2].

Regarding the polarity of the electrodes in unique version adult/pediatric, follow the directions on the labels
of the electrode pad (according to the instructions of the manufacturer of the defibrillator to be used).

SIDE EFFECTS

• Plate adhesive may cause light cutaneous irritation.

• The prolonged transthoracic stimulation or the repeated administration of defibrillation shock may cause

more or less noticeable skin reddenings according to the supplied energy.

• A lack in adhesion and/or air presence under the electrode may cause burnings.

PRECAUTIONS AND WARNINGS

• Use the product only on defibrillators brands indicated on the labels.

• Check that the product is compatible with the specific model of defibrillator intended to be used.

• Read the instructions for use of the defibrillator, with particular attention on the placement of

multifunction electrodes, their polarity and the power to be supplied.

• In paediatrics and for some models of automatic defibrillators the use of specific reducing power devices

or the adoption of special precautions may be required. Always pay a special attention to energy levels set
on the defibrillator and that can be delivered to the paediatric patient (see section "MODE OF USE").

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ATTENTION

Paediatric multifunction electrodes marked with the symbol shown beside are indicated
for use with automatic defibrillators.

• The electrode choice should be based on the evaluation of chest size and weight of the patient. Paediatric

electrodes used beyond the specified energy limit may cause also major skin burns; on the contrary the
extended active surface of adult electrodes may jeopardize the therapy when used for pediatric treatment.

• After an extended period of transthoracic pacing the ability to detect the evoked ECG signal can be reduced.

In this case it is necessary to provide for the collection of the evoked signal by a separate set of ECG
electrodes.

• Replace the multifunction electrodes after 24 hours from their application on the patient's skin.

• Check the expiration date on the package. Do not use after this date.

• Do not use multifunction electrodes if removed from the envelope for more than 24 hours. The adhesive

pads are to be applied within 30 minutes after removal of the protective coating.

• Check that the packaging is intact: do not use the product otherwise.

• Do not use the multifunction electrodes if the gel is removed from the support or if it is ripped, torn or dry.

Any discoloration localized on gel or on conductive foil does not affect the functionality of the product.

• Do not use the multifunction electrodes if during removal of the protective coating the product is damaged

(eg. the insulating coating of the contact has detached or there are tears in the foam support and/or in the
electrode).

• Do not bend, do not cut and do not squash the adhesive pads.

• Do not use the multifunction electrodes if the connector, the cable or the clips appear to be damaged.

• Check on the operating instructions of the defibrillator at which safety distances the devices (surgeon's

electric knife, RF ablators, diathermy equipment, mobile phones, etc.) that emit strong electromagnetic
interferences must be placed.

• To prevent accidental damage from electric shock, ensure that during discharge operators are not in

contact with the electrode pads, with the patient, or with conductive parts close to the patient.

• When defibrillators are used near oxygen sources or other flammable gases, use extreme care to avoid risk

of fire or explosion.

• The product neither is sterile nor can be sterilized.

• The product is disposable. For use on a single patient. Discard after use.

POTENTIAL COMPLICATIONS

There are no complications related to the use of multifunction electrodes.

ATTENTION: The defibrillator discharge may cause irregularities in the operation of an implanted
pacemaker/defibrillator [1]; apply the multifunction electrodes at a distance of at least 8cm [9]. After
defibrillator discharge check its operation.

ATTENTION: If the chosen energy level is insufficient the success of therapy may be jeopardizing. On the
contrary, higher levels may modify the enzyme structure without actual evidence of myocardial damage.

PRODUCT LIFE AND STORAGE

Check the expiration date printed on the package.
The product should be stored in its original packaging in rooms with environment conditions of
temperature (5-35°C) and relative humidity (20-80%), specified on the label. The storage at extreme
temperatures must be limited to short periods (24 hours at -30°C or +65°C). Prolonged storage at extreme
temperatures can shorten the life of the product.

ATTENTION: The overlap of weights on the packaging could damage the product.

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Rescue Life - User Manual Rev. 3.1

87

DISPOSAL

Refuses deriving from health structures must be disposed in according to the regulation in force.

WARRANTY AND LIMITATIONS

PROGETTI S.r.l. guarantees that the product complies with Directive 93/42/EEC. No responsibility may be
ascribed to the producer who shall not be held liable for medical costs, director indirect damage due to
lacking function or malfunction of the above product, when used differently from the instruction for use. We
recommend to report opportunely any malfunction or defect of the product to ELPRO S.r.l. or PROGETTI S.r.l.

DESCRIPTION OF USED SYMBOLS

0068

EC Mark &

Notified Body

Identification

Manufacturer

information

Manufacture

date

Catalogue

Number

Batch

number

Pcs. per

box/pack

Use before of

the date

Temperature

range

for storage

Operating

body

temperature

range

Humidity

range

for storage

Keep

away from

humidity

Keep away

from sun

light

Warning: read

the enclosed

documentation

Consult

instructions for

use

Do not

reuse

Latex free

Disposable

multifunction

electrodes

are not sterile

Paediatric

disposable

multifunction

electrodes

indicated for

use with

automatic

defibrillators

ELPRO S.r.l. Doc.N.: TF-RescueLife-2.0/8.1ENG-6.0

MEDICAL ELECTRONICS Rev. 6.0

*IF YOU WANT RECEIVE DEDICATED DECLARATION OF CONFORMITY FOR YOUR DEVICE SERIAL NUMBER AND/OR UPDATED ONE,

PLEASE CONTACT ELPRO S.R.L. OFFICE TO THE EMAIL [e-mail]

Declaration of EC conformity

to council

Directive 93/42/EEC of 14 June 1993 and subsequent amendments

concerning medical devices

MANUFACTURER: ELPRO S.r.l.
Strada del Rondello, 5
10028 Trofarello (TO)
ITALY

PRODUCT: Defibrillator
MODEL: Rescue LIFE
GMDN Code: 17882

CLASS: II b

STANDARDs REFERENCES: EN ISO 13485:2016

EN 60601-1:2006+A1:2013+A12:2014, EN 60601-1-2:2015, EN 60601-2-4:2011,
EN 60601-2-27:2014, EN 60601-2-31:2008+A1:2011, EN 62353:2014, EN 62366-1:2015,
EN 60601-1-6:2010, EN 62304:2006, EN ISO 14971:2012, EN ISO 15223-1:2012,
MEDDEV 2.7/1 Rev.4, MEDDEV 2.12-1 Rev.8, MEDDEV 2.12/2 Rev.2

SERIAL NUMBER: *

WE HEREWITH DECLARE THAT THE ABOVE MENTIONED PRODUCT(S) MEET THE TRANSPOSITION INTO NATIONAL

LAW, THE PROVISIONS OF COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES,
ACCORDING TO ESSENTIAL REQUIREMENTS AND SUBSEQUENT AMENDMENTS.
ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURER.
ALSO, THE DEFIBRILLATOR IS MANUFACTURED BASED ON: DIRECTIVE 2011/65/EEC AND ITS SUBSEQUENT
AMENDMENTS (ROHS). THE PRODUCT CONCERNED HAS BEEN MANUFACTURED UNDER A QUALITY MANAGEMENT
SYSTEM ACCORDING TO ANNEX II OF DIRECTIVE 93/42/EEC.

NOTIFIED BODY: MTIC InterCert S.r.l. (N.0068)

Via Moscova, 11
20017 Rho - MI, ITALY

EC MARKING: 0068

EC CERTIFICATE N°: 0068/QCO – DM/031-2009

EXPIRE DATE: 2021, May 19th

FIRST ISSUE: 2009, May 20th

PLACE, DATE : TROFARELLO (TO) – 2019, 01

st

March

SIGNATURE:

Dr. CESARE MANGONE

MANAGEMENT REPRESENTAIVE

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Rescue Life - User Manual Rev. 3.1

89

APPENDIX E

WARRANTY CERTIFICATE

WARRANTY CONDITIONS

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 ELPRO S.r.l..

This warranty does not cover any accessories.

ELPRO S.r.l. will replace damaged parts and components, according to its option.

ELPRO S.r.l. will replace cost free those parts and components under guarantee in its

laboratory.

CLIENT:

____________________________________________________

____________________________________________________

____________________________________________________

DEVICE: Biphasic Defibrillator/Monitor

Model: RESCUE LIFE SN _____________________

VALIDITY starting from : ___/___/_______

Delivery date:_______

Invoice N°_____________________dated__________________

Rescue Life - User Manual vers. 3.1

ELPRO S.r.l.

Strada del Rondello, 5
10028 Trofarello (TO)
ITALY

www.elpromedical.com

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