Gima Rescue LIFE User manual

Rescue Life User Manual vers. 2.3 March 2010
1
External Biphasic Defibrillator/monitor
Version 2.3, March 2010
GIM SP
WEB-SITE:
www.gimaitaly.com
E-M IL: [email protected]
U
UU
U
U
UU
U
U
UU
Us
ss
s
s
ss
s
s
ss
se
ee
e
e
ee
e
e
ee
er
rr
r
r
rr
r
r
rr
r M
MM
M
M
MM
M
M
MM
Ma
aa
a
a
aa
a
a
aa
an
nn
n
n
nn
n
n
nn
nu
uu
u
u
uu
u
u
uu
ua
aa
a
a
aa
a
a
aa
al
ll
l
l
ll
l
l
ll
l
R
R
R
E
E
E
S
S
S
C
C
C
U
U
U
E
E
E
L
L
L
I
I
I
F
F
F
E
E
E

Rescue Life User Manual vers. 2.3 March 2010
2
INDEX
Safety Instructions Page 3
Introduction Page 5
Warranty Page 6
Service Page 7
How to use this manual Page 8
Electrical safety guidelines Page 8
Device operation and storage guidelines Page 9
Cleaning and maintenance Page 10
Product description Page 11
Intended use Page 12
Indications Page 12
Contraindications Page 12
Intended users Page 12
Operational controls and indicators Page 13
Front panel keys Page 14
Function keys (F1-F5) Page 15
Light indicators Page 15
Start screen Page 16
Operational screen Page 17
Start-up menu Page 18
Operational screen guide Page 19
Input ports, printer Page 20
Input Connectors Page 20
Device preparation Page 21
Product check Page 21
How to test the defibrillator Page 21
Patient preparation Page 21
ECG patient cable connection and electrodes placement Page 22
Defibrillation procedure in manual or advisory ( DV) Mode Page 23
Semiautomatic ED mode Page 24
Printing and paper change Page 25
Battery charge Page 26
Data/time setup Page 26
P CEM KER (optional) Page 27
ED semiautomatic operation (optional) Page 28
Semiautomatic ( ED) mode flow chart Page 30
Data Base Page 31
Data Base Screen Page 32
ppendix – Biphasic defibrillation Page 33
ppendix B – ccessories Page 39
ppendix C – Technical Specifications Page 40
Technical Features Page 42
PPENDIX D- CE declaration of conformity Page 43
PPENDIX E- Warranty Certificate Page 44

Rescue Life User Manual vers. 2.3 March 2010
3
S FETY INSTRUCTIONS
GENER L
- ssure yourself prior and after the use of the RESCUE LIFE that the unit is in safe
and usable condition (cables integrity, pads, battery status).
- ssure 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.
DEFIBRILL TOR
- Never put in contact the defibrillator paddles (short circuit).
- Defibrillation in manual mode must be performed only by highly trained medical
personnel.
- 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.
- The patient must not be touched during defibrillation.
- Be sure that the parts of the patient body, such as the head or limbs are not in
touch with metal parts, bed frames or stretchers, in order to prevent accidentally
creating current path for the defibrillation impulse.
- 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 ED mode.
- The shock paddles including handles should always be cleaned thoroughly after
use.
- 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 pads (defibrillation and monitoring). Check that the case
is in good condition and that the disposable pads have not yet reached their
expiration date.

Rescue Life User Manual vers. 2.3 March 2010
4
SHOCK OR FIRE H Z RDS
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. void
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 ELECTRIC L 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 situation, if possible.
POSSIBLE IMPROPER DEVICE PERFORM NCE
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
lways check that the battery is fully charged.
Plug the C supply when the device displays a low battery warning.

Rescue Life User Manual vers. 2.3 March 2010
5
INTRODUCTION
Thank you for choosing the RE CUE LIFE.
The RE CUE LIFE monitor/defibrillator is a complete acute cardiac care response system
designed for basic life support (BL ) and advanced life support (AL ) patient management
protocols.
These operating instructions include information and procedures related to all features of
the RE CUE LIFE monitor/defibrillator. Your RE CUE LIFE monitor/defibrillator may not
have all of these features.
Please read this Operator’s Manual carefully and thoroughly before using the RE CUE LIFE.
This Manual contains instructions on how to operate and maintain the RE CUE 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 .r.l. designs and manufactures all of its products in accordance with international
standards (93/42/EEC). This ensures that ELPRO .r.l. provides products of high quality
and reliability.
In this regard:
• Only persons authorized by ELPRO .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 .r.l.

Rescue Life User Manual vers. 2.3 March 2010
6
W RR NTY
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 within two years after the date of purchase.
When the device malfunctions during the warranty period it will be repaired free of charge at
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.

Rescue Life User Manual vers. 2.3 March 2010
7
SERVICE
Only ELPRO .r.l. or its authorized representatives should service the device. If unauthorized
personnel service the device during the warranty period, the warranty will become null and void.
When the device is not functioning properly, it has to be submitted for maintenance immediately.
When any abnormalities are found in the device or when a danger to bodily harm exists, the
device has to be repaired fast and adequately by authorized personnel.
When the need for maintenance arises:
Please contact ELPRO .r.l. or its authorized representatives immediately. Prepare a summary of
the problems. Also include the name of model, product serial number, date of purchase, name of
sales representative, customer information.
Main service center:
ELPRO S.r.l
Via Bruno Buozzi 28
10024 Moncalieri (Torino) Italy
Email: [e-mail]
Web site: www.elpromedical.com

Rescue Life User Manual vers. 2.3 March 2010
8
HOW TO USE THIS M NU L
 This Operator’s Manual contains all the information a user needs to operate the RE CUE
LIFE properly. RE CUE LIFE is designed for monitoring the patient ECG signals and to
deliver defibrillation shocks in MANUAL, ADVI ORY or AED mode.
 In case you have any problems regarding the operation of the device, please don’t
hesitate to contact the manufacturer.
 PROGETTI .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.
ELECTRIC L S FETY 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:
It is a Class II, BF equipment in terms of electrical safety (EN 60601-1).
For the ECG patient cable input is a Class II, CF (EN60601-1)
The Electromagnetic compatibility level is Class B according to the
EN 60601-1-2 (Electromagnetic Compatibility Requirements).

Rescue Life User Manual vers. 2.3 March 2010
9
DEVICE OPERATION AND STORAGE GUIDELINES
Do not operate or store the device in conditions that are
beyond the following specified limits.
Operating Conditions
Temperature -10 °C to 50 °C
Humidity 5 % to 95 % (non-condensing)
torage Conditions
Temperature -20 °C to 70 °C
Humidity 5 % to 95 % (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.
Only personnel authorized by the manufacturer shall
open the device for servicing. There are no user
serviceable components inside the device.

Rescue Life User Manual vers. 2.3 March 2010
10
CLE NING ND M INTEN NCE
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.
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.
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.

Rescue Life User Manual vers. 2.3 March 2010
11
PRODUCT DESCRIPTION
RESCUE LIFE is an external defibrillator/monitor.
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 10 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 RE CUE 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 3 leads ECG monitoring cable
assembly from PROGETTI .r.l. (3+3 traces).
Optional, RE CUE LIFE can be ordered with ADVI ORY/ AED mode, Pacemaker, 5 leads and 10
leads ECG cable as well as pO2.
On the AED version RE CUE LIFE includes a mass storage memory for recording the ECG trace
and events.
Integrated thermal printer allows the hardcopy of the ECG traces.
The RE CUE 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 ch
ildren under the age of 8 years or weighing less than 25 Kg do
not exceed 4 Joule/Kg.
Do not use ED mode in children under 8 years old.
If batteries are not fully charged after a 4 hours charging period,
please contact the manufacturer or its authorized representatives.
If batteries are not fully charged after a 4 hours charging period,
please contact the manufacturer or its authorized representatives.

Rescue Life User Manual vers. 2.3 March 2010
12
INTENDED USE
INDIC TIONS
Asynchronous defibrillation – the shock delivery is not synchronized with the ECG 'R' peak.
In asynchronous defibrillation, the RE CUE LIFE is indicated for use on patients with the
following symptoms:
a) Unconsciousness
b) Absence of normal breathing and
c) Lack of detectable pulse.
ynchronous defibrillation – the shock delivery is synchronized with the 'R' peak of the
patient’s ECG.
In synchronous defibrillation, the RE CUE LIFE is indicated for use on patients with ECG's
that show the presence of Atrial Fibrillation.
CONTR INDIC TIONS
The RE CUE LIFE should not be used on patients that:
a) Are conscious
b) Are breathing normally
c) Have detectable pulse.
INTENDED USERS
In manual mode the RE CUE 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.
When used in AED mode, the RE CUE 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 is intended 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 RE CUE LIFE defibrillator in AED mode

Rescue Life User Manual vers. 2.3 March 2010
13
OPER TION L CONTROLS ND INDIC TORS
- Shock Key: To be used to deliver the shock when using disposable
pads.
- Charge Key: To be used to charge the energy selected when using
disposable pads.
- Speed Dial: Used to navigate and modify the settings on main screen
or in other sub-menus.
- ON status LED: Indicates that the defibrillator is ON.
- Battery Charge LED: Indicates that the battery is being charged.
- Function Keys: Quick selection of the functions displayed on the screen
Speed
Dial
Charge
Key
Shock Key
(defibrillation)
Battery
Charge LED
ON/OFF
Switch
Function
Keys
ON status
LED

Rescue Life User Manual vers. 2.3 March 2010
14
FRONT P NEL KEYS
ON/OFF Key
Power On-Off push button of RE CUE LIFE. At switch on, if the
paddles are disconnected, the battery status and colck set-up
screen will appear. In this case to start ECG monitoring press F1
key.
To access the DATA BA E (only on the AED models) press F3
key(MEM).
To switch off the RE CUE LIFE press once the ON/OFF button. To
power-off the device press the On-Off key only once.
hock Key
(defibrillation)
SHOCK
When the red light inside this key is on it means that RE CUE
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
pushbuttons on the pads handles.
Charge Key
CH RGE
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 pushbuttons on the pads handles.
peed Dial
ENERGY
Control the functional settings of the device.
When pressed, on the screen the parameter to change will be
displayed. By rotating the peed Dial is possible to change the
selected parameter. Energy is the first parameter that can be
selected.

Rescue Life User Manual vers. 2.3 March 2010
15
FUNCTION KEYS (F1-F5)
ST RT
SCREEN OPER TION L SCREEN P CE M KER MENU
F1
ST RT
operation
DIS RM – internal
discharge
elect the pace maker rhythm. To
set the requested rhythm use the
peed dial.
F2
PRINT – start/stop printing
elect pace maker current. et the
current intensity using the peed
Dial.
F3
MEMORY
Data Base P CER – enable PaceMaker et the pace maker mode: manual or on demand
F4
SYNC – enable ync or No
ync Mode witch on/off the pace maker
F5
SET CLOCK MENU – default parameters
setup Exit the pace maker mode
LIGHT INDIC TORS
Indicator (LED)
B TTERY
CH RGE
Indicates that the AC power supply is connected and the batteries
are charging. When the device is off and the charge is finished this
light will switch off.
Power ON LED
The light indicates that the defibrillator is on.
Indicator CH RGE
(on the shock key)
Will be illuminated red at charge end to indicate that the energy
selected was charged and the device is ready for defibrillation.

Rescue Life User Manual vers. 2.3 March 2010
16
ST RT SCREEN
The start screen will be displayed when RE CUE LIFE is switched on with the defibrillation pads
disconnected.
tart operation (F1)
Enter Data Base(F3)
Available only on
AED model
et Clock(F5)
Use the peed Dial
to set date and time

Rescue Life User Manual vers. 2.3 March 2010
17
OPER TION L SCREEN
At power ON, if the pads are connected the RE CUE LIFE will start the operation.
If the pads are not connected the start screen will be displayed.
TIME
HEART
RATE
ECG
TRACE
ENERGY
ELECTION
BATTERY
TATU
ECG
TRACE
PEED
ECG
TRACE
GAIN
ALARM
ON/OFF
TRACE
ELECTION
OPERATION
MODE
ENERGY
CHARGE
TATU
pO2
DATA
DATE
ME AGE
AREA
F1
INTERNAL
DI CHARGE
F2
TART/ TOP
PRINTING
F3
TART
PACER
F4
YNC/NO
YNC MODE
TATU
F5
ENTER
ET-UP

Rescue Life User Manual vers. 2.3 March 2010
18
ST RT-UP MENU
The TART-UP menu is accessible pressing the F5 key (MENU) on the operational screen and all
the values can be changed using the peed Dial.
Pressing the peed Dial will select the field to change and rotating the peed dial will change the
field value.
The entered values can be stored (when the ‘ AVE ETUP’) is selected and will be used as default
values when RE CUE 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).
TART-UP MENU FIELD :
L RM HR M X et the maximum heart rate alarm
L RM HR MIN et the minimum heart rate alarm
L RM O2 M X et the pO2 maximum alarm
PRINT MODE et the print mode automatic or manual
LP FILTER Enable/disable the low pass filter (ECG trace)
NOTCH FILTER Enable/disable the AC line noise filter (ECG trace)
TR CE SPEED et the ECG trace speed for the display and printer
TR CE G IN et the ECG trace gain for the display and printer
L RM ON/OFF Enable/disable all the alarms
HR BEEP Enable/disable the heart rate beep
S VE SETUP ave the actual settings and exit the menu
The HR BEEP is not stored and when the machine is switched on, will be active (heart rate beep
on). It can be set to off only for the actual working session.

Rescue Life User Manual vers. 2.3 March 2010
19
OPER TION L SCREEN GUIDE
SPEED DI L USE
The peed Dial allows to set the parameters displayed in the right side of the screen. Press the
peed Dial in order to highlight them. When a parameter has been selected, rotate the peed Dial
for changing its value.
ENERGY elect defibrillation Energy from 1J to 230J.
MODE elect the Mode: manual (MANUAL), advisory (ADV) or semiautomatic
(AED).
TR CE
elect ECG traces that the user choose to display or print. When the patient
cable is connected, traces I,II,III or aVR, aVL, aVF can be selected. When
the patient cable is disconnected, the ECG trace is acquired by defibrillation
pads (lead II).
SPEED elect the speed of ECG traces (display and printer): 5mm/s, 10mm/s,
25mm/s and 50mm/s
G IN elect the ECG gain (display and printer): 5mm/mV, 10mm/mV and
20mm/mV.
L RM
ST TUS Enable or disable the ECG heart rate alarm or the pO2 alarm
OPER TION L SCREEN FE TURES
- CH RGE ST TUS (Energy):
When charge status bar is empty (gray color), the capacitor is not charged (0 joule).
By pressing the CHARGE key (when disposable pads are connected) or by pressing both
pushbuttons on the pads handle when standard pads are in use, the capacitor start to charge
to the selected Energy level and the bar status becomes red indicating that the charging
procedure is on.
- B TTERY ST TUS:
Indicates the charging batteries status. If the level is below 50% connect the AC cord to
start charging the battery.
- SpO2 D T (OPTION L):
When the pO2 sensor is connected, it indicates the oxygen saturation and the heart rate
acquired.