Gima RESCUE 230 User manual

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INDEX
Safety Instructions Page 3
Introduction Page 4
Warranty Page 5
Service Page 6
How to use this manua Page 7
Device operation guide ines Page 8
Storage and operating environment guide ines Page 9
C eaning and maintenance Page 10
Product description Page 11
Intended purposes Page 12
Operationa front pane contro s and indicators Page 13
Front pane contro functions keys Page 14
Keys F1-F4 secondary functions Page 15
Light indicators Page 15
Disp ay messages guide Page 16
Disp ay organization Page 17
Input connectors photo Page 18
Input connectors Page 18
Device preparation Page 19
How to test the defibri ator
Patient preparation
Page 19
Page 20
Defibri ation procedure Page 20
Printing and paper change Page 21
Battery charge Page 22
Date/time set-up Page 22
Set-Up Menu Page 23
Scope of de ivery Page 24
Technica data Page 26
Biphasic waveform Page 27
E ctromagnetics emissions Page 28
E ectromagnetic Immunity Page 29
Recommended separation distances Page 32
CE dec aration of conformity Page 33

3
RESCUE 230
Externa Biphasic Defibri ator
With ECG monitoring
User manua
Safety instructions
Genera
-Assure yourse f prior and after the use of the RESCUE 230 that the unit is in safe
and usab e condition (cab es integrity, battery status).
-RESCUE 230 is not intended for use in areas of high y inf ammab e anesthetics or
other inf ammab e substances, especia y in oxigenous areas.
-RESCUE 230 does not have to be put or used nearby a nuc ear spin tomography
p ant, which is turned on.
Defibri ator
-Defibri ation must be performed on y by responsib e trained doctors.
-Be sure that both surfaces of the shock padd es are comp ete y moistened with
ge .
-The shock padd es must be he d at distance from other e ectrodes and any meta
parts in contact with the patient.
-The patient must not be touched during defibri ation.
-Be sure that the parts of the patient body, such as the head or imbs are not in
touch with meta parts, bed frames or stretchers, in order to prevent accidenta y
creating current path for the defibri ation impu se.
-During defibri ation with connected ECG cab e ensure that a binding c ips are
connected with the patient.
-When defibri ating chi dren do not exceed 50J.
-The shock padd es inc uding hand es shou d a ways be c eaned thorough y after
use.

4
INTRODUCTION
Thank you for choosing the RESCUE 230. Please read this Operator s Manual carefully and
thoroughly before using the RESCUE 230. This Manual contains instructions on how to
operate and maintain the RESCUE 230.
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). 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 all 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.
This device has to be operated by personnel who have undergone training in Advanced
Cardiac Life Support. In this mode, the operator must know how to interpret ECGs.
To ensure safety and reliability, use only parts and accessories recommended by ELPRO S.r.l.
If you intend to use this device in conjunction with other devices not specified in this manual,
please notify the manufacturer.

5
WARRANTY
The products of ELPRO S.r.l. are designed and manufactured according to european standards
( 93/42/EEC).
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 one year after the date of purchase.
When the device malfunctions during the warranty period (RESCUE 230 subjected to operating
conditions within the specified limits), 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 :
The name of model, product serial number, date of purchase, name of sales representative,
information of customer and a brief description of the problems.
Name of Product Manual Biphasic Defibrillator
Model RESCUE 230 Serial No.
Date of Purchase Sales Representative
Address
Name
Customer Information
Contact No.
Brief Description of
Problems

6
Service
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.
ELPRO S.r.l. or its authorized representatives are obliged to service the device free of charge
during the warranty period.
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
There are no user-serviceable parts in the RESCUE 230. The user should not attempt any repair
beyond what we recommend in the maintenance section of this manual.
Main service center:
ELPRO S.r.
Strada del Rondello 5
10028 Trofarello (Torino) Italy
Sito Web: www.elpromedical.com

7
How to Use This Manua
Contents of This Manua
This Operator s Manual contains all the information a user needs to operate the RESCUE 230
properly.
In case you have any problems regarding the operation of the device, please don t hesitate to
contact the manufacturer.
Safety Messages
The following safety messages are used to emphasize the safety practices that must be observed
and followed during the operation of the RESCUE 230. The operator must follow the instructions in
all the Danger, Warning, Caution, and Notice messages found throughout this Operator s Manual
In the event that the device is damaged due to misuse or negligence by a user, the manufacturer
or the authorized representatives shall not be responsible for the damage or loss to the product.
Conditions, hazards, or unsafe practices that can resu t in
serious persona injury or death.
Conditions, hazards, or unsafe practices that can resu t in minor
persona injury, damage to the RESCUE 230, or oss of data
stored in the device.
Used to denote items that are important during insta ation,
operation, or maintenance of the device.
Immediate hazards that wi resu t in persona injury or death.

8
Device Operation Guidelines
Genera Guide ines
Do not operate or store the device in conditions that are
beyond the following specified limits.
Operating Conditions
Temperature 0 °C to 50 °C
Humidity 5 % to 95 % (non-condensing)
Storage Conditions
Temperature -20 °C to 70 °C
Humidity 5 % to 95 % (non-condensing)
Do not store the device in areas that are directly exposed to
sunlight
Do not store the device in areas with highly
fluctuating temperatures
Do not store the device near heating equipment
Do not store the device in areas where there is high
vibration (in excess of Category 10 of MIL-STD-
810E)
Do not operate or store the device in environments
with high concentration of flammable gas or
anesthetics.
Do not operate or store the device in areas with
high concentration of dust
Only personnel authorized by the manufacturer shall
open the device for servicing. There are no user
serviceable components inside the device.

9
Storage and Operating Environment Guide ines
Avoid damp locations. Do not operate and store the device beyond the specified limits. Do not
operate the device with wet hands.
Do not expose the device to direct sunlight during storage.
Do not store the device in areas with highly fluctuating temperatures.
Do not store the device close to heating equipment and appliances.
Do not store the device near sources of vibration.
Do not store and operate the device in locations that are exposed to chemicals, explosive gas
and solvents.
Keep the device away from dusty environments.
There are no user serviceable parts inside the RESCUE 230. Only authorized service personnel
should open the device for repairs.
During recharging, when the device is connected and disconnected from the mains power
connector, hold the plug and not the electrical cord.
Operating environmenta condition imits:
Temperature: 0 °C to 50 °C
Re ative Humidity: 5 % to 95 % (non-condensing)
Storage environmenta condition imits:
Temperature: -20 °C to 70 °C
Re ative Humidity: 5 % to 95 % (non-condensing)
E ectrica Safety Guide ines
Use the only the original power supply during recharging. See the section Chapter on Power
Supplies for more details.
During recharging, do not place the device where the environmental conditions exceed the
storage conditions specified in the Storage and Operating Environment Guidelines
Do not use the RESCUE 230 if it has been submerged in water. Ca
immediate y for service assistance.
During operation, the device shou d be p aced away from sources
of e ectromagnetic interference such as motors, generators, X-Ray
equipment, radio transmitters, ce u ar mobi e te ephones and
others, as these might interfere with the signa s being acquired.
The RESCUE 230 is c assified as fo ows:
- It is a C ass II, BF equipment in terms of e ectrica shock
prevention (EN 60601-1). It is not proper to operate this device
around combustib e anesthetic or so vents.
- For the ECG patient cab e is a C ass II, CF (EN60601-1).
- The E ectromagnetic emission eve is C ass B according to EN
60601-1 (Safety of E ectric Medica Equipment), and the noise
redemption is B eve according to the EN 60601-1-2
(E ectromagnetic Compatibi ity Requirements).

10
C eaning and Maintenance
After each use, clean the RESCUE 230 using a soft, damp cloth moistened with any of the
following solvents:
Soap and water
70% solution isopropyl alcohol
Chlorine bleach and water mixture (30 ml bleach/liter of water)
Ammonia-based cleaners
Hydrogen peroxide
Although there are no user serviceable parts inside the RESCUE 230, the operator can do
maintenance checks that will help ensure that the device stays in mint condition.
Check the case of the device for any apparent damage.
Check the ports (defibrillator lead port, adapter power port) to see that they are tightly in
place.
Check the accessories, especially the defibrillation pads, to see that they are in good condition
and for the disposable pads, that they have not yet reached their expiration dates.
Check the battery status and if it under 75%, please connect the AC charger.
Do not immerse any part of the RESCUE 230 in f uids.
Do not et any f uid enter the case of the device.
Do not spi iquids on the case of the device.
Do not use strong, acetone-based c eaners in c eaning the device.
Do not use abrasive materia s in c eaning the unit, especia y on
the LCD disp ay.
Do not steri ize the RESCUE 230.

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Product Description
The RESCUE 230 is a manual external defibrillator and ECG Monitoring. It is a battery powered,
lightweight and portable device designed to deliver defibrillation shocks during rescue operations.
The user has to do the analysis of the ECG of the patient and set the energy of the shock to be
delivered. The choices are 10, 20, 30, 50, 100, 150, 200 and 230 (all in Joules). The energy value
can be fine tuned from 3 to 10J in steps of 1J and from 10 to 230J in steps of 5J.
Synchronized cardioversion can also be done. During synchronized cardioversion, the defibrillating
shock is delivered within 40 milliseconds of the occurrence of a QRS peak.
The RESCUE 230 may also be used to do ECG monitoring. ECG monitoring only is done by
connecting the custom designed, 4 leads ECG monitoring cable assembly from ELPRO S.r.l.
In this case RESCUE 230 will display/print 3+3 traces ( I,II,III – aVR, aVL, aVF).
The RESCUE 230 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
The
The RESCUE 230 is NOT intended for pediatric use. It may be used in
chi dren over the age of 8 years (weighing 25kg or above).
In any case, the decision to defibri ate is of the operating doctor.
Do not remove or change the interna battery pack. If it is necessary
to have it changed, contact the manufacturer or its authorized
representatives.

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Intended Purposes
Indications
Asynchronous defibrillation – the shock delivery is not synchronized with the QRS peak
In asynchronous defibrillation, the RESCUE 230 is indicated for use on patients with the following
symptoms
a) Unconsciousness
b) Absence of norma breathing and
c) Lack of detectab e pu se.
Synchronous defibrillation – the shock delivery is synchronized with the QRS peak of the patient s
ECG.
In synchronous defibri ation, the RESCUE 230 is indicated for use on patients with ECGs
that show the presence of Atria Fibri ation:
Contraindications
The RESCUE 230 should not be used on patients that:
a) Are conscious
b) Are breathing norma y
c) Have detectab e pu se.
Intended Users
The RESCUE 230 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
ECGs.

13
ON/OFF
BUTTON
Operationa front pane contro s and indicators
ENERGY
SELECTION
ENERGY
CHARGE
BATTERI
E
CHARGING
INDICATOR
PRINTER
ECG CABLE
CONNECTOR
LCDisp ay
RELEASE
SHOCK
INTERNAL
DISCHARGE
SYNCRO
MODE
SELECTION
PRINT
START/STOP
PAPER FEED
SpO2
CONNECTOR

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FRONT PANEL CONTROL FUNCTIONS KEYS
Key ON/OFF
Power On-off push button of RESCUE 230
At switch on, if the paddles are disconnected, the battery status
and clock set-up screen will appear . To set-up the clock use F1-
F3 keys else to start ECG monitoring press F1 key.
To shut-off the device press the ON/OFF key only once.
Key SHOCK
When the red light inside this key is on it means that
RESCUE230 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.
Key CHARGE
This key will start the energy charging to the selected level. It is
active only with the disposable pads.
To start the charging with the standard pads press both pushbuttons on
the pads handles.
Key MENU
Controls the device set-up functions.
When pressed, on the display will appear the specific functions
for the F1-F4 keys.
Key SYNC
Used for the sync mode (defibrillation will be done in sync with
the R-wave of the ECG complex).
The sync mode is displayed on the screen.
Key DISCH
Pressing this key will discharge the energy internally.
(If no discharge is actuated, after 30 sec the RESCUE 230 will
discharge internally the energy).
ENERGY se ection
keys
Used to select the energy level desired. The corresponding light
will switch on and the energy value will be displayed on the
screen.(set value).
Key PRINT
Enables to obtain a hardcopy of the ECG traces and the device
set-up values.
Key FEED
Paper feed key.

15
Keys F1-F4 secondary functions
Pressing the MENUE key on the screen the secondary functions of F1-F4 will be displayed.
The functions are described on the following table:
BASIC FUNCTION MENU 1 MENU 2
F4
DSCH –internal discharge
Change the ECG traces
displayed/printed: I,II,III or
aVR,aVL,aVF
Enable/disable the
NOTCH filter (line noise)
F3
SYNC – set sync mode Set the scan velocity:
5mm/s,12.5mm/s or 25mm/s
Enable/disable the LP
filter (muscular tremors)
F2
PRINT – start/stop printing Set the ECG trace gain:
5mm/mV,10mm/mV or 20mm/mV
Enter the set-up menu
F1
FEED – paper feed Enable/Disable the alarms sound Exit menu
Light indicators
BATTERY
Charging Light
(on the ON/OFF
key)
Indicates that the AC power supply is connected and the batteries are
charging. When the charge is finished this light will switch off.
When RESCUE 230 is switched on, the light may be on even if the
batteries are fully charged (the device is in backup mode, using the
batteries and the AC supply)
ENERGY
Se ection Light
(on the energy
selection keys)
The light indicates the energy level selected .
DEFIBRILLATION
ENERGY READY
(on the shock Key)
Indicates that the energy selected was charged and the device is
ready for defibrillation.

16
SpO2, heart rate
SpO2 BPM
---- % -----
OPERATIONAL SCREEN
Disp ay Messages guide
CHECK PADS The defibrillation pads are disconnected.
IMPEDANCE
Indicates the impedance out of range (min 20 ohm, max 200 ohm).
Verify the pads contact with the patient chest and add more conductive
gel.
ARMING RESCUE 230 is charging the capacitor to the energy level selected.
READY
Indicates that the capacitor is charged and the device is ready for
defibrillation. In Sync mode the shock will be released only when a valid
ECG wave R peak is detected. In this mode make sure a valid ECG trace
is available on the display.
BAT OK/LOW Indicates the battery status. If LOW then please connect the AC power
supply.
DATE
TIME
HEART
RATE
ECG TRACE
ENERGY SELECTION
BATT STATUS AND FILTERS
SPEED AND GAIN OF THE
ECG TRACE

17
Disp ay organization
When the 4 leads ECG patient cable is disconnected, the display will show only one ECG trace
(II) input from the defibrillation pads.
Connecting the 4 leads ECG patient cable the display will show 3+3 ECG traces: I,II,III or
aVR, aVL, aVF based on the user selection (see menu functions).
Please make sure to connect all ECG patient cable terminals to the patient limbs before
proceeding with the defibrillation.
Using the SpO2 sensor option, the display will show only 2 ECG traces (patient cable
connected) and the SpO2 wave. The So2 and the heart rate will be displayed on the bottom
left side of the display. The heart rate on the top of the screen is related only to the ECG
signals.
The display also indicates the selected energy level, the filters status, the gain and velocity of
the ECG wave as well as the battery status and the clock (date and time).
DEFIBRILLATION PADS CONNECTORS

18
AC POWER SUPPLY CONNECTOR
Input Connectors
Defibri ation Pads input
(left side down)
Used for the defibrillation pads.
For the disposable pads please order also the adapting
cable.
SpO2 input
(front panel)
Used for the SpO2 sensor (optional). The RESCUE230 will
automatically recognize the sensor and will modify
accordingly the display.
ECG patient cab e input
(front panel)
Input for the ECG 4 leads patient cable. The RESCUE230
will automatically recognize the cable and will modify the
accordingly the display.
Battery charger AC
power supp y
(right side down)
Battery charger and AC power supply input.
USE ONLY THE ORIGINAL AC POWER SUPPLY.

19
Device Preparation
Unpacking
1) Carefully inspect the packing container and the device for any damage that might have been
sustained during shipping.
2) Check the shipping list to ensure that the unit comes with the complete accessories.
How to test the defibri ator
Only for the defibrillator testing it is possible to charge from the front panel or the standard
paddles and discharge internally. If the defibrillator is charged using this mode the maximum
energy will be 50J.
It is strong y advised not to charge the defibrillator when the paddles are not attached to the
patient. In this case when attaching the paddles after charging in the testing mode the maximum
energy of the shock will be only 50J independently of the energy preset on the front panel
Defibri ation pads connectors p ug-in
Push the connector (STERNUM-APEX) up to the end and turn it right until it locks.
To unplug the connectors, pull the connector lever and turn it left up to the stop and then pull it
out.
PADS CONNECTUORS INSERTION
It is important to have a the necessary accessories a the time. Make sure
that you have the comp ete accessories during unpacking.

20
Patient Preparation
Evaluate the condition of the patient. The patient must exhibit the symptoms for which the
defibrillation is indicated. These symptoms are:
Unconsciousness
Absence of norma breathing and
Lack of detectab e pu se.
If the patient is exhibiting the said symptoms, do the following:
- Remove clothing from the patient s chest. Wipe moisture and clip or shave excessive
chest hair.
- If using the standards pads, make sure to use on each one enough conductive gel.
- If using disposable pads, peel off their protective sheets. Attach the pads to the patient.
The sticky side must be in contact with the patient s skin. Place the pads in accordance
with the graphic guide at the back of the pads. The placement is also shown in the figure
below
How to connect the patient cab e for ECG monitoring
Lead ‘N’ , : right leg
Lead ‘R’ , (RA) : right arm
Lead ‘F’ , (LL) : left leg
Lead ‘L’ , (LA) : left arm
Connect the patient cable lead in its proper port ‘ECG’ placed on the frontal panel of the device.
Defibri ation procedure
1. Switch on the device using the ON/OFF push button. By default the energy is set to 150 J.
The ECG trace and the heart rate will be displayed .
2. Select the energy level required.
3. If you are using the standard pads, apply the paddles to the patient chest and press both push
buttons on the handles to start charging to the selected energy.
If you are using disposable pads press the CHARGE push button to start charging after placing
the pads to the patient chest.
The ARMING message will be displayed and the charging sound will start.
When the charge ends the READY message will be displayed and on the SHOCK key the red light
will go on. This means that the RESCUE 230 is ready for defibrillation.
STERNUM
APEX
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