leroy biotech ELECTROvet EZ User manual

35 Boulevard du Libre Echange – 31650 Saint-Orens-de-Gameville
FRANCE
TEL: [phone]
WEB: www.leroybiotech.com
EMAIL: [email protected]
USER MANUAL V 1.1
ELECTROvet EZ
Z

USER MANUAL
1. INTRODUCTION 3
2. BASIC FEATURES 3
General characteristics 3
General view 4
Symbols and marking 5
Front panel 6
Rear panel 6
Double foot-switch 6
Contact electrode 7
Needle electrode 7
3. GETTING STARTED 8
The unique treatment identifier 8
Start-up 9
The Pulse Evaluation System 10
When does GREEN LED LIGHT ON? 10
When does RED LED LIGHT ON? 10
LCD screen, LED lights& buzzer indications 11
Complete shut-off 11
4. RECOMMENDATIONS FOR USE 12
General recommendations 12
The device 12
The electrodes 12
The environment 13
The contraindications 13
The liability 13
The warranty 14
5. MAINTENANCE 15
Cleaning the box and the foot-switch 15
Cleaning, disinfection and sterilization of the electrodes 15
6. TROUBLESHOOTING 16
7. TECHNICAL SPECIFICATION 17
Protection 17
User interface 17
Standards 17
Disposal and recycling 18
Manufacturer ID 18
8. OUTPUT POWER CURVES 19
History of the treatment 20
9. Connection to an electrocardiogram 22
10.SETTING ELECTRICAL PROTOCOLS 23
General characteristics 23
Recommendations for use 23
Use 23
Technical Characteristics 27
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1. INTRODUCTION
Thank you for choosing the ELECTROvet EZ designed to realize veterinary
electrochemotherapy sessions.
After removing from the box, please check for any transit damage, if damage to the box is found,
please contact LEROY Biotech immediately.
Together with this unit, you will find the following:
-1 double foot-switch ([1 CHARGE] — [2 PULSE])
-1 removable mains lead with earthed connection
-1 electrode
-1 pen
-1 caliper
- 1 USB key containing:
- your invoice
- the user manual of your ELECTROvet EZ
- Terms of Sales of LEROY Biotech
2. BASIC FEATURES
ELECTROvet EZ is a pulse generator. This veterinary device is used for the treatment of tumors
on animals.
General characteristics
-Treatment with electrochemotherapy (applying electrical pulses into a saturated tumor with
cytotoxic agent).
-Standard electrical protocol.
-Control by foot-switch.
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General view
1
ON/OFF switch
8
Foot-switch connector
2
Fuse housing
9
ON LED
3
Electrical plug
10
Charge LED
4
Electrocardiogram connector
11
Active LED
5
USB port
12
Failure LED
6
LCD Display (2 lines)
13
Electrode
7
Electrode connector
14
Double foot-switch
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13
14
1
2
3
4
5
7
8
9 10 11 12
6

Symbols and marking
Symbols
Meaning
Symbols
Meaning
Caution electrode
connector with high
voltage, electric shock
hazard
100-240
V
47-63Hz
Electrical alimentation
Footswitch connector
XXXXX
Serial number
Power indicator
15W
Power
Charge indicator
Time-delay fuses
characteristics
Pulse delivered indicator
IP30
International Protection
Marking 30
Pulse undelivered indicator
Grounded connection
mandatory
Pulse transmission
indicators
CE marking
[email protected]
m
Manufacturer email
address
Refer to this document
GHT-EZ003A
Part number
USB port
Electrocardiogram connector
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Front panel
This comprises indicator lamps, LCD Screen
LED and connectors:
-LCD Screen LED: displays a unique
treatment number as well as information on the
operation of the machine.
-Electrode connector: connection to the
different kind of electrodes.
-Foot-switch connector: connection to the
double foot-switch.
-ON LED: this is blue, lights up when ON/OFF switch of the device is ON (I).
-CHARGE LED: this is orange, lights up after the foot-switch [1 PULSE] have been pressed.
Note: a single "beep" is heard parallel to the press of the foot-switch [1 PULSE].
-ACTIVE LED: this is green, lights up when electrical pulses have been fully transmitted after
pressing the foot-switch [1 CHARGE] then [2 PULSE]. Note: a double "beep" is heard parallel
to the press of the foot-switch.
-FAILURE LED: this is red, lights up when the electrical pulses were not able to be delivered
correctly, after pressing the foot-switch [1 CHARGE] then [2 PULSE]. Note that a long "beep"
is heard parallel to the press of the foot-switch.
Rear panel
-ON/OFF switch: Position I: ON.
-Fuse housing: contains the fuses designed
to protect the unit.
-Electrical Plug: connection to the power
source by a standard plug.
-Electrocardiogram connector: connection
to an electrocardiogram. Only when needed.
-USB port: contains the USB key on which
all your treatments are automatically
recorded.
Double foot-switch
-The double foot-switch sends the electrical
pulses. One should successively press the
left pedal [1 CHARGE] then the right pedal [2
PULSE] for sending pulses.
-The left foot-switch [1 CHARGE] allows for
preparation of the device to send pulses
(loading capacitors).
-The right foot-switch [2 PULSE] allows to
send pulses, once the orange indicator lamps
is on.
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Contact electrode
This electrode allows the treatment of surface
lesions. It is composed of conductive material
and is applied by placing the part
perpendicular to the handle on the lesion.
Connected to the ELECTROvet EZ, it
delivers 8 pulses (1300 V) of 100μsec each 2
msec. A double orthogonal application
permeabilizes cells on 1 cm3.
Needle electrode
-This electrode allows the treatment of
deeper lesions. It is composed of four
needles of 1.5 cm long.
-Connected to the ELECTROvet EZ, it
delivers 8 pulses (1000 V) of 100μsec each 2
msec. On the contrary of the contact
electrode, only a single application is
needed to permeabilize cells on 0.9 cm3.
-If properly maintained, and not damaged,
these electrodes can be reused up to 20
times (1 use = 1 treatment of a lesion during
a session). Any additional use or use of
damaged and / or contaminated instruments is not allowed.
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3. GETTING STARTED
Before using the electroporator for the first time please take time to read the following pages to
familiarise yourself with the operation of the unit.
We strongly recommend that all users of the electroporator are trained in its operation.
The electroporator is very easy to use. By following this simple operating sequence in
conjunction with the pictures of the electroporator, its panels and its symbols, you will be able to
ensure your session has correctly been done every time.
Use of ELECTROvet EZ is restricted to qualified veterinarians only in a practice.
The unique treatment identifier
ELECTROvet EZ generates at each start (O / I) a unique number consisting of a series of
digits and letters on 5 alphanumeric characters. This number corresponds to the unique
treatment identifier.
Example of unique treatment identifier: "00178".
The unique treatment identifier is displayed on the top line of the LCD display.
It is very important to note this unique treatment identifier in the medical file of the
treated animal because it will allow to associate the information collected during the
session of electrochemotherapy and the treated animal.
The electroporator saves in a text file all the information on the session and waveforms
corresponding to the electrical current you have sent, collected during your
electrochemotherapy session. This file is saved on the USB key connected to the USB port at
the back of your ELECTROvet EZ.
The name of this file is composed of the unique treatment number followed by the extension
".TXT".
Thus, if you want to review the profile of the electrical pulses received by the animal during the
electrochemotherapy session No. F5YU3, you will have to look on the USB key for the file
name: F5YU3.TXT.
For this reason it is very important to note in the animal's file this unique treatment
number.
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Start-up
1. Place the device on a level surface or on one that has a slope of less than 10°.
2. Connect the electrode to the electrode connector. Important: do not use an electrode if it
looks damaged.
3. Connect the foot-switch to the foot-switch connector.
4. Connect the electrical plug into the electrical socket.
5. Turn the electrical switch to the ON position (I). The blue LED lights up. The device is ready to
use.
6. Note down the unique treatment identifier in your medical file of the treated animal.
7. Electrode is applied on the lesion.
8. Press on the left foot-switch [1 CHARGE], to charge the device. The orange LED lights up,
displayed message on LCD screen : «#CHARGING#» and single «#beep#» is heard.
9. Press on the right foot-switch [2 PULSE], to send pulses.
-If the electrical pulses have been fully transmitted, a double "beep" is heard and the green
LED lights up.
-If the electrical pulses have not been fully transmitted, a long “beep” is heard and the red
LED lights up.
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The Pulse Evaluation System
The ELECTROvet EZ has an innovative pulse evaluation system.
Thanks to this system it is no longer necessary to visualize the current curves and the intensity
curves of the delivered pulses to ensure that the pulsed train has been delivered perfectly and
therefore will be effective.
We explain below in detail how this evaluation system of delivered pulses works:
When does GREEN LED LIGHT ON?
*Green LED is always accompanied by a short double sound.
*Green LED lights on ( accompanied by a short double sound) ONLY when voltage (Volt)
and current (Amps) comply with the following requirements:
#
1°. the average measured current of each pulse is between 0,1 Amps and 20 Amps,
AND
2°. the average measured voltage of each pulse is between:
GREEN LIGHT = GOOD DELIVERY OF PULSES
_____________________________________________________________________
When does RED LED LIGHT ON?
In all other cases than those mentioned above, the red indicator lights up accompanied
by a long blast.
RED LIGHT = WRONG DELIVERY OF PULSES
1,200 Volts and 1,300 Volts for contact electrodes
450 Volts and 500 Volts for needle electrodes.
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LCD screen, LED lights& buzzer indications
Complete shut-off
Turn the ON / OFF switch to O.
BLUE
ORANGE
GREEN
RED
Buzzer
State
LCD Screen
blink
off
off
off
(1) Electrode not connected
NO ELECTRODE
blink
blink
blink
blink
(2) Reboot due to watchdog
detected
ERROR[001] - CONTACT
LEROY BIOTECH
blink
blink
blink
off
(3) Client ID not
programmed
WRONG CLIENT ID
blink
blink
off
off
(4) Until USB key removal
WRONG FILE
PARAMETERS
blink
off
blink
off
(4) Until USB key removal
UPDATE OK
blink
blink
off
off
USB Key must be always
connected
USB KEY MISSING
on
off
off
off
(5) Electrode connected
ELECTRODE OK
blink
off
off
blink
(6) No configuration for
electrode
ELECTRODE UNKNOWN
on
off
off
off
(7) System ready
READY
on
blink
off
off
System charging
CHARGING
on
on
off
off
1 short
beep
System charged
CHARGED
blink
blink
off
blink
1 long
beep
(8) System locked
ERROR[002] - CONTACT
LEROY BIOTECH
on
off
off
off
Sending pulses
SENDING PULSES
on
off
on
off
2 short
beeps
Pulses delivered
DELIVERED
on
off
off
on
1 long
beep
Pulses not delivered:
electrodes are not in contact
with the tumor
NOT DELIVERED
on
off
off
on
1 long
beep
Disjunction: the pulses
cannot be delivered
DISJUNCTION
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4. RECOMMENDATIONS FOR USE
WARNING: ELECTRIC SHOCK HAZARD
ELECTROvet EZ generates high voltages. Users must read and apply
following recommendations.
General recommendations
-Before using the device for the first time, clean, decontaminate and sterilize the electrode.
See Section - Maintenance.
-Before the ELECTROvet EZ is used for the first time, it is essential to carry out tests on a
plastic surface to determine how pulses are sent and to help to adopt the right clinical
procedure. Repeat these exercises as many times as necessary.
-The disassembly of the device is strictly prohibited. To maintain LEROY Biotech product
warranty, it must not be altered or modified in any way. Changes or product modifications will
void your warranty.
The device
-Make sure the device is properly plugged in. The use of the electrical socket with its grounded
connection is mandatory.
-Check the accessories and cords regularly to locate any insulation fault and replace them if
necessary.
-Do not use the device if it occurs to be defective in any way. In the event of a malfunction,
contact the supplier.
The electrodes
-It is essential to replace used or damaged ELECTROvet EZ accessories with the appropriate
new ELECTROvet EZ accessories to avoid damaging or burning out the device.
-Prior to each use, needle electrodes must be cleaned, decontaminated and sterilized.
Connected electrodes that are not being used temporarily must be kept well away from the
patient.
-The patient should never come into contact with grounded metal parts (operating table,
support, etc.) during the use of the device. If you want to minimize the motion of the patient
when the pulses are delivered, try the following tips:
-use ropes,
-protect the down side eyes,
-avoid the nerves.
-Direct contact between the practitioner’s skin and the patient’s should be avoided when the
pulses are being delivered.
-ELECTROvet EZ has a safety system that limits the intensity delivered. If the device detects
that intensity is too high, it stops sending pulses. This occurs when the resistance of the
treatment area is too weak (too much pressure applied with the electrode, too much gel, liquid
or blood on the treatment area, i.e., in a conductive environment).
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-If an impulsion is observed on another human being than the animal, a light numbness will be
felt without any grave consequences.
-«#Type of electrodes should be chosen according to the particular target tissue and provided
appropriate electroporation in whole desired treated#area. A good contact between electrodes
and the skin is essential, which can be assured by depilation and an application of a water-
based gel when [contact] electrodes are used. For deeper, e.g., subcutaneous,
tumor#nodules, needle, invasive electrodes should be used to achieve the target tumor
tissue.#» (Tozon et al, 2016).
The environment
-Due to the electromagnetic field, there may be some disturbances caused to other electrical
equipment when ELECTROvet EZ is in use.
-For users with a pacemaker or any other active implant, there is a potential risk due to
possible interference affecting the pacemaker. If there is any doubt, seek the advice or
approval of suitably qualified persons.
-ELECTROvet EZ can be used in presence of pregnant women.
The contraindications
-The use of the ELECTROvet EZ should follow the same chemotherapy regulations observed
in your own country.
-The limitations of electrochemotherapy using the LEROY Biotech ELECTROvet are:
-Lack of understanding of the theory of electrochemotherapy.
-Incomplete anesthesia.
-Disregard of the patient's general condition.
The liability
LEROY Biotech may not be held liable in any of the following cases:
- Failure to follow LEROY Biotech's recommendations.
- Repairs, including those carried out by persons not approved by LEROY Biotech.
- Any use other than the uses specified in this manual.
- Failure to comply with the requirements specified in this manual.
LEROY Biotech reserves the right to modify the unit and/or amend the user manual without prior
notice.
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The warranty
LEROY Biotech shall, in the first 36 months from the date of purchase, repair or replace free of
charge any parts which prove to be defective in workmanship and/or materials.
LEROY Biotech shall not be so liable in the event that the purchaser has failed to adhere to the
instructions contained herein or if the electroporator has been abused, interfered with, altered,
repaired or serviced by any unauthorized party that may also result in the protection provided by
the equipment being impaired.
Consumer’s statutory rights are not affected.$
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5. MAINTENANCE
Cleaning the box and the foot-switch
-The foot-switch is designed for use in a damp environment (protection factor: 67). The rest of
the device, except the electrodes, must be kept shielded from spatters of excessive liquids
(protection factor: 30).
-It is not advised to use cleaning products or disinfectants that contain flammable agents. If
this is necessary, however, make sure the product evaporates and that no traces of the
combustible agent remain on the device or electrodes when starting it up.
Cleaning, disinfection and sterilization of the electrodes
a) Necessary equipment
-Running water
-Latex gloves
-Containers
-Cleaning product
-Drying wipes
-Microporous sterilizing bag 270mm*70mm
-Sealing machine
-Autoclave
b) Cleaning and disinfecting
-Rinse with running water.
-Clean with cleaning product in a container.
-Rinse with running water.
-Disinfection in a surgical spirit bath in another container (500mL in 5L).
-Rinse with running water.
-Dry with wipes.
Remove any fragments of tissue that may have adhered to the electrode. Make sure the product
has completely evaporated.
Do not attempt to clean an electrode in an ultrasonic tank.
c) Put in microporous sterilizing bag
-Cut the microporous sterilizing bag at 20 cm.
-Seal the electrodes in the bags.
d) Sterilization
The entire electrodes can be sterilized. The electrodes have been tested 20 times each without
any deformation or alteration of the color of efficiency.
It is essential to sterilize the electrode before each use.
Requirements and sterilization cycle according to the equipment:
Wet heat sterilization: 122.5°C at 1.16 bar for 20 minutes.
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6. TROUBLESHOOTING
Faults
Possible causes
Remedies
Nothing working, the blue
LED doesn't light up
The ON/OFF switch is
on O (Off)
Turn the ON/OFF switch to I
(On)
Power cord not properly
connected
Check the electrical plug
No electrical current
Check electrical current supply
Fuse(s) not working
Change the external fuses
Only the blue LED flashes,
«#NO ELECTRODE#»
message
Electrode not connected
Connect the electrode
Faulty electrode
Replace the electrode
The blue LED lights up but
the orange LED does not
Foot-switch not properly
connected
Connect the foot-switch
Faulty footswitch
Replace the foot-switch
Needle electrode is difficult to
insert into the lesion
Needle electrode worn
Replace the electrode
The tumor is too hard
Use the L-shaped electrodes
Electrical pulses not
delivered, the red LED lights
up and a long “beep” is heard
+ «#DISJUNCTION#»
Right foot-switch 2
PULSE was not pressed
long enough
Repeat the procedure. Press on
left foot-switch 1 CHARGE then
right foot-switch 2 PULSE longer
Difficult contact with the
lesion and contact
electrode
Contact with the lesion should
not be too firm to allow the
electrical pulse movement from
cell to cell. Contact electrode
should be applied to the lesion
without pressure
Electrode worn
Replace the electrode
Tumor too bloody
Dry the tumor and repeat the
procedure
Soiled electrode
Set the device to O (Off)
position and clean the electrode
Electrical pulses not
delivered, the red LED lights
up and a long “beep” is heard
+ «#NOT DELIVERED#»
The electrodes are not
in contact with the tumor
Place the electrodes on the
tumor and repeat the procedure
Two or more LEDs flash with
one long beep
Electrode configuration
unsuitable
Contact LEROY Biotech by
giving them the displayed
message
The blue LED and the orange
LED flash «#USB key
missing#»
USB key not connected
Connect the USB key
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7. TECHNICAL SPECIFICATION
Protection
Two 5 mm x 20 mm 2.5A time-delay fuses type IEC 60127-6 (2 W - for example: ref. 0034.3125
Schurter).
User interface
ON/OFF switch on rear panel.
Electrical cord, electrode and foot-switch connectors.
Blue, orange, green, red indicator lamps.
Buzzer (95 dBA at 10 cm).
Standards
Manufactured in accordance with the regulations and standards in force:
-2006/95/CEE of 12/12/2006,
-2004/108/CEE of 15/12/2004,
-Transposition to the French national legislation by Decree no. 95-1081 of 03/10/1995,
-NF EN 60 335-1 of 2013,
-NF EN 55 011 and A1 of 2011,
-NF EN 61000-6-1 of 2007,
-NF EN 61 000-3-2 of 2006,
-NF EN 61 000-6-3 and A1 of 2011.
ELECTROvet EZ is not authorized for use on humans. This device is reserved for veterinary use
only. LEROY Biotech is not responsible for any other uses.
Weight
3.3 Kg
Dimensions
190 x 90 x 320 mm
Working Altitude
0 - 2000m
Operating temperature
5- 40° C
Storage temperature
0 - 70 °C
Working relative humidity
0 - 70 %
Input Voltage
90 - 264 VAC
Alternating current frequency
47 - 63 Hz
Storage relative humidity
0 - 90 %
Maximum Voltage
1500V
Maximum Current
20A
Output frequency
0.1 Hz - 10 kHz
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Disposal and recycling
Due to the legislation (decree n°2005-829), July 20th 2005, purchase of electrical and electronic
equipment imposes duties on the user to organize and finance the removal and treatment of
waste.
-ELECTROvet EZ and its accessories can only be disposed of by an authorized collector of
electronic devices or by return to LEROY Biotech.
-Under no condition should ELECTROvet EZ or its accessories be disposed of by the user.
Be sure this product is disposed of correctly; you will help to protect the environment.
-The use of the WEEE symbol indicates that this product must not be treated as household
waste, but must be treated separately, in conformity to the Directive 2002/96/CE.
-For more detailed information on the recycling of this product, please contact your local
authority or your house waste disposal service provider.
Manufacturer ID
LEROY Biotech
35 Boulevard du Libre Echange – 31650 Saint-Orens-de-Gameville - France
TEL: [phone] - EMAIL: [email protected] - WEB: www.leroybiotech.com
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8. OUTPUT POWER CURVES
With contact electrode:
With needle electrode:$
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1300
Voltage (V)
0 2 4 6 8 10 12 14 Time
(msec)
500
Voltage (V)
0 2 4 6 8 10 12 14 Time
(msec)

History of the treatment
CAUTION: THE USB KEY MUST ALWAYS BE CONNECTED TO THE
ELECTROVET EZ USB PORT FOR SAVING THE HISTORY OF THE
TREATMENTS.
The ELECTROvet EZ has a removable 16GB USB drive on which files are stored with a
history of your treatments.
Thanks to these files it is possible to keep all the information related to a treatment
(delivered pulses, voltage, intensity, duration, etc.) and to visualize this information in a
spreadsheet (excel, numbers, etc).
Following is the main features of this file of histories.
1. General information about the files type
The output file will be a coded text file. The character separator will be the character <TAB>.
2.Name of the file
The file name has the following structure: <TREATMENT_ID> .txt where
<TREATMENT_ID> is the unique treatment identifier automatically generated by the
ELECTROvet EZ and displayed on the first line of the LCD device screen when you switch
the device on.
This unique number automatically changes each time the device is restarted
(activation of the ON / OFF button). There is no other way to change this unique number than to
restart the ELECTROvet EZ.
3. File saving
The file is created if and only if a USB key is connected to the ELECTROvet EZ.
If a USB key is connected to the ELECTROvet EZ then the file is saved to the root of the
key.
If no USB flash drive is connected to the ELECTROvet EZ, it is impossible to output
pulses and the device will display an error by flashing the BLUE and ORANGE LEDs, and
displaying the message : «#USB KEY MISSING!».
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