IGEA Cliniporator EPS02 User manual
User Manual
MU-EPS02ect_UK - Rev. 3.5_September 2019
Software Rev. 2.6
© IGEA
Cliniporator model EPS02 – User manual
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CONTENT
1INTRODUCTION ............................................................................................................................... 5
1.1General Information .................................................................................................................... 5
1.2Intended Purpose of the Device ................................................................................................ 5
1.3Indications for Use ....................................................................................................................... 6
1.4Type of User and Patient ............................................................................................................ 6
2GENERAL DESCRIPTION .............................................................................................................. 7
2.1System Components ................................................................................................................... 7
2.2Description of the CLINIPORATOR Device ............................................................................. 8
3SAFETY INSTRUCTIONS ............................................................................................................. 11
3.1Warnings ..................................................................................................................................... 11
3.2Cautions ...................................................................................................................................... 12
3.3Contraindications and Warnings ............................................................................................. 13
3.4Side Effects ................................................................................................................................ 14
3.5Small Bibliography ..................................................................................................................... 15
4INSTALLATION AND START UP ................................................................................................. 16
4.1System Location and Conditions of Use ................................................................................ 16
4.2System Installation .................................................................................................................... 16
4.3Voltage Supply Selection ......................................................................................................... 16
4.4Operating the C L I N I P O R A T O R Device .......................................................................... 17
4.5Work Positions ........................................................................................................................... 17
4.6System Start up ......................................................................................................................... 18
4.7Selftest Screen ........................................................................................................................... 19
4.8Login Screen .............................................................................................................................. 23
4.9Unit shutdown ............................................................................................................................ 24
5TREATMENT PERFORMANCE ................................................................................................... 25
5.1Main Menu .................................................................................................................................. 25
5.2System Time Setting ................................................................................................................. 25
5.3Entering Patient Data ................................................................................................................ 27
5.4Electrode Recognition ............................................................................................................... 28
5.5Non-recognition of the electrode ............................................................................................. 30
5.6Electrode selection .................................................................................................................... 32
5.7ECG Synchronisation ................................................................................................................ 33
5.8Minimum Requirements for the ECG Synchronisation ........................................................ 35
5.9Treatment Screen ...................................................................................................................... 36
5.10ECG Synchronisation during the Treatment .................................................................... 40
5.11Serious Errors of the Power Part during Operation ........................................................ 42
5.12Storing and Exporting Treatment Parameters and Waveforms .................................... 43
6USE OF ELECTRODES ................................................................................................................ 47
6.1Electrodes ................................................................................................................................... 47
6.2Handle for Connecting the Electrodes .................................................................................... 48
6.2.1Connecting/Disconnecting the handle to CLINIPORATOR ..................................... 48
6.2.2Cleaning, Care and Recommended Replacement of the Handle. .......................... 49
6.2.3Handles Storage Instructions ....................................................................................... 50
6.3Connecting the Electrode to the Handle and How to Use the Electrode .......................... 50
7TROUBLESHOOTING ................................................................................................................... 51
7.1Documented Problems and Solutions .................................................................................... 51
7.2Error Messages .......................................................................................................................... 51
7.3Unknown cause Error Messages ............................................................................................ 55
8MAINTENANCE .............................................................................................................................. 56
8.1Routine Maintenance ................................................................................................................ 56
8.2Periodical Preventive Maintenance ........................................................................................ 56
8.3Cleaning ...................................................................................................................................... 57
8.4Mains isolation ........................................................................................................................... 57
8.5Fuses Replacement .................................................................................................................. 57
8.6Power Supply Cord Replacement ........................................................................................... 58
9TECHNICAL DATA ......................................................................................................................... 59
Cliniporator model EPS02 – User manual
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9.1General Information .................................................................................................................. 59
9.2Power Supply Specifications ................................................................................................... 59
9.3Environmental Conditions ........................................................................................................ 59
9.4EN 60601-1 Classification........................................................................................................ 59
9.5Medical Device Directive Classification 93/42/EEC and 2007/47/EEC............................. 59
9.6Terms of Use ............................................................................................................................. 59
9.7Technical Specifications ........................................................................................................... 59
9.8High Voltage Pulses ................................................................................................................. 60
9.9Electromagnetic Compatibility ................................................................................................. 60
9.10End of Life Disposal ............................................................................................................ 64
9.11Essential performances ...................................................................................................... 64
10SYMBOLS ........................................................................................................................................ 65
10.1Standard Symbols Used ..................................................................................................... 65
10.2Non Standard Symbols ....................................................................................................... 66
11WARRANTY AND MANUFACTURER'S LIABILITY .................................................................. 67
ANNEX 1 - EC CERTIFICATE ................................................................................................................. 68
Cliniporator model EPS02 – User manual
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1 INTRODUCTION
1.1 General Information
The instructions of the present manual pertain solely to the use of C L I N I P O R A T OR EPS02
model, hereinafter referred to as CLI N I P O R A T OR.
CLINIPORATOR shall be operated exclusively by a medical staff who received specific
training and was instructed to correctly use the equipment.
Contact IGEA or IGEA’s authorized distributors to receive all relevant informations.
The instructions for the correct use of electrodes or medical devices necessary for
treatment delivery are not dealt with in this manual. Before using the electrodes, it is
necessary to consult the instruction sheets provided with them.
IGEA reserves the right to implement modifications or updates which will improve the
performance of devices without changing the images or instructions found in this manual.
The Safety instructions found in the following pages are divided into Warnings and Cautions;
Warnings are safety instructions that, if neglected, might lead to serious adverse events
involving the patient, the operator, any other person or the environment.
Cautions are safety instructions that, if neglected, might lead to undesired events, of
marginal or negligible severity, that might involve the patient, the operator, any other
person, or might cause failure to the device.
1.2 Intended Purpose of the Device
CLINIPORATOR is a medical device for electroporation.
Electroporation is a physical phenomenon occurring in the cell membrane as cells are exposed
to an electric field with proper characteristics.
CLINI P O R A T O R delivers voltage pulses based on standard parameters or as specified by
the operator, which are then applied to the patient using the approved type of electrodes.
The potential difference due to the pulses creates an electric field which acts on the cell
membrane and induces an alteration which displays at macroscopic level an increased
permeability of the membrane.
Molecules that normally do not go past the cell membrane either in diffusion or active transport,
after electroporation can reach the intracellular environment.
Electroporation makes it possible, or rather increases the therapeutic effects of injected drugs,
by temporarily increasing the cell membrane’s permeability enabling the cells to absorb the
injected substances.
Electroporation is the basis for electrochemotherapy (ECT)
The device shall not be used for different purposes other than those intended.
THE MEDICAL ASPECT OF TREATMENT PROCEDURES BASED ON ELECTROPORATION IS
NOT DEALT WITH IN THIS MANUAL.
KINDLY READ THE SCIENTIFIC REFERENCE FOR THIS PURPOSE.
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