IGEA Cliniporator EPS02 User Manual Download

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User Manual

Summary of Contents for Cliniporator EPS02

Page 2: ...MU EPS02ect_UK Rev 3 5_September 2019 Software Rev 2 6 IGEA...

Page 3: ...rode Recognition 28 5 5 Non recognition of the electrode 30 5 6 Electrode selection 32 5 7 ECG Synchronisation 33 5 8 Minimum Requirements for the ECG Synchronisation 35 5 9 Treatment Screen 36 5 10 E...

Page 4: ...evice Directive Classification 93 42 EEC and 2007 47 EEC 59 9 6 Terms of Use 59 9 7 Technical Specifications 59 9 8 High Voltage Pulses 60 9 9 Electromagnetic Compatibility 60 9 10 End of Life Disposa...

Page 5: ...l 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 elect...

Page 6: ...he application of electrical pulses which the system is able to deliver as specified in this manual During electroporation of tumour tissue it is recommended to follow the instructions indicated in St...

Page 7: ...ble control pedal Figure 2 which allows the generation and delivery of electrical pulses Figure 1 Handle Figure 2 Double pedal In order to perform the treatment CLINIPORATOR must be used together with...

Page 8: ...CLINIPORATOR to the handle Figure 1 and or electrodes Grip It is used to facilitate the movement of the device Pedal connector indicated by the wording Pedal It allows to connect the double control p...

Page 9: ...ernal radio device serial port and the power unit found in the lower part of the system USB port A further USB port allows connection with the external devices necessary for data transfer software upd...

Page 10: ...r removable protection fuses and power socket Main electric switch On off switch Transformer and Support for protection fuses Device which allows to select the voltage supply of CLINIPORATOR Protectio...

Page 11: ...tion of flammable mixtures in the area is such that they could explode in the presence of sparks If anesthetic substances containing oxygen or nitrous oxide are used a safe distance between pipes or p...

Page 12: ...code entered through the software interface Disregarding this warning may result in undesirable effects including ineffective treatment unnecessary discomfort for the patient and possible slight compl...

Page 13: ...25 While touching the patient do not touch with bare fingers the RS232 connector on the rear of the monitor 26 On switching on the device check the cooling fans functionality 27 In case of malfunction...

Page 14: ...ght increase the risk that the treatment especially if applied in the precordial area or in proximity of the heart might provoke cardiac fibrillation atrial or ventricular or other arrhythmias In case...

Page 15: ...Surg Oncol 2008 34 232 40 5 Mir LM Bases and rationale of the electrochemotherapy Eur J Cancer Suppl 2006 4 38 44 6 Sersa G The state of the art of electrochemotherapy before ESOPE study Advantages a...

Page 16: ...ion CLINIPORATOR must be installed only by specialized IGEA staff The parameters which allow the operators to access the system username and password are entered during the installation procedure In t...

Page 17: ...in Figure 3 4 5 Work Positions During patient treatment the expected work positions require the device to be outside of the sterile field as shown in Figure 8 Figure 8 Examples of work positions It is...

Page 18: ...system Figure 9 Splash screen loading of the operating system If the monitor power supply green light does not turn on check if the reset button on the lower side of the monitor Figure 4 is not in OFF...

Page 19: ...the FPGA card Testing the overlength alarm Testing capacitor charge and discharge Treatment simulation with test of relay operation Information message on performed checks Software distribution infor...

Page 20: ...second message is displayed inviting the operator to insert a USB pen drive to save the error data by pressing the button or cancel the operation by pressing the button and proceed with the automatic...

Page 21: ...remove the external media Figura 14 USB pen drive scan The message in Figure 15 appears when the Export phase is completed successfully It is therefore possible to remove the USB pen drive and press...

Page 22: ...the error diagnosed is related to the automatic recognition device of the electrode the message shown in Figure 19 appears and the manual recognition procedure is enabled Pressing the confirm button a...

Page 23: ...rer information After typing the username and password in the fields and by using the keyboard if the credentials are correct the confirmation button activates and by pressing it the operator can acce...

Page 24: ...t shows the screen in Figure 23 Only at this stage the device can be turned off moving the rear panel switch Figure 5 ref in O position Figure 23 Turn off screen WARNING Do not move the mains switch t...

Page 25: ...ormation Figure 24 Main menu screen 5 2 System Time Setting In the top right area of the main menu Figure 24 the current date and time are shown The date cannot be modified If the date is incorrect pl...

Page 26: ...nual 26 Figure 25 Time setting screen A dialogue window is displayed Figure 26 with the message that the device will automatically shut down after pressing the confirmation button Figure 26 Automatic...

Page 27: ...bols and _ It is not permitted to use a number as the first character of the patient s name or surname age Figure 27 Patient Data Screen national insurance document number i e health insurance card IM...

Page 28: ...the Patient Data screen The button allows the operator to go back to the main menu Figure 24 The button activates only after recognising at least one electrode and allows to start the treatment In th...

Page 29: ...ted This process is mandatory according to security obligations and allows the use of the same electrode for a single patient for 6 hours only To mark the electrode and to automatically configure the...

Page 30: ...ctrode for the same patient after 6 hours from the first use Electrode code is duplicated The electrode has an invalid or duplicate code and cannot be used for security reasons Electrode has been chan...

Page 31: ...igure 37 is displayed By pressing the confirmation button again the manual electrode security code entry screen is displayed as seen in Figure 35 First select the electrode that you want to use by cli...

Page 32: ...gnised electrode is the one displayed on the window since it is automatically selected The selected electrode is identified through its code displayed against a green background In the field are shown...

Page 33: ...priate connector located on the rear panel Figure 38 ECG connection On the Electrode Selection screen Figure 37 the button will be displayed in order to perform this operation In the beginning this bu...

Page 34: ...en detected the signal is disturbed or the signal is not appropriate In these cases a dialogue box Figure 41 appears allowing the operator to repeat or cancel the process Figure 41 ECG signal not foun...

Page 35: ...g if the signal is in negative logic the correct synchronism with the R wave is not guaranteed capable of delivering a current of at least 15mA delay between R wave and trigger signal lower than 10ms...

Page 36: ...lected are in the top right area For the ECT treatment only in the lower part of the screen is displayed a timer minutes seconds that can be activated by pressing the forward button The timer starts a...

Page 37: ...oing charging process is graphically represented by a battery shown in the button that fills up progressively When the charging process is completed the battery is completely full and the button turns...

Page 38: ...al pressed ongoing treatment In case the pedal pulse is not pressed within 10 seconds the treatment procedure will automatically be cancelled If any treatment is delivered after 5 minutes the capacito...

Page 39: ...res the charging conditions after treatment delivery As soon as the charge button turns green CLINIPORATOR is ready to repeat the treatment The background of the status frame remains coloured to show...

Page 40: ...red background the detection of the pressure of the ARM pedal will be disabled and it will not be possible to deliver the treatment Figura 50 Red ECG icon During application of the treatment an anoma...

Page 41: ...itors are not discharged In addition interrupted treatment data are saved At the end of the countdown time the status window confirms that the treatment has been interrupted and a dialog box displays...

Page 42: ...e of malfunction of the same on the monitor appears a message that provides information on the causes of the problem an example is shown in Figure 58 Figure 53 Serious error in the power part The mess...

Page 43: ...and can be elaborated afterwards through commercial applications such as MS Excel 2003 or later Open Office spreadsheet etc The name of each file related to a treatment is made up of date time name an...

Page 44: ...nformation file status icon exported to be exported back up data yyyymmddhhmmss year month day hour minute second name and family name of the patient corresponding to the patient s data records see se...

Page 45: ...to contain the files to be exported Figure 56 USB stick connection request A subsequent message informs about the free space required for the USB pen drive Figura 57 Richiesta di inserimento della US...

Page 46: ...USB pen drive can be removed By pressing the confirmation button the dialogue box closes and the selected files in Figure 55 are deselected and marked as exported In the only case the function Export...

Page 47: ...length and for presence of partially insulated needles To be used together with Handle IG0M915 Green Needle electrode linear configuration The various models differ for needle length To be used toget...

Page 48: ...ectrode models must be connected to CLINIPORATOR using the Handle accessory supplied together with CLINIPORATOR There are two handle models the Blue and the Green one They are both designed for multip...

Page 49: ...alkaline hydrocarbon based detergents ketone or very strong bases such as sodium hydroxide that could damage the handle The handle can be sterilised in autoclave up to 20 times at 121 C for 15 min ca...

Page 50: ...of the electrode and are not contained in the present manual To deliver a treatment with CLINIPORATOR it is important to follow the electrode recognition process in this way CLINIPORATOR will automati...

Page 51: ...t The electrode has already been used for another patient Use a new electrode Bad ECG signal Treatment aborted ECG signal is noisy or absent for more than 120 seconds Wait for the ECG signal to be res...

Page 52: ...d by the synchronizer is inaccurate select a different Lead refer to the user manual of the synchronizer The synchronizer ECG cable is disconnected Check the connections between the ECG cable and the...

Page 53: ...de Electrode code not allowed in the treatment mode chosen The electrode chosen is not habilitated for EGT mode Select only electrodes habilitated for EGT mode Not in proper state The system tried to...

Page 54: ...error The USB cable coming from the power part is disconnected from the relative USB port of the Panel PC Connect the USB cable coming from the power part to the USB port of the Panel PC Then restart...

Page 55: ...tate Can t reset ECG ABORT condition Internal error Can t test firmware integrity Internal Unknown error Charge error in HV discharging Invalid firmware version Charge error in invalid state No biteta...

Page 56: ...rical hazards or inoperativity of the device Table 1 Routine maintenance 8 2 Periodical Preventive Maintenance Table 2 shows preventive maintenance interventions recommended to ensure correct operatio...

Page 57: ...solating the internal cirtcuits Acting on the button on the Panel PC has no effect as to isolation of any part from the mains voltage 8 5 Fuses Replacement The device is equipped with protection fuses...

Page 58: ...unscrew the screw which secures the cable clip to the rear panel of the device open the cable clip and remove it from the old cable apply it to the new cable at a distance of 23 cm from the VDE plug...

Page 59: ...st electrical risks CLASS I Applied part class Defibrillation proof type BF applied parts Liquids penetration IPX0 No special protection on the device Al least IPX6 Pedals C L IN IPORATO R cannot be u...

Page 60: ...it is used in this environment Emission test Compliance Guidelines electromagnetic environment RF emissions CISPR 11 Group 1 CLINIPORATOR uses a radiofrequency device exclusively for internal functio...

Page 61: ...e as that of a typical commercial or hospital environment Voltage holes short interruptions and voltage changes on lines of power supply input IEC 61000 4 11 5 UT 95 hole in UT per 0 5 cycles 40 UT 60...

Page 62: ...locoa should be lower than the compliance level for each frequencyb level Interference can occur near devices marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for...

Page 63: ...y has been verified Cable Type Maximum length Power Supply cable Not shielded 3 m Electrodes connection cables Not shielded 3 m Pedal cable Not shielded 2 0 m Synchronisation cable ECG Sync Shielded 1...

Page 64: ...1 1 essential performance is defined as the performance of a clinical function for which loss or degradation beyond the limits specified by the manufacturer is deemed to pose an unacceptable risk The...

Page 65: ...f type BF applied part Printed on the front cover of the generator near to the output connector Federal Communications Commission Printed on the data plate 0051 European Conformity mark with the ident...

Page 66: ...indicated beside this symbol Printed on the data plate Electrical source the features of the electrical source used for the generator power supply are indicated beside this symbol Printed on the data...

Page 67: ...cases anticipated and described in this manual 6 Remote connection to the unit is in compliance with the procedures described in this manual by IGEA 7 The operator regularly performs each checking pro...

Page 68: ...ANNEX 1 EC CERTIFICATE...

Page 69: ......

Page 70: ...IGEA S p A Via Parmenide 10 A 41012 Carpi MO Italy PHONE 059 699600 FAX 059 695778 email info igeamedical com http www igeamedical com...

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IGEA Cliniporator EPS02, User Manual

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