RU2828346C2 - Device for electrosurgical treatment and method of operation thereof - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device for electrosurgical treatment, comprising: an apparatus and a generator for powering an electrosurgical instrument and a control device for controlling the generator in accordance with data (MD) of the selected mode, an external memory for storing data (IMD) of individual modes assigned to the selected operators, authentication device capable of identifying operators to allow access to data stored in the device memory (IMD) to control the generator or to create such data (IMD), wherein to create an individual mode, a mode generator is provided for recording data entered by an authenticated operator and generating corresponding data (IMD). Method of operating a device for electrosurgical treatment, in which a generator of an apparatus for supplying an electrosurgical instrument is controlled, in accordance with selected modes, wherein to each selectable mode there are mode data (MD) specified for change, which determine physical parameters of voltage and/or current, and effect levels set by the user, identifying the operator by means of an authentication device, wherein to generate data (IMD) of individual modes, such physical parameters of current or voltage are set, which are beyond the adjustment capabilities available within the selection of modes and effect levels.

EFFECT: broader capabilities of the doctor-expert on individual adjustment of operating parameters of the apparatus with corresponding increase in the operational flexibility of the apparatus and facilitation of access to the corresponding non-standard settings for authorized users.

12 cl, 5 dwg

Description

The invention relates to a device for electrosurgical treatment of an animal patient or a human patient, as well as to a method for operating the device for treatment.

Electrosurgery uses instruments that are supplied with current and voltage from a power supply to affect the patient's body to achieve the desired effect, such as coagulation, incision, etc. For this purpose, the surgical apparatus has a high-frequency generator to generate the current and a control device, usually with software control, to ensure the generator operates according to specified modes.

In this connection, publication DE 102009042428 B4 discloses a method for constructing a control program for such a surgical generator. The known method is based on representing the states assumed by the surgical generator depending on specified events in the form of a finite state machine. The finite state machine is then converted into a control program, with the help of which the instrument and/or the generator are controlled.

The finite state machine defines conditions which, when they occur, describe the change from one given state to another given state of the system. However, the finite state machine does not allow transitions to states that are not found in it. This is a limitation with respect to the states selected by the user. The same applies to the case where the user is provided with only given modes to select from on the control panel of the device with the possibility of adjusting the effect level within the mode used, as is typical in practice. In this case, the user can ultimately only switch between given states. The given states are tested with documentation of the effects they create and are therefore legally safe to use. Thus, there is no possibility of direct access to the physical quantities of the impact current.

In addition, a method for operating an electrosurgical generator using algorithms for controlling the electrosurgical generator is known from EP 3028657 A1. These algorithms use so-called configuration files, which are modified and processed by an interpreter program. Thus, the generator is controlled based on the configuration files. Physical parameters such as power, current, voltage, energy, coagulation parameters, etc. can be configured via the user interface, for example on a scale with levels from 1 to 10 or from 1 to 5. Configuration files can be provided in the device or, for example, on a cloud update server.

Furthermore, aspects of algorithm-based control of surgical generators are discussed in publications EP 3028657 A1, WO 2018/210792 A1, EP 1337194 A1 and EP 1617776 B1. In particular, publication EP 1617776 B1 describes programming of an electrosurgical generator by a user using software commands. The control software created in this way can be stored on portable machine-readable data carriers and/or can be received or sent by transmitting signals.

The objective of the invention is to create a device for electrosurgical treatment of an animal patient or a human patient, as well as a method for controlling such a device, which would, on the one hand, ensure the safety of the treatment, and on the other hand, impose as few restrictions as possible on the doctor performing the operation with respect to medical interventions.

These mutually contradictory requirements are satisfied by the device according to claim 1 and the method according to claim 7 of the invention formula:

The device proposed in the invention comprises a device for powering at least one tool. The device comprises a generator that produces voltage for the tool, as well as electric current used to power the tool. The generator is controlled by a control device that allows the operator to select modes. Each mode includes mode data that specify the physical parameters of the current and/or voltage. The control device is designed with the ability to control the generator in accordance with the data of the mode selected by the operator.

In addition, the apparatus comprises a selector device by means of which the operator can manually select a mode. Additionally, for at least one selectable mode, preferably for several or all selectable modes, the selector device provides the ability to set (adjust) the desired effect level.

In addition, the device can be connected via a corresponding data line (data transmission line) to a memory located outside the device. This memory can be, for example, a cloud, a web server or another data storage location that can be connected to via a data line. The data line is, in particular, an information network (data transmission network), for example a private or public information network, such as the Internet, etc. The memory can store data of individual modes, individually assigned to selected operators. For this purpose, identifiers are associated with the data of individual modes. The corresponding identifier indicates what rights the selected operator has to these data of the individual mode. These rights can be, for example, the authority to change the data of the individual mode and/or to use the data of the individual mode.

The device contains an authentication device that allows individual identification of operators. Once authenticated, the operator can use the individual mode data in accordance with his/her rights, i.e., for example, he/she can modify this data and transfer it to the device for use in it. Alternatively, a user with a lower privilege level, who has the right only for subsequent use, can be authenticated to transfer the individual mode data to his/her device for use.

Furthermore, the authentication device may be configured to register the use of the individual mode data and - if desired or necessary - to transmit the corresponding information to the accounting unit. The authentication device is also configured to block or delete the individual mode data after the authentication action has been completed.

The device proposed in the invention both ensures compliance with existing safety standards and additionally opens up new possibilities in carrying out treatment. In any case, the unauthenticated user has access to the standard modes with the possibility of setting (adjusting) the effect level for the selected mode. The authenticated operator, on the other hand, can - if he has the highest authentication level - create (generate) and/or change the data of the individual mode and in doing so preferably has direct access to the physical parameters of the voltage and/or current, as well as to other parameters, such as, for example, the duration of exposure during treatment, maximum power, maximum energy, control parameters, evaluation of the result of instrument recognition, etc. The data of the individual mode created in this way can only be used by this one operator, to whom these data thereby "belong". The operator can use these data of the individual mode within the framework of his freedom of action as a doctor in carrying out treatment without the need for separate certification of his activity. In addition, he can himself or through someone else draw up a specification, i.e. a description, of the individual mode created by him and link this description with the data of the individual mode. In this way, he can make the individual mode he has created available to subsequent users, who, after authentication, are authorized to download the individual mode data to their devices and use this data there, but not to change it. Together with the individual mode data, they can download (from the server) the specification, i.e. the description of the mode, and then use this individual mode within the framework of their freedom of action as doctors in carrying out treatment. Information about such use can be collected and accounted for by means of an accounting module in accordance with the licensing model or another usage accounting model. Information about subsequent use of the individual mode data can be registered and made available to the owner of the individual mode data.

In general, it is possible to collect information on the use of certain modes, the duration of such use, the number of use sessions, etc., for standard modes as well as individual modes, and generate corresponding data on the basis of this information. It may be possible to transmit this data via a data line to a central server. This data can be the basis for an accounting model that takes into account the use of the device or instrument by the user. If this data is anonymized, it can serve the purpose of statistical accounting of the use of modes.

In order to prevent unauthorized subsequent use of the personal mode data and the resulting dangers for personnel and patients, the authentication device preferably provides a logout option that blocks the use of the personal mode data after an authenticated operator has logged out of his account. The option to log out can be offered, for example, on the screen. Alternatively, this option can be linked to the power switch function of the device, so that after switching off the device, the personal mode data are only accessible after authentication by an authorized operator. This is independent of whether the personal mode data were resident in the device memory or must be loaded again from a memory located outside the device.

Assigning individual mode data to different operators and managing rights to this data allows authenticated operators, regardless of the physical machine they are working on, regardless of the operating room in a hospital, or other local circumstances, to access their individual mode data anywhere, such as over the Internet. Users can download this data to suitably equipped machines to use the treatment options they have developed.

To support the generation of individual modes, a mode generator may be provided, which is capable of registering the input user data of an authenticated operator in relation to the physical parameters of voltage and/or current or other quantities (power, work, amplitude factor (crest factor), etc.) and generating individual mode data on their basis. The mode generator provides the ability to access several physical parameters of the output voltage or current with or without the ability to obtain professional consultations from trained qualified personnel at the central point providing technical support, which preferably also contains memory for storing individual modes. The physical parameters of voltage and/or current may be, for example, the following: peak voltage, voltage and/or current duty cycle, duty cycle, applied electrical work, maximum power, a value characterizing the strength or quality of the spark discharge created, minimum power, the shape of the modulation envelope of the voltage or current curve, modulation shapes, modulation depth (degree), change in one of the specified parameters over time, change in one of the specified parameters depending on the measured quantities, such as, for example, current, voltage, resistance, etc.

Thanks to the mode generator, the user has access to such physical parameters of current or voltage that are otherwise unavailable to the operator. This creates the possibility for operators (i.e. doctors or other users) to develop action modes based on their medical experience and save these modes for their use, as well as to publish such modes and provide other doctors (subsequent users) with the possibility of using them.

Individual modes can be created, for example, by means of a program or application on an external computer. This can be done on the server, on an external computer connected to the server, on a device connected to the server or such a computer by a third party, or on the electrosurgical unit by the operator or an auxiliary person. The external computer can then send the individual mode data directly to the server or first transmit it to the electrosurgical unit, which then transmits the data to the server.

For example, individual modes can be built on the basis of specified modes. For example, one device of the applicant company has a "preciSECT" mode, which is used for working with anatomical tweezers. This mode is distinguished by the fact that the maximum voltage and amplitude coefficient (crest factor) are controlled by the value of the resistance measured on the tweezers. The use of this mode in laparoscopy can be unfavorable, since when using it, accidental contact with metal trocars leads to undesirable results. The ability to generate data of an individual mode allows the operator to create his own individual mode, with laparoscopic use of which it is possible to avoid interfering effects.

Also, some users want an instrument, such as an electric scalpel, to provide stronger hemostasis and/or less cutting power. The operator can achieve this by adjusting the crest factor and power limit, which are not usually available as adjustable parameters.

Another example is the EndoCutQ mode proposed by the applicant company. This mode provides a voltage increase through three cutting pulses in order to avoid excessively fast cutting when removing polyps with loops. If the user wants to use this mode for endoscopic submucosal dissection (ESD) with a needle instrument, some users will find it disturbing, since in this case, the initial cut with a slight delay is not necessary. By building an individual mode based on the EndoCutQ mode, the operator can quickly help himself here.

Another example is the SwiftCOAG mode proposed by the applicant company. In this mode, the power and adjustable voltage can be adjusted by stepwise selection of effect levels. However, some users want a sharper cut with a shorter stroke of the pump piston, and then a more pronounced hemostasis. This desired behavior can be realized by initially setting higher values of voltage and power and reducing these parameters according to the resistance recorded on the instrument. This makes it possible to offer the operator - if he builds data for individual modes for this - such treatment options that he can subsequently always use himself and, if necessary, license to colleagues.

The proposed device and the proposed method of programming the device create the possibility of expanding the range of instruments used by adapting the specified modes to other instruments within the framework of constructing individual modes. The technical result achieved by implementing the invention consists in expanding the capabilities of the expert physician to individually adjust the operating parameters of the device with a corresponding increase in the operational flexibility of the device and facilitating access to the corresponding non-standard settings for authorized users.

These and other advantages of the invention, as well as its implementation options, are discussed in the drawings, description and claims. The drawings show:

Fig. 1 is a functional diagram of the apparatus for powering the tool proposed in the invention,

Fig. 2 - presented in the form of diagrams curves of the change in time of the generator voltage and the current consumed by the tool in one example of implementing the invention,

Fig. 3 - curves of change in voltage and current over time, similar to those shown in Fig. 2, but with a modification undertaken by the user,

Fig. 4 - curves of the change in generator voltage over time at different tissue resistances and

Fig. 5 shows the curves of the change in generator voltage over time at different tissue resistances, but with a modification undertaken by the user.

Fig. 1 shows a device 10 intended for treating a human patient or an animal patient 11, shown in Fig. 1 only conditionally in the form of a cross-section of an arbitrary part of the body in which electrosurgical treatment is carried out. The device 10 includes an apparatus 12 and a neutral electrode 13 and an instrument 14 connected to it. The instrument 14 has at least one electrode 15, through which an action current is transmitted to the body of the patient 11, which is diverted from the patient by the neutral electrode 13 and directed back to the apparatus 12. Thus, the instrument 14 is a monopolar instrument. However, the possibilities of implementing the invention are not limited to monopolar instruments - it can also find application when using bipolar or multipolar instruments. The instrument 14 can also be an instrument designed for use in open surgery, for laparoscopic or endoscopic use.

The device 10 also includes an external memory 16, i.e. one implemented outside the apparatus 12, which, for example, may be part of an external server 17. The server 17 and/or the memory 16 may be temporarily or permanently connected to the apparatus 12 via an information line 18. The information line 18 may be a wired electrical or optical line, may be a radio line, or may be a combination of these. In particular, the information line may be implemented by the Internet.

The external server 17 may be implemented as a special hardware complex or as a virtual machine consisting of hardware that includes several servers and services several clients. In particular, a connection or the possibility of establishing a connection of the external server 17 with several devices 12 located in different places, in particular in different hospitals or treatment centers, may be provided. A variant is possible in which all devices 12 of the considered purpose, manufactured by one manufacturer, are connected or can be connected to one and the same server 17.

The apparatus 12 comprises a generator 19 for supplying the instrument 14 with high-frequency voltage U, which ensures the possibility of flowing through the patient 11 of a corresponding high-frequency current i. For outputting the voltage U and/or current i of the required shape, the generator 19 has a control input 20, connected to the control device 21. The control device 21 is designed with the possibility of controlling the generator 19 in accordance with the data of the MD mode, which are stored for this purpose, for example, in the corresponding memory 22. The memory 22 can also be the memory area of the computerized device for controlling the apparatus, realizing all the functions considered above and described below, in particular also the function of the control device 21.

The mode data define the physical parameters of the voltage U and/or current i, wherein the control device 21 is designed with the possibility of controlling the generator 19 in accordance with these specified values. The transfer of the mode data MD from the corresponding memory 22 to the control device 21 is shown conditionally in Fig. 1 by arrow 23.

The apparatus 12 also includes a selector device 24, which relates in particular to the apparatus control means, designed with the possibility of selecting a mode and for this purpose having, for example, a control panel with real controls or a touch screen 25 with virtual controls. Any other device suitable for reproducing symbols can also be used as a selector device 24, such as, for example, a touch panel, a mobile phone or another input-output device. The selector device 24 can be part of the apparatus 12 or can be made separately from this apparatus, in which case it is connected to the apparatus by an information line.

The selector device 24 allows selecting different modes by means of the corresponding control elements 26, 27, 28. For example, mode 26 can be a cutting mode, mode 27 - a precision cutting mode, and mode 28 - a coagulation mode. For example, in the actual apparatus manufactured by the applicant company, three modes of monopolar cutting (autoCUT, highCUT, dryCUT), two modes of endoscopic cutting (endoCUTQ, endoCUTI) and two modes of bipolar cutting (autoCUT bipolar, highCUT bipolar) are distinguished. With regard to coagulation, a total of 11 different modes are known (softCoag, swiftCoag, TwinCoag, preciseSect, sprayCoag, forced APC, pulsed APC, precise APC, soft Coag bipolar, forced Coag bipolar, Thermosil). Each selectable mode 26, 27, 28, or selector switch for selecting it, may be associated with an additional switch 29, 30, 31, or a corresponding input field, by means of which the intensity of the mode is set (adjusted). In this case, the intensity or level of the effect is usually the only selectable and settable value for the mode 26, 27 or 28 selected in the corresponding case.

In this connection, reference should be made to Fig. 2. It shows at the top a curve characterizing the change in voltage U at the terminal for connecting the tool 14. Here, only as an example, a mode with an unmodulated high-frequency voltage is shown, for example, a cutting mode. The various adjustable effect levels are assigned to different peak values of the high-frequency voltage generated by the generator 19. At a low effect level, the high-frequency voltage U has a low peak value. At a high effect level, it has a high peak value. The peak value is selected, for example, by means of the input means 29.

In other modes, for example in the precision cutting mode or in the coagulation mode and in general, the effect level selected by means of the corresponding input means 29, 30, 31 may also relate to other physical quantities. Examples of these are: the internal resistance of the generator, the maximum current, the minimum current, the maximum power, the minimum power, the converted electrical work, the amplitude factor (crest factor), the type of modulation, the ratio of the pulse and pause durations or the duty cycle in amplitude modulation, the duration of the rising edge and/or the falling edge of an individual high-frequency voltage pulse, the repetition rate of pulses or pulse sequences, the maximum duration of switching on, the duration of the increased power at the beginning of activation, the level of the activated power at the beginning of activation, etc. However, in any case, how exactly the input means acts on the above-mentioned physical quantities to influence the effect level is fixed and cannot be varied by the input means and selector switches discussed above.

The modes provided by the device 12 within the above-described adjustment possibilities have been tested and certified by the device manufacturer. For each of these modes 26, 27, 28 and for any other mode provided on a general basis, there is an exact description of the mode, available for recall from the memory of the device 12 or available for download from the server 17. In this way, the operator can quickly and reliably obtain information about the available modes and the method of their application. Accordingly, limiting the possible operating modes of the generator 19 to the MD mode data stored in the memory 22 serves the interests of patient safety. But it also limits the possibilities of using the device 10.

The invention provides an additional possibility for the operator to use individual modes in the device 12 that have not undergone the general procedure of certification and permission for use. For this purpose, the selector device 24 contains an authentication device 32, by means of which the user can create his own account (personal account) and then, for example, constantly log into his account using his name and password. In the preferred case, this user account is initially located on the server 17. As a supplement or alternative, it can be stored as an original or a copy in the device 12. If the user has logged into the account on the device 12, he has direct access via additional elements 33 of the control panel or other input means to the physical parameters of the voltage U or current i, such as, for example: maximum or minimum peak voltage, maximum or minimum peak current, maximum or minimum power, maximum or minimum work performed, maximum or minimum duty cycle, cutting start parameters (current, voltage or other values at the start of cutting), duty cycle, rise time, fall time, pause duration, adjustable parameters, etc. For example, via elements 33 of the control panel, the operator can select a previously created and available mode and vary its characteristics, going beyond the effect level setting. On this basis, the operator creates IMD data of the individual mode, which can be stored in the corresponding memory 34. Thus, the elements 33 of the control panel and the software modules connected to them form a generator of individual modes.

Memory 34 may be a memory area of the device control unit or a separate storage device. The data of the individual mode are transmitted to the control unit 21 upon activation, which is indicated by arrow 35 in Fig. 1. The operator can thus create a modified or completely his own mode and use it for treatment within the limits of his freedom of action as a doctor when performing treatment.

In addition, the device 12 may contain a communication module 36, connected or connectable via the information line 18 to the communication unit 37 of the server 17. In this case, the communication module 36 is designed with the possibility of transmitting IMD data of the individual mode, created by the authenticated operator, to the server 17 with the transmission of these data via the communication unit 37 to the memory 16.

However, the server 17 serves, at least preferably, not only for the passive storage of the IMD individual mode data created by the authenticated user. The communication unit 37 can also be supported by suitable auxiliary programs in the creation of the IMD individual mode data. For example, means can be provided for checking the IMD individual mode data, warning of a thermal or electrical overload of the instrument 14 or the generator 19 or of expected damage to the patient 11. Such means can be simple comparators, indicating, for example, the exceeding of threshold values of power on the patient, maximum voltages or maximum currents. In addition, it can be an artificial intelligence based on algorithms or a learning artificial intelligence, which, on the basis of a plurality of IMD individual mode data created by different operators, issues warnings in the event of a significant deviation from the previously created IMD individual mode data. The communication unit 37 may also contain an interface for a human operator who, for example, being a specialist with a medical or technical education, is available as a contact person and checks the IMD data of individual modes.

To explain the operation of the device based on the IMD data of the individual mode, reference should first be made to Fig. 2. In this case, it is assumed that the user has first selected a normal certified mode, for example, the cutting mode 26, selecting the highest effect level, i.e. the highest peak voltage value. During operation on the patient, the current change characteristic may correspond to that shown below in Fig. 2. This current characteristic is minimal if the current passes through tissue with high resistance, and maximal if the current passes through tissue with low resistance. To explain the invention, let us now assume that the resulting peak currents, for example indicated by pos. 38 in Fig. 2, are undesirable. The operator could avoid such peak currents by setting a lower effect level. However, in the case of tissue with high resistance, as shown, for example, by pos. 39, this would lead to too small currents flowing. The apparatus proposed in the invention gives the operator the opportunity to create (build) an individual mode, such as shown in Fig. 3. To do this, he needs to set, for example, the maximum value of the peak current |i _max |. In this way, the operator has created an individual mode in which, at the maximum level of the effect, the current, however, does not exceed the maximum value |i _max |.

The operator can save this individual mode in memory 34 with the possibility of recalling it from memory for repeated use at a later date. To do this, the operator must be authenticated on the device 12. This individual mode is made available only to the operator for use within the framework of his freedom of action as a doctor in carrying out treatment, who has authenticated himself for the use of this individual mode. Such an operator is either the creator of the individual mode or the person who has received the right to use it.

At the same time, such an operator can also upload the IMD data of the individual mode to the server 17, providing colleagues with the opportunity to download them from the server. For this, the IMD data of his individual mode receive an identifier, for example a name, which the authenticated operator enters via the input device 25 and uploads to the server 17. For this, the authenticated operator can set the conditions of subsequent use, for example the conditions for granting a license, or select them from a specified list and associate them with his individual mode.

The creation of IMD data of an individual mode is not limited to limiting the voltage, current or other electrical parameters. It is also possible to make qualitative changes to the modes or to create your own modes. For this purpose, refer to Figs. 4 and 5. Fig. 4 shows the precision cutting mode 27, in which the voltage U is adapted to the determined tissue resistances. At very high tissue resistance, the voltage change is characterized by curve A. As the tissue resistance decreases, the voltage characteristic changes toward longer intervals and shorter pulses until, at very low tissue resistance, the voltage characteristic D is reached.

If the operator finds, for example, that at low and very low tissue resistance (curves C and D) the instrument 14 behaves in an undesirable manner (e.g. the cutting resistance is too high), he can change the selected cutting mode after authentication. For example, at low tissue resistance the operator can include weakened pulses in the interpulse pauses, as shown in Fig. 5 by the voltage curve C'. At very low tissue resistance the operator can, for example, apply a low high-frequency voltage in the interpulse pauses, as is illustrated by the voltage curve D' solely as an example. Other parameters of the voltage characteristic and/or the current characteristic or other electrical parameters can also be varied.

In this case, it is also possible to grant another operator access to the individual mode created in this way, for which purpose this mode is uploaded as an uncertified individual mode to server 17, where it is posted for subsequent use after licensing.

The device proposed in the invention for electrosurgical treatment of patients comprises an apparatus 12 with an electric generator 19, which allows selecting different modes 26, 27, 28. In addition to selecting the available modes 26, 27, 28 and setting the effect level for them, an authenticated operator can create at least one individual mode in the apparatus 12 for himself and, if necessary, for selected colleagues as subsequent users, and generate corresponding IMD data of the individual mode, on the basis of which the generator 19 operates outside the certified modes. This opens up treatment options for the operator that are otherwise unavailable to him. In one embodiment of the invention, the generation of individual modes can be carried out without restrictions, so that the authenticated operator can perform all settings completely freely within the physical limitations of the apparatus. A variant is also possible in which the control device of the apparatus limits the setting options in order to limit or eliminate dangers for patients and personnel. In addition, the control device of the apparatus can set different restrictions on the setting options on the basis of different authentications.

Reference designations:

10 device

11 patient

12 apparatus

13 neutral electrode

14 tool

15 electrode

16 external memory

17 external server

18 information line

19 generator

20 generator control input

21 MD control device mode data

IMD data of individual modes

22 memory for MD mode data

23 arrows

24 selector device

25 touch screen

26 mode (selector switch): cutting mode

27 mode (selector switch): precision cutting mode

28 mode (selector switch): coagulation mode

29 Effect level input tool for cutting mode

30 Effect level input tool for precision cutting mode

31 Effect Level Input Tools for Coagulation Mode

32 authentication device

33 control panel elements, mode generator

34 memory for IMD data of individual modes

35 arrow

36 communication module

37 communication block

38 peak current

39 minimum current

|i _max | maximum current value

Claims (20)

1. A device (10) for electrosurgical treatment of an animal patient or a human patient (11), comprising: - an apparatus (12) intended for powering at least one electrosurgical instrument (14) and comprising a generator (19) producing a voltage (u) for powering the electrosurgical instrument (14) with an electric current (i), and a control device (21) configured to control the generator (19) in accordance with selectable modes (26, 27, 28) stored in memory (22) with the possibility of selecting them, wherein each selectable mode (26, 27, 28) includes mode data (MD) specifying the physical parameters of the current (i) and/or voltage (u), and the control device (21) is configured to control the generator (19) in accordance with the data (MD) of the selected mode (26, 27, 28), - a selector device (24) designed with the possibility of manual selection of a mode (26, 27, 28) and additionally with the possibility of setting the required effect level for at least a portion of the selectable modes (26, 27, 28), - memory (16) located outside the device (12) with the ability to store data (IMD) of individual modes, individually assigned to selected operators, - an authentication device (32) capable of individually identifying operators and configured to permit the transmission to the device (12) of individual mode data (IMD) of the authenticated operator and/or to permit access to the individual mode data (IMD) stored in the device memory (34) for controlling the generator (19) or with the capability of creating such individual mode data (IMD), and also configured to block or delete the individual mode data (IMD) upon completion of the authentication action, characterized in that, for creating an individual mode, a mode generator (33) is provided, configured to register data entered by an authenticated operator in relation to the physical parameters of voltage (u) and/or current (i), and to generate corresponding data (IMD) of the individual mode, wherein the data (IMD) of the individual mode relate to such physical parameters of current (i) or voltage (u) that are outside the adjustment capabilities available within the framework of selecting modes and effect levels. 2. The device according to claim 1, characterized in that the control device (21) is designed in such a way as to influence, on the basis of the established effect level, at least one of the physical parameters of the selected mode (26, 27, 28), relating, in particular, to voltage (u), current (i), power (P), work (W). 3. A device according to one of the previous points, characterized in that the memory (16) located outside the apparatus (12) is part of a server (17) connected or being connected to the apparatus (12) via an information line (18). 4. A device according to one of the preceding paragraphs, characterized in that the authentication device (32) is designed in such a way that it allows the authenticated operator to log out of the account to complete the authentication action. 5. A device according to one of the preceding paragraphs, characterized in that it is possible to transfer data (IMD) of the individual mode to a memory (16) located outside the apparatus (12) together with an identifier identifying the authenticated operator. 6. The device according to claim 5, characterized in that it is possible to allow downloading of individual mode data (IMD) related to one authenticated operator and stored in memory (16) located outside the apparatus (12) for another authenticated operator, who is a subsequent user. 7. A method for operating a device (10) for electrosurgical treatment, including controlling a generator (19) of an apparatus (12) intended for powering at least one electrosurgical instrument (14), generating voltage (u) and supplying electric current (i) to the instrument (14), in accordance with selectable modes (26, 27, 28) stored in memory (22) with the possibility of selecting them, characterized in that: - each selectable mode (26, 27, 28) has preset data (MD) of the mode that are not available for the user to change, defining the physical parameters of voltage (u) and/or current (i), and the effect levels set by the user, - individually identify the operator by means of an authentication device (32), on the basis of which the transmission of the individual mode data (IMD) of the authenticated operator to the device (12) and/or access to the individual mode data (IMD) stored in the device memory (34) for controlling the generator (19) or the creation of such individual mode data (IMD), whereby upon completion of the authentication action the individual mode data (IMD) are blocked or deleted, characterized in that, to generate data (IMD) of individual modes, such physical parameters of current (i) or voltage (u) are set that are beyond the adjustment capabilities available within the framework of the selection of modes and levels of the effect. 8. The method according to item 7, characterized in that the data (IMD) of individual modes, individually assigned to selected operators, are stored in memory (16) located outside the apparatus (12). 9. The method according to item 7 or 8, characterized in that the data (IMD) of individual modes is stored on a server (17) connected or being connected to the apparatus (12) via an information line (18). 10. The method according to one of paragraphs 7-9, characterized in that to complete the authentication action, the ability to log out of the account is provided. 11. The method according to one of paragraphs 7-10, characterized in that the individual mode is created by means of a mode generator (33) that records data entered by an authenticated operator in relation to the physical parameters of voltage (u) and/or current (i), and generates corresponding data (IMD) of the individual mode. 12. The method according to one of paragraphs 7-11, characterized in that the data (IMD) of the individual mode is transmitted to the memory (16) located outside the device (12) together with an identifier identifying the authenticated operator, and the loading of the data (IMD) of the individual mode, related to one authenticated operator and stored in the memory (16) located outside the device (12), is permitted for another authenticated operator, who is a subsequent user.