Surgical operation equipment and control method thereof

Abstract

The device of the invention for surgical treatment of a patient comprises a device (12) with an electrical generator (19) at which different modes (26, 27, 28) can be selected. In addition to selecting the modes (26, 27, 28) offered and adjusting their effect strength, the certified therapist can generate for himself and, if applicable, for selected colleagues as re-users of the device (12) at least one individual mode and assigned individual mode data (IMD), based on which the generator (19) is operated outside the authenticated mode. In doing so, the therapist can be offered treatment possibilities which would otherwise be denied to him.

Description

Technical Field

[0001] The present invention relates to a device for surgical treatment of an animal or human patient and to a method for operating a treatment device. Background Art

[0002] In electrosurgery instruments are used which are supplied with current and voltage by a supply device in order to produce a desired effect on a patient, such as coagulation, cutting, etc. To this end, the surgical apparatus comprises a radiofrequency generator for generating the therapeutic current and a control device which is usually programmed to operate the generator according to a predetermined pattern.

[0003] In this regard, DE 10 2009 042 428 B4 discloses a method for creating a control program for such a surgical generator. The method is based on the description of states that must be adapted by the surgical generator according to predefined events in the form of a state machine. The state machine is then converted into a control program, by which the instrument and / or the generator is controlled.

[0004] The state machine defines conditions which, if they occur, characterize a transition from a predefined state to another defined state of the system. However, the state machine does not allow transitions to states that would not occur in itself. These are restrictions on the states that can be selected by the user. The same applies if only predefined modes are offered for selection by the user interface of the device for the user and within the context of one mode the intensity of the effect can be adjusted, as is usually the case in practice. Here, too, the user can ultimately choose only between predefined states. The predefined states are approved and documented with their effects and are therefore legally safe. Therefore, no direct access to the physical values ​​of the therapeutic current is provided.

[0005] Furthermore, a method for operating an electrosurgical generator is known from EP 3 028 657 A1, with which algorithms for controlling an electrosurgical generator can be provided. These algorithms use so-called configuration files, which can be modified and processed by an interpreter. Thus, the control of the generator is based on the configuration files. Physical parameters such as, for example, power, current, voltage, energy, coagulation parameters, etc. can be adjusted via a user interface, for example on a scale from 1 to 10 or 1 to 5. The configuration files can be provided in the device or, for example, in a cloud-based update server.

[0006] In addition, EP 3 028 657 A1, WO 2018 / 210792 A1, EP 1 337 194 A1 and EP 1 617 776 B1 show aspects of the control of surgical generators based on algorithms. In particular, it is known from EP 1 617 776 B1 that a user programs an electrosurgical generator by programming commands. The control software thus created can be stored on a mobile computer readable medium and / or can be received or sent by signal transmission. Summary of the invention

[0007] The object of the present invention is to provide an apparatus for surgical treatment of animals or human patients and a method for controlling such an apparatus, by means of which the necessary treatment safety can be achieved on the one hand and minimal restrictions on the medical measures of the treating physician can be achieved on the other hand.

[0008] The device according to claim 1 and the method according to claim 9 meet these inherently contradictory requirements.

[0009] The device of the present invention comprises a device for powering at least one device. The device comprises a generator, which provides a voltage for the device and a current serving the powering of the device. The generator is controlled by a control device, which provides a mode selectable by a therapist for selection by the therapist. The mode data is part of each mode defining a plurality of physical parameters of the current and / or voltage. The control device is configured to control the generator according to the mode data of the mode selected by the therapist.

[0010] Furthermore, the device comprises a selection device, by means of which the treating person can manually select a mode. Furthermore, the selection device provides the possibility of adjustment of the desired effect intensity for at least one, preferably a plurality or all selectable modes.

[0011] In addition, the device can be connected to a memory arranged outside the device via an appropriate data connection. The memory can be, for example, a cloud, a web server or another memory location that can be reached via a data connection. The data connection is in particular a data network, such as a dedicated or public data network, the Internet, etc. Individual mode data can be stored in the memory, the individual mode data being assigned to the individual mode, which is individually assigned to the selected treatment personnel. For this purpose, an identifier is assigned to the individual mode data. The corresponding identifier indicates which permissions the selected treatment personnel has for these individual mode data. Permission can be, for example, the power to modify the individual mode data and / or use the individual mode data.

[0012] The device comprises an authentication device by which the treating person can be individually identified. The treating person can use the individual mode data according to his rights after authentication, i.e., for example, modify them and transfer them to the device for use there. Alternatively, a less privileged user who is only authorized for reuse can be authenticated to transfer the individual mode data for use on his device.

[0013] Furthermore, the authentication device may be configured to register the use of the individual mode data and, if desired or necessary, send it to the accounting unit. The authentication is further configured to block or delete the individual mode data after termination of said authentication.

[0014] With this device, previous safety standards are met and additional treatment options are also opened. However, the usual mode is selectively provided for unauthenticated users, and the effect intensity for the selected mode can be adjusted. If the authenticated treatment staff has the highest authentication level, he can create and / or modify the individual mode data, and thus can directly access the physical parameters of voltage and / or current and other parameters, such as, for example, treatment duration, maximum power, maximum energy, feedback control parameters, evaluation of instrument identification, etc. The individual mode data created in this way can only be used for this one treatment staff to whom the data "belongs". The treatment staff can use these individual mode data in the context of therapeutic medical freedom without specific verification for his activities. He can also create a data table, i.e., a description of the individual mode created by him, or create a data table and can link the description with the individual mode data. Therefore, he can make the individual mode data created by him accessible to the re-user who obtains the authority after authentication, so as to load the individual mode data onto their device and use them there without modifying them. Together with the individual mode data, they can download the data table, i.e., the mode description, and then can use the individual mode in the context of their therapeutic medical freedom. This usage may be detected and may be debited by the accounting module through a licensing model or other accounting model.Re-use of individual schema data may be registered and may be available to the owner of the individual schema data.

[0015] In general, the use of a standard mode or also a specific mode of an individual mode, the duration of use, the number of uses, etc. can be detected and corresponding data generated therefrom. It can be provided that these data are sent to a central server via a data connection. These data can be the basis of a calculation model for charging users for the use of the device or apparatus. If the data are anonymous, they can be used for statistical determination of the mode or use.

[0016] In order to avoid unauthorized reuse of the individual mode data and the attendant dangers to personnel and patients, the authentication device preferably includes a check-out option which prohibits the use of the individual mode data after the check-out of the authenticated treatment personnel. The check-out option may be, for example, an option provided on the screen. Alternatively, it may be connected to the on / off switch of the device so that after switching off the device, the individual mode data are only accessible after authentication by an authorized treatment personnel. This is independent of whether the individual mode data are memory resident contents saved in the device or whether they have to be downloaded again from a memory provided outside the device.

[0017] The distribution of individual modality data to different treatment personnel and the management of their rights allows certified treatment personnel to access their individual modality data at any location, for example, via the Internet, independently of the physical device they work with, independently of the operating room in a hospital or any other local environment. Users can download the data on their devices configured for this purpose in order to be able to use the treatment options developed by them.

[0018] To support the generation of individual patterns, a pattern generator may be provided which detects user input of certified therapy personnel regarding physical parameters of voltage and / or current or other values ​​(power, work, crest factor, etc.) and generates individual pattern data therefrom. The pattern generator allows access to multiple physical parameters of the voltage or current provided with or without professional advice from trained experts in a support central department, where preferably also the memory for storing the individual patterns is located. The physical parameters of the voltage and / or current may be, for example:

[0019] Peak voltage, duty cycle of the voltage and / or current, switch-on duration, applied electrical work, maximum power, a parameter characterizing the intensity or quality of the spark produced, minimum power, envelope shape of the voltage or current, modulation form, modulation depth, time-dependent change of one of the above parameters, change of one of the above parameters depending on a measured value (such as, for example, current, voltage, resistance, etc.).

[0020] The user can access such physical parameters of current or voltage through the pattern generator, which are otherwise excluded from access by the therapist. In doing so, the possibility is provided that the therapist (i.e., physician or other user) develops patterns from their medical experience and provides them for their own use as well as publishes such patterns and makes them available to other physicians (re-users).

[0021] For example, the individual mode can be created via a program or application of an external computer. It can be executed on the server, on an external computer connected to the server, on a device connected to the server or the computer by an external expert, or at the surgical device itself by a treating or assisting person. The external computer can then send the individual mode data directly to the server, or can first transmit them to the surgical device, which then transmits the data to the server.

[0022] For example, the individual modes may be based on predefined modes. For example, the applicant's device provides a "preciSECT" mode, which is used for the operation of dissecting forceps. This mode is characterized in that the maximum voltage and the crest factor are controlled by the resistance value measured at the forceps. This mode cannot be well applied in laparoscopy, because it can lead to undesirable results in case of unintentional contact with the metal trocar. With the possibility of creating individual mode data, the treatment staff can create his own individual mode, which avoids interference effects during laparoscopic application.

[0023] Some users also desire stronger hemostasis and / or less cutting properties of instruments such as electroscalpels. Users can achieve this through adaptation of crest factors and power limits that are not normally accessible as adjustment parameters.

[0024] Another example is the "EndoCutQ" mode provided by the applicant. This mode provides a voltage increase on top of the three cutting pulses so as not to cut too fast during polyp removal with a loop. This mode may be a distraction for some users if he wants to use it during endoscopic submucosal dissection (ESD) with a needle instrument, since now it should not cut initially with a slight delay. By generating a separate mode on the basis of "EndoCutQ", the therapist himself can quickly provide a remedy.

[0025] Another example is the "SwiftCOAG" mode offered by the applicant. The power and regulation voltage of this mode can be adapted by the effect level. However, some applicants expect sharper parts during fewer pump gaps and subsequently more pronounced hemostasis. By the adjustment of the initially higher voltage and power and the reduction of these parameters triggered by the resistance determined at the device, the desired behavior can be achieved. In doing so, such a treatment option can be offered to the therapist if he creates individual mode data for this (which he can then use himself and, if desired, he can license to colleagues).

[0026] With the proposed device and the proposed method for programming the device, the possibility is created to widen the range of usable instruments, since predefined modes are adapted to other instruments in the context of individual mode creation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] These and further advantages as well as modifications and advanced embodiments of the invention are apparent from the drawings, the description and the claims. The drawings show:

[0028] Figure 1 The device of the present invention for powering an apparatus is illustrated in a functional block diagram;

[0029] Figure 2 is a time-dependent progression of generator voltage and current received by the instrument in an exemplary application in graphical form;

[0030] Figure 3 is based on Figure 2 However, the time-dependent course of voltage and current in the case of modifications performed by the user;

[0031] Figure 4 is the time-dependent progression of the generator voltage for different tissue resistances, and

[0032] Figure 5 is the time-dependent progression of the generator voltage for different tissue resistances, however with modification by the user. DETAILED DESCRIPTION

[0033] Figure 1 An apparatus 10 for treating a human or animal patient 11 is shown. Figure 1 1 is shown only symbolically in the form of a cross-section of an arbitrary body part on which an electrosurgical treatment is performed. The device 12 to which the neutral electrode 13 and the instrument 14 are connected is part of the apparatus 10. The instrument 14 comprises at least one electrode 15, via which a treatment current is transmitted to the patient 11, which current is led out of the patient through the neutral electrode 13 and returned to the device 12. The instrument 14 is therefore a monopolar instrument. However, the present invention is not limited to monopolar instruments, but can also be used in bipolar or multipolar instruments. Moreover, the instrument 14 can be an instrument configured for surgical use, laparoscopic use or endoscopic use.

[0034] Furthermore, an external memory 16 is part of the device 10, i.e. a memory provided outside the apparatus 12, which may be, for example, part of an external server 17. The server 17 and / or the memory 16 may be temporarily or continuously connected to the apparatus 12 via a data connection 18. The data connection 18 may be a wired electrical, optical data connection or a radio connection or a combination thereof. In particular, the data connection may be implemented via the Internet.

[0035] The external server 17 can be implemented in the form of separate hardware or as a virtual machine within hardware that includes multiple servers and serves multiple customers. In particular, it can be assumed that the external server 17 is connected or can be connected to multiple devices 12 located at different locations (also in different hospitals or treatment centers). It is possible that all devices 12 of one manufacturer configured for this purpose are connected or can be connected to the same server 17.

[0036] The device 12 comprises a generator 19 for supplying a radiofrequency voltage U to the instrument 14 so that a corresponding radiofrequency current i can flow through the patient 11. In order to provide the voltage U and / or the current i in the desired form, the generator 19 comprises a control input 20 connected to a control device 21. The control device 21 is configured to control the generator 19 in accordance with mode data MD, which are provided for this purpose in a corresponding memory 22. A memory part of a computer-supported device control can be used as the memory 22, wherein the device control implements all the functions described above and below, in particular also the functions of the control device 21.

[0037] The mode data predefine a plurality of physical parameters of the voltage U and / or the current i, wherein the control device 21 is configured to control the generator 19 according to this requirement. The transmission of the mode data MD from the allocated memory 22 to the control device 21 is carried out in Figure 1 Indicated by arrow 23.

[0038] The selection device 24 is part of the apparatus 12, in particular part of its control, wherein the selection device 24 is configured in a selection mode and comprises for this purpose, for example, a control panel with real control elements or a touch screen 25 with virtual control elements. Moreover, every other suitable device for representing symbols, such as a touch pad, a mobile phone or another input / output device, is suitable as the selection device 24. The selection device 24 can be part of the apparatus 12 or can be configured separately therefrom and can then be connected thereto via a data connection.

[0039] The selection device 24 can select different modes via corresponding control elements 26, 27, 28. For example, mode 26 can be a cutting mode, mode 27 a precise cutting mode, and mode 28 a coagulation mode. For example, in the applicant's real device, three monopolar cutting modes (autoCUT, highCUT, dryCUT), two endoscopic cutting modes (endoCUTQ, endoCUTI) and two bipolar cutting modes (autoCUT bipolar, highCUT bipolar) are distinguished. For coagulation, a total of eleven different modes (softCoag, swiftCoag, TwinCoag, preciseSect, sprayCoag, forced APC, pulsed APC, precise APC, soft Coag bipolar, forced Coag bipolar, Thermosil) are established. Another selection switch 29, 30, 31 or a corresponding input panel can be assigned to each optional mode 26, 27, 28 or its selection switch, via which the intensity of the mode can be adjusted. The intensity or effect intensity is therefore generally an exclusively selectable and definable value for the respective selected mode 26 , 27 or 28 .

[0040] For this purpose, refer to Figure 2 . It shows the course of the voltage U at the connection for the instrument 14. Merely by way of example, a mode with a non-modulated radiofrequency voltage is shown for this purpose, for example a cutting mode. Different adjustable effect intensities are assigned to different peak voltages of the radiofrequency voltage generated by the generator 19. In the case of low effect intensities, the radiofrequency voltage U has a small peak value. In the case of high effect intensities, it has a high peak value. The peak value can be selected, for example, via the input device 29.

[0041] In other modes (e.g. precision cutting mode or coagulation mode) and in general, the intensity of the effect that can be selected at the corresponding input device 29, 30, 31 may also refer to other physical parameters. Examples are: internal resistance of the generator, maximum current, minimum current, maximum power, minimum power, conversion power, crest factor, modulation type, pulse-to-pulse ratio or duty cycle with on / off modulation, rise duration and / or fall duration of a single RF voltage impulse, repetition rate of a pulse or pulse train, maximum on time, duration of the increased power at the beginning of activation, amount of activation power at the beginning of activation, etc. However, in any case, the way how the input device affects the physical parameters just mentioned in order to affect the intensity of the effect is set and cannot be changed with the input device and selection switch discussed previously.

[0042] In the context of the adjustment possibilities described so far, the modes provided by the device 12 are approved and verified by the manufacturer of the device. For each of these modes 26, 27, 28 and for each additional generally provided mode provided in the memory of the device 12 or which can be downloaded from the server 17, there is a precise mode description. Thus, the treating staff can be quickly and reliably informed of the provided modes and how they are to be used. The restriction of the mode data MD provided in the memory 22 by the type of operation of the generator 19 thus serves the purpose of patient safety. However, it limits the application possibilities of the device 12.

[0043] According to the invention, it is assumed that the therapist can use additional individual modes of the device 12 that are usually not verified and issued. For this purpose, the selection device 24 includes an authentication device 32, via which the user can establish his own user account and can then always log in to his user account, for example by name and password. The user account is preferably mainly established in the server 17. In addition or as an alternative, it can also be provided in the device 12 as an original or a copy. If the user is already logged in at the device 12, he directly accesses the physical parameters of the voltage U or current i via an additional control panel 33 or other input device, such as, for example: maximum or minimum peak voltage, maximum or minimum peak current, maximum or minimum power, maximum or minimum work done, maximum or minimum switch-on duration, cutting start parameters (current, voltage or other values ​​during the start of cutting), duty cycle, response time, decay time, pause duration, feedback control parameters, etc. For example, the therapist can select a preset and provided mode and change it in addition to adjusting the effect intensity. On this basis, the therapist generates individual mode data IMD, which can be provided in the allocated memory 34. The control panel 33 and the software modules connected thereto thus form a single pattern generator.

[0044] The memory 34 can be a memory area of ​​the device controller or also a separate memory. The individual mode data are sent to the control device 21 during activation, which Figure 1 denoted by arrow 35. In doing so, the therapist can create a modified or completely separate model and use it for his therapeutic purposes in the context of therapeutic medical freedom.

[0045] Furthermore, the device 12 may comprise a communication module 36 connected or connectable to a communication module 37 of the server 17 via the data connection 18. The communication module 36 is thus configured to send the individual modality data IMD generated by the authenticated treatment personnel to the server 17 and via the communication module 37 to the memory 16.

[0046] However, the server 17 is at least preferably not only used for the passive storage of the individual mode data IMD created by the authenticated user. More precisely, the communication module 37 can be supported by a suitable support program during the creation of the individual mode data IMD. For example, a device for correcting the individual mode data IMD can be provided, which indicates the thermal or electrical overload of the instrument 14, the generator 19, or also indicates the expected damage of the patient 11. Such a device can be a simple comparator, for example, indicating the power threshold access to the patient or the maximum voltage or the maximum current. It can also be an artificial intelligence based on an algorithm, or it can also be an artificial intelligence capable of learning, which outputs a warning based on multiple individual mode data created by different treatment personnel, if it obviously deviates from the individual mode data IMD created in other ways. The communication module 37 can also include an interface for human treatment personnel, which is available as a medical and technical personnel (as a contact) and modifies the individual mode data IMD.

[0047] To explain the operation based on the individual pattern data IMD, first refer to Figure 2 It is assumed that the user first selects a common verification mode (e.g. cutting mode 26) and thus selects the highest effect intensity (i.e. the highest voltage peak). During the action on the patient, it is possible to obtain Figure 2 The current course shown in FIG. If the current flows through a tissue with high resistance, the current course is minimum, and if the current flows through a tissue with low tissue resistance, the current course is maximum. To illustrate the present invention, it is now assumed that, for example, Figure 2 The resulting peak current at 38 in FIG. 1 is undesirable. The therapist can avoid this peak current because he adjusts a lower effect intensity. However, this will result in a current that is too low in tissues with high resistance, such as at 39. In the device of the invention, the therapist now has the possibility to create individual modes, such as Figure 3 For this purpose, for example, he defines the maximum absolute value for the peak current |i max In doing so, he created a system in which the current at maximum effect strength does not, however, exceed the maximum absolute value |i max | Single mode.

[0048] The therapist can store this individual mode in the memory 34 and can make it available for later repetition. To do this, he must be authenticated on the device 12. This individual mode is only available to therapists in the context of their therapeutic medical freedom, who are authenticated for using this individual mode. This therapist is the creator of the individual mode or a person who has obtained the right to use it.

[0049] However, the therapist can make the individual modality data IMD available in the server 17 for downloading also by colleagues. His individual modality data IMD are for this purpose provided with an identifier (e.g. a name) which the certified therapist enters via the input device 25 and uploads to the server 17. For this purpose, the certified therapist can also define conditions for reuse (e.g. permission conditions) or select them from a predefined list and link them with his individual modality.

[0050] The creation of individual pattern data IMD is not limited to voltage or current or other electrical parameters. The patterns can also be qualitatively modified or individual patterns can be created. For this purpose, reference is made to Figure 4 and 5 . Figure 4 A precise cutting mode 27 is shown, in which the voltage U is adapted to the determined tissue resistance. In the case of very high tissue resistance, a voltage course A is produced. As the tissue resistance decreases, the voltage course changes to greater distances and shorter pulses until a voltage course D is reached in the case of very low tissue resistance.

[0051] If the therapist realizes, for example, that he has undesirable behavior of the instrument 14 (e.g. too high cutting resistance) in cases of low and very low tissue resistance (C and D), he can modify the selected cutting mode for authentication. For example, he can insert decaying pulses in the pulse pauses in cases of low tissue resistance, such as Figure 5 In the case of very low tissue resistance, he can, for example, apply a low radiofrequency voltage in the pulse pause, as shown in the voltage course D' by way of example only. Other parameters of the voltage course and / or current course or other electrical parameters can also be varied.

[0052] It also applies here that the individual model created in this way can be accessed by other therapists, since it is loaded onto the server 17 as an unauthenticated individual model and is made available there for reuse after authorization.

[0053] The device of the present invention for surgical treatment of a patient comprises a device 12 with an electrical generator 19, at which different modes 26, 27, 28 can be selected. In addition to selecting the modes 26, 27, 28 provided and adjusting their effect strength, the certified treatment personnel can also generate at least one individual mode and associated individual mode data IMD for themselves and, if applicable, for selected colleagues who are re-users in the device 12, based on which the generator 19 can be operated outside the verification mode. In doing so, the treatment personnel are provided with treatment possibilities that would otherwise be denied to him. In one embodiment, the generation of individual modes can be performed without restriction, so that the certified treatment personnel can make all adjustments completely freely within the physical limitations of the device. It is also possible that the device controller limits the adjustment possibilities in order to limit or exclude hazards to patients and personnel. It is further possible that the device control presets different limitations of the adjustment possibilities based on different authentications.

[0054] List of reference numerals:

[0055] 10 Equipment

[0056] 11 patients

[0057] 12 Installation

[0058] 13 Neutral electrode

[0059] 14 Equipment

[0060] 15 electrodes

[0061] 16External memory

[0062] 17 External Servers

[0063] 18Data connections

[0064] 19 Generator

[0065] 20 Generator control input 20

[0066] 21 Control Equipment

[0067] MD Mode Data

[0068] IMD Individual Mode Data

[0069] 22 Memory for pattern data MD

[0070] 23 Arrows

[0071] 24Select Equipment

[0072] 25 Touch screen

[0073] 26 modes (select switch): cutting mode

[0074] 27 modes (select switch): Precision cutting mode

[0075] 28 modes (select switch): Condensation mode

[0076] 29 Input device for cutting mode effect intensity

[0077] 30 Input device for precise cutting mode effect intensity

[0078] 31 Input device for the intensity of condensation mode effects

[0079] 32 Authentication devices

[0080] 33 Control panel, pattern generator

[0081] 34 Memory for individual mode data IMD

[0082] 35 Arrows

[0083] 36 Communication Module

[0084] 37 Communication Block

[0085] 38 Peak current

[0086] 39Minimum current

[0087] |i max | Absolute maximum current value.

Claims

1. A device for surgical treatment of animals or human patients, A device for supplying power to at least one device, wherein: The device comprises a generator for creating a voltage for supplying an electric current to the instrument, and a control device configured to control the generator according to a selectable mode stored in the control device and provided for selection, wherein mode data are assigned to each selectable mode, said mode data defining a plurality of physical parameters of said current and / or said voltage, and wherein said control device is configured to control said generator according to the mode data of said selectable mode, with a selection device which is configured for manual selection of a mode and which is additionally configured for at least some of said selectable modes for adjustment of a desired intensity of effect, having a memory arranged outside the device, in which individual mode data can be stored, the individual mode data being assigned to individual modes which are individually assigned to selected treatment personnel, having an authentication device by which a treatment person can be individually identified and which can be configured to allow the transmission of individual mode data of the authenticated treatment person on the device and / or access to individual mode data stored in a memory of the device for controlling the generator or to create such individual mode data, and which is also configured to block or delete the individual mode data in the event of termination of authentication, characterised in that a pattern generator is provided for generating selectable patterns, which detects a user input of a certified therapeutic person regarding a physical parameter of said voltage and / or said current and is configured to generate allocated individual pattern data, And is characterized in that said individual mode data refers to such physical parameters of said current or said voltage which exceed the available adjustment possibilities in the context of the selection of mode and effect intensity.

2. The device according to claim 1, characterized in that The control device is configured to influence at least one of the physical parameters of the selected mode based on the adjusted effect intensity.

3. The device according to claim 1 or 2, characterized in that The memory arranged outside the device is part of a server which is connected or connectable to the device via a data connection.

4. The device according to claim 1 or 2, characterized in that The authentication device is configured to provide a checkout option for determination of the authentication.

5. The device according to claim 1 or 2, characterized in that The individual mode data may be transferred to a memory along with an identifier identifying the authenticated treating individual.

6. The device according to claim 5, characterized in that The individual mode data stored in the memory assigned to a certified therapeutic person may be accessed by another certified therapeutic person for downloading.

7. A method for operating a therapeutic device: controlling a generator, which is a device for powering at least one instrument capable of generating a voltage and supplying an electric current to the instrument, according to an optional mode stored in a memory and provided for selection, in, Mode data are part of each selectable mode, which define a number of physical parameters of voltage and / or current which cannot be modified by the user and the intensity of the effect which can be adjusted by the user, wherein the treatment person is individually identified by the authentication device, thereby allowing the transmission of individual mode data of the authenticated treatment person to the device and / or access to individual mode data stored in a memory of the device for controlling the generator or creating such individual mode data, and wherein the individual mode data is also blocked or deleted in the event of termination of the authentication, It is characterized in that such physical parameters of the current or of the voltage which exceed the available adjustment possibilities in the context of the selection of the mode and the effect intensity are defined for generating the individual mode data.

8. The method according to claim 7, characterized in that The individual mode data are stored in a memory arranged outside the device, the individual mode data being part of an individual mode which is individually assigned to a selected therapeutic person.

9. The method according to claim 7 or 8, characterized in that: The individual mode data is stored on a server which is connected or connectable to the device via a data connection.

10. The method according to claim 7 or 8, characterized in that: Terminate authentication via the checkout option.

11. The method according to claim 7 or 8, characterized in that: Individual patterns are created by a pattern generator which detects user input by an authenticated therapist regarding physical parameters of said voltage and / or said current and generates assigned individual pattern data.

12. The method according to claim 7 or 8, characterized in that: The individual mode data is transmitted to a memory together with an identifier identifying the authenticated therapeutic staff, and the individual mode data allocated to the authenticated therapeutic staff stored in the memory is published for downloading by another authenticated therapeutic staff.

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