Medical device

Abstract

Medical device comprising a first electronic assembly (50) and at least a second electronic assembly (30, 60, 70, 80, 90, 100) which is detachably connected to the first electronic assembly (50) such that - during normal operation of the medical device, at least one second electronic assembly (30, 60, 70, 80, 90, 100) cannot be separated from the first electronic assembly (50), and - during maintenance and / or repair of the medical device, at least one second electronic assembly (30, 60, 70, 80, 90, 100) can be separated from the first electronic assembly (50), characterized in that the first electronic assembly (50) includes a control unit which is configured to detect a permanent or temporary separation of the at least one second electronic assembly (30, 60, 70, 80, 90, 100) from the first electronic assembly (50), wherein the first electronic assembly (50) comprises an uninterruptible power supply (52), the at least one second electronic assembly (30, 60, 70, 80, 90) comprises a volatile data storage device (31, 61, 62, 71, 72, 81, 82, 91, 92) which, when connected between the first electronic assembly (50) and the at least one second electronic assembly (30, 60, 70, 80, 90, 100), is supplied with an operating voltage by the uninterruptible power supply (52) in order to prevent loss of the data stored on the volatile data storage device (31, 61, 62, 71, 72, 81, 82, 91, 92), and wherein the control is configured to access the volatile data storage (31,61,62,71,72,81,82,91,92) for writing and reading when the first electronic assembly (50) is connected to at least one second electronic assembly (30,60,70,80,90).

Description

[0001] The invention relates to a medical device comprising a first electronic assembly and at least one second electronic assembly which is detachably connected to the first electronic assembly in such a way that, during normal operation of the medical device, the at least one second electronic assembly cannot be separated from the first electronic assembly, and during maintenance and / or repair of the medical device, the at least one second electronic assembly can be separated from the first electronic assembly.

[0002] Modern medical devices typically contain several electronic assemblies that perform different functions. These usually include a control assembly, which comprises the main control system of the medical device, and one or more functional assemblies, which contain the circuits required for specific functions of the medical device. However, for the purposes of this invention, the term "electronic assemblies" also refers to assemblies whose primary function is not electronic, but rather, for example, mechanical, as long as these assemblies contain electronic components. This can explicitly include electronic components that are solely intended to detect or indicate the separation of the respective assemblies from other assemblies.

[0003] The control module can, for example, include a standard PC with a processor, memory modules, and a user interface, while functional modules can include high-frequency generator modules, microwave generator modules, ultrasonic generator modules, pumps, and / or valves. Other functional modules can include patient interface modules for galvanic isolation of a patient circuit or monitoring modules for detecting malfunctions of the medical device.

[0004] Due to the high complexity of such medical devices, the individual electronic components are designed as separate assemblies that can be detachably or connectably linked. The connection is usually made via screw terminals or plug connectors.

[0005] The connections are designed in such a way that separation of the assemblies from one another is not intended during operation of the medical device. For this purpose, the assemblies are, for example, arranged in a common closed housing.

[0006] However, during maintenance or repair of the device, the assemblies may or must be separated from each other, for which the common housing is opened and / or removed.

[0007] For patient and operational safety of such medical devices, it is essential that the correct, coordinated function of all components is tested after assembly. This is the only way to reliably prevent malfunctions due to faulty or incomplete connections. This functional test is generally performed and documented by the manufacturer as part of the final inspection before delivery.

[0008] During its intended lifespan, a medical device requires regular maintenance, which may necessitate opening or removing the device's housing. Repairing the medical device may also require opening or removing the housing.

[0009] Since, in principle, every time the housing is opened or removed, there is a possibility that a connection between electronic components of the medical device has been at least temporarily interrupted, a complete functional test of the medical device must always be performed. This is time-consuming and sometimes unnecessary if a disconnection of components has not actually occurred. However, if the functional test is omitted, there is a risk that the patient and / or operational safety of the medical device will be compromised by a connection that was once disconnected and subsequently reconnected incompletely or incorrectly.

[0010] US Patent 2013 / 0 191 032 A1 describes a method for validating a medical device with multiple components, each component having specific software stored on it. To ensure that the software components of a system are compatible, the software versions of all components are determined at startup and compared with a compatibility database. US Patent 2012 / 0172687 A1 describes a method for checking the compatibility of a computer with a medical device. For this purpose, simulated or recorded data from the medical device is fed into a control program running on the computer, and the computer's outputs are checked to see if they match the expected outputs. German Patent DE 10 2014 219 572 A1 describes a system with multiple electronic modules that can communicate with each other via various wireless interfaces.The DE 10 2015 003 967 A1 describes a modular ventilation system comprising a ventilator which can be extended with additional modules to include further functions.

[0011] The object of the invention is therefore to reduce the effort required for the maintenance and / or repair of a medical device without compromising patient and operational safety.

[0012] This problem is solved according to the invention by a medical device comprising a first electronic assembly and at least one second electronic assembly which is detachably connected to the first electronic assembly in such a way that, during normal operation of the medical device, the at least one second electronic assembly cannot be separated from the first electronic assembly, and during maintenance and / or repair of the medical device, the at least one second electronic assembly can be separated from the first electronic assembly, characterized in that the first electronic assembly includes a control unit which is configured to detect a permanent or temporary separation of the at least one second electronic assembly from the first electronic assembly.

[0013] Because the medical device's control system automatically detects whether a connection between two electronic assemblies has been permanently or temporarily severed, it can be ensured that a comprehensive functional test is performed when necessary. Conversely, the functional test can be omitted if it is not required because no separation of electronic assemblies has occurred. In the context of this invention, the term "separation" also includes the replacement of the affected assembly with a substitute assembly.

[0014] According to a further development of the invention, the control system can be configured to prompt a user of the medical device, via a user interface, to subject the medical device to a functional test upon detection of the separation of at least one second electronic assembly from the first electronic assembly.

[0015] The final inspection of a medical device after a maintenance procedure can, in this case, consist of briefly putting the device into operation, i.e., switching it on. The user is then prompted to perform a functional test if necessary. Otherwise, the medical device is immediately ready for use.

[0016] The functional test can be a full or limited functional test, whereby the medical device's control system can specify the required scope of the test based on the type and number of separate assemblies. The functional test may include electronic or mechanical adjustments.

[0017] In a preferred embodiment of the invention, the control system is configured to allow the medical device to be put into operation only after a functional test has been performed. This prevents a user from accidentally or improperly putting the medical device into operation after maintenance or repair without performing the necessary functional test.

[0018] According to the invention, the medical device is designed such that the first electronic assembly comprises an uninterruptible power supply, the at least one second electronic assembly comprises a volatile data storage device, which, when a connection exists between the first electronic assembly and the at least one second electronic assembly, is supplied with an operating voltage by the uninterruptible power supply in order to prevent loss of the data stored on the volatile data storage device, and that the control system is configured to access the volatile data storage device for writing and reading when a connection exists between the first electronic assembly and the at least one second electronic assembly.

[0019] The uninterruptible power supply can be a buffer battery.

[0020] In a further embodiment of the invention, the connection between the first electronic assembly and the at least one second electronic assembly is established via at least one third electronic assembly, which in turn is detachably connected to the first electronic assembly and the at least one second electronic assembly. In this way, connections to electronic assemblies that are not directly connected to the first electronic assembly can also be monitored.

[0021] In an advantageous further development of a medical device according to the invention, the control system is configured to write first recognition data to the volatile data storage after a successful functional test of the medical device, to read second recognition data from the volatile data storage at each commissioning of the medical device, and to detect a temporary or permanent separation of the at least one second electronic assembly from the first electronic assembly if the read second recognition data does not match the written first recognition data.

[0022] The initial identification data could, for example, be a timestamp generated after successful functional testing of the medical device. This timestamp is written by the controller to the volatile data memory of at least one other electronic module. When the medical device is put into operation, the controller reads the volatile data memory and compares the read data with the previously stored timestamp. If the connection between the modules has been interrupted since the last functional test, the contents of the volatile data memory are lost and can no longer correspond to the original timestamp. The controller recognizes that the modules have been disconnected from each other in the interim.

[0023] In one embodiment of the invention, the medical device may be an electrosurgery generator or may comprise an electrosurgery generator.

[0024] Additionally or alternatively, the medical device may be or include an ultrasound generator.

[0025] The medical device may also additionally or alternatively be a microwave generator or include a microwave generator.

[0026] The invention is explained below using several figures as examples. These show: Fig. 1: an electrosurgical system, Fig. 2: a medical device.

[0027] In Fig. Figure 1 shows an electrosurgical system 1, consisting of a medical device 10, which in this example is an electrosurgical generator, and two applicators 20 and 21. Applicator 20 can be connected to the medical device 10 via a connector 22. Applicator 21 can be connected to the medical device 10 via a connector 23. For this purpose, the medical device 10 has sockets 24 and 25.

[0028] The medical device 10 also has a user interface 30, which in the example shown is designed as a touch-sensitive monitor (touchscreen).

[0029] In Fig. Figure 2 shows the basic structure of the medical device 10. The medical device 10 comprises the user interface 30 with a daughterboard 35, a power supply unit 40, a control unit 50, a high-frequency generator unit 60, a microwave generator unit 70, an ultrasound generator unit 80, a patient interface unit 90, and a monitoring unit 100. The sockets 24 and 25 are arranged on the patient interface unit 90.

[0030] The modules 30, 35, 60, 70, 80, and 90 each comprise volatile data storage devices 31, 36, 61, 62, 71, 72, 81, 82, 91, and 92, the function of which will be explained later. The control module 50 comprises a non-volatile data storage device 51.

[0031] The control module 50 is supplied with operating voltage by the power supply module 40 via connection 101. The control module passes the operating voltage on to the user interface 30, the daughterboard 35, and modules 60, 70, 80, 90, and 100 via connections 101, 102, 103, 104, 105, 106, and 107. In parallel, the operating voltage charges a buffer battery 52 located in the control module 50, which continues to supply operating voltage to modules 30, 35, 60, 70, 80, 90, and 100 when the power supply module 40 is switched off. The buffer battery 52 is typically a rechargeable battery. Alternatively, a non-rechargeable battery can be used; in this case, charging the buffer battery 52 by the operating voltage is omitted.

[0032] The control module 50 also exchanges input and output data with the user interface 30 via connection 102.

[0033] Via connections 103, 104, and 105, control module 50 sends control commands to modules 60, 70, and 80. Likewise, the output signals generated in modules 60, 70, and 80 are transmitted via these connections to control module 50, from where they are routed via connection 106 to patient interface 90. At patient interface 90, the output signals from modules 60, 70, and 80 are galvanically isolated and routed to sockets 24 and 25, depending on the desired operating mode.

[0034] The monitoring module 100 continuously determines the operating states of modules 60, 70, and 80 via connections 108, 109, and 110, and the operating state of the patient interface 90 via connection 111. If an impermissible operating state is detected, the monitoring module sends a shutdown signal to the control module 50 via connection 107.

[0035] The medical device 10 is built into a closed housing 120.

[0036] After the medical device 10 has been assembled, it must undergo a complete functional test. This functional test is triggered via the user interface 30 and monitored by the control unit 50. After a successful functional test, the control unit generates a recognition signal, which may be a timestamp, and stores it in the data memory 51.

[0037] In parallel, the control unit 50 writes the recognition signal to the data storage devices 31, 36, 61, 62, 71, 72, 81, 82, 91, 92.

[0038] When the power supply unit 40 of the medical device 50 is switched off, the battery 52 takes over the electrical supply of the data storage units 31, 36, 61, 62, 71, 72, 81, 82, 91, 92. Data storage units 31, 61, 71, 81, 91 receive their operating voltage directly via connections 102, 103, 104, 105, 106. Data storage units 62, 72, 82, 92, on the other hand, receive their operating voltage via connection 107, the unit 100, and connections 108, 109, 110, 111. Data storage unit 36 ​​receives its operating voltage via the user interface 30.

[0039] Each time the medical device 10 is put into operation, the control unit 50 now reads the data storage devices 31, 36, 61, 62, 71, 72, 81, 82, 91, 92 and compares the read data with the data stored on the non-volatile data storage device 51.

[0040] If any of the connections 102, 103, 104, 105, 106, 107, 108, 109, 110, or 111 have been disconnected since the medical device was last put into operation, then at least one of the data storage devices 31, 36, 61, 62, 71, 72, 81, 82, 91, or 92 has been temporarily disconnected from its operating voltage and has therefore lost its stored data. This is detected by the control unit 50, and a prompt is issued via the user interface 39 to perform a complete functional test of the medical device 10. The control unit 50 preferably prevents the medical device 10 from being put into operation before a new functional test has been completed.

[0041] From the information about which data storage device has lost its data, the control unit 50 can also determine which of the connections has been severed. This information can also be output via the user interface 30. Based on the information thus obtained, the control unit 50 can also determine whether and to what extent a functional test of the medical device 10 is required.

[0042] In an embodiment not shown, the housing 120 or a part thereof can also be equipped with a volatile data storage device, so that the control assembly 50 can detect whether the housing 120 has been opened. This information can be taken into account when determining a required functional test.

Claims

[1] Medical device comprising a first electronic assembly (50) and at least a second electronic assembly (30, 60, 70, 80, 90, 100) which is detachably connected to the first electronic assembly (50) such that - during normal operation of the medical device, at least one second electronic assembly (30, 60, 70, 80, 90, 100) cannot be separated from the first electronic assembly (50), and - during maintenance and / or repair of the medical device, at least one second electronic assembly (30, 60, 70, 80, 90, 100) can be separated from the first electronic assembly (50), characterized by , that the first electronic assembly (50) includes a control which is configured to detect a permanent or temporary separation of the at least one second electronic assembly (30, 60, 70, 80, 90, 100) from the first electronic assembly (50), wherein the first electronic assembly (50) comprises an uninterruptible power supply (52), the at least one second electronic assembly (30, 60, 70, 80, 90) comprises a volatile data storage device (31, 61, 62, 71, 72, 81, 82, 91, 92) which, when connected between the first electronic assembly (50) and the at least one second electronic assembly (30, 60, 70, 80, 90, 100), is supplied with an operating voltage by the uninterruptible power supply (52) in order to prevent loss of the data stored on the volatile data storage device (31, 61, 62, 71, 72, 81, 82, 91, 92), and wherein the control is configured to access the volatile data storage (31,61,62,71,72,81,82,91,92) for writing and reading when the first electronic assembly (50) is connected to at least one second electronic assembly (30,60,70,80,90). [2] Medical device according to claim 1, characterized by, that the control is configured, upon detection of separation of at least one second electronic assembly (30, 60, 70, 80, 90, 100) from the first electronic assembly (50), to prompt a user of the medical device via a user interface (30) to subject the medical device to a functional test. [3] Medical device according to claim 2, characterized by , that the control system is set up, to allow the medical device to be put into operation only after a functional test has been carried out. [4] Medical device according to claim 1, characterized by , that the connection between the first electronic assembly (50) and the at least one second electronic assembly (60,70,80,90) is established via at least one third electronic assembly (100), which in turn is detachably connected to the first electronic assembly (50) and the at least one second electronic assembly (60,70,80,90). [5] Medical device according to any one of claims 1 to 4, characterized by that the control system is set up, - to write initial recognition data to the volatile data storage (31,61,62,71,72,81,82,91,92) after a successful functional test of the medical device, - to read second identification data from the volatile data storage (31,61,62,71,72,81,82,91,92) each time the medical device is put into operation, and - to detect a temporary or permanent separation of at least one second electronic assembly (30, 60, 70, 80, 90) from the first electronic assembly (50) if the second recognition data read does not match the first recognition data written. [6] Medical device according to any of the preceding claims, characterized by that the medical device is an electrosurgical generator or includes an electrosurgical generator. [7] Medical device according to any of the preceding claims, characterized bythat the medical device is an ultrasound generator or includes an ultrasound generator. [8] Medical device according to any of the preceding claims, characterized by that the medical device is a microwave generator or includes a microwave generator.

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