WO2019137774A1

WO2019137774A1 - Medical device system and electronic medical device

Info

Publication number: WO2019137774A1
Application number: PCT/EP2018/085920
Authority: WO
Inventors: Borg Enders; Sascha JASKOLA
Original assignee: Olympus Winter & Ibe Gmbh
Priority date: 2018-01-15
Filing date: 2018-12-19
Publication date: 2019-07-18
Also published as: DE102018100760A1

Abstract

The invention relates to a medical device system comprising: at least one electronic medical device (300, 600, 810, 820, 830) which is configured to generate operating and/or diagnostic data during continuous operation and to provide said data via a first diagnostic interface (306, 811, 821, 831), and at least one data storage device (500, 700, 850), which is configured to receive operating and/or diagnostic data from the at least one electronic medical device (300, 600, 810, 820, 830) via the first diagnostic interface (306, 811, 821, 831) and to store said data. The medical device system is characterized in that in the event of a fault of the at least one electronic medical device (300, 600, 810, 820, 830), the data storage device (500, 700, 850) is configured to provide the stored operating and/or diagnostic data wholly or partially via a second diagnostic interface (504, 855).

Description

Medical device, data storage device and electronic medical device

The invention relates to a medical device system, comprising: at least one electronic medical device, which is eigerichtet, operating and / or during operation

Generate diagnostic data and provide a first diagnostic interface, and at least one data storage device, which is set up, operating and / or

Receive and store diagnostic data from the at least one electronic medical device via the first diagnostic interface.

Furthermore, the invention relates to a data storage device and an electronic medical device

Almost all modern medical devices today have electronic controls that monitor the operating status and / or the function of the respective medical device by numerous sensors. In case of a malfunction of the medical device the

To find fault source easier, the data obtained by the sensors are often used as diagnostic data in a memory element of the medical device

stored. In addition, further operating data, such as

User input, to be stored.

If a malfunction occurs in the medical device, then the operating and / or

Diagnostic data are read via a diagnostic interface. A service technician can draw conclusions about possible causes of failure from the operating and / or diagnostic data.

Since a service technician is often not always on site, the diagnostic interface of a medical device can be connected via a network, for example, with a service center of the manufacturer. Operating and / or diagnostic data can then be quickly examined by experts in the event of a fault. The deployment of a local service technician can then be optimally prepared with the knowledge gained.

In modern hospitals, medical devices are partly networked with one another. For example, the individual medical devices in an operating room are often connected to a medical device controller so that different medical devices can be operated via a uniform user interface. Furthermore, it is known to connect medical imaging devices with data storage devices to image or

Save video data. Such data are only of limited use in fault diagnosis. In the currently known methods of making operational and / or diagnostic data of medical devices available to troubleshoot, various problems arise. Access to data stored in the medical device presupposes that the electronic control of the medical device functions so far that the data is read out and transmitted via the

Diagnostic interface are provided. If, on the other hand, the controller itself is affected by the malfunction, the data can no longer be retrieved and therefore can no longer be evaluated. Another serious problem is that the interconnection of electronic medical devices with a network makes the medical devices susceptible to malware. In medical devices, a standardized computer architecture with familiar operating systems such as Linux or Windows is often used. Thus, medical devices connected to the Internet can accidentally or deliberately become victims of malware such as viruses, worms or ransomware. If infested with appropriate malware, the medical devices can be compromised during operation or completely paralyzed.

It is therefore an object of the invention to provide a medical device system which is improved with respect to the described problem.

This object is achieved according to one aspect of the invention by a

Medical device system, comprising: at least one electronic medical device, which is eigesichtet to generate operating and / or diagnostic data during operation and provide a first diagnostic interface parts, and at least one data storage device which is set, operating and / or diagnostic data of the at least one electronic medical device via the first diagnostic interface to receive and store, which is further developed in that the data storage device is set, in the event of a malfunction of the at least one electronic medical device, the stored operating and / or diagnostic data wholly or partially via a second

Provide diagnostic interface.

The fact that the operating and / or diagnostic data is stored on the data storage device and provided by the latter when necessary ensures that the data are still available and can be evaluated even in the event of a serious malfunction of the medical device in order to draw conclusions about the cause of the fault , At the same time, the intermediary of the data storage device between the medical device and the outside world reduces the risk that the medical device will pass through

Malware is compromised. In a preferred embodiment of a medical device system according to the invention, the first diagnostic interface is a unidirectional data interface, which is a

Data transmission only from the at least one electronic medical device to the data storage device allowed. This is also in the case of compromise of the

Data storage device by malicious software, a transfer of malicious software to the medical device excluded. Likewise, a compromise of the medical device can be prevented in the event that the first diagnostic interface is accidentally or intentionally connected to a compromised third party device.

The first diagnostic interface can be a USB interface or include such USB interfaces are particularly flexible and can therefore be integrated into a medical device very easy.

In an advantageous embodiment of the invention, the second diagnostic interface is a bidirectional data interface via a bidirectional data interface can For example, the data storage device may communicate with a service center and selectively provide such operational and / or diagnostic data as requested by the service center.

The second diagnostic interface can be Ethernet, LAN, WLAN and / or

Be or include mobile radio interface. With appropriate interfaces, the data storage device can directly or via a local or global network with a

Service Center be connected.

In one possible embodiment of a medical device system according to the invention, the data storage device has a user interface. In this case, the data storage device can be set up in response to an interface obtained via the user interface

Request signal from identification data of at least one electronic

Medical device and from stored operating and / or diagnostic data to generate an error report and output via the second diagnostic interface.

In a suitably designed medical device system, an operator of the system may, in the event of a malfunction of the medical device, via the user interface of the medical device

Data storage device trigger the generation of an error report.

The user interface may include a simple push button. In the event of a malfunction of the medical device, the user then merely has to actuate the push-button switch in order to trigger the error report.

According to an advantageous embodiment of the invention, the key switch is a mobile key switch, which is connected to the data storage device via a wired or wireless signal line or connectable. The mobile push button can then

For example, be attached to an operating panel of a medical device, so that a user of the medical device does not have to first locate the data storage device in case of failure to trigger the error report. Instead, the operator only needs to actuate the pushbutton on the front panel of the medical device.

The object is further achieved by a data storage device and / or an electronic medical device of a medical device system according to the above statements

The invention will be explained in more detail with reference to some exemplary representations. Show it: 1 shows a medical device system according to the prior art,

2 shows a medical device system according to the invention,

3 shows a possible construction of a medical device system according to the invention,

Fig. 4: another medical device system according to the invention. 1 shows a medical device system according to the prior art. The

Medical device system includes an electronic medical device 100. The medical device 100 has a controller 101, which with a user interface 102, a

Memory element 103, a function module 104, a data interface 105, and a diagnostic interface 106 communicates.

The functional function of the electronic medical device 100 is implemented in the functional module 104; it may be, for example, an electrosurgical generator, an insufflator, an endoscope controller or the like.

Through the user interface 102, a user of the electronic medical device 100 may select or input various modes of operation and / or parameters, which may then be passed from the controller 101 to the functional module 104. The

User interface 102 may include a display and an input device. Display and input device can also be combined as a touch-sensitive display.

Furthermore, the controller 101 stores operational and / or diagnostic data on the

Memory element 103 from. The memory element 103 may include, for example, a hard disk and / or a flash memory.

Via the diagnostic interface 106, the electronic medical device 100 can be connected to a service center 10. The connection may be via a network 120, such as a hospital network and / or the Internet.

The electronic medical device 100 is connected to a medical device controller 200.

The medical device controller 200 in turn comprises a controller 201, a

User interface 202, as well as a plurality of data interfaces 203, 204, 205, 206.

The connection between the medical device controller 200 and the electronic

Medical device 100 is manufactured by connecting the data interface 105 to the data interface 203. Via the data interfaces 204, 205, 206, the medical device controller 200 can be connected to further, not shown, electronic medical devices. The medical device controller 200 may have its own memory element 207 in order to store operating and / or diagnostic data there.

If a malfunction occurs during operation of the electronic medical device 100, the contents of the memory element 103 can be read out via the diagnostic interface 108.

The stored data can then be used to draw conclusions about the cause of the fault. The reading out of the memory element 103 can take place via a diagnostic device, not shown, which is connected to the diagnostic interface 106. The reading of the memory element 103 can also be done directly from the service center 1 10.

For reading the memory element 103, it is required that the controller 101 of the electronic medical device 100 function properly. If this is not the case, since, for example, the control itself is affected by the disturbance, then this can

Memory element 103 are no longer read.

In addition, if the diagnostic interface 106 is permanently connected to the network 120, there is a risk that the electronic medical device 100 will be compromised by malware.

FIG. 2 shows a medical device system according to the invention. As far as that

2 corresponds to the medical device system of FIG. 1, the respective elements in FIG. 2 are provided with a reference number increased by 200 and will not be explained again in detail.

The medical device system comprises an electronic medical device 300 with a controller 301, a user interface 302, a memory element 303, a function module 304, a data interface 305, and a diagnostic interface 306

The electronic medical device 300 is connected to a medical device controller 400. The medical device controller comprises a controller 401, a user interface 402, and data interfaces 403, 404, 405, 406. The connection of the medical device controller 400 to the electronic medical device 300 takes place via the data interfaces 305 and 403 Unlike the medical device system illustrated in FIG. 1, the medical device system illustrated in FIG. 2 comprises a data storage device 500. The data storage device 500 includes a controller 501, a user interface 502, a data interface 503, a diagnostic interface 504, and a storage element 505.

The data storage device 500 is connected to the diagnostic interface 306 of the electronic medical device 300 via the data interface 503. Here, the diagnostic interface 306 of the electronic medical device 300 is designed as a unidirectional data interface and can only transfer data from the electronic medical device 300 to the

Data storage device 500 send.

The controller 301 of the electronic medical device 300 in turn continuously determines operating and / or diagnostic data and stores it on the memory element 303.

At the same time, the controller 301 also outputs this operating and / or diagnostic data continuously via the diagnostic interface 306. This operational and / or diagnostic data is received by the data interface 503 and transmitted by the controller 501 on the

Memory element 505 stored. The storage element 505 may be a hard disk with sufficient storage capacity to store operating and / or diagnostic data over several hours of operation. In this case, these data can be overwritten by a new operation and / or diagnostic data after a predetermined trouble-free operation of the electronic medical device 300.

If a malfunction now occurs during operation of the electronic medical device 300, the previously determined operating and / or diagnostic data are available for evaluation independently of the function of the electronic medical device 300. For this purpose, the controller 501 of the data storage device 500 can read this data from the memory element 505 and provide it via the diagnostic interface 504.

The diagnostic interface 504 may be connected locally to a diagnostic device to read the data, or as directly connected to a service center 310 as shown in FIG. For this purpose, a network 320 can be used again. Alternatively, the connection between the data storage device 500 and the service center 310 may be via a cellular connection. For this purpose, the diagnostic interface 504 a

Mobile interface include.

The output of the operating and / or diagnostic data by the data storage device 500 may be triggered in different ways. For example, the controller 501 detect when no data is received via the data interface 503, and interpret this as a fault of the electronic medical device 300. Then, the controller 501 may automatically generate an error report from the stored operational and / or diagnostic data and send it to the service center 310.

Alternatively, the service center 310 or a locally connected diagnostic device may request the creation of an error report via the diagnostic interface 504.

As another option, the creation of an error report may be initiated by a user via the user interface 502 of the data storage device 500.

The creation of the error report can be carried out in several stages. For example, a first error report that is triggered by a user may only include identification data of the electronic medical device 500 and possibly an indication of the type of the fault. The service center 300 can then use this data to determine what further data is needed for an analysis of the fault and transmit this to the data storage device 500. In the data storage device 500, the requested data is then compiled into a second error report and transmitted to the service center. In this case, the first error report, which includes only a small amount of data, can be sent over a mobile connection, while for the second, more comprehensive error report, a connection via a network is selected.

An error report can contain different data. In addition to the already mentioned identification data of the electronic medical device 300, this may include the following, among others:

Log files,

Environmental data,

Status information

User actions.

FIG. 3 shows a possible construction of a medical device system according to the invention. The medical device system comprises an electronic medical device 600 with a housing 601 and an operating front 602, on which various display and operating elements 603, 604, 605, 606 are arranged. The medical device system further comprises a data storage device 700, which is arranged behind the electronic medical device 600 in the example shown. The data storage device 700 is equipped with a mobile pushbutton 701, which is connected to the data storage device 700 via a flexible line 702 and is part of a user interface of the data storage device 700. The tactile switch 701 is attached to the front panel 602 of the electronic medical device 600, for example by means of an adhesive or a magnet

By pressing the key switch 701, a user of the electronic

In the event of a failure, the medical device 600 initiates the creation and dispatch of an error report by the data storage device 700. To do this, the user does not first have to locate the data storage device 700.

The connection of the key switch 701 to the data storage device 700 can also be wireless, for example by means of an infrared interface or a Bluetooth connection.

FIG. 4 shows another possible medical device system. The system includes a plurality of electronic medical devices 810, 820, 830 and a data storage device 850.

The structure of the electronic medical devices 810, 820, 830 and the data storage device 850 substantially corresponds to the structure shown in Figure 2, unless otherwise described below.

Each of the electronic medical devices 810, 820, 830 has a diagnostic interface 81 1 821, 831, which is connected to or can be connected to one of a plurality of data interfaces 851, 852, 853 of the data storage device 850.

Instead of the illustrated 3 electronic medical devices 810, 820, 830 can

Medical device system also include any other number of electronic medical devices. The electronic medical devices 810, 820, 830 may further be connected to a medical device controller, not shown.

The data storage device 850 further includes a diagnostic interface 855.

In the illustrated medical device system, each of the three electronic medical devices 810, 820, 830 continuously provides operational and / or diagnostic data about the respective one Diagnostic interface 81 1, 821, 831 to the data storage device 850 from where they are stored.

In the event of a malfunction of one of the electronic medical devices 810, 820, 830, an error report can again be generated from the corresponding operating and / or diagnostic data which can be sent to a service center 860 via the diagnostic interface 855. For this purpose, in turn, a network 870 or not shown

Cellular connection can be used. To trigger an error report, the data storage device 850 may have multiple mobile

Tastschalter 856, 857, 858, which can be arranged on the respective electronic medical devices 810, 820, 830.

With regard to the configuration of the push-button switch 856, 857, 858, reference is made to the comments on FIG.

Claims

1 medical device system, comprising:

at least one electronic medical device (300, 600, 810, 820, 830) adapted to generate operational and / or diagnostic data during operation and to provide it via a first diagnostic interface (306, 811, 821, 831); and at least one data storage device (500, 700, 850) configured to operate and / or receiving diagnostic data from the at least one electronic medical device (300, 600, 810, 820, 830) via the first diagnostic interface (306, 81, 1, 821, 831),

characterized in that

the data storage device (500, 700, 850) is adapted, in the event of a malfunction of the at least one electronic medical device (300, 600, 810, 820, 830), to provide all or part of the stored operating and / or diagnostic data via a second diagnostic interface (504, 855)

2 medical device system according to claim 1, characterized in that the first diagnostic interface (306,81 1, 821, 831) is a unidirectional data interface, which allows data transmission only from the at least one electronic medical device (300,600,810,820,830) to the data storage device (500,700,850)

3 medical device system according to claim 1 or 2, characterized in that the first diagnostic interface (306,811, 821, 831) is or includes a USB interface.

4 medical device system according to one of the preceding claims, characterized

characterized in that the second diagnostic interface (504, 855) is a bidirectional data interface

5 medical device system according to one of the preceding claims, characterized

characterized in that the second diagnostic interface (504, 855) is or comprises an Ethernet, LAN, WLAN and / or mobile radio interface.

6 medical device system according to one of the preceding claims, characterized

in that the data storage device (500,700,850) has a

User interface (502).

7 medical device system according to claim 6, characterized in that the

A data storage device (500,700,850) is adapted to generate an error report from identification data of the at least one electronic medical device (300,600,810,820,830) and from stored operational and / or diagnostic data in response to a request signal received via the user interface (502) and via the second diagnostic interface (504,855). issue.

8. medical device system according to claim 8 or 7, characterized in that the data storage device (500,700,850) is further arranged, in response to a request received via the second diagnostic interface (504,855) additional stored operating and / or diagnostic data on the second

Output diagnostic interface (504,855).

9 medical device system according to one of claims 8 to 8, characterized in that the user interface comprises a push-button switch (701).

10. medical device system according to claim 9, characterized in that the

Key switch (701) is a mobile key switch that is connected or connectable to the data storage device (700, 850) via a wired or wireless signal line (702).

1 1 data storage device of a medical device system according to one of claims 1 to 10

12 Electronic medical device of a medical device system according to one of claims 1 to 10.