DEVICE FOR TRANSMITTING OPERATIONAL AND MACHINE DATA OF A MEDICAL DEVICE, MEDICAL DEVICE AND METHOD FOR TRANSMITTING OPERATIONAL AND MACHINE DATA OF A MEDICAL DEVICE
Patent Information
- Application Number
- DE502017017043
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-12-30
- Filing Date
- 2017-12-29
- Publication Date
- 2025-09-25
- Estimated Expiration
- 2037-12-29
AI Technical Summary
Existing methods for recording and analyzing operating and machine data from medical devices, such as dialysis machines, during treatment are hindered by safety concerns and the need for specialized power supplies, preventing real-time data collection and analysis.
A device comprising a data input, programmable memory unit, voltage input, and transmission unit that allows for the temporary storage and wireless transmission of operating and machine data from medical devices to an evaluation device, ensuring electrical isolation and power supply through the medical device's voltage, enabling data collection during treatment without external power sources.
Enables safe, real-time data collection and analysis of medical device operations without disrupting treatment, facilitating efficient troubleshooting and root cause analysis by service technicians.
Description
Technical area
[0001] The present invention relates to a device for transmitting operating and machine data of a medical device to an evaluation device, a medical device, and a method for transmitting operating and machine data of a medical device to an evaluation device. The medical device is preferably a device for extracorporeal blood treatment, for example, a dialysis machine for performing hemodialysis, hemofiltration, hemodiafiltration, and / or another dialysis treatment. The medical device can also be a peritoneal dialysis machine, an acute dialysis machine, a liver replacement therapy machine, or an apheresis machine.
[0002] When a medical device is operated, for example when performing dialysis treatment, but also in other operating states of the medical device, the medical device can generate operating and machine data. Based on the operating and machine data, wear and tear of components of the medical device and / or functional limitations of components can be determined. The support of a service technician may be required to determine and rectify the cause. For some of the operating and machine data generated, it is also possible that the cause cannot be identified and rectified on-site by a service technician, so in this case the support of the development department of the manufacturer of the medical device is desirable. For this purpose, it is helpful to record or log the operating and machine data of the medical device, preferably selectively.At the manufacturer, and especially in its development department, a software tool can be used to view and analyze the operating and machine data, for example, which offers special visualization options to enable the causes to be found using other analysis tools. Technical background
[0003] Until now, the recording of the operating and machine data to be viewed and analyzed has been done using, for example, a portable computer or laptop connected to the medical device. However, for safety reasons, this cannot simply be connected to the medical device during treatment, and especially not during medical dialysis treatment. Furthermore, a power supply specifically approved for medical applications is required for the portable computer. This means that, for example, operating and machine data collected during operation cannot be recorded.
[0004] Patent US 8,217,781 B2 describes a method for facilitating the maintenance of a household appliance. Publication US 2011 / 185035 A1 describes a device for root cause analysis of medical devices. Publication GB 2 329 983 A, GB 2 225 459 A, EP 0 597 817 A2, and WO 96 / 10233 A1 describe data loggers and / or removable data loggers. US 2009 / 100132 A1 also discloses a central collector for storing data in the form of a removable dongle. Description of the invention
[0005] For quick and simplified root cause determination and elimination, it is desirable to record operating and machine data even while the medical device is in operation.
[0006] Here and in the following, operation of the medical device is understood to mean the treatment of a patient. In particular, this operation differs from, for example, maintenance, during which no patient is treated and, consequently, the above-mentioned safety considerations are not relevant.
[0007] Accordingly, an object to be achieved by the present invention is to provide a device, a medical device and a method which allow simplified transmission and, if necessary, further recording for the evaluation of operating and machine data of a medical device.
[0008] This problem is solved by the respective subject matter of the independent patent claims. Advantageous further developments emerge from the subclaims, the present description, and the figures.
[0009] Accordingly, a device for transmitting operating and machine data of a medical device, preferably a dialysis machine, to an evaluation device is proposed, wherein the device comprises a data input for receiving operating and machine data of the medical device, a programmable memory unit configured to store at least some of the received operating and machine data, a voltage input configured to supply the device with an operating voltage provided by the medical device, and a transmission unit configured to transmit the stored operating and machine data to the evaluation device.
[0010] Using this device, the medical device's operating and machine data can be read, temporarily stored, and then transferred to the evaluation device. This makes it possible to separate the reception and storage of the operating and machine data from their transfer to the evaluation device.
[0011] The device also provides electrical isolation between the medical device and the evaluation device, preventing any electrical interference with the medical device from the power supply and / or grounding of the evaluation device during treatment and / or the storage and / or transmission and / or evaluation of operating and machine data by the evaluation device. Accordingly, the reception and storage of operating and machine data with the device can also be performed during the actual medical treatment of a patient using the medical device.
[0012] The evaluation device can be a preferably portable computer, in particular a laptop. The evaluation device can also be a mobile device, for example a smartphone or a tablet. By means of the device, it is possible to record and forward various operating and machine data of the medical device without influencing the operation of the medical device and without the evaluation device having to remain with the medical device or connected to it while the operating and machine data is being stored. The mobile device, for example the smartphone or tablet, can also be connected in the communication path between an evaluation device and the device, such that the data is first transmitted from the device to the mobile device and from there to the evaluation device.
[0013] Preferably, the voltage input of the device is configured to be connected to a voltage output of the medical device, at which the operating voltage is provided. In other words, the device is supplied with energy via the medical device. The operating voltage can be used, in particular, to supply energy to the storage unit and / or the transmission unit. For this purpose, the device can contain further electronic components for dividing and / or converting the operating voltage. It is possible for all components of the device to be supplied with energy exclusively by means of the operating voltage when the device is connected to the medical device. In other words, when the device is connected to the medical device, the device is not connected to any further voltage source.Alternatively or additionally, it is possible for the device to have only the voltage input as a supply connection and to be free of further supply connections that can be connected to a, in particular external, voltage source.
[0014] Powering the medical device, while avoiding additional power sources, can be particularly advantageous in medical applications. In particular, by eliminating the need for an external power supply and powering the device via the medical device, the device has a much lower impact on the electrical and / or functional safety of the medical device being monitored. In contrast, an alternative device (such as a laptop) powered by an external power supply requires a power supply specifically approved for medical applications and cannot be connected to the medical device during operation, and especially not during medical treatment.
[0015] According to at least one embodiment, the device comprises a data input for receiving operating and machine data of the medical device. Preferably, the device comprises a plurality of data inputs. For example, the data input is configured to be connected to a data output of the medical device. The operating and machine data can then be data signals transmitted via the data output. If the device has a plurality of data inputs, these can each be configured to be connected to a data output from a plurality of data outputs of the medical device or to the data outputs of different medical devices. In particular, a data output of the medical device can be uniquely, preferably uniquely, assigned to each data input of the device.
[0016] According to at least one embodiment, the device comprises a programmable memory unit. The memory unit can comprise a processor or microchip for programming and a storage medium. For example, the memory unit contains a microcontroller. Furthermore, the programmable memory unit can comprise communication ports for transmitting, in particular outputting and / or receiving, the operating and machine data.
[0017] The storage unit is configured to store at least a portion of the received operating and machine data. The portion of the operating and machine data to be stored may, for example, be operating and machine data to be monitored or recorded, which is of particular importance, for example, to the evaluation device. Using the data input and the programmable storage unit, a data readout process can thus be performed, for example, in which the operating and machine data of the medical device are received via the data input, and a portion of the operating and machine data selected by the storage unit is stored in the memory. The selection can, for example, be preconfigured by means of a configuration specification in the storage unit, wherein the configuration specification can, for example, be specified and / or modified by the evaluation device and / or the mobile terminal.In addition, it is possible that the received operating and machine data contain an additional specification based on which the operating and machine data to be saved are determined and saved accordingly.
[0018] Instead of the selected operating and machine data, it is also possible to save all operating and machine data output by the medical device via its data output.
[0019] For example, storage can be temporary, i.e., until the stored operating and machine data is transmitted, particularly with a time delay, to an evaluation device. This enables, for example, asynchronous transmission of the operating and machine data, in which the evaluation device is only temporarily connected to the transmission unit—for example, when a service technician with a corresponding evaluation device is near the medical device or when no treatment is being performed using the medical device.
[0020] The data input can be configured to forward the received operating and machine data, which was provided, for example, at the data output of the medical device, to the storage unit. For this purpose, the data input can be electrically and / or data-technically connected to the storage unit, preferably to the processor of the storage unit.
[0021] According to at least one embodiment, the device comprises a transmission unit. The transmission unit is configured to transmit the stored operating and machine data to the evaluation device. For example, the transmission unit contains a receiving antenna for wirelessly transmitting and / or receiving the stored operating and machine data to the evaluation device. Thus, the evaluation device is not connected to the medical device for transmitting the operating and machine data.
[0022] The operating and machine data are transmitted to the evaluation device at a transmission speed. This transmission speed may differ from the reception speed at which the operating and machine data are received from the medical device via the data input. The reception speed may be the speed at which the operating and machine data are generated and / or transmitted from the medical device to the device.
[0023] The transmission speed is preferably the maximum speed of the transmission protocol via which the transmission unit is connected to the evaluation device. Since the operating and machine data are consolidated in the storage unit, they can be collected and transferred at the transmission speed when a connection exists between the transmission unit and the evaluation device.
[0024] The device described here is particularly designed to provide worldwide support to service technicians in the difficult task of troubleshooting root causes. For example, when operating and machine data occur in the medical device, the service personnel and / or an operator of the medical device first send or communicate the known facts about the problem to be analyzed to the service and development engineers in the development department. The development department can then, for example, send a device preconfigured using a configuration specification to the service personnel. Alternatively or additionally, it is possible for the development department to send the configuration specification to the service personnel in the form of a file, with the service personnel independently transferring the configuration specification to the device using an evaluation device.The device can be tailored to the problem to be analyzed, particularly through the configuration default, and / or contain parameters to be stored. The configuration can always be performed externally and not via the medical device itself, which is why setting the configuration default on the device has no impact on the medical device.
[0025] The device is preferably designed to be compact. For example, the device is designed to be no larger than the size of a palm. Due to its compact design, the device can be easily shipped, for example, by mail, and / or become part of the basic equipment of service personnel. The device's simple construction allows it to be used with a wide variety of device types. In addition to its use for root cause analysis of medical devices, other types of data acquisition are also possible, for example, in the context of PMCFU (Post Market Clinical Follow-Up) studies.
[0026] According to at least one embodiment of the device, the transmission unit is configured to receive a configuration specification from an evaluation device and forward it to the storage unit. For example, the configuration specification is created using the evaluation device and then transmitted to the transmission unit.
[0027] According to at least one embodiment of the device, the portion of the operating and machine data to be stored is specified by means of the configuration specification. The configuration specification can, in particular, contain information about operating and machine data of the medical device to be acquired. For example, the storage unit contains operating software that can be set using the configuration specification. The configuration specification can be compiled using the operating software and, for example, converted into control signals. For example, the evaluation device can be used to define operating and / or machine data of the medical device that are to be read out as operating and machine data to be acquired. This can enable selective storage of received operating and machine data of the medical device. This operating and / or machine data can be stored in the configuration specification and sent to the device.
[0028] According to at least one embodiment, the reception of the configuration specification by the transmission unit is blocked during operation of the medical device. For this purpose, the device can be configured to receive the operating state of the medical device and, in particular, to detect the operation of the medical device. During operation of the medical device, for example in the case of medical treatment, the reception of data by means of the transmission unit can then be blocked. The blocking can be carried out, for example, using a microcontroller, which can be part of the transmission unit and / or the memory unit. Alternatively or additionally, it is possible for transmission by means of the transmission unit to be blocked during operation of the medical device. In particular, any external communication can then be blocked during operation of the medical device.
[0029] According to at least one embodiment of the device, the device is configured to be connected to and / or disconnected from the medical device during operation. In particular, the device is configured to be mechanically releasably and / or electrically conductively connected to and / or disconnected from the medical device during operation. Furthermore, it is possible for the device to be disconnected from the medical device during the data readout process and / or while the device is being supplied with the operating voltage.
[0030] Preferably, the device is configured to receive the operating state of the medical device and to detect the operation, and then to electrically isolate any conductive connections to the outside or which do not lead to the medical device and / or to disconnect any further voltage sources.
[0031] According to at least one embodiment, the device comprises at least one control output configured to send a control signal to a data unit of the medical device. The control signal contains information and / or instructions about the operating and machine data to be provided by the medical device. The control signal can be predetermined, for example, by the configuration specification. The memory unit can be configured to provide the control signal and to send it to a control input of the medical device via the control output, wherein the control input can transmit the control signal to the data unit. The control input and the control output can then be configured to be connected to one another, in particular in an electrically conductive manner.
[0032] Here and below, the data input and / or control output can also be a physical line. Data exchange, i.e., the transmission of operating and machine data and / or the transmission of the control signal, can also take place via at least one, in particular two, lines and / or via a CAN bus. Communication on a line can be bidirectional.
[0033] Using the control signal, the device can, for example, request specific operating and machine data that may be useful for root cause analysis. Alternatively or additionally, it is possible to use the control signal to define measures that prevent communication overload during data retrieval. This is made possible, in particular, by the medical device's clearly identifiable operating mode.
[0034] According to at least one embodiment of the device, the storage unit has a processing unit for processing at least a portion of the operating and machine data. Processing preferably occurs before the portion of the operating and machine data to be stored is stored. The processed portion is preferably the portion of the operating and machine data to be stored and / or the stored portion. For example, the processing unit can be configured to prepare the operating and machine data. Processing the stored operating and machine data can include compressing the operating and machine data. This can enable time-saving data transmission.
[0035] Furthermore, it is possible for at least some of the stored operating and machine data to be averaged and / or encrypted during processing. The processing of the operating and machine data can also include an evaluation of the operating and machine data. For example, the operating and machine data is compressed and / or reduced during an evaluation by only storing operating and machine data outside a predetermined standard range. Alternatively or additionally, the processing unit can imprint a time stamp and / or a date on at least some of the operating and machine data. This can make it possible to document the time at which the operating and machine data occurred.
[0036] The transmission unit is a wireless transmission unit. The wireless transmission unit is preferably based on a low-energy emission standard, such as Bluetooth. This can enable electromagnetic compatibility and / or a reduction of electromagnetic radiation. For example, the transmission unit comprises a Bluetooth transmitter. The use of the term "transmitter" here and below does not exclude the possibility of receiving operating and machine data. It is possible for the wireless transmission unit to be configured to be locked or deactivated during a treatment mode, i.e., in particular during patient treatment. For example, a signal is sent from the medical device to the device during the treatment.Alternatively or additionally, it is possible for the medical device to transmit a date and / or time stamp describing the current operating state of the medical device. This allows the device to detect whether a treatment is currently in progress. The device is configured to check whether a corresponding signal has been received from the medical device and, if such a signal is received, to either restrict outward communication to sending only or to prevent it entirely. This can be achieved by partially or completely deactivating the transmission unit.
[0037] According to at least one embodiment of the device, the wireless transmission unit is configured to receive configuration data from the evaluation device while the device is connected to the medical device. The wireless transmission unit is configured to transmit the stored operating and machine data to the evaluation device while the device is connected to the medical device. For example, the transmission unit and / or the evaluation device can have a wireless transmission unit, such as a Bluetooth transmitter, for this purpose. It may thus be possible to send the configuration specification to the device or to read the stored operating and machine data from it without having to disconnect the device from the medical device.The transmission unit can be configured to enable the reception of configuration data and / or the output of stored operating and machine data during operation of the medical device. This can ensure safe and uninterrupted operation of the medical device in conjunction with efficient root cause analysis.
[0038] According to at least one embodiment of the device, it is designed in the manner of a dongle. A dongle can be a compact hardware component in this case and in the following. A dongle can be designed to be compact. A dongle can, for example, be set up to connect to a system, whereby the system can receive additional functions through the dongle. The device can then, for example, be designed to be no larger than the size of a palm of your hand. For example, the device extends in any spatial direction by a maximum of 10 cm, preferably a maximum of 8 cm, and particularly preferably a maximum of 5 cm. Due to the compact design of the device, it requires little space. Furthermore, particularly due to the compact design, there can be lower risks of contamination of the device, for example by germs and / or chemical substances.
[0039] According to at least one embodiment, the device comprises a first connection component. The first connection component can comprise a communication interface and a power supply interface. The communication interface comprises the data input and, if appropriate, and / or the control output; the power supply interface comprises the voltage input. The data input, the voltage input, and the control output can be terminals of the first connection component.
[0040] The first connection component can be suitable for being plugged into a second connection component of the medical device. The second connection component of the medical device can be a service interface of the medical device. The first connection component can be designed in the manner of a female connector, and the second connection component can be designed in the manner of a male connector, in particular one that interacts with the first connection component, or vice versa. For example, the first connection component is a plug and the second connection component is a socket, or vice versa.
[0041] For example, the first connection component and the second connection component are a D-Sub connection pair or a USB connection pair, where a connection pair here and below can be the combination of a female and a male connector of a mechanical plug-in connection. The first connection component can then be, for example, a D-Sub connector or a USB connector. In particular, the first connection component can be suitable for a CAN bus connection.
[0042] According to at least one embodiment, the first connection component is configured to connect the device to the medical device in a mechanically detachable and / or electrically conductive manner. A "mechanically detachable connection" here and below is a mechanical connection between two components that can be released non-destructively, i.e., without destroying the components, and preferably without additional tools, such as screwdrivers or solvents. The electrically conductive connection can be established via the voltage input. Furthermore, an electrically conductive connection is possible via the data input, for example, for transmitting electrical data signals.
[0043] According to at least one embodiment, the first connecting component is configured such that a grounding of the device is connected to a grounding of the medical device. In particular, the device and the medical device can be at the same electrical potential and shielded from the outside.
[0044] The first connection component can have a connector housing in which the terminals of the first connection component are located. The connector housing can be electrically insulating and / or electrically shielding. The connector housing can provide contact protection for the terminals. The connector housing can be multi-part or single-part, with the single-part design being preferred due to its easier operation. A "multi-part connector housing" exists here and below when the connector housing is formed with or consists of several spatially separated components. In this case, some of the terminals of the first connection component, for example, the data input, can be located in a first housing, while the remaining terminals are located in a second housing and / or optionally further housings of the first connection component.In a "one-piece connector housing," all terminals of the first connecting component are located in a single connector housing. A one-piece connector housing can be formed as a single piece or consist of several directly adjacent parts.
[0045] According to at least one embodiment of the device, it comprises an electrically insulating housing which contains at least the memory unit and the transmission unit. The housing can contain or consist of an encapsulation or an encapsulation of the electronic components of the device. Alternatively or additionally, the housing can have or consist of a container made of plastic. It is possible for the housing to be directly adjacent to the optionally present connector housing of the optionally present first connection component or to be formed integrally therewith. By means of the housing, the electronic components of the device can be protected, for example, from external influences which could be potentially dangerous for the operation of the device and / or the medical device. The housing can serve as contact protection for the device.This can prevent sparks from contact or electrical contamination of the device and / or the medical device.
[0046] Furthermore, a medical device, preferably for performing dialysis treatment, is specified. For example, the medical device is a dialysis machine for monitoring and / or performing dialysis treatment. The medical device is preferably configured to be connected to a device described here for transmitting operating and machine data to an evaluation device. This means that all features described for the device are disclosed for the medical device, and vice versa.
[0047] According to at least one embodiment of the medical device, it comprises a data output for transmitting operating and machine data of the medical device to a device, preferably the device described above. In particular, the data output can be configured to be connected to the data input of the device described above, preferably in a mechanically detachable and / or electrically conductive manner.
[0048] According to at least one embodiment, the medical device comprises a voltage output configured to output an operating voltage for supplying the device. It is possible for the operating voltage to be output throughout the entire operation of the medical device. Alternatively, it is possible for the medical device to have a voltage unit for monitoring the voltage output. This makes it possible to output the operating voltage only when the device is plugged into the medical device and / or a switching signal is present at the additional connection. For example, the switching signal can be applied to the additional connection using the device. By avoiding a voltage constantly present at the voltage output by using a voltage unit, the safety of the medical device can be increased, for example.
[0049] According to at least one embodiment, the medical device comprises a data unit configured to provide the operating and machine data at the data output as a function of a control signal. "As a function of a control signal" here and below means that a content of the plurality of operating and machine data provided at the data output by the data unit varies as a function of the control signal. The content of the plurality of operating and machine data can be, for example, a type of data, signals and / or parameters contained in the operating and machine data, a scope of the operating and machine data, and / or a duration of the data output. The control signal can be specified by a configuration specification stored in the device, in particular the memory unit, which can be the configuration specification described in connection with the device.For example, the medical device further comprises a control input that can be connected to a control output of the device. The control signal can then be provided by the device via the control output and forwarded to the data unit via the control input of the medical device.
[0050] According to at least one embodiment of the medical device, it comprises a second connection component. The second connection component has a voltage output. Furthermore, the second connection component can comprise the data output. Preferably, the second connection component contains a plurality of data outputs, for example as part of a CAN bus system. The second connection component is configured to receive a first connection component of a device for transmitting operating and machine data of the medical device or to be connected to the first connection component. In particular, the medical device can be mechanically detachably and / or electrically conductively connected to the device by means of the second connection component and the first connection component.For example, the second connection component is a CAN bus connector, which can contain at least one CAN bus, in particular two CAN buses.
[0051] Furthermore, a method for transmitting operating and machine data of a medical device, preferably a dialysis machine, to an evaluation device is specified. The method is preferably used for transmitting operating and machine data of a medical device described herein. Furthermore, the method is preferably carried out using a device described herein. This means that all features disclosed for the device and / or the medical device are disclosed for the method, and vice versa.
[0052] According to at least one embodiment of the method, a device is provided. The device comprises a data input, a programmable memory unit, a voltage input, and a transmission unit. The device is preferably the device described above.
[0053] According to at least one embodiment of the method, the device is connected to the medical device, preferably in a mechanically detachable and / or electrically conductive manner. The connection is made such that the device is supplied with an operating voltage provided by the medical device via the voltage input. The connection can also be made by means of the optionally present first connection component of the device, for example by plugging the first connection component into a second connection component of the medical device. The device can also be connected to the medical device in such a way that the data input is connected to a data output of the medical device. Alternatively or additionally, the connection can be made such that a voltage input of the device is connected to a voltage output of the medical device.
[0054] The method includes receiving operating and machine data of the medical device via the data input. The operating and machine data can, for example, be provided at the data output of the medical device. Part of the operating and machine data is stored using the storage unit. For example, the operating and machine data can be processed using a processing unit of the device before being stored.
[0055] The stored operating and machine data are transmitted to an evaluation device. The transmission takes place via the transmission unit. The transmission is performed while the device is connected to the medical device. In an alternative, it is possible for the device to be separated from the medical device before transmission and then connected, in particular in a mechanically detachable and / or electrically conductive manner, to the evaluation device.
[0056] According to at least one embodiment of the method, the device is supplied via the voltage input with an operating voltage provided by the medical device via the voltage output. Preferably, the device is supplied exclusively by the operating voltage applied to the voltage input when it is connected to the medical device.
[0057] According to at least one embodiment, the method further comprises the steps of connecting the device to an evaluation device, and transmitting a configuration specification from the evaluation device to the storage unit. The steps are preferably carried out by means of the transmission unit. For this purpose, a wireless connection is established between the transmission unit and the evaluation device. The transmission unit is a wireless transmission unit, and the evaluation device can have a wireless transmission unit. The configuration specification can then be transmitted to the device by means of the transmission unit, and the configuration specification can be forwarded to the storage unit. The device is preferably disconnected from the evaluation device after the configuration specification has been transmitted.
[0058] According to at least one embodiment of the method, the transmission of the configuration specification, and in particular the connection of the device to the evaluation device, is carried out while the device is connected to the medical device. The transmission of the stored operating and machine data to the evaluation device is carried out while the device is connected to the medical device. In other words, the transmission of the stored operating and machine data and, if applicable, the transmission of the configuration specification takes place after the device is connected to the medical device and before the device is disconnected from the medical device. The transmission of the configuration specification and / or the stored operating and machine data can take place, in particular, during operation of the medical device.
[0059] The transmission unit is a wireless transmission unit, wherein the stored operating and machine data are transmitted to the evaluation device via the wireless transmission unit while the device is connected to the medical device. Furthermore, the configuration specification can be transmitted to the device via the wireless transmission unit while the device is connected to the medical device. For this purpose, the evaluation device can have a wireless transmission unit that transmits the configuration data to the transmission unit.
[0060] According to at least one embodiment of the method, the device is connected to the medical device while the medical device is in operation. Alternatively or additionally, the device is disconnected from the medical device, optionally in a further step, while the medical device is in operation. Connecting and / or disconnecting the device to or from the medical device therefore preferably has no influence on the operation, and in particular the operational safety, of the medical device. The device can therefore be plugged into or disconnected from the medical device, for example, while a medical treatment, in particular a dialysis treatment, is being carried out. This enables root cause analysis and rectification even without a lengthy and sometimes not easily possible termination of the treatment.In particular, operating and machine data occurring during treatment can be examined instantly.
[0061] According to at least one embodiment of the method, this further comprises providing the evaluation device, which has an input interface. The input interface can, for example, be a keyboard and / or a touchscreen in conjunction with application software, in particular graphical, of the evaluation device, such as an app. Furthermore, the method comprises entering the configuration data into the evaluation device via the input interface. For example, all possible configuration specifications are displayed in a type of graphic checklist on a screen of the evaluation device and can be provided by a user, such as service personnel or the development department.
[0062] According to at least one embodiment of the method, this further comprises further processing of the stored operating and machine data by means of the evaluation device. The evaluation device can, for example, be identical to the evaluation device. For example, the stored operating and machine data are graphically displayed, stored, compressed, managed, and / or otherwise further processed by means of the evaluation device. The evaluation device can further have internet access and / or fax access. For example, this makes it possible to send the stored operating and machine data by email and / or fax and / or to access an information database of the manufacturer of the medical device by means of the evaluation device. For example, the evaluation device can have application software for further processing the stored operating and machine data.In particular, it is possible for the stored operating and machine data to be transferred simultaneously with the storage of other operating and machine data. This allows, for example, to check whether the configuration specification is suitable for root cause analysis while the operating and machine data is being read out, and to adjust the configuration specification if necessary. Short description of the characters
[0063] In the following, the device described here, the medical device described here and the method described here are explained in more detail using exemplary embodiments and the associated figures. Figures 1 and 2 schematically show exemplary embodiments of a device described here using schematic representations. Figures 3 and 4 schematically show exemplary embodiments of a device described here and of a medical device described here using schematic representations. Figure 5 shows an exemplary embodiment of a method described here using a schematic representation. Detailed description of the characters
[0064] Identical, similar, or functionally identical elements are provided with the same reference numerals in the figures. The figures and the relative sizes of the elements depicted in the figures are not to be considered to scale. Rather, individual elements may be exaggerated for clarity and / or clarity.
[0065] Based on the schematic representation of the Figure 1An embodiment of a device 100 described here is explained in more detail. The device 100 is in the embodiment of the Figure 1 designed like a dongle, which can be connected to a corresponding data output for the transmission of operating and machine data of a medical device.
[0066] The device 100 serves to store operating and machine data of a medical device 500, which may be a dialysis machine, for example. The device can further be configured to transmit operating and machine data to an evaluation device. The device comprises a data input 12 for receiving operating and machine data of the medical device 500, a programmable memory unit 20 configured to store at least some of the received operating and machine data, and a transmission unit 30 configured to transmit the stored operating and machine data to the evaluation device. Furthermore, a voltage input 11 configured to supply the device 100 with an operating voltage provided by the medical device 500 is provided.
[0067] The programmable memory unit 20 comprises, in particular, a storage device, for example, a non-volatile memory, and a processor or microchip. The processor or microchip is configured to support the storage process and / or process data and / or handle communication, etc. The processor or microchip can be programmed using configuration specifications and then serves, among other things, as a processing unit for processing operating and machine data.
[0068] The device 100 also comprises a first connection component 10 with the voltage input 11 and signal lines 12, 13. The signal lines 12, 13 can be a data input 12 and a control output 13. However, it is also possible for the signal lines 12, 13 to be one, in particular a single, bidirectional interface, such as a CAN bus. In this case, only one connection is shown purely as an example. In the illustrated embodiment, the first connection component 10 is a plug, which is designed depending on the configuration of the corresponding socket of the medical device.
[0069] The first connection component 10 can, in particular, also have a plurality of data inputs 12 and / or control outputs 13, which correspond to the data outputs and control inputs present on the respective medical device. For example, the connection component 10 can have separate signal lines 12, 13 for operational control communication and for protective system communication of the medical device. Such a configuration allows the device 100 to be adapted to the internal communication structure of the medical device. For example, the medical device has two separate CAN buses—one for the operational control communication of the medical device and another for the protective system communication of the medical device.
[0070] The first connection component 10 can also be designed with data inputs 12 and / or control outputs 13 for different medical devices, so that the device 100 can be designed to transmit operating and machine data of different medical device types.
[0071] Furthermore, the voltage input 11 is also schematically shown as a single connection, but includes at least two poles and, if necessary, a ground connection to ensure the voltage supply to the device 100 when connected to the medical device. The voltage input 11 can also be designed to be compatible with multiple medical devices.
[0072] The first connecting component 10 further includes a connector housing 14 that surrounds and connects the remaining components of the first connecting component 10. In the embodiment of the Figure 1The connector housing 14 is formed as a single piece. All connections of the first connecting component 10 are thus located in a single connector housing 14. The connector housing 14 and the connections arranged therein together form a plug connection that corresponds to the socket provided by the medical device.
[0073] The device 100 further comprises a housing 40 on which the connector housing 14 and in which the storage unit 20 and the transmission unit 30 are located.
[0074] The memory unit 20 is connected to the voltage input 11, the data input 12 and the control output 13 of the first connection component 10. In the Figure 1Not shown is a possible electrical connection between the voltage input 11 and the transmission unit 30, via which the transmission unit 30 can also be supplied with electrical energy. This allows the storage unit 20 to store operating and machine data supplied from the medical device via the data input 12. The operating and machine data can be received at the data input 12 from the medical device over a predetermined period of time and stored in the storage unit 20. Accordingly, the operating and machine data are accumulated in the storage unit 20.
[0075] In a preferred embodiment, the operating and machine data received from the medical device are each provided with a time stamp when they are stored in the storage unit 20.
[0076] The storage unit 20 is connected via a first transmission port 21 to a second transmission port 31 of the transmission unit 30. Accordingly, the transmission unit 30 can communicate with the storage unit 20 and receive the operating and machine data stored in the storage unit 20 and then transmit them to an evaluation device (not shown here).
[0077] If the operating and machine data are stored in the storage unit 20 for a predetermined period of time, the transmission unit 30 can be used to perform a time-delayed transmission of the operating and machine data to the evaluation device. In particular, the operating and machine data stored over a predetermined period of time are then transmitted to the evaluation device all at once—for example, whenever a service technician is present and the transmission unit 30 is communicating with the service technician's evaluation device. The transmission can occur at specific times, for example, when the medical device signals that treatment has ended.
[0078] The transmission unit 30 is designed as a wireless transmission unit 30, by means of which the operating and machine data stored in the storage device 20 can be wirelessly transmitted to the evaluation device. Suitable transmission protocols include those with low electromagnetic emissions, for example, short-range transmission protocols such as Bluetooth.
[0079] According to an alternative not according to the invention, the transmission unit 30 can also be designed in the form of a plug connection, wherein the plug connection formed by the first connection component 10 can also serve to transmit the operating and machine data by means of the transmission device 30.
[0080] The device 100 may have further components, in particular further connections.
[0081] Based on the schematic representation of the Figure 2A further embodiment of a device 100 described here is explained in more detail. The embodiment of the Figure 2 differs from the embodiment of the Figure 1 in the mechanical design of the first connecting component 10 as follows.
[0082] First, the connector housing 14 of the device 100 of the embodiment of the Figure 2 formed in several parts. In particular, the voltage input 11 is located in a first part of the connector housing and the data input 12 and the signal output 13 are located in a second part of the connector housing. The two parts of the connector housing are spatially separated from each other and / or electrically insulated from each other. Alternatively or in addition to the representation of the Figure 2 it is possible that a part of the connector housing is located on a side of the housing 40 of the device facing away from another part of the connector housing.
[0083] In the embodiment of the Figure 2 The transmission unit 30 also has connections 32, which are connected to the data input 12 and the control output 13. For example, this enables a wired connection, not according to the invention, of the device 100 to the evaluation device by means of the first connection component 10. Alternatively, the device 100 can have a further connection component, for example, a further plug, which can be used to connect the device 100 to the evaluation device.
[0084] Based on the schematic representation of the Figure 3An embodiment of a medical device 500 is explained in more detail. The medical device 500 is preferably a dialysis machine for performing a dialysis treatment, for example, for performing hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis, acute dialysis, liver replacement therapy, apheresis, and / or another dialysis treatment.
[0085] The medical device 500 comprises a second connection component 50 with a voltage output 51, a data output 52, and a control input 53. The second connection component 50 can comprise additional data outputs and control inputs (not shown in the figures). Furthermore, the medical device 500 includes a first connection 541, a second connection 542, a third connection 543, a data unit 55, and data terminals 551.
[0086] The second connection component 50 is designed to receive a first connection component 10 of a device 100, in particular the device 100 of the embodiment of the Figure 1 , respectively. In particular, the voltage output 51, the data output 52, and the control input 53 are designed for connection to a voltage input 11, a data input 12, and a control output 13 of the device 100.
[0087] By means of the medical device 500, an operating voltage suitable for supplying power to a device 100 can be applied to the voltage output 51 via the first connection 541. The data output 52 and the control input 53 are connected to the data unit 55 via the second connection 542 and the third connection 543, respectively.
[0088] Based on the schematic representation of the Figure 4An embodiment of a device 100 and a medical device 500 described here is explained in more detail. Shown is a device 100 according to the embodiment of the Figure 1 , which by means of the first connecting component 10 into the second connecting component 50 of a medical device 500 according to the embodiment of the Figure 3 is plugged in. For clarity, the connections of the device 100 and in particular of the first connection component 10 or of the medical device 500 and in particular of the second connection component 50 are shown in the Figure 4 not shown.
[0089] Furthermore, an evaluation device 60 is provided, which includes a wireless transmission unit and an input interface 61. The evaluation device 60 can be provided, for example, in the form of a mobile terminal such as a smartphone or a tablet. The evaluation device 60 is therefore not in electrical contact with the medical device 500, but instead receives the operating and machine data stored in the storage device 20 wirelessly via the transmission unit 30.
[0090] If, in an alternative not according to the invention, no wireless interface is present and the transmission takes place via the plug of the first connection component 10 by plugging the device 100 into the evaluation device 60, the evaluation device 60 is also not in electrical contact with the medical device 500, since the device 100 can only be plugged into either the medical device 500 or the evaluation device 60.
[0091] Accordingly, a time-delayed or asynchronous transmission of operating and machine data from the medical device 500 to the evaluation device 60 takes place without there being any electrical contact between the evaluation device 60 and the medical device 500.
[0092] Based on the schematic representation of the Figure 5An embodiment of a method described here is explained in more detail. The transmission of the operating and machine data of the medical device 500 to the evaluation device 60 can, for example, take place as follows. In a first method step 701, a configuration specification is sent by the evaluation device 60 to the wireless transmission unit 30 of the device 100 and forwarded from there to the storage unit 20. In the storage unit 20, the configuration specification is compiled in a second method step 702, and a control signal is generated, which is sent via the control output 13 of the device 100 to the control input 53 of the medical device 500 and forwarded via the first connection 541 to the data unit 55.In accordance with the control signal, the data unit 55 provides operating and machine data, which it outputs via the second connection 542 to the data output 52, where the operating and machine data are forwarded to the storage unit 20 via the data input 12 of the device 100 (third method step 703). If necessary, the storage unit 20 then extracts a portion of the operating and machine data from the received operating and machine data and stores this portion. The extraction or filtering of the operating and machine data to be stored from the multitude of received operating and machine data is carried out based on the configuration specification. However, it is also possible for the storage unit 100 to store the multitude of operating and machine data entirely as stored operating and machine data.
[0093] Alternatively, it is possible that no control signal is sent to the data unit 55 or that no data unit 55 is present. In this case, the medical device 500 always provides the same operating and machine data, regardless of the configuration specification. The storage unit 20 then extracts the portion of the operating and machine data to be stored based on the configuration specification.
[0094] In an additional fourth method step 704, which is preferably performed before storage, the stored operating and machine data can be processed or otherwise prepared, for example, by encrypting or averaging the operating and machine data. The operating and machine data thus processed and, preferably subsequently, stored are then transmitted to the evaluation device in a fifth method step 705 by means of the transmission unit 30. The stored operating and machine data can be transmitted during the data readout process. Alternatively, the transmission can be delayed, i.e., after storage has been fully completed.
[0095] In a further preferred embodiment, all operating and machine data generated in the medical device 500 during operation of the medical device 500 are read out by the device 100 at the data output 52 of the medical device 500 and received at its data input 12. The transmission of control data from the device 100 to the medical device 500 is thus unnecessary. Accordingly, the device 100 only "listens" to the operating and machine data generated in the medical device 500, for example, by monitoring a corresponding bus. Accordingly, the design of the control output 13 of the first connection component 10 of the device 100 and thus also the design of the control input 53 in the medical device 500 can be dispensed with. List of reference symbols
[0096] 100Device 10First connection component 11Voltage input 12Data input 13Control output 14Connector housing 20Storage unit 21First transmission connection 22Connections 30Transmission unit 31Second transmission connection 32Transmission unit connections 40Housing 500Medical device 50Second connection component 51Voltage output 52Data output 53Control input 541First connection 542Second connection 543Third connection 55Data unit 551Data connections 60Evaluation device 61Input interface 701First process step 702Second process step 703Third process step 704Fourth process step 705Fifth process step
Claims
1. A device (100) for transmitting operating and machine data of a medical apparatus (500), preferably a dialysis apparatus, to an evaluation device (60), wherein the device (100) comprises - a data input (12) for receiving operating and machine data of the medical apparatus (500), - a programmable memory unit (20), which is configured to store at least part of the received operating and machine data, - a voltage input (11) which is configured to supply the device (100) with an operating voltage, provided by the medical apparatus (500), and - a transmission unit (30) which is configured to transmit the stored operating and machine data to the evaluation device (60), wherein the transmission unit (30) is configured to wirelessly transmit the operating and machine data, stored in the storage unit (20), to the evaluation device (60) while the device (100) is connected to the medical apparatus (500), and wherein the device (100) is configured to prevent external communication or limit it to transmission when a signal, corresponding to the operating state of the medical apparatus (500), is transmitted from the medical apparatus.
2. The device (100) according to claim 1, wherein the signal comprises a date and / or a time stamp describing the operating state and / or wherein the signal describes a presence of a current treatment mode.
3. The device (100) according to claim 1 or 2, wherein - the transmission unit (30) is configured to receive a configuration specification from the evaluation device (60) and to forward it to the programmable memory unit (20) and - the programmable memory unit (20) is configured by the configuration specification to store operating and machine data in accordance with the configuration specification.
4. The device (100) according to the preceding claim, wherein receiving the configuration specification by the transmission unit (30) is blocked during operation of the medical apparatus (500).
5. The device (100) according to any one of the preceding claims, wherein the device (100) is configured to be connected to and / or disconnected from the medical apparatus (500) during operation of the medical apparatus (500).
6. The device (100) according to any one of the preceding claims, wherein the storage unit (20) has a processing unit for processing at least part of the operating and machine data.
7. The device (100) according to any one of the preceding claims, wherein the device (100) is configured in the manner of a dongle.
8. The device (100) according to any one of the preceding claims, comprising a housing (40) configured to be electrically insulating which contains the storage unit (20) and the transmission unit (30).
9. A system comprising a device (100) according to any one of the preceding claims and a medical apparatus (500), preferably for carrying out a dialysis treatment, wherein the device (100) has a first connection component (10) and the medical apparatus (500) has a second connection component (50), and the device (100) is inserted into and connected to the second connection component (50) of the medical apparatus (500) by means of the first connection component (10), and wherein the medical apparatus (500) comprises a data output (52) for sending operating and machine data of the medical apparatus (500) to a data input (12) of the device (100) connected thereto and a voltage output (51) for providing an operating voltage to a voltage input (11) of the device (100) connected thereto for supplying the device (100).
10. A method for transmitting operating and machine data of a medical apparatus (500), preferably a dialysis machine, to an evaluation device (60), the method having the following steps: - providing a device (100) comprising a data input (12), a programmable memory unit (20), a voltage input (11) and a transmission unit (30); - connecting the device (100) to the medical apparatus (500) such that the device (100) is supplied, via the voltage input (11), with an operating voltage, provided by the medical apparatus (500); - receiving operating and machine data of the medical apparatus (500) via the data input (12); - storing at least part of the operating and machine data in the storage unit (20); - transmitting the stored operating and machine data to the evaluation device (60) by means of the transmission unit (30) wherein the operating and machine data, stored in the storage unit (20), are transmitted wirelessly to the evaluation device (60) while the device (100) is connected to the medical apparatus (500) and wherein the device prevents external communication or limits it to transmission when a signal, corresponding to the operating state of the medical apparatus, is transmitted from the medical apparatus.
11. The method according to claim 10, wherein the signal comprises a date and / or a time stamp describing the operating state and / or wherein the signal describes a presence of a current treatment mode.
12. The method according to claim 10 or 11, further having the following steps: - connecting the device (100) to the evaluation device (60) and - transmitting a configuration specification from the evaluation device (60) to the programmable memory unit (20).
13. The method according to any one of claims 10 to 12, wherein the transmitting of the configuration specification is carried out by the evaluation device (60) while the device (100) is connected to the medical apparatus (500).
14. The method according to any one of claims 10 to 13, wherein connecting the device (100) to the medical apparatus (500) and / or disconnecting the device (100) from the medical apparatus (500) is carried out during operation of the medical apparatus (500).