TESTING OF A REVERSE OSMOSIS SYSTEM FOR USE IN DIALYSIS MACHINES

Abstract

The invention relates to an electronic safety system for an RO installation (RO), which RO installation is designed for use with at least one dialysis device (D). For this purpose, the system comprises: the RO installation (RO), which is intended to produce ultrapure water and has a sensor unit (S) for capturing sensor data, the RO installation (RO) comprising an electronic data interface (RO-S) in order to transmit the sensor data captured by the sensor unit (S); an analysis apparatus (AE), which is intended to analyze a water sample of the RO installation with respect to safety requirements and in particular for contamination and to produce results data, the analysis apparatus (AE) also having an analysis interface (AE-S) in order to transmit the produced results data in electronic form; and a network (NW) for the exchange of data between the medical apparatuses, in particular between the RO installation (RO) and the analysis apparatus (AE).

Description

[0001] Title: Review of a reverse osmosis system for use with dialysis machines

[0002] Description The present invention lies in the field of water technology in the medical sector and relates in particular to the safety verification of reverse osmosis systems used for medical devices, especially dialysis machines, to ensure that the required water is of sufficient quality and free from (bacterial) contamination. The invention relates in particular to a system, an analysis device, a reverse osmosis system, a server, a method for the safety verification of supplied water, and a computer program.

[0003] Dialysis machines are operated with ultrapure water. Reverse osmosis systems (hereinafter referred to as RO systems) are used to provide this ultrapure water.

[0004] The fundamental physical principle of reverse osmosis serves to concentrate substances dissolved in liquids. It reverses the natural osmosis process using pressure. The RO process can be schematically described as follows: two containers filled with liquid (e.g., water) of unequal concentration, particularly salt concentration, are separated by a semipermeable membrane. After applying osmotic pressure to the container where the concentration is to be increased, the solvent molecules can migrate against their "natural" osmotic flow. The applied pressure must be higher than the pressure generated by the osmotic tendency to equalize concentrations. This process forces the solvent molecules into the compartment where the dissolved substances are less concentrated. Thus, this method reduces the concentration of unwanted substances on the purified water side.

[0005] The water produced by the RO system is used in the medical field, particularly for operating dialysis machines such as the Fresenius Medical Care 5008 hemodialysis system and other extracorporeal blood treatment devices. To ensure compliance with the stringent safety requirements of these medical devices, it is essential that the water is supplied in the required quality. Therefore, the ultrapure water produced by the RO system is tested at defined intervals to ensure compliance with chemical and microbiological safety requirements. This testing is carried out in external laboratories. The testing conditions are defined in the ISO 23500 standard, "Guidance for the preparation and quality management of fluids for haemodialysis and related therapies."

[0006] Typically, a water sample of ultrapure water is taken from the RO system or the connected ring main and sent to a laboratory. This laboratory usually requires several days to provide a laboratory report or results, which, according to current best practices, are then sent to the operator of the RO system by mail or telephone.

[0007] The prior art procedure described above has the significant disadvantage that it can sometimes take several days to a week for the laboratory results to be available on the local system. If the result indicates, for example, contamination with bacterial pathogens or another safety defect, the connected dialysis machines can only be switched off by the RO system after the information has been transmitted locally to the RO system. During this period, a safety risk exists because the machines continue to operate with poor water quality. In such a case, the current procedure thus represents a safety gap. Based on the known prior art procedure, the present invention therefore aims to improve the safety of RO systems and the medical devices connected to them.Furthermore, the analytical capabilities of the collected data (sensor data, laboratory values, etc.) are to be improved. Safety-relevant data is also to be made available earlier. Additionally, the information provided through technical notifications is to be enhanced and directly usable locally on the device.

[0008] This problem is solved according to the invention by an electronic security system, an analysis device, an RO system, a server and a method for security verification of supplied water and a computer program product according to the accompanying, interdependent patent claims.

[0009] The invention is described below with reference to the system-based solution to the problem, and thus, among other things, with reference to a security system. Features, advantages, or alternative embodiments mentioned here are also transferable to the other claimed subject matter and vice versa. In other words, the other subject matter claims (which, for example, relate to the analysis device, the RO system, or the server) and the method claims can also be further developed with the features described or claimed in connection with the system. The corresponding functional features of the method are thereby realized by corresponding physical modules, in particular by electronic hardware modules or microprocessor modules, of the system or the device, and vice versa.

[0010] According to a first aspect, the invention relates to an electronic safety system for a reverse osmosis (RO) plant, wherein the safety system can be operated as a central, server-based, and in particular cloud-based system to ensure sufficient ultrapure water quality, and wherein the RO plant is designed for application and / or operation with a network of medical devices, in particular dialysis machines. The safety system comprises:

[0011] - the RO system, which is intended for the production of ultrapure water and which is equipped with a sensor unit for recording sensor data, in particular conductivity before and after the membrane with a retention capacity, and wherein the RO system includes an electronic data interface for the exchange of analog and / or digital data in order to send the sensor data recorded by the sensor unit to an external instance outside the RO system;

[0012] - an analytical device, which may be equipped, for example, in a laboratory with a laboratory-technical device for examining or analyzing the water quality of a water sample from the RO plant with regard to safety requirements for the ultrapure water (e.g., with regard to contamination) and which is intended to generate result data in response to the analysis of the water sample, wherein the analytical device is further equipped with an analytical interface to send the generated result data in electronic form to an external entity outside the analytical device;

[0013] - a network for data exchange between medical technology facilities of the security system, in particular between the RO system and the analysis facility.

[0014] According to a preferred embodiment, the system comprises a server designed to receive sensor data from the RO system and / or the results data from the analysis device, and further designed to transmit the results data to the RO system and / or to those medical devices connected to the RO system for control purposes. Optionally, the results data can also be transmitted to other devices integrated within the respective unit (clinic / hospital department) where the RO system is installed. This embodiment of the invention has the advantage that the server can be cloud-based, thus ensuring that sufficient technical resources (such as processor power, storage capacity, and the implementation of applications, e.g., for evaluation purposes) are always available.Furthermore, this enables centralized processing and aggregation of data, whereby the generated data can be forwarded quickly and early to the decentralized clients (e.g. medical devices, RO systems) via a network connection or corresponding control interfaces.

[0015] Another important technical advantage is that the RO system and / or, for example, the dialysis machine can be directly controlled and / or regulated based on the results data. If the results data indicate a water quality deficiency, this can be forwarded as early as possible and directly to the receiving devices, such as the dialysis machines, so that they can be immediately disconnected from the RO water system or replaced with a different connection, if possible. Furthermore, the evaluation unit on the server can access a rule set that can be dynamically adapted even during operation. This rule set contains rules that define, for example, that in the event of a fault, warning messages are generated and sent to various computer-based or electronic receiving devices (e.g., a ward physician's mobile device or a computer in the nurses' station) to enable rapid intervention.

[0016] The server with the evaluation application can also receive additional data from other data sources, such as a water supply unit designed to supply water to the RO system, or from other devices connected to, supplied by, or operated by the RO system. The water supply unit can be equipped with a measuring unit to record water consumption data and transmit it to the server. According to a preferred embodiment of the invention, the server can provide a first result based on the transmitted water consumption data and / or sensor data. For this purpose, an evaluation unit can be provided on the server that evaluates the received data based on a stored rule data set. The rule data set can also be dynamically modified during system operation.

[0017] A rule could, for example, state: "If the sensor data falls below or exceeds a predefined threshold, then the water quality is insufficient," or "If the sensor data is within a predefined range and the water consumption data is below a threshold, then the water quality is sufficient." The preliminary result determined in this way can either be output on the server via a user interface (e.g., as a warning message in the first example above) and / or forwarded to the reverse osmosis system or other devices.

[0018] This preliminary result is based solely on measured values ​​and sensor data. To validate the preliminary result, further analysis is planned. For this purpose, a water sample is analyzed in the analytical unit. The resulting data can then be provided. This data can then be transmitted to the server to validate or refute the preliminary result. Depending on the outcome, the results are displayed again on a user interface of the server and / or forwarded to the RO system or other devices. The latter occurs particularly if the water quality is deemed insufficient, allowing for the rapid implementation of countermeasures, especially disconnecting the dialysis machines from the water supply. This improves the quality of the evaluation and provides information about water quality independently of laboratory analysis.The RO system can thus be monitored much more closely, which is advantageous. Conversely, the analysis result from the laboratory analysis can also potentially be specified using sensor and / or consumption data, or a cause can even be narrowed down or identified. The application for evaluation and validation – as described above – does not necessarily have to run on the server, but can also be outsourced, for example, directly to the RO system or the analysis unit.

[0019] In a further advantageous embodiment of the invention, the system further comprises a water supply unit for supplying water to the RO system, wherein the water supply unit includes a measuring unit for measuring water consumption data and wherein the measuring unit includes a bus interface for transmitting the recorded water consumption data (particularly preferably to the server). More comprehensive evaluation processes can be initiated with this data, and more extensive results can be provided. For example, an analysis result can be assigned to the water consumption data in terms of time in order to provide a more comprehensive statement. Limit values ​​can be defined for consumption values, such as water consumption per hour / day / week / treatment. If such a limit value is exceeded, a notification is generated. Until then, it is unclear why the exceedance occurred. If further water quality data is available, such as...If the conductivity of the raw water or feed water also shows an exceedance of the limit value, the cause can already be narrowed down / determined using this intelligent link.

[0020] In a further advantageous embodiment of the invention, the result data are recorded electronically in a predefined, standardized format. This allows all result data to be processed uniformly on the server and / or received on the RO system, even if the analytical equipment is operated by different operators using different methods and / or applications. This increases the compatibility of the system and connected systems.

[0021] The sensor data acquired by the sensor unit includes parameters that represent the correct functioning of the RO system. These parameters include those relating to water conductivity; in particular, two different parameters are recorded: before and after the membrane (feed water conductivity and permeate conductivity), as well as parameters relating to retention capacity. The retention capacity R can be determined, for example, using the feed water conductivity cSP and the permeate conductivity cP as follows:

[0022] R [%] = (cSp-cP) / cSp * 100

[0023] In alternative embodiments of the invention, further parameters can be recorded to increase the informative value of the analysis or the evaluation on the server (e.g. electricity and water consumption of the water treatment plant, water temperature, water hardness, chlorine concentration).

[0024] The task is further solved by an RO plant for the production of ultrapure water with a sensor unit for recording sensor data and with an electronic data interface intended for use in a safety system described above.

[0025] The task is further solved by an analytical device, which may be located, for example, in a laboratory with at least one laboratory-technical device for examining or analyzing the water quality of a water sample from the RO plant with regard to safety requirements for the ultrapure water (e.g., with regard to contamination), and wherein the analytical device is designed to generate electronic result data in response to the analysis of the water sample, and wherein the analytical device is further equipped with an analytical interface to send the generated result data in electronic form to an external entity outside the analytical device, and wherein the analytical device is designed for use in a safety system according to one of the above aspects.

[0026] The task is further accomplished by a server for the coordinated processing of security data from a reverse engineering (RO) system, which is operated for at least one medical device, in particular a dialysis machine, the server being intended for use in a security system as described above. The server is configured with:

[0027] - an electronic data interface for exchanging digital and / or analog data in order to receive the sensor data captured by the sensor unit;

[0028] - an analysis interface to receive the result data generated by the analysis device in electronic form.

[0029] In an advantageous embodiment of the invention, the server is further equipped with a memory for storing the received data and / or interacts with a database and / or includes a processing unit for the specific processing of the received data. This also allows historical data to be processed.

[0030] The task is further solved by a procedure for the safety-related verification of an RO system designed for operation with at least one medical device, in particular a dialysis machine, comprising the following procedure steps:

[0031] - Recording sensor data during the operation of the RO plant, which is intended for the production of ultrapure water;

[0032] - Sending the acquired sensor data to an external communication partner in electronic form. The external communication partner is therefore located outside the RO system and outside the RO system, thus ensuring independent testing.

[0033] In a preferred embodiment of the invention, after the sensor data has been transmitted, or concurrently on a laboratory system, a water sample from the RO system can be analyzed with regard to safety requirements in order to generate result data based on the analysis. The generated result data can be sent electronically, and in particular for controlling the RO system and / or the dialysis machine, to the aforementioned devices. Alternatively, the RO system and / or the dialysis machine can also be controlled based on the result data.

[0034] In a preferred embodiment of the invention, the acquired sensor data is transmitted continuously or in a time-controlled manner during the operation of the RO system and / or after predefined events.

[0035] In a further, preferred embodiment of the invention, the sensor data and the result data are fed to a server for central processing and stored there, and in particular are subjected to a statistical evaluation across RO systems.

[0036] In a further, preferred embodiment of the invention, the result data are used directly to control the at least one medical device in order to be able to trigger an emergency interruption or an emergency stop locally, if necessary.

[0037] The invention also relates to a computer program product comprising a computer program. The computer program includes software code intended for executing the method described above. The computer program product can be implemented in software or hardware and, in addition to the computer program, may also include operating instructions, a data carrier, and / or packaging. In particular, the process steps of acquiring, transmitting, generating, and transmitting result data are triggered and / or executed by software. Analyzing the sample, on the other hand, may comprise several steps, some of which may require human operation, while generating the result data can be fully automated.

[0038] The following defines the terms used in this application.

[0039] A reverse osmosis (RO) system is used to produce ultrapure water and is connected to at least one medical device to supply it with this ultrapure water. It can therefore also be referred to as a medical device. The RO system may include an electronic processing unit (e.g., a CPU, FPGA, microprocessor, etc.). The sensor unit may be integrated into the electronic processing unit. The ISO 23500:2014 standard defines the requirements for dialysis water (ultrapure water) that an operator of such a system must meet. It refers to the ISO 13959:2014 standard, "Water for haemodialysis and related therapies," which applies to manufacturers of these systems and specifies the following requirements for the microbiological and chemical quality of dialysis water:

[0040]

[0041]

[0042] The correct functionality of the RO system is defined, among other things, by the retention capacity of sodium chloride (table salt), which - depending on the requirements profile for the ultrapure water - should be between 90% and 99.8%.

[0043] The RO system and the laboratory system with its analyzer are installed and deployed on two separate systems. Typically, the RO system is located within a dialysis center (e.g., in an area separate from the dialysis unit), where the dialysis machines are also operated. The laboratory system, on the other hand, is located in an external laboratory outside the dialysis center. This ensures that the analysis can be performed independently (and therefore without influence) by the system operator, thus avoiding potential conflicts of interest. The analyzer and the RO system communicate via a data connection. This connection can be internet-based and, for example, use a protocol from the HTTP(S) protocol suite. The RO system and the laboratory system are operated on different platforms and by different operators.

[0044] The analytical unit can be part of a laboratory system for examining water samples. The analytical unit is the electronic component and serves for digital data processing and data communication with external communication systems. In addition to the analytical unit, the laboratory system typically includes at least one other laboratory device or instrument (such as a conductivity meter, an ion chromatograph, a mass spectrometer, or an atomic absorption spectrometer for the quantitative determination of individual ions, etc.). The laboratory system serves to detect water contaminants and to perform biological and / or chemical analyses as well as bacteriological examinations.One aspect of the invention relates to a comprehensive analysis of the water sample from the RO system; thus, not only is the chlorine content tested, but further investigations are carried out to detect water contaminants (pollutants, biological impurities, or bacteriological contamination, etc.). The analysis, performed using the various devices and / or laboratory equipment mentioned above as examples, yields a laboratory result. This result is fed into the analysis unit, which is designed to automatically generate result data – for example, in the form of an electronic message. The result data can be prepared for transmission to external communication partners.The results data are to be transmitted, in particular via a data connection, to the RO system and / or a cloud-based server and / or the medical devices, in order to initiate further measures if necessary. The network is an electronic network for data transmission. It can operate using various protocols. For example, the connection between the RO system and the server can be designed as an MBUS system (especially according to the EN13757 series of standards), and the analyzer communicates with the server and / or the medical devices via an IP-based protocol, e.g., using messages in an XML structure. For data exchange, the RO system and / or the analyzer are equipped with interfaces: the RO system with a data interface (e.g., using an IP-based protocol) and the analyzer with an analysis interface (e.g., using a protocol).HL7); this interface also allows the transfer of data in a tabular data structure, such as in CSV, Microsoft Excel, OpenOffice Calc, or XML formats, etc. The generated results can be transmitted as status messages (insufficient water quality - sufficient water quality) or as more comprehensive message packages containing further details about the analysis. These packages can also include metadata such as a timestamp, sample condition, and the duration of the analysis.

[0045] As described above, the system can include a server – preferably cloud-based. The server aggregates and preferably stores the collected and generated data. This may involve access to a connected database. The server can be used for coordinated data processing. "Concerted" in this context refers to the fact that the results data have been calculated for a network of dialysis machines, specifically for those dialysis machines supplied by the respective RO system. However, the coordinated calculation can also be performed locally on a dedicated device, but still centrally and for all machines in the network. The server can include an evaluation unit in the form of an evaluation application (software) or an evaluation circuit (hardware). The evaluation unit is an electronic component. The evaluation circuit can, for example, be a...The system can be designed as an electronic circuit with digital and / or analog circuit components, which may include evaluation logic. This logic is used to assess the quality levels maintained by an analyzed RO system and to issue a warning message if these levels are not met. The warning message can be transmitted via appropriate data interfaces to the RO system, to a control unit of the RO system, and / or directly to the medical devices (dialysis machines). For immediate signaling, a traffic light indicator can be displayed on a user interface (red for insufficient quality, green for sufficient quality, and yellow for a warning or exceedance of action levels, e.g., depending on whether relevant limits are exceeded or not reached).The evaluation circuit can access a set of rules for analysis, which may be stored in a database or memory and defines a policy for prioritizing a set of result data. The evaluation circuit can preferably be activated automatically when new result data is generated or transmitted. The result data is preferably sent to the recipients for regulation and / or control purposes via a push protocol. The recipients can be the RO system or the dialysis machine. The evaluation is preferably assigned to a specific RO system. If a central server is used that collects and analyzes data from all or selected RO systems (e.g., from all systems in a specific geographic region or dialysis network), a statistical analysis can also be performed to provide results that are valid across all RO systems.It is also possible to develop an evaluation that can then resolve the messages for the systems depending on the RO system identity (for example via a corresponding identification note).

[0046] An important aspect of the present solution is that the medical technology equipment of the safety system, which includes the RO system, the laboratory system with the analysis equipment and may also include the water supply unit and / or the dialysis machines, is connected via two different connections:

[0047] A data connection for exchanging electronic messages and digital data, such as sensor data and / or result data and

[0048] A pipe connection for the exchange of physical media, such as ultrapure water and / or a water sample.

[0049] An increased level of reliability can be achieved through an additional verification measure. This involves first evaluating the sensor data acquired locally on the RO system (either locally, in a processing unit within the RO system, or externally in a processing unit on the server or at the analytical instrument) to provide a preliminary result. This preliminary result is then, if necessary, provided to the analytical instrument and is either confirmed (validated) or rejected (falsified) by the analysis of the water sample. This allows for an even earlier provision of a preliminary result on the RO system. Furthermore, reliability can be increased by verifying the preliminary result again.

[0050] The invention is described below for a dialysis machine as an example of a medical device, e.g., a hemodialysis machine. However, it is obvious to those skilled in the art that the invention can also be applied or transferred to other medical devices, computer-controlled equipment, (fluid management) machines, or blood treatment devices that require ultrapure water for operation. This can also apply, for example, to peritoneal dialysis machines if they process ultrapure water. It is possible for the transmission of sensor data from the RO system and / or consumption data from the water supply system or another device (e.g., regarding gas consumption, electricity consumption, consumption of temperature resources for heating or cooling, etc.) to be carried out at a configurable time interval for processing by the evaluation application.

[0051] In a preferred embodiment of the invention, it is configurable to which devices the result data should be sent. For example, it can be configured so that if the data includes a high-priority warning message (water quality insufficient), it is sent to a monitoring unit of the clinic / operator and to other entities, while in the case of a positive result (sufficient quality), it is sent only to the server and / or the relevant RO system. This has the advantage that correctly operating systems are not burdened with unnecessary messages. However, it can also be desirable and configured so that all result types are always available on all devices. This way, the operator (of the clinical facility and / or the RO system) always has an automatic overview of all systems and their statuses at a glance.

[0052] Another solution to the problem consists of a computer program product that is loaded or loadable into the memory of a computer or electronic or medical device with a computer program for carrying out the procedure described above when the computer program is executed on the computer or electronic or medical device.

[0053] Another solution involves a computer program to carry out all the steps of the procedure described above, provided the computer program is executed on a computer, electronic device, or medical device. It is also possible for the computer program to be stored on a medium readable by the computer or the electronic or medical device.

[0054] The following detailed description of the figures discusses exemplary embodiments, which are not to be understood as restrictive, along with their features and further advantages, using the drawing as an example.

[0055] Brief description of the figures Fig. 1 shows a schematic representation of a device according to the invention.

[0056] Security system with an RO system for operating dialysis machines and a server and their data exchange according to an advantageous embodiment of the invention.

[0057] Fig. 2 is a flowchart of a process according to a preferred

[0058] embodiment of the invention.

[0059] Fig. 3 schematically shows the data exchange between the dialysis machine and

[0060] Server and the RO system according to an embodiment of the invention and

[0061] Fig. 4 shows an alternative embodiment of the invention compared to that shown in Fig. 1.

[0062] Security system without a server.

[0063] Detailed description of the figures

[0064] The invention will now be described in more detail using exemplary embodiments and with reference to the figures.

[0065] The invention relates to an electronic messaging system for RO systems RO, which are operated and used for dialysis stations with at least one dialysis machine or other medical devices D and which communicate a quality status of the RO system RO.

[0066] Fig. 1 shows a first embodiment of the invention, in which the system 1 comprises a server SV. The server SV can be configured, at least partially, for evaluating water quality data. The evaluation of the water quality is based on various input parameters provided by different devices (RO system RO, analysis unit AE, database DB, etc.).

[0067] For this purpose, a safety system 1 is provided, comprising several medical devices, including medical devices each with electronic components for data processing and communication. The RO system RO is designed to produce ultrapure water, which must be supplied to one or—usually—several dialysis machines D in a dialysis station to enable their operation. To ensure sufficient quality of the supplied ultrapure water (compliance with the limit values ​​for contaminants, e.g., aluminum, chlorine, fluorides, nitrates, sulfates, and / or zinc—the limit values ​​for a respective maximum concentration are defined in the ISO 13959:2014 standard as specified above), the RO system RO is equipped with a sensor unit S for acquiring sensor data (shown in Figure 1, by way of example, with sensors S1, S2, and Sn).In addition, the RO system includes an electronic data interface RO-S to transmit the sensor data acquired by the sensor unit S.

[0068] The RO system is supplied by a water supply unit W, which serves to deliver water so that it can be purified or treated within the RO system. The water supply unit W comprises several electronic modules, including a measuring unit M, which is designed to determine water consumption data 32. Various measuring methods and sensors or signal transmitters can be used for this purpose. Furthermore, the water supply unit W includes interfaces for data communication, which can be configured in the form of an MBUS interface. Other medical devices of system 1, such as the server SV and / or the analysis unit AE, can communicate with the water supply unit W via this MBUS interface. This enables the analysis unit AE to acquire sensor data directly from the water supply unit W.This has the advantageous effect that the analysis unit AE can perform a more comprehensive evaluation, which in particular takes into account the water consumption data 32 and, if applicable, other sensor data recorded on the water supply unit W for the calculation of the result data.

[0069] In a further advantageous embodiment of the invention, the sensor data acquired by the water supply unit W can be forwarded to the RO system RO. This has the advantage that the sensor data from the water supply unit W can be combined with the locally acquired sensor data from the RO system to calculate a preliminary result, which is then sent to the analysis unit for validation purposes. The preliminary result can be displayed on an output unit (e.g., a screen) of the water supply unit W and / or the RO system RO for local verification. This allows for more comprehensive and informative calculations of the preliminary result. The analysis unit AE can be arranged in a laboratory system. The laboratory system, equipped with laboratory equipment, is designed to analyze a water sample from the RO system with regard to safety requirements and, in particular, contamination. Based on the analysis result and, if applicable,Taking into account additional sensor data (from the water supply unit W and / or the RO system RO), result data is calculated or generated according to predefined rules. The result data is also provided in a digital format, specifically a results format. This can be a configurable data structure, particularly in XML format. The analysis unit AE also includes an analysis interface AE-S to send the generated result data electronically to external communication partners (especially to the RO system RO and / or the connected dialysis machines D).

[0070] The facilities and devices of safety system 1 are interconnected via a network NW. As indicated in Fig. 1, several dialysis machines D and / or other facilities are typically connected to an RO system. This is represented in Fig. 1 by the two exemplary devices D1 and Dn.

[0071] In a (first) preferred embodiment of the invention, shown in Fig. 1, the security system 1 comprises a server SV. This server is preferably centrally accessible via network interfaces over a technical communication network NW and can be configured as a cloud server. The server SV exchanges data with the connected devices, in particular with the RO system RO, the medical devices D, the analysis unit AE, and optionally with a database DB. In this first embodiment of the invention, an evaluation application or evaluation functionality is implemented on the server SV in a processor P, which is intended for evaluating the detected data.In particular, the results data, sensor data, and, if applicable, historical data from a database (DB) are processed according to predefined rules to generate a result message about the quality status of the water supplied by the RO system. This result message can preferably be used to control the RO system (RO) and / or the connected dialysis machines (D). This allows the relevant results to be made available directly at the point of use.

[0072] In a preferred embodiment of the invention, the database can also contain configurable rules that specify when the results data are to be sent to the respective recipients. Furthermore, it can be defined—e.g., specifically for certain geographic regions or countries—which additional functions and messages are to be sent to the recipients along with the results data in a data package. The functions can include, for example, control functions for the dialysis machine and / or the RO system (switching the dialysis machine on and off, restricting the device's functionality—especially depending on the analysis result, etc.), and the messages can include the generation of warning messages (e.g., on the RO system, indicating that the water quality does not meet the required safety standards, with information on limit exceedances).The rules can be specified differently for each recipient of the result data (or data packages) or for different recipient groups during a configuration phase. This advantageously achieves an important additional flexibility.

[0073] The SV server and the evaluation application implemented on it can preferably be deployed as a web platform and browser-based. The SV server can access a local storage MEM for further calculations, e.g., statistical analyses, and / or store the calculated or imported data there.

[0074] As briefly explained above, the analytical unit (AE) is designed to generate result data from the laboratory report or results in a predefined format for transmission to external communication partners. In Fig. 1, the dashed arrows (from the water supply unit W to the RO system RO and from the RO system to the analytical unit AE) indicate that this is not a data transfer, but rather the transfer of physical media. In the first case, water is transferred to the RO system RO, and in the second case, a water sample is transmitted to the analytical unit AE. The other arrows indicate the electronic exchange of analog and / or digital data.

[0075] Basically, the system can be operated in two different versions.

[0076] As described above, in a first embodiment shown in Fig. 1, a central server SV is connected to system 1. The evaluation application for analyzing the detected data is implemented on server SV. Server SV is preferably cloud-based and accessible via IP protocol-based interfaces (e.g., TCP / IP) SV-S1 and SV-S2. In this embodiment of the invention, the exchanged data from the respective sender (e.g., RO system RO, analysis unit AE) is first forwarded to the central server SV, which then sends the received data either directly or in pre-processed form to the respective receiver (e.g., RO system RO, analysis unit AE). Data from the water supply unit W and / or data from the dialysis machines D can also communicate via interfaces SV-S1 and SV-S2 (not explicitly shown in Fig. 1).In this embodiment, the server SV acts as a proxy or intermediary node in the chain between the data source and the data sink. This embodiment of the invention has the advantage that all data can be aggregated on the server SV for further evaluation and processing. In particular, historical data sets can be compared with current data sets to provide more detailed information (e.g., "In 80% of cases where the results do not indicate sufficient water quality, the sample was taken from a group of RO systems located in a specific geographic region" or "In 90% of cases where the results do not indicate sufficient water quality, the sample was taken during a specific time period"). In particular, a statistical analysis can be performed that is comprehensive across multiple RO systems.Furthermore, reference data obtained can be provided on other RO systems for comparison / reference purposes. Manually entered data relating to the RO system RO can also be considered within the evaluation application. The MEM storage system can be used for accessing and storing the data. In a second embodiment of the invention, no central server is provided. In this case, the RO system and / or the water supply unit W and / or the dialysis machine D interact directly with the analysis unit AE and vice versa. This second embodiment is represented in Fig. 1 by the fact that at least the RO system RO communicates directly (without mediation by the server SV) with the analysis unit AE, which is indicated by the arrow between the corresponding interfaces RO-S, AE-S, which runs without mediation by the server SV.In this case, the evaluation application for analyzing the data and calculating the results message can be provided, at least partially, on the analysis unit (AE). The application can also be partially implemented on other electronic devices. The results data or the results message then include a control data set designed to control the respective device. In case of an error (e.g., insufficient ultrapure water quality), the control data set can include a section that triggers, for example, the output of a warning message and / or the shutdown of the RO system. Furthermore, the control data set can include a notification field that triggers a notification to other instances or devices. This notification should be executed particularly when the control data set has been transmitted to the external communication partner (e.g., the RO system). For example,Automatic warning messages are triggered directly and locally on the dialysis machines D connected to the RO system RO. This has the advantage that in safety-critical cases, the relevant information is immediately available locally, allowing necessary measures to be initiated directly without intermediaries.

[0077] Instances must be informed. In an advantageous version, the result data or the result message must be released by a user (e.g., a laboratory physician) before it is forwarded to other devices and instances. This can be done via a provided field and a user input recorded therein. Release can be linked to different user roles (with specific permissions).

[0078] This embodiment is explained in more detail below with reference to Fig. 4.

[0079] Fig. 2 shows the sequence of the method according to a preferred embodiment of the invention. After the start of the method for the safety-related quality testing of the RO system RO and thus the intended operation of connected dialysis machines D, sensor data are acquired in step 100 during the operation of the RO system RO. This preferably occurs at predefined time intervals, after preconfigurable events (e.g., when another dialysis machine D is connected and / or after a certain number of dialysis treatments have been performed), and / or continuously during RO operation. In step 200, the sensor data acquired on the RO system RO and / or on the water supply unit W are transmitted electronically to an external communication partner (outside the RO system). Depending on one of the two embodiments described above, the sensor data are transmitted to the server SV or to the analysis unit AE.The analysis unit AE receives the water sample and analyzes it to provide results. This occurs in step 300. In the subsequent step 400, the generated results are transmitted electronically to the RO system and / or the medical device D, either directly to the respective devices RO, D, and / or to the server SV. From the server SV, the data is then forwarded and can also be stored centrally. This allows a first RO system RO to access reference data from other second RO systems for comparison. The process can then be executed iteratively or terminated.

[0080] Fig. 3 shows a sequence diagram with the two different variants for data exchange between the electronic units of system 1 described above:

[0081] 1. With a central server SV and an evaluation application implemented on it (dash-dot lines);

[0082] 2. Without a server (solid lines). Here, the RO system, the dialysis machines D, and the measuring unit M interact directly with the evaluation application, which in this case is implemented on the analysis unit AE.

[0083] During operation of the RO system, sensor data 31 are acquired locally and transmitted directly to the analysis unit AE (solid arrow). Alternatively, the sensor data 31 are first transmitted to the server SV and from there to the analysis unit AE (shown as a dashed line in Fig. 3). In parallel or simultaneously, water consumption data 32 are acquired on the measuring unit M of the water supply unit W or another device. In the first variant, this data is transmitted to the server SV for evaluation purposes (shown as a dashed line in Fig. 3). Alternatively or cumulatively, the water consumption data 32 can also be transmitted to the analysis unit AE (solid line). In this case, an application for evaluating the data is implemented on the analysis unit AE, so that the corresponding functionality of the server SV is transferred to the analysis unit AE (schematically shown in Fig. 4).Based on the completed laboratory test or analysis, the analysis unit AE generates a result data set 33, which is then either transmitted directly to the medical devices RO, D, W (solid lines) or, in the other configuration, via the server SV, which then forwards the data in processed or unprocessed form to the recipients RO, DW (shown as a dashed line in Fig. 3). The processing and evaluation on the server SV can include further process steps, as described above, such as statistical analysis or comparison with historical data. The further result of these process steps is labeled 33' in Fig. 3 and can be transmitted to the respective local instances RO, W, D.

[0084] Fig. 4 schematically shows an embodiment in which the system is operated without a server. The dashed lines (W -> RO, RO -> AE) represent – ​​as in Fig. 1 – not data exchange, but the transmission of physical products (water, ultrapure water). Regarding data exchange, the RO system RO and the analysis unit AE, and optionally the water supply unit W, interact directly with each other via a network, which can be, for example, TCP / IP-based. In this embodiment of the invention, the functionality that was implemented on the server SV in the first embodiment is implemented on the analysis unit AE. The data from the water supply unit W or its measuring unit M, the sensor data from the RO system RO, and optionally data from the dialysis machines D are sent directly to the analysis unit AE and processed there. It is also possible for the water supply unit W to be connected to the RO system RO via a data interface.The data acquired by the water supply unit W can then be sent indirectly to the analyzer AE via the RO system. For processing the acquired data on the analyzer AE, reference data can be read from the database DB, and conversely, the data acquired by the analyzer AE and the processed data can be stored in the database DB. The analysis result is then either transmitted to the RO system (dash line), which then forwards the data to the water supply unit W and the dialysis machine D (also dashed line), or the data can be sent directly from the analyzer AE to the dialysis machine D and / or to the water supply unit W for control purposes (this configuration is indicated in Fig. 4 by the solid arrow).

[0085] Finally, it should be noted that the description of the invention and the exemplary embodiments are not to be understood as limiting with regard to a specific physical realization of the invention. All features explained and shown in connection with individual embodiments of the invention can be provided in different combinations in the subject matter of the invention in order to simultaneously realize their advantageous effects. Thus, for example, it is also within the scope of the invention to provide other central units, such as a database DB, as an alternative or cumulative to the server SV. Likewise, in addition to the dialysis machines D, other medical devices and / or computer-based devices (including mobile devices) can be connected to the RO system RO, on which the result data is displayed.It is particularly obvious to a person skilled in the art that the invention can be applied not only to dialysis machines, but also to other medical devices D for whose operation ultrapure water from an RO system is required. For example, monitoring the quality of the ultrapure water can also be used for sterilization and washing processes for the sterilization of clinical instruments.

[0086] Furthermore, the components or modules of the safety system for monitoring the quality of the ultrapure water can be implemented across multiple physical products. For example, within the scope of the invention, an application for evaluating the results data can be arranged completely or partially on the analysis device AE, or the application can be implemented completely or partially on the server SV. Additionally, sections of the computer program for executing the process can also be implemented directly on the medical devices D and RO.

[0087] The scope of protection of the present invention is defined by the claims and is not limited by the features explained in the description or shown in the figures. REFERENCE MARK

[0088] D Medical device, in particular dialysis machine

[0089] SV Server

[0090] P Evaluation unit

[0091] MEM storage

[0092] RO reverse osmosis system, or RO system for short.

[0093] AE Analysis Unit

[0094] AE-S analysis interface of the analysis facility

[0095] RO-S data interface of the RO system

[0096] W Water supply unit

[0097] M Measuring unit of the water supply unit

[0098] MBUS bus interface of the water supply unit

[0099] 100 Acquiring sensor data

[0100] 200 Sending sensor data recorded at the RO system

[0101] 300 Generating result data

[0102] 400 Sending result data

[0103] DB database

[0104] NW Network

Claims

PATENT CLAIMS 1. Electronic security system for an RO facility (RO) designed for use with at least one medical device (D), in particular a dialysis machine, comprising: - the RO system (RO) which is designed for the production of ultrapure water and is equipped with a sensor unit (S) for recording sensor data and wherein the RO system (RO) includes an electronic data interface (RO-S) to transmit the sensor data recorded by the sensor unit (S); - a laboratory system comprising at least one laboratory device and an analysis unit (AU), wherein the at least one laboratory device is designed to analyze a water sample from the RO system with regard to safety requirements and in particular contamination, and wherein the analysis unit (AU) is designed to generate result data based on the analysis by the at least one laboratory device, and wherein the analysis unit (AU) is further equipped with an analysis interface (AU-S) to transmit the generated result data in electronic form; - a network (NW) for data exchange between medical technology facilities of the security system, in particular between the RO facility (RO) and the analysis facility (AE).

2. Safety system according to claim 1, wherein the system comprises a server (SV) designed to receive the sensor data of the RO system (RO) and / or the result data of the analysis device (AE) and further designed to transmit the result data to the RO system (RO) and / or to the medical device (D) for the purpose of control and / or regulation.

3. Security system according to one of the preceding claims, wherein the system further comprises a water supply unit (W) intended for supplying water to the RO system (RO) and wherein the water supply unit (W) comprises a measuring unit (M) for measuring water consumption data and wherein the measuring unit (M) comprises a bus interface (MBUS) for transmitting the recorded water consumption data. Safety system according to one of the preceding claims, wherein the sensor data includes parameters for conductivity and / or parameters for retention capacity. A safety system according to one of the preceding claims, wherein a preliminary result is calculated locally from the recorded sensor data and sent to the analysis unit (AE) to be validated or falsified in the analysis unit (AE) on the basis of the received water sample. RO system (RO) for the production of ultrapure water with a sensor unit (S) for recording sensor data and with an electronic data interface (RO-S) intended for use in a safety system according to one of the preceding claims. Analysis device (AD) for a laboratory system comprising at least one laboratory apparatus for analyzing a water sample with regard to safety requirements, wherein the analysis device (AD) is intended to generate result data based on the analysis of the water sample and to send this data electronically via an analysis interface (AD-S), and wherein the analysis device (AD) is intended for use in a safety system according to one of the preceding claims. Server (SV) for the coordinated processing of security data of an RO system (RO) operated for at least one medical device (D), in particular a dialysis machine, wherein the server (SV) is intended for use in a security system (1) according to the preceding system claims, comprising: - an electronic data interface (SV-S1) to receive the sensor data acquired by the sensor unit (S); - an analysis interface (SV-S2) to receive the result data generated by the analysis device in electronic form. Server (SV) according to the immediately preceding claim, wherein the server (SV) further comprises a memory (MEM) for storing the received data and / or interacts with a database (DB) and / or comprises an evaluation unit (P) for further processing of the received data. Server (SV) according to one of the preceding claims directed to the server, wherein the server (SV) further comprises a control interface to control the RO system (RO) and / or the medical device(s) (D) to control based on the result data. 1 1. Procedure for the safety-related verification of an RO system (RO) designed for use with at least one medical device (D), in particular a dialysis machine, comprising the following procedure steps: - Acquisition (100) of sensor data during the operation of the RO plant (RO) intended for the production of ultrapure water; - Sending (200) the recorded sensor data to an external communication partner in electronic form; - Receiving result data that includes an analysis of a water sample from the RO- The facility represents compliance with safety requirements.

12. A method according to the preceding method claim, wherein the acquisition (100) of the sensor data is carried out continuously or in a time-controlled manner during the operation of the RO system (RO) and / or after predefinable events.

13. A method according to any of the preceding method claims, wherein the sensor data and the result data are supplied to a server (SV) for central processing and stored there, and in particular are subjected to a statistical evaluation across RO systems.

14. Method according to one of the preceding method claims, wherein the result data are directly transmitted to the medical device (D) and / or to the RO system. (RO) can be used to control the respective and, if necessary, can trigger an emergency shutdown locally.

15. Computer program product comprising a computer program with program sections for carrying out all process steps of the method according to one of the preceding method claims, if the computer program is based on a is executed on a computer or electronic device.