Checking a reverse osmosis installation for use in a dialysis device

Abstract

The invention relates to an electronic safety system for an RO facility (RO) which constitutes an application for the use of at least one dialysis device (D). To this end, the system comprises an RO facility (RO) which determines a configuration with a sensor unit (S) for detecting sensor data for producing ultrapure water, and wherein the RO facility (RO) comprises an electronic data interface (RO-S) in order to transmit the sensor data detected by the sensor unit (S), and further comprises an analysis device (AE) which determines for analyzing a water sample of the RO facility with regard to safety requirements and in particular with regard to contamination and generating result data, wherein the analysis device (AE) is further configured with an analysis interface (AE-S) in order to transmit the generated result data in electronic form, a network (NW) for data exchange between medical technology devices, in particular between the RO facility (RO) and the analysis device (AE).

Description

TECHNICAL FIELD

[0001] The present invention is in the field of water technology in the medical field and relates, inter alia, to a safety check for a reverse osmosis installation for a medical technology device, in particular a dialysis device, in order to be able to provide the required water in sufficient quality and in a manner free from (bacterial) contamination. The invention relates, inter alia, to a system, an analysis device, a reverse osmosis installation, a server and a method for safety checking of water delivered and to a computer program product. BACKGROUND

[0002] Dialysis devices are operated by means of ultrapure water. In order to be able to provide ultrapure water, a reverse osmosis installation (abbreviated in the following as RO installation on the basis of the English name) is used.

[0003] The basic physical principle of reverse osmosis serves to concentrate substances dissolved in a liquid. Here, the natural osmosis process is reversed by means of pressure. Schematically, the RO process can be described in such a way that two vessels are filled with a liquid, for example water, with different substance contents and in particular salt contents, which are separated from one another by a semipermeable membrane. After the use of an osmotic pressure in the vessel in which the concentration is to be increased, the molecules of the solvent can migrate against their “natural” osmosis propagation direction. Here, the applied pressure must be higher than the pressure that arises as a result of the osmotic requirement for a concentration equilibrium. This method presses the molecules of the solvent into the compartment in which there is a lower degree of concentration of the dissolved substances. That is to say, by means of this method, the concentration of the substances that are undesirable on the side of the pure water is reduced.

[0004] In the medical field, and in particular in order to operate dialysis devices, for example the Fresenius Medical blood dialysis system 5008 and other extracorporeal blood treatment devices, water produced by means of an RO installation is required and is delivered there.

[0005] In order to comply with the strict safety requirements of medical technology devices, it is absolutely necessary to provide water in the required quality. For this purpose, the ultrapure water prepared by the RO installation is checked for compliance with chemical and microbiological safety requirements in defined time intervals. This is carried out in external laboratories. The conditions for the check are defined in the standard ISO 23500 “Guidance for the preparation and quality management of fluids for haemodialysis and related therapies”.

[0006] Generally, a water sample of the ultrapure water is extracted from the RO facility or the connected ring line and sent to a laboratory. The laboratory generally requires several days of time to provide a laboratory report or result, which is forwarded to the operator of the RO facility by mail or telephone call in the prior art.

[0007] However, the above-described method according to the prior art has the non-negligible disadvantage that it takes sometimes several days or up to a week of time until the laboratory result is provided at the local facility. If the result, for example, indicates the presence of a bacterial pathogen contamination or other safety failure, the connected dialysis device can only be switched off from the RO facility after the information has been locally forwarded to the RO facility. There is a safety risk during this time period, since the device continues to run with poor water quality. Thus, the method so far shows a safety defect in this case. SUMMARY

[0008] Based on the known method according to the prior art, it is therefore an object of the present application to improve the safety of the RO facility and the medical-technical device connected thereto. Furthermore, the analysis capability of the collected detection data (sensor data, laboratory values, etc.) should be improved. Furthermore, safety-relevant data should be provided earlier. Furthermore, the information provided should be improved by means of technical notification and directly locally usable on the device.

[0009] The object is achieved according to the present application by the electronic safety system, the analysis device, the RO facility, the server and the method for safety checking of the delivered water and the computer program product according to the present application.

[0010] In the following, the present application is described according to the solution of the object in terms of a system and in particular according to a safety system. Herein, the features, advantages or alternative implementation forms mentioned can likewise be transferred to the other claimed subject matters and vice versa. In other words, the other entity embodiments (for example for an analysis device, a RO facility or a server) and the method embodiments can also be improved by means of the features described and claimed in connection with the system. The respective functional features of the method are here constituted by the respective subject modules, in particular by the electronic hardware modules or microprocessor modules of the system or the device and vice versa.

[0011] According to a first aspect, the present application relates to an electronic safety system for a RO facility, 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 facility is configured for application and / or operation in connection with a medical-technical device, in particular a dialysis device. The safety system comprises:

[0012] - an RO facility which determines for producing ultrapure water and which is constituted with a sensor unit for detecting sensor data, in particular detecting conductivity upstream and downstream of a membrane with a retention rate of < 0.1 % and wherein the RO facility comprises an electronic data interface for exchanging analog and / or digital data in order to transmit sensor data detected by the sensor unit to an external entity outside the RO facility;

[0013] - an analysis device which can be constituted for checking or analyzing water quality of a water sample of the RO facility in terms of safety requirements for ultrapure water, for example with regard to contamination, for example in a laboratory with laboratory devices, and which can determine for generating result data as a response to the analysis of the water sample, wherein the analysis device is further constituted with an analysis interface in order to transmit the generated result data in electronic form to an external entity outside the analysis device;

[0014] - a network for data exchange between the medical technology devices of the safety system, in particular between the RO facility and the analysis device.

[0015] According to a preferred embodiment form, the system comprises a server which determines for receiving the sensor data of the RO facility and / or the result data of the analysis device and which further determines for forwarding the result data to the RO facility and / or to a medical technology device connected to the RO facility for control purposes. If necessary, the result data can also be forwarded to further devices which are integrated in the respective unit (clinic / hospital department) in which the RO facility is installed. The advantage of this embodiment form of the application is that the server can be constituted in the cloud, in turn always providing sufficient technical resources (for example processor power, memory capacity, execution of applications, for example for evaluation purposes). Furthermore, a central processing and data aggregation can thus be realized, wherein the generated data can be quickly and early forwarded to the surrounding clients (for example, medical technology devices, RO facility) via a network connection or a corresponding control interface.

[0016] Another important technical advantage is that the RO facility and / or the dialysis device, for example, can be directly open-loop and / or closed-loop controlled on the basis of the result data. If the result data, for example, indicate an insufficiency in terms of water quality, this can be forwarded to the receiving device, i.e. the dialysis device, for example, as early as possible and directly in order to disconnect the dialysis device from the RO water system or, if possible, to replace it by another interface. Furthermore, the evaluation means on the server have access to a rule base which can also be dynamically adjusted during operation, in which rules are provided which define, for example, that in the event of a fault an alarm notification is generated and sent to different computer-based or electronic receiving accounts, for example, a mobile end device of a ward physician or a computer in a nurses' station, in order to enable rapid measures.

[0017] The server with the evaluation application can furthermore receive further data from other data sources, for example, a water supply unit which determines the water delivered to the RO facility or other devices connected to the RO facility or supplied by the RO facility or operated by means of the RO facility. The water supply unit can be equipped with a measuring unit in order to detect water consumption data and to forward it to the server. According to a preferred embodiment of the application, the server can already provide a first result on the basis of the forwarded water consumption data and / or sensor data. For this purpose, an evaluation unit can be provided on the server which evaluates the received data on the basis of a stored rule data set. The rule data set can also be dynamically changed during operation of the system.

[0018] The rules can be, for example: "if the sensor data is below or above a predefinable threshold value, then the water quality is insufficient" or "if the sensor data lies within a predefinable interval and the water consumption data is below a threshold value, then the water quality is sufficient". The preliminary result thus determined can be issued on the server via a user interface, for example, as an alarm notification in the case of the first example above, and / or can be forwarded to the RO facility and further devices.

[0019] The preliminary results, however, are based on measurement values and sensor data only. In order to verify the preliminary results, a further analysis is carried out. For this purpose, the water sample is analyzed in an analysis device. The result data can thus be provided. The result data can now be forwarded to the server in order to verify or falsify the preliminary results. Depending on the case, the result data is issued again on the user interface of the server and / or forwarded to the RO facility or to a further device. The latter takes place, in particular, when the quality is assessed as insufficient in order to take countermeasures as quickly as possible and, in particular, to disconnect the dialysis device from the water supply network. Thus, on the one hand, the quality of the assessment can be improved, while, on the other hand, conclusions about the quality can also be provided independently of the laboratory-technical analysis. Thus, the RO facility can advantageously be monitored much more closely. Furthermore, in contrast, the analysis results derived from the laboratory analysis can also be specified by means of sensor data and / or consumption data or, if necessary, even defined or given a cause. The application for the assessment and verification, as described above, does not necessarily have to be executed on the server, but can also be transferred, for example, directly to the RO facility or to the analysis device.

[0020] In a further advantageous embodiment of the application, the system also comprises a water supply unit which determines for the water to be delivered into the RO facility, and which comprises a measuring unit for measuring water consumption data, and wherein the measuring unit comprises a bus interface in order to transmit the detected water consumption data, in particular preferably to the server. By means of these data, a more comprehensive evaluation process can be initiated and more extensive results can be provided. Thus, for example, the analysis results can be related to the water consumption data in terms of time in order to be able to provide more far-reaching conclusions. For the consumption values, for example, the water consumption per hour / day / week / treatment, limit values can be defined. If this limit value is exceeded, a notification is generated. It is not yet clear why the exceeding has been caused. If now there are further water quality data, for example, the conductivity of the raw water or the feed water, and if this value also shows an exceeding of the limit value, the cause can thus be defined / determined by means of this intelligent correlation.

[0021] In a further advantageous embodiment of the application, the result data in electronic form is detected in a predefinable standardized format. All result data can thus be uniformly processed on the server and / or received on the RO facility; even if the analysis devices are operated by different operators with different methods and / or applications. This increases the compatibility of the system and the connected systems.

[0022] The sensor data detected by the sensor unit comprises parameters which represent a correct functioning of the RO facility. The parameters which comprise the sensor data detected by the sensor unit comprise, inter alia, two different parameters which are detected here, namely upstream and downstream of the membrane (feed water conductivity, permeate conductivity), and a parameter with respect to the retention rate. The retention capacity R can be determined, for example, by means of the conductivity of the feed water cSP and the conductivity of the permeate cP as follows:

[0023] R [%] = (cSP - cP) / cSP * 100.

[0024] In an alternative embodiment of the application, further parameters can also be detected in order to improve the significance of the analysis or evaluation on the server (for example, electrical and water consumption of the water treatment facility, water temperature, water hardness, chlorine concentration).

[0025] The object is furthermore achieved by an RO facility for producing ultrapure water, having a sensor unit for detecting sensor data and an electronic data interface which is intended for use in the above-mentioned safety system.

[0026] The object is furthermore achieved by an analysis device which can be constituted, for example, in a laboratory which has at least one laboratory-technical device for checking or analyzing the water quality of a water sample of the RO facility with respect to the safety requirements of the ultrapure water (for example, with respect to contamination), and wherein the analysis device is intended to generate electronic result data as a response to the analysis of the water sample, wherein the analysis device is also constituted with an analysis interface in order to send the generated result data in electronic form to an external entity which is located outside the analysis device, and wherein the analysis device is intended for use in the safety system according to one of the above-mentioned aspects.

[0027] The object is furthermore achieved by a server for coordinated processing of safety data of an RO facility which is operated for at least one medical-technical device, in particular a dialysis device, wherein the server is intended for use in the safety system as described above. The server is constituted with:

[0028] - an electronic data interface for exchanging digital and / or analog data in order to receive the sensor data detected by the sensor unit;

[0029] - an analysis interface in order to receive the result data in electronic form generated by the analysis device.

[0030] In an advantageous embodiment of the application, the server is also constituted with a memory for storing the received data and / or interacts with a database and / or comprises a processing unit for specifically processing the received data. Thus, historical data can also be processed.

[0031] The object is also achieved by a method for performing a security-technical check of an RO facility, which is constituted for the operation of at least one medical-technical device, in particular a dialysis device, with the following method steps:

[0032] - detecting sensor data during the operation of the RO facility for producing ultrapure water;

[0033] - transmitting the detected sensor data in electronic form to an external communication partner. The external communication partner is thus arranged outside the RO facility and outside the RO facility system, so that an independent check of the RO facility can be ensured.

[0034] In a preferred embodiment of the application, the water sample of the RO facility is analyzed on a laboratory system with regard to safety requirements after or parallel to the transmission of the sensor data, in order to generate result data on the basis of the analysis. The generated result data can be transmitted in electronic form and, in particular, to the devices mentioned above for controlling the RO facility and / or the dialysis device. Alternatively, the RO facility and / or the dialysis device can also be adjusted on the basis of the result data.

[0035] In a preferred embodiment of the application, the transmission of the detected sensor data takes place continuously or time-controlled during the operation of the RO facility and / or depending on predefinable events.

[0036] In another preferred embodiment of the application, the sensor data and the result data are fed to a server for central processing and storage there and, in particular, for a statistical evaluation across RO facilities.

[0037] In another preferred embodiment of the application, the result data are transmitted directly to at least one medical-technical device for controlling the medical-technical device, so that an emergency interruption or emergency shutdown can be triggered locally if necessary.

[0038] The present application also relates to a computer program product comprising a computer program. The computer program comprises software code which determines for carrying out the above-mentioned method. The computer program product can be implemented in software or in hardware and can comprise, in addition to the computer program, a user manual, a data carrier and / or a packaging. In particular, the method steps of detecting, sending, generating result data and sending thereof are triggered and / or carried out by software. The analysis of the sample can comprise a plurality of work steps which sometimes require manual operation, whereas the generation of the result data can be carried out fully automatically.

[0039] In the following, terms used in this application are defined.

[0040] The RO facility is an RO facility for producing ultrapure water and is used together with at least one medical-technical device in order to supply the medical-technical device with ultrapure water. The RO facility can therefore also be referred to as a medical-technical device. The RO facility can comprise an electronic processing unit (for example in the form of a CPU, FPGA, microprocessor, etc.). The sensor unit can be implemented on the electronic processing unit. The standard ISO 13959:2014 defines requirements for dialysis water (ultrapure water) which the operator of the respective facility has to comply with. Here, the standard ISO 13959:2014 "Water for haemodialysis and related therapies" is used which is used for the manufacturer of the facility and which prescribes the following requirements for the microbiological and chemical quality of the dialysis water:

[0041]

[0042]

[0043] The correct functionality of the RO facility is defined, inter alia, via the retention rate of sodium chloride (table salt) which, according to the requirement profile for ultrapure water, should lie between 90% and 99.8%.

[0044] The RO facility and the laboratory system with the analysis device are installed and provided on two different, separate systems. Usually, the RO facility is provided in a dialysis center (for example in a separate area from the dialysis area) in which also the dialysis machines are operated. The laboratory system is set up in an external laboratory which is located outside the dialysis center. The reason for this is that the analyses carried out can also be carried out independently (and thus unaffected) by the operator of the RO facility. A conflict of interest can thus be avoided. The analysis device and the RO facility communicate via a data connection. The data connection can be based on the Internet and can for example be based on a protocol of the http protocol family. The RO facility and the laboratory system are operated on different platforms and by different operators.

[0045] The analysis device can be a component of a laboratory system for examining water samples. The analysis device is an electronic component and serves for digital data processing and data communication to external communication entities. Thus, in addition to the analysis device, the laboratory system usually comprises at least one laboratory-technical device or apparatus (for example, a conductivity measuring apparatus, an ion chromatograph, a mass spectrometer or an atomic absorption spectrometer for quantitative determination of individual ions, etc.). The laboratory system serves for detecting contamination of the water and for performing biological and / or chemical analyses and bacteriological examinations. Thus, one aspect of the application relates to a comprehensive analysis of the water sample of the RO facility; thus, not only the chlorine content is detected, for example, but further examinations are performed in order to detect contamination of the water (dirt, biological or bacterial impurities, etc.). Based on the analyses performed by means of the different above-mentioned exemplary mentioned apparatuses and / or laboratory-technical devices, laboratory-technical results are provided. Said results are delivered to the analysis device, which determines, from which the result data is automatically generated, for example, in the form of an electronic message. The result data can be configured for sending to external communication partners. The result data is to be sent, in particular, to the RO facility and / or a cloud-based server and / or a medical-technical apparatus via a data connection in order to be able to initiate further measures there, if necessary.

[0046] The network is an electronic network for transmitting data. The network can be operated in different protocols. Thus, the connection between the RO facility and the server can be designed as an MBUS system (in particular according to the standards of the standard series EN 13757), and the analysis device can communicate with the server and / or the medical-technical apparatus via an IP-based protocol, for example, by means of messages in XML structure. For data exchange, the RO facility and / or the analysis device are equipped with interfaces: the RO facility with a data interface (for example, by means of an IP-based protocol) and the analysis device with an analysis interface (for example, HL7); via the interfaces, data can also be transmitted in the form of tabular data structures, for example, in the formats csv, Microsoft Excel or OpenOffice Calc or xml, etc.

[0047] The generated result data can be forwarded in the form of a status notification (water quality insufficient - water quality sufficient) or in the form of a more extensive message package, wherein the message package comprises further details on the analysis. The message package can also comprise metadata, for example, a time stamp, a sample status, a duration of the examination, etc.

[0048] As described above, the system can comprise a - preferably cloud-based - server. The detected and generated data are aggregated and preferably stored in the server. To this end, access to a connected database can be provided. The server can be used for a coordinated processing of the data. In this context, "coordinated" relates to the fact that composite structure result data for the dialysis devices have already been calculated, i.e. result data have already been calculated for the dialysis devices fed by the respective RO facility. However, the calculation of the coordination can also be carried out locally on a dedicated device, nevertheless centrally and together for all devices in the composite structure.

[0049] On the server, an evaluation device in the form of an evaluation application (software) or an evaluation circuit (hardware) can be constituted. The evaluation device is an electronic component. The evaluation circuit can for example be constituted as an electronic circuit with digital and / or analog circuit components, which can comprise an evaluation logic. The evaluation logic serves to evaluate which quality level the analyzed RO facility adheres to in order to issue a warning notification in the case of non-adherence. The warning notification can be issued via a respective data interface to the RO facility, to the control unit of the RO facility and / or directly to the medical technology device (dialysis device). For a direct signaling, a traffic light function can be issued on the user interface (red for too low quality, green for sufficient quality and yellow for a warning or intervention level exceeded, for example depending on exceeding or falling below a relevant limit value). The evaluation circuit can have access to a rule set for the evaluation, which can in particular be stored in a database or a memory in the form of rules and which defines a strategy for prioritizing a certain amount of result data. The evaluation circuit can preferably be activated automatically if new result data are generated or forwarded. The result data are preferably transmitted to the recipient according to a PUSH protocol for regulation and / or control purposes. The recipient can be the RO facility or the dialysis device.

[0050] The evaluation is preferably associated with a specific RO facility. If a central server is used, which collects data from all or selected RO facilities, for example from all facilities in a specific geographical region or dialysis composite structure, and evaluates them, a cross-RO facility result can also be provided by means of a statistical evaluation. It is also possible to constitute an evaluation which can then resolve the notification for the facility (for example via a respective identification indication) by means of the RO facility identification.

[0051] An important aspect of the present solution is that the medical technology device of the safety system comprises the RO facility, the laboratory system with the analysis device and in addition can also comprise the water supply unit and / or the dialysis device, which are connected via two different connections, respectively:

[0052] 1. Data connection for exchanging electronic messages and digital data, such as sensor data and / or result data, and

[0053] 2. Line connection for exchanging physical media, such as ultrapure water and / or water samples.

[0054] A higher level of security can be achieved by additional checking measures. This consists in that the sensor data detected locally on the RO facility (locally, in the computing unit of the RO facility, or externally in a computing unit on a server or analysis device) are evaluated first in order to provide a preliminary result. The preliminary result is then provided to the analysis device, if necessary, and confirmed (verified) or rejected (falsified) by means of an analysis of the water sample. A preliminary result can thus be provided earlier on the RO facility. Furthermore, the security can be increased by means of a recheck of the preliminary result.

[0055] In the following, the application is described with respect to a dialysis device, such as a hemodialysis device, as an example of a medical-technical device. However, it is obvious to the person skilled in the art that the application can likewise be applied and transferred to other medical-technical, computer-controlled devices or (fluid management) machines or blood treatment devices which require ultrapure water for operation. This can also apply, for example, to a peritoneal dialysis device if it processes ultrapure water.

[0056] It is possible that the sensor data of the RO facility and / or the consumption data of the water supply device or other devices (for example with respect to gas consumption, current consumption, consumption of temperature resources for heating or cooling, etc.) are transmitted in configurable time intervals in order to be processed by the evaluation application.

[0057] In a preferred embodiment of the application, it is configurable which device the result data should be sent to. It is thus possible, for example, to set that if the data contain a high-priority alarm notification (insufficient water quality), the data are sent to the monitoring unit of the hospital / operator and to a further entity, while in the case of a good situation (sufficient quality) only to the server and / or the associated RO facility. This has the advantage that the error-free operating facility is not loaded with unnecessary notifications. However, it is also possible and configurable that all result types are always available on all devices. The operator (of the clinical device and / or the RO facility) can thus always automatically observe all facilities and facility states at a glance.

[0058] A further object solution is a computer program product, which can be loaded into the memory of a computer or an electronic or medical-technical device, or which can be loaded with a computer program, if the computer program is executed on a computer or an electronic or medical-technical device, for carrying out the method described in detail above.

[0059] A further object solution provides a computer program, if the computer program is executed on a computer, an electronic or medical-technical device, for carrying out all method steps of the method described in detail above. It is also possible here to store the computer program on a medium readable for the computer or the electronic or medical-technical device. BRIEF DESCRIPTION OF DRAWINGS

[0060] In the following detailed description of the drawings, embodiments and their features and further advantages are explored with the aid of the drawings.

[0061] Figure 1 According to an advantageous embodiment of the application, a schematic diagram of a safety system according to the application is shown, which has a RO facility for operating a dialysis device and a server and the data exchange thereof.

[0062] Figure 2 According to a preferred embodiment of the application, a flow chart of the method is shown.

[0063] Figure 3 According to a preferred embodiment of the application, the data exchange between a dialysis device and a server and a RO facility is shown schematically, and

[0064] Figure 4 The application of the safety system without a server is shown with regard to an alternative embodiment in Figure 1 to the first embodiment. DETAILED DESCRIPTION

[0065] In the following, the application is described in detail with the aid of the drawings by means of embodiments.

[0066] The application relates to an electronic message system for a RO facility RO, which operates and is applied for a dialysis station with at least one dialysis device or other medical-technical device D, and which communicates the quality state of the RO facility RO.

[0067] Figure 1 A first embodiment of the application is shown, in which the system 1 comprises a server SV. The server SV can be at least partially configured for evaluating the water quality data. The evaluation of the water quality is based on different input variables provided by different devices (RO facility RO, analysis device AE, database DB, etc.).

[0068] To this end, a safety system 1 is provided, which comprises a plurality of medical-technical devices, wherein medical-technical apparatuses each having electronics for data processing and for communication are comprised.

[0069] The RO facility RO determines for the production of ultrapure water, which has to be delivered to one or - usually - a plurality of dialysis devices D of a dialysis station, by means of which the dialysis devices can be operated. In order to ensure that the quality of the delivered pure water is sufficient (limit values for pollutants, such as aluminium, chlorine, fluorine, nitrate, sulphate and / or zinc - the limit values for the respective maximum concentrations are defined in the standard ISO 13959:2014 as described above - are adhered to), the RO facility RO is constructed with a sensor unit S for detecting sensor data (exemplarily with sensors S1, S2, Sn in Figure 1 Furthermore, the RO facility RO comprises an electronic data interface RO-S in order to transmit the sensor data detected by the sensor unit S.

[0070] The water supply unit W feeds the RO facility RO, which is used to deliver water, by means of which the water can be cleaned or treated in the RO facility RO. The water supply unit W comprises a plurality of electronic modules, such as in particular a measuring unit M, which determines for the ascertainment of water consumption data 32. To this end, different measuring methods and sensors or signal sensors can be used. Furthermore, the water supply unit W comprises an interface for data communication, which can in particular be constructed in the form of an MBUS interface MBUS. Other medical-technical devices of the system 1, such as a server SV and / or an analysis device AE, can communicate with the water supply unit W via the interface MBUS. It is thus possible that the analysis device AE can directly detect sensor data from the water supply unit W. This has the advantageous effect that the analysis device AE can perform a more extensive evaluation, which takes into account in particular the water consumption data 32 and, if necessary, further sensor data detected on the water supply unit W for the calculation of result data.

[0071] In a further advantageous embodiment of the application, the sensor data detected on the water supply unit W can be forwarded to the RO facility RO. This has the advantage that the sensor data of the water supply unit W can be calculated as a preliminary result by means of the locally detected sensor data of the RO facility, which can be transmitted to the analysis device for verification. The preliminary result can be output on an output unit (such as a screen) of the water supply unit W and / or on the RO facility RO for local control. A more extensive calculation of the preliminary result can thus be performed, which is more convincing.

[0072] The analysis device AE can be arranged in a laboratory system. The laboratory system with the laboratory technology device is determined for analyzing the water samples of the RO facility with regard to safety requirements and in particular with regard to contamination. Based on the analysis results and, if necessary, taking into account additional detected sensor data (from the water supply unit W and / or from the RO facility RO), the result data is calculated or generated according to the provided rules. The result data is also provided in a digital format, in particular in a result format. Here, the format can be a configurable data structure, in particular a data structure according to the XML format. Furthermore, the analysis device AE comprises an analysis interface AE-S in order to send the generated result data in electronic form to external communication partners, in particular to the RO facility RO and / or to the connected dialysis devices D.

[0073] The devices and apparatuses of the safety system 1 are connected to one another via the network NW.

[0074] As shown in Figure 1 , a plurality of dialysis devices D and / or further devices are usually connected on the RO facility. This should be represented in Figure 1 by the two exemplary shown devices D1, Dn.

[0075] The safety system 1 comprises in the (first) preferred implementation form of the application shown in Figure 1 a server SV. The server is preferably centrally accessible via the network interface via the 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 facility RO, the medical technology devices D, the analysis device AE and, if necessary, with the database DB. In the first implementation form of the application, an evaluation application or evaluation functionality is implemented in a processor P on the server SV, which determines for evaluating the detected data. In particular, the result data and the sensor data and, if necessary, the historical data from the database DB are processed according to predefinable rules in order to indicate a result message about the quality state of the water provided by the RO facility. The result message can preferably be used to control the RO facility RO and / or the connected dialysis devices D. Thus, the relevant results can be provided directly locally at the time of use.

[0076] In a preferred embodiment of the application, configurable rules can also be stored in the database, which specify when the result data is to be sent to the respective recipient. Furthermore, it can be possible to limit, for example specifically for certain geographical regions or countries, which additional functions and messages are sent to the recipient together with the result data in the data packet. The functions can be, for example, control functions for the dialysis device and / or the RO facility (switching on and off the dialysis device, limiting the device functionality, in particular depending on the analysis results, etc.), and the messages can be the creation of an alarm notification (for example, on the RO facility indicating that the water quality does not meet the required safety requirements in the event of an indication of an exceeded limit value). The rules can be specified differently in the configuration phase specifically for the respective recipient or recipient group of the result data (or data packet). An important further flexibility is thus advantageously achieved.

[0077] The server SV and the evaluation application executing thereon can preferably be provided as a web platform and browser-based. The server SV can have access to a local memory MEM for further calculations, for example statistical evaluations, and / or for storing the calculated or read-in data there.

[0078] As already briefly set out above, the analysis device AE determines the result data for generating from the laboratory report or the laboratory results according to a predefined format in order to transmit the result data to an external communication partner.

[0079] In Figure 1 The arrows indicated by dashed lines (from the water supply unit W to the RO facility RO and from the RO facility to the analysis device AE) indicate that in this case no data transfer is involved, but rather the transfer of physical media, i.e. in the first case the transfer of water to the RO facility RO and in the second case the transfer of a water sample to the analysis device AE. The other arrows indicate the electronic exchange of analog and / or digital data.

[0080] In principle, the system can be operated in two implementation variants.

[0081] As described above, in Figure 1In the first embodiment variant shown in Fig. 1, a central server SV is connected to the system 1. An evaluation application for evaluating the detected data is then executed on the server SV. The server SV is preferably cloud-based and accessible via an IP protocol-based interface (e.g. TCP / IP) SV-S1, SV-S2. In this embodiment of the application, the exchanged data is first conducted from the respective sender (e.g. RO facility RO, analysis device AE) to the central server SV, which then sends the received data directly or in pre-processed form to the respective recipient (e.g. RO facility RO, analysis device AE). For this purpose, data from the water supply unit W and / or data from the dialysis device D can also be communicated via the interface SV-S1, SV-S2 (in Figure 1 Fig. 1, not explicitly shown). In this embodiment, the server SV thus acts as a proxy server or intermediary node in the chain between the data source and the data sink. This embodiment of the application has the advantage that all data can be aggregated on the server SV in order to be able to perform further evaluations and processing. Thus, it is possible, inter alia, to compare historical data sets with current data sets in order to be able to provide further conclusions (e.g. "In 80% of the cases in which the result data indicates insufficient water quality, samples were taken from a group of RO facilities located in a particular geographical region" or "In 90% of the cases in which the result data indicates insufficient water quality, samples were taken in a particular time period". Statistical evaluations across RO facilities can be performed, inter alia. Furthermore, the reference data sought here can be provided on other RO facilities for comparison / reference purposes. Furthermore, data input manually with respect to the RO facility RO can also be taken into account in the scope of the evaluation application. For accessing and storing the data, a memory MEM can be used.

[0082] In a second embodiment of the application, no central server is provided. In this case, the RO facilities and / or the water supply unit W and / or the dialysis device D directly interact with the analysis device AE and vice versa. The second embodiment should be used in Figure 1The following applies: At least the RO facility RO communicates directly (without intervention of the server SV) with the analysis device AE, which is indicated by the arrow between the respective interfaces RO-S, AE-S, which operate without intervention of the server SV. In this case, evaluation applications for evaluating the data and for calculating the result message can be provided at least partially on the analysis device AE. The applications can also be implemented partially on other electronic devices. The result data or the result message then comprises a control data set, which is configured for controlling the respective device. In the event of a fault (insufficient quality of the ultrapure water), the control data set can contain a section which, for example, triggers the emission of an alarm notification and / or the shutdown of the RO facility RO. Furthermore, the control data set can contain a notification area which triggers a notification to a further entity or device. In particular, the notification should only be generated when the control data set has been transmitted to an external communication partner (for example, to the RO facility RO). Thus, for example, an alarm notification can be triggered directly and locally on the dialysis device D, which is connected to the RO facility RO. This has the advantage that in safety-critical cases, the relevant information is provided directly locally, and the necessary measures can be initiated directly, without having to notify entities connected in between. In an advantageous variant, it is proposed that the result data or the result message must be released by a user (for example, a laboratory consultant) before it is forwarded to further devices and entities. This can be performed via a provided area and a user input detected thereon. The release can be linked to different roles of the user (with specific qualifications).

[0083] The following applies: At least the RO facility RO communicates directly (without intervention of the server SV) with the analysis device AE, which is indicated by the arrow between the respective interfaces RO-S, AE-S, which operate without intervention of the server SV. In this case, evaluation applications for evaluating the data and for calculating the result message can be provided at least partially on the analysis device AE. The applications can also be implemented partially on other electronic devices. The result data or the result message then comprises a control data set, which is configured for controlling the respective device. In the event of a fault (insufficient quality of the ultrapure water), the control data set can contain a section which, for example, triggers the emission of an alarm notification and / or the shutdown of the RO facility RO. Furthermore, the control data set can contain a notification area which triggers a notification to a further entity or device. In particular, the notification should only be generated when the control data set has been transmitted to an external communication partner (for example, to the RO facility RO). Thus, for example, an alarm notification can be triggered directly and locally on the dialysis device D, which is connected to the RO facility RO. This has the advantage that in safety-critical cases, the relevant information is provided directly locally, and the necessary measures can be initiated directly, without having to notify entities connected in between. In an advantageous variant, it is proposed that the result data or the result message must be released by a user (for example, a laboratory consultant) before it is forwarded to further devices and entities. This can be performed via a provided area and a user input detected thereon. The release can be linked to different roles of the user (with specific qualifications). Figure 4 The embodiment is described in detail.

[0084] Figure 2A flow of a method according to a preferred embodiment form of the application is shown. After starting the regular operation D of the dialysis device connected in turn the method for the quality check of the security technology of the RO facility RO, in step 100 sensor data are detected during the operation of the RO facility RO. This is preferably carried out at predefinable time intervals after preconfigurable events (for example, upon connection of a further dialysis device D and / or after performing a certain number of dialyses) and / or continuously during the RO operation. In step 200, the sensor data detected on the RO facility RO and / or on the water supply unit W are transmitted in electronic form to an external communication partner (outside the RO facility). According to one of the two above-described embodiment variants, the sensor data are forwarded to the server SV or to the analysis device AE. The analysis device AE furthermore receives a water sample and analyzes it in order to then be able to provide result data. This is carried out in step 300. In a subsequent step 400, the generated result data are forwarded in electronic form directly to the respective device RO, D and / or to the server SV for controlling the RO facility and / or the medical-technical device D. The result data are then forwarded from the server SV with intervention and can also be centrally stored in the server. Thus, the first RO facility RO can also access reference data from other second RO facilities in a similar form. Thereafter, the method can be carried out iteratively or ended.

[0085] Figure 3 A sequence diagram is shown with the two different variants described above for the data exchange between the electronic units of the system 1 :

[0086] 1. With a central server SV and an evaluation application (dotted line) executed thereon;

[0087] 2. Without a server (solid line). Here, the RO facility and the dialysis device D and the measuring unit M interact directly with the evaluation application, which in this case is executed on the evaluation device AE.

[0088] During the operation of the RO facility, sensor data 31 are detected locally and are forwarded directly therefrom to the analysis device AE (solid arrow). Alternatively, the sensor data 31 are first forwarded to the server SV and from there to the analysis device AE (shown in Figure 3 ). In parallel or simultaneously, water consumption data 32 are detected on the measuring unit M or another device of the water supply unit W, which are forwarded to the server SV for evaluation in the first variant (shown in Figure 3The water consumption data 32 are transferred to the server SV (dotted line) and are evaluated there. Alternatively or cumulatively, the water consumption data 32 can also be transferred to the analysis device AE (solid line). In this case, an evaluation application is executed on the analysis device AE to evaluate the data, so that the corresponding functionality of the server SV is transferred to the analysis device AE in this case (in Figure 4 The analysis device AE generates a result data set 33 on the basis of the performed laboratory examination or analysis, which is now likewise transferred directly to the medical-technical devices RO, D, W (solid line) - or in other embodiment variants via the intervention and / or storage of the server SV, which then forwards the data to the recipients RO, D, W in processed or unprocessed form (in Figure 3 The processing and evaluation on the server SV can include further process steps, as described above, for example a statistical evaluation or a comparison with historical data. Further results of these process steps are indicated by the reference sign 33' in Figure 3 and can be transferred to the respective local entity RO, W, D.

[0089] Figure 4 An embodiment is schematically shown in which the system operates without a server. The dashed lines (W -> RO, RO -> AE) do not - as in Figure 1 indicate a data exchange, but rather the transfer of physical products (water, ultrapure water). With regard to the data exchange, the RO facility RO and the analysis device AE, and if necessary the water supply unit W, interact directly with one another via a network, which can be based on TCP / IP, for example. In this implementation form of the application, the functionality described below, which was implemented on the server SV in the first embodiment, is implemented on the analysis device AE. The data of the water supply unit W or of its measuring unit M, the sensor data of the RO facility RO and, if necessary, the data of the dialysis device D are sent directly to the analysis device AE and processed there. It is also possible for the water supply unit W to be connected to the RO facility RO via a data interface. The data detected on the water supply unit W can then be sent indirectly and via the intervention of the RO facility RO to the analysis device AE. In order to process the data read in on the analysis device AE, reference data can be read in from the database DB, and, conversely, data and processed data detected by the analysis device AE can be stored in the database DB. The analysis results are then transferred to the RO facility (dashed line), which then forwards the data to the water supply unit W and the dialysis device D (also dashed line), or the data can be sent directly from the analysis device AE to the dialysis device D and / or to the water supply unit W for control (this embodiment is indicated by solid arrows in the drawing).

[0090] Finally, it is to be pointed out that the description and the embodiments of the present application are not to be understood as being restricted to a specific physical implementation of the present application as such. All features described and shown in connection with the various embodiments of the present application can be provided in different combinations in the subject matter of the present application in order to achieve their advantageous effects simultaneously. Thus, for example, also within the scope of the present application, in addition to or in lieu of the server SV, other central units, such as a database DB, are provided. Also, in addition to the dialysis device D, further medical-technical devices and / or computer-aided devices, also mobile terminal devices, can be connected to the RO facility RO on which the result data is output. It is particularly obvious to the person skilled in the art that the present application can be used not only for dialysis devices but also for other medical-technical devices D for which operation requires ultrapure water from the RO facility RO. Thus, monitoring the quality of the ultrapure water can also be used, for example, for sterilization and cleaning processes for sterilizing clinical instruments.

[0091] Furthermore, the components or modules of the safety system for monitoring the quality of the ultrapure water can be implemented distributed on a plurality of physical products. Thus, for example, within the scope of the present application, the application for evaluating the result data is completely or partially provided on the analysis device AE or the application is completely or partially executed on the server SV. Furthermore, sections of the computer program for executing the method can also be executed directly on the medical-technical device D, the RO.

[0092] The scope of the protection of the present application is given by the claims and is not restricted to the features recited in the specification or in the drawings.

[0093] List of reference signs:

[0094] D medical-technical device, in particular dialysis device

[0095] SV server

[0096] P evaluation device

[0097] MEM memory

[0098] RO reverse osmosis facility, RO facility for short

[0099] AE analysis device

[0100] AE-S analysis interface of the analysis device

[0101] RO-S data interface of the RO facility

[0102] W water supply unit

[0103] M measuring unit of the water supply unit

[0104] Bus interface of an MBUS water supply unit

[0105] 100 detecting sensor data

[0106] 200 sending detected sensor data on an RO facility

[0107] 300 generating result data

[0108] 400 sending result data

[0109] DB database

[0110] NW network

Claims

1. An electronic safety system for an RO facility (RO) which is designed for use with at least one medical-technical device (D), having - the RO facility (RO) which is designed for producing ultrapure water and which is equipped with a sensor unit (S) for detecting sensor data, and wherein the RO facility (RO) comprises an electronic data interface (RO-S) for transmitting the sensor data detected by the sensor unit (S), wherein the sensor data detected by the sensor unit include two different parameters on the conductivity of the water upstream and downstream of the membrane and a parameter on the retention rate, - a laboratory system having at least one laboratory-technical device and an analysis device (AE), wherein the at least one laboratory-technical device is designed for analyzing a water sample of the RO facility with regard to safety requirements, and wherein the analysis device (AE) is designed for generating result data on the basis of the analysis by the at least one laboratory-technical device, wherein the analysis device (AE) is further equipped with an analysis interface (AE-S) for transmitting the generated result data in electronic form, - a network (NW) for data exchange between the RO facility (RO) and the analysis device (AE), - a server (SV) in which the detected and generated data are collected and which is designed for coordinated processing of the data, wherein result data are calculated for a dialysis device fed by the respective RO facility, wherein the server (SV) is designed for receiving the sensor data of the RO facility (RO) and the result data of the analysis device (AE) and for forwarding the result data to the RO facility (RO) and / or to the medical-technical device (D) for control.

2. The safety system according to claim 1, wherein the medical-technical device (D) is a dialysis device.

3. The safety system according to claim 1 or 2, wherein the at least one laboratory-technical device is designed for analyzing a water sample of the RO facility with regard to contamination.

4. The safety system according to claim 1 or 2, wherein the system further comprises a water supply unit (W) which is designed for delivering water to the RO facility (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 detected water consumption data.

5. The safety system according to claim 1 or 2, wherein preliminary results are calculated locally from the detected sensor data, which are transmitted to the analysis device (AE) for verification or falsification in the analysis device (AE) on the basis of the received water sample.

6. The safety system according to claim 1 or 2, wherein the server (SV) has: ​ ​ ​ ​ - an electronic data interface (SV-S1) for receiving sensor data detected by the sensor unit (S); - an analysis interface (SV-S2) for receiving result data generated by the analysis device in electronic form.

7. The safety system according to claim 6, 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 device (P) for further processing the received data.

8. The safety system according to claim 6, wherein the server (SV) further comprises a control interface for controlling the RO facility (RO) and / or at least one of the medical technical devices (D) based on the result data.

9. A method for safety checking a RO facility by means of a safety system according to any one of claims 1 to 8, the RO facility being configured for application with at least one medical technical device (D), the method having the following method steps: - detecting sensor data during operation of the RO facility (RO) for producing ultrapure water; - transmitting the detected sensor data in electronic form to an external communication partner; - receiving result data representing an analysis of a water sample of the RO facility with respect to safety requirements.

10. The method according to claim 9, wherein the medical technical device (D) is a dialysis device.

11. The method according to claim 9 or 10, wherein the detection of the sensor data is carried out continuously or time-controlled during operation of the RO facility.

12. The method according to claim 9 or 10, wherein the sensor data and the result data are fed to a server (SV) for central processing and storage there.

13. The method according to claim 12, wherein the sensor data and the result data are fed to a statistical evaluation across RO facilities.

14. The method according to claim 9 or 10, wherein the result data are transmitted directly to the medical technical device (D) and / or the RO facility (RO) for corresponding control thereof.

15. The method according to claim 14, wherein the result data can locally trigger an emergency shutdown.

16. A computer program product having a computer program, the computer program having program sections for carrying out all method steps of the method according to any one of claims 9 to 15, if the computer program is executed on a computer or an electronic device.

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