EA041201B1 - REVERSE OSMOSIS UNIT CONTROL FOR DIALYZER APPLICATIONS - Google Patents

Description

The invention relates to water treatment technology in the field of medicine and concerns, in particular, the safety control of reverse osmosis plants used for medical devices, in particular dialyzers, in order to prepare water of satisfactory quality, free from (bacterial) contamination. The invention relates, in particular, to a system, an analyzer, a reverse osmosis plant, a server, a method for monitoring the safety of supplied water, and a computer software product.

Dialyzers operate on extra pure water. In order to prepare especially pure water, reverse osmosis plants are used (due to the English designation, hereinafter briefly RO-installations).

The physical principle of reverse osmosis is based on the concentration of substances dissolved in liquids. At the same time, with pressure, the process of natural osmosis becomes reversed. Schematically, the RO process can be described in such a way that two containers are filled with a liquid (for example, water) with different content of substances and, in particular, salt, separated from each other by a semipermeable membrane. After the application of osmotic pressure in the vessel in which the concentration is to be increased, the solvent molecules may migrate against their natural osmotic propagation direction. In this case, the applied pressure must be higher than the pressure arising due to the osmotic demand to equalize the concentrations. The solvent molecules enter the compartment where the solutes are at a lower concentration. This method therefore reduces the concentration of undesirable substances on the pure water side.

The water prepared by the RO plant is required in the field of medicine and in particular for the operation of dialyzers, such as the Fresenius Medical Care 5008 hemodialysis system, and other extracorporeal blood purification devices.

In order to comply with the strict safety requirements of medical and technical devices, the preparation of water of the required quality is an indispensable condition. For this, the highly pure water prepared by the RO plant is examined at certain time intervals for compliance with chemical and microbiological safety requirements. This is carried out in external laboratories. Study conditions are defined in ISO 23500 Guidelines for the preparation and quality management of hemodialysis fluids and concomitant therapy.

As a rule, a sample of ultrapure water is taken from an RO plant or an attached ring pipeline and sent to the laboratory. It usually takes several days for a lab report or lab result to be produced, which in the prior art is sent to the operator of the RO facility by mail or telephone.

However, the steps of the prior art described above have the significant disadvantage that, until the result of laboratory tests is available, it can sometimes take from several days to one week. If this results in, for example, contamination with bacterial pathogens or another security breach, the connected dialyzers can only be disconnected from the RO unit after the information has been transferred to it. At this temporary stage, there is a safety risk as the instruments continue to operate on poor quality water. In this case, known actions create, thereby, a security hole.

The invention is based on the task of improving the safety of RO installations and medical devices connected to them. In addition, the ability to analyze the collected recorded data (data from sensors, laboratory values, etc.) should be improved. Also safety-relevant data should be prepared earlier. Further, the prepared information should be improved by means of technical reports and used directly on site in the device.

This problem is solved according to the invention by means of an electronic security system, an analyzer, an RO-installation, a server, a method for monitoring the safety of the supplied water and a computer program product in accordance with the appended claims.

The invention is described below with the help of a system solution of the problem and, thus, also with the help of a security system. The features, advantages or alternative embodiments mentioned herein can also be transferred to other claimed objects and vice versa. In other words, also other object-related claims (eg, directed to an analyzer, RO plant or server) and method-related claims can be supplemented by features described or claimed in connection with the system. In this case, the respective functional features of the method are implemented by means of respective object-related modules, in particular electronic hardware modules or microprocessor modules, systems and devices and vice versa.

According to a first aspect, the invention relates to an electronic security system for an RO plant, wherein the security system can operate as a central server and, in particular, a cloud system to ensure satisfactory high-purity water quality, and moreover, the RO plant is designed to be used and / or work in combination with a medical device. technical devices, in particular dialyzers. The security system includes

RO-installation, which is designed to produce ultra-pure water and is made with a touch

- 1 041201 unit for recording data from sensors, in particular conductivity before and after the membrane with a delay, and moreover, the RO-installation contains an electronic data interface for the exchange of analog and / or digital data in order to transfer the data recorded by the sensor unit from the sensors to an external device outside the RO plant;

an analyzer that can be made, for example, in a laboratory with a laboratory device for examining or analyzing the quality of an RO water sample in relation to compliance with the safety requirements of high-purity water (for example, in relation to contamination) and is intended to generate effective data in response to sample analysis water, and the analyzer is made with an analyzing interface to transmit the generated result data in electronic form to an external device outside the analyzer;

network for data exchange between medical devices of the security system, in particular between the RO-installation and the analyzer.

According to one preferred embodiment, the system includes a server designed to receive data from the sensors of the RO unit and/or the result data of the analyzer and transmit the result data for the purpose of control to the RO unit and/or to those medical devices that are connected to the RO. - installation. If necessary, the resulting data can also be transmitted to other devices included in the respective department (clinic, hospital department) in which the RO unit is installed. This variant has the advantage that the server can be executed in the cloud and thus always sufficient technical resources (eg processor performance, memory capacity, application implementation, eg for evaluation purposes) can be created. In addition, central data processing and aggregation can be achieved in this way, wherein the generated data can be sent to decentralized clients (eg medical devices, RO plant) quickly and in a timely manner via a network connection or appropriate control interfaces.

Another important technical advantage is to be seen in the fact that the RO unit and/or, for example, the dialyzer can be controlled and/or regulated directly on the basis of the output data. If the resulting data shows, for example, a lack of water quality, this can be transmitted as early as possible and directly to the receiving devices, i.e., for example, dialyzers, to be disconnected directly from the RO-installation or replaced with another connection, if possible . In addition, the evaluation device on the server can use a database that is dynamically adapted also during operation, in which rules are stored that determine, for example, that in the event of a malfunction, warning messages are generated that are transmitted to various computerized or electronic receiving nodes (for example, mobile terminals). head of the department or to the computer in the nursing room) to quickly take the necessary action.

The server with the evaluation application can also receive data from other data sources, such as a water supply unit that is designed to supply water to the RO plant, or from other devices connected to or powered by the RO plant or working with it. The water supply unit may be provided with a measuring unit to record water flow data and transmit it to a server. According to one preferred embodiment, the server can prepare the first result and/or data from the sensors already based on the transmitted water flow data. To do this, the server may be provided with an evaluation unit that evaluates the received data on the basis of a set of rules stored in memory. The latter can also change dynamically during system operation.

One rule could, for example, be: If the sensor data falls below or exceeds a pre-set threshold, then the water quality is poor, or If the sensor data is within the pre-set range and the flow rate is below the threshold, then the water quality is good. The preliminary result obtained in this way can be issued either on the server via the user interface (eg in the first example above in the form of a warning message) and/or transmitted to the RO-installation or other instruments.

However, this preliminary result is based only on measured values and data from sensors. To recognize the preliminary result as valid, additional analysis is provided. To do this, the water sample is analyzed in the analyzer. Following this, the resulting data can be prepared. This result data may be transmitted to the server to validate or invalidate the provisional result. Depending on this, the resulting data can again be output on the user interface of the server and/or transmitted to the RO plant or other devices. The latter occurs, in particular, when the quality is deemed unsatisfactory in order to respond as soon as possible and, in particular, to disconnect the dialyzers from the water supply. Thus, it is possible, firstly, to improve the quality of the assessment, and, secondly, to draw a conclusion about the quality also independently of the laboratory analysis. The RO plant can thus be monitored in an advantageous manner substantially more frequently. In addition, on the contrary, also the result of the analysis, originating from the laboratory analysis, can be specified by data from sensors and/or flow data, or, if necessary, can even be localized or the cause can be indicated. The evaluation application for evaluation and validation, as described above, does not have to be run on the server, but can also be transferred, for example, directly to the RO plant or to the analyzer.

In another preferred embodiment, the system includes a water supply unit that is designed to supply water to an RO plant, the water supply unit comprising a measuring unit for measuring water flow data, the measuring unit comprising a bus interface for transmitting recorded water flow data ( in particular, preferably on the server). With this data, more complex evaluation processes can be run and more complex results obtained. Thus, the result of the analysis over time can be assigned to the water flow data so that a more complete conclusion can be drawn. Limit values can be defined for flow rates, such as water flow per hour/day/week. If this limit value is exceeded, a message is issued. It is still unclear why the excess occurred. If other water quality data are available, such as the conductivity of raw and drinking water, and if this value also indicates a limit value exceeded, the cause can already be located/determined using this smart link.

In another preferred embodiment, the result data is recorded electronically in a predetermined, standardized format. Therefore, all result data can be uniformly processed at the server and/or received at the RO facility even when the analyzers are operated by different operators in different ways and/or with different applications. This increases the compatibility of the system and connected systems.

The sensor data recorded by the sensor unit includes parameters that represent the correct functioning of the RO plant. The parameters include water conductivity parameters, in particular two different parameters are recorded here, namely before and after the membrane (drinking water conductivity, permeate conductivity) as well as retention parameters. The retention capacity R can be determined, for example, using the conductivity cSp of drinking water and the conductivity cP of permeate as follows:

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

Alternatively, other parameters may be logged in order to improve the information content of the analysis or evaluation on the server (eg, energy and water consumption of the water treatment plant, water temperature, water hardness, chlorine concentration).

The object of the invention is further solved by means of an RO plant for producing ultrapure water, comprising a sensor unit for recording data from sensors and an electronic data interface, intended for use in the security system described above.

The object of the invention is further solved by means of an analyzer, which can be carried out, for example, in a laboratory with at least one laboratory device for examining or analyzing the quality of a water sample of an RO plant in relation to compliance with the safety requirements of high-purity water (for example, in relation to contamination) , and moreover, the analyzer is designed to generate result data in response to the analysis of a water sample, moreover, the analyzer is made with an analyzing interface to transmit the generated result data in electronic form to an external device outside the analyzer, and moreover, the analyzer is intended for use in a security system in accordance with one of the above aspects.

The object of the invention is further solved by means of a server for coordinated processing of safety data of an RO installation operated for at least one medical device, in particular a dialyzer, the server being intended for use in the security system described above. The server is provided with an electronic data interface for exchanging digital and/or analog data in order to receive data registered by the sensor unit from the sensors;

with an analysis interface to receive the resulting data generated by the analyzer in electronic form.

In one preferred embodiment, the server is further configured with a memory for storing the received data and/or interacts with a database and/or includes a processing unit for specific processing of the received data. In this way, historical data can also be processed.

The objective of the invention is further solved by means of a method for monitoring the safety of an RO-installation designed to work with at least one medical device, in particular a dialyzer, which includes the following steps:

registration of data from sensors during the operation of an RO-installation designed to produce ultra-pure water;

transfer of recorded data from sensors in electronic form to an external switching device. The latter is thus located outside the RO plant and outside the RO system, so that control independent of the RO plant can be guaranteed.

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In one preferred embodiment, after the transmission of data from the sensors, or in parallel with this, the RO plant water sample can be analyzed for safety compliance on the laboratory equipment in order to generate effective data from the analysis. The generated result data in electronic form, and in particular for the control of the RO unit and/or the dialyzer, can be transmitted to the above mentioned devices. Alternatively, the RO unit and/or the dialyzer can also be adjusted based on the performance data.

In one preferred embodiment, the transmission of recorded data from the sensors is continuous or time-controlled during operation of the RO plant and/or according to predetermined results.

In another preferred embodiment, the data from the sensors and the resulting data are fed to a server for central processing and stored there, and in particular fed to a statistical evaluation covering the RO plant.

In another preferred embodiment, the resultant data is fed directly to at least one medical device to control it, in order to locally initiate an emergency interruption or an emergency shutdown if necessary.

The invention also relates to a computer program product including a computer program. The computer program includes software code that is designed to implement the method described above. The computer program product may be implemented in software or hardware and, in addition to the computer program, also contain an instruction manual, a data carrier and/or packaging. In particular, the steps of recording, transmitting, generating and transmitting result data may be initiated and/or performed by software. On the other hand, sample analysis may involve several work steps, while the generation of result data may, in turn, take place fully automatically.

The terms used in this application are defined below.

An RO plant is an RO plant for producing ultra-pure water used with at least one medical device to supply it with ultra-pure water. Therefore, it can also be called a medical-technical device. An RO plant may contain an electronic processing unit (eg, in the form of a CPU, FPGA, microprocessor, etc.). The sensor unit may be implemented in an electronic processing unit. ISO 23500:2014 defines the requirements for dialysis water (high purity water) that must be met by the operator of the respective facility. However, it is based on the ISO 13959:2014 Water for hemodialysis and related therapy standard used by the manufacturers of these units, which specifies the following requirements for the microbiological and chemical quality of dialysis water: ______________________

Wednesday Limit values Total colonies cfu/ml Endotoxin concentration EU/ml ISO 13959:2014 "Water for hemodialysis and concomitant therapy" Water for dialysis < 100 (*AL = 150) <0.25 (*AL=0.125) *AL = Action Level. ISO 13959:2014: The concentration from which steps should be taken to break the trend towards higher, unacceptable values. The value is usually 50% of the limit value. Parameter with confirmed toxicity in dialysis Limit value [mg/l] Electrolyte Limit value [mg/l] trace elements Limit value [mg/l] ISO Aluminum 0.01 Calcium 2 Antimony 0.006 1359: Lead 0.005 Potassium 8 Arsenic 0.005 2014 Fluoride 0.2 Magnesium 4 Barium 0.1 total chlorine 0.1 Sodium 70 Beryllium 0.0004 Copper 0.1 Cadmium 0.001 Nitrate as (N) 2 Chromium 0.014 Sulfate 100 Mercury 0.0002 Zinc 0.1 Selenium 0.09 Silver 0.005 Thallium 0.002

The correct functioning of the RO plant is determined, among other things, by the ability to retain sodium chloride (common salt), which, depending on the profile of requirements for ultra-pure water, should be 90-99.8%.

The RO-installation and the laboratory system with the analyzer are designed as two different separate systems. Typically, the RO unit is located in a dialysis center (for example, in a department separated from the dialysis department) in which dialysis machines are also operated. The laboratory system, in contrast, is located in an external laboratory located outside the dialysis center. This is justified by the fact that the analysis can also be carried out independently (and thus without influence) from the operator of the facility. This can avoid conflicts of interest. Analyzer and RO plant communicate

-4041201 via data connection. It can be based on the Internet and, for example, on the protocol of the http(s) family of protocols. The RO facility and the laboratory system are operated on different platforms and by different operators.

The analyzer can be a component of a laboratory system for the study of water samples. The analyzer is an electronic component and is used for digital data processing and for transmitting data to external communication devices. In addition to the analyzer, the laboratory system thus usually also contains at least one laboratory apparatus or laboratory instrument (for example, a conductivity meter, an ion chromatograph, a mass spectrograph or an atomic absorption spectrometer for the quantitative determination of individual ions, etc.). The laboratory system serves to detect water contamination and to carry out biological and/or chemical analysis, as well as bacteriological studies. One aspect of the invention thus relates to a broad analysis of a water sample from an RO plant; therefore, not only, for example, the chlorine content is checked, but also other studies are carried out to detect water contamination (mechanical, biological or bacteriological pollution, etc.). On the basis of the analysis carried out by means of the various instruments and/or laboratory devices mentioned above as an example, a laboratory result is obtained. It is fed to an analyzer, which is designed to automatically generate result data, for example in the form of an electronic message. The resulting data can be prepared for transmission to external switching devices. The resulting data must be transmitted, in particular, via a data connection to the RO plant and/or to the cloud server and/or to medical devices, so that additional measures can be taken there if necessary.

The network is an electronic network for data transmission. It can work with different protocols. Thus, the connection between the RO-installation and the server can be made in the form of an MBUS system (in particular, according to the EN 13757 standard), and the analyzer communicates with the server and/or medical devices via the IP protocol, for example, by means of notifications with an XML structure. For data exchange, the RO-installation and/or the analyzer are made with interfaces: the RO-installation with a data interface (for example, via the IP protocol), and the analyzer with an analysis interface (for example, HL7); table structure data can also be transferred via this interface, for example in csv, Microsoft Excel or OpenOffice Calc or xml formats, etc.).

The output data generated can be transmitted as status messages (poor water quality - satisfactory water quality) or as more extensive message packets, the message packets including additional details for analysis. They may also include metadata such as timestamp, sample status, study duration, etc.

As mentioned above, the system may include a server, preferably a cloud server. The server aggregates registered and generated data and is primarily stored in memory. To do this, access to a connected database can be provided. The server can serve for coordinated data processing. The term coordinated in this context means that the result data is calculated for a complex of dialyzers, namely for those dialyzers that are fed from the corresponding RO-unit. However, a coordinated calculation can also be carried out locally on an individual device, but, nevertheless, centrally and for all devices of the complex.

The evaluation device may be implemented on the server in the form of an evaluation application (software) or an evaluation circuit (hardware). The evaluation device is an electronic component. The evaluation circuit may be implemented, for example, in the form of an electronic printed circuit with digital and/or analog circuit components, which may contain an evaluation logic structure. The latter serves to evaluate which quality level the RO-installation complies with in order to issue a warning message if it is not. It can be issued via appropriate data interfaces to the RO unit, to the control unit of the RO unit and/or directly to medical devices (dialyzers). For direct signaling, a traffic light function can be performed on the user interface (red for too low quality, green for fair quality, and yellow for warning or exceeding alarm levels, for example depending on whether the respective limit values are exceeded or not reached). The evaluation scheme may use a set of rules for evaluation, which may be stored in a database or in memory, and defines a strategy for prioritizing a certain amount of result data. The scoring scheme can be activated advantageously automatically if new result data is generated or transmitted. They are transmitted to the receivers for regulation and/or control via the push protocol. The receiver can be an RO unit or a dialyzer.

The evaluation is carried out predominantly by a certain RO-installation. In the case of using a central server that aggregates data from all or selected RO-installations (for example, from all installations in a certain geographic region or from a dialysis facility) and evaluates them,

- 5 041201 it is also possible to obtain a result covering the RO installations by means of a statistical evaluation.

It is also possible to conduct evaluation which may trigger messages for installations depending on their identity (for example, via an appropriate identifier).

An important aspect of this solution should be seen in the fact that the medical-technical devices of the security system, which include the RO-unit and the laboratory system with the analyzer, and, in addition, may also include a water supply unit and/or dialyzers, are connected accordingly through two different connections:

1. Data connection for the exchange of electronic notifications and digital data, such as data from sensors and / or result data.

2. A pipeline connection for the exchange of physical media, such as ultra-pure water and/or a water sample.

An increased degree of security may be provided by an additional control measure. It lies in the fact that the data from the sensors recorded locally on the RO-installation is additionally evaluated (locally in the computing unit of the RO-installation or externally in the computing unit on the server or on the analyzer) in order to obtain a preliminary result. It is then obtained, if necessary, on the analyzer, and it is either confirmed (recognized as valid) or rejected (recognized as invalid) by analyzing the water sample. Thus, the preliminary result can be obtained earlier in the RO plant. In addition, security can be improved by re-checking the preliminary result.

The invention is described below with a dialyzer as an example of a medical device, such as a hemodialyzer. However, for a person skilled in the art it is obvious that the invention can be applied to or transferred to other medical-technical, computer-controlled or fluid management devices or blood purification devices that require ultrapure water for operation. This may, for example, also apply to peritoneal dialyzers if they use extra pure water.

It is possible that the transmission of data from the sensors of the RO installation and/or data on the flow rate of the water supply or other device (for example, regarding gas flow, energy, temperature resources for heating or cooling, etc.) occurs in a configurable time interval for their processing by the evaluation application.

In one preferred embodiment, it is possible to configure to which instruments the resulting data is to be transmitted. Thus, for example, it can be configured that data containing a high-priority warning message (water quality is not satisfactory) is transmitted to the hospital/operator's control unit and to other devices, and in case of unsatisfactory quality, only to the server and/or to the corresponding RO installation. This has the advantage that properly functioning installations will not be loaded with unnecessary messages. It may also be desirable and may also be configured so that all result data is always available on all instruments. In this way, the operator (hospital equipment and/or RO plant) always has an automatic overview of all plants and their states at a glance.

Another solution to the problem lies in a computer program product that is loaded or loaded into the memory of a computer or an electronic or medical technical device and includes a computer program for implementing the method described in detail above, if the computer program is executed on a computer or an electronic or medical technical device.

Another solution to the problem provides a computer program for carrying out all steps of the method described in detail above, if the computer program is executed on a computer or an electronic or medical device. It is also possible for the computer program to be stored on a medium readable by a computer or an electronic or medical device.

In the following detailed description of the drawings, embodiments of the invention, which should not be understood as limiting it, are discussed with its features and other advantages.

Brief description of the drawings

The drawings show:

Fig. 1 is a schematic of the proposed security system with RO-installation for the operation of dialyzers and the server and the exchange of data between them in accordance with the preferred embodiment of the invention;

Fig. 2 is a flowchart of the method in accordance with the preferred embodiment of the invention;

Fig. 3 is a schematic diagram of the communication between the dialyzer, the server and the RO unit in accordance with an embodiment of the invention;

fig. 4 is an alternative to FIG. 1 version of the security system without a server.

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Detailed description of the drawings

The invention is described in more detail in the examples of its implementation with reference to the drawings.

The invention relates to an electronic notification system for RO units RO which are used in dialysis units with at least one dialyzer or other medical devices D and report the quality status of the RO unit.

In FIG. 1 shows a first embodiment of the invention in which system 1 includes an SV server. It may be performed at least in part to evaluate water quality data. The water quality assessment is based on different input parameters provided by different instruments (RO-installation RO, analyzer AE, database DB, etc.).

To this end, a security system 1 is proposed, comprising several medical devices, including medical devices, respectively, with electronic components for data processing and for communication.

The RO plant RO is designed to produce ultra-pure water, which must be supplied to one or, as a rule, several dialyzers D in the dialysis department in order for them to work. To ensure a satisfactory quality of the extra pure water supplied (observance of the limit values for contamination, e.g. aluminium, chlorine, fluoride, nitrate, sulphate and/or zinc, the limit values for the corresponding maximum concentration are defined in the ISO 13959:2014 standard mentioned above). RO installation RO is made with a sensor unit S for recording data from sensors (in Fig. 1 as an example, sensors S1, S2, Sn). In addition, the RO installation RO comprises an electronic data interface RO-S for transmitting the data recorded by the sensor unit S from the sensors.

RO plant The RO is powered by the water supply unit W so that it can be cleaned or prepared in the RO plant RO. The water supply unit W contains several electronic modules, including a measuring unit M, which is designed to determine the water flow data 32. For this, various measurement methods and sensing elements or signal sensors can be used. Further, the water supply unit W contains interfaces for data communication, which can be implemented, in particular, in the form of an MBUS interface. Other medical devices of the system 1, such as, for example, the server SV and/or the analyzer AE, can communicate with the water supply unit W via this MBUS interface. Thus, the analyzer AE can record data from the sensors directly from the water supply unit W. This has the advantageous effect that the analyzer AE can perform a more comprehensive evaluation which takes into account, for the calculation of the resultant data, in particular the water flow data 32 and, if necessary, other data from the sensors recorded in the water supply unit W.

In another preferred embodiment, the sensor data recorded in the water supply unit W can be transmitted to the RO installation RO. This has the advantage that the data from the sensors of the water supply unit W can be calculated with the locally recorded data from the sensors RO of the RO plant to obtain a preliminary result, which is transmitted to the analyzer for validation. The preliminary result can be displayed for local control on a display unit (eg monitor) of the water supply unit W and/or RO plant RO. Thus, it is possible to carry out more complex calculations of the preliminary result, which are more informative.

The AE analyzer can be located in the laboratory system. The laboratory system with laboratory equipment is designed to analyze the water sample of the RO plant in terms of compliance with safety requirements and, in particular, contamination. Based on the result of the analysis and, if necessary, taking into account additionally recorded data from the sensors (water supply unit W and/or RO plant RO), result data are calculated or created in accordance with established rules. They are also created in digital format, in particular in the format of the final result. This can be a configurable data structure, in particular in XML format. The analyzer AE further comprises an analysis interface AE-S for transmitting the result data generated electronically to external switching devices (in particular to the RO unit RO and/or connected dialyzers D).

Devices and devices of the security system 1 are interconnected by a network NW.

As seen in FIG. 1, a number of dialyzers D and/or additional devices are typically connected to an RO unit. This is shown in FIG. 1 with two exemplary instruments D1, Dn.

In the (first) preferred embodiment, the security system 1 comprises a server SV. It has predominantly central access via the NW technical communication network and can be implemented as a cloud server. The server SV communicates with the connected devices, in particular with the RO-installation RO, medical devices D, analyzer AE and, if necessary, with the database DB. In this first embodiment, an evaluation application or evaluation function is implemented on the server SV in the processor P, which/which is designed to evaluate the detected data. In particular, result data, data from sensors and, if necessary, historical data from the database DB are processed according to predetermined rules in order to display a result notification of the quality status of the water treated by the RO plant. The effective notification can be used advantageously to control the RO unit RO and/or connected dialyzers D. In this way, relevant results can be obtained directly locally at the point of use.

In one preferred embodiment, the database may also store configurable rules that specify when result data should be transmitted to the appropriate receivers. In addition, for example, specifically for certain geographic regions or countries, it can be determined which additional functions and notifications, together with the resulting data, should be transmitted in the form of a data packet to the receivers. Functions can be, for example, dialyzer and/or RO unit control functions (connecting/disconnecting the dialyzer, limiting its functionality, in particular depending on the analysis result, etc.), while notifications can be about creating warning messages. messages (e.g. in an RO plant that the water quality does not meet the safety requirements, indicating that limit values have been exceeded). The rules can be specified differently during the configuration phase individually for the respective result data receivers (or data packets) or groups of receivers. This advantageously achieves an important additional flexibility.

The SV server and the evaluation application implemented therein may be predominantly web-based and browser-based. For additional calculations, such as statistical evaluations, the SV server may use the local MEM memory and/or store calculated or read data there.

As briefly explained above, the AE analyzer is designed to generate output data in a predetermined format from a laboratory report or laboratory results in order to transmit them to external switching devices.

In FIG. The dashed arrows in Fig. 1 (from the water supply unit W to the RO-unit RO and from the RO-unit to the analyzer AE) show that here we are talking about the transfer of not data, but physical media, i.e. in the first case, water is supplied to the RO-installation RO, and in the second case, the water sample is sent to the analyzer AE. Other arrows indicate the electronic exchange of analog and/or digital data.

In principle, the system can operate in two versions.

As mentioned above, in the first embodiment in FIG. 1, a central SV server is connected to system 1. An evaluation application is implemented in the SV server to evaluate the detected data. The SV server is designed as a cloud server and is accessed via IP-based interfaces (eg TCP/IP) SV-S1, SV-S2. In this variant, the exchanged data is first sent to the central server SV, which then sends the received data, either directly or in pre-processed form, to the appropriate receiver (eg, RO plant RO, analyzer AE). For this, data from the water supply unit W and/or data from the dialyzers D can also be communicated via interfaces SV-S1, SV-S2 (not shown in FIG. 1). Thus, in this example, the SV server acts as a proxy or intermediary node in the chain between the data source and the data receiver. This option has the advantage that all data can be aggregated on the SV server for further evaluation and processing. Thus, in particular, historical datasets can be reconciled with current datasets to obtain further information (e.g. In 80% of cases where the resulting data does not show satisfactory water quality, the sample was taken from a group of RO installations located in one specific geographical region or In 90% of cases where the resulting data does not show satisfactory water quality, the sample was taken in a certain time phase). In particular, a statistical evaluation can be performed that covers RO installations. In addition, the reference data obtained in this way on other RO installations can be used for matching/reference. The evaluation application can also take into account manually entered data regarding the RO plant. MEM memory can be used to access and store data.

In the second option, the central server is not provided. In this case, the RO unit and/or the water supply unit W and/or the dialyzer D interacts directly with the analyzer AE and vice versa. This second variant is shown in Fig. 1 in that at least the RO installation RO directly (without the mediation of the server SV) communicates with the analyzer AE, which is indicated by an arrow between the respective interfaces RO-S, AE-S. In this case, an evaluation application can be implemented at least partially in the analyzer AE for evaluating the data and for calculating the result notification. Partially, the application can also be implemented in other electronic devices. The result data or result notification then contains a set of control data made to control the respective device. In the event of an error (unsatisfactory high purity water quality), the control data set may contain a section that triggers, for example, a warning message and/or a shutdown of the RO plant. In addition, the control data set may contain a notification field that triggers notification from other devices or devices. This notification must be carried out in particular when a set of control data has been transferred to an external switching device (for example, to an RO plant). Thus, for example, warning messages can be automatically triggered both directly and locally on D dialyzers connected to the RO unit. This has the advantage that, in safety-critical cases, the relevant information is provided directly locally and thus the required measures can be taken directly without the need to inform intermediate devices. In one preferred embodiment, it is envisaged that the result data or result notification must be made available to the user (eg, a laboratory doctor) before it is transferred to other instruments and devices. This can be done through a prepared field and user input registered on it. Opening access can be associated with different user roles (with specific permissions).

This option is explained in more detail below with the help of FIG. 4.

In FIG. 2 shows the flow of the process according to a preferred embodiment of the invention. After starting the safety quality control method of the RO unit RO and thus checking the proper operation of the connected dialyzers D in step 100, data from the sensors are recorded during the operation of the RO unit RO. This occurs predominantly at predetermined time intervals according to pre-configured results (for example, when an additional dialyzer D is connected and/or after a certain number of dialysis runs) and/or continuously during the operation of the RO unit. In step 200, the sensor data registered at the RO plant RO and/or the water supply unit W are transmitted electronically to an external switching device (outside the RO plant). Depending on one of the two options described above, the data from the sensors is transmitted to the SV server or to the AE analyzer. The AE analyzer takes a water sample and analyzes it to create result data. This takes place in step 300. In a subsequent step 400, the generated result data is electronically transmitted to control the RO unit and/or the medical device D or directly to the respective devices RO, D and/or to the server SV. From the SV server, they are then transferred further and, in addition, can be stored centrally there. In this way, the first RO installation RO can also use the reference data of other second RO installations in a comparable manner. Thereafter, the method may be repeated or completed.

In FIG. 3 shows a sequential program with both of the above-described different options for data exchange between the electronic units of system 1.

1. With a central SV server and an evaluation application implemented in it (dash-dotted lines).

2. Without a server (solid lines). Here the RO unit, the dialyzers D and the measurement unit M interact directly with the evaluation application, which in this case is implemented in the analyzer AE.

During the operation of the RO-installation, the data 31 from the sensors are locally recorded and transmitted from there directly to the AE analyzer (solid arrow). As an alternative, the data 31 from the sensors are transmitted first to the server SV and from there to the analyzer AE (indicated in dashed lines in FIG. 3). In parallel or simultaneously, in the measuring unit M of the water supply unit W or other device, water flow data 32 are recorded, which in the first variant are transmitted to the server SV for the purpose of evaluation (in Fig. 3 is indicated by a dotted line). Alternatively or cumulatively, the water flow data 32 may also be transmitted to the analyzer AE (solid line). In this case, a data evaluation application is implemented in the parser AE, so that the corresponding function of the server SV is performed by the parser AE (shown schematically in FIG. 4). The analyzer AE, on the basis of a laboratory study or analysis, creates a set of result data 33, which is also transmitted either directly to medical devices RO, D, W (solid lines), or in another embodiment through the medium and / or memory of the server SV, which transmits then the data in the processed or raw form to the receivers RO, D, W (in Fig. 3 indicated by dashed lines). Processing and evaluation at the SV server may include additional process steps as described above, such as statistical evaluation or matching with historical data. The further result of these process steps is shown in FIG. 3 pos. 33' and can be transferred to the corresponding local devices RO, W, D.

In FIG. 4 schematically shows an example in which the system operates without a server. The dashed lines (W -> RO, RO -> AE) represent, as in FIG. 1, not data exchange, but the transfer of physical media (water, ultra-pure water). With regard to communication, the RO plant RO, the analyzer AE and, if necessary, the water supply unit W communicate directly with each other via a network, which can be based, for example, on the TCP/IP protocol. In this variant, the AE analyzer implements the function that was implemented in the SV server in the first example. The data of the water supply unit W or its measuring unit M, the data from the sensors of the RO-installation RO and, if necessary, the data of the dialyzers D are transferred directly to the analyzer AE and processed there. It is also possible for the water supply unit W to be connected to the RO plant RO via a data interface.

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Claims (10)

nyh. The data registered in the water supply unit W can then be transmitted indirectly via the ROset RO to the analyzer AE. To process the read data in the parser AE, the reference data from the data base DB can be read, and conversely, the data registered by the parser AE and the processed data can be stored in the database DB. The result of the analysis is then transmitted either to the RO unit (dashed-dotted line), which then transmits data to the water supply W and to the dialyzer D (also dashed-dotted line), or the data can be transmitted by the analyzer AE directly to the dialyzer D and to the water supply W with control goal (this option is indicated in Fig. 4 by a solid arrow). In conclusion, it should be pointed out that the description of the invention and examples of its implementation, in principle, should not be understood as a limitation with respect to its specific physical implementation. All of the features explained and depicted in conjunction with particular embodiments of the invention may be provided in various combinations with the subject matter of the invention to simultaneously realize their preferred effects. Thus, for example, also within the scope of the invention, alternatively or cumulatively to the server SV, other central units, for example a database DB, can be provided. In the same way, in addition to the dialyzers D, other medical-technical and/or computerized devices (also mobile terminals) can be connected to the RO-unit RO, on which result data are output. For a specialist, in particular, it is obvious that the invention can be applied not only to dialyzers, but also to other medical devices D, the operation of which requires high-purity water from the RO-installation RO. For example, ultrapure water quality control can also be used for sterilization and rinsing processes for the sterilization of medical instruments. In addition, structural elements or modules of the safety system for monitoring the quality of highly pure water can be implemented with distribution over several physical media. Thus, for example, within the scope of the invention, the application for evaluating result data can be fully or partially implemented in the analyzer AE or in the server SV. In addition, sections of the computer program for implementing the method can also be implemented directly in medical and technical devices D, RO. The scope of protection of the claimed invention is defined by the claims and is not limited to the features explained in the description or shown in the drawings. List of reference positions D - medical and technical device, in particular a dialyzer SV-server R - evaluation device MEM - memory RO - reverse osmosis plant, briefly RO plant AE - analyzer AE-S - analyzer analysis interface RO-S - RO plant data interface W - water supply unit M - measuring block of the water supply unit MBUS - bus interface of the water supply unit 100 - registration of data from sensors 200 - transmission of sensor data registered in the RO-installation 300 - creating performance data 400 - transmission of result data DB - database NW - network CLAIM 1. An electronic security system for a RO unit (RO) designed for use with at least one medical device (D), namely a dialyzer, comprising RO-installation (RO) for obtaining ultra-pure water, made with a sensor unit (S) for recording data from sensors, and RO-installation (RO) contains an electronic data interface (RO-S) for transmitting data registered by the sensor unit (S) from the sensors, wherein the data from the sensors recorded by the sensor unit includes parameters representing the correct functioning of the RO plant, namely the conductivity of drinking water and the conductivity of the permeate, from which the retention capacity of the RO plant is determined, a laboratory system with at least one laboratory apparatus and analyzer (AE), wherein at least one laboratory apparatus is configured to analyze a water sample of the RO-installation in relation to contamination, and the analyzer (AE) is configured to generate result data based on the analysis of the water sample, and the analyzer (AE) additionally performs 10 041201 nen with evaluation interface (AE-S) for transferring generated result data x in electronic form via a data connection to a RO-installation or a cloud server and/or medical devices; a network (NW) for data exchange between the RO-installation (RO) and the analyzer (AE), additionally containing a water supply unit (W) to the RO-installation (RO), the water supply unit (W) comprising a measuring unit (M) for measuring water flow data, the measuring unit (M) comprising a bus interface (MBUS) for transmitting the recorded water flow data. 2. The system according to claim 1, in which the RO-installation and the laboratory system with the analyzer are made as two different separate systems, and the RO-installation and the analyzer communicate with each other via a data connection, which can be based on the Internet. 3. The system according to claim 1, comprising a server (SV) for receiving data from the sensors of the RO-installation (RO) and / or the resultant data of the analyzer (AE) and / or for transmitting the resultant data to the RO-installation (RO) and / or to the medical - a technical device (D) for the purpose of control and/or regulation. 4. A system according to any one of the preceding claims, wherein the recorded data from the sensors additionally comprise delay parameters. 5. The system according to any of the previous paragraphs, in which, according to the registered data from the sensors, a preliminary result is locally calculated, which is transmitted to the analyzer (AE) for its recognition in the analyzer (AE) based on the received water sample as valid or invalid. 6. The system according to any one of the previous paragraphs, containing a server (SV) for coordinated processing of safety data RO-installation (RO), containing an electronic data interface (SV-S1) for receiving data registered by the sensor unit (S) from sensors; analysis interface (SV-S2) for receiving result data generated by the analyzer in electronic form, additionally containing a memory (MEM) for storing the received data and/or configured to interact with a data base (DB) and/or containing an evaluation device (P) for further processing of the received data, as well as a control interface for controlling the RO-installation (RO) and/or the medical device or medical devices (D) based on the resulting data. 7. A method for monitoring the safety of an RO-installation (RO) made for use with at least one medical and technical device (D), namely a dialyzer, using the system according to claim 1, including the following steps: registration (100) of data from sensors during operation of an RO-installation (RO) designed to produce ultra-pure water; transmission (200) of the registered data from the sensors in electronic form to an external switching device; reception of result data representing the analysis of a water sample of the RO-installation in relation to compliance with safety requirements and transmission of the resultant data directly to the medical-technical device (D) and / or to the RO-installation (RO) for their respective control with the possibility of initiating, if necessary, local emergency interrupt. 8. The method according to the previous paragraph, in which the registration (100) of data from the sensors is carried out continuously or with time control during operation of the RO installation (RO) and / or according to predetermined results. 9. The method according to any one of the preceding claims, wherein the data from the sensors and the resulting data are sent to a server (SV) for central processing and stored there and sent to the statistical evaluation covering the RO installation. 10. A computer-readable storage medium containing a partitioned computer program for carrying out all the steps of the method according to any of the preceding method claims, if the computer program is executed on a computer or electronic device. -