Apparatus and method for the forgery-proof marking of products and for enabling device functionalities

Abstract

The present invention is directed to apparatuses and methods for the forgery-proof marking of products that interact with devices. The apparatuses and methods are used to enable device functionalities. For this purpose, it is proposed to measure parameters of apparatuses for marking products or parameters of products and to store them re-readably in an encrypted form.

Description

[0001] Fresenius Medical Care AG

[0002] D-61352 Bad Homburg

[0003] Device and method for the counterfeit-proof marking of products and for enabling device functionalities

[0004] Technical area

[0005] The invention lies in the field of counterfeit-proof markings for marking products and for enabling device functionalities of devices that interact with the products.

[0006] background

[0007] Manufacturers of all types of products have an interest in ensuring that their products are clearly identifiable and can be assigned to them. This is the only way to ensure that a product has the product characteristics guaranteed by the original manufacturer. This particularly applies to products that interact with other products, such as devices. For example, printer cartridges interact with printers. The manufacturer of a printer guarantees that, when using printer cartridges manufactured by the manufacturer, the printer will function properly and with its guaranteed characteristics.

[0008] For this purpose, the current state of the art uses, for example, special integrated circuits that identify a printer cartridge. Information is stored on the integrated circuit that identifies the manufacturer and, if applicable, the individual product. When such a cartridge is inserted into the printer, the printer reads the circuit and identifies the cartridge as an original cartridge. Accordingly, it activates printing.

[0009] However, the use of special integrated circuits has several disadvantages. Firstly, it increases the product price. However, it has also been shown that such circuits can be copied by imitators or alternative suppliers. If a product, such as an individual printer cartridge, is to be specifically labeled, the label must be individual and unique, and the use of the printer cartridge must be made known to all printers. However, this requires the printers to communicate the use of a single printer cartridge with all other printers over a network and to be configured accordingly. This increases the costs and requirements for use.

[0010] Another area of ​​technology where the use of original or certified products is crucial is that of medical devices.

[0011] Products from the field of dialysis will serve as examples of medical technology products below. However, the invention can be applied to any technical field and, in particular, to any medical technology application without inventive step. Dialysis is a method for purifying the blood of patients suffering from renal insufficiency. This is generally done using dialysis machines that purify the blood either extracorporeally in the field of hemodialysis or within the patient's peritoneum in the field of peritoneal dialysis. There are various treatment methods for performing dialysis treatment. Those skilled in the art will be familiar with, for example, hemodialysis, hemofiltration, hemodiafiltration, and peritoneal dialysis.

[0012] Regardless of the procedure or device used for dialysis treatment, it requires the use of disposable medical items, which, for hygiene reasons, are generally intended to be used only once. These include, in particular, products containing blood and / or medical fluids, such as dialysis filters, blood lines, fluid containers such as bags containing dialysis fluid, substituate, or concentrates for producing these fluids, drip chambers, and the like.

[0013] Dialysis filters, for example, are subject to special quality requirements, as the actual blood purification takes place in the dialysis filter, and blood is passed along a semipermeable membrane through a special dialysis fluid. Accordingly, high quality standards and assurance of appropriate product quality also apply to the dialysis fluid. Other examples of dialysis products subject to high quality standards include the dialysis fluid for peritoneal dialysis, which is injected into the patient's peritoneum, or heparin, calcium, and citrate solutions, which are injected into the patient's blood in hemodialysis to address coagulation problems in the extracorporeal bloodstream, as well as blood thinning substitution solutions. It is obvious that the quality of the aforementioned products has a direct impact on treatment and thus on patient safety and health.It may also happen that the use of third-party products for standard treatments is permitted if they have demonstrable standard properties, but certain treatment options are only enabled with original products from the manufacturer of the dialysis machine because these require special product properties that common products certified only for standard procedures do not have.

[0014] Original products have specific product features for which a manufacturer is liable. These guaranteed features include, in particular, specific quality standards that often increase the price of a product.

[0015] This gives users an incentive to forgo the use of original products and instead use cheaper alternatives. However, the manufacturer of the dialysis machines cannot accept liability for the use of alternative products.

[0016] It is therefore in the interest of the manufacturer of original products that their products are marked in a way that prevents counterfeiting, and that devices, such as dialysis machines, that interact with such marked products or disposables are configured to read and evaluate the marking. When reference is made to original products below, this specifically refers to products that are certified and approved by a manufacturer for use with very specific devices.

[0017] Such a marking is intended to be used in the case of dialysis to enable special non-standard treatment procedures, to ensure the quality of treatment and to prevent the unlawful imitation of original products in order to avoid risks to the patient.

[0018] However, the invention can also be used for any other application where the use of original products is essential. Summary of the invention

[0019] The invention is therefore based on the object of creating devices and methods for the forgery-proof marking of products, in particular of disposable medical articles, and devices that interact with such products and only activate certain device functionalities when they have recognized the originality of a product with which they are intended to interact.

[0020] The object is achieved by a device according to claim 1, a product according to claim 7, a device according to claim 9 and methods according to claims 12 and 14.

[0021] The subclaims are directed to preferred embodiments of the invention.

[0022] Common markings for product identification include optical codes such as barcodes or QR codes, which store information that identifies the product. This information can be encrypted or unencrypted. In any case, such graphic codes can be copied using simple means. It doesn't matter whether the information is encoded in encrypted or unencrypted form, as the graphic represented by a barcode or QR code can be easily copied using photocopying. The content of the information is irrelevant; the only important thing is that it can be copied.

[0023] The invention is based on the idea of ​​linking the stored content of a marking identifying the product with a measurable parameter. The result of the parameter measurement is stored encrypted on the marking. The key for encrypting and decrypting the information is kept secret by the original manufacturer of the product or the device interacting with it. In practice, it is unavoidable that products cannot be produced and reproduced with arbitrary precision due to their manufacturing process. Accordingly, individual products of a product vary within the manufacturing variances. Such variances can cause differences in many parameters of the product. For example, the dimensions of a product or even the weight can vary.

[0024] If such a parameter of the product is measured, this information can be stored in encrypted form in a device for marking the product. For example, an encrypted QR code containing the result of the parameter measurement can be attached or applied to the product.

[0025] A potential imitator who wishes to create a product labeled in this way and claiming to be an original product faces difficulties. They cannot decrypt the information encrypted on the label of an original product available to them because they lack the decryption key. Accordingly, they do not know which parameter of the product is linked to the stored information. But even if they did know, they could not store the result of a measurement of this parameter encrypted in a label that corresponds to the encryption of the original product because they lack the necessary encryption key.

[0026] The only way to copy an original product equipped with a marking device according to the invention would be to reproduce the original product in exactly the same form, with all product features, including the marking. However, this is virtually impossible for manufacturing reasons, or only possible with very high effort, which would make such a product immensely more expensive. Brief description of the drawings

[0027] Further details and aspects of the present devices and methods are described in more detail, inter alia, with reference to embodiments shown in the drawings.

[0028] Shown are: Figure 1 shows an exemplary representation of an embodiment of a device according to the invention; Figure 2 shows an exemplary representation of a further embodiment of a device according to the invention; Figure 3 shows an exemplary representation of an embodiment of a product according to the invention; Figure 4 shows an exemplary representation of an embodiment of a device according to the invention with a product according to the invention; Figure 5 shows an exemplary representation of a system and a method for documenting the use of products that interact with devices.

[0029] Detailed description of implementation examples

[0030] Figure 1 shows an exemplary representation of an embodiment of a device 100 according to the invention.

[0031] In this embodiment, the device 100 is in a flat, rectangular shape as a label or tag. Such a tag 100 can identify any product, for example, by being attached to it. This connection is advantageously inseparable; for example, the device 100 can be glued to a product.

[0032] Two electrically conductive contact points 101 are mounted on the device 100. These can be electrically contacted by a corresponding device. Both contact points 101 are electrically connected by a conductive structure 104. The structure 104 has an electrical resistance R, the value of which depends on several parameters. These parameters include the specific conductivity of the material of the structure, as well as the width, thickness, and length of the structure, which in the exemplary embodiment shown in Figure 1 is designed as a conductor track.

[0033] The course of the structure 104 is specific to the device 100 and is advantageously random or quasi-random. One possible implementation of the structure 104 provides for it to be made of electrically conductive ink, and for the course of the structure between the two contact points 101 to be random or quasi-random.

[0034] For this purpose, appropriate random generators or other random or quasi-random variables, such as the manufacturing time and date, are used during device manufacturing. These random or quasi-random data are then converted into an equally random pattern of structure 104 using arbitrary algorithms and implemented by printing with conductive ink. The specific conductivity of the ink used is also subject to tolerances or can be specifically influenced by mixing it with non-conductive liquid, so this parameter can also be random or quasi-random.

[0035] As a result, the magnitude of the resistance R between the two contact points 101 is random or quasi-random.

[0036] In the following, "quasi-random" means that random generators known to those skilled in the art are used. These only generate pseudo-random numbers because they are based on deterministic algorithms and, given an identical starting value, always produce the same sequence of numbers. "Random," on the other hand, means that statistical fluctuations are used to generate random numbers, for example, manufacturing variances, noise, measurement inaccuracies, etc. The value of this resistance R is determined after the structure 104 of the device 100 has been manufactured by a corresponding measuring device and stored in the memory device 103 in an encrypted, readable form. In the embodiment of Figure 1, the memory device 103 is embodied as a QR code. Any other memory device, such as barcodes or non-volatile, erasable electronic memory, is also conceivable.

[0037] It is essential that the storage is encrypted and that the key for decrypting the stored information is kept secret.

[0038] The measurable parameter of device 100 in the embodiment of Figure 1 is therefore the electrical resistance R that develops between connection points 101. This is advantageously random or quasi-random.

[0039] It is also possible that the parameter is not intentionally random. Due to the manufacturing variances that can never be ruled out, each manufactured structure is subject to certain tolerances, which also follow a statistical distribution and therefore differ with a high probability for each production run. However, the embodiment in which the parameter is intentionally random or quasi-random has the advantage that the differences in the measurable parameter thus generated can reach a predetermined minimum size. For this purpose, the random generators are configured accordingly to generate random structures that exhibit a minimum difference. The minimum difference is based on the measurement accuracy during production and during use of the product that is intended to interact with the device 100.

[0040] In a manner analogous to the embodiment in Figure 1, random or quasi-random structures can also be generated during production, which realize other electrical quantities or structures, such as capacitances or inductances or combinations thereof, such as resonant circuits or complex networks. The information stored in encrypted form in the memory device 103 can then store corresponding properties such as the size of the capacitance or inductance, resonance frequencies and quality of corresponding electrical resonant circuits or impedance responses of complex electrical networks. Likewise, a temperature behavior of the generated structure can also be stored, which serves to make the measurement of the parameter independent of the ambient temperature. As the person skilled in the art knows, electrical resistances, for example, are subject to a more or less pronounced temperature dependence.If this temperature dependence is known, for example, through appropriate tests with the materials used, this information can also be stored in the storage device 103 and taken into account accordingly during the measurement. This ensures that the measurement of the measurable parameter is comparable to the stored value over a wide temperature range by determining the temperature during the measurement and correcting the measured value according to the information about the temperature dependence.

[0041] A potential imitator of a device 100 is faced with several difficulties.

[0042] To imitate the device 100, he can easily measure the resulting resistance, but he lacks the knowledge of how to store this information in an appropriately encrypted form because he does not have the appropriate key.

[0043] They could attempt to copy the device one-to-one, including the storage device (i.e., copying the QR code 103, for example). To do so, however, they would have to reproduce the resulting resistance as accurately as possible. Due to its random nature, however, this corresponds to a value that cannot easily be replicated using, for example, standard resistors from a standard series (E3, E6, E12, E24, E48, E96). This massively increases the manufacturing effort and makes it more expensive. Furthermore, they might have to ensure that their imitation has identical temperature behavior to structure 104 of the original product. If they want to copy structure 104 identically, they must first determine the resistivity of the conductive inks used, apply an ink with the corresponding resistivity, and precisely reproduce the structure.This procedure is also extremely complex, which eliminates the incentive to copy the device.

[0044] In order to increase the security of the device 100, several measurable parameters of the device 100 can also be stored in encrypted form in the storage device 103.

[0045] This is shown in the embodiment shown in Figure 2.

[0046] In the embodiment according to Figure 2, the geometric course of the structure 104 is determined as an additional parameter and is also stored in encrypted form in the storage device 103.

[0047] This can be done with any optical sensor 201, for example, a camera or a scanner device. For example, a photosensor with individual light-sensitive sensor cells or pixel sensors (X1Y1, X1Y2, X2Y1, ... XnYn) can be used, in which the course of the structure 104 can be determined by a measurable reaction of the sensor cells.

[0048] In the example of Figure 2, the specific profile results from a measurable reaction of the sensor cells shaded by the structure. This can be realized, for example, by an embodiment in which the device 100 is at least partially transparent and can be illuminated. If the device is held in front of the optical sensor 201 and illuminated, the individual sensors opposite the structure, such as cells X2Y1 to X7Y2 in Figure 1, are shaded, which can be determined accordingly by reading the sensor. Thus, the profile of the structure can be determined.

[0049] A potential imitator of the device would therefore not only have to exactly reproduce the resistance value, but also the exact course of the structure, which makes this task even more difficult. Another embodiment provides for the additional or alternative determination of a further optical property of the device, which can also be random or quasi-random. Thus, using the same device as shown in Figure 2, the transmittance of the device 100 can also be determined at a specific location or in general. This determination of the transmittance is carried out by illuminating the sensor 201 with a reference light source and then holding the device 100 in front of it. At a reference location, which is advantageously not covered by the structure 104, the illuminance of an individual sensor is measured with and without the structure 100 held in front of it.Which individual sensor is used for this purpose can also be determined randomly or quasi-randomly. The transmittance at this location can be determined from the ratio of the two measured illuminances. This information, i.e., both the individual cell used and the measured transmittance, can also be stored in encrypted form in the memory device 103.

[0050] A potential imitator of the device 100 would have to reproduce the device 100 in such a way that it has exactly the same transmittance at every point on the device as the original device, because he does not know which point is used to measure the transmittance.

[0051] This measure also increases the difficulty for a potential imitator to imitate the device 100.

[0052] The original manufacturer, however, is not required to exercise any particular precision when manufacturing device 100. The invention is based on the principle of using manufacturing-related tolerances or randomly or quasi-randomly generated parameters for individual marking. Accordingly, high precision in manufacturing is not necessary or even desirable. However, when measuring parameters such as resistance, gradient, and transmittance at a specific location, sufficient accuracy is assumed. This means that deviations due to measurement inaccuracies can be tolerated when using device 100 to mark a product.

[0053] In general, it can be provided that when measuring the measurable parameter and comparing it with the encrypted stored value, predetermined tolerances are accepted by which the measured value may deviate from the stored value of the measurable parameter in order to accept the product marked as an original product.

[0054] In practice, it turns out that the measurement of parameters such as resistance, transmittance, shape of a structure, etc. can regularly be carried out with far greater accuracy and at much lower costs than the production of a device with very specific parameters.

[0055] Accordingly, the effort to imitate or copy a product 100 is much higher and more expensive than the production of such a product for a manufacturer who knows the key to encrypt the measured parameters.

[0056] The previously described combination of multiple measured and stored parameters of device 100 exacerbates the difficulty for an imitator. This makes simple copying almost impossible or so complex that imitation is not economically viable.

[0057] Other parameters that can be measured and are subject to manufacturing tolerances or can be deliberately generated randomly or quasi-randomly include the reflectance of surfaces, a dimension, a weight, a color, a color combination, an optical pattern, or a mechanical pattern. The parameter can be a parameter of the device 100 itself or of a product marked with it. However, the device 100 can also be the product itself, for example, if it is an integral part of the product.

[0058] In addition to the result of the measurement of the measurable parameter of

[0059] Device 100 can store additional information in storage device 103. This additional information can include: date of manufacture, manufacturer, name, serial number, country of manufacture, expiration date, or compatibility information of the product marked with device 100. This information can be stored encrypted or unencrypted.

[0060] If the device 100 and the product to be marked with the device are two initially separate units, the device can advantageously be manufactured separately from the product.

[0061] It is also possible to monitor the use of a product marked with a device 100. In principle, a device 100 can be unique if care is taken during manufacturing to generate random parameters or parameter combinations only once. If the information about the measured parameters stored in the storage device 103 is read by a device that has a product marked with the device 100, it can be stored in the device or in a network resource accessible to a cohort of devices.

[0062] If a counterfeit product is subsequently read that stores the same, actually unique, parameter or parameter combination, it can be recognized that it has already been used. Accordingly, a device can refuse to allow the product, which is most likely a counterfeit, to be used again.

[0063] In a further embodiment, after reading the information stored on the storage device 103, the device 100 can be manipulated in such a way that the parameters that are supposed to be measurable are no longer measurable.

[0064] For example, after measuring the electrical resistance R between the contact points 101, a sufficiently high voltage can be applied to the contacts so that a sufficiently high current flows through the structure 104, which forms the resistance R, to destroy the structure at one or more locations. This procedure is known to those skilled in the art as "fusing." This prevents the device 100 from being completely analyzed again, and a copy of the device 100 is thus ruled out.

[0065] In an analogous manner, for example, the device can be printed or drilled after the storage device has been read out in order to make it difficult or impossible to determine the measurable parameters again.

[0066] Figure 3 shows a product according to the invention which is designed as a disposable medical article, namely as a dialysis filter 300.

[0067] Medical disposables are particularly critical in terms of product quality and design. Manufacturers of medical devices and disposable medical devices, or medical accessories that interact with a medical device, have a particular interest in ensuring that only original parts they manufacture themselves are used. This is the only way to ensure that treatments performed with the medical device in conjunction with disposable medical devices or accessories can be carried out with the intended parameters and that the patient is not endangered.

[0068] The dialysis filter according to Figure 3 comprises a device 100 according to the invention. The originality of the dialysis filter is therefore provable because only the manufacturer of the dialysis filter knows the key used to store the measurement result of the measurable parameter of the device.

[0069] The dialysis filter can be marked, for example, by affixing a device 100 designed as a label, marker, tag, or sign to the dialysis filter 300. Another embodiment provides for the device to be implemented as an integral component of the dialysis filter. For example, the resistance structure 104 can be printed directly onto the housing of the dialysis filter 300 during manufacture of the dialysis filter. Similarly, an optical code (QR code 103), which encodes the measurement result of the measurable parameter (e.g., the resistance resulting from the resistance structure 104), can be printed onto the housing of the dialysis filter. Both embodiments are symbolized in Figure 3 by the dashed border of the device 100.

[0070] Figure 4 shows a device according to the invention, which is embodied by way of example as a dialysis machine 400. The invention can be implemented with any other technical device in which the originality of the parts used is to be ensured. All embodiments described below in connection with a dialysis machine are, insofar as technically possible and sensible, also possible with any other technical device by adapting the corresponding devices and products. The representation of the dialysis machine 400 in Figure 4 is greatly simplified. The dialysis machine 400 in Figure 4 comprises a display 403, which can be embodied as a touchscreen for interaction with a user. Furthermore, the dialysis machine comprises a receiving device 401 for receiving a dialysis filter 300, with which the machine interacts to carry out a dialysis treatment.The recording device 401 comprises means (not shown) for measuring the measurable parameter (104) of the dialysis filter 300, as well as for reading the storage device 103. A control device 402 is configured to control the dialysis machine.

[0071] The dialysis machine 400 must be equipped with a dialysis filter 300 to perform a treatment. Of course, additional parts or disposable parts not shown in Figure 4 that interact with the dialysis machine 400 are required to perform a treatment. These include, for example, tubing sets, concentrate containers for producing medicinal substances such as fluids, drip chambers, and the like. Each of these parts can be marked according to the invention in a similar way to the dialysis filter 300. According to the invention, the dialysis machine 400 is configured to verify the authenticity of the dialysis filter 300 with which it interacts to perform a treatment. This can be done in various ways.

[0072] The dialysis machine itself can have devices 401 for measuring the measurable parameter of the device 100. For example, the dialysis machine 400 can have receiving devices for receiving the dialysis filter 300, which have corresponding electrical contacts that contact the electrical contacts 101 of the device 100 when the dialysis filter is received, thus enabling a measurement of the resistance of the structure 104. In Figure 4, this device is symbolically represented in simplified form as a rectangle 401. The resulting resistance can then be determined via this electrical contact. The dialysis machine 400 can also have a readout device for reading the information stored in encrypted form in the storage device 103. This can be, for example, a camera or a QR code or barcode scanner. A readout device for electronically stored information, such as RFID or NFC readers, is also conceivable.

[0073] The dialysis machine 400 and the dialysis filter 300 used, which interacts with the machine, can be configured such that they can interact in only one specific relative position to ensure the measurement of the measurable parameter and the reading of the storage device 103. This can be achieved by appropriately shaping the dialysis filter 300 and the receiving device 401, which allows the part to be received in only one specific position. This type of positive fit can generally be applied to any device and to any interacting or cooperating parts marked according to the invention.

[0074] Another embodiment provides for the use of an external device for measuring the measurable parameter and for reading the storage device 103. This has the advantage that devices, such as dialysis machines, do not necessarily have to be retrofitted as long as they are configured to receive information about the authenticity of a used part. This is possible, in particular, via any data connection of the device, for example a network connection. Here, the measurable parameter is measured by an appropriately configured external device, which is also configured to read the encrypted stored information. The external device has the key to decrypt the stored information and can thus determine whether the information matches the measured parameter.In one embodiment, the external device can also send the read code undecoded to a central instance, such as a server, where the information is decoded and sent back to the external device. The result of the check, whether the measured parameter matches the decoded information from the storage device, is then communicated to the device 400, which is intended to interact with the part 300 marked according to the invention, in any desired manner, for example, via a (protected) network connection.

[0075] The dialysis machine 400, which is informed of the authenticity of a part to be used, can initiate further activities depending on this information. The control unit 402 can be configured accordingly for this purpose. For example, the dialysis machine can display information on a screen 403 indicating whether an original part or a non-original part has been detected. In the latter case, corresponding warnings can inform the user of the risks of not using an original part.

[0076] Furthermore, treatment may be prevented in whole or in part if no original part is detected. For example, certain treatment options may only be enabled when original parts are used, while basic treatments may also be possible with non-original parts. Treatment options that are only enabled for dialysis machines when original parts are used, for example, include hemodiafiltration, single-needle dialysis, dialysis for pediatric patients, etc. It may be possible to accept alternative products for basic treatments that do not need to be marked according to the invention. However, if the dialysis machine detects that a marking according to the invention is present but is a counterfeit, any treatment may be refused.This is the case when the measurement of the measurable parameter and the stored information about it do not match.

[0077] In any case, the reading and / or use as well as the refusal or activation of treatments or treatment options can be documented by storing the relevant information.

[0078] As already described, after reading in the information stored on the storage device 103, the dialysis machine can manipulate the device 100 in such a way that the parameters that are supposed to be measurable are no longer measurable and / or manipulate the device after reading out the storage device in such a way that a renewed determination of the measurable parameters is made difficult or impossible.

[0079] Other technical areas and applications in which the marking and methods according to the invention can be used include, for example, the automotive industry or aviation.

[0080] For both areas, it is important that, for example, spare parts are used that are not counterfeit and meet certain minimum requirements.

[0081] Accordingly, vehicles and aircraft can be designed to allow operation only if the originality of a replacement part, which has been routinely checked, for example, at maintenance intervals or unscheduled when defects occur, has been proven by the marking according to the invention.

[0082] This can be achieved, for example, by having control units of vehicles or aircraft, after noticing a need for maintenance or a defect, only allow continued operation when the control unit is informed of the originality of the installed part by reading the memory device and comparing it with the measurement of the measurable parameter of a spare part marked according to the invention.

[0083] This can be done, for example, by scanning an optical code (QR Code 103) with a corresponding scanner and measuring at least one measurable parameter, for example the resulting electrical resistance, with a corresponding measuring device.

[0084] If the authenticity of the part equipped with device 100 is determined in the manner already described, this can be communicated to the control unit of the vehicle or aircraft in any manner, for example, by transmission via an OBD (On Board Diagnostic) interface or through other network connections. The control unit is accordingly configured to enable operation of the vehicle or aircraft only if the authenticity of the part has been determined in the manner described.

[0085] Another method and devices used to make it more difficult to imitate original parts are described below.

[0086] In the prior art, products such as disposable medical devices can be marked with a unique code, such as a QR code. If the creation of a measurable parameter of the product is omitted as described above, a copycat product can be created by copying such a marking. To make the use of such a copycat product more difficult, it can be provided that every reading and / or use of a product marked in this way is stored in a central location. Devices that work with correspondingly marked products have a data connection to the central location (e.g., cloud storage) and are informed accordingly about the previous use of a product and can react accordingly in the manner already described.

[0087] Figure 5 shows an exemplary embodiment based on a dialysis treatment. The design described in Figure 5 can be implemented with any other technical device in which the authenticity of the parts used must be ensured. All embodiments described below in connection with a dialysis machine are also possible with any other technical device, provided they are technically feasible and reasonable.

[0088] In this example, a smartphone 501 is used to read the code 103 of a disposable medical article 300 in a step 510. The smartphone sends the read information to a central location (cloud storage or server) 503. Optionally, a device ID of the dialysis machine 400 or patient data, such as the patient name or patient ID of the patient 504, can also be read with the smartphone in a step 511. The form in which this data is available is irrelevant. For example, it can also be optically encoded (QR code, as shown in Figure 5) and stored on the dialysis machine and the patient, but it can also be transmitted electronically. The smartphone 501 transmits the read code 103 and, if applicable, the optionally read patient and / or device data to the central location 503 in step 512.In this case, the decoding of the code 103 can take place in the smartphone 501 itself, provided that the decryption code is stored therein, or the decoding takes place in the central location 503 itself. The latter has the advantage that the decryption code remains at a central location.

[0089] At the central location 503, the reading of the code 103 is documented and it is checked whether a reading or use of the product marked with the code 300 unique code has already been documented previously.

[0090] The use of the disposable medical device 300 can be documented by the dialysis machine sending a corresponding message to the central location, at least indirectly via the smartphone, after the treatment has been completed.

[0091] To enable device functionalities or treatment options, activation is requested from the central location 503. Such activation can include an activation code that is sent back to the smartphone in step 513. Such an activation code can be an alphanumeric code that is displayed on the smartphone and, after being entered into the user interface 403 on the dialysis machine, causes the control unit 402 to activate the corresponding device functionalities or treatment options on the dialysis machine. Direct activation is also possible, such that the activation code is transmitted to the dialysis machine 400 via a corresponding data connection (step 514).

[0092] If the central location 503 determines that the scanned code has already been scanned previously and / or the use of a product bearing the scanned code is already known, the activation of the dialysis machine for treatment may be refused in whole or in part.

[0093] The embodiment shown in Figure 5 shows a smartphone as a device for reading the marking 503 and the data exchange between the central location 503 and the dialysis machine 500.

[0094] Any other appropriately equipped device, such as a tablet computer or smartwatch, can be used for this purpose. The use of such a device can be avoided entirely if its functionality is present in the dialysis machine itself.

[0095] This procedure also makes it possible to detect and prevent the reuse of disposable medical devices or to release them only for a certain number of uses.

Claims

Patent claims 1. Device (100) for marking a product, comprising a storage device (103) which stores the result of a measurement of at least one measurable parameter of the product or the device (100) in an encrypted, readable manner.

2. The device (100) of claim 1, wherein the at least one measurable parameter is a property of at least a portion of the product or device that was generated during manufacture of the product or device using a method for generating random or quasi-random numbers, whereby the result of the measurement is random or quasi-random.

3. Device (100) according to one of the preceding claims, wherein the at least one measurable parameter is a physical, optical, mechanical, chemical or electrical parameter or a combination thereof.

4. Device (100) according to one of the preceding claims, wherein the parameter is an electrical resistance, a capacitance, an inductance, a transmittance, a reflectance, a dimension, a weight, a color, a color combination, an optical pattern or a mechanical pattern.

5. Device according to one of the preceding claims, according to which the storage device (103) comprises an optical coding of the measurement result of the measurable parameter.

6. Device (100) according to one of the preceding claims, wherein the device is in the form of a label, marker, tag or sign.

7. Product (300) which has or comprises a device (100) according to one of the preceding claims.

8. Medical device, disposable medical device, blood filter, dialysis filter (300), medical tubing set, medical fluid container, drip chamber according to claim 7.

9. Device (400) that can interact with a device (100), a product or a medical product (300) according to one of the preceding claims, comprising a reading device (401) that is configured to read the memory device (103), and a measuring device (401) that is configured to measure the at least one measurable parameter, wherein the device (400) enables or disables device functionalities that can be carried out with the device (400) depending on the read-out result and the measurement.

10. Device (400) according to claim 9, which is configured to manipulate the device (100) after reading the memory device (103) in such a way that reading the memory device (103) and / or measuring the measurable parameter is no longer possible.

11. Device (400) according to claim 9 or 10, wherein the device is a medical device and is particularly configured to carry out a blood treatment such as hemodialysis, hemodiafiltration, plasmapheresis or peritoneal dialysis, wherein the device functionalities are treatment options.

12. A method for marking a product (300) comprising the steps: Measuring at least one measurable parameter of the product (300) or a device (100) for marking the product (300), Encrypted and re-readable storage of the measurement result on a storage device (103).

13. The method according to claim 12, comprising the steps: Manufacturing at least one part A of the product (300) or the device (100) using a method for generating random or quasi-random numbers, wherein measuring the at least one measurable parameter of the product or device is measuring a parameter of the at least one part A such that the result of the measurement is random or quasi-random.

14. A method for enabling device options comprising the steps of: i) measuring the at least one measurable parameter of the product (300) or the device (100) obtained from a method according to claims 12 or 13, ii) reading the storage device (103) and decoding the information contained therein, iii) comparing the decoded information from step ii with the result of the measurement from step i and, depending on the comparison, enabling or disabling device functionalities of a device.

15. The method according to claim 14, comprising the subsequent step: iv) manipulating the product (300) or the device (100) such that reading the storage device (103) and / or measuring the measurable parameter is no longer possible.

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