Medical Device

Abstract

The present invention pertains to medical device (1), preferably a dialysis device for performing a hemodialysis, and/or hemofiltration and/or hemodiafiltration, comprising a first functional module (CPU1) and a second functional module (CPU2), wherein an operating hours counter (2) for counting the operating hours is provided in the first functional module (CPU1), and wherein the first functional module (CPU1) is configured to store an operating hours value determined by the operating hours counter (2) in the a first storage (M1) of the first functional module (CPU1), wherein a second storage (M2) is provided in the second functional module (CPU2), wherein the second functional module (CPU2) is configured to store the operating hours value determined by the operating hours counter (2) of the first functional module (CPU1) in the second storage (M2).

Claims

1. Medical device (1), preferably a dialysis device for performing a hemodialysis and/or hemofiltration and/or hemodiafiltration, comprising a first functional module (CPU1) and a second functional module (CPU2), wherein an operating hours counter (2) for counting the operating hours is provided in the first functional module (CPU1), and wherein the first functional module (CPU1) is configured to store an operating hours value determined by the operating hours counter (2) in the a first storage (M1) of the first functional module (CPU1), wherein a second storage (M2) is provided in the second functional module (CPU2), characterized in that the second functional module (CPU2) is configured to store the operating hours value determined by the operating hours counter (2) of the first functional module (CPU1) in the second storage (M2).

2. Medical device (1) according to claim 1, characterized in that the first functional module (CPU1) is a main control module and/or an operating system and/or the second functional module (CPU2) is a monitoring system and/or a protection system, wherein, optionally the first functional module (CPU1) and the second functional model (CPU2) each comprise an individual microprocessor.

3. Medical device (1) according to claim 1 or 2, characterized in that at least two further functional modules (CPU2, CPU3, CPU4) are provided in addition to the first functional module (CPU1), which each comprise an individual storage (M2, M3, M4), wherein the further functional modules (CPU2, CPU3, CPU4) are each configured to store the operating hours value determined by the operating hours counter (2) of the first functional module (CPU1) in the respective storage (M2, M3, M4), and wherein optionally, each functional module (CPU1, CPU2, CPU3, CPU4) comprises an individual microprocessor.

4. Medical device (1) according to one of the preceding claims, characterized in that a communication interface (3) is provided between the first functional module (CPU1) and the second functional module (CPU2), which is configured to transmit the operating hours value determined by the operating hours counter (2) of the first functional module (CPU1) to the second storage (M2), optionally to each storage (M2, M3, M4) of the further functional modules (CPU2, CPU3, CPU4).

5. Medical device (1) according to one of the preceding claims, characterized in that a synchronization device (4) is provided, which is configured to automatically synchronize the operating hours values stored in the storages (M1, M2, M3, M4) of the functional modules (CPU1, CPU2, CPU3, CPU4) to each other and/or to automatically restore the operating hours values.

6. Medical device. According to one of the preceding claims, characterized in that the storage (M1) provided in the first functional module (CPU1) and/or the storage (M2, M3, M4) provided in the second functional module (CPU2) and/or all functional modules (CPU2, CPU3, CPU4) is a non-transient storage medium.

7. Medical device (1) according to one of the preceding claims, characterized in that the first storage (M1) of the functional module (CPU1) is configured to store further values, optionally configuration values and/or set up values and/or calibration values, wherein the second functional module (CPU2) is configured to store the further values stored in the storage (M1) of the first functional module (CPU1) in the second storage (M2), and wherein optionally the synchronization device (4) is configured to automatically synchronize the further values stored in the storages (M1, M2, M3, M4) of the functional modules (CPU1, CPU2, CPU3, CPU4) to each other and/or to automatically restore said values.

8. Method for counting the operating hours of a medical device, preferably a dialysis device for performing a hemodialysis and/or hemofiltration and/or hemodiafiltration, which comprises a first functional module (CPU1) and a second functional module (CPU2), wherein the first functional module (CPU1) determines the operating hours with an operating hours counter (2) and wherein the determined operating hours value is stored in a storage (M1) of the first functional module (CPU1), characterized in that the operating hours value determined by the operating hours counter (2) of the first functional module (CPU 1) is stored in a second storage (M2) comprised by the second functional module (CPU2).

9. Method according to claim 8, characterized in that the operating hours value determined by the operating hours counter (2) of the first functional module (CPU 1) is stored in a further storage (M2, M3, M4) of further functional modules (CPU2, CPU3, CPU4).

10. Method according to claim 8 or 9, characterized in that an automatic synchronization and/or restoring of the operating hours values is performed, when a deviation of the operating hours values stored in the storages (M1, M2, M3, M4) exists.

11. Method according to claim 10, characterized in that the automatic synchronization and/or restoring of the operating hours values is performed after a user input and/or after maintenance and/or switching on of the medical device (1) and/or according to schedule.

12. Method according to claim 10 or 11, characterized in that the automatic synchronization and/or restoring of the operating hours values is performed, when a predefined minimal deviation of the operating hours values stored in the storages (M1, M2, M3, M4) exists.

13. Method according to any of the claims 10 to 12, characterized in that the operating hours value which is most frequently present in the storages (M1, M2, M3, M4) is used as a basis for the synchronization and/or restoring of the operating hours values.

14. Method according to any of the claims 8 to 13, characterized in that further values are stored in the first storage (M1) of the first functional module (CPU1), optionally configuration values and/or set up values and/or calibration values, and the further values stored in the storage (M1) of the first functional module (CPU1) are stored in the second functional module (CPU2) in the second storage (M2), and wherein optionally the further values stored in the storages (M1, M2, M3, M4) of the functional modules (CPU2, CPU3, CPU4) are automatically synchronized to each other and/or are automatically restored.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Preferred further embodiments of the invention will be more readily appreciated by reference to the following detailed description when being considered in connection with the accompanying drawings in which:

[0039] FIG. 1 is a schematic view of a medical device with multiple functional modules; and

[0040] FIG. 2 is a schematic view of a dialysis device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0041] In the following, preferred embodiments will be explained with reference to the accompanying figures. In the figures, like elements are denoted by identical reference numerals and repeated description thereof may be omitted in order to avoid redundancies.

[0042] FIG. 1 schematically shows the composition or setup of a medical device 1, for example in form of a dialysis device for performing a hemodialysis and/or hemofiltration and/or hemodiafiltration.

[0043] In the medical device 1 a first functional module CPU1 is provided, which is, e.g., provided in the form of a main control module, which is responsible for the control of the medical device 1. With the first functional module CPU1 the treatment of the patient, for example, is controlled with the medical device.

[0044] The first functional module CPU1 comprises a microprocessor and a storage or memory M1. The storage M1 is preferably configured as a non-transitory storage medium to ensure a storage independently of the electrical supply of the functional module CPU1.

[0045] Furthermore, a second functional module CPU2 is provided in the medical device, which also comprises a microprocessor and a second non-transitory storage medium M2. The first functional module CPU1 and the second functional module CPU2 may be configured, for example, as a main control module or operating system on the one hand and as a protection system on the other hand.

[0046] Both functional modules CPU1 and CPU2 may be configured redundantly with respect to each other, such that the protection system CPU2 may monitor the main control module CPU1. In case of a downtime of the main control system CPU1 the protection system CPU2 may intervene and may accordingly bring the medical device in a safe state and/or trigger an alarm and/or output a failure or error message.

[0047] Furthermore, a further functional module CPU3 is provided in the medical device 1, which may be adapted or formed as a monitoring system. Further functional modules may be providedas indicated by the dashed lines in FIG. 1for example in the form of the functional module CPU4, which may assume further functions within the medical device 1.

[0048] The functional modules CPU1, CPU2, CPU3, CPU4 each comprise an individual storage, M1, M2, M3, M4, preferably a non-transitory storage medium.

[0049] In the first functional module CPU1 an operating hours counter 2 is furthermore provided, by which the operating hours of the medical device 1 are counted and may be outputted as operating hours value. The operating hours counter 2 accordingly uses, for example, the processor frequency of the microprocessor in the first functional module CPU1 and accordingly increments the operating hours value after switching on the medical device 1. Alternatively, the treatment time or another time value, which should be measured during the operating time of the respective medical device 1, may be counted.

[0050] The operating hours value determined by the operating hours counter 2 in the first functional module CPU1 is stored or saved in the non-transitory storage M1 of the first functional module CPU1.

[0051] The storing may be performed, for example, every minute or in shorter or longer time intervals. The storing may also be exclusively or additionally performed upon the switching off of the device and/or at the start and/or completion of a treatment.

[0052] The operating hours value determined by the operating hours counter 2 provided in the first functional module CPU1 is furthermore communicated to e.g. the second functional module CPU2, the third functional module CPU3, anddepending on the implementationalso to the fourth functional module CPU4 and/or a further functional module via a communication interface 3 and is also stored in each of the respective storages M2 and M3 anddepending on the implementationalso in the optionally provided storage M4 and/or in the storages of optionally provided other functional modules. Accordingly, during normal operation and depending on the implementation a synchronization of the operating hours values exists in all storages M1, M2, M3, and optionally M4 of the respective functional modules CPU1, CPU2, CPU3, and optionally CPU4.

[0053] When replacement of a functional module is required, for example, the second functional module CPU2, an initialization is accordingly performed upon the insertion of the replacement functional module CPU2 and a comparison of the operating hours values recorded in the storages M1, M2, M3, and optionally M4 is performed.

[0054] In case of a replacement of the functional module it is determined that the operating hours value recorded in the storage M2 of the replaced functional module CPU2 does not correspond to the operating hours values that are recorded in the storages M1, M3, and optionally M4. Accordingly, the operating hours value present in the storage M2 of the replaced functional module CPU2 is restored by means of a synchronization device 4, which may be provided in the first functional module CPU1, based on the operating hours values recorded in the storages M1, M3, and optionally M4 of the other functional modules CPU1, CPU3, and optionally CPU4.

[0055] Accordingly, an automatic restoring and/or synchronization of the operating hours values occurs in all storages M1, M2, M3, and optionally M4 of the functional modules CPU1, CPU2, CPU3, and optionally CPU4, such that a synchronization of the operating hours values is provided. Hence, a comparison or a reset of the storage by a servicing technician does not need to be performed. Instead, an automatic comparison is provided.

[0056] If a deviation of the individual operating hours values in the respective storages M1, M2, M3, and optionally M4 is present, a majority decision, for example, is made by the synchronization device 4, when a deviation above a minimum is present, such that the operating hours value which is present in the largest number in the storages M1, M2, M3, and optionally M4, is given priority. Obviously, a majority decision may already be made when using three storages M1, M2, M3 and the additional optional storage M4 or the storage of further optional functional modules are not required for said decision, but may be considered in the decision, when present, although this is not necessary.

[0057] In case of a replacement of the functional module CPU2 this is accordingly the case in all functional modules CPU1, CPU3, and optionally CPU4, due to the synchronization of the operating hours values except for the newly inserted functional module CPU2. Hence, an automatic restoring of the operating hours values in all storages M1, M2, M3, and optionally M3 may accordingly be achieved.

[0058] In this way, also a backup of the operating hours value, which is determined by the operating hours counter 2 in the first functional module CPU1, is accordingly achieved in the storages M2, M3, and optionally M4 of the other functional modules CPU2, CPU3, and optionally CPU4. Hence, a simple replacement of the functional modules is possible without losing the information regarding the elapsed operating time of the medical device 1.

[0059] In an exemplary embodiment, the operating hours value recorded in the first storage M1 is assumed to be valid for the restoring of the operating hours value, when a deviation smaller or equal to 5 hours between the individual operating hours values in the storages M2, M3, M4 and the first storage M1 of the first functional module CPU1 exist. The operating hours values in the storages M2, M3, and optionally M4 are set to the operating hours value derived from the first storage M1, if required.

[0060] In case of a deviation larger than 5 hours, a majority decision is made by recognizing which of the storages M1, M2, M3, and optionally M4 is defective and the wrong operating hours value is then automatically corrected. For safety reasons, the largest operating hours value of all operating hours values identified as being valid is taken.

[0061] The validity is determined as follows: If Wenn |M1M2|5 h is true, the operating hours value in the storage M1 of the CPU1 and the operating hours value in the storage M2 of the CPU2 are identified as being valid. In general, the following comparisons need to be performed for each of the operating hours values stored in said storages:

|M1M2|MAX_DEV

|M1M3|MAX_DEV

|M2M3|MAX_DEV

[0062] If no correction is possible (for example, because the deviation between all operating hours values is larger than 5 hours), a failure or error message is outputted.

[0063] Aside from the operating hours values also further values of the medical device may be redundantly stored or stored with a backup in the storages M1, M2, M3, and optionally M4 of the functional modules CPU1, CPU2, CPU3, and optionally CPU4. For example, configuration values and/or setup values and/or calibration values of the first functional module CPU1 may be stored in the storages M1, M2, M3, and optionally M4, and may be held synchronously by means of the synchronization device 4, such that, in case of a replacement of a functional module CPU1, CPU2, CPU3, and optionally CPU4, and in particular of the first functional module, it may be automatically relied upon the configuration values and/or setup values and/or calibration values.

[0064] In FIG. 2 the medical device 1 is configured as a dialysis device according to a further embodiment. Accordingly, the device comprises a dialyzer 10, which comprises a blood space 14 and a dialysate space 16, wherein both spaces are separated from each other by means of a membrane 12. Dialyzers of this kind are generally known. They comprise a housing, wherein, for example, multiple cylindrically shaped hollow fiber membranes are adjoined into a hollow fiber bundle. Blood flows through the interior space of the hollow fiber membranes while dialysate flows in the space between the hollow fiber membranes and the filter housing. Obviously, other configurations of dialyzers may be provided.

[0065] Accordingly, the blood space 14 is to be understood as the sum of areas or regions, wherein blood flows in the dialyzer 10, and the dialysate space 16 is to be understood as the sum of the areas or regions, wherein dialysate flows. The wall of the membrane of the dialyzer 10 is configured as a semipermeable membrane, such that a mass exchange between the blood and the dialysate may occur. During hemodialysis, said exchange occurs by diffusion until a concentration balance is established between the blood space 14 and the dialysate space 16. Depending on the pore size of the membranes, larger or smaller molecules are allowed to pass into the dialysate space 16.

[0066] In operation, the dialysis device 1 is connected to a patient. The blood of the patient flows into the blood space 14 of the dialyzer 10 by means of a blood feed line 140 and is accordingly recirculated to the patient by means of the recirculation line 142. In the dialysate space 16 of the dialyzer 10 the dialysate preferably flows in counterflow direction with regard to the blood flow, as indicated by the arrows in FIG. 2. During the dialysis, the above described mass exchange between the blood and the dialysate occurs, wherein the latter subsequently exits the dialyzer 10 via the conduit or line 162. The dialysate hence includes the substances that have been removed from the blood circulation during the dialysis.

[0067] The dialysate is provided by a dialysate device 18. The dialysate device 18 facilitates that the dialysate flows into the dialysate space 16 via a dialysate line 160 and exits the dialysate space 16 via the dialysate line 162 and is recirculated to the dialysate device 18. The spent or used dialysate fed to the dialysate device 18 may be either separated from fresh dialysate and accordingly be disposed of or may at least partially be reused by a corresponding purification. It may also be provided that the dialysate is already disposed of upstream of the dialysate device 18.

[0068] To feed the dialysate in the accordingly formed dialysate circuit a dialysate pump (not shown) is provided, which, for example, may be arranged upstream or downstream of the dialyzer 10 or also in the dialysis device 18.

[0069] Accordingly, a blood pump for feeding the blood in the blood circuit of the dialyzer 10 is also provided (not shown). In addition, further dialysis components, such as valves, clamps, drip chambers, pressure measuring devices, or anti-coagulation pumps, may be provided, which are, however, not shown in detail in the embodiment according to FIG. 2.

[0070] Also, two functional modules CPU1, CPU2 are arranged in the dialysis device 1, which essentially correspond to the functional modules according to FIG. 1.

[0071] The functional modules CPU1, CPU2 are connected to each other via a communication interface 3, such that the operating hours value, which is counted or determined by the operating hours counter 2 provided in the first functional module CPU1, is saved in the non-transitory storage medium M1 of the first functional module CPU1 and furthermore is transmitted to the second functional module CPU2 via a communication interface 3 and is saved in the corresponding storage M2 thereof. Accordingly, during normal operation and depending on the implementation, a synchronization of the operating hours values in all storages M1 and M2 of the respective functional module CPU1, CPU2 occurs.

[0072] Although not shown in further detail, further functional modules and/or a synchronization device may also be optionally provided, as described e.g. with respect to the embodiment of FIG. 1.

[0073] The first functional module CPU1 and the second functional module are depicted in FIG. 2 as separate functional modules, which are each communicatively connected to the dialysate device 18. Accordingly, it may be provided that the first functional module CPU1 is provided as a main control module or operating system, which assumes control of the medical device 1. Accordingly, the treatment of the patient with the medical device 1 is accordingly controlled with the first functional module CPU1. The second functional module CPU2 thereby fulfills the function of e.g. a protection system, which may monitor the main control module CPU1 and may bring the medical device 1 accordingly in a secure or safe state, in case of a downtime or defect of the main control system CPU1. The second functional module CPU2 may be configured to be redundant to the main control module. Although the functional modules CPU1, CPU2, as depicted in FIG. 2, are connected with the dialysate device 18, they may also be, alternatively, or in addition, connected to other components of the dialysis device 1 to accordingly control other functions of the dialysis treatment. For example, the functional modules may be connected to pumps and/or valves, which feed the blood or the dialysate in the respective circuit. Furthermore, the functional modules may be arranged in a separate device or may also be integrated in corresponding components, for example, as an integrated control device, wherein the operating hours value is stored in different storage media.

[0074] Where applicable, all of the respective features as depicted in the exemplary embodiments may be combined with each other and/or may be exchanged according to the scope of the invention.

LIST OF REFERENCE NUMERALS

[0075] 1 Medical device [0076] 10 Dialyzer [0077] 12 Membrane [0078] 14 Blood space [0079] 140 Blood feed line [0080] 142 Recirculation line [0081] 16 Dialysate space [0082] 160 Dialysate line [0083] 162 Dialysate line [0084] 18 Dialysate device [0085] 2 Operating hours counter [0086] 3 Communication interface [0087] 4 Synchronization device [0088] CPU1 First functional module [0089] CPU2 Second functional module [0090] CPU3 Third functional module [0091] CPU4 Fourth, optional functional module [0092] M1 First storage [0093] M2 Second storage [0094] M3 Third storage [0095] M4 Fourth, optional storage