HK1163876B - Method for managing data from analysis appliances - Google Patents

Description

Method and system for managing data of analysis device

Technical Field

The invention relates to a method for managing data of an analysis device, in particular for transferring data between a first and a second analysis device.

Furthermore, the invention relates to an analysis device and a system having an analysis device.

The invention further relates to a computer program product which can be used to carry out the method mentioned at the outset on a programmable evaluation device.

Background

A preferred field of application of such analytical devices or analyzers lies in the field of medical diagnostics, where such devices are used, for example, for the analysis of body fluids, in particular blood analysis.

Such analyzers are often used for the decentralized determination of point of interest (POC) parameters, such as blood gas (O)₂，CO₂pH), electrolyte (K)⁺，Na⁺,Ca⁺⁺,Cl^-) Metabolites (blood glucose and lactic acid), hematocrit, hemoglobinWhite parameter (tHb, SO)₂Etc.) and bilirubin. Human whole blood is mostly used as sample material here, but applications in veterinary medicine and also applications for serum, plasma, urine and dialysate samples are also possible.

Such analyzers have a corresponding measuring element and a computing unit, for example a programmable microcomputer or a dedicated circuit, connected thereto, which controls the functions of the analyzer and accordingly forms a control stage. Furthermore, the analyzer has a storage unit (e.g., a 2.5 "inch hard disk as a main data storage), which is also referred to as an internal storage medium. By means of this memory unit, all settings (configuration data) and measurement results (measurement data), user data and patient or subject data (which can also be changed by the user) are usually stored internally. Some of this data may be output to or input by other systems or from other data stores as desired. For data exchange with laboratory and hospital information systems or various server/client based data and equipment management systems, protocols such as astm e1394, 91 or POCT 1-a or HL7 exist.

The problem of exchanging data in the case of electrochemical analysis devices is also detailed in german utility model document DE20113153U 1. In order to achieve data exchange in a simple manner, a data read and write unit with a removable semiconductor memory card is disclosed as a solution in this document. The data read and write unit and the card replace, if known, interfaces for transmitting the measurement data and the device parameters to a central data processing station via a corresponding communication network.

It should also be mentioned here that a method for data protection and reconstruction of data in conjunction with a PC is disclosed in US2006/0294420a 1. Such data protection is usually done in a time-controlled manner or triggered manually. In the method, the configuration data required for reconstructing the protected data are processed in an isolated manner from the data to be protected, so that these configuration data are more easily retrieved in the case of reconstructing the data.

Furthermore, it should be noted here that US2006/0148463a1, in which a malfunction of a mobile phone is specified, wherein the malfunction of the mobile phone is mainly caused by an error or a faulty setting. In this case, the task of reconstructing the original settings is presented. This task is solved by a monitoring module that stores a large number of original settings as soon as a SIM card is inserted into the mobile phone and that reestablishes the original settings when the settings of the mobile phone do not correspond to the original settings.

None of the above protocols nor the aforementioned disclosures in the patent and utility documents address the inherent problems of data transfer in the case of known analyzers. These data transfer methods used to date have, in particular, the following disadvantages:

manual intervention (e.g. selecting data, launching a backup application) is required.

Manual backup methods usually imply data loss when needed, since data output is not performed immediately before device damage occurs.

The backup data may need to be encrypted and decrypted separately.

Solutions implemented in hardware (printer controller, disk controller, part of its own processor and interface to storage medium) are often expensive.

Disclosure of Invention

It is therefore an object of the present invention to provide an analysis device, a system and a computer program product which can be used, in particular in the event of a failure of the analysis device, for example at the control level (computing unit) or in an internal storage medium (data memory), to transfer all relevant data to a backup analysis device in order to continue the analysis operation as quickly and as trouble-free as possible.

This object is achieved by a method according to claim 1, by an analysis device according to claim 12, by a computer program product according to claim 14, and by a system according to claim 15.

In the method according to the invention for managing data of an analysis device, in particular for transferring data between a first and a second analysis device, provision is made for: the first analysis device newly deposits or modifies data in the internal storage medium and continuously redundantly stores the newly deposited or modified data in the nonvolatile removable storage medium during operation, and the data redundantly stored on the removable storage medium of the first analysis device is input into the internal storage medium of the second analysis device.

The analysis device which manages data according to the invention and is designed to carry out the method according to the invention has: an internal storage medium for storing data newly deposited or modified in the analysis apparatus; and a memory interface for accessing the non-volatile removable storage medium, such that newly deposited or modified data can be stored redundantly in the removable storage medium during operation of the analysis device by means of the memory interface. The analysis device is a medical diagnostic device, for example an analysis device for analysis of body fluids, in particular a blood analysis device.

The term "internal memory" as used herein is to be understood as a volatile or non-volatile memory which is not allowed to be removed during operation of the analysis device and which is necessary for the operation of the analysis device. The internal memory may be implemented as, for example, a semiconductor memory or a magnetic memory (hard disk) or an optical memory.

The exchangeable storage medium is a non-volatile storage medium which is not required for the basic function of the analysis device, for example for carrying out an analysis, but merely redundantly stores the data present on the internal memory of the first analysis device. The first analysis device does not use data redundantly stored on the removable storage medium for its operation. In this sense, the removable storage media is independent of the internal memory. However, as will be described in further detail below, provision may be made for safety reasons: the analysis device only starts or continues to operate when it has access to the removable storage medium.

Furthermore, in the computer program product according to the invention: the computer program product can be loaded directly into a working memory of a programmable evaluation device and has program code sections which carry out the method according to the invention when the computer program product is implemented by means of the evaluation device.

By providing the measures according to the invention, it is advantageously achieved that the redundant data are stored continuously in addition to the storage on the main internal memory during operation of the analysis device, also redundantly on a second non-volatile removable storage medium, the second storage medium not being integrated in the analysis device. Since the internal storage medium and the removable storage medium are independent of one another, i.e., are not functionally associated with one another, data errors that occur accidentally on the internal storage medium during the storage and/or modification of data cannot propagate to the removable storage medium. According to the invention, provision is made for: the analysis device continuously stores the newly deposited and/or modified data redundantly on the nonvolatile removable storage medium during its operation. It is to be understood that data is written redundantly onto the additional removable storage medium immediately after its formation (for example in an internal storage medium or even directly in the control stage). Here, data mirroring is not performed, but data is written independently of another storage medium. This also constitutes a distinction from a "Redundant Array of Independent Disks (RAID) system. That is, such RAID systems are used to organize the multiple physical hard disks of a computer into logical drives that guarantee high data security in the event of failure of individual hard disks. Thus, for example, when connecting two hard disks that form a logical drive, the same data is mirrored, i.e., redundantly stored, on all the hard disks. However, the mirror disk is not an alternative to data protection in the conventional sense, since inadvertent or faulty writing operations are also transferred instantaneously to the mirror disk. Thus, in contrast, according to the present invention, data is written on storage media independent of each other, so that the problems inherent in a RAID system are avoided.

In a preferred embodiment the non-volatile second (external) storage medium, i.e. the removable storage medium, is a compact flash card (CompactFlash-Karte). In principle, however, all possible external non-volatile storage media, such as, for example, other memory cards, USB sticks or external hard disks, can be used according to the invention. These storage media can be inserted directly into corresponding slots of the analysis device or can be connected to the analysis device by means of corresponding connection terminals/interfaces. The following embodiments can also be implemented: wherein the non-volatile second (external) storage medium is connected to the analysis device via a network, for example when the external non-volatile storage medium is configured as a network memory or network hard disk. If the first and second analysis devices are connected to the external non-volatile removable storage medium via a network, in this case no physical transfer (replacement) of the external removable storage medium between the analysis devices is required. More precisely, the data transfer can take place here in the following manner: corresponding access authorizations are made to the equivalent second analysis device for accessing the corresponding data of the first analysis device. Therefore, the name "removable storage medium" has also been chosen to indicate: unlike the internal storage medium, a non-integrated (second) storage medium can be used alternately for the two analysis devices.

In a preferred embodiment of the invention, analysis devices are used for carrying out the method according to the invention, which analysis devices have a socket (e.g. a compact flash card socket) or interface for connecting an external non-volatile storage medium and also have corresponding control elements (memory element, write element, read element, data processing element …).

Thus, with the aid of the invention it is advantageously achieved that: data can be transferred to the second analysis device quickly and without problems in the event of a fault or damage situation at the first analysis device. For the data transfer required from the first analysis device to the second analysis device, for example, only the flash memory card has to be removed from the first analysis device and inserted into the second analysis device. The data stored on the flash memory card are copied into the internal memory of the second analysis device. The second analysis device thus takes over all the stored data of the first analysis device that were accepted immediately before the fault situation. Therefore, the flash memory card inserted into the second analysis device fulfills the function of the redundant removable storage media. Thus, for example, an analysis performed with a first analysis device can be performed with a second analysis device substantially without long interruptions and substantially without transitions, while at the same time maintaining data consistency.

Further particularly advantageous embodiments and refinements of the invention emerge from the dependent claims and the following description.

The field of application of the method is in particular the field of medical diagnostic and analytical devices, as is the case, for example, in analytical devices for analyzing body fluids, in particular in blood analytical devices. In a preferred embodiment, in the system according to the invention, the first analytical device and the second analytical device equivalent thereto are formed by identically constructed analyzers.

In order to ensure that all the data required for the operation of the equivalent analysis device are present, it has proven advantageous: depending on the case and application, the data represents at least one of the following listed data types, namely:

i) the configuration data is stored in a memory of the computer,

ii) measuring the data of the measurement data,

iii) the data of the subject,

iv) sample data, and

v) user data.

In particular, configuration data are to be understood as device settings, such as language, IP address, display screen, country setting, energy management, network setting, calculated and displayed measurement units, used measurement parameters, measurement, calibration and quality control limits, quality measurement materials, safety settings, audio settings, planned automatic execution of analyzer functions, peripheral devices, etc.

The measurement data includes measurement results, raw data, image data, measurement signals, data to be processed continuously, and the like.

The subject data comprises, inter alia, a patient identification label.

The sample data comprises, inter alia, a sample identification number, a sample acquisition time, a sample type and/or an acquisition temperature.

The user data comprises inter alia a user identification number, user specific authorizations, a user profile (Benutzerprofil) and so on.

Since in a preferred embodiment also substantially all data types can be written together redundantly, regular synchronization cycles between the storage media are not required. For purely device-specific (and therefore will be readily used for equivalent analytical devices) calibration and quality control data, the following possibilities exist:

a) pure device-specific calibration and quality control data are not written onto removable storage media (e.g., compact flash cards).

b) Pure device-specific calibration and quality control data are also written on the removable storage medium (and only a decision is made as to the use of said calibration and quality control data when the equivalent analytical device is put into operation).

Data security or data authenticity, which is often required in medical or other types of data acquisition, can advantageously be obtained by at least encrypting the data stored in the removable storage medium. In addition, the data may be protected from abuse by passwords and/or usernames. Thus, redundant data is optionally protected from unauthorized access.

In one embodiment of the method according to the invention, the first evaluation device, when connected to the new removable storage medium, outputs the data stored in the internal storage medium to the new removable storage medium only if the new removable storage medium does not already contain the useful data of the external evaluation device. Thereby preventing inadvertent overwriting of valid data on the removable storage medium.

In order to obtain a link (also referred to as a meta-ancestor) between the analysis device and the removable storage medium, a unique identification number (for example a serial number) assigned to the removable storage medium, for example at the time of manufacture or supply, can be stored in the configuration data of the analysis device before the analysis device is put into operation for the first time (in a device-specific normal operating form, for example a measurement and/or analysis operation). Alternatively, a unique identification number (e.g. serial number) assigned to the analysis device, for example at the time of manufacture or supply, can be stored on the removable storage medium before the analysis device is put into operation for the first time, in order to establish the assignment of the data stored on the removable storage medium to its source, i.e. the analysis device from which the data originates.

Alternatively, for security reasons, it may be required that the uniquely identified external (removable) storage medium is present as a security measure in the analysis device at the time of system start-up and its check in order for the analysis device to be operational. If the external storage medium is removed from the analysis device in continuous operation, this can be recognized by an error at the next write attempt. The analysis device can then enter a system-stop state and can only be operated again if the correct (exchangeable) storage medium is present in the analysis device. It is therefore advantageous, in particular, to check the availability of the removable storage medium when the analysis device is first put into operation and, if the removable storage medium is not available, to permit this operation or to a limited extent, but in particular to prevent the redundant storage of relevant data on the removable storage medium.

In order to ensure that the analysis device cannot be put into operation with every arbitrary removable storage medium for the purpose of redundant data storage, it has proven to be a reliable measure that the removable storage medium contains the hardware tokens required for the operation of the analysis device.

If it is determined that the removable storage medium is available, checking: whether the data present on the removable storage medium originate from another analysis device and, if so, the data contained in the removable storage medium are entered into the internal storage medium of the analysis device.

The decision whether to enter data redundantly stored in the removable storage medium into the analysis device can be made for safety reasons also as a function of user interaction. For the case that it is determined that the removable storage medium is empty, the user interaction may be replaced by an automatic decision, i.e. outputting data from the analysis device to the removable storage medium. With regard to this input process, it is advantageous for the traceability of the data input to record the process, which can preferably be done by means of a so-called Audit Trail (audio-Trail).

According to a preferred embodiment, the execution of the method according to the invention is carried out by means of a programmable analysis device according to the invention. The analysis device usually has a program memory, a working memory, and a microprocessor, wherein the microprocessor forms the control stage of the analysis device and is coupled to an internal memory and a memory interface. A computer program is stored by means of a program memory, which computer program implements the method according to the invention when it is implemented by means of a microprocessor. The execution of the method can also be carried out by means of an analysis device, in which dedicated (e.g. fixed-wiring) circuits are used for the application whose logic is represented by the method according to the invention.

In addition, a system is specified with two analysis devices according to the invention, wherein in one of the two analysis devices, during operation of the one analysis device, the newly stored and/or modified data and the data redundantly stored in the exchangeable storage medium are used continuously for the operation of the other partial device when the other analysis device accesses the exchangeable storage medium.

Drawings

The invention will be explained in detail again below on the basis of an embodiment with reference to the drawings, to which, however, the invention is not restricted. In the figures, identical components are provided with the same reference symbols.

Figure 1 shows highly schematically and in block diagram form an analysis device according to an embodiment of the invention,

figure 2 shows the method according to the invention in flow chart form,

figure 3 shows highly schematically an analysis device in a first perspective view,

fig. 4 shows the analysis device according to fig. 3 in a second perspective view, an

Fig. 5 shows a detail of the analysis device according to fig. 3.

Detailed Description

Fig. 3 and 4 show a possible configuration and externally visible components of a medical blood analyzer implemented as the analysis device 1. In fig. 3, the analysis device 1 is shown substantially from the front. On the top side of the analysis device 1 there is a printer 2, which printer 2 forms part of the user interface. Also part of this user interface is a screen 3, preferably a touch screen, which is arranged substantially on the front side of the analysis device 1. On the front side there is also a device door 4, which is shown in an open state. The opened device door 4 reveals a measurement module 5 with a sensor cartridge, a sample input module 6, an autococ module 7 and a fluid bag 8. On the right side of the analysis device 1 there is a USB interface 9. Fig. 4 shows the analysis device 1 essentially from the rear. On the rear side, a network terminal 10 is present, to which network devices 11 are connected, and to which network terminals 10 network devices 11 are connected. By means of the network switch 12, the analysis device arrangement can be switched on and off. Between the network switch 12 and the network connection terminal 10, there are two safety devices and two status LEDs, which are indicated together by the reference numeral 13. Furthermore, an interface region 14 is shown, which interface region 14 is detailed in FIG. 5.

The interface area shown in fig. 5 has two USB connection terminals 15, an interface 16 for a barcode scanner, an RS232 service plug 17, an RJ45 network connection terminal 18, a potential balancing plug 19 and a memory interface 20 for a flash memory card. The function of the memory interface 20 will be described in more detail below with respect to fig. 1 and 2.

Fig. 1 shows a block diagram of an analysis device 1 and an equivalent analysis device 100, which analysis device 1 and analysis device 100 have the structural elements required for the study of the specific invention. In this case, the equivalent analyzing apparatus 100 is implemented to be the same in construction as the analyzing apparatus 1, but this is not necessarily required. The analysis device 1 has an internal storage medium 21 and a control stage 22 in addition to the memory interface 20. The coupling of the memory interface 20 and the internal storage medium 21 to the control stage 22, which is sufficiently known to the person skilled in the art, is not described in further detail here. In contrast to the equivalent analysis device 100, a flash memory card 23 is inserted into the analysis device 1, so that data D newly stored and/or modified in the internal storage medium 21 can also be recorded together redundantly in the flash memory card 23. With the aid of the analysis device 1 or 100, the method according to the invention can now be carried out, as will be discussed later with the aid of fig. 2.

The start of the method shown in fig. 2 is represented by block 24. In a block 25 following this, the configuration of the analysis device 1 is read. Then branch to block 26, check in block 26: whether or not the flash memory card 23 is available in the memory interface 20. If this is not the case, the operation of the analysis device 1 is stopped with an error report in block 27. Alternatively, a limited operation of the analysis device 1 may be allowed until the last flash memory card 23 is inserted.

In the case of the analysis device 1, the result of this check is positive, and the method continues in block 28, in block 28 checking: whether the flash memory card 23 is empty or not. If the flash memory card 23 is empty, further processing of the boot-up procedure continues in block 29. If the flash memory card 23 is not empty, the configuration of the flash memory card 23 is read in block 30 and then in block 31 it is checked: whether the serial number of the inserted flash memory card 23 contained in the configuration of the flash memory card 23 remains the same as when the analysis device 1 was last started. Alternatively, it is possible here to check: whether the serial number or other identification number of the analysis device 1 corresponds to the serial number or identification number of the analysis device stored on the flash memory card 23.

If the serial number of the inserted flash memory card 23 is identical to the serial number of the flash memory card 23 stored in the internal memory of the analysis device (or alternatively the serial number of the analysis device 1 stored on the flash memory card 23 is identical to the serial number of the currently used analysis device), this means that the flash memory card 23 continues to be located in the analysis device 1 used so far, so that the start-up procedure continues in block 29. If the serial number of the inserted flash memory card 23 (or alternatively the serial number of the analysis device 1 stored on the flash memory card 23) and thus the hitherto allocation of the flash memory card 23 and the analysis device 1 has changed, branching to a block 32 representing a user interaction in which the user can agree to enter the data stored on the flash memory card 23 into the internal storage medium of the analysis device 1 or refuse to do so. If the user refuses to do so, the operation of the analysis device 1 stops with an error report at block 27. If the user agrees to enter data, in block 33 data is entered into the internal storage medium of the analysis device 1, the current allocation of the exchangeable storage medium and analysis device being carried out by storing the identification number of the exchangeable storage medium or analysis device accordingly, and the start-up procedure is continued in block 29. The user interaction 32 is an additional security feature that may optionally be omitted.

The transition from the basic initialization of the analysis device 1, which actually starts the program, to the start of the data recording is marked by block 29, wherein the presence of the flash memory card 23 in the analysis device 1 is queried again in block 34, and in the case of the absence of the flash memory card 23, the operation of the analysis device 1 is stopped with an error report in block 27.

In case a flash memory card 23 is present, it is checked again in block 35: whether the flash memory card 23 is empty or not. If the flash memory card 23 is empty, the newly deposited and/or modified data D stored in the internal storage medium of the analysis device 1 are output to the flash memory card 23 in block 39 and then a further start-up of the analysis device is continued in block 38, but this start-up is no longer important for the purposes of the present invention.

If the flash memory card 23 is not empty, a check is made in block 36: whether the software version of the flash memory card 23 corresponds to the software version of the analysis device 1, i.e. whether the data present on the flash memory card 23 are present in the same structure as the data present in the analysis device 1. If not, branching is made to a block 39, the data stored in the internal storage medium of the analysis device 1 in the block 39 being output to the memory card 23; further activation of the analysis device then continues in block 38.

If the software version of the flash memory card 23 corresponds to the software version of the analysis device 1, in a block 37 it is checked: whether the database of the flash memory card 23 corresponds to the database of the internal storage medium 21 of the analysis device 1, that is to say whether the data present on the memory card 23 corresponds to the data present in the analysis device 1. If these databases do not coincide, branching is made to block 39, the data stored in the internal storage medium of the analysis device 1 in block 39 being output to the flash memory card 23; further activation of the analysis device then continues in block 38. If the databases are consistent, a branch is immediately made to block 38.

After the end of the start-up, the evaluation device 1 is switched into the following operating mode: in this operating mode, newly stored and/or modified data D are continuously stored redundantly on the flash memory card 23. In the event of a fault, all data D to be transferred (for example, configuration data, user data, patient data and measurement results) are therefore written into the additional exchangeable storage medium 23 during the continuous operation of the evaluation device 1 immediately after production. This corresponds to a normal operation (measurement or analysis operation) of the analytical device 1 in order.

If now a flash memory card 23 is inserted into the memory interface 20 of the equivalent analysis device 100, which flash memory card 23 was previously used on the analysis device 1 and was inserted into a new analysis device 100, for example because of a problem in the previously used analysis device 1, the process is schematically illustrated in fig. 1 by means of a dashed line 39 and symbolizes the removal of the flash memory card 23 from the analysis device 1 and the insertion of the flash memory card 23 into the analysis device 100. The previously described start-up procedure is then performed in the analysis device 100. The input of the data D present on the memory card 23 into the internal memory 21 of the analysis device 100 is indicated by a dashed line denoted by reference sign DIMP. Thereafter, normal operation of the equivalent analyzing apparatus 100 is performed.

The starting point in the further description of the method is that the analysis device 1 has already been put into operation for the first time in the past. This state is for example represented by corresponding data D in the internal storage medium 21.

It is optionally to be noted here that the user or the analysis device 1 or 100 or the flash memory card 23 itself can prevent overwriting of the data D on the internal storage medium 21 as well as on the flash memory card 23, but this is not shown in detail in fig. 2.

The aforementioned analysis device 1 or 100 and the method which can be performed with the analysis device now allow different damage situations to be addressed. In the event of a damage situation I (damage to the analysis device 1) and/or a damage situation II (damage to the PC) and/or a damage situation III (damage to the main data carrier 1, i.e. the internal storage medium), the external exchangeable storage medium 23 is transferred, installed in a standby analyzer (e.g. the equivalent analysis device 100) and used there.

As described above, the backup device (second analyzer, for example equivalent analysis device 100) is here either a) a device which has never been put into operation before (and therefore does not contain such relevant data D), or b) a device which has been put into operation before (and therefore already has relevant data D on the basis of the previous operation of the device). In both cases, the method according to the invention provides method steps adapted to the respective case.

In a damage situation IV (damage to the external data carrier, i.e. the removable storage medium 23), the external data carrier can be updated (replaced), wherein the relevant data D is stored all the way to the internal storage medium 21.

In the case of the analytical device 1 being put into operation, it is possible, for example, to operate as follows:

a) the presence of the flash memory card 23 (e.g. configured as a compact flash card) is checked the first time the analyzer software is switched on. If the CF card 23 is not present, the analysis device 1 cannot be started or run. But if flash memory card 23 is present, its serial number is read. If the serial number does not correspond to the serial number stored in the configuration, the data D stored in the flash memory card 23 is entered into a database in the internal storage medium 21. All changes are recorded in the audit trail.

b) The presence of compact flash card 23 is checked the first time the analyzer software is turned on. If no CF card 23 is present, a reminder is displayed: the backup mode is not active and data D is not stored redundantly. The backup mode can then be reactivated, for example manually or automatically, as soon as an empty CF card 23 is detected in the analysis device 1.

When the external replaceable storage medium 23 is replaced, for example, the following operations may be performed:

a) if a flash memory card 23 with a serial number which does not correspond to the serial number stored in the configuration is detected on the already operating evaluation device, the relevant data D, in particular configuration data, user data and measurement data, are automatically output from the database of the internal storage medium 21 to the new card 23. All data D to be protected is written onto the newly functioning flash memory card 23.

b) If a flash card 23 with a serial number that does not correspond to the serial number stored in the configuration is detected on the already operating analysis device 1 or 100 and the CF card 23 is not empty, the user can choose whether data D should be input or output.

Thus, by means of the invention, a method for managing and transferring the relevant data D of the analysis device 1 or 100 can also be described, wherein the analysis device 1 or 100 respectively has an internal memory 21 and wherein the relevant data D relates to the specific configuration of the first analysis device 1 and the parameter values measured hitherto with this first analysis device 1 and the relevant background information,

the method comprises the following steps:

● providing an additional external non-volatile storage medium 23 in the first analysis device 1;

● continuously redundantly store all newly deposited and/or modified relevant data D on the external non-volatile storage medium 23 and the internal memory 21 of the first analysis device 1 during operation of the first analysis device 1;

● in the event of a transfer of the redundantly stored data D onto the second analysis device 100, the external non-volatile storage medium 23 is removed from the first analysis device 1 and the external non-volatile storage medium 23 is inserted into the second analysis device 100;

● reads the relevant data D stored on the external non-volatile storage medium 23, which are stored during operation of the first analysis device 1, into the internal memory 21 of the second analysis device 100;

● continue the operation (analysis or measurement) with the second analysis device 100 using the read-in correlation data D.

The resulting advantages of this solution are listed below:

by storing all data D continuously redundantly, no additional logic or time control of the auto-sync cycle is required, unlike known backup methods.

The data store (Databestand) can be reconstructed at each instant, if necessary immediately before the fault event (without quantization losses due to manual or automatic synchronization cycles).

By checking for the presence of the uniquely identified internal storage medium 23 and using it as a token, the analysis device 1 or 100, which may store the data D interstitially or even non-redundantly, is prevented from being put into operation.

By requiring the presence of a specific unique storage medium 23 in the case of commissioning and implemented adjustments, in which conditions there are input scenarios and output scenarios, the necessity of human interaction is avoided.

The same configuration can be simply transferred to many analysis devices 1 or 100.

In the event of a fault, the above-mentioned record of data D can be used as documentation and/or error reports.

The user can immediately continue the measurement on the second analysis device 100 with his specialized and familiar user interface without having to perform a manual reset on the backup device 100.

Although the invention is discussed in the context of a blood analyzer according to the description of the figures, the invention can also be used in other scientific and/or industrial applications. For the sake of completeness, it is also noted that the use of the indefinite article "a" or "an" does not exclude that a feature concerned may also be present in multiples. Likewise, the terms "stage", "unit", "module" or "device" etc. do not exclude that these may be constituted by a plurality of components, which may also be spatially distributed, if desired.

Claims (28)

1. A method for transferring data between first and second analysis devices,

wherein the first analysis device newly stores or modifies data in an internal storage medium and continuously stores the newly stored or modified data redundantly during operation in a non-volatile removable storage medium which is inserted directly into an insertion module of the first analysis device or is connected to the first analysis device,

data redundantly stored on a removable storage medium of a first analytical device is input into an internal storage medium of an equivalent second analytical device by physical transfer of an external removable storage medium between analytical devices, wherein the data redundantly stored in the removable storage medium is configuration data of the first analytical device, and

the availability of the removable storage medium is checked when the analysis device is put into operation, and if the removable storage medium is not available, the operation cannot be performed or can be performed only to a limited extent.

2. Method according to claim 1, characterized in that the availability of the removable storage medium is checked when the analysis device is put into operation, and if the removable storage medium is not available, the operation can be performed without redundantly storing data on the removable storage medium.

3. The method of claim 1, wherein the configuration data represents device settings.

4. The method according to claim 3, characterized in that the device settings are language, IP address, display screen, country settings, energy management, network settings, calculated and displayed metrics, used measurement parameters, measurements, calibration and quality control limits, quality measurement material, safety settings, audio settings, planned automatic execution of analyzer functions, and/or peripheral devices.

5. The method according to one of claims 1 to 4, wherein the analytical device is a medical diagnostic analytical device.

6. The method according to one of claims 1 to 4, wherein the analysis device is an analysis device for analyzing a body fluid.

7. The method according to one of claims 1 to 4, wherein the analysis device is a blood analysis device.

8. Method according to one of claims 1 to 4, wherein the data redundantly stored in the removable storage medium furthermore represent at least one of the following listed data types:

i) the data is measured and the data is transmitted,

ii) the data of the subject,

iii) a sample data of the sample data,

iv) user data.

9. The method of claim 8, wherein the measurement data is measurement results, raw data, image data, measurement signals, and/or data that continues to be processed, the sample data is a sample identification label, a sample acquisition time, a sample type, and/or an acquisition temperature, and the user data is a user identification label, a user-specific authorization, and/or a user profile.

10. The method according to one of claims 1 to 4, wherein at least the data redundantly stored in the removable storage medium is encrypted.

11. Method according to one of claims 1 to 4, wherein at least the data stored redundantly in the removable storage medium are protected against misuse by means of passwords and/or usernames.

12. Method according to one of claims 1 to 4, characterized in that the first evaluation device, when connected to a new removable storage medium, outputs the data stored in the internal storage medium to the new removable storage medium if the new removable storage medium does not already contain valid data of a foreign evaluation device.

13. Method according to one of the preceding claims 1 to 4, wherein the unique identification number of the replaceable storage medium assigned to the respective analysis device is stored in the internal storage medium of the respective analysis device before the analysis device is put into operation for the first time or the unique identification number of the analysis device is stored in the replaceable storage medium assigned to the respective analysis device.

14. The method of claim 1, wherein the removable storage media comprises hardware tokens required for operation of the analysis device.

15. The method according to claim 1 or 14, wherein, if a replaceable storage medium is available, it is checked that: whether the data storage present on the removable storage medium originates from another analysis device and, if so, the redundantly stored data contained in the removable storage medium are input into the internal storage medium of the analysis device.

16. The method of claim 15, wherein the decision whether to enter the data redundantly stored in the removable storage media into the analysis device is dependent on user interaction.

17. The method of claim 15, wherein the input of data redundantly stored on the removable storage media is recorded.

18. The method of claim 15 wherein the input of data redundantly stored on the removable storage media is recorded in an audit trail.

19. Analysis device (1, 100) for managing data (D) for carrying out the method according to one of claims 1 to 18, having: an internal storage medium (21) for storing data (D) newly deposited or modified in the analysis device (1, 100), and

a memory interface (20) for accessing a non-volatile exchangeable storage medium (23) makes it possible to continuously store newly stored or modified data (D) in the exchangeable storage medium (23) by means of the memory interface (20) during operation of the analysis device (1, 100) in a redundant manner and to check the availability of the exchangeable storage medium when the analysis device is put into operation, said operation being not possible or only being possible to a limited extent if the exchangeable storage medium is not available.

20. Analytical device (1, 100) according to claim 19, characterised in that the availability of the exchangeable storage medium is checked when the analytical device is put into operation, and if the exchangeable storage medium is not available, the operation can be performed without redundantly storing data on the exchangeable storage medium.

21. The analysis device (1, 100) according to claim 19, wherein the analysis device (1, 100) is a medical diagnostic analysis device.

22. The analysis device (1, 100) according to claim 19, wherein the analysis device (1, 100) is an analysis device for analyzing a body fluid.

23. The analysis device (1, 100) according to claim 19, wherein the analysis device (1, 100) is a blood analysis device.

24. An apparatus for transferring data between first and second analysis devices, comprising:

means for newly storing or modifying data in an internal storage medium by a first analysis device and continuously storing the newly stored or modified data redundantly in a nonvolatile removable storage medium, which is inserted directly into a plug-in module of the first analysis device or is connected to the first analysis device, during operation and which is connected to the first analysis device

Means for inputting data redundantly stored on a removable storage medium of a first analysis device into an internal storage medium of an equivalent second analysis device by physical transfer of an external removable storage medium between analysis devices, wherein the data redundantly stored in the removable storage medium are configuration data of the first analysis device, and

means for checking the availability of the removable storage medium when the analysis device is put into operation and for disabling or only enabling a limited amount of the operation when the removable storage medium is not available.

25. Device according to claim 24, characterized in that the means for checking the availability of the replaceable storage medium when the analysis device is put into operation and making said operation impossible or only limitedly possible when the replaceable storage medium is not available comprise means for making said operation possible without redundantly storing data on the replaceable storage medium when the replaceable storage medium is not available.

26. The device of claim 24, wherein the configuration data represents device settings.

27. The device of claim 26, wherein the device settings are language, IP address, display screen, country setting, energy management, network setting, calculated and displayed metrics, used measurement parameters, measurement, calibration and quality control limits, quality measurement material, security settings, audio settings, planned automatic execution of analyzer functions, and/or peripherals.

28. A system having two analysis apparatuses according to one of claims 19 to 23, wherein data (D) which are continuously newly stored and/or modified in one of the two analysis apparatuses during operation of the one analysis apparatus (1, 100) and which are redundantly stored in the exchangeable storage medium (23) are used for the operation of the other analysis apparatus (100, 1) when the other analysis apparatus (100, 1) accesses the exchangeable storage medium (23).