DE102017118847A1 - Documentation system for medical devices and devices of rescue technology - Google Patents

Abstract

The invention proposes a documentation system for a product, with a provided on the product, wirelessly readable information chip, the chip contains a link to a cloud storage (1), wherein the cloud memory (1) designed as a file folder and the product associated memory space (2), and with a wireless reader, the Internet link capable of following the link for establishing a connection to the memory space (2) is configured, and a display for displaying information stored in the memory space (2) , wherein the memory space (2) comprises two areas, namely a first, open, freely accessible area (4), which contains in the form of files at least one instruction manual of the product, and a second, protected and accessible only after entry of access data area (5), which in the form of files contains further information about the product.

Description

The invention relates to a documentation system for medical devices and devices of rescue technology, and a method for maintaining the documentation of a medical device or a device of the rescue technology.

For the purposes of this proposal, a medical product is a product manufactured or placed on the market by a so-called manufacturer and used by a so-called operator to maintain or restore human health. Examples of medical products from the field of rescue are so-called spineboards or so-called basket carriers, which serve to recover injured or injured persons. Furthermore, the present proposal can also find application for a rescue equipment. For example, not as medical devices, but as rescue equipment emergency cases or rescue backpacks for paramedics are referred to, the items contained in these containers are again regularly medical devices. According to the proposal, the term rescue technology also includes the objects of the fire-fighting technology including the fire-extinguishing technology. In summary, the individual medical devices or devices of rescue technology are referred to below as "product".

In all cases, it is up to the operators to monitor the functionality and usability of the products. In the territory of the Federal Republic of Germany, for example, the so-called Operator Regulation applies to medical devices. The medical device must be checked at regular intervals and the result of the test recorded in a test report. For safety reasons, it may also be stipulated that the medical device should not be used after reaching a predetermined service life, so that the operator should obtain replacement in good time, for example. For the correct handling of a medical device the manufacturer has to provide a user manual. As a result, not inconsiderable documentation effort has to be carried out for each medical device. In particular, if a larger number of medical devices have to be managed in larger organizations such as fire brigades, hospitals, companies or the like and the corresponding documentation must be allocated to each individual medical device, this documentation requirement represents a considerable expense for the organization concerned. Similar requirements as for The medical devices can also be made for rescue equipment, ie for all the above-mentioned objects, which are referred to as product in the present proposal.

The invention has for its object to provide a documentation system with which the documentation of medical devices or devices of the rescue technology is simplified. Furthermore, the invention has for its object to provide a method for maintaining the documentation of a medical device or a device of the rescue technology.

This object is achieved by a documentation system according to claim 1 and by a method according to claim 7. Furthermore, the invention proposes to use a technical documentation system for managing the documentation of a product according to claim 13. Advantageous embodiments of the invention are described in the subclaims.

In other words, the invention proposes that a wirelessly readable information store be provided on the product. The chip may for example be arranged in a label which can be glued to the product or sewn to the product. The label makes it possible to subsequently design conventional products according to the proposal and to provide them with the information store. Or the chip can already be arranged on or in the product during production, for example on a surface of the product, or in a cavity of the product, or possibly even in the material of the product itself, for example by inserting a chip into an injection mold and is then encapsulated so that it is surrounded on all sides by the material of the injection-molded component.

The chip may advantageously not only have the electronic memory module and an antenna for wireless communication, but also a housing. Such packages provided with the chip and the antenna are also referred to as "smart tags" and are commercially advantageous in many different configurations commercially available and allow easy handling, since the electronic memory module and the antenna are protected within the housing. Commercially available housings are designed very varied in terms of their dimensions and shape, for example, similar to a rice grain, a coin or a check card. With regard to their strength or flexibility, they can be made comparatively stiff as an injection-molded body, or designed as a laminate, depending on the materials used and layer thicknesses, similar stiff as a check card or highly flexible, for example as a flexible label which adhered to a tube of a product can be.

With regard to the wireless communication standard used, various radio standards come into question. For example, the chips can be configured as a transponder or RFID chip ("Radio Frequency Identification") or as an NFC chip ("Near Field Communication"). The intentionally low range of the wireless NFC transmission is advantageous in that it ensures the correct assignment of the data received in the reader when reading an NFC chip, even if there are other products in the vicinity, namely because their NFC chips outside the read range of the reader. A typical application, for example, the multiple medical devices that may be located within the same rescue case or rescue backpack. Therefore, the present proposal is always explained below with reference to the use of an NFC chip, but only as an example that other wirelessly readable information storage or communication standards can apply.

When the contents of the label are read by an NFC reader, certain information about the product is not transferred from the label to the reader. Rather, the NFC chip contains a link to a cloud storage. When using a web-enabled reader, therefore, a connection is established to this cloud storage, in particular to a storage space within the cloud storage, which is assigned to exactly this product. The present proposal is based on the consideration that each product is assigned its own such storage space. For example, the cloud storage may be provided by the manufacturer of the products and may have a number of storage locations equal to the number of products placed on the market by the manufacturer.

The storage space associated with the product in the cloud storage contains two areas. An open area is immediately visible if the NFC chip is read out by means of the NFC-capable reader. This so-called open area may contain information that everyone should see about this product. In particular, it is proposed by law to deposit an operating manual for the product in this open area. Furthermore, for example, for this product in the open area of the memory space a reference to related products can be deposited. For example, an indication of straps that can be used with the respective basket support or the respective spineboard. The fact that this information is stored in the cloud storage, gives the manufacturer the advantageous opportunity to be able to adjust the operating instructions over the useful life of the product, for example, if this is due to certain knowledge gained in the meantime or due to an amended regulation or Legislation should be advised. The development of new accessory products, which can improve or expand the application options or the handling of the product advantageous, can currently be maintained in this way always in the cloud storage to all related products of the manufacturer, so that thereby each for the operator optimal Handling and use of the products is supported and facilitated.

In the protected area of the memory space further information about the product can be deposited, which should not be accessible to anyone without further ado, but rather this second, protected area is password-protected, so that it is accessible only after entry of corresponding access data. Further information about the product can be stored in this area, such as test reports for the tests already carried out so that they can be retrieved easily at any time. Furthermore, information about the location or the allocation of the product can be stored in this protected area, for example, in which vehicle or in which building or in which room the product in question is stored, or which department or group within a larger one Organization of this product is assigned. Furthermore, advantageously, a test instruction can be stored in the memory space, either in the open area or in the protected area of the memory location, wherein in this test instruction the measures are listed, which are prescribed for the verification of the product. Also in this case results for the manufacturer of the product the advantageous possibility to update such test instructions for the products manufactured by him and, for example, to adapt immediately to changing regulations. Thus, the operator is ensured that he can always use up-to-date test instructions that take the latest findings into account when carrying out a test.

In this case, it may be particularly advantageous to provide the operator with the corresponding test protocols in an up-to-date form as editable documents, so that the test is run through the execution of such a test protocol and thus it can be ensured that all of them are checked Aspects taken into account and all the measures described above are carried out and recorded accordingly.

Furthermore, it can be advantageously provided that in the protected area of the storage space, a registration date or the maximum allowable latest date of use of the product is stored. If the operator initially logs into the protected area of the storage space and this product is registered for this operator, from the moment of this registration on the time for the maximum allowable life of the product can be calculated and, for example, in the open or even in the protected area of the storage space. Furthermore, from the date of this registration, messages can automatically be sent to the operator reminding him in due time, for example, of carrying out the corresponding checks of the product, or reminding him sufficiently in advance of the maximum permissible service life so that the operator can discard the product in good time and if necessary can procure an adequate replacement. Therefore, it is advantageous in the registration provided that the operator specifies a contact address, such as an email address, mobile phone number, street address o. The like., So that the appropriate communication can be delivered electronically or by mail.

In particular, it can advantageously be provided that the protected area of the storage space is accessible to a plurality of individual users of the operator, so that, for example, several responsible persons can have access to the information stored in this protected area of the storage space.

The organization of the cloud storage can advantageously be hierarchical, similar to what is known from the folder structure of a PC. For example, the cloud storage can be considered the largest parent folder in which the manufacturer of the products provides storage for all of the products he manufactures and places on the market. These memory locations are each comparable to a separate file folder, within this memory space again two subordinate file folders are provided which represent on the one hand the open and on the other hand the password-protected area of the memory space according to the access rights for these folders. Furthermore, it can be provided that a plurality of file folders designated as memory locations are combined in a higher-level file folder within the entire cloud memory so that, for example, for a particular operator, all memory locations in such a folder can be provided within the cloud memory. In this way, it is possible to assign access rights not only individually for the individual products, but also to assign higher-level permissions, so that, for example, such an "operator folder" password protected can be accessible and then, for example, a reviewer of the operator's overview over all products operated by this operator. It can be advantageously provided that after entering the password for the operator folder not only all products or associated memory locations of this operator are displayed, but that at the same time the access authorization to the respective protected areas of the corresponding memory locations are enabled, so that accordingly authorized personnel with little effort to access the documentation of all products of this operator.

The handling of the proposed documentation system is comparatively easy both for the manufacturer and for the operator: the manufacturer provides a storage space for the product manufactured and marketed by the manufacturer in the aforementioned cloud storage, the storage space being mentioned in the two divided into open and protected areas. In the open area of the storage space, the manufacturer deposits a user manual for the product. In addition, the manufacturer may deposit a test instruction or a test protocol which can be edited by the operator and not yet completed in the open area or even in the protected area of the memory location. Other additional information can be deposited by the manufacturer either in the open or in the protected area of the memory space, such. B. Declarations of conformity o. The like ..

Furthermore, it is provided that an NFC chip is attached to the product, which contains a link to the mentioned memory location, for example to the open area of the memory location.

In a first embodiment, it may be provided that the NFC chip contains only the mentioned link, so that the corresponding labels can be processed by the manufacturer in a particularly simple manner by each of the labels can be used on any product of this manufacturer and For example, when configured as a self-adhesive label, can be glued to any product of this manufacturer.

In another embodiment, it may be provided that the NFC chips are each provided for a specific type of products, for example exclusively for a basket carrier, for a spine board, for an emergency case or the like. In this case, it may be provided by the manufacturer First, a particular product is made, then an NFC chip is attached to the product, which is intended for this type of product and contains the appropriate information as to which product it is. Subsequently, this NFC chip can be read by a reader with the manufacturer, so that fully automatically for this individual, manufactured and labeled product a corresponding storage space in the cloud storage is created and then the desired information is also written automatically by the manufacturer in the memory. For example, the instruction manual in the open area of the memory space, as well as the test instructions, a declaration of conformity and, if necessary, an editable by the operator test report.

When such a labeled product reaches the operator, an NFC reader can be approximated to the NFC chip of the product. By using NFC technology, near field communication, interference or interference with other equipment is ruled out due to the short range of this wireless transmission technology. When the reader has been brought sufficiently close to the NFC chip of the product, typically at a distance of a few millimeters, an NFC connection is automatically established between the NFC chip and the NFC reader. The NFC chip is automatically read by the reader and then also automatically establishes a data connection to the storage space in the cloud storage, for example directly to the open area of this storage space.

Subsequently, information about the product is automatically made available to the operator by the operator being able to see, for example, the operating instructions in the open area of the memory location, or this information is made available to the operator by being able to download this information.

Alternatively, it can be provided that the operator enters his access data and thus obtains access to the protected area of the memory space so that he is allowed access to the files available there.

For security reasons, it may be provided that the files stored in the open area are only provided with a read authorization for the operator, so that the operator can access this information, but the information can not be deleted or changed. In the context of the present proposal, for example, the corresponding read authorization may also include the authorization to make copies of the corresponding files, for example by means of a download.

In the protected area, however, can advantageously be deposited files that are each provided with a read permission, or possibly also with a write permission for the operator, so that there, for example, the mentioned editable forms, eg. As test reports, can be deposited. The fact that such rewritable files are stored exclusively in the protected area of the storage space, it is ensured that revisions of the corresponding files can be made only by authorized persons.

As already mentioned, for example, test records can be stored in the protected area, which document the inspection of the product.

A corresponding test instruction, which explains the measures prescribed for a product inspection, can also be deposited in the protected area. Particularly advantageous, however, such a test instruction can be stored in the open area of the memory, so that the protected area is actually accessible only to the operator and the manufacturer, for example, automatically set changed versions of the test instruction in the open area of the memory space and in this way can make the necessary updates without having to intervene in the protected area, which can therefore be reserved exclusively for the operator.

It can be provided that the test instruction is designed as a writable file, so that this test instruction after it has been filled, also represents the test protocol and can be stored in the protected area of the memory. The use of the described documentation system is particularly advantageous for managing the documentation of products because the products are products that are relevant to human health. With the aid of the proposed documentation system, access to the relevant data of a product can be simplified. In particular, access to the operating instructions for this product is possible without problems and virtually at any time, in each case in an optimally current version, since this can be provided and updated by the manufacturer in the cloud storage. The operator will be able to easily review the required documentation, for example regarding the availability of the respective test protocols.

The present proposal is explained in more detail below with reference to the purely schematic representation.

In the drawing, a cloud memory is designated overall by 1 and symbolized by a rectangular area. Within this cloud storage 1 are several memory slots 2 provided, purely by way of example, a number of four memory locations 2 to a so-called operator folder 3 is summarized. In every space 2 is an open area 4 as well as a protected area 5 intended.

By analogy with the directory structure of a Windows computer, for example, the cloud memory 1 be regarded as a parent file folder within which the operator folder 3 is arranged as a subordinate file folder, in turn, the four memory locations shown 2 as turn contains subordinate file folder. Apart from the operator folder 3 are inside the file folder of cloud storage 1 the remaining file folders in the form of the remaining memory locations 2 arranged.

Any storage space 2 is in itself a parent file folder, the subfolder on the one hand, the open area 4 and on the other hand, the protected area 5 contains, being in these areas 4 and 5 then each of the files are stored, which relate to the respective individual product, the respective storage space 2 assigned.

LIST OF REFERENCE NUMBERS

1

Cloud storage

2

memory

3

Operators folder

4

Open area

5

protected area

Claims (14)

Documentation system for a medicinal product or rescue device, referred to collectively as a product, with an information store provided on the product, which can be read out wirelessly, designated as a chip, the chip containing a link to a cloud memory (1), wherein the cloud memory (1) has a storage space (2) designed as a file folder and associated with the product, and having an NFC-enabled reader internet-capable following the link to connect to the memory space (2) and having a display for displaying information stored in the memory location (2), the storage space (2) having two areas, namely a first, open, freely accessible area (4) which contains in the form of files at least one operating manual of the product, and a second protected area (5) accessible only after the entry of access data; which in the form of files contains further information about the product. Documentation system after Claim 1 , characterized in that in the protected area (5) a test protocol is deposited. Documentation system after Claim 1 or 2 , characterized in that in the memory space (2) a test instruction is deposited, which contains the prescribed for a review of the product measures. Documentation system according to one of the preceding claims, characterized in that in the protected area (5) a registration date and / or the maximum, latest date of use of the product is stored. Documentation system according to one of the preceding claims, characterized in that information about the whereabouts of the product is stored in the protected area (5). Documentation system according to one of the preceding claims, characterized in that the cloud memory (1) for managing at least two products has at least two memory locations (2), each memory location (2) being associated with only one specific product. A method for maintaining the documentation of a product, wherein • in a cloud memory (1) creates a space allocated to this product (2) and this storage space (2) is divided into two areas, namely in a first, open, freely accessible area ( 4) and a second protected area accessible only after input of access data (5), • at least one operating manual of the product is stored by a manufacturer of the product in the open area (4) of the storage space (2) in the form of files, the product is provided with a wirelessly readable information memory called a chip containing a link to the memory location (2), • a wireless reader approximated to the product's chip, a wireless connection automatically established, the chip automatically read out and the link following automatically establishes a data connection to storage space (2) in the cloud storage (1), and then either an information on the product from the open area (4) is made available to the operator by display on the reader or by download, or after entry of access data the operator access to the protected area (5) of the memory space (2) and to the existing files. Method according to Claim 7 , characterized in that in the open area (4) only files are deposited, which are provided with a read permission for the operator. Method according to Claim 7 or 8th , characterized in that in the protected area (5) files are deposited, which are each provided with a read permission and / or a write permission for the operator. Method according to Claim 9 , characterized in that in the protected area (5) a test protocol is stored, which documents the verification of the product. Method according to one of Claims 7 to 10 , characterized in that in the storage space (2) a test instruction is deposited, in which the measures prescribed for a review of the product measures are explained. Method according to Claim 11 , characterized in that the test instruction is designed as a recordable file in the form of a fillable test protocol. Use of a documentation system, With a wirelessly readable information memory, referred to as a chip, which contains a link to a cloud storage (1), And the cloud memory (1) has a memory space (2) configured as a file folder, Wherein the storage space (2) has two areas, namely a first, open, freely accessible area (4), and a second, protected area (5) accessible only after input of access data, • and with an NFC-enabled reader, following the link to connect to the storage space (2) is internet-enabled, and having a display for displaying information stored in the storage space (2), for managing the documentation for a product, • where the chip is provided on the product The storage space (2) in the cloud storage (1) is assigned to the product, • the open area (4) contains in the form of files at least one operating manual of the product, • and the protected area (5) contains more information about the product in the form of files. Use of a documentation system, which according to one of Claims 2 to 6 is designed.

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