DE102005028476B4 - Method for producing a medical technology system - Google Patents

Abstract

Method for producing a medical-technical system (1),
- In which the medical device system (1) with medical components (K1, K2, K3) is fitted, each of which a radio identification element (I1, I2, I3) is assigned, in which respective radio identification element (I1, I2, I3) at least one identification data element (i11, i12, i21, i22, i31, i32) is stored
In which the medical-technical system (1) is manufactured in a given geographical production area (3),
In which the access (5) to the manufacturing area (3) is equipped with a radio reading device (2) arranged and arranged in such a way that
in that an identification data element (i11, i12, i21, i22, i31, i32) from the radio identification element (I1, i1) automatically transports one of the medical-technical components (K1, K2, K3) via the access (5) into the production area (3). I2, I3), which is assigned to the medical technology component (K1, K2, K3),
- And in which by the radio-reading device (2) during transport of the medical component (K1, K2, ...

Description

The The invention relates to a method for producing a corresponding medical technical system.

The remarkable technical development in the field of medical technology leads to getting bigger and bigger technically more complex medical systems, such as X-ray systems, Computed Tomography Systems or Magnetic Resonance Imaging Systems. such Medical technology systems are based on the interaction of a multitude various medical components, such as in the case of an X-ray system an X-ray unit, an X-ray detector unit, a device tripod, an examination table, an image intensifier, and many more, even smaller, medical components.

by virtue of the high safety requirements in the medical field It requires that the interaction of medical components takes place particularly reliably within a medical technology system.

There modern medical systems on complex electronic and Software components based, already the absence a seemingly insignificant medical technology component or an incorrect version number in the software component of a control unit to a failure or malfunction of a medical device Systems lead. This can be fatal in everyday clinical practice, for example to lead.

to Identification of goods are currently establishing so-called RFID (Radio Frequency Identification) - Method for identification data (elements) contactless and to be able to read and save without visual contact.

One RFID system includes, for example, a radio identification element (Also transponder, RFID tag, chip, tag, RFID tag or chip called), be stored on the identification data elements can, a radio reading device (also transceiver unit or reader called) and central control and / or storage facilities for Processing, storage and, if necessary, forwarding of the identification data (elements).

The RFID transponders sometimes differ quite a bit from each other. The structure of an RFID transponder, for example, sees an antenna, an analogue circuit for receiving and / or transmitting (transponder) as well as a digital circuit and a permanent memory in front. RFID transponders can use one have multi-writable memory in which during the lifetime the transponder information can be stored.

RFID transponder There are basically two versions: active and passive RFID transponders. Active RFID transponders are battery operated and can typically both read and described. active RFID transponders are normally idle; d. H. they do not send out information. Only if a special activation signal is received, the transmitter is activated. Passive RFID transponders get their energy to send information from the received Radio waves. The amount of stored data is much lower as with active RFID transponders. In their memory is usually a unique identification number (GUID) deposited. Some passive transponders come with a rewriteable memory equipped.

The closest publication US 2005/0088306 A1 describes the use of RFID tags for the management and distribution of medical products, including pharmaceutical products or the like.

The DE 101 25 936 A1 deals with the labeling of additional parts for medical devices by means of an electronic memory chip. It is specifically described here the application to a device for generating acoustic shock waves for extracorporeal shockwave therapy.

In the DE 100 64 789 A1 For example, a method and an apparatus for configuring and monitoring a system unit of a medical diagnostic system by means of electronic information transmission are described.

From the DE 196 29 646 A1 a device for automatic identification of components of medical devices is known in which a video-endoscope system is described.

Similarly, in the EP 1 347 638 A1 an automatic adjustment of an endoscopic video camera system using an electronic memory chip, such as an RFID transponder described on the camera head, with the help of which the camera head used can be identified and the system can be properly adjusted.

It Now is an object of the invention to provide a method for producing a indicate a medical system that is reliable This medical technology system allows.

These The object is achieved by the subject-matter features of the independent claim solved. Advantageous and expedient developments are in the dependent claims specified.

at a method for identifying medical components is medical technology components such as electronic Assemblies, functional units or software components each associated with at least one radio identification element, the For example, connected to the medical device component or is a part of it.

at the radio identification element is for example an RFID tag, an RFID chip or an RFID tag. In at least one radio identification element is at least one - in particular readable - identification data element such as For example, a component name, a serial number This implementation level, a version number, a part number and / or a revision number stored the appropriate medical component.

to Identification of at least one medical component of the medical technology system becomes an identification data element from a radio identification element, that of the medical technology Component is assigned, by a radio-reading device, which in turn, at least temporarily associated with the medical technology system is, in particular automatically after activation of the radio-reading device read.

at the radio-reading device is in particular a with the radio identification element via Radio signals corresponding radio reading device, such as an RFID scanner.

By this kind of identification of medical components becomes that reaches to a particular medical device system belonging medical components and their current status both detected reliably, precisely and / or exhaustively during manufacture as well as during maintenance can be. This in turn allows a reliable one Operation of such a complex medical technology system.

moreover is achieved by manufacturing, maintenance and reliable operation a medical technology system with reduced effort are possible, because the corresponding identification data, which for example to handle several multi-digit number and / or letter codes can, no longer consuming manually detected by an installer or service technician have to, but, in particular automatically, by the radio-reading device be recorded.

Further Advantages lie in the fact that so far for the component identification Required component and packaging signage deleted or simplifies accompanying documents on the components and that warehouse management is simplified as they at least can be partially automated realized.

Preferably becomes an identification data element for the first time in the production stored a medical component. Alternatively or additional For this purpose, an identification data element for the first time when installing a medical device component, which is also an acquisition component can act, stored in a medical device system. The stored identification data elements are preferably included a modification, in particular a repair, an installation / removal, an exchange or an update or an update of a medical-technical component according to newly stored, modified, changed or supplemented. By this configuration, it is easily possible on a medical technology System-related identification data elements from the beginning up-to-date to keep. this makes possible it to determine which medical systems with identical Malfunction Identification data elements with identical contents exhibit. So can the cause of a possible Malfunction quickly detected or even prevented a malfunction become.

modern Medical technology systems are technically so complex that often not just the current status of medical technology components influences the function of the medical technology system, but also "past" states or modifications the function of the medical system influence. A preferred embodiment therefore provides that successive modifications of a medical component or a medical-technical system according to successive, especially in terms of a component resume or system resume (Device History Record). This storage can be done by including the respective modification date. This also ensures that causes of possible malfunction quickly be recognized, especially if they have theirs. Reason in a "past" status to have.

Preferably, a subset of medical-technical components, which are located in particular in a screened-off with respect to the radio-read device environment, such as a generator cabinet, an auxiliary radio read assigned direction. In order to identify a medical component from the subgroup, an identification data element from a radio identification element assigned to the medical technology component is read out by the auxiliary radio reading device and forwarded, for example, to a radio reading device or a central control or memory device. By means of this measure, it is also possible to detect medical-technical components which are located in an environment shielded with respect to the radio-reading device.

Prefers is a method in which the medical device system with a Remote maintenance system is connectable or connected. About the Remote maintenance system can then with the help of the medical device associated radio reading device the identification data elements of the various system components read out and z. B. the information obtained in the Maintenance taken into account become. this makes possible a current central data storage far away from a medical Device, for example, the manufacturer of medical technology System. As a result, the above-explained determination of the cause a malfunction and their rectification further facilitated.

The The object is achieved by a method for producing a medical technology system or Subsystem in which the medical technology system with medical components stocked is assigned to each of which a radio identification element, in which respective radio identification element at least one identification data element is stored.

The medical system or subsystem is in a given geographic manufacturing area. Access to the geographical Manufacturing area is equipped with a radio reading device, which is set up and arranged such that during transport a medical component on access to the geographical Manufacturing Area automatically an identification data element is read from the radio identification element that the medical technology Component is assigned. By the radio reading device during transport of the medical component over the Access to the manufacturing area read identification data elements automatically in a system file stored in the medical technology system.

The secure capture of precisely the components that are transported through the access is preferably by a to the dimensions of the access correspondingly adapted range of the radio signals transmitted by the Radio identification elements are broadcast, and / or a to the dimensions of the access correspondingly adapted receiver sensitivity of the radio-reading device guaranteed.

By this type of manufacturing of medical systems is achieved that the kind and the status of the in a medical technical system integrated medical components during manufacture recorded reliably and completely automatically and with minimal effort can be. this makes possible an automated determination of the degree of completion. In addition, can be prevented from urgently needed medical technology Components are not or in a wrong version in the medical device System to be installed. This allows the reliable operation of a medical technology Systems, for example, in a hospital, be ensured.

According to one preferred embodiment, the radio reading device is set up and arranged that even when transporting one of the medical technology Components over access from the geographical area automatically an identification data element is read from the radio identification element that the medical technology Component is assigned.

moreover can Identification data elements used in the transport of one of the medical-technical components from the given geographical area by the radio-reading device be automatically deleted from the system file. This increases the quality and timeliness of identification data elements stored in the system file.

Especially preferred is a method for producing a medical technology System in which the radio reading device is set up such that when transporting the medical system via access from the geographical Area automatically identification data elements from the radio identification elements be read, the medical technology components of medical technology Systems are assigned. In addition, based on the read out Identification data elements a verification, a supplement, an adjustment and / or a correction of the already stored in the system file Identification data elements performed. This will achieve that the finished medical technology system once again can be subjected to an automatic check and disagreements to the identification data elements already stored in the system file tracked can be.

A medical device system made according to the invention or a device made according to the invention can also be used before and / or after delivery the assembly using a radio-reading device to be checked for completeness.

A Identification of the medical technology components of a medical technology Systems after commissioning a medical technology system The customer preferably serves as the basis for an automatic, in particular complete and current, preparation of a proof of delivery. This can, for example, via a Telecommunication connection such as WLAN (Wireless Access Network), automatically transmitted to the manufacturer of the medical technology system and be archived there.

moreover can based on the information thus requested, if necessary automatically, in particular via a Telecommunication connection, medical replacement components be ordered. After replacement of the responsible for the malfunction medical component become the identification data elements the built-in medical replacement component automatically by a, in particular mobile, radio reading device of a service technician detected. These identification data elements are, in particular via a Telecommunication connection, to the manufacturer of the medical technology Systems transmitted and there, for example, as part of a component resume or System CVs (Device History Record), which for example already created during production, in a system file saved. In addition, the Identification data elements stored in a proof of delivery file ge become. Both the system file and the proof of delivery file can to the operator of the medical technology system in the system delivery supplied and maintained at the operator. Preferably these two files synonymous with the manufacturer in a long-term storage archived in the long term.

in the As part of the application, the invention is exemplified by medical technology Components and systems closer explained. Of course However, the invention and its developments are not limited thereto, but include other technical systems or methods of manufacture technical systems. In particular, the invention also includes a Process for the preparation of a technical system in which the technical system is equipped with technical components, each of which is assigned a radio identification element, wherein in a radio identification element at least one (readable) Identification data item is stored, in which the technical System (or subsystem) in a given geographic area which provides access to the geographical area is equipped with a radio-reading device, set up in such a way and arranged that when transporting a technical component over the Automatically access an identification data item in the geographical area is read from the radio identification element, that of the medical component assigned.

The Invention will be described below with reference to exemplary embodiments on the attached Figures closer explained. Show it:

1 a schematic representation of a medical technology system,

2 a schematic representation of a manufacturing scenario.

1 shows a medical technology system 1 such as an x-ray system, a computed tomography system, or a nuclear spin tomography system.

The medical-technical system has a plurality of medical-technical components K1, K2, K3 which are connected to one another. Each medical-technical components K1, K2, K3 is assigned a radio-identification element I1, I2, I3. In this example, these radio identification elements I1, I2, I3 each carry two identification data elements i11, i12, i21, i22, i31, i32. In addition to the medical technical components shown in the figure, the medical technology system 1 have further medical-technical components, which also radio identification elements can be assigned.

Part of the medical technology system 1 is also a radio-reading device 2 , which is designed to read the identification data elements i11, i12, i21, i22, i31, i32 from the radio identification elements I1, I2, I3 accordingly.

Alternatively, the radio-reading device 2 also outside the medical technology system 1 arranged and not part of the medical technology system 1 be. In this case, the radio-reading device 2 used in conjunction with several different medical systems.

The radio reading device 2 and the radio identification elements I1, I2, I3 are radio-configured so that they can exchange data with each other, wherein the data connections used for this purpose either only from the radio identification elements I1, I2, I3 to the radio-reading device 2 or set up or set up in both directions.

The radio reading device 2 can with one Memory device for storing identification data elements i11, i12, i21, i22, i31, i32 and be equipped with a suitably configured control device. In addition, the radio reading device 2 with a z. B. spatially from the medical device system 1 be connected to separate central storage and / or control device, from and to which identification data elements i11, i12, i21, i22, i31, i32 can be transmitted. The data transmission can take place wirelessly and / or line-bound according to per se known transmission standards, such as Bluetooth or WLAN, or according to specially developed for this purpose transmission method.

2 shows the manufacturing environment in which a, in particular according to the invention, medical system is produced. It is a geographically specified manufacturing area 3 such as a production bunk, including access 5 to this manufacturing area 3 shown. At the entrance to the manufacturing area 3 is a radio reading device 2 arranged.

In the manufacturing area 3 There are already two medical-technical components K1, K2 together with associated radio-identification elements I1, I2. These components K1, K2 are components of a medical technology system to be manufactured. A third component K3 together with wireless identification element I3 is still outside the production area 3 For example, in a warehouse or at a supplier.

Both the transport of the component K3 through the access 5 in the manufacturing area 3 as well as the transport of one of the components K1, K2 through the access 5 from the manufacturing area 3 be by the radio technically configured radio reading device 2 detected.

The radio identification elements I1, I2, I3 assigned to the medical technology components K1, K2, K3 transported through the access are automatically read out. The corresponding identification data elements i11, i12, i21, i22, i31, i32 are correspondingly stored, changed or deleted in a system file. So can always get the complete and current status of all in a medical device system 1 already integrated medical components K1, K2 are determined.

When the medical system is completed and also through access 5 from the manufacturing area 3 is transported by the radio-reading device 2 automatically read all or predetermined identification data elements i11, i12, i21, i22, i31, i32 from the radio identification elements I1, I2, I3 of the medical device system and compared with the stored in the system file S identification data elements i11, i12, i21, i22, i31, i32. This comparison should normally result in a match of the data. The system file S is z. B. in a memory of a control device 4 deposited, which with the radio-reading device 2 connected is.

It is again explicitly pointed out at this point, that the figures are only examples. The medical technology System can use any number of medical components include, which may also be summarized in subsystems.

Claims (4)

Method for producing a medical-technical system ( 1 ), - in which the medical technology system ( 1 ) is equipped with medical-technical components (K1, K2, K3) to each of which a radio identification element (I1, I2, I3) is assigned, in which respective radio identification element (I1, I2, I3) at least one identification data element (i11, i12, i21, i22 , i31, i32) - in which the medical-technical system ( 1 ) in a given geographic manufacturing area ( 3 ), - where the access ( 5 ) to the manufacturing area ( 3 ) with a radio reading device ( 2 ) arranged and arranged such that, during the transport of one of the medical-technical components (K1, K2, K3) via the access ( 5 ) in the manufacturing area ( 3 ) an identification data element (i11, i12, i21, i22, i31, i32) is read from the radio identification element (I1, I2, I3), which is associated with the medical component (K1, K2, K3), - and in which by Radio reading device ( 2 ) during transport of the medical component (K1, K2, K3) via the access ( 5 ) in the manufacturing area ( 3 ) read identification data elements (i11, i12, i21, i22, i31, i32) automatically in a system file (S) of the medical technical system ( 1 ) get saved. Method for producing a medical-technical system ( 1 ) according to claim 1, in which the radio reading device ( 2 ) is arranged and arranged such that during the transport of one of the medical-technical components (K1, K2, K3) via the access ( 5 ) from the manufacturing sector ( 3 ) an identification data element (i11, i12, i21, i22, i31, i32) is read from the radio identification element (I1, I2, I3), which is associated with the medical technical component (K1, K2, K3), and in which by Radio reading device ( 2 ) when transporting one of the medical components (K1, K2, K3) via the access ( 5 ) from the manufacturing sector ( 3 ) read identification data elements (i11, i12, i21, i22, i31, i32) automatically from the system file (S) of the medical technology system ( 1 ) to be deleted. Method for producing a medical-technical system ( 1 ) according to claim 1 or 2, wherein the radio reading device ( 2 ) is set up such that during transport of the medical technology system ( 1 ) about access ( 5 ) from the manufacturing sector ( 3 ) automatically read identification data elements (i11, i12, i21, i22, i31, i32) from the radio-identification elements (I1, I2, I3), the medical-technical components (K1, K2, K3) of the medical-technical system ( 1 ) and that a verification of the identification data elements (i11, i12, i21, i22, i31, i32) already stored in the system file (S) is performed. Method for producing a medical-technical system ( 1 ) according to one of claims 1 to 3, in which the system file (S) of the medical technology system ( 1 ) is archived in a long-term store.