Active device for compatibility check of system components and connected devices

Through the active testing and monitoring functions of the compatibility testing device, the compatibility issues between medical imaging systems and additional components or systems are solved, ensuring the stable, safe and high-quality operation of the system, and solving the problem of limited image quality and function.

CN119213505APending Publication Date: 2024-12-27KONINKLIJKE PHILIPS NV
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Patent Information

Application Number
CN202380041375.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-05-19
Filing Date
2023-05-09
Publication Date
2024-12-27

AI Technical Summary

Technical Problem

Compatibility issues with medical imaging systems with additional components or systems lead to reduced image quality, limited functionality and system availability, especially in case of non-original spare parts and software upgrades, which can cause false diagnosis and radiation exposure safety risks.

Method used

Provides a compatibility testing device, including a connection module and a compatibility check engine, monitors data communications, checks responses, measures performance and image quality, identifies dynamic compatibility issues, and enables or disables additional features through active testing interfaces and protocols. Ensure compatibility and security.

Benefits of technology

Ensure that medical imaging systems can operate stably and safely after being connected to external devices or software upgrades, identify and resolve potential compatibility issues, improve image quality and system availability, reduce risks, and ensure that functions and performance meet defined quality levels.

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Abstract

The invention relates to medical imaging. In order to enable a medical imaging system with connected components to operate stably and / or safely, a compatibility testing device for compatibility checking of components that can be connected to the medical imaging system is provided. The compatibility testing device comprises a connectivity module and a compatibility checking engine. The connection module is connectable to a compatibility test interface of the medical imaging system. The compatibility check engine is configured to perform one or more compatibility tests to determine compatibility between the connected component and the medical imaging system and generate results associated with the one or more compatibility tests.
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Description

Technical Field

[0001] The present invention relates to medical imaging, and in particular to a compatibility test device and system for compatibility checking of components connectable to a medical imaging system, a medical imaging system, and a method of operating the compatibility test device. Background Art

[0002] Nowadays, imaging systems are connected to multiple additional components and / or systems, which provide additional signals and / or information via analog and / or digital interfaces. However, compatibility of interfaces and compatibility of protocols are not always guaranteed. A second source of uncertainty, and also a risk, is that the spare parts used are not always original supplier spare parts, sometimes even OEM replacement parts, whose quality is not always guaranteed by the supplier. Even providing more functions or reducing functions may lead to situations with limited compatibility and the result is a reduction in functionality, image quality and / or system availability and uptime. US2016 / 371442A1 describes a compatibility check mechanism that can include a reader, a check mechanism, a writer and an approver. Summary of the invention

[0003] It is therefore an object of the present invention to enable a medical imaging system having connected components to operate stably and / or safely.

[0004] The objects of the invention are solved by the subject matter of the independent claims. Further embodiments and advantages of the invention are incorporated in the dependent claims. Furthermore, it should be noted that all embodiments of the invention regarding the method can be carried out in the order of the steps described, which, however, is not necessarily the only and necessary order of the steps of the method presented herein. The method disclosed herein can be performed in another order of the disclosed steps without departing from the corresponding method embodiment, unless explicitly mentioned to the contrary below.

[0005] According to a first aspect of the present invention, a compatibility testing device is provided for performing compatibility checking on a component connectable to a medical imaging system. The compatibility testing device comprises a connectivity module and a compatibility checking engine. The connectivity module is connectable to a compatibility testing interface of the medical imaging system. The compatibility checking engine is configured to perform one or more compatibility tests to determine compatibility between the connected component and the medical imaging system and to generate results associated with the one or more compatibility tests.

[0006] The inventors of the present invention have found that one problem faced by system vendors is that the obligation to provide agreed product quality and / or service may result in reduced image quality or even erroneous diagnosis for imaging systems such as magnetic resonance imaging (MRI), computed tomography (CT), digital radiography (DXR), positron emission tomography (PET), single photon emission computed tomography (SPECT), image-guided interventional therapy (IGIT) and ultrasound (US). For example, non-standard messages from one component may cause side effects in another component and have unintended consequences in the final image generation or cause the second component to malfunction. Due to such unplanned interactions, imaging modalities involving ionizing radiation may exceed radiation exposure safety limits for patients and / or operators. The inventors of the present invention have also found that providing additional or fewer functions may result in a situation of limited compatibility and, as a result, reduced functionality, image quality and / or system availability and uptime. This situation may occur due to future software upgrades (e.g., different versions).

[0007] In order to solve at least one of the above problems, the present disclosure provides a compatibility testing device to test, for example, the compatibility and availability of necessary functions, which may be beneficial to service engineers. The compatibility testing device can be an external device, a permanent control unit in an imaging system, or a part of an interface to an external device with an additional "blocking function". This can also ensure that changes are identified and checked after connecting different external devices, replacing parts and / or software upgrades, and even temporarily enabling / disabling these changes through a pay-per-use model. Real-time checking also makes it possible to certify whether the ordered functions have a defined quality level in the operating environment. This will be explained in detail below, especially with respect to Figure 1 and Figure 3 The example shown in .

[0008] According to a first aspect of the invention, the medical imaging system is configured to exchange data with connected components via a data interface according to a communication protocol. The one or more compatibility tests include compatibility testing of the connected components with the data interface and / or the communication protocol.

[0009] In the prior art document US2016 / 371442A1, the compatibility check is defined by reading content from the device's memory, and acceptance or rejection of the use of a component is based on "compatibility data entries in the memory", which is, however, static (predefined) information.

[0010] To this end, it is proposed that the compatibility test device can actively test the interface and protocol. Therefore, the compatibility test device can actively check the timing and data sequence during data exchange to identify dynamic problems. In this way, as will be described in detail below and in particular for Figure 4 As shown in the example, the compatibility test device disclosed herein can, for example, perform active measurements or tests based on action-reaction patterns in real-time scenarios. The compatibility test device disclosed herein can distinguish individual functions that can be enabled or disabled. The compatibility test device disclosed herein can even check not only basic functions, but also test performance and achievable quality levels.

[0011] In addition, the imaging system is usually connected to several additional components and / or systems, which may provide additional signals and / or information through analog and / or digital interfaces, which may have interface signals with different voltage levels. This exemplary compatibility test can ensure compatibility of the interface and compatibility with the protocol.

[0012] According to an embodiment of the present invention, the compatibility check engine is configured to perform one or more of the following operations:

[0013] monitoring data communications between the medical imaging system and connected components and determining whether the data communications comply with a predetermined communication protocol;

[0014] communicating with the connected component using messages to elicit a response, and comparing the elicited response to an expected response to determine whether the connected component is compatible with the medical imaging system; and

[0015] An event representing a change or activity occurring in an operating environment of the medical imaging system is triggered, a reaction of the connected component to the event is monitored, and a determination is made based on an action-reaction pattern whether the connected component is compatible with the medical imaging system.

[0016] This will be explained in detail below, especially for Figure 3 The example shown in .

[0017] According to an embodiment of the present invention, the one or more compatibility tests include a functionality check to determine whether the connected component supports additional functionality.

[0018] Additional functionality or reduced functionality may lead to a situation of limited compatibility and ultimately reduced functionality.This exemplary compatibility check may enable certification of ordered functionality with a defined quality level in an operational environment.

[0019] According to an embodiment of the present invention, in response to determining that the connected component does not support the additional function, the compatibility testing device is configured to perform one or more of the following operations:

[0020] disabling said additional functionality of the connected component;

[0021] preventing communication between the connected component and the medical imaging system; and

[0022] Medical imaging systems are configured in different settings to support additional functionality of connected components.

[0023] According to an embodiment of the present invention, in response to determining that the connected component supports the additional function, the compatibility testing device is configured to perform one or more of the following operations:

[0024] Enable additional functionality for connected components;

[0025] When it is determined that the connection component has similar functionality to the additional functionality but has a different communication protocol, performing a verified message conversion to enable the additional functionality in the connection component; and

[0026] Provides information about the connected components and settings of the medical imaging system.

[0027] According to an embodiment of the invention, the one or more compatibility tests comprise measuring a performance characteristic of the medical imaging system with the connected components to determine whether the measured performance characteristic is within a defined quality level.

[0028] This will be explained in detail below, especially for Figure 3 The example shown in .

[0029] According to an embodiment of the present invention, the compatibility check engine is configured to perform one or more of the following operations:

[0030] receiving sensor data obtained from an imaging phantom, determining performance of the medical imaging system based on the sensor data, and determining whether the performance of the medical imaging system meets the defined quality level; and

[0031] Image data of an imaging phantom acquired by the medical imaging system is received, image quality of the acquired image data is determined, and it is determined whether the image quality meets the defined quality level.

[0032] According to an embodiment of the invention, the one or more compatibility tests comprise simulation of out-of-range data to check the reaction of the connected components.

[0033] Simulating out-of-range data to check the reaction of connected components can allow testing of system security, as components may operate in a "data firewall attack and detection mode."

[0034] According to an embodiment of the present invention, the one or more compatibility tests include compatibility testing of known and certified third-party components to generate compatibility test results.

[0035] In other words, compatibility with known and certified third-party systems and devices can be checked. Real-time testing may provide more reliable results than the "device name" of the connected device.

[0036] According to an embodiment of the present invention, the compatibility checking engine is configured to determine a risk level based on results associated with the one or more compatibility tests.

[0037] According to one embodiment of the present invention, in response to determining that the determined risk level is within an allowable risk range, the component may be allowed to operate with the medical imaging system. In response to determining that the determined risk level exceeds the allowable risk range, the compatibility check engine is configured to generate an error message and / or trigger an operation to reduce the risk level.

[0038] Depending on the risk level, additional functions and features may be allowed to operate.

[0039] For example, a compatibility checking engine may block communications between a medical imaging system and a connected component.

[0040] According to a second aspect of the present invention, there is provided a system for checking compatibility of a component connected to a medical imaging system. The system comprises a compatibility testing apparatus according to the first aspect and any related examples and an imaging phantom having a sensor arrangement. The sensor arrangement comprises one or more sensors configured to acquire sensor data indicative of performance of the medical imaging system.

[0041] In this way, the compatibility test device can be used as a service tool with some additional physical measurement capabilities.

[0042] According to a third aspect of the present invention, a medical imaging system is provided, comprising the compatibility testing device according to the first aspect or the system according to the second aspect.

[0043] According to a fourth aspect of the present invention, there is provided a method of operating the compatibility testing apparatus according to the first aspect to perform a compatibility check on a component connected to a medical imaging system, the method comprising:

[0044] connecting the connection module of the compatibility test device to the data interface of the medical imaging system; and

[0045] One or more compatibility tests are performed to determine whether the connected component is compatible with the medical imaging system.

[0046] As used herein, the term "modality" refers to a recording unit for recording data (e.g. examination image data), such as an X-ray unit, a computed tomography scanner, etc. Such a unit may include a data processing unit for processing and local storage of the data (i.e. examination image data) for a limited time.

[0047] The terms "first", "second", "third", etc. used herein are intended to distinguish different objects, but do not indicate a specific order of the objects. For example, the first module, the second module, etc. are intended to distinguish different modules, but do not indicate a specific order of the modules.

[0048] It should be understood that all combinations of the above concepts and the additional concepts discussed in more detail below (assuming that these concepts are not mutually inconsistent) are intended to be part of the inventive subject matter disclosed herein. In particular, all combinations of the subject matter of the claims are intended to be part of the inventive subject matter disclosed herein.

[0049] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] In the drawings, like reference numerals generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.

[0051] Figure 1 An exemplary compatibility testing apparatus for compatibility checking of components connected to a medical imaging system is illustrated.

[0052] Figure 2 Another exemplary compatibility testing apparatus for compatibility checking of components connected with a medical imaging system is illustrated.

[0053] Figure 3 Another exemplary compatibility testing apparatus for compatibility checking of components connected with a medical imaging system is illustrated.

[0054] Figure 4 Another exemplary compatibility testing apparatus for compatibility checking of components connected with a medical imaging system is illustrated.

[0055] Figure 5 An exemplary system for compatibility checking of components connected to a medical imaging system is illustrated.

[0056] Figure 6 A flow chart describing a method of operating a compatibility testing apparatus is illustrated. DETAILED DESCRIPTION

[0057] Figure 1An exemplary compatibility testing device 10 for compatibility checking of a component 20 connected to a medical imaging system 30 is illustrated. The exemplary compatibility testing device 10, the component 20, and the medical imaging system 30 form a system 100. In some examples, as Figure 1 As shown in FIG, component 20 may be an external device (indicated by a solid line), such as an MR coil, an electrocardiogram (ECG) device, a breathing sensor, a microphone, an MR system's electronics, etc., which may be connected to a magnetic resonance imaging (MRI) scanner. Component 20 may be connected to a data interface of a medical imaging system 30, such as Figure 1 Component interface 42 is shown. In some examples, component 20 can be a system component (not shown), i.e., a component within medical imaging system 30. Component 20 can include a software module having machine instruction blocks and data stored in a memory (not shown). The software module can be executed in a programmable processor coupled to the memory. The software module can interact with one or more other software modules to perform certain desired functions.

[0058] The illustrated example medical imaging system 30 may include any suitable means for recording data (e.g., imaging data). Examples of medical imaging systems 30 may include, but are not limited to: CT scanners for computed tomography, MRI scanners, digital subtraction angiography equipment, X-ray imaging equipment for digital radiography, PET scanners for positron emission tomography, SPECT scanners for photon emission computed tomography, and ultrasound (US) imaging equipment.

[0059] The illustrated example compatibility testing apparatus 10 includes a connectivity module 12 and a compatibility checking engine 14. In general, the example compatibility testing apparatus 10 may include various physical and / or logical components for communicating and manipulating information, which components may be implemented as hardware components (e.g., computing devices, processors, logic devices), executable computer program instructions (e.g., firmware, software) executed by various hardware components, or any combination thereof, as required by a given set of design parameters or performance constraints. Although Figure 1 A limited number of components may be shown by way of example, but it is understood that a greater or lesser number of components may be employed for a given implementation.

[0060] In some implementations, the exemplary compatibility testing device 10 may be embodied as or in a device or apparatus, such as a server, a workstation, or a mobile device. The compatibility testing device 10 may include one or more microprocessors or computer processors that run appropriate software. For example, the compatibility checking engine 14 of the compatibility testing device 10 may be implemented by one or more of these processors. The software may have been downloaded and / or stored in a corresponding memory, for example, a volatile memory such as RAM or a non-volatile memory such as flash memory. The software may include instructions that configure one or more processors to perform the functions described herein.

[0061] It should be noted that the exemplary compatibility testing apparatus can be implemented with or without a processor, and can also be implemented as a combination of dedicated hardware for performing some functions and a processor (e.g., one or more programmed microprocessors and associated circuits) for performing other functions. For example, the functional units of the compatibility testing apparatus 10, such as the interconnect module 12 and the compatibility checking engine, can be implemented in a device or apparatus in the form of programmable logic (e.g., a field programmable gate array (FPGA)). In general, each functional unit of the compatibility testing apparatus can be implemented in the form of a circuit.

[0062] The connection module 12 of the illustrated example may allow the exemplary compatibility testing device 10 to be operatively connected to the medical imaging system 30 for data exchange. The connection module 12 may include a data bus system or a communication network. Figure 1 A limited number of connection modules may be shown by way of example, but it is understood that multiple connection modules may be used for a given implementation. For example, multiple connection modules may be connected to different physical interfaces (e.g., data buses) and may be configured according to system configuration.

[0063] The compatibility check engine 14 of the illustrated example may be configured to monitor data transmitted between the component 20 and the medical imaging system 30 and / or measure performance characteristics of the medical imaging system 30 and the connected component 20 to perform a compatibility check.

[0064] exist Figure 1 In the example shown in , the exemplary compatibility test apparatus 10 is an external device, which can be connected to the medical imaging system 30 via, for example, a data bus system or a communication network. Figure 2As shown in , the exemplary compatibility testing device 10 can be part of a medical imaging system 30. The exemplary compatibility testing device 10 can report the results of one or more compatibility tests via the compatibility testing interface 40, which can give a technician the opportunity to easily access the compatibility of the connected components. The compatibility testing interface 40 can work on a standardized interface. The exemplary compatibility testing device 10 can provide a series of standardized diagnostic trouble codes via the compatibility testing interface 40, which allows people to quickly identify and resolve compatibility issues with connected components. As a further example, Figure 3 As shown in , the exemplary compatibility testing apparatus 10 may be embodied in an interface (eg, component interface 42 ) between a medical imaging system 30 and a component 20 (ie, an external device), and may have a function of disconnecting the external device.

[0065] Generally speaking, the compatibility checking engine 14 may be configured to perform one or more compatibility tests to determine compatibility between connected components and the medical imaging system and to generate results associated with the one or more compatibility tests.

[0066] The medical imaging system 30 is configured to exchange data with the connection component 20 via a data interface according to a communication protocol. The one or more compatibility tests include compatibility tests of the connected components with the data interface and / or the communication protocol. Accordingly, the compatibility testing device is configured to perform active testing of interfaces and protocols. The compatibility testing device can actively check the timing and data sequence during data exchange to identify dynamic problems. For example, as will be described in detail below, the compatibility testing device can actively measure or test based on action-reaction patterns in real-time scenarios, for example. The compatibility testing device can distinguish between various functions that can be enabled / disabled. The compatibility testing device can even check not only basic functions, but also performance and achievable quality levels. Compared with the prior art, the acceptance or rejection of the use of components in the prior art is based on static and predefined information, while the compatibility testing device disclosed herein is configured to perform active compatibility testing and monitoring to avoid errors and detect dynamic problems.

[0067] In some examples, one or more compatibility tests may include a functional check to determine whether the connected component 20 supports additional functionality. In response to determining that the connected component does not support the additional functionality, the compatibility testing device may be configured to disable the additional functionality of the connected component or configure the medical imaging system in different settings to support the additional functionality for the connected component. In response to determining that the connected component supports the additional functionality, the compatibility testing device may be configured to enable the additional functionality for the connected component. When it is determined that the connected component has functionality similar to the additional functionality but has a different communication protocol, the compatibility check engine may be configured to perform a verified message conversion to enable the additional functionality in the connected component. The compatibility check engine may be configured to provide information about the connected components and settings of the medical imaging system. In this way, the components can be used in similar settings of the imaging system.

[0068] In some examples, one or more compatibility tests may include measuring performance characteristics of the medical imaging system 30 and the connected component 20 to determine whether the measured performance characteristics are within a defined quality level.

[0069] In some examples, one or more compatibility tests may include simulations of out-of-range data to check the reaction of connected components.

[0070] In some examples, the one or more compatibility tests may include compatibility testing of known and certified third-party components to generate results of the compatibility testing.

[0071] In some examples, the compatibility check engine can be configured to determine a risk level based on the results associated with one or more compatibility tests. The performance check engine 14 can provide information about the risk. Depending on the determined risk level, functions and added features are allowed to run and / or error / information messages are generated.

[0072] The above exemplary compatibility test can be run using one or more different modules. For example, Figure 4 Another example of a compatibility testing device 10 for performing compatibility checking on a component 20 connected to a medical imaging system 30 is shown. The compatibility checking engine 14 of the illustrated example includes a plurality of modules for performing compatibility checking. Figure 3 A limited number of modules may be shown by way of example, but it is understood that a greater or lesser number of modules may be employed for a given implementation. The functionality of each module may be implemented by hardware, firmware, software, or a combination thereof. The compatibility check engine 14 may exchange data with the medical imaging system 30 via an interface protocol.

[0073] In some examples, such as Figure 4As shown, the compatibility check engine 14 may include a first module 14a configured to communicate with the connected component 20 using messages to elicit a response, and compare the elicited response with an expected response to determine whether the connected component is capable of operating in the medical imaging system 30. For example, the first module 14a may be connected to a data interface to monitor answers given by the connected component 20 based on specific trigger conditions. The first module 14a may be implemented as an analyzer to examine or collect data exchanged between the component 20 and the medical imaging system 30 via an interface protocol. The first module 14a may examine the answers to reveal inefficiencies, errors, or other problems occurring between the component 20 and the medical imaging system 30, thereby, for example, allowing stability and reliability analysis. The first module 14a may actively communicate messages with the connected component 20 to elicit an expected response.

[0074] In some examples, such as in Figure 4 As shown in , the compatibility check engine 14 may include a second module 14b, which is configured to trigger events representing changes or activities occurring in the operating environment of the medical imaging system 30. The second module 14b is also configured to monitor the reaction of the connected component 20 to the event, and determine whether the connected component can operate in the medical imaging system based on the action-reaction pattern. For example, the event may include a software update of the medical imaging system. For example, the event may include a change in the hardware of the medical imaging system. The second module 14b can check the information pattern (e.g., data pattern, parameter pattern, etc.) and / or timing pattern of the reaction of the connected component to determine whether the connectable component can operate in the medical imaging system.

[0075] In some examples, such as Figure 4 As shown, the compatibility check engine 14 may include a third module 14c, which is configured to perform a functional check to determine whether the connected component 20 supports the additional function, and in response to determining that the connected component 20 supports the additional function, enable the additional function in the connected component 20 and / or in the medical imaging system 30. In order to implement the additional function in the medical imaging system 30, the medical imaging system 30 can be reconfigured in different ways. Alternatively, a feedback signal can be provided to the medical imaging system 30. For example, the third module 14c may include a certified function enabler that allows the additional function when compatibility and defined operating conditions are confirmed in the actual configuration. For example, an enabled additional software feature (after an upgrade) that requires interaction with the hardware can only be installed in selected cases. If the connected devices are not directly compatible due to protocol differences, but have similar functions in other aspects, the third module 14c can allow a verified message conversion to enable the additional function in the connected device, which complies with the validity of such operation agreed by the manufacturer.

[0076] In some examples, such as Figure 4 As shown, the compatibility check engine 14 may include a fourth module 14d, which is configured to monitor data communications between the medical imaging system and the connected components and determine whether the data communications follow a predetermined communication protocol. For example, the fourth module 14d can detect one or more of abnormal commands, data ranges, undefined formats, etc. If the command, data range, or data format issued by the device is abnormal, the data will be recorded and may be sent to the target device when the target device is in a safe / service mode to quantify the possible impact of such communication. Typical device interactions recorded by passive listening will be used to reproduce the conditions of typical scanning / imaging operations and analyze radiation exposure and image quality. When all parameters are acceptable, the combination of device and software settings will be certified for safe operation. Depending on the findings, different actions may be triggered. Either downgrade the configuration to ensure safe operation, or perform "certified operation" in the actual setting. If all tests are performed within the defined quality specifications, the scope limit can define the quality level and the performance of the certification.

[0077] In some examples, such as Figure 4 As shown, the compatibility check engine 14 may include a fifth module 14e, which is configured to receive a component identifier from the connected component. The fifth module 14e is also used to determine whether the connected component is a known and certified third-party component, and perform a compatibility check to obtain a test result. In other words, the fifth module 14e can check the compatibility of the medical imaging system with known and certified third-party systems and devices through real-time testing to obtain a more reliable result than only the component identifier of the connected component. In some examples, connected devices and / or software upgrades are paid features and may only be allowed to work if compatibility is given. For example, a function can be provided that allows the system to enable / disable additional functions based on compatibility checks and payment / order information so that business control can be linked to the check (this must be completed before enabling).

[0078] In some examples, such as Figure 4As shown in , the compatibility check engine 14 may include a sixth module 14f, which is configured to receive sensor data obtained from an imaging phantom. The sixth module 14f is configured to determine the performance of the medical imaging system based on the sensor data, and determine whether the performance of the medical imaging system meets the quality criteria and / or provide feedback on the performance parameters of the medical imaging system 30 together with the connected component 20. For example, the sixth module 14f may allow the radiation exposure of various parts of the test model itself. The measured data (e.g., radiation exposure) can be compared with the allowed ranges of these measured parameters to determine whether the performance of the medical imaging system meets the quality criteria. Alternatively or additionally, the sixth module 14f can provide feedback on the performance parameters of the medical imaging system 30 with the connected component 20.

[0079] In some examples, such as Figure 4 As shown in , the compatibility check engine 14 includes a seventh module 14g, which is configured to receive image data of an imaging phantom acquired by a medical imaging system. The seventh module 14g is configured to determine the image quality of the acquired image data, and determine whether the image quality meets a defined quality level. For example, the seventh module 14g can be configured to test the image quality, such as contrast, resolution, and noise level in the resulting image, to determine whether the image quality meets the defined quality level.

[0080] In some examples, such as Figure 4 As shown in , the compatibility check engine 14 may include an eighth module 14h, which is configured to receive sensor data collected by a sensor that monitors the operating environment of the medical imaging system, and determine whether the connected component is capable of operating in the medical imaging system at a defined quality level in the monitored operating environment. The device can be tested under different influencing parameters. Examples of influencing environmental conditions may include, but are not limited to, heat, humidity, and / or poor power supply conditions or cooling conditions.

[0081] Figure 5 An exemplary system for compatibility checking of components connected to a medical imaging system is illustrated. The exemplary system 100 includes a component 20 (in Figure 5 Also referred to as a device under test (DUT), a diagnostic system 30 having a compatibility test interface 40, and a remote command center 50.

[0082] The diagnostic system 30 may be an MRI scanner. MRI is a non-invasive examination that is essential for disease detection, diagnosis, and treatment management. The following will be discussed in detail using an MRI system as an example. However, it should be understood that the following description is also applicable to other modalities, such as CT, PET, SPECT, IGIT, DXR, and US.

[0083] The DUT device 20 can be any external device, such as an MR coil, an electrocardiogram (ECG) device, a respiratory sensor, a microphone, the electronics of the MR system, etc., which can be connected to a magnetic resonance imaging (MRI) scanner. In some cases, smart connected devices connected to a bed or MR scanner are FDA-cleared as standalone devices, but may be incompatible when combined with other devices. RF coils from different vendors can be used in different systems through smart interfaces or wireless functions. The installation of MR systems is not the same in terms of internal RF screen wave propagation, and signal integrity issues may occur.

[0084] The compatibility test can be directed by an operator at a remote operation center 50. The aforementioned compatibility test device 10 can be embodied in a diagnostic system 30. The MR system can be equipped with a compatibility test interface 40. The DUT device can be fixed and located at a defined position controlled by the system. Interactive test software can be provided to guide the user through the test process. The local operator can connect the sensing element to the DUT device. For example, a special model and bracket can be used to test the radio frequency coil. Artifacts such as B0 uniformity, B1 transmit field compatibility, signal integrity, etc. can be detected and identified. The compatibility test device can distinguish the level of MRI imaging artifacts according to the compatibility guidelines including local sensors. For some tests, an automatic test procedure can be activated. The local operator can follow a robot controlled by a local state machine and cloud service data. When the test is completed and passed, the device under test or a combination of different devices and their compatibility may obtain a special compatibility certificate. The DUT device can then be used in certain settings of the imaging system. The certificate can be stored in the cloud and allow the device to be used for a specified time. Remote or automated testing can support positioning and monitoring through three-dimensional sensing (3D).

[0085] Compatibility testing can be performed following a test procedure selected from a list of predefined test modes, such as "Minimum Requirements", "Normal Operation" and "Testing for Options / Upgrades". Depending on the selected test mode, Figure 3 One or more modules 14a-14h shown may be used to perform one or more compatibility checks. Each compatibility test may include protocol standards, integrity of command implementation and / or data range and allowed / not allowed values. For example, to test system security, the connected device may be operated in a "data firewall attack and detection mode" when the second module 14b simulates out-of-range data to check the reaction of other connected devices. For this test, the safety of the imaging system / patient must be ensured. Therefore, no active scanning operations should be performed when such safety tests are initiated.

[0086] One or more different test modes may be initiated during an idle mode of system operation of the diagnostic system 30. For example, a "minimum requirements" test mode may be frequently run during an idle mode of system operation to ensure stable operation is tracked. An "option / upgrade test" test mode may be executed only after any hardware or software changes have been made and / or on a predefined regular schedule.

[0087] In the scanning mode of the diagnostic system 30, the compatibility test device 10 can be configured to be in a listening mode to monitor the data exchange between the DUT device 20 and the diagnostic system 30 to detect abnormal commands, data ranges, undefined formats, etc. For example, if abnormal commands, data ranges, and / or non-standard data formats are detected from the device, such data can be recorded and sent to the target device when the target device is in a safe / service mode to quantify the possible impact of such communication. Typical device interactions recorded by passive listening can also be used to reproduce the conditions of typical scanning / imaging operations. Radiation exposure and image quality can be analyzed. When all parameters are acceptable, the combination of device and software settings will be certified for safe operation.

[0088] Depending on the findings, different actions may be triggered. In some examples, a degraded configuration may be performed to ensure safe operation or "certified operation" in a real setting. Scope limits may be used to define the quality level and certified performance if all tests are performed within the defined quality specifications. If the replaced parts have an impact on performance, the issues found may result in a simple warning, functional degradation, or uncertified operation.

[0089] Since payments are linked to agreed contractual and operating conditions, all findings may have an impact on service and maintenance, but also on the business model. For example, the use of uncertified parts for replacement may affect the guaranteed image quality and the service commitments provided by the supplier to the customer. Therefore, such a device can serve as a neutral instance to report on the actual status of the system and the relevant quality certifications, as well as compliance / non-compliance with the signed contractual conditions.

[0090] This could include services provided by third parties and parts supplied by OEMs, which may have specialized certifications, such as being trusted by the original supplier but with a different specification level. Different levels of functionality may also be certified by different component suppliers – and can be identified and checked by the system.

[0091] Figure 6A flow chart describing a method 200 of operating a compatibility test device as described herein to perform a compatibility check on a component connected to a medical imaging system is shown. At block 210, a connection module of the compatibility test device is connected to a compatibility test interface of the medical imaging system. At block 220, the connected compatibility test interface performs one or more compatibility tests as described herein to determine whether the connected component is compatible with the medical imaging system.

[0092] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0093] As used herein in the specification and claims, the terms "a" and "an" should be understood to mean "at least one" unless expressly stated otherwise.

[0094] The phrase "and / or" as used in the specification and claims herein should be understood to mean "one or both" of the elements so combined, i.e., the elements are present in combination in some cases, and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" elements so connected. Optionally, other elements may be present in addition to the elements specifically identified by the "and / or" clause, whether related or unrelated to those elements specifically identified.

[0095] As used herein in the specification and claims, the phrase "at least one", in reference to a list of one or more elements, should be understood to mean at least one element selected from one or more of the elements in the listed elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the listed elements. This definition also allows for the optional presence of elements other than the elements specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to the specifically identified elements.

[0096] In a further exemplary embodiment of the present invention, a computer program or a computer program element is provided, characterized in that it is adapted to perform the method steps of the method according to one of the preceding embodiments on a suitable system.

[0097] The computer program element can therefore be stored on a computing unit, which can also be part of an embodiment of the present invention. The computing unit can be suitable for executing the steps of the above method or causing the execution of the steps of the above method. In addition, it can be suitable for operating the components of the above device. The computing unit can be suitable for automatically operating and / or executing the user's command. The computer program can be loaded into the working memory of a data processor. The data processor can therefore be equipped to implement the method of the present invention.

[0098] This exemplary embodiment of the invention covers both a computer program that right from the beginning uses the invention and a computer program that by means of an update turns an existing program into a program that uses the invention.

[0099] Furthermore, the computer program element may be able to provide all necessary steps to implement the procedures of an exemplary embodiment of the method as described above.

[0100] According to another exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is proposed, wherein the computer readable medium has a computer program element stored thereon, the computer program element being as described in the previous section.

[0101] The computer program can be stored and / or distributed on suitable media, such as optical storage media or solid-state media provided together with other hardware or as part of other hardware, but the computer program can also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems.

[0102] However, the computer program may also be provided over a network like the World Wide Web and may be downloaded from such a network into a working memory of a data processor. According to a further exemplary embodiment of the invention, a medium for making a computer program element available for downloading is provided, the computer program element being arranged to perform one of the previously described embodiments of the invention.

[0103] Although several innovative embodiments have been described and illustrated herein, a person skilled in the art will readily envision a variety of other ways and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is shown as being within the scope of the innovative embodiments described herein. More generally, a person skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or application to which the innovative teachings are used. A person skilled in the art will recognize or be able to determine many equivalents of the specific inventive embodiments described herein using no more than routine experimentation. Therefore, it should be understood that the foregoing embodiments are presented only by way of example, and within the scope of the appended claims and their equivalents, the inventive embodiments may be practiced in a manner different from that specifically described and claimed. The innovative embodiments of the present disclosure relate to each individual feature, system, article, material, complete set of equipment, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits and / or methods, if such features, systems, articles, materials, kits and / or methods are not mutually inconsistent, are included within the innovative scope of the present disclosure.

Claims

1. A compatibility testing device (10) for performing compatibility checking on a component (20) that can be connected to a medical imaging system (30), the compatibility testing device comprising: Connecting module (12); as well as Compatibility Check Engine (14); wherein the connection module is capable of being connected to the medical imaging system; wherein the compatibility check engine is configured to perform one or more compatibility tests to determine compatibility between the connected component and the medical imaging system and to generate results associated with the one or more compatibility tests; wherein the medical imaging system is configured to exchange data with connected components via a data interface (42) according to a communication protocol; and The one or more compatibility tests include testing the compatibility of the connected components with the data interface and / or the communication protocol.

2. The compatibility testing device according to claim 1, in, The compatibility check engine is configured to perform one or more of the following operations: monitoring data communications between the medical imaging system and connected components and determining whether the data communications comply with a predetermined communication protocol; communicating with the connected component using messages to elicit a response, and comparing the elicited response to an expected response to determine whether the connected component is compatible with the medical imaging system; as well as An event is triggered that represents a change or activity occurring in an operating environment of the medical imaging system, a reaction of the connected component to the event is monitored, and a determination is made based on an action-reaction pattern whether the connected component is compatible with the medical imaging system.

3. A compatibility testing device according to any one of the preceding claims, in, The one or more compatibility tests include a functionality check to determine whether the connected component supports additional functionality.

4. The compatibility testing device according to claim 3, in, In response to determining that the connected component does not support the additional functionality, the compatibility testing device is configured to perform one or more of the following operations: disabling said additional functionality for the connected component; preventing communication between the connected component and the medical imaging system; and The medical imaging system is configured in different settings to support the additional functionality for the connected components.

5. The compatibility testing device according to claim 3 or 4, in, In response to determining that the connected component supports the additional functionality, the compatibility testing device is configured to perform one or more of the following operations: enabling said additional functionality for the connected component; When it is determined that the connected component has a similar function to the additional function but has a different communication protocol, performing a verified message conversion to enable the additional function in the connected component; and Information about the connected components and settings of the medical imaging system is provided.

6. A compatibility testing device according to any one of the preceding claims, in, The one or more compatibility tests include measuring performance characteristics of the medical imaging system with connected components to determine whether the measured performance characteristics are within a defined quality level.

7. The compatibility testing device according to claim 6, in, The compatibility checking engine is configured to perform one or more of the following: receiving sensor data obtained from an imaging phantom, determining performance of the medical imaging system based on the sensor data, and determining whether the performance of the medical imaging system meets the defined quality level; as well as Image data of an imaging phantom acquired by the medical imaging system is received, image quality of the acquired image data is determined, and it is determined whether the image quality meets the defined quality level.

8. A compatibility testing device according to any one of the preceding claims, in, The one or more compatibility tests include simulating out-of-range data to check the reaction of the connected components.

9. A compatibility testing device according to any one of the preceding claims, in, The one or more compatibility tests include compatibility testing of known and certified third-party components to generate results of the compatibility testing.

10. A compatibility testing device according to any one of the preceding claims, in, The compatibility checking engine is configured to determine a risk level based on the results associated with the one or more compatibility tests.

11. The compatibility testing device according to claim 10, in, In response to determining that the determined risk level is within an allowable risk range, enabling the additional functionality to operate with the medical imaging system; and Wherein, in response to determining that the determined risk level exceeds an allowable risk range, the compatibility checking engine is configured to generate an error message and / or trigger an operation to reduce the risk level.

12. A system (100) for performing compatibility checking on a component connected to a medical imaging system, comprising: A compatibility testing device according to any one of the preceding claims; as well as an imaging phantom having a sensor arrangement; Therein, the sensor arrangement comprises one or more sensors configured to acquire sensor data indicative of a performance of the medical imaging system.

13. A medical imaging system (30), comprising: A compatibility testing device according to any one of claims 1 to 11 or a system according to claim 12.

14. A method (200) of operating the compatibility testing device according to claim 1 to perform compatibility checking on a component connected to a medical imaging system, the method comprising: Connecting the connection module of the compatibility testing device to the compatibility testing interface of the medical imaging system; as well as One or more compatibility tests are performed to determine whether the connected components are compatible with the medical imaging system.