Radiation Therapy Equipment and Access Authorization

Abstract

A method for determining whether a radiotherapy device should be authorized for use, the radiotherapy device being configured to provide therapeutic radiation to a patient. The radiotherapy device comprises a plurality of components, each of the plurality of components being coupled to at least one identifier, the at least one identifier being configured to provide data identifying the component coupled thereto. The method comprises: receiving data identifying each of the plurality of components of the radiotherapy device from the identifier; determining whether at least one authorization criterion is satisfied based on the identification data and the authorization data; and determining that the treatment device is authorized for use if the at least one authorization criterion is satisfied.

Description

Technical Field

[0001] The present disclosure relates to radiotherapy equipment. In particular, the present disclosure relates to automatic identification of radiotherapy equipment components and ensuring that a field maintenance engineer attending to the radiotherapy equipment is properly authorized. Background Art

[0002] Radiotherapy equipment is an important tool in modern cancer treatment. Radiotherapy equipment is a large, complex machine with many moving parts and interacting mechanisms. Despite precise design and rigorous testing, some of the components of a radiotherapy machine may degrade during the life of the machine. Therefore, radiotherapy equipment requires repair and maintenance to ensure that they continue to operate in an optimal manner and that the machine meets safety and regulatory requirements.

[0003] It is desirable to ensure that radiotherapy equipment is composed of components that have been tested and deemed safe for use with the equipment, and that the components have been properly authorized for use with the equipment. This allows manufacturers and owners of radiotherapy equipment to ensure that their equipment always meets safety standards, regulatory requirements, and always operates in an optimal manner.

[0004] The existing process is cumbersome for on-site maintenance engineers, and although safety checks are performed on-site, there is still the possibility of human error, which prolongs the maintenance and repair procedures of radiotherapy equipment.

[0005] Another problem associated with the previous setup is that there is no mechanism on site to prevent unauthorized engineers from maintaining and attempting to repair the radiotherapy equipment. Typically, unauthorized personnel do not have the knowledge and experience necessary to properly repair the radiotherapy equipment in a manner that ensures the equipment can still operate within safety and regulatory requirements.

[0006] It is also desirable that only properly authorized personnel be able to install, repair and / or maintain the radiotherapy machine. This helps maximize the likelihood that the equipment will always operate in accordance with safety and regulatory requirements.

[0007] The present disclosure is directed to addressing these and other shortcomings encountered in the prior art by providing a method for determining whether a radiotherapy device should be authorized for use and a method for determining whether a maintenance engineer is authorized to maintain a particular radiotherapy device. Summary of the invention

[0008] Various aspects of the invention are set out in the independent claims. Optional features are set out in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Specific embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0010] Figure 1A radiotherapy device that may be used in accordance with the systems and methods of the present disclosure is depicted;

[0011] Figure 2 A schematic diagram of a system according to the present disclosure is depicted;

[0012] Figure 3 A method according to the present disclosure is described;

[0013] Figure 4 A method according to the present disclosure is described;

[0014] Figure 5 A method according to the present disclosure is described;

[0015] Figure 6 A method according to the present disclosure is depicted. DETAILED DESCRIPTION

[0016] The present application generally relates to ensuring that safety standards or safety criteria are met by comparing identification data associated with various components of a radiotherapy machine with authorization data stored in an authorization database. Each component is coupled (e.g., connected) to an identifier such as an RFID tag that can provide identification information about the component coupled thereto. If the safety standards or safety criteria are met, the radiotherapy device is authorized for use. One or more radiotherapy devices may include any of a linear accelerator (linac), an MRI machine, and an MR linear accelerator.

[0017] Figure 1 A linear accelerator that may form part of a system according to the present disclosure is depicted. The linear accelerator is adapted to deliver a radiation beam to a patient during a radiotherapy treatment and is configured to deliver a radiation beam to a patient during a radiotherapy treatment. In operation, the linear accelerator device generates and shapes a radiation beam according to a radiotherapy treatment plan and directs the radiation beam toward a target site within a patient.

[0018] Medical linear accelerator machines are inevitably complex, with many interacting components. Figure 1 An overview of the operation of a typical linear accelerator is given in the linear accelerator equipment depicted in Figure 1 The linear accelerator apparatus depicted in the diagram includes a radio frequency wave source, a waveguide, an electron source, a system capable of creating a strong vacuum including one or more vacuum pumps, a heavy metal target that produces X-rays when struck by the electron beam, and a complex arrangement of magnets capable of redirecting and focusing the electron beam onto the target. Figure 1 The apparatus depicted in also includes a treatment head housing various devices configured to, for example, collimate and shape the resulting X-ray beam.

[0019] An RF wave source 102 (e.g., a magnetron) generates RF waves. The RF wave source 102 is coupled to the waveguide 104 (e.g., through a circulator) and is configured to pulse the RF wave into the waveguide 104. The RF wave passes from the RF wave source 102 through an RF input window into an RF input connecting pipe or tube. An electron source 106 (e.g., an electron gun) is coupled to the waveguide 104 and is configured to inject electrons into the waveguide 104. In the electron source 106, electrons are thermally emitted from the cathode filament when the cathode filament is heated. The temperature of the cathode filament controls the number of electrons injected. The injection of electrons into the waveguide 104 is synchronized with the pumping of the RF wave into the waveguide 104. The design and operation of the RF wave source 102, the electron source 106, and the waveguide 104 enable the RF wave to accelerate the electrons to very high energy as the RF wave and the electrons propagate through the waveguide 104.

[0020] The design of the waveguide 104 depends on whether the linear accelerator uses standing waves or traveling waves to accelerate electrons, but the waveguide generally includes a series of cells or cavities, each connected by a hole or "iris" through which the electron beam can pass. The order in which these cavities are coupled is such that a suitable electric field pattern is formed that accelerates the electrons propagating through the waveguide 104. As the electrons are accelerated in the waveguide 104, the path of the electron beam is controlled by a suitable arrangement of guide magnets or guide coils surrounding the waveguide 104. The guide magnet arrangement may include, for example, two sets of quadrupole magnets.

[0021] Once the electrons have been accelerated, they may enter a flight tube. The flight tube may be connected to the waveguide by a connecting tube. The connecting tube or connecting structure may be referred to as a drift tube. The drift tube also forms part of a vacuum tube. The RF wave leaves the waveguide through an RF output connecting conduit or tube coupled to the drift tube. The RF exits the vacuum system through an RF output window of the sealed vacuum system.

[0022] The flight tube is also maintained under vacuum conditions by a pump system. The electrons can travel along a cyclotron path toward a heavy metal target. The target can include, for example, tungsten. While the electrons travel through the flight tube, a focusing magnet arrangement functions to direct the beam and focus the beam on the target. The cyclotron path allows the overall length of the linear accelerator to be reduced while ensuring that the accelerated electron beam consisting of electrons with a small energy spread is focused on the target.

[0023] To ensure that the propagation of electrons is unimpeded as the electron beam travels towards the target, the waveguide 104 is evacuated using a vacuum system including a vacuum pump 130 or vacuum pump arrangement. The pump system is capable of creating ultra-high vacuum (UHV) conditions in the waveguide 104 and in the flight tube.

[0024] When high energy electrons hit the target, X-rays are generated in all directions. The target is located inside the flight tube and at the end of the flight tube to seal the vacuum system. The flight tube also includes a target window that is transparent to X-rays and is positioned to allow X-rays generated when the linear accelerator is operated to pass from the evacuated flight tube through the target window into the treatment head 110. At this time, the primary collimator blocks the X-rays from traveling in certain directions and only allows the forward traveling X-rays to pass through to produce a cone-shaped beam. The X-rays are filtered and then passed through one or more ion chambers for dose measurement. The beam can be shaped in various ways by a beam shaping device (for example, by using a multi-leaf collimator) and then allowed to enter the patient as part of the radiotherapy treatment.

[0025] In some embodiments, the linear accelerator is configured to emit an X-ray beam or an electron particle beam. This embodiment allows the device to provide electron beam therapy, i.e., an external beam therapy in which electrons rather than X-rays are directed toward a target area. It is possible to "switch" between a first mode that emits X-rays and a second mode that emits electrons by adjusting components of the linear accelerator. In essence, it is possible to switch between the first mode and the second mode by moving a heavy metal target into or out of the electron beam path and replacing it with a so-called "electron window." The electron window is substantially transparent to electrons and allows electrons to leave the flight tube.

[0026] The end of the flight tube can be sealed by a component including a target and an electron window. Then, it is possible to switch between the first mode and the second mode by moving the flight tube so that the electron beam is directed to the target or the electron window. Therefore, the drift tube connecting the waveguide to the open end of the flight tube is slightly flexible to allow the flight tube to move. In other words, when the user changes between using electron and x-ray energy, the flight tube will move, which puts the tungsten target (x-ray) or the electron window (electron) in the treatment position.

[0027] The linear accelerator device also includes several other components and systems. The entire system is cooled by a water cooling system (not shown in the figure). The water cooling system can be particularly used to cool the waveguide 104, the target, and the radio frequency source 102. In order to ensure that the linear accelerator does not leak radiation, appropriate shielding is also provided. Those skilled in the art will understand that the linear accelerator device used for radiotherapy treatment will have additional devices, such as a frame for supporting and rotating the linear accelerator treatment head / radiation source, a patient support surface, and a controller or processor configured to control the linear accelerator device. The device also includes an imaging device or device, such as a KV imager, which can interact with the linear accelerator to provide an image-guided radiotherapy system.

[0028] In some embodiments, the radiotherapy device can be an MR linear accelerator. The MR linear accelerator device includes an MR imaging device and a radiotherapy (RT) device, which can include a linear accelerator device. When in operation, the MR imager generates an MR image of the patient, and the linear accelerator device generates a radiation beam according to the radiotherapy treatment plan, shapes the radiation beam, and guides the radiation beam toward a target area in the patient's body. Technicians will recognize that such an MR imaging device can include a main magnet, one or more gradient coils, one or more receiving coils, and an RF pulse applicator. The operation of the MR imaging device is controlled by a controller.

[0029] The object or patient support surface is configured to move between a first position substantially outside the cabin and a second position substantially inside the cabin. In the first position, the object or patient can climb onto the patient support surface. Then, the support surface and the patient can be moved into the cabin to the second position so that the patient can be imaged by an MR imaging device and / or imaged or treated using an RT device. Movement of the patient support surface is achieved and controlled by an object support surface actuator (which can be described as an actuation mechanism). The actuation mechanism is configured to move the object support surface in a direction parallel to the central axis of the cabin and defined by the central axis of the cabin.

[0030] Figure 2 2 is a schematic diagram of a system according to the present disclosure. The system includes a radiotherapy device 200. The radiotherapy device depicted in the figure includes a linear accelerator (linac) device and may also include an MR imager, so that the radiotherapy device can be described as an MR linac.

[0031] In the radiotherapy device of the present disclosure, at least one component of the radiotherapy device includes a marker. In a preferred embodiment, multiple components of the radiotherapy device each include a corresponding marker. For example, any of the following components may include their respective markers: magnetron, waveguide, electron gun, each of the accelerating and focusing magnets, and dosimeter and other components in the linear accelerator treatment head.

[0032] The identifier is suitable for identifying the corresponding component of the radiotherapy equipment and is configured to identify the corresponding component of the radiotherapy equipment. The identifier can be described as a label or a tag. The identifier carries, contains or otherwise includes information that allows the component to be identified. The identifier can be, for example, a radio frequency identification inlay, or a label. The identifier can be described as an "identification data carrier" because they are configured to carry data about identifying the components to which they are attached.

[0033] The identifiers are configured to provide identification information (which may be described as identification data) about the components with which they are associated. The identification information may include a unique ID associated with the component assigned during the manufacturing process. The identification information may also include information such as the "type" of the component, e.g., whether the component is a magnetron, electron gun, or other component type.

[0034] The radiotherapy device includes a reader 241 configured to receive information from each unique identifier. As will be discussed in more detail below, the reader may include an RFID reader, an antenna, a camera, a scanner, or a mechanism for reading physical symbols. The reader 241 is coupled to the device controller and is configured to provide a signal indicating the identity of each of the multiple components of the radiotherapy device 200 to the device controller 240.

[0035] Figure 2 The radiotherapy device 200 depicted in the figure is a schematic diagram and is intended for illustrative purposes only. The device 200 includes a flight tube 206, curved guide magnets 215, 225, 220, a waveguide 204, and an electron gun 202. These are examples of components that can be provided with markers. In addition, any radiotherapy device can be provided with markers, such as magnetrons, beam shaping devices (such as MLCs), circulators, processors, and storage devices, etc.

[0036] The first embodiment of the marker - RFID

[0037] In a first embodiment, the identifier includes an RFID tag or inlay. The RFID tag is attached to a component of the radiotherapy device. In a first embodiment, the system includes an RFID reader, and the RFID reader includes an antenna 241. The antenna 241 is coupled in a communicative manner with a device controller 240, and the device controller 240 is configured to receive and process data acquired by the RFID reader. The antenna 241 can be described as an RFID reader and can be part of an RFID initiator. In a system according to the present disclosure, the RFID reader including the antenna 241 can be described as an RFID initiator, and the RFID tag of the identifier can be described as a target.

[0038] There are two principles of RFID operation mode. In the first mode, each identifier includes an active RFID tag, and in the second mode, each identifier includes a passive RFID tag. In the active mode, each identifier includes a power supply. This can be an internal battery or a connection to an external power supply. Each tag is configured to generate its own electromagnetic field and send (i.e., provide) identification information. The identifier can provide identification information in response to a signal received from an RFID initiator (so-called transponder or "active transponder" system) or provide identification information at regular intervals (so-called "beacon" system). Each identifier can include a power supply and an active transmitter, which is configured to repeatedly send identification data of the identification component. In the second passive operation mode, the RFID tag of each identifier obtains power from antenna 241. The initiator antenna 241 creates an electromagnetic carrier field, and each RFID target modulates the carrier field in a specific manner to provide identification information.

[0039] In one example according to the first embodiment, the device controller 240 controls the operation of one or more fixed antennas 241 so that the device controller 240 can communicate with RFID tags comprising components of the radiotherapy device 200. In this example, the identifiers include passive RFID tags, and one or more antennas 241 (also referred to as reader antennas) provide power in the form of radio frequency waves to each identifier.

[0040] In this example, the radiotherapy device 200 includes a device controller 240, which is coupled to an RFID tag reader, such as an antenna 241 depicted at 241. The radiotherapy device also includes at least one component and preferably includes a plurality of components, each of which is equipped with, provided with, or otherwise includes an identifier, which includes a passive RFID tag. In operation, the controller sends a signal to the RFID tag reader and also controls the RFID tag reader to query the component identifier. The device controller 240 can then receive identification information from each identifier and interact with the central processor 270 in a manner described elsewhere herein to ensure that each component is properly authorized for use with the device 200. The advantage of this example is that the machine is automatic and can perform its own "authorization check" at any time when prompted by the device controller 240.

[0041] In a related example, a radiotherapy device may include multiple RFID tag readers, each coupled to a device controller 240. This may be described as a reader network or a sensor network. Each tag reader may be disposed around or near the device to ensure that each RFID tag on the device 200 is interrogated and the signal generated by it is received.

[0042] In a second example, a field maintenance engineer uses a dedicated RFID reader or scanner to scan equipment 200. The reader is configured to communicate with the RFID tags, receive signals indicating identification information from each tag, and pass these signals or the decoded identification information to the equipment controller 240.

[0043] Thus, the device controller 240 is configured to receive identification information that the identifier has provided from each component of the device 200. This information may be stored in the device controller memory 240.

[0044] Second Embodiment of the Marker - Optical Mark Recognition

[0045] In a second embodiment according to the present disclosure, each marker comprises an optical tag or an optical marker. For example, the optical marker can be a QR code or a barcode. The optical tag can be used instead of or in combination with RFID tags and other public markers.

[0046] In disclosed embodiments, the optical marking may include a serial number. Several components of the radiotherapy device may include a serial number identification plate. The serial number identification plate may be affixed to a spare component to be added to the radiotherapy device, or alternatively a tamper-proof label that enables a maintenance engineer to scan the component identity.

[0047] These markings can be read by a dedicated optical scanner, which can be located around the radiotherapy device or included in the radiotherapy device. In one example, the radiotherapy device includes multiple optical readers / scanners, such as cameras, each configured and positioned to scan the identifier of at least one component of the radiotherapy device. Each optical reader or scanner is coupled to the device controller 240 to provide identification information about each of the multiple components to the device controller. In another example, each field maintenance engineer carries a dedicated optical scanner configured to read the optical markings / identifiers of each component.

[0048] The third embodiment of the marker - physical marking

[0049] In a third embodiment according to the present disclosure, each identifier includes a physical mark containing identification information. The physical mark may include, for example, lines that together form a mark indicating a unique component ID. For example, a physical mark similar to a QR code may be "printed" on a label fixed to the device or component along with a serial number or other identification details.

[0050] It is also contemplated that a combination of different marker types may be used. For example, the system may include a combination of RFID tags and / or optical tags and / or physical tags.

[0051] Skilled artisans will recognize that while RFID, optical tags, and physical tags are discussed, any automatic identification technology may be used.

[0052] Store a list or log of component IDs in the device controller

[0053] In a disclosed embodiment, the device controller receives identification information from the identifier via the reader 241 and maintains a parts list, log, or database stored in the device controller memory 245. In an example using RFID tags, the reader 241 periodically interrogates each identifier of the radiotherapy device 200, and the device controller periodically updates the database stored in the local memory 245. For example, the device can perform this authorization check every day, such as at midnight every day. If necessary, the database stored in the device controller / local memory 245 can be viewed, accessed, and updated by the device controller 240. The device controller also periodically synchronizes the database with the central controller 270. This can be described as sending data identifying at least one component of the radiotherapy device to the central controller 270. The central controller 270 can then compare the identification data (e.g., data included in the database) received at the central controller 270 with the authorization data in a manner described elsewhere herein.

[0054] The part of the equipment containing the marker

[0055] Any and all components of a radiotherapy device may contain a marker. Exemplary components include magnetrons, electron guns, circulators, waveguides, one or more vacuum pumps, imaging panels, beam shaping devices (e.g., MLCs), bending / steering magnets, and MR imaging devices may include main magnets, gradient coils, receive coils, RF pulse applicators (etc.). It is contemplated that at least the more expensive / higher priced components will be equipped with markers.

[0056] Tamper-evident / tamper-proof mechanism

[0057] Additionally, in some embodiments, each identifier has an anti-tamper or tamper-evident mechanism that allows manufacturers and owners of radiotherapy equipment to prevent or learn of attempts to remove the identifier (e.g., to counterfeit or resell equipment components without authorization).

[0058] For example, there may be physical protection for visually inspected items such as a "Do not use if seal is broken" label. This physical means allows visual inspection of the label to verify the provenance of the label itself.

[0059] System Characteristics: Processor and Authorization Database

[0060] The radiotherapy device also includes a device controller 240 and a device controller memory 245. The device controller 240 is configured to receive or generate identification information identifying at least one component of the radiotherapy device based on information provided by at least one identifier. The device controller 240 is electrically coupled and / or communicatively coupled to the device controller memory 245.

[0061] The device controller 240 is communicatively coupled to the central controller 270 (e.g., via the network 250). The device controller 240 is configured to transmit (i.e., send) data such as identification information to the central controller 270. The central memory 275 may include a server among several different servers as part of a cloud storage solution. The central controller 270 is communicatively coupled to a plurality of radiotherapy devices (not shown) via the network 250. Each radiotherapy device includes a device controller, a device controller memory, and a plurality of components with attached identifiers.

[0062] The device controllers 240 and the central controller 270 can each be described as a processor, a computer, or a computing device. The controllers can be connected to each other (e.g., a network connection) and / or to other machines in a local area network (LAN), an intranet, an extranet, or the Internet (e.g., a network connection). The controllers can each operate as a server or client machine in a client-server network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. The controllers can each be a personal computer (PC), a tablet computer, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a network appliance, a server, a network router, a switch or a bridge, or any machine capable of executing (sequentially or otherwise) a set of commands that specify actions to be performed by the machine. In addition, although Figure 2 While only two controllers are depicted, the term "controller" should also be construed to include any collection of multiple machines (e.g., computers) that individually or collectively execute a set (or multiple sets) of commands to implement one or more of the methods discussed herein.

[0063] The method of the present disclosure can be implemented on one or more device controller memories and remote controller memories or any other computer-readable medium. The medium can be a non-transient computer-readable medium. The computer-readable medium carries computer-readable instructions, which are set to be executed on a processor so that the controller / processor performs any method or all methods described herein. The term "computer-readable medium" used herein refers to any medium storing data and / or instructions for causing the processor to operate in a specific manner. Such storage media may include non-volatile media and / or volatile media. Non-volatile media may include, for example, optical disks or magnetic disks. Volatile media may include dynamic memory. Exemplary forms of storage media include floppy disks, flexible disks, hard disks, solid-state disks, tapes or any other magnetic data storage media, CD-ROMs, any other optical data storage media, any physical media with one or more hole patterns, RAMs, PROMs, EPROMs, FLASH-EPROMs, NVRAMs, and any other memory chips or cassettes.

[0064] The arrangement, system and method of the present disclosure include an authentication database. The authentication database stores information about which components are authorized for use with which radiotherapy equipment. The data forming the authentication database is stored on the central memory 275 and can be queried by the central controller 270. The authentication database includes information about each component of the radiotherapy equipment that has been provided with an identifier. The authentication database stores each unique component ID and information about which radiotherapy equipment each component is authorized by the manufacturer to be used with. Each radiotherapy equipment can be identified by a unique equipment ID. Each unique component ID can be associated with a specific unique radiotherapy equipment ID. Alternatively or in addition, each unique component ID can be associated with a specific service contract. As with each radiotherapy equipment, each service contract has its own unique identification ID. Each radiotherapy equipment has its own service contract, and which component is authorized to be used with the machine can be managed by the terms of the service contract.

[0065] The authorization database may also include information about the owner of the equipment. The authorization database may be queried to determine, for example, which component currently forms part of a particular radiotherapy device, who owns the radiotherapy device, and whether the component that forms part of the machine is authorized for use with the machine. The authorization database may also include information about the remaining time of the warranty period for a particular component, information about the remaining service life of the component, and information about whether the component has been scrapped or considered unsafe to use during repair and maintenance. For example, the authorization database may store information indicating that a particular magnetron (as identified by its unique component ID) has been scrapped. The authorization database may also include information about the operating status of a particular component. The operating status of a component may indicate that the component is considered usable, unsafe to use, within or outside the warranty period, listed as scrapped or "considered scrapped", lost, not authorized to be used by any device, and the like.

[0066] For example, if a magnetron shows signs of failure, the problem can be diagnosed and repaired on site. Alternatively, the magnetron can be sent out through a so-called maintenance loop (sometimes involving the original supplier). The supplier or other off-site inspection point can repair the magnetron and return it to the on-site radiotherapy equipment. Alternatively, the supplier or other off-site inspection point can determine that a specific magnetron is faulty and cannot be repaired. In this case, the authorization database is updated to indicate that the component is no longer valid / authorized for use. If the central controller 270 learns that the component is used by any radiotherapy equipment, it is likely that the safety standards will no longer be met, and the central controller 270 determines that the equipment is not authorized for use.

[0067] The radiotherapy device 200 also includes an authorization mechanism 290. The authorization mechanism 290 is controlled by the device controller 240. The authorization mechanism 290 is configured to allow or not allow the operation of the radiotherapy device based on information provided by the device controller. In an exemplary embodiment, the authorization mechanism 290 includes an automatic stop or shut down mechanism that can stop or shut down the radiotherapy device 200. The authorization mechanism 290 is a safety mechanism that is configured to interrupt the operation of the radiotherapy device 200 if any component forming part of the device 200 is not authorized for use with the machine.

[0068] In a simple exemplary embodiment of the authorization mechanism 290, the mechanism includes a controllable switch located between a power source configured to power the radiotherapy device 200 and the device 200 itself. When the switch is closed, power is supplied to the radiotherapy device 200 in accordance with normal operation of the device. However, if the device controller 240 realizes that a safety standard has not been met, the switch is opened and therefore the radiotherapy device 200 cannot be powered on, rendering the radiotherapy device 200 inoperable. As will be discussed in more detail elsewhere herein, safety standards may relate to whether a particular component is authorized for use with the machine, whether a component has been or should be scrapped, or whether the age of a component has exceeded its useful life.

[0069] The authorization mechanism may incorporate existing known clinical safety checks. For example, it is known to perform a check to confirm whether the system can be used clinically, which is always checked when a clinical user logs in. This simple mechanism may be an implementation of the authorization mechanism.

[0070] It is also possible to have multiple mechanisms to shut down power to specific components. For example, if an electron gun is not authorized for use with the machine, the power to the electron gun can be shut down. In another example, if a fault is detected in the imaging flat panel, but the user is not imaging a patient during this time, the device can be determined to be authorized for use and the device can still operate. It is conceivable to have multiple authorization mechanisms based on the (clinical) techniques that the user is expected to use during this time. If all authorization checks are successful, the device is authorized for use and the user can continue to work.

[0071] method

[0072] Figure 3 A flowchart depicts a method according to the present disclosure. The method is suitable for execution, for example, by a central controller 270. In step 310, data identifying at least one component of a radiotherapy device is received. The data may be described as identification data or identification information. The identification data may be received from a device controller 240 associated with the radiotherapy device 200, or directly from a dedicated reader (e.g., an RFID reader or an optical tag scanner). The identification data includes information that allows a specific component of the radiotherapy device to be identified. The identification data may include a unique ID assigned to the component when the component is manufactured, as discussed elsewhere herein. The identification information may also include a unique device ID that identifies the radiotherapy device 200. In other words, the identification data may include information that allows the radiotherapy device and at least one component of the radiotherapy device to be identified.

[0073] In a preferred embodiment, the identification data comprises information allowing each of a plurality of components of the radiotherapy device or machine to be identified.The data identifying at least one component of the radiotherapy device may comprise a list or catalogue of component IDs.

[0074] In a simple example, the device controller 240 receives identification information from a magnetron, electron gun, or dosimeter of a linear accelerator device. The identification information includes a unique ID for each of the magnetron, electron gun, and dosimeter and a unique ID for the radiotherapy device of which they form a part. The device controller 240 may pass the identification information to the central controller 270 via the network 250, and the central controller receives the identification information at step 310.

[0075] At step 320, the identification information and the authorization data are compared based on at least one authorization criterion. The authorization criterion may also be described as a security criterion. The authorization data is stored in an authorization database. The comparison may include querying the authorization database stored in the central memory 275 by the central controller 270. The comparison includes checking whether the security criterion is met. Checking whether the security criterion is met may include checking that each component identified in the identification data received at step 310 is listed as authorized for use with the radiotherapy machine 200 of which they form a part. For each component, the security criterion may be that the component is listed in a specific operating state. For example, step 320 may include ensuring that the component is not considered to have been lost, scrapped or damaged, or is not considered to be operating outside its safety parameters, based on information contained in the authorization database. Checking whether the security criterion is met may include checking whether each component is authorized for use under a specific service contract. The service contract may be identified by a unique identification ID, which in turn may be tied to a specific radiotherapy device or machine. This means that a specific component may be authorized for use under a specific service contract, which in turn authorizes the component to be used with a specific machine.

[0076] In step 330, it is determined whether the security criteria are met. This step is based on the comparison of step 320 discussed above. In other words, it is determined whether the security criteria are met by comparing the identification data with the authorization data.

[0077] If the safety standards are met, the radiotherapy equipment is authorized for use in step 340. In other words, the equipment is considered safe and suitable for operation. In the simple example given above, in which the identification data includes information about only three components (i.e., a magnetron, an electron gun, and a dosimeter), it can be determined that each of these components is authorized for use under a service contract bound to the radiotherapy equipment in which they are currently located. Therefore, the equipment is considered to be safe for operation. It will be understood that safety standards can be designed according to the specific goals of the manufacturer, such as to ensure that regulatory requirements are met, that components that should have been scrapped are not present in the equipment, and that no components are improperly installed in a machine in which the components are not authorized for use. If the safety standards are not met, the equipment is not authorized for use in step 350. This can include determining that the equipment is unsafe to operate.

[0078] Optionally, after one or both of steps 340 and 350, the method further comprises sending a message or indication to the device controller 240 indicating whether the at least one component is authorized for use with the radiotherapy device. In other words, the indication indicates that the at least one safety standard has been met, or that the at least one safety standard has not been met. This will refer to Figure 4 In the disclosed embodiment, in response to determining at step 350 that a component of the radiotherapy device is not authorized for use, an email or other message indicating the reason for the authorization failure is sent to the device owner and / or an Elekta maintenance engineer. This allows the owner or engineer to decide whether the system requires human intervention.

[0079] Figure 4 The flowchart of FIG. 1 depicts a method according to the present disclosure. The method is suitable for being executed, for example, by the device controller 240 of the radiotherapy device 200, or by a combination of a dedicated identifier / tag reader and the device controller 240.

[0080] In step 410, data identifying at least one component of the radiotherapy device is received. The manner in which the data is received depends on the specific implementation of the automatic identification technology. For example, the identification information can be received at the device controller after an RFID tag disposed on each component is interrogated by an antenna in communication with the device controller. Alternatively, a field maintenance engineer can use an RFID, optical tag, or physical tag scanner or reader to scan each identifier associated with the radiotherapy device. The scanner or reader may include a processor that allows the scanner or reader to process signals or information received from the component identifier.

[0081] In the example where radiotherapy equipment comprises a plurality of components, each having its own identifier, the data identifying at least one component of the radiotherapy equipment may comprise data identifying a plurality of equipment. This may be in the form of a list or catalogue of component IDs.

[0082] At step 420, the identification information is sent to the central processor for comparison with the authorization data. It will be appreciated that the scanner or reader may be in communication with the network 250 and may therefore send the information collected from the identifier directly to the central processor 270. Alternatively, the scanner or reader may send the information to the device controller 240 to allow the device controller 240 to send the identification data to the central processor 270. Figure 3 In step 310, data identifying at least one component of a radiotherapy device is received by a central processor.

[0083] At step 430, an indication is received indicating whether the at least one component is authorized for use with the radiation therapy device. The indication may be received from the central processor 270 after determining at step 330 whether the at least one safety criterion is satisfied.

[0084] In response to receiving the indication at step 430, the device controller 240 may send a signal to the authorization authority. The device controller 240 sends a signal to the authorization authority 290 based on the received indication, and the authorization authority 290 allows the device 200 to operate or stops the device 200 from operating based on the signal. In one example, the device controller 240 allows the radiotherapy device to operate in response to receiving an indication that all components of the device are authorized for use with the radiotherapy device.

[0085] In a simple example, refer to Figure 3 and Figure 4 In a method, data identifying a particular magnetron forming part of a particular radiotherapy machine is received at a central controller 270. The identification data is compared with data forming part of an authorization database, and it is determined that the magnetron has been incorrectly installed in a particular radiotherapy device. Data stored in the authorization database indicates that the magnetron is instead authorized for use with another different radiotherapy machine owned by the same hospital. Therefore, the safety standards are not met and the particular radiotherapy device is not authorized for use. The central processor 270 transmits the decision to the device controller 240, which in turn commands the authorization authority to prevent the device from operating. The device is prevented from operating until the magnetron component has been replaced with a correctly authorized component and the device controller 240 has received an indication of the correct authorization from the central controller 270.

[0086] In some embodiments, instead of utilizing an authorization body that can control whether the device can be operated, or in addition to this functionality, one or more notifications can be issued after the authorization in step 340 or the determination in step 350 that the device should not be authorized. For example, after step 350, a notification can be issued to the device manufacturer, informing the manufacturer of any components in the radiotherapy device in step 330 that do not meet safety standards or safety guidelines. For example, the manufacturer can be informed that one or more components are not authorized for use with the radiotherapy device of which they now form a part. A notification can also be sent to the device owner to inform of any components that do not meet safety standards or guidelines. The notification itself can be displayed as a warning on the display control screen or an automatically generated email to inform the manufacturer which components the authorization check was unsuccessful. The identification of components that are not authorized for use with the radiotherapy device can result in the recording of any such components in an event log stored in the device controller memory 245 and / or the central controller memory 275.

[0087] The method disclosed herein reduces the time and possible errors associated with manually checking that the parts of radiotherapy equipment are correctly authorized. The disclosed method allows for stronger control over which parts form a part of the radiotherapy equipment. Therefore, it can ensure that only certified or authorized parts form a part of the equipment. Before the equipment is declared operable during service, counterfeiting, unauthorized repair and resale of replacement machine parts can be identified and prevented. This method helps manufacturers, machine owners and other supply chain entities to ensure compliance with regulations and ensure that counterfeit or uncertified re-repaired parts cannot be circulated and cannot be used.

[0088] Data log

[0089] The authorization database may also include a log of all service-related actions performed on, with, or associated with a specific equipment component. This can be described as a service log of actions performed by an engineer. For example, each time a specific component is repaired, a field maintenance engineer updates the database with the details of the repair. When a service action involves replacing a component, this should be recorded and verified by an automatic startup program. Combined with the history of information (e.g., an initial list stored locally in the device or centrally stored) of regularly received identification of specific equipment components that form a part of the equipment and the event log of the service action, a field maintenance engineer can confirm locally or remotely which new components have been assembled, when they were replaced, and by whom they were replaced.

[0090] The data log may store other data in addition to or in lieu of the service-related data. The method may include maintaining a data log storing received data identifying each of the plurality of components. The data log may be stored locally in the device, or centrally. The data log may form part of a central authorisation database.

[0091] In one example, the installation time of each of the plurality of components can be from a data log. In this example, the data log stores the received identification data and a timestamp indicating the date of data reception. The time from the earliest timestamp associated with that component until the current time represents the installation time of that component. The method includes storing the data in the data log. In this example, the authorization data includes the service life of one or more of the plurality of components, and the authorization criteria include an installation time threshold. Therefore, determining whether at least one authorization criterion is met may include comparing the installation time with the service life based on the installation time threshold. According to one example, the service life of the electron gun of the radiotherapy device is listed as 12 months in the authorization database. The service life may be based on information provided by the manufacturer, or may be based on data from service-related actions associated with the particular electron gun. The service life may be based on data received from the electron gun and / or the device regarding the performance of the electron gun. The earliest recorded identification information received from the electron gun indicated in the data log of the radiotherapy device was received 11 months ago. Based on the installation time threshold of the electron gun of 1 month, that is, 1 month from reaching the end of its service life, the radiotherapy device is considered to be unauthorized for use. The method may also include sending a series of instructions and / or warnings to the user equipment manufacturer when the installation time of the electron gun approaches the service life. This comparison of installation time and service life can be used to trigger the ordering of spare parts or the appointment of a service point, thereby reducing machine downtime.

[0092] In another example, the authorization threshold is not based on the installation time, but the expected position. In this example, each identifier includes a power supply and an active transmitter, which is configured to repeatedly send data identifying the component. The radiotherapy device includes a receiver, which is configured to receive a signal from the active transmitter of the identifier. Based on the signal strength at the receiver, the position of the active transmitter can be determined using known techniques such as triangulation, and thus the position of the component or item to which the identifier is fixed. In this way, the position of each of the multiple components can be derived from the data log. In this example, the method also includes determining the signal strength when receiving data identifying the component from the active transmitter, and recording the signal strength in the data log along with the received identification data. The user can view the data log to view each ping location in order to view the movement of the identifier, and therefore the movement of the component to which the identifier is attached. The user can request the last known position of one or more of the multiple components, and the radiotherapy device processor will provide the user with the position in response to the request. The position can be provided to the device with which the user makes the request. As described below, the use of multiple receivers allows the position of the component to be determined more accurately in two or more coordinate axes. For example, two receivers spatially separated along an axis parallel to the ground can be used to determine the approximate coordinates of a marker on that axis.

[0093] In this example, the authorization data may include an expected position of one or more of the plurality of components, and the authorization criteria may include a distance threshold. Determining whether at least one of the authorization criteria is met includes comparing the determined position of the component to the expected position of the component based on the distance threshold. In one example, based on the distance measurement from the radiotherapy machine, it may be determined that the component has been unloaded or not properly installed in the correct radiotherapy machine. This functionality may be used to resolve irregularities in the operation of components in the field, which sometimes results in components being installed in incorrect radiotherapy machines.

[0094] The method may also include receiving data identifying a newly installed component of the radiotherapy device from an identifier coupled to the newly installed component. The identification data associated with the component cannot be found in the data log stored in the radiotherapy device memory, indicating that the component is a new component. This determination can be confirmed by querying a central authorization database to determine whether the new component is authorized for use with the radiotherapy machine. Therefore, the method may also include determining that the newly installed component is newly installed based on the received identification data and the data stored in the data log, and determining whether at least one authorization criterion is met based on the identification information and authorization data received from the newly installed component. If at least one authorization criterion is met, the radiotherapy device is authorized for use.

[0095] Scan and view replacement parts

[0096] In a particular embodiment, when a radiotherapy device is first built on site (e.g., in a hospital), it will not operate until the identity of each component has been checked with a central authorization database and authorized by a central controller. Thereafter, each time the machine is serviced or repaired, before the device becomes operational, it will again be checked whether its components are authorized for use before it becomes operational.

[0097] In a simple example, a field maintenance engineer attends to a device that has been determined to be operating poorly. The engineer determines that the fault is related to a magnetron. The engineer determines that in order to correct the fault, the magnetron must be replaced. In the following procedure, the engineer removes the old, faulty magnetron from the radiotherapy machine and updates the central database to indicate that the magnetron has been scrapped. Similarly, the database can be updated to indicate that the operating status of the old magnetron is faulty or inoperable. The field maintenance engineer updates the database to reflect that a new replacement magnetron has been installed in the radiotherapy machine. The new magnetron is now listed as authorized for use by the radiotherapy machine, while the old faulty magnetron is now listed as not authorized for use with any radiotherapy machine. When the radiotherapy machine has been repaired and powered on for operation, data identifying the replacement magnetron is received at the device controller and sent to the central controller to be compared with the authorization data. The device can only be operated when the new part is authorized. Similarly, if at a later date a unique ID associated with an old, defunct magnetron is received at the central controller 270, authorization for that part will fail and the device containing the defunct magnetron will not be considered operational.

[0098] Tracking the removal of parts from radiotherapy equipment

[0099] According to one example, the method may include: connecting a power supply of each identifier to a device power source; determining that a component of the plurality of components has been disconnected from the device power source; and continuing to receive identification data and recording the signal strength and the received identification data in a data log.

[0100] When installed on a radiotherapy device, the internal power supply of the active marker is continuously charged due to its connection to the radiotherapy device power supply. When extracted from the device, the component tracking signal will be activated. For example, a chip or small processor forming part of the marker will determine that it is no longer being charged by the radiotherapy device. The radiotherapy device itself may also determine that the marker has been disconnected from the device power supply and that the component is undergoing maintenance action, being replaced, or otherwise disconnected from the radiotherapy device.

[0101] As part of the "Teardown" action currently in effect when replacing a component, the FSE tags the return event with ID (component + serial #). Per the outbound event protocol, the component location will be registered. Each ping will be logged until out of range. Since items left for collection on hospital premises will be picked up by the courier, the component will remain in range until it is picked up.

[0102] Update and maintain accuracy of central database

[0103] Specific field maintenance engineers can be granted access to the database based on their seniority, qualifications and / or length of time in the service and repair industry, etc. Logistics and supply chain personnel can also be granted specific access rights, allowing them to update the authorized database based on their respective access rights.

[0104] In some examples, a component unique ID is generated at the time of manufacture. A component is assigned a specific ID, such as its serial number, and an entry is created for the component in the authorization database. The entry indicates the type of component and its unique ID as well as its status. The status of a component may indicate, for example, that it has been purchased by a maintenance / repair entity and / or may indicate that the component is in a warehouse. Each status may also have an associated timestamp, which allows the authorization database to be used to determine how long a particular item or component has been in storage.

[0105] Once it is determined that a particular radiotherapy device requires a replacement part, such as by field testing by a field maintenance engineer or by predictive or diagnostic maintenance techniques, an order can be processed for that part and its status can be updated from an indication that it is in the warehouse to an indication that it is en route to the particular radiotherapy device. At this point, the authorization database is updated to indicate that the particular part is for use with the particular radiotherapy device.

[0106] Alternatively, when installing new parts or replacing parts, the authorization database can be updated by an authorized field maintenance engineer at the equipment site. In this example, the engineer updates the database through his own special computer or through the equipment controller 240 to indicate that the part has been installed in a specific device and is therefore authorized to be used with the device.

[0107] Other embodiments

[0108] It will be understood that the description of the above specific embodiments is by way of example only and is not intended to limit the scope of the present disclosure. Many modifications of the described embodiments are contemplated, some of which will now be described, and many modifications of the described embodiments are intended to fall within the scope of the present disclosure.

[0109] Inventory Management

[0110] The presence of RFID tags on various components of radiotherapy equipment is also beneficial in the areas of inventory management and asset tracking. A central database can store information about "events" associated with each specific component. These events can have associated event data, such as the location of the identifier of each component and which RFID reader is read. As part of these embodiments, multiple antenna readers are placed along the supply chain so that readers can scan equipment components at key times and key locations during the service life of the equipment components. Event data can include the location and time when the component is scanned by the tag (identifier) ​​reader. Event data can also include information identifying the component scanned by the tag reader.

[0111] For example, refer to Figure 3 and Figure 4 In one example, an engineer updates a central authorization database to indicate that at least one component of a radiotherapy device does not meet safety standards and / or that at least one component is no longer authorized for use with a particular radiotherapy device. The component may be an electron gun, for example, which has reached the end of its useful life and is therefore no longer suitable for use with a radiotherapy device. The engineer updates the database to reflect that the electron gun is about to be scrapped and destroyed. Identification data associated with the electron gun, which may be derived from an identifier, is now associated with authorization data stored in a central memory, which indicates that the electron gun has been scrapped and is not authorized for use with any radiotherapy device.

[0112] When it has been determined that a component requires scrapping and / or destruction, a field maintenance engineer on site removes it and takes it to a scrapping site, or arranges for the component to be collected and transported to a scrapping site. These actions are determined by logistics procedures.

[0113] The presence of the identifier allows the electron gun to be tracked on its journey when it goes to an officially certified scrapping site. Tag readers can be placed at the entrance / exit of the manufacturer's loading vehicle to record and enter which parts and machine components have been loaded onto the vehicle. In this example, when the scrapped electron gun is loaded onto a vehicle at the hospital site to be taken away from the site for scrapping, the antenna tag at the vehicle loading door reads the electron gun tag, and the central authorization database is updated to reflect that a new event has occurred regarding the component, that is, the component has been loaded onto the vehicle for transportation to the scrapping site. When the component is unloaded from the transport vehicle and when the component arrives at the scrapping site, the component is also scanned similarly and the relevant event data is recorded. This function helps to ensure that when a component is deemed unsuitable for use in a radiotherapy device, the component is indeed completely scrapped or properly disposed of, and therefore helps manufacturers meet their regulatory requirements as maintenance suppliers.

[0114] In other examples of the disclosed embodiments, this functionality is also used when shipping / transporting components to the site. For example, when a component leaves a factory or warehouse, a tag reader placed at the warehouse exit reads the tag and updates a central database to record new events related to the component. For example, new event data may indicate that the component has left the warehouse. Subsequent events may include scanning the component and reading its identifier when the component is loaded onto a transport vehicle, and scanning the component again and reading its identifier when the component arrives at a hospital or other machine site.

[0115] Using the disclosed methods together, it is possible to determine when a warranty period associated with a relationship between a supplier of a component (e.g., a magnetron) and a supplier of the device begins (e.g., the warranty period may begin when the component is provided to the supplier of the device), and when a warranty period associated with a relationship between a supplier of the radiotherapy device and a customer / purchaser of the radiotherapy device begins (the warranty period may begin when the purchaser / owner begins using the device). Making the warranty period of components in stock visible helps companies manage their inventory more efficiently and in a manner that ensures that components are provided within the correct warranty period. The disclosed methods also help avoid situations where undesirable warranty mismatches occur, which could result in situations where a supplier of the radiotherapy device is obligated to repair a faulty component even when the component was provided by a third-party supplier.

[0116] A problem with prior art arrangements and methods is that engineers / couriers often have difficulty locating physical items (including parts for radiotherapy equipment) on hospital premises. Hospitals are large, sprawling and complex with multiple entry points (reception desk(s), incoming goods, outbuildings etc.), which means that tracking delivery and / or pickup points can be difficult or impossible.

[0117] The present application relates to assembling a plurality of components of a radiotherapy device and / or other physical items associated with the maintenance and assembly of the radiotherapy device with an identifier capable of providing identification information about the component. For example, a unique ID. Preferably, the identifier includes a power source and an active transmitter, the active transmitter being configured to repeatedly (e.g., at regular or intermittent intervals) transmit the identification information. The signal generated by the component / machine for the authorization scheme can be used to locate the component and nearby items, for example, using RFID / WIFI.

[0118] This location sensing and tracking solution can be used throughout the supply chain. For example, a component for delivery may be equipped with a small power supply that is activated by the shipping store when a request is received to ship a component of a device or other item to a hospital location. The activation process obtains the unique ID of the component (item + serial number #) and updates the authorization database to indicate that the component is associated with specific shipment information (order + tracking id). The identifier is configured to intermittently transmit an ID signal on a dedicated channel that can be received by receivers within a certain range. Once within the range of any such receiver (for example, one or more receivers forming part of a radiotherapy device), the component location is registered on a central authorization database and updated on a per ping basis.

[0119] As described above, when within the range of a properly configured receiver, each ping location can be stored in a log file to show the movement of the marker and therefore the movement of the component to which the marker is attached. Engineers / operators can access the location database to view the real-time (last known) location of the component. The data log can be used to calculate the potential vector of the component or item when it is out of range. The potential vector can be used to help track the component or item (for example, if the component or item is considered lost). A "receiver" (forming part of a radiotherapy machine and / or appropriately arranged throughout the hospital) will have a variable receiver site to detect the position on the transverse plane and the rise relative to the machine. The radiotherapy equipment may include a plurality of receivers, which are separated from each other in space, each of which is configured to receive a signal from a marker, and the marker sends identification data about their components / articles. Therefore, the receiver can be used to determine the position of the component in multiple coordinate axes, for example, based on the signal strength received by each receiver in the plurality of receivers by using triangulation techniques. The combination of multiple machines (each having one or more receivers) allows the relative distance to be calculated to more accurately determine the position of the component.

[0120] According to one example, each hospital is mapped in 3D with the locations of radiotherapy equipment marked on the map. This gives engineers and / or operational users a visual representation to determine the relative location of a component and, based on the determined distance of the component from each of the various receivers, determine which equipment the component is likely to be installed on or where in the hospital the component or item can be found.

[0121] Interaction between authorization data and event data

[0122] In other implementations of the disclosed concept, differences between stored authorization data relating to a particular component and stored event data regarding the particular component may be automatically flagged.

[0123] For example, if a magnetron has been deemed faulty by a remote maintenance engineer, its authentication data will indicate that it is not authorized for use with any radiotherapy equipment. This indication will be inconsistent with event data showing, for example, that the part has been returned to a warehouse rather than a scrapping site. More generally, the authorization data will also be inconsistent with event data indicating that a faulty magnetron has been loaded onto a transport vehicle but never arrived at the scrapping site. These discrepancies can be flagged and handled by the central controller / processor.

[0124] In another example, it may be determined that a particular component, such as a waveguide, is authorized for use with a particular radiotherapy device at a particular hospital. Then, the last available event data indicates that the waveguide has been shipped to a different location. Thus, using the disclosed method, there are at least two possible ways to confirm that the waveguide has been installed in a device for which it is not authorized. In the first method, when the waveguide is installed in an "incorrect" radiotherapy device, it will be detected based on the Figure 3 and Figure 4 . The device will read the label on the waveguide and thereby receive (410) data identifying the waveguide, send (420) the identification data to the central processor for comparison with the authorization data, and receive (430) an indication that the waveguide is not authorized for use with the radiotherapy device. This may trigger other actions, such as an alarm that the device is not operating within regulations and / or safety requirements, a prompt on a screen, a central database may be updated to schedule a maintenance engineer to visit to check the authorization status of the waveguide, the device may be blocked from operation by an authorization agency, etc. In another independent method that does not rely on a self-authorization check performed by the device, the central processor may check the database for inconsistencies or "flags". An inconsistency will occur when it is noted that the waveguide authorization data indicating that the waveguide is authorized for use with the "correct" radiotherapy device or a particular customer or hospital does not match the location indicated by the event data where the waveguide was delivered. This may trigger any, some, or all of the above triggers.

[0125] Using the disclosed methods, differences between “event data” (i.e., the location and time the part was scanned) and “authorization data” (i.e., the location and hospital where the part is authorized for use) can be identified and discovered algorithmically, using AI, or by humans and quickly acted upon.

[0126] The method disclosed herein reduces the time and possible errors associated with manually checking that the components of radiotherapy equipment are correctly authorized. The disclosed method allows for stronger control of the components that form a part of the radiotherapy equipment. Therefore, it can ensure that only certified or authorized components form a part of the equipment. Forgery and unauthorized repair and resale of replacement machine components can be confirmed and prevented during maintenance before declaring the equipment operational. The present method helps manufacturers, machine owners and other supply chain entities to ensure regulatory compliance and ensure that forged or uncertified repaired components cannot be circulated and used.

[0127] The method disclosed herein allows automatic tracking of changes in key machine components on each radiotherapy device. It is beneficial to prevent unauthorized components from being installed on the device, or at least to identify such installation. Component components can be tracked through the supply chain and warehouse, including continuous tracking of components in FSE trucks and FSE personal warehouses. Key components can be tracked when they are returned to the manufacturer for scrapping. The method disclosed herein allows automatic triggering of service point appointments and spare component orders. The use of each component can be tracked by age, and repeated changes in specific components (such as expensive components) can be monitored. The equipment construction status (configuration) when the equipment leaves the factory can be retained. The movement of individual component components throughout the system (including equipment to equipment) can be tracked. The implementation and compatibility management of FCO can be tracked. Faulty components confirmed according to the recommendations of the original component manufacturer can be located and tracked. By tracking the component component type version as part of the identification data, it is possible to quickly confirm that the control system software is incompatible with certain component type versions.

[0128] On-site maintenance engineer authorization

[0129] When performing repairs or scheduled maintenance at a location, a field maintenance engineer (FSE) often needs to access the equipment controller, that is, a computer or computer system located at the site of the radiotherapy equipment. The field maintenance engineer may need to view information related to the operation of the equipment, such as information from the previous few weeks or months, to help diagnose the problem. For example, the field maintenance engineer can view information related to the current or power supplied to a specific component in the past few weeks. By comparing the data with existing thresholds and data patterns, specific problems can usually be diagnosed, or possible causes of the problem can be eliminated. The equipment controller also controls some operating parameters of the equipment. The field maintenance engineer can adjust these parameters in order to perform diagnostic tests. Alternatively, the field maintenance engineer can adjust these parameters in order to solve specific problems and thus ensure that the equipment continues to operate within safe parameters.

[0130] For example, the optimum current to be supplied to the cathode of the electron gun in order to provide a particular linear accelerator beam energy decreases with aging and decay of the cathode filament. Thus, the current through the filament required to ensure the maximum dose rate for a particular linear accelerator energy decreases over time. Correcting the optimum gun current for a particular linear accelerator energy is part of a routine service check performed by a field maintenance engineer.

[0131] In addition, when a radiotherapy device encounters a problem during operation and a safety interruption occurs, information related to the interruption (such as the time and reason for the interruption) will be stored in the device controller. Depending on the nature of the safety interruption, the device controller may require an authorized engineer to access the device controller and confirm that the problem has been resolved and / or the radiotherapy device is fit for operation again.

[0132] However, it will be understood that access to the device controller should be limited to authorized field maintenance engineers or other authorized personnel, such as clinicians. Often, general engineers or even field clinicians will attempt to repair or service the device, however, without the correct knowledge and training, even seemingly simple repairs can lead to complications and errors.

[0133] Thus, in the disclosed method, the radiotherapy equipment may require potential maintenance engineers to identify themselves and after passing an authorization check, they are deemed authorized to maintain and / or repair the radiotherapy equipment.

[0134] In this method, an authorization database stores data about which maintenance engineers are authorized to maintain a specific radiotherapy machine. The authorization database stores data related to each maintenance engineer. The authorization data may indicate that a specific engineer is authorized to, for example, maintain all machines of a specific type or category. An engineer may be authorized to perform certain activities but not other activities; for example, an engineer may be authorized to install a specific device but not to repair a specific device. The authorization data may indicate that a specific engineer is authorized to perform a specific maintenance activity based on the characteristics of the device (e.g., type, model, age) and who owns the device (e.g., a specific hospital). The authorization data may authorize engineers based on the content of a maintenance contract related to a specific customer, device, device group, device type, etc. The authorization data may indicate that a specific engineer is authorized to perform a specific maintenance activity based on the device owner or the hospital associated with the device, for example, an engineer may be authorized to maintain all linear accelerator radiotherapy devices owned by a specific hospital, rather than linear accelerator radiotherapy devices owned by different hospitals. Different engineers may also be authorized by component or member type. For example, a specific engineer may have been trained on a specific component and is therefore authorized to maintain magnetrons and related devices, but may not have been trained on being authorized to maintain electron guns. This authorization is usually based on the training the engineer has undergone and the materials they have read and / or the hardware and software tools they have been trained to use.

[0135] Equipment and facilities

[0136] The apparatus and infrastructure for performing the method are generally similar to those described above. A central computer, processor, or "controller" 270 can access an authorization database stored in a central memory 275. A computer, processor, or "controller" 240 located at the radiotherapy device 200 is communicatively coupled to the central processor 270 (e.g., via a network 250). In the manner generally described above, the device controller 240 is capable of requesting and receiving information from the central controller 270 and the central memory 275, and the central processor 270 is capable of requesting and receiving information from the device controller 240 and the device controller memory 245.

[0137] In addition, when performing this further method, each device controller is communicatively coupled to an input device. The input device may include an input device, system or arrangement. The input device is arranged to collect identification information from a potential maintenance engineer and pass the identification information to the device controller 240. The input device may include any of the following: a keyboard, a touch screen or GUI, a scanner or input mechanism for biometric recognition (e.g., a fingerprint scanner, a retinal scanner, a camera arrangement configured to scan the face of a potential maintenance engineer as part of a facial recognition system, or a microphone arrangement configured to capture and evaluate / review the voice of a potential maintenance engineer as part of a voice recognition system). The input device may include a device that allows information about the signature of a potential maintenance engineer to be collected, for example, the input device may include an electronic pen and notepad or a similar system that allows the characteristics of the engineer's signature to be measured according to known signature analysis and authorization methods, such as the shape, size, pressure of the signature when signing, the tilt angle of the pen, etc.

[0138] In one example, each field maintenance engineer (FSE) has his own portable processing device, such as a laptop computer. The laptop computer can be provided by the maintenance and repair company where the field maintenance engineer works. The laptop computer is an input device and can be connected to the equipment controller 240, which is located at the radiotherapy equipment and coupled to the radiotherapy equipment. For example, the field maintenance engineer's laptop computer can be coupled to the equipment controller via a LAN or Ethernet cable. Once coupled to the equipment controller, the field maintenance engineer's laptop computer can send a query request to the controller to determine the identity of the radiotherapy equipment. The radiotherapy equipment controller then sends back identification information that identifies the radiotherapy equipment, such as a unique ID number for the equipment. As will be explained in more detail below, the field maintenance engineer's laptop computer and other processing devices can store or host a dedicated access control application that stores information related to the access rights of a specific field maintenance engineer.

[0139] Cloud / central computer "perspective" approach

[0140] Figure 5 The flowchart of depicts a method according to the present disclosure. The method is suitable for execution by, for example, a central controller 270. In step 510, engineer identification data identifying at least one potential maintenance engineer is received. The data can be described as identification data or identification information that identifies at least one potentially authorized maintenance engineer. The identification data can be received from an equipment controller 240 associated with the radiotherapy equipment 200, or directly from a processing device associated with the potential engineers themselves (such as their mobile device). The form and content of the identification data depends on the input device used. The engineer identification data is entered or provided by the engineer via an input device. For example, in an embodiment utilizing the use of a keyboard or touch screen, the identification data may include a username and password.

[0141] At step 520, device identification data or device identification information identifying at least one radiotherapy device is received. This may include a device unique ID. The device identification data may include product name, type, age, repair and maintenance status, and owner information. It should be noted that step 520 may be performed before step 510, or the information may be provided to the central controller simultaneously as part of the same query, communication, or message.

[0142] At step 530, the identification data is compared to the authorization data based on at least one authorization criterion. The comparison may include querying an authorization database stored in central memory 275 by central controller 270. At step 540, a determination is made as to whether at least one authorization criterion is satisfied. Steps 530 and 540 may be described as determining whether the authorization criterion is satisfied based on the engineer identification data, the equipment identification data, and the authorization data.

[0143] The authorization criteria are based on information stored in an authorization database. The authorization database may store any or all of the following information: information related to the skills / training of each field maintenance engineer; hardware and software tools that can be used to repair each of a plurality of radiotherapy devices; manuals or other documents that may be useful to field maintenance engineers when repairing radiotherapy devices; specific machine configuration information, for example, specific machine configuration information based on installed base information and / or specific machine configuration information uploaded when each device is installed; the type of actions planned to be performed on the machine, such as corrective, planned, or preventive maintenance; optional or mandatory upgrades, or new installations; data on components (both hardware and software) that have been changed or installed during past site visits. This data will update the machine configuration recorded in the Installed Base database; and the maintenance contracts associated with each machine.

[0144] The authorization criteria may be based on any or all of the information stored in the authorization database. The authorization criteria may simply be that an engineer identified by the engineer identification data should be listed in the authorization database as authorized to maintain the radiotherapy equipment identified by the device identification data.

[0145] Each field maintenance engineer may have an authorization "level". The authorization level assigned to a particular field maintenance engineer may be based on any courses and training they have taken, their qualifications and / or experience, the materials they have indicated they have read, and any other factors detailed above that are stored in the authorization database. The authorization level may be personalized for a particular field maintenance engineer. The access rights granted to a field maintenance engineer may be based on the field maintenance engineer's authorization level. For example, the ability to adjust operating parameters associated with a particular machine component may be limited based on the authorization level.

[0146] If the authorization criteria are met, then at step 550, the engineer is authorized to maintain the radiotherapy equipment. A notification or communication that the maintenance engineer is authorized to maintain the equipment is sent to the equipment controller 240. The notification may indicate access rights that are specific to the particular engineer. Authorizing the engineer to maintain the radiotherapy equipment may include providing the engineer with a stored or one-time password and / or user name, which grants specific access to the equipment controller, through the equipment controller or a portable processing device associated with the field maintenance engineer. If a one-time password is generated, the password may have a time limit so that the field maintenance engineer is authorized to have specific access rights only during a limited time (e.g., a specific day). After that time, the field maintenance engineer's access rights expire and he or she must pass the authorization check again.

[0147] If access is granted via a field maintenance engineer's laptop or other portable processing device, the expiration of access rights is controlled by an access control application on the laptop. At regular intervals, the laptop reestablishes a connection to the authorized software on the machine being accessed.

[0148] After this step, access to certain functions on the device controller 240 may be granted based on the communicated access rights. In other words, access rights and / or permissions may be granted to authorized maintenance engineers. The access rights may include the ability to adjust parameters related to the operation of the radiotherapy device, such as the current and power levels at or supplied to specific components of the radiotherapy device, the ability to adjust the alignment of the beam using a beam alignment system, and the like. The access rights may include the ability to view and edit usage data related to the components of the radiotherapy device. The access rights may include the ability to view and edit manuals and technical information about each component of the radiotherapy device.

[0149] As discussed elsewhere in this article, the access rights granted to field maintenance engineers are determined by the product and the skills of the specific field maintenance engineer. Some radiotherapy equipment may have a single level of maintenance access rights. However, some complex products, such as linear accelerator equipment, may have different access levels, that is, different authorization levels may be assigned to different field maintenance engineers. For example, calibration of radiation energy is a very technical skill that requires a lot of knowledge and training, and requires training that is different from replacing some other mechanical / electronic components. To give another example, maintenance work related to motors or potentiometers and related to geometric calibration requires different skills from replacing magnetrons.

[0150] Alternatively, if the authorization criteria are not met, the engineer is not authorized to maintain the radiotherapy machine at step 560. In this case, certain access rights and / or permissions described above are not granted. In addition, the authorization database may be updated to indicate that an unauthorized engineer attempted to access restricted information or functionality at the equipment controller 240.

[0151] In some embodiments, the authorization database is updated with event data indicating that someone attempted to maintain the radiotherapy device or access the device controller 240. The authorization database may be updated for the identified radiotherapy device with any of the following information: the name of the maintenance engineer, the time when the engineer attempted to maintain or access the radiotherapy device (whether the attempt was successful or not), etc.

[0152] Methods for computer "viewing angles" in radiotherapy equipment

[0153] Figure 6 The flowchart of FIG. 1 depicts a method according to the present disclosure. The method is suitable for execution by, for example, the device controller 240 of the radiotherapy device 200, or by a combination of a dedicated mobile or portable device and the device controller 240 associated with a potentially authorized maintenance engineer.

[0154] At step S610, data identifying at least one potential maintenance engineer is received. The manner in which the data is received depends on the particular implementation. For example, engineer identification information may be received from an input device. In an example where the input device is a fingerprint scanner, the engineer identification information is collected by the fingerprint scanner and transmitted to the device controller 240.

[0155] At step S620, the engineer identification information and the device identification data are sent to the central processor for comparison with the authorization data. In some embodiments, the device is associated with a specific radiotherapy device, and this association is stored in the device memory 245, which means that it can be automatically provided to the central processor by the device controller 240. In other embodiments, the device identification data can be entered or provided by the potential maintenance engineer.

[0156] At step 630, an indication is received indicating whether the potential maintenance engineer is authorized to maintain or access the radiation therapy device. The indication may be received from the central processor 270 after determining whether at least one security criterion is satisfied at step 540. After receiving the indication that the engineer is authorized and the indication that access rights should be granted to the identified maintenance engineer, access rights and permissions are granted to the maintenance engineer based on the notification.

[0157] Simple Example

[0158] In accordance with Figure 5 and Figure 6 In a simple example of a flowchart of , an engineer enters a user name and password through a keyboard coupled to a computer associated with a specific radiotherapy device. The user name and password may be provided by the device manufacturer, or by a repair and maintenance company authorized to provide repair services under a maintenance contract.

[0159] The user name and password entered by the maintenance engineer are received on the device computer via the keyboard input device (step 610) and transmitted to the central server or computer (step 620). The device computer also transmits the unique ID associated with the radiotherapy device to the central server.

[0160] The server receives the username and password (step 510) and the unique ID (step 520), and determines whether the maintenance engineer is authorized to maintain the radiotherapy machine based on the information stored in the authorization database (steps 530 and 540). For example, the authorization database may indicate that the engineer has received appropriate courses and training, and is therefore certified to maintain and repair all radiotherapy equipment manufactured by the company that manufactures the identified radiotherapy equipment. Therefore, the central processor determines that the engineer is authorized to provide maintenance for the equipment (step 550), and transmits to the equipment controller that the engineer should be granted full access and permissions. The equipment controller receives the message or instruction from the central processor (step 630) and grants the engineer full access to maintain the radiotherapy equipment.

[0161] The disclosed method is advantageous for several reasons. Manufacturers and maintenance and repair providers of radiotherapy equipment can ensure that only authorized maintenance engineers can maintain the machines by controlling access rights. For example, by ensuring that only authorized maintenance engineers can adjust parameters related to the operation of the equipment, it can be ensured that the equipment is always operated in accordance with safety and regulatory requirements. The disclosed method also allows owners of radiotherapy equipment (e.g., hospitals), for example, by ensuring that they only employ properly certified and trained maintenance engineers to repair and maintain their radiotherapy equipment, to make more informed decisions about the maintenance of their machines.

[0162] Offline implementation

[0163] In another disclosed embodiment, each field maintenance engineer has their own portable processing device, such as a laptop, computer, mobile phone or tablet. A dedicated access control application is installed on the processing device. Communication between the portable processor and the device controller may mean that real-time communication with a central server or database is not necessary.

[0164] The access control application stores authorization data. The authorization data may include information related to the field maintenance engineer's access rights, such as the field maintenance engineer's right to log into the device controller associated with a specific radiotherapy device, and / or the field maintenance engineer's right to adjust and view specific data and functions related to the radiotherapy device. The authorization data may include any of the authorization data discussed above, such as data related to the materials downloaded to their portable devices by the field maintenance engineer, such as whether the field maintenance engineer has downloaded the latest manuals, knowledge articles, or software tools. As described above, the authorization data may include a qualification certificate granted to the engineer indicating that he / she has the skills to perform repair and maintenance work on a specific component.

[0165] The application can support offline workflows if there is no connection to the network at the radiotherapy equipment site. This may be the case when the hospital has strict policies or network access is unreliable, or when the radiotherapy equipment is installed in a military location. In addition, WiFi is often not available in the treatment room. It is also advantageous to use offline workflows as a safety backup, such as allowing field maintenance engineers to access equipment controllers and repair equipment when the network at a particular site is unreliable or otherwise not working.

[0166] Figure 5 The method may also be performed by a portable processing device associated with (e.g., owned by) a field maintenance engineer. In step 510, the portable processing device receives identification data identifying at least one potentially authorized maintenance engineer. This may be a username and password or other information as described above. Alternatively, the application may retrieve the engineer identification data from a local memory. The engineer identification data may refer to access credentials. The engineer identification information may also include the date and / or time when the access credentials were most recently authenticated by the central database.

[0167] At step 520, device identification information or data is received. The device identification data may be obtained by a device controller. In one example, a field maintenance engineer connects or couples a portable processing device to a device controller (e.g., via a LAN or Ethernet cable), and an access control application queries the device controller and receives information about the identity of the radiotherapy device.

[0168] At step 530, the received identification information is compared with the authorization data based on the authorization criteria in a simple manner similar to that described above. However, the authorization check is not performed by a central processor or server, but by a dedicated access control application, and the authorization data is stored in a local memory accessible by the access control application.

[0169] In some examples, the portable processing device first checks whether network access is available and, if so, sends the engineer identification data and the device identification data to the central processor for comparison with the authorization data, as described above with reference to Figure 6 As described in step 620 of the flowchart of FIG. If network access is not available, the process is performed locally, ie, the authorization data stored locally is consulted.

[0170] In some examples, the access control application periodically communicates with the central database to update the authorization data stored locally on the portable processing device. The portable processing device is associated with a particular field maintenance engineer, and therefore the authorization information related to the field maintenance engineer is downloaded and stored in a local memory accessible by the portable processing device. In one example, the portable processing device can perform regular (e.g., daily) "check-ins" at the central controller. Regular check-ins ensure that the locally stored authorization data is correct when compared to the authorization data stored in the central authorization database. If the centrally stored authorization data has been updated, the update is downloaded and stored locally on the field maintenance engineer's portable processing device.

[0171] In other embodiments, Figure 5 The method depicted in the embodiment includes an optional additional step of checking whether a time criterion associated with the locally stored authorization data is met. For example, if it is determined that the authorization data stored locally on the portable processing device has not been updated with the central database within a certain time period, then the field maintenance engineer is not granted access and the field maintenance engineer is not authorized to maintain the radiotherapy machine. The time period can be described as a time threshold, which can be, for example, a week or a specific number of days.

[0172] The above authorization check prevents previous field maintenance engineers from gaining access to the equipment controller when, for example, their employment has ended. The time threshold is used to ensure that people cannot try to circumvent the authorization check using a portable processing device with expired authorization data. The time period is also used to ensure that the field maintenance engineer has access to the latest and most up-to-date maintenance information. For example, if a new diagnostic test, new repair, or new safety information is available for a specific radiotherapy device or one of its components, the correct combination of authorization check and time period will ensure that the field maintenance engineer has read the relevant materials and updated their training accordingly. Moreover, unless the FSE regularly updates their knowledge and training, some training and qualifications obtained by the FSE are time-limited and may therefore become invalid. For example, if the qualification that the FSE is authorized to perform beam correction has expired, this will be updated in the central database. In an embodiment where the central database is consulted in real time when the correction is to be performed, the FSE will fail the authorization check in step 540 and will not be granted access, that is, the FSE will be deemed to be unauthorized to maintain the radiotherapy machine. If a real-time check cannot be performed due to the absence of a network, the authorization data stored in the portable processing device of the FSE will be consulted. Since the authorization data stored there is regularly updated with the central database, the locally stored authorization data will be up to date within a threshold defined by the threshold time period.

[0173] The access control application can have other uses. For example, the application can store and update a series of electronically published software and manuals. The application manages these electronic tools (software, manuals and knowledge articles) and ensures that these are up to date by synchronizing and communicating with the central processor.

[0174] In one example, if the field maintenance engineer has not downloaded the latest manual, knowledge article or software tool, the engineer can be prevented from accessing the machine or some of its functions. The application can also manage hardware tools of similar measuring devices that need regular correction. These tools can be identified by a readable bar code or QR code such as a mobile phone in a manner similar or identical to the above description of the radiotherapy equipment component identifier, such as by a component or hardware tool identifier. In short, the application stored on the notebook computer of the field maintenance engineer can have a database of available hardware and software tools, manuals and knowledge articles that the engineer should use when doing certain tasks. The database should also have a certificate of qualification granted to the engineer indicating that he / she already has the skills to do the work. If the FSE does not have the latest software or hardware tools, or does not have the relevant qualifications or training for the maintenance to be performed by the plan, they are not granted access to the equipment.

[0175] In an example of additional functionality, in an emergency situation where a laptop cannot connect to the authorized software for any reason, a time-expiring password may be granted by a dedicated help desk.

[0176] Two-factor authentication or multi-factor authentication

[0177] The present disclosure also includes elements of multi-factor authentication. This can be accomplished through a combination of multiple portable processing devices (e.g., a mobile phone and a laptop) associated with a particular FSE. In such an example, the FSE must present two factors (i.e., two pieces of evidence) before access is granted and they are authorized to maintain the radiotherapy equipment.

[0178] In the public example, refer to Figure 5 and Figure 6 , after entering identification information through an input device and / or his laptop, the field maintenance engineer is authorized in step 550. However, as part of a multi-factor authentication mechanism, the central processor may additionally send a message to the FSE's mobile device. The message may be an SMS or other text-based message, an instant message, or an email. The message provides "one-time" login details, which may include a username and a password. The one-time password expires after a certain amount of time. The one-time password must then be provided to the device controller before the FSE is granted access. In this way, multi-factor authentication is provided: the person requesting access to the device controller must provide a first factor (e.g., I have a laptop associated with an authorized FSE and / or I am able to provide identification information associated with an authorized FSE through an input device), and also provide a second factor (I have access to a mobile device associated with an authorized FSE).

[0179] Disclosed herein is a method for determining whether a maintenance engineer is authorized to repair or maintain a radiotherapy device, the radiotherapy device including a linear accelerator and configured to provide therapeutic radiation to a patient. The method includes: receiving data identifying at least one maintenance engineer; determining whether at least one authorization criterion is met based on the engineer identification data and the authorization data; and authorizing the maintenance engineer to repair or maintain the radiotherapy device if at least one authorization criterion is met. Authorizing the maintenance engineer to repair or maintain the radiotherapy device may include: providing login details that allow the maintenance engineer to access a device controller, the device controller being configured to store data about the operation of the radiotherapy device and being configured to control the operation of the radiotherapy device.

[0180] The methods described herein may be implemented on a computer-readable medium, which may be a non-transitory computer-readable medium. The computer-readable medium carries computer-readable instructions that are configured to be executed on a processor so that the processor performs any or all of the methods described herein.

[0181] The term "computer-readable medium" as used herein refers to any medium storing data and / or instructions for causing a processor to operate in a particular manner. Such storage media may include non-volatile media and volatile media. Non-volatile media may include, for example, optical disks or magnetic disks. Volatile media may include dynamic memory. Exemplary forms of storage media include floppy disks, flexible disks, hard disks, solid-state drives, tapes or any other magnetic data storage media, CD-ROMs, any other optical data storage media, any physical media with one or more hole patterns, RAM, PROM, EPROM, FLASH-EPROM, NVRAM, and any other storage chips or cassettes.

[0182] This article discloses the following numbered clauses:

[0183] 1. A method for determining whether a radiotherapy device should be authorized for use, wherein the radiotherapy device is configured to provide therapeutic radiation to a patient, the method comprising: receiving data identifying at least one component of the radiotherapy device; determining whether at least one authorization criterion is met by comparing the identification data and the authorization data; and determining that the radiotherapy device is authorized for use if at least one authorization criterion is met.

[0184] 2. A method for determining whether a radiotherapy device should be authorized for use, wherein the device is configured to provide therapeutic radiation to a patient, the method comprising: receiving data identifying at least one component of the radiotherapy device; sending the identification data to a central processor for comparison with authorization data; and receiving an indication indicating whether the radiotherapy device is authorized for use.

[0185] 3. A method according to clause 1 or clause 2, wherein the at least one component comprises at least one identifier configured to provide data identifying the at least one component.

[0186] 4. The method of clause 3, wherein the at least one identifier is one of a passive RFID tag, an active RFID tag, an optical marker, or a physical marker.

[0187] 5. A method according to any of the preceding clauses, wherein comparing the identification data and the authorization data comprises checking that at least one component identified in the identification data is listed in an authorization database as authorized for use with the radiotherapy device.

[0188] 6. A method according to any of the preceding clauses, wherein receiving data identifying at least one component of the radiotherapy device comprises: receiving identification information from each corresponding component of a plurality of components of the radiotherapy device.

[0189] 7. The method according to any of the preceding clauses further includes: if at least one authorization criterion is not met, determining that the radiotherapy equipment is not authorized for use.

[0190] 8. A method according to clause 7, wherein in response to determining that the radiotherapy device is not authorized for use, the method further includes at least one of the following: sending an indication to the device owner indicating that the device is not authorized, sending an indication to the device manufacturer indicating that the device is not authorized, and updating the authorization database to indicate that the device is not authorized for use.

[0191] 9. A system comprising a radiotherapy device configured to provide therapeutic radiation to a patient and a device processor having a device memory, the device processor being communicatively coupled to a central processing unit, the device processor having computer executable instructions which, when executed by the device processor, cause the device processor to perform the method described in any of the preceding clauses.

[0192] 10. The system of clause 9, further comprising an RFID tag interrogator.

[0193] 11. A method for determining whether a field maintenance engineer is authorized to repair and / or maintain radiotherapy equipment, the method comprising: receiving engineer identification data identifying at least one potentially authorized field maintenance engineer; receiving equipment identification data identifying at least one radiotherapy equipment; comparing the engineer identification data and the equipment identification data with the authorization data; determining whether authorization criteria are met based on the comparison; and determining that the potentially authorized field maintenance engineer is authorized to repair and / or maintain the radiotherapy equipment if at least one authorization criterion is met.

[0194] 12. A method for determining whether a field maintenance engineer is authorized to repair and / or maintain radiotherapy equipment, the method comprising: receiving engineer identification data identifying at least one potentially authorized field maintenance engineer; sending the engineer identification data and equipment identification data to a central processor for comparison with authorization data; and receiving an indication indicating whether the potentially authorized field maintenance engineer is authorized to repair and / or maintain radiotherapy equipment.

[0195] The above embodiments have been described by way of example only, and the described embodiments and arrangements are to be considered in all respects only as illustrative and not restrictive. It will be appreciated that the described embodiments and arrangements may be varied without departing from the scope of the present invention.

Claims

1. A method for determining whether a radiotherapy device should be authorized for use, the radiotherapy device being configured to provide therapeutic radiation to a patient, the radiotherapy device comprising a plurality of components, each of the plurality of components being coupled to at least one identifier, the at least one identifier being configured to provide data identifying the component coupled thereto, the method comprising: receiving data identifying each of the plurality of components of the radiation therapy device from the identifier; determining whether at least one authorization criterion is satisfied based on the identification data and the authorization data; as well as determining that the radiotherapy device is authorized for use if the at least one authorization criterion is met; wherein each identifier comprises a power supply and an active transmitter, the active transmitter being configured to repeatedly transmit data identifying a component, wherein the radiotherapy device comprises a receiver configured to receive a signal from the active transmitter, and the position of each of the plurality of components can be obtained from a data log based on the strength of the signal received at the receiver; wherein the authorization data includes an expected position of one or more of the plurality of components, and the authorization criteria includes a distance threshold, such that determining whether the at least one authorization criterion is satisfied includes: comparing the determined position of the component to the expected position of the component based on the distance threshold; Wherein, the method further comprises: maintaining a data log storing the received data identifying each of the plurality of components; determining a signal strength when receiving data identifying a component from an active transmitter; The signal strength is recorded in the data log along with the received identification data.

2. The method according to claim 1, wherein: The at least one identifier is one of a passive RFID tag, an active RFID tag, an optical marker, or a physical marker.

3. The method according to claim 1, wherein: Determining whether at least one authorization criterion is satisfied comprises checking that each component identified by the identification data is listed in an authorization database as authorized for use with the radiation therapy device.

4. The method according to claim 1, further comprising: If the at least one authorization criterion is not met, it is determined that the radiation therapy device is not authorized for use.

5. The method according to claim 4, wherein: In response to determining that the radiotherapy device is not authorized for use, the method also includes at least one of the following: sending an indication to the owner of the radiotherapy device indicating that the radiotherapy device is not authorized; sending an indication to the manufacturer of the radiotherapy device indicating that the radiotherapy device is not authorized; and updating the authorization database to indicate that the radiotherapy device is not authorized for use.

6. The method according to claim 1, wherein: The installation duration of each of the plurality of components can be obtained from the data log, the data log storing the received identification data and a timestamp indicating a date the data was received; Wherein, the authorization data includes the service life of one or more components among the multiple components, and the authorization standard includes an installation time threshold, so that determining whether at least one authorization standard is met includes: comparing the installation time with the service life based on the installation time threshold.

7. The method according to claim 6, further comprising: receiving data identifying the newly installed component of the radiation therapy device from an identifier coupled to the newly installed component; determining that the newly installed component is newly installed based on the received identification data and the data stored in the data log; determining whether at least one authorization criterion is satisfied based on the identification data and the authorization data received from the newly installed component; as well as If the at least one authorization criterion is met, it is determined that the radiation therapy device is authorized for use.

8. The method according to claim 1, wherein: The radiotherapy device comprises a plurality of receivers configured to receive signals from the active transmitter, and wherein the position of the component is determinable in at least two coordinate axes.

9. The method of claim 1, further comprising, in response to a user request, providing a last known location of one or more of the plurality of components.

10. The method according to any one of claims 1 to 9, further comprising: Connecting the power supply of each marker to the power supply of the device; subsequently determining whether a component of the plurality of components has been disconnected from a power source of the device; as well as Identification data continues to be received and the signal strength is recorded in the data log along with the received identification data.

11. A method of determining whether a radiotherapy device should be authorized for use, the radiotherapy device being configured to provide therapeutic radiation to a patient, the radiotherapy device comprising a plurality of components, each of the plurality of components being coupled to at least one identifier, the at least one identifier being configured to provide data identifying the component coupled thereto, the method comprising: receiving data identifying each of the plurality of components of the radiation therapy device from the identifier; sending the identification data to a central processor to determine whether at least one authorization criterion is satisfied based on the identification data and the authorization data; and receiving an indication indicating whether the radiotherapy device is authorized for use; wherein each identifier comprises a power supply and an active transmitter, the active transmitter being configured to repeatedly transmit data identifying a component, wherein the radiotherapy device comprises a receiver configured to receive a signal from the active transmitter, and the position of each of the plurality of components can be obtained from a data log based on the strength of the signal received at the receiver; wherein the authorization data includes an expected position of one or more of the plurality of components, and the authorization criteria include a distance threshold, such that determining whether at least one authorization criterion is satisfied includes comparing the received determined position of the identified component to the expected position of the identified component based on the distance threshold; Wherein, the method further comprises: maintaining a data log storing the received data identifying each of the plurality of components; determining a signal strength when receiving data identifying a component from an active transmitter; The signal strength is recorded in the data log along with the received identification data.

12. The method according to claim 11, wherein: The at least one identifier is one of a passive RFID tag, an active RFID tag, an optical marker, or a physical marker.

13. The method according to claim 11, wherein: Determining whether at least one authorization criterion is satisfied comprises checking that each component identified by the identification data is listed in an authorization database as authorized for use with the radiation therapy device.

14. The method according to any one of claims 11 to 13, further comprising: If the at least one authorization criterion is not met, it is determined that the radiation therapy device is not authorized for use.

15. The method according to claim 14, wherein: In response to determining that the radiotherapy device is not authorized for use, the method also includes at least one of the following: sending an indication to the owner of the radiotherapy device indicating that the radiotherapy device is not authorized; sending an indication to the manufacturer of the radiotherapy device indicating that the radiotherapy device is not authorized; and updating the authorization database to indicate that the radiotherapy device is not authorized for use.

16. A radiotherapy apparatus configured to provide therapeutic radiation to a patient, the radiotherapy apparatus comprising: a plurality of components, each of the plurality of components being coupled to at least one identifier, the at least one identifier being configured to provide data identifying the component coupled thereto; and A device processor coupled to a device memory, the device memory storing computer executable instructions which, when executed by the device processor, cause the device processor to implement the method of any one of the preceding claims 1 to 15.

17. The device of claim 16, further comprising at least one receiver.

18. The apparatus according to claim 17, wherein: The receiver is an RFID tag interrogator.

19. A computer-readable medium comprising computer-executable instructions, which, when executed by a processor, cause the processor to implement the method of any one of claims 1 to 15.

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